Device Modification Analysis Summary
Contents
1. Specifications of Ruby Classification Customer Requirement Specification amp Other Requirements Design Input CRS No Requirements Design Input No Items Product Specifications See main text for details Req Ruby 11 08 J AM 1 0 Req Ruby 12 Req Ruby 12 01 45 50dB2. M Uty PC Ut y Req Ruby 11 05 4 7 Job P DA Req Ruby 11 06 DRYPIX7000 Req Ruby 11 07
3. K12N0097A Req Ruby 17 02 Z1280039 21280042 45 21280057 Z12S0071 SE 5 Req Ruby 18 Req Ruby 18 01 Req Ruby 18 02 de Req Ruby 19 Req Ruby 19 01 1 3 Req Ruby 20 Req Ruby 20 01 DRYPIX7000 Specifications of Ruby Classification Customer Requirement Specification amp Other Requirements Design Input CRS No Requirements Design Input No Items Product Specifications See main text for details 4 Req Ruby 21 Req Ruby 22 7500 3 Req Ruby 21 01 Req Ruby 22 01 K14N0234 7500 3 FIT FC Req Ruby 23 Req Ruby 22 02 7500 3 PC
4. L AN L AN 18 Req Ruby 25 Req Ruby 26 Req Ruby 25 01 K14N0231 LCA 14N0233 L CA DRYPIX7000 2 0 2 1 Req Ruby 28 3 Req Ruby 27 ELT Soe eG SS K14N0235B EE E Ruby Specifications Ruby Specifications Supplement Design amp Architecture LI External View Panel Sorter Optional attached DPX7000 Supplement Ruby Specifications Architectural Comparison between Ruby and D
5. 3GB 6 GB 4 Req Ruby 11 DRYPIX Req Ruby 11 01 DRYPIX7000 3 7000 1 5 0 3 0 Req Ruby 11 02 DRYPIX7000 Req Ruby 11 03 ON OFF On Off On Wake On LAN Off Req Ruby 11 04 15 MDD 12
6. Req Ruby 15 01 JIS T0601 1 1999 EMC JIS T0601 1 2 2002 Req Ruby 15 02 FDA IEC60601 1 1988 Am1 Am2 Medical Device 21CFR Part EMC IEC60601 1 2 2001 807 Req Ruby 15 03 IERT HHS TEC60825 1 2001 Light emitting ProductsLaser notice 50 Req Ruby 15 04 Req Ruby 15 05 MDD 93 42 EEC Medical Device Directive MDR Medical Device Regulations EN60601 1 1990 Am1 Am2 Am13 EN60825 1 2001 EMC EN60601 1 2 2001 IEC60601 1 1988 Am1 Am2 EMC IEC60601 1 2 2001 Req Ruby 15 06 7 Acquisition of Req Ruby 16 To obtain a license for certification conducted by a Req Ruby 16 01 JUL UL60601 1 2003 license for certification body who gives written assurance that a certification medical device process or service conforms to the specified requirements prescribed in the relevant medical device standards Req Ruby 16 02 IT UV EN60601 1 1990 Am1 Am2 Am13 8 GEVEIOE 9 E MI GEV 1 0 Req Ruby 17 Req Ruby 17 01
7. Req Ruby 23 01 Req Ruby 23 02 K12N0097A No 03 03 02 K12N0097A No 03 02 03 K12N0097A No 03 03 04 800mm 20mm 50mm 200mm bal SEH E 20mm Req Ruby 24 02 PC USB Req Ruby 24 03 Req Ruby 24 04 Req Ruby 24 05 PC Log Req Ruby 24 06
8. 40 45dB Req Ruby 12 02 25ppm 2ppm 10ppm 0 1ppm 0 5ppm 5 4Req Ruby 13 Req Ruby 13 01 Req Ruby 13 02 Ee Req Ruby 13 03 Req Ruby 13 04 Req Ruby 13 05 UL T UV Req Ruby 13 06 Req Ruby 13 07 DICOM Conformance Statement DICOM Req Ruby 14 Req Ruby 14 01 Req Ruby 14 02 10 C 50 C WE 10 90 RH BRECE 500 1060hPa 6 Req Ruby 15
9. CRS No Requirements Design Input No Items Product Specifications See main text for details 3 Requirements Req Ruby 07 02 Starting time Cold Start 10 to 15 min at 25 C 12 min is a target value in design Hot Start 3 to 5 min Energy efficient power down mode Energy efficient sleep mode 7 to 10 min 10 to 15 min Req Ruby 08 Films e g DI HL DI HLc used for the conventional DRYPIX7000 is applicable to this System Req Ruby 08 01 Types of films DI HL and DI HLc are used Service personnel sets a film type blue or clear when this System is installed Bar code reader of the film loading unit identifies the film type lot and the like from the bar code label when films are set to the unit same as DRYPIX7000 Bar code information is printed in any remaining areas other than the effective image recordable area of a film Req Ruby 09 Any films among 14 x17 film 14 x14 film 10 x14 film 10 x12 film and 8 x10 film is selectable Req Ruby 10 Connectability to FCR is comparable to DRYPIX7000 Req Ruby 09 01 Req Ruby 10 01 Sizes of films Connectable devices 14 x 17 100 sheets per box 14 x 14 100 sheets per box 10 x 14 150 sheets per box per box 10 x 12 150 sheets per box Films specified in size via modality are printed out Function that a film size is changeable according to each AE title is equipped available fil
