(213 days)
Not Found
Not Found
No
The provided text does not mention AI, ML, or related terms, nor does it describe features or processes typically associated with AI/ML in medical imaging (like training/test sets, performance metrics like AUC, or specific algorithms). The description focuses on the imaging modalities and intended use for detecting and assessing lipid-core plaques and general intravascular pathology.
No.
The device is used for imaging and assessment of coronary arteries and lipid core burden, as well as for ultrasound examination of coronary intravascular pathology. It is a diagnostic device, not a therapeutic one.
Yes
The intended use explicitly states the system is for the "detection of lipid-core-containing plaques of interest" and "assessment of coronary artery lipid core burden," which are diagnostic purposes to identify and characterize pathology.
No
The device description is not provided, but the intended use clearly describes an "Imaging System" that utilizes near-infrared and ultrasound modalities. These modalities inherently require hardware components (probes, sensors, etc.) to acquire the images. Therefore, it is not 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. They are performed outside of the living body.
- Device Function: The TVC™ Imaging System is described as performing near-infrared and ultrasound examinations of coronary arteries in patients. This means the examination is being performed inside the living body (in vivo).
- Intended Use: The intended use clearly states the system is for examining coronary arteries in patients undergoing invasive coronary angiography and for ultrasound examination of coronary intravascular pathology. These are procedures performed directly on the patient.
Therefore, because the device operates and performs its examinations directly within the patient's body, it falls under the category of an in vivo diagnostic or imaging system, not an in vitro diagnostic.
N/A
Intended Use / 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.
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.
Product codes
OGZ, OBJ
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Near-infrared, Ultrasound
Anatomical Site
coronary arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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