(29 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 training or testing data sets typically associated with AI/ML development.
No
The device is an imaging system for diagnostic purposes, not a device that treats or prevents conditions.
Yes
The device is an imaging system (digital X-ray) that acquires, displays, and processes images to bring out "diagnostic details." The output is intended for interpretation by a human operator, making it a diagnostic device.
No
The device description explicitly lists hardware components such as an image receptor (various types of detectors), a computer, and a monitor, in addition to the imaging software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The InfiMed i5TM Digital X-ray Imaging System is an imaging system that uses X-rays to create images of the inside of the body. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "digital X-ray imaging" and "general radiographic examinations and applications," "general fluoroscopy, interventional fluoroscopy or angiography imaging procedures." These are all imaging modalities, not in vitro tests.
- Device Description: The description focuses on the components involved in capturing and processing X-ray images (X-ray detector, computer, monitor, imaging software).
Therefore, the InfiMed i5TM Digital X-ray Imaging System falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The InfiMed i-m 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 i3M 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 i3tM 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 is TM 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 (comma separated list FDA assigned to the subject device)
OWB, JAA, IZI
Device Description
The InfiMed if 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 i5m 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 InfiMcd i ma 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), computer, monitor, and the digital imaging system.
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
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.
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 if 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.
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, sans-serif font. To the left of the word is a black, geometric shape that resembles a tilted square with a curved line extending from the top. The text and shape are the primary elements in the image, set against a white background.
JUN 1 0 2011
Section 3: 510(k) Summary
Date Prepared: May 11, 2011 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: iSTM Digital X-ray Imaging System (with FLAATZ 560) Common Name: Digital X-ray Imaging System Classification Name(s): Product Codes: i5TM Digital X-ray Imaging System (with FLAATZ 560) OWB, JAA, 121 Predicate Device: 510(k) Number: Product Codes: InfiStitch for iSTM . K101833 MOB
Device Description:
The InfiMed if 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 i5m 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 InfiMcd i ma 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), computer, monitor, and the digital imaging system.
Intended Use:
The InfiMed ifm 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
121 Metropolitan Park Drive, Liverpool, New York 13088 Main Document - Page 10 of 32
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Image /page/1/Picture/0 description: The image shows the word "INFIMED" in all caps. To the left of the word is a black logo that is abstract in nature. The logo is made up of two shapes, one on top of the other.
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 if TM 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, camutor, monitor and imaging software.
For the DR application, the InfiMed if™ 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 angiography imeing 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, i5m Digital X-ray Imaging System (with FLAATZ 560), also has the billiouth interface with an additional image receptor, DRTECH FLAATZ 560. 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 if 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 InfiMed i³™ Digital Xray Imaging System (with FLAATZ 560) has no new indications for use, has no
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Image /page/2/Picture/0 description: The image shows the word "INFIMED" in bold, black letters. To the left of the word is a black, abstract graphic. The graphic appears to be a diamond shape with a curved line extending from the top.
significant technological 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 Main Document - Page 12 of 32
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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health and 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, and the text is in a clear, sans-serif font.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Catherine Mulcahy Quality Assurance Manager InfiMed. Inc. 121 Metropolitan Drive LIVERPOOL NY 13088
JUL 30 2012
Re: K111344
Trade/Device Name: i5TM Digital X-ray Imaging System (with FLAATZ 560) Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, JAA and IZI Dated: May 11, 2011 Received: May 12, 2011
Dear Ms. Mulcahy:
This letter corrects our substantially equivalent letter of June 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 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
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Image /page/5/Picture/0 description: The image shows the logo for INFIMED. The logo consists of a stylized graphic to the left of the word "INFIMED" in all capital letters. The graphic is a black geometric shape with a curved line above it. The text is in a bold, sans-serif font.
Section 2: Indications for Use
K111344 510(k) Number (if known):
Device Name: if TM Digital X-ray Imaging System (with FLAATZ 560)
Indications for Use:
The InfiMed i-m 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 i3M 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 i3tM 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 is TM 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)
oncurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary S. Patil
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K111344
121 Metropolitan Park Drive, Liverpool, New York 13088 Main Document - Page 9 of 32