10. Floor vibration condition Complying with Fuji s Medical Device Quality Standards K12N0097A Floor levelness 10 mm m in all directions 1 100 or less of gradient Floor flatness 10mm or less Req Ruby 03 08 Ventilation condition Ventilation in an area where the system is placed 54m h or less per system Equal to or lower than that of DRYPIX7000 Req Ruby 03 09 IAntimagnetic field The system normally operates at DC 100 Gauss without any problem Req Ruby 04 01 Vibration condition when loading Random vibration 5 to 500Hz X Y and Z axis 24 hours each Totally 72 hours 300000 km assumed it on the mobile When moving Acceleration 1G Req Rub 4 02 Vibration condition when loading References for Operating Vibration amp Shock of the Medical Device Quality Standards K12N0097A it on the mobile When operating Specifications of Ruby Classification Customer Requirement Specification amp Other Requirements Design Input CRS No Requirements Design Input No Items Product Specifications See main text for details Req Ruby 04 03 Environmental condition temperature amp humidity when loading it on the mobile The system normally operates under the conditions specified in Section Req Ruby 03 05 It is assured that the system can normally operate after reaching the above environmental conditions by rising temperature levels starting from 10 C in a Mammograp
11. m FUJIFILM Fuji Medical Systems USA Ilgl Imaging amp Information Device Modification Analysis Summary Ref no DMA 2004 09 Part I Product Information Description of Change Product DRYPIX 4000 Medical Dry Laser Imager Predicate Device Name amp 510 k DRYPIX 7000 5000 Medical Dry Laser Imagers K033377 Description of Change The DRYPIX 4000 represents a modification of the above cleared device The DRYPIX 4000 uses the same laser exposure technology thermal development technology film conveyance layout and imaging film as the DRYPIX 7000 5000 It also has the same indications for use as the DRYPIX 7000 5000 including the printing of digital mammography images FFDM It differs in component layout more accessibility for released and jammed films and it is also designed to withstand vibration and shocks in a mobile environment Other similarities and differences are documented in the attached SE Feature Comparison table Part II Device Modification Analysis Checklist 1 Could the change or modification significantly affect the safety or effectiveness of the subject device No 2 Is there a significant change to the design material chemical composition energy or manufacturing process No 3 Is there a significant change to the intended use of the subject device No 4 Is there a significant change to the labeling i e Warnings additional claims which may affect the safety or effectiveness of the device No Par
12. DRYPIX7000 is equipped The test patterns comparable with the conventional DRYPIX7000 can be output Req Ruby 01 03 Req Ruby 01 04 Printing function of annotation Annotation strings can be printed out on the upper portion and lower portion of a film Normal character size 40 pixels for standard twice strings three times and four times each that of normal character size can be set The annotation strings can be indicated in accordance with DICOM Annotation BOX SOP Class or by setting configuration via PC utilities Alphanumeric Japanese and Chinese characters can be indicated as readable strings Conversion function of macro characters reception date of printing sender s IP address identifier optional string corresponding to IP address and AE title is employed This system can translate to print out such annotation strings of image format in accordance with DICOM Annotation BOX SOP Class Test patterns printing function The 24 steps densitometry pattern 17 steps densitometry pattern QC test pattern and SMPTE test pattern can be output to control the density The flat test pattern can be output to check the nonuniformity The sharpness and the double density sharpness test patterns can be output to measure the sharpness The lattice test pattern can be output to adjust the format The uniformity test pattern can be output to adjust the uniformity Sufficient security system functions Req Ruby 01 05 Security measures Th
