TVC IMAGING SYSTEM MODEL NIRS-MC7-70

• K Number: K123108
• Device Name: TVC IMAGING SYSTEM MODEL NIRS-MC7-70
• Manufacturer: Infraredx, Inc.
• Date Cleared: 2013-03-15 ( 163 days)
• Product Code: OGZ , IYO , OBJ
• Regulation Number: 870.1200
• Type: Traditional
• Panel: Cardiovascular
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

1. The TVC™ Imaging System is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography.
   a. The System is intended for the detection of lipid-core-containing plaques of interest.
   b. The System is intended for the assessment of coronary artery lipid core burden.
2. The System is intended for ultrasound examination of coronary intravascular pathology.
   a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.

Device Description

Not Found

AI/ML Overview

This FDA letter is a 510(k) clearance for the TVC Imaging System, meaning it has been determined to be substantially equivalent to a legally marketed predicate device. While it indicates the device can be legally marketed, it does not typically contain the detailed study information needed to fully answer your questions about acceptance criteria and study proving device performance. Such information is usually found in the 510(k) submission itself (which includes the scientific data and clinical studies), rather than in the clearance letter.

Therefore, based solely on the provided text, I can only provide limited information. Many of your questions, particularly those about specific performance metrics, sample sizes, ground truth establishment, and expert qualifications, cannot be answered from this document.

Here's what can be extracted:

• Device Name: TVC™ Imaging System
• Intended Use (Indications for Use):
  • Near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography for:
    • Detection of lipid-core-containing plaques.
    • Assessment of coronary artery lipid core burden.
  • Ultrasound examination of coronary intravascular pathology in patients who are candidates for transluminal coronary interventional procedures.

Regarding your specific questions and what can/cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance:

   • Cannot be provided. The clearance letter does not include specific performance metrics or acceptance criteria from the underlying studies. This information would be in the 510(k) submission.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Cannot be provided. The clearance letter does not detail the clinical studies, including sample sizes, data provenance, or study design (retrospective/prospective). This would be in the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Cannot be provided. The clearance letter does not describe how ground truth was established or the details of expert involvement. This would be in the 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Cannot be provided. The clearance letter does not describe adjudication methods. This would be in the 510(k) submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Cannot be provided. The clearance letter does not mention if an MRMC study was performed or any human-AI comparative effectiveness. The device's primary function as described (NIRS and IVUS imaging) doesn't inherently suggest an AI-assisted interpretation component for human readers in the way an AI diagnostic algorithm might.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Likely applicable, but details not provided. The description focuses on the system intended for examination and assessment. For a diagnostic imaging system, the "standalone" performance would typically refer to its ability to generate images and measurements for the intended use, which would have been demonstrated in the submission. However, specific standalone performance metrics or the nature of an "algorithm only" test are not detailed in this letter.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Cannot be provided. The clearance letter does not specify the type of ground truth used in the studies. This would be in the 510(k) submission.

8. The sample size for the training set:

   • Cannot be provided. As this is a 510(k) clearance for an imaging system (NIRS and IVUS), the concept of a "training set" in the context of machine learning (like an AI algorithm) may not be directly applicable in the same way, unless the device incorporates such algorithms. Even if it does, the sample size would not be in this clearance letter.

9. How the ground truth for the training set was established:

   • Cannot be provided. (See point 8).

In summary: The provided document is an FDA clearance letter confirming substantial equivalence. It does not contain the detailed technical and clinical study results that would typically include acceptance criteria, performance metrics, sample sizes, ground truth methodologies, or expert qualifications. To obtain this information, you would need to access the full 510(k) submission (K123108) itself, which is often available through the FDA's public database.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

March 15, 2013

Infraredx, Inc. Steven Chartier 34 Third Avenue Burlington, MA 01803 US

Re: K123108

Trade/Device Name: TVC Imaging System Model NIRS-MC7-70 Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OGZ, OBJ, IYO Dated: February 11, 2013 Received: February 13, 2013 -

Dear Steven Chartier:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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

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Page 2 - Steven Chartier

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, Misbranding by reference to premarket notification (21CFR 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.htmfor 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Owen P. Faris -S

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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Infraredx TVC Imaging System

Premarket Notification Special 510(k)

Section 8

Indications for Use

510(k) Number (if known): K123108

Device Name: TVC™ Imaging System

Indications for Use:

• 1. The TVC™ Imaging System is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography.
  • The System is intended for the detection of lipid-core-containing plaques a. of interest.
  • The System is intended for the assessment of coronary artery lipid core b. burden.
• 2. The System is intended for ultrasound examination of coronary intravascular pathology.
  • a. Intravascular uitrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.

Prescription Use × (21 CFR 801 Subpart D) AND/OR

Over the Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Owen P. Faris -S
2013.03.15 13:54:59
'-04'00'

Section 8: Page 1 of 1

Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).