I5 DIGITAL X-RAY IMAGING SYSTEM (WITH SDX-4336CP)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the word "INFIMED" in bold, sans-serif font. To the left of the word is a logo that appears to be a square with a curved arrow pointing towards it. The logo and the word are both in black and white. The image is simple and clear. # KII2180 ## Section 3: 510(k) Summary AUG 1 0 2011 Date Prepared: August 4, 2011 Contact Person: Catherine Mulcahy Quality Assurance Manager Telephone: Fax: 315-453-4545 x288 315-453-4550 Submitter Name: InfiMed, Inc. 121 Metropolitan Drive Liverpool, NY 13088 Device Trade Name: 15m Digital X-ray Imaging System (with SDX-4336CP) Common Name: Digital X-ray Imaging System Classification Name(s): i3m Digital X-ray Imaging System (with SDX-4336CP) Product Codes: OWB, JAA, 121 Predicate Device: iPTM Digital X-ray Imaging System 510(k) Number: K093066 Product Codes: MQB, JAA #### Device Description: The InfiMed i*™ Digital X-ray Imaging System is a high resolution digital imaging system designed for digital X-ray imaging through the use of an X-ray detector. The InfiMed i-TM Digital X-ray Imaging System is designed to support general radiography (excluding mammography), fluoroscopy, interventional fluoroscopy or angiography imaging procedures through a single common imaging platform. The modified InfiMed i'm Digital X-ray Imaging System consists of an X-ray imaging receptor (any of the following: CCD Camera, Trixell Pixium 3543, Trixell Pixium 4600, Varian PaxScan 4336R, Varian PaxScan 4343R, Carestream Health Detector, Samsung LTX240AA01-A, Toshiba FDX 4343R, DRTECH FLAATZ 560, Samsung SDX-4336CP), computer, monitor, and the digital imaging system. #### Intended Use: The InfiMed i TM Digital X-ray Imaging System is a high resolution digital imaging system intended to replace conventional film techniques, or existing digital systems, in multipurpose or dedicated applications specified below. The 15th Digital X-ray Imaging System enables an operator to acquire, display, process, export images to portable media, send images over a network for long term storage and distribute hardcopy images with a > 121 Metropolitan Park Drive, Liverpool, New York 13088 Main Document - Page 10 of 32 {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the word "INFIMED" in bold, sans-serif font. To the left of the word is a logo that appears to be a stylized diamond shape with a curved line extending from the top. The logo and the word are both in black. laser printer. Image processing algorithms enable the operator to bring out diagnostic details difficult to see using conventional imaging techniques. Images can basitored locally for temporary storage. The if TM Digital X-ray Imaging System has the ability to interface with a variety of image receptors from CCD cameras to commercially wonly bole flat panel detectors. The major system components include an image receptor, commuter, monitor and imaging software. For the DR application, the InfiMed if TM Digital X-ray Imaging System is intended for use in goneral radiographic examinations and applications (excluding fluornsony, angiography, and mammography). For the RF/DSA application, the InfiMcd if TM Digital X-ray Imaging System is intended for use where general fluoroscopy, interventional fluoroscopy or anglography imaging procedures are performed. ## Technological Characteristics Comparison: The modified device supports the same modalities as the predicate device with the same components or imaging concepts, and delivers equivalent or better image quality us the predicate device. The companson chart reveals that functions performed by the predicate device are performed by the modified i " Digital X-ray Imaging System. The modified device, ifsh Digital X-ray Imaging System (with SDX-4336CP), has the ability to interface with an additional image receptor, Samsung SDX-4336CP. Therefore, the modified device is substantially equivalent to the predicate device. ## Non-clinical Tosts Discussion: Validation was completed in accordance with the Validation Protocols included with this submission. Protocols were designed, executed and documented according to the Design Validation process with predetermined test methods and corresponding acceptance criteria. In conclusion, all release criteria have been met and the modified if TM Digital Xray Imaging System is as safe and effective as the predicate dovice. #### Clinical Tests Discussion: Clinical Data submitted is consistent with FDA guidance document "Guidance for Industry and/or for PDA Reviewers/Staff and/or Compliance: Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices" available at the website http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandCuidance/Guidanc eDocuments/ucm073781.pdf. #### Conclusion: Based upon the results of Verification and Validation testing, the InfiMed i TM Digital Xray Imaging System (with SDX-4336CP) has no new indications for use, has no > 121 Metropolitan Park Drive, Liverpool, New York 13088 Main Document - Page 11 of 32 {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the word "INFIMED" in bold, sans-serif font. To the left of the word is a logo that appears to be a stylized diamond shape with a curved line extending from the top. The logo and the word are both in black, contrasting with the white background. significant technological differences, and is as safe and effective as, and therefore substantially equivalent to the above listed current legally marketed predicated device. 121 Metropolitan Park Drive, Liverpool, New York 13088 {3}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002 JUL 30 2012 Ms. Catherine Mulcahy Quality Assurance Manager InfiMed. Inc. 121 Metropolitan Drive LIVERPOOL NY 13088 Re: K112180 Trade/Device Name: i5TM Digital X-ray Imaging System (with SDX-4336CP) Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, JAA and IZI Dated: July 27, 2011 Received: July 28, 2011 Dear Ms. Mulcahy: This letter corrects our substantially equivalent letter of August 10, 2011. We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of {4}------------------------------------------------ medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely Yours, Janine M. Morris Janine M. Morr Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "INFIMED" in bold, black letters. To the left of the word is a logo that appears to be a stylized diamond shape with a curved line above it. The logo and the text are the main focus of the image. ## Section 2: Indications for Use 510(k) Number (if known): K112180 Device Name: i*m Digital X-ray Imaging System (with SDX-4336CP) Indications for Use: The InfiMed if TM Digital X-ray Imaging System is a high resolution digital imaging system intended to replace conventional film techniques, or existion digital systems, in multipurpose or dedicated applications specified below. The iSm Digital X-78V Imaging System cnables an operator to acquire, display, process, export images to portable media, send images over a network for long term storage and distribute hardcopy images with a laser printer. Image processing algorithms enable the operator to bring out diagos vice details difficult to see using conventional imaging techniques. Images can be stored locally for temporary storage. The ism Digital X-ray Imaging System has the ability to interface with a variety of image receptors from CCD cameras to commercially wailable flat panel detectors. The major system components include an image receptor, computer, monitor and imaging software For the DR application, the InfiMed i *** Digital X-ray Imaging System is intended for use in general radiographic examinations and applications (excluding fluorosopy, angiography, and mammography). For the RF/DSA application, the InfiMed if TM Digital X-ray Imaging System is intended for use where general fluoroscopy, interventional fluoroscopy or anglography imaging procedures are performed. Prescription Use (Part 2) CPR 801 Subpart D) · AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) nourrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Mary S. Patel Division Sign-Off Division Sign Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K112180 121 Metropolitan Park Drive, Liverpool, New York 13088 Main Document - Page 9 of 32