13. control panel When a tray of the main unit fails films will be output to the uppermost sorter bin Req Ruby 02 05 Sorter fitting position Fit a sorter to the film release unit 2 Performance Requirements Req Ruby 03 This System reduces restraints on installation by applying 100V power source the space saving function and the like more easily in comparison with DRYPIX7000 Req Ruby 04 This System can be installed in a Mammography Screening Mobile When an optional component is mounted Req Ruby 03 01 Req Ruby 03 02 Size of Unit Main unit only W 600xD 550xH1000 to W 630xD 600xH1100 Main unit with sorter W 600xD 550xH1300 to W 630xD 600xH1400 Width and depth of the floor dimension don t include a locally protruding area Weight Main unit only 130 to 150Kg Main unit with sorter 135 to 180Kg Req Ruby 03 03 Req Ruby 03 04 Power supply voltage IAC100 to 120V 10 12A or less IAC200 to 240V 10 7A or less Voltage source capacity 1 2kVA or less Req Ruby 03 05 Req Ruby 03 06 Environmental working condition Temperature 15 C to 30 C operating Humidity 15 to 70 RH No dew condensation Atmospheric pressure 700 to 1060hPa Environmental working condition Temperature 0 C to 45 C Avoid freezing non operating Humidity 10 to 90 RH No dew condensation Atmospheric pressure 500 to 1060hPa Req Ruby 03 07 Floor installation surface
14. 0 1 Change in Regulatory Action Determination sterilization resp Performance wes A DRYPIX 4000 Medical Dry Laser Imager Specification or I SAL No Note Bolded solid lines represent the selected path for this evaluation C Submit 2 Document analysis No K and file Specifications of Ruby Customer Requirement Specification amp Other Requirements Design Input Product Specifications See main text for details Classification CRS No Requirements Design Input No 1 Functional Req Ruby 01 Number of trays for film supply is increased after installing Req Ruby 01 01 Number of trays for film supply Two trays are available The upper tier tray is normally equipped The lower tier tray is optional Future addition is available on the market Requirements the main unit and two different size trays can be used simultaneously A pack of films can be accumulated on the specified loading part Req Ruby 01 02 Any size of films can be selected according to each tray Size of tray is set by the qualified service personnel as Service Setting Number of accumulable films on Up to 150 sheets of films can be accumulated to store them the specified loading part Printing function of annotation strings comparable with the conventional
15. Direct modulation Direct modulation D se Thermal dry developer Thermal dry developer Thermal dry developer Throughput 115 films hr 14 x17 180 films hr 14 x17 130 films hr 14 x17 170 films hr 10 x14 240 films hr 10 x14 180 films hr 10 x14 200 films hr 8 x10 180 films hr 8 x10 Film type Fuji dry imaging film DI HL bluelFuji dry imaging film DI HL blue Fuji dry imaging film DI HL blue Film size 14 x17 14 x14 10x14 14x17 10x14 8 x10 14x17 10x14 8 x10 10 x12 8 x10 Film holding capacity 150 sheets 150 sheets 100 sheets 100 sheets 100 sheets 100 sheets 2 film tray optional 2 3 film trays optional 2 3 film trays optional Daylight loading no magazine Yes optional Sampling raster 100 um x 100 um 100 um x 100 um 100 um x 100 um 50 um x 50 um 50 um x 50 um 50 um x 50 um 10 pixels mm 10 pixels mm 10 pixels mm sampling 20 pixels mm 50 um mode 20 pixels mm 50 um mode 20 pixels mm 50 um mode pixels 5080 x 7200 50 i E mode 5080 x 7200 50 um mode 5080 x 7200 50 um mode 80see 65 sec 14 bits 3 0 to 3 6 configurable Yes Auto Gradation curve variability 8 independent types selectable 8 independent types selectable 8 independent types selectable Yes Yes Format 1 2 3 4 6 8 9 12 15 16 20 11 2 3 4 6 8 9 12 15 16 20 11 2 3 4 6 8 9 12 15 16 20 i 24 or mixed 4 25 30 35 24 or mix
