(115 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 development (training/test sets, performance metrics like AUC, etc.).
No
The device is an imaging system designed to acquire, display, and process X-ray images, not to provide therapy. Its purpose is diagnostic imaging.
Yes
The device is described as enabling the operator to "bring out diagnostic details" and is intended for use in general radiographic examinations, fluoroscopy, interventional fluoroscopy, or angiography imaging procedures, all of which are diagnostic applications.
No
The device description explicitly lists hardware components such as an X-ray imaging receptor (various types), a computer, and a 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, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Function: The InfiMed i one Digital X-ray Imaging System is described as a digital imaging system that uses X-rays to create images of the inside of the body. It replaces conventional film techniques or existing digital systems for various radiographic and fluoroscopic applications.
- Lack of Biological Sample Analysis: The device does not analyze biological samples taken from the body. Its function is to capture images using external radiation.
Therefore, the device falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The InfiMed i one 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 i2M 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 i TM Digital X-ray Imaging System is intended for use where general fluoroscopy, interventional fluoroscopy or angiography imaging procedures are performed.
Product codes
JAA, MQB, OWB
Device Description
The InfiMed i-TM 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?™ 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 ism 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, Trixell Pixium RF4343), computer, monitor, and the digital imaging system.
Mentions image processing
Image processing algorithms enable the operator to bring out diagnostic details difficult to see using conventional imaging techniques.
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-TM 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/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073781.pdf.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
KIGS416
Image /page/0/Picture/1 description: The image shows the word "INFIMED" in bold, black letters. To the left of the word is a black, abstract graphic. The graphic is composed of several geometric shapes that are arranged in a way that suggests movement or direction. The word "INFIMED" is written in a sans-serif font, with each letter clearly defined.
MAR 1 7 20i1
JAA, MQB
Section 3: 510(k) Summary
| Date Prepared: | 11/19/2010 |
|---|---|
| Contact Person: | Catherine Mulcahy |
| Quality Assurance Manager | |
| Telephone: | 315-453-4545 x288 |
| Fax: | 315-453-4550 |
| Submitter Name: | InfiMed, Inc. |
| 121 Metropolitan Drive | |
| Liverpool, NY 13088 | |
| Device Trade Name: | Nexus DRF Digital X-ray Imaging System |
| Common Name: | Digital X-ray Imaging System |
| Classification Name(s): | Nexus DRF Digital X-ray Imaging System |
| Product Codes: | |
| JAA, MQB, OWB | |
| Predicate Device: | 510(k) Number: |
| Product Codes: |
Device Description:
15TM Digital X-ray Imaging System
The InfiMed i-TM 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?™ 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 ism 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, Trixell Pixium RF4343), computer, monitor, and the digital imaging system.
Intended Use:
The i 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 i37M 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
121 Metropolitan Park Drive, Liverpool, New York 13088 Page 1 of 3
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Image /page/1/Picture/1 description: The image shows the word "INFIMED" in bold, sans-serif font. To the left of the word is a black graphic that appears to be a stylized, abstract shape. The graphic is composed of geometric forms, including a curved element at the top.
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 i5m 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 i 201 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 i TM Digital X-ray Imaging System. The modified device, Nexus DRF Digital X-ray Imaging System, also has the ability to interface with an additional image receptor, Trixell Pixium RF4343. 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-TM 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/MedicalDevices/DeviceRegulationandGuidance/Guidanc eDocuments/ucm073781.pdf.
Conclusion:
Based upon the results of Verification and Validation testing, the Nexus DRF Digital Xray Imaging System has no new indications for use, has no significant technological
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Image /page/2/Picture/1 description: The image shows the word "INFIMED" in bold, black letters. To the left of the word is a black graphic that looks like a stylized check mark or arrow. The letters are all capitalized and evenly spaced. The image is simple and clear, with a focus on the company name.
differences, and is as safe and effective as, and therefore substantially equivalent to the above listed current legally marketed predicate device.
121 Metropolitan Park Drive, Liverpool, New York 13088
Page 3 of 3
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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a blue emblem on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The emblem features a stylized human figure with outstretched arms, and the text is written in a serif font, also in blue.
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: K103416
Trade/Device Name: Nexus DRF 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: November 19, 2010 Received: November 22, 2010
Dear Mr. Shah:
This letter corrects our substantially equivalent letter of March 17, 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. Morri 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 graphic that appears to be a stylized logo. The logo is composed of geometric shapes, including a diamond shape and a curved line that resembles a swoosh or a stylized leaf. The overall impression is that of a corporate logo for a company named Infimed.
Section 2: Indications for Use
510(k) Number (if known): K/034/6
Device Name: Nexus DRF Digital X-ray Imaging System
Indications for Use:
The InfiMed i one 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 i2M 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 i TM Digital X-ray Imaging System is intended for use where general fluoroscopy, interventional fluoroscopy or angiography imaging procedures are performed.
Prescription Use V (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 In Vitro Diagnostic Devices (OIVD)
Main S Patel
Division Sign-Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K103416
121 Metropolitan Park Drive, Liverpool, New York 13088 Main Document - Page of / af