TVC IMAGING SYSTEM, TVC INSIGHT CATHETER

K130719 · Infraredx, Inc. · OGZ · Oct 17, 2013 · Cardiovascular

Device Facts

• Record ID: K130719
• Device Name: TVC IMAGING SYSTEM, TVC INSIGHT CATHETER
• Applicant: Infraredx, Inc.
• Product Code: OGZ · Cardiovascular
• Decision Date: Oct 17, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

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 Story

TVC Imaging System combines near-infrared spectroscopy (NIRS) and intravascular ultrasound (IVUS) via TVC Insight Catheter; used during invasive coronary angiography/interventional procedures. System inputs: NIRS signals and IVUS ultrasound echoes from coronary arteries. Processing: NIRS detects lipid-core-containing plaques and assesses lipid core burden; IVUS provides structural imaging of coronary pathology. Output: Integrated NIRS/IVUS images and data displayed for physician review. Used in cath lab by interventional cardiologists to identify lipid-rich plaques and guide clinical decision-making during coronary interventions. Benefits: improved visualization of vessel wall composition and plaque characteristics to inform treatment strategy.

Clinical Evidence

No clinical data provided in the summary; substantial equivalence supported by bench testing and performance verification.

Technological Characteristics

Combination NIRS/IVUS imaging system. Uses TVC Insight Catheter for intravascular access. NIRS utilizes spectroscopic analysis for lipid detection; IVUS utilizes ultrasound transducers for structural imaging. System is a cart-based console with integrated software for signal processing and image reconstruction. Connectivity via standard hospital interfaces. Sterilization: Catheter is provided sterile (EtO).

Indications for Use

Indicated for patients undergoing invasive coronary angiography or candidates for transluminal coronary interventional procedures requiring examination of coronary arteries and intravascular pathology.

Regulatory Classification

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.

Predicate Devices

• Infraredx TVC Imaging System (K120534)

Submission Summary (Full Text)

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## 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

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## 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 [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, Ph.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 K130719

Section 8

## Indications for Use

510(k) Number (if known):

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.
- 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.

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'

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