16. RYPIX 7000 e The recording synchronous heat development system is employed with the specified conveyance layout in a same manner as DRYPIX 7000 e Up to two 2 trays can be mounted for future additions e Released films can be accessed from all directions from three directions except the right hand side when a sorter is attached e Jammed films are removed from the front top or right side face e Control boards and power supply system shall be placed collectively to the lower part of this System e Optional sorter can be attached to the upper part of this System e Combination of adding parts and mounting a vibration proof platform can give to harmonize with the required conditions when loading this System on a mobile Indication for Use Ruby is indicated for use in providing diagnostic quality medical images on film for aid in physician diagnosis including the printing of images and associated identification information from various digital imaging source modalities including but not limited to Computed Tomography CT Magnetic Resonance Imaging MRI Ultrasound Computed Rdiography Digital Radiography Digital Mammography and Nuclear Medicine Supplement B n FUJIFILM Fuji Medical Systems USA Isl Imaging amp Information Substantial Equivalence SE Feature Comparison DRYPIX 4000 to DRYPIX 7000 amp DRYPIX 5000 Fuji DRYPIX 5000 Light source modulation Laser diode Laser diode Laser diode Direct modulation
17. ding Twice as many as the number of pixels described above on both main and sub scanning CR images are recorded at the maximum number of recording pixel Any images other than CR images defines a recording area at a same size in a manner as a printing area of annotation strings is subtracted from the max number of recording pixels to format cimm 2 5 5 0 Main Direction 94 or more 75 or more Sub direction 94 or more 75 or more Req Ruby 05 06 IDensity dispersion within a film Req Ruby 05 07 INonuniformity Flaw R AD lt 0 1 at OD 1 2 Any nonuniformity or flaws does not affect the diagnosis Any problems on image quality does not arise The limit samples for nonuniformity is specified according to a nonuniformity type Size of Point defect Under 0 2mm Specifications 5 or less 10 10cm 2 or less 1 1cm 0 2mm or more None Dimensional accuracy of image Dimensional accuracy of overall width 0 0 5 a Req Ruby 05 10 Curl after development 040 6 Dimensional accuracy of each part Keep a film curl level within 20mm or less from the surface of radiographic film illuminator Req Ruby 05 11 IAccuracy of density correction Req Ruby 05 12 IDensity change due to development Density correction within the following accuracy is available Gradient end characteristic FogsOD lt 0 3 same as FL IM D AD 0 05 or less 0 3sOD lt 2 0 AD 0 07 or le
18. e Operating System can be updated as Service function A anti virus software can be installed as Service function The pattern file of the anti virus software can be updated by users Images stored in HDD e g to reprint images and to copy any image data to the other media can be printed out only when the registered user gives the authentication Req Ruby 02 Sorter attaching not less than 3 bins can be mounted for future additions Req Ruby 02 01 Number of sorter bins Three bin sorter unit is available to set as an optional for future addition Totally four bin sorting together with a tray equipped with the main unit can be allowed The numbering of the bins with the configuration setting via PC utilities is allowed in an up to down order and vice versa Req Ruby 02 02 Number of films accumulable on Up to 30 sheets of films can be accumulated each sorter bin Bins should be made of suitable materials to avoid scratching the film surface when films are taken out of such bin Req Ruby 02 03 Types of Sorting The following sorting types are available To output films to the desired bin by designating the bin number complying with DICOM to output films to such bin specified by each AE title via configuration setting and to output films to such bin by specifying each film size via configuration setting Req Ruby 02 04 When a sorter fails When a sorter fails the user will remove it to release films to a tray of the main unit via the
