(22 days)
Not Found
No
The document mentions "Image processing algorithms" but does not use terms like AI, ML, deep learning, or neural networks, nor does it describe characteristics typically associated with AI/ML models such as training data, test data, or performance metrics like AUC or sensitivity/specificity in the context of an AI/ML output. The validation focuses on equivalence to a predicate device and adherence to existing guidance for solid-state X-ray imaging devices.
No
The device is an imaging system used for diagnosis, not for treating a condition.
Yes
The device is described as "enabling an operator to acquire, display, process, export images... Image processing algorithms enable the operator to bring out diagnostic details difficult to see using conventional imaging techniques," clearly indicating its role in generating and processing images for diagnostic interpretation.
No
The device description explicitly lists hardware components such as an X-ray imaging receptor (various types), computer, and monitor, in addition to the imaging software. This indicates it is a system with both hardware and software, not a software-only device.
Based on the provided text, the InfiMed i5m Digital X-ray Imaging System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The InfiMed i5m Digital X-ray Imaging System is described as a digital X-ray imaging system that replaces conventional film techniques or existing digital systems. It acquires, displays, processes, and manages digital X-ray images.
- Intended Use: The intended use is for general radiographic examinations and applications, including fluoroscopy, interventional fluoroscopy, and angiography. These are all imaging procedures performed directly on the patient, not on specimens taken from the patient.
- Device Components: The components listed (image receptor, computer, monitor, imaging software) are consistent with an in-vivo imaging system, not an in-vitro diagnostic device.
The device is clearly designed for in-vivo imaging, meaning it is used to image the inside of the living body. This is distinct from the purpose of an IVD.
N/A
Intended Use / Indications for Use
The InfiMed iSTM 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 i5m 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 laser printer. Image processing algorithms enable the operator to bring out diagnostic details difficult to see using conventional imaging techniques. Images can be stored locally for temporary storage. The i2m Digital X-ray Imaging System has the ability to interface with a variety of image receptors from CCD cameras to commercially available flat panel detectors. The major system components include an image receptor, computer, monitor and imaging software.
For the DR application, the InfiMed i-714 Digital X-ray Imaging System is intended for use in general radiographic examinations and applications (excluding fluoroscopy, 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 angiography imaging procedures are performed.
Product codes (comma separated list FDA assigned to the subject device)
JAA, MQB, OWB
Device Description
The InfiMed i m 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-1 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 platforms.
The modified InfiMed if me 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), computer, monitor, and the digital i maging system. The InfiStitch for i-m Digital X-ray Imaging System is an option which allows the operator to generate sequential radiographic images and electronically jointhum to create a single electronic image. This feature will be available for any InfiMed customer utilizing the i-The Digital X-ray Imaging System DR application on any flat parel detector.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Tests 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 i-m Digital Xray Imaging System is as safe and effective as the predicate device.
Clinical Tests Discussion:
Clinical Data submitted is consistent with FDA guidance document "Guidance for Industry and/or for FDA 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/McdicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073781.pdf.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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Image /page/0/Picture/0 description: The image shows the word "INFIMED" in bold, black letters. To the left of the word is a black, geometric shape that resembles a stylized diamond or square with curved lines. The font of the word is sans-serif, and the letters are closely spaced together. The overall impression is a logo or branding element for a company or product named Infimed.
Section 3: 510(k) Summary
Date Prepared:
6/30/10
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:
·InfiStitch for i5™ Digital X-ray Imaging System
Common Name:
Digital X-ray Imaging System
Classification Name(s): InfiStitch for i5m4 Digital X-ray Imaging System
Product Codes: JAA, MQB, oWB
101833
JUL 2 8 2010
(
Predicate Device: iSTM Digital X-ray Imaging System
510(k) Number: K093066
Product Codes: JAA. MOB
Device Description:
The InfiMed i m 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-1 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 platforms.
The modified InfiMed if me 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), computer, monitor, and the digital i maging system. The InfiStitch for i-m Digital X-ray Imaging System is an option which allows the operator to generate sequential radiographic images and electronically jointhum to create a single electronic image. This feature will be available for any InfiMed customer utilizing the i-The Digital X-ray Imaging System DR application on any flat parel detector.
