TVC IMAGING SYSTEM MODEL NIRS-MC7-70

K123108 · Infraredx, Inc. · OGZ · Mar 15, 2013 · Cardiovascular

Device Facts

• Record ID: K123108
• Device Name: TVC IMAGING SYSTEM MODEL NIRS-MC7-70
• Applicant: Infraredx, Inc.
• Product Code: OGZ · Cardiovascular
• Decision Date: Mar 15, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

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 of interest. 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.

Device Story

TVC Imaging System combines near-infrared spectroscopy (NIRS) and intravascular ultrasound (IVUS) to examine coronary arteries. Device inputs include optical and acoustic signals acquired via specialized catheter during invasive coronary angiography. System processes these inputs to detect lipid-core-containing plaques and assess lipid core burden; provides ultrasound imaging of coronary pathology. Used in cardiac catheterization labs by interventional cardiologists. Output displayed on console for real-time visualization and analysis. Assists clinicians in identifying lipid-rich plaques and assessing coronary anatomy to guide interventional decision-making. Benefits include improved characterization of coronary artery disease beyond standard angiography.

Clinical Evidence

No new clinical data provided. Substantial equivalence supported by bench testing and performance verification demonstrating that the modified device performs as intended and remains equivalent to the predicate.

Technological Characteristics

System integrates NIRS and IVUS modalities. Employs a catheter-based probe for intravascular data acquisition. Connectivity includes standard medical imaging interfaces. Software-based signal processing for image reconstruction and lipid core detection. Sterilization via standard methods for intravascular catheters.

Indications for Use

Indicated for patients undergoing invasive coronary angiography or candidates for transluminal coronary interventional procedures requiring examination of coronary arteries and assessment of lipid-core-containing plaques.

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 (K111353)

Submission Summary (Full Text)

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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