19. ed 4 25 30 35 36 42 48 49 54 56 60 63 64 36 42 48 49 54 56 60 63 64 36 42 48 49 54 56 60 63 64 Yes ize w x d x h 735mm x 680mm x 1240mm 203 kg 448 Ibs Power 100 120 Vac 12A 50 60Hz 200 220 230 240 Vac 100 110 120 Vac 12A 200 to 240 Vac 7A 50 60Hz 11 10 9 5 9A 50 60Hz 50 60Hz
20. hy screening mobile Req Ruby 04 04 Start up time Req Ruby 05 The specific level of image quality and stability comparable with or more than DRYPIX7000 DI HL system is kept Req Ruby 05 01 From 15 min When starting up at 15 30 C to 90 min When starting up at 10 C 14 bits Req Ruby 05 02 IMaximum density Dmax Req Ruby 05 03 Size of recording pixel Req Ruby 05 04 IMaximum number of pixels for Req Ruby 05 05 ICTF In combination with FCR PROFECT CS this System is applicable to mammography screening Maximum density can be adjusted by designating a level under DICOM or by setting configuration using a density correction table as follows When Dmax3s3 0 the Dmax3 0 table is used when 3 0 lt Damx 3 3 the Dmax3 3 table is used and when 3 3 lt Damx 3 6 the Dmax3 6 table is used 100um 0 5 standard 50um 0 5 optional 14 x17 films and 14 x14 films also can be recorded at 50um The system can carry out 100um recording in STANDARD mode and 50ym recording in FINE mode STANDARD and FINE are DICOM Requested Resolution IDs The system having two AE titles for 100um amp 50m recording above as DICOM PrintSCP can carry out recording in compliance with the designated AE title In case of 100um recording 14 x17 film 3520x4280 14 x14 film 3520x3520 10 x14 film 3600x2540 8 x10 film 2000x2510 10 x12 film 3016x2506 In case of 50um recor
21. in material ee Change type y 45 5 No C2 1 1 perating Principle v y Will the material of Change YES 3 C3 A C2 2 the implant be Change in material Is device an 4 Yes Yes likely to contact No formulation implant 2 body tissues or fluids Energy Type Yes A Change No No No A Ne C4 i wl C2 2 7 Change Poi Will the material of C2 1 2 Change in device Environmental Yes ER Els the device be performance Specifications likely to contact specifications Yes body tissues or d No fluids in vivo Yes i No Performance C4 1 Material ordered d Specifications Yes toa No Go to Technology or j specification y Performance Change al No d C2 3 Change in device H formance is Ergonomics of B8 1 indicat poriorma Yes Document analysis patient user Yes EE Yes specifications k and file Ben interface i Submit I N E Yes No No Yes C2 2 1 Considerin Dimensional gem YES Are clinical data No are ee Ga requirements of Specifications B8 2 meceasany io Performance Change ISO 10993 1 is No evaluate S amp E for Yes 9 No additonal Se y purposes of required Software or Substantial equiv No Firmware Yes Change Document analysis and file No i D No d ZE Document analysis oN Submit X j d and file Ei KN of Change LY es B8 3 Do results of packaging design validation NO m i H Yes raise new issues No of S amp E v Change in B1
22. ms larger than the originally designated ones first and then in reducing order The System is connected to a variety of diagnostic imaging systems corresponding to DICOM Printing 8 x 10 150 sheets If a film size is changeable the System will print the related to A diagnostic imaging system of non correspondent to any networks can be connected via DrypixLink A diagnostic imaging system Interface corresponding to E DMS Toshiba Protocol is connected via FN PS551 DrypixLink Req Ruby 10 02 Corresponding DICOM service Images for medical use are printed out corresponding to the following DICOM Print SOP Classes Verification SOP Class Basic Gray Scale Print Management Meta SOP Class Print Job SOP Class Basic Annotation SOP Class Queue Management SOP Class User Preference LUT SOP Class See DICOM Conformance Statement for more detailed specifications in each Service Class Req Ruby 10 03 INumber of Associations 1 10 Variable corresponding to configuration setting connected to simultaneously Req Ruby 10 04 1 32 Req Ruby 10 05 8800Rows x 8800 Columns Req Ruby 10 06 HDD
