(213 days)
-
- 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.
-
- 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.
Not Found
The provided text is a 510(k) premarket notification decision letter from the FDA for the Infraredx TVC Imaging System. It does not contain the detailed information necessary to answer all the questions about acceptance criteria and study particulars. The letter primarily focuses on regulatory approval based on substantial equivalence to predicate devices and outlines general regulatory obligations.
However, based on the limited information provided in the "Indications for Use" section (Section 8 of the original submission, which is referenced in the letter), we can infer the primary performance goals for the device. The "Indications for Use" state:
- 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.
- The System is intended for ultrasound examination of coronary intravascular pathology.
- Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.
Given this, the acceptance criteria would revolve around the ability of the device to accurately detect lipid-core-containing plaques and assess coronary artery lipid core burden using near-infrared, and to perform ultrasound examination of coronary intravascular pathology.
Based on the provided document, I cannot complete most of the requested information because the 510(k) decision letter does not include the detailed study design and results. The information below reflects what could be inferred as acceptance criteria and explicitly states where the document is insufficient to answer the question.
Inferred Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Indications for Use) | Reported Device Performance (Not Available in this Document) |
|---|---|
| Accurate detection of lipid-core-containing plaques of interest via Near-Infrared (NIR) | Not Available in this document |
| Accurate assessment of coronary artery lipid core burden via NIR | Not Available in this document |
| Effective ultrasound examination of coronary intravascular pathology | Not Available in this document |
Detailed Study Information
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not available in this document. The 510(k) decision letter does not include details on the test set, its size, or provenance.
-
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)
- Not available in this document.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not available in this document.
-
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
- Not applicable based on available information. The device described (TVC Imaging System) is an imaging system (hardware and associated software for image acquisition and analysis), not explicitly stated to be an AI-assisted diagnostic tool for human readers in the context of an MRMC study. While it provides "assessment of coronary artery lipid core burden" and "detection of lipid-core-containing plaques," the document does not describe its interaction with human readers for improved diagnostic accuracy in an MRMC setting.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not available in this document. The document does not specify if a standalone performance study was conducted.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not available in this document.
-
The sample size for the training set
- Not available in this document. The 510(k) decision letter does not provide details about training data, as it primarily focuses on the regulatory decision rather than detailed technical study methodologies.
-
How the ground truth for the training set was established
- Not available in this document.
{0}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
DEPARTMENT OF HEALTH & HUMAN SERVICES • USA
October 17, 2013
Infraredx, Inc. Steve Chartier 34 Third Ave Burlington, MA 01803 US
Re: K130719
Trade/Device Name: TVC Imaging System, TVC Insight Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Combination Near-Infrared / IVUS Imaging System Regulatory Class: Class II Product Code: OGZ, OBJ Dated: July 15, 2013 Received: July 16, 2013
Dear Steve 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
{1}------------------------------------------------
Page 2 - Steve Chartier
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 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 (OS) 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.goy/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 (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Owen P. Faris -S
for
Bram D. Zuckerman, Ph.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
{2}------------------------------------------------
Infraredx TVC Imaging System
Premarket Notification K130719
Section 8
Indications for Use
510(k) Number (if known):
Device Name: TVC™ Imaging System
Indications for Use:
-
- 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.
-
- 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.
Prescription Use _ X (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)
Digitally signed by
Owen P. Faris -S
Date: 2013.10.17
11:22:37 -04'00'
Section 8: Page 1 of 1
§ 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).