(163 days)
Not Found
Not Found
No
The provided 510(k) summary does not contain any mention of AI, ML, deep learning, or related terms, nor does it describe features or performance metrics typically associated with AI/ML-powered devices.
No
The device is an imaging system intended for detection and assessment of plaques and pathology, not for treating a condition.
Yes
The device is described as an "Imaging System" intended for "detection" and "assessment" of lipid-core-containing plaques and coronary artery lipid core burden, as well as for "ultrasound examination of coronary intravascular pathology," all of which point to its use in diagnosing conditions within the coronary arteries.
No
The intended use describes an "Imaging System" and mentions "near-infrared examination" and "ultrasound examination," which strongly implies the use of hardware components for image acquisition. The lack of a device description prevents definitive confirmation, but the nature of the imaging modalities points away from a software-only device.
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 TVC™ Imaging System is described as an imaging system for the near-infrared examination and ultrasound examination of coronary arteries in vivo (within the living body). It directly visualizes structures within the body.
- Lack of Sample Analysis: There is no mention of the device analyzing samples taken from the patient.
Therefore, the TVC™ Imaging System falls under the category of medical imaging devices used for direct visualization within the body, not for analyzing samples in vitro.
N/A
Intended Use / Indications for Use
Indications for 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 a. of interest.
- The System is intended for the assessment of coronary artery lipid core b. burden.
-
- 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.
Product codes (comma separated list FDA assigned to the subject device)
OGZ, OBJ, IYO
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
near-infrared, ultrasound
Anatomical Site
coronary arteries
Indicated Patient Age Range
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Intended User / Care Setting
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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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
Not Found
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
§ 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).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three lines representing the staff and two snakes intertwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
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
1
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 (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, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
2
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:
-
- 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.
-
- 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