23. ss 2 0sOD lt 2 7 AD 0 10 or less 2 7sOD lt 3 0 AD 0 20 or less 3 0sODs3 6 AD 0 05 at OD 1 2 Req Ruby 05 13 IExposure temperature A humidity dependency Req Ruby 05 14 IAccuracy of built in densitometer 15 i AD 0 05 at OD 1 2 Built in densitometer with calibration function is equipped AD 0 02 or less FogsOD lt 3 0 AD 0 05 or less 3 0sODs3 6 Req Ruby 05 16 Interpolated scaling processing Configuration is set to change SSM processing to A VR processing and vice versa according to each AE title Req Ruby 05 Gradation processing Configuration is set to change BAR processing to SAR processing and vice versa according to each AE title Req Ruby 06 IApprox 80 to 100 sheets of 14 x 17 films can be processed Req per hour y Throughput Req Ruby 07 Convenient maneuverability like a short starting time is inherited from DRYPIX7000 Req Ruby 07 01 Initial output time of film 30 types of standard image formats 1 to 80 frames and 10 types of mixed image formats are output Details on the formats are stipulated in DICOM Conformance Statement 14 x17 film 100 to 115 sheets h 10 x14 film 150 to 170 sheets h 75 to 85 seconds Films are released at high speed of 100mm s or more same as DRYPIX7000 Specifications of Ruby Classification Customer Requirement Specification amp Other Requirements Design Input
24. t III Attached Documentation Please list below and attach any documentation used to support this Device Modification Analysis 1 Regulatory Action Determination Flowchart for DRYPIX 4000 2 Ruby DryPix 4000 Specifications dated 8 24 2004 3 Ruby DryPix 4000 Specifications Supplement dated 8 24 2004 4 Substantial Equivalence SE Feature Comparison Table Page 1 of 2 m FUJIFILM Fuji Medical Systems USA lgl Imaging Information Ref no DMA 2004 09 PLEASE CHECK ONE _X_ The above information has been reviewed and it has been judged that Fuji has no pre market obligations to the FDA for the subject device and marketing of the device may begin immediately subject to the general controls imposed by FDA for such a device A more detailed narrative for this decision shall be documented either in the comment section below or in attached documentation such as a memo letter etc It has been determined that a pre market obligation exists therefore a 510 k pre market notification shall be filed by FMSU and cleared by FDA prior to marketing of such a device A more detailed narrative for this decision shall be documented either in the comment section below or in attached documentation such as a memo letter etc Comments The DRYPIX 4000 is considered a modification of the previously cleared DRYPIX 7000 5000 Dry Laser Imagers The modification consists of technology and or performance changes Based on this eval
25. uation it appears that these changes 1 do not affect indications for use 2 do not require clinical data to evaluate safety and effectiveness and 3 do not raise new issues of safety and effectiveness Therefore it is my conclusion that the DRYPIX 4000 does not change indications for use nor does it significantly affect any safety or effectiveness issues than what is already identified in the premarket notification for predicate devices DRYPIX 7000 5000 Therefore I have reached a conclusion that the DRYPIX 4000 represents a modification that does not require a 510 k submittal QARA SIGNATURE ee t November 15 2004 Frank Gianelli Date Regulatory Coordinator Page 2 of 2 ls the change due to Recall Submit if the changes involve Safety and Efficacy Al Labeling Change Yes Does change and file Document analysis affect indications Yes for use No e Change in warnings or precautions No CS E Yes 9 contraindication No Ag Delete a E TEEN contraindication No A5 ls the labeling being revised for clarity to insure L No a safer or more effective use Yes y Submit D d J B1 B2 B3 B4 B5 B6 B7 B8 B9 B10 Materials Yes Control C2 y Mechanism Yes Change
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