Intended Use:
The InfiMed i5m Digital X-ray Imaging System is a high resolution digital imaging system intended to replace conventional film techniques, or existing digital systems, in
1
Image /page/1/Picture/0 description: The image shows the word "INFIMED" in all capital letters. To the left of the word is a black logo. The logo appears to be a stylized design, possibly representing a medical or technological concept.
multipurpose or dedicated applications specified below. The i5m 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 laser printer. Image processing algorithms enable the operator to bring out diagnostic details difficult to see using conventional imaging techniques. Images can be stored locally for temporary storage. The i2m Digital X-ray Imaging System has the ability to interface with a variety of image receptors from CCD cameras to commercially available flat panel detectors. The major system components include an image receptor, computer, monitor and imaging software.
For the DR application, the InfiMed i500 Digital X-ray Imaging System is intended for use in general radiographic examinations and applications (excluding fluoroscopy, 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 angiography 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 as the predicate device. The comparison chart reveals that functions performed by the predicate device are performed by the modified if TM Digital X-ray Imaging System. The modified device, InfiStitch for if Digital X-ray Imaging System, also has the ability to interface with an additional image receptor, Toshiba FDX4343R. Therefore, the modified device is substantially equivalent to the predicate device.
Non-clinical Tests 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 i-m Digital Xray Imaging System is as safe and effective as the predicate device.
Clinical Tests Discussion:
Clinical Data submitted is consistent with FDA guidance document "Guidance for Industry and/or for FDA 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/McdicalDevices/DeviceRegulationandGuidance/Guidanc eDocuments/ucm073781.pdf.
Conclusion:
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Image /page/2/Picture/0 description: The image shows the word "INFIMED" in all capital letters. To the left of the word is a black graphic that appears to be a stylized logo. The font of the word is bold and sans-serif. The image is black and white.
Based upon the results of Verification and Validation testing, the InfiMed InfiStitch for if TM Digital X-ray Imaging System has no new indications for use, has no simificant technological differences, and is as safe and effective as, and therefore substantially equivalent to the above listed current legally marketed predicate device.
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Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in a bold, sans-serif font and is blue. The text is likely part of a document or presentation.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
InfiMed, Inc. % Mr. Jigar Shah Consultant mdi Consultants, Inc. 55 Northern Blvd., Suite 200 GREAT NECK NY 11021
JUL 30 2012
Re: K101833
Trade/Device Name: InfiStitch for iSTM Digital X-ray Imaging System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, JAA, and MQB Dated: June 30, 2010 Received: July 1, 2010
Dear Mr. Shah:
This letter corrects our substantially equivalent letter of July 23, 2010.
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. Drue, 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 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
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Image /page/5/Picture/0 description: The image shows the word "INFIMED" in bold, black letters. To the left of the word is a black, geometric shape that resembles a stylized diamond or square. The letters are evenly spaced and appear to be a sans-serif font. The overall impression is a logo or brand name.
Section 2: Indications for Use
K101833 510(k) Number (if known):
Device Name: InfiStitch for i5m Digital X-ray Imaging System
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 existing digital systems, in multipurpose or dedicated applications specified below. The i5m 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 laser printer. Image processing algorithms enable the operator to bring out diagnostic details difficult to see using conventional imaging techniques. Images can be stored locally for temporary storage. The i2m Digital X-ray Imaging System has the ability to interface with a variety of image receptors from CCD cameras to commercially available flat panel detectors. The major system components include an image receptor, computer, monitor and imaging software.
For the DR application, the InfiMed i-714 Digital X-ray Imaging System is intended for use in general radiographic examinations and applications (excluding fluoroscopy, 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 angiography imaging procedures are performed.
Prescription Use \ (Part 21 CFR 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)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | OIVD |
|---|---|
| (Division Sign-Off) | |
| Division of Radiological Devices | |
| Office of In Vitro Diagnostic Device Evaluation and Safety | |
| 610K. | K101833 |