TVC Imaging System, TVC Catheter

• K Number: K163345
• Device Name: TVC Imaging System, TVC Catheter
• Manufacturer: Infraredx, Inc.
• Date Cleared: 2017-06-21 ( 204 days)
• Product Code: OGZ IYO
• Regulation Number: 870.1200

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 Description

The TVC Imaging System™ is an intravascular imaging device with the ability to simultaneously assess vessel composition and structure using near-infrared spectroscopy (NIRS) and intravascular ultrasound (IVUS). This dual-modality instrument performs near-infrared spectroscopic analysis of the vessel to detect lipid core-containing plaques of interest (LCP) displayed in a map called a Chemogram, and simultaneously generates high resolution IVUS images that display structural details of the vessel and plaque in transverse and longitudinal views.

Predicate Devices

K141682

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a dual-modality imaging system (NIRS and IVUS) for assessing coronary arteries. It mentions image display (Chemogram) and structural details but does not mention any algorithms or processing that would indicate the use of AI or ML for analysis, interpretation, or decision support. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".

Therapeutic

No
The device is described as an "intravascular imaging device" intended for "near-infrared examination of coronary arteries" and "ultrasound examination of coronary intravascular pathology" to detect and assess plaques. This indicates a diagnostic rather than a therapeutic function.

Diagnostic

Yes

The device is intended for the near-infrared examination of coronary arteries to detect lipid-core-containing plaques and assess coronary artery lipid core burden, as well as for ultrasound examination to assess coronary intravascular pathology. These uses clearly indicate its role in diagnosing medical conditions within the coronary arteries.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an "intravascular imaging device" and describes hardware components like a catheter and controller, indicating it is not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVDs are used to examine specimens derived from the human body. The TVC Imaging System™ is an intravascular imaging device that directly examines the coronary arteries within the patient's body using near-infrared spectroscopy and ultrasound. It does not analyze samples taken from the patient.
• The intended use describes direct imaging and assessment of structures and composition within the coronary arteries. This is characteristic of an in vivo imaging device, not an in vitro diagnostic.

Therefore, the TVC Imaging System™ falls under the category of an in vivo imaging device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

OGZ, IYO

Device Description

The TVC Imaging System™ is an intravascular imaging device with the ability to simultaneously assess vessel composition and structure using near-infrared spectroscopy (NIRS) and intravascular ultrasound (IVUS). This dual-modality instrument performs near-infrared spectroscopic analysis of the vessel to detect lipid core-containing plaques of interest (LCP) displayed in a map called a Chemogram, and simultaneously generates high resolution IVUS images that display structural details of the vessel and plaque in transverse and longitudinal views.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Near Infrared and Ultrasound Imaging System

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)

Performance Testing (Bench): Verification and validation testing was performed on the TVC Imaging System™ with the TVC Catheter and Controller to demonstrate that the new catheter and modified controller met all design specifications. The results of the tests showed the TVC Catheter (TVC-C195-42) and Controller passed all tests conducted and met specification.

Validation testing of the Commercial UI Software and Controller Software with the modifications listed above showed passing results for all specifications.

Performance Testing (Animal): An in vivo assessment was conducted where swine underwent a single surgical procedure on Day 0 in which the Infraredx TVC Catheter was placed and a pullback was performed in each of 3 coronary arteries per animal. There were no safety concerns in the swine coronary artery model 6 days after imaging with the Infraredx TVC Catheter.

An additional in vivo assessment was conducted where swine underwent a single interventional procedure in which stents were implanted in the coronary arteries in such a manner as to appose a portion of the stent to the vessel wall and malappose another portion of the stent. Infraredx TVC Catheter imaging was performed through the implanted stent to determine apposition and malapposition of the stent with each of the test and predicate catheters. The Infraredx TVC Catheter and MC10 Console and Controller (PBR) were determined to meet the objectives of this study and found to be equivalent to the predicate product.

Performance Testing (Clinical): None Provided

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.

K141682

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

Regulation Number and Section

§ 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).

Summary

0

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Infraredx, Inc. Stephen Sum Sr. VP of Technology Innovation and Regulatory Affairs 34 Third Avenue Burlington, Massachusetts 01803

Re: K163345

Trade/Device Name: TVC Imaging System, TVC-MC10/TVC-MC10i TVC Catheter, TVC-C195-42 Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OGZ, IYO Dated: May 16, 2017 Received: May 19, 2017

Dear Stephen Sum:

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device

1

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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.htm for 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

M.A. Willemsen

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K163345

Device Name

TVC Imaging System™, TVC-MC-10/TVC-MC-10i TVC Catheter, TVC-C195-42

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

Section 5: Traditional 510(k) Summary

Submitted by:	Infraredx, Inc.
Contact Person:	Stephen Sum
Sr. VP of Technology Innovation and Regulatory Affairs
Infraredx, Inc.
34 Third Ave.
Burlington, MA 01803
Tel: [phone]
Fax: [phone]
Email: [e-mail]
Date of Summary:	November 28, 2016
Device Trade Name:	TVC Imaging System™, TVC-MC-10 / TVC-MC-10i
TVC Catheter, TVC-C195-42
Common or Usual Name:	Ultrasonic Pulsed Echo Imaging System
Diagnostic Intravascular Catheter
Classification:	21 CFR 892.1560
21 CFR 870.1200
Class:	II
Product Code:	IYO, OGZ
Predicate Device(s):	TVC Imaging System (K141682)
Device Description:	The TVC Imaging System™ is an intravascular imaging device with the
ability to simultaneously assess vessel composition and structure using near-
infrared spectroscopy (NIRS) and intravascular ultrasound (IVUS). This
dual-modality instrument performs near-infrared spectroscopic analysis of
the vessel to detect lipid core-containing plaques of interest (LCP) displayed
in a map called a Chemogram, and simultaneously generates high resolution
IVUS images that display structural details of the vessel and plaque in
transverse and longitudinal views.
Indication 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. |
   | Technological
   Characteristics: | The TVC Imaging System™ is composed of three main components: the
   TVC Catheter, the TVC Controller (Pullback and Rotation Device (PBR)),
   and the TVC Console. These three interconnected components work
   together to produce dual images of NIRS and IVUS in a single scan of the
   vessel. |

4

The proposed device has the same technological characteristics and is similar in design and configuration as compared to the currently marketed predicate device.

General Characteristics:
Characteristic	Predicate
TVC-C195-32 and TVC-
MC9, MC9i (K141682)	New Device
TVC-C195-42 and TVC-
MC10, MC10i	Comparison with
Predicate Device
Product Function	Near Infrared and Ultrasound
Imaging System	Near Infrared and Ultrasound
Imaging System	Same
Intended Use	The TVC Imaging SystemTM 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.	The TVC Imaging SystemTM 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.	Same
Where Used	Coronary	Coronary	Same
System
Components	NIR/IVUS Catheter
Portable or Fixed Console
(Laser, SBC, power supply) and
Controller	NIR/IVUS Catheter
Portable or Fixed Console
(Laser, SBC, power supply) and
Controller	Same
Classification	Catheter -
Product Code OGZ
21 CFR 870.1200
System
Product Code IYO
21 CFR 892.1560	Catheter -
Product Code OGZ
21 CFR 870.1200
System
Product Code IYO
21 CFR 892.1560	Same
Clinical data in
510(k)	No	No	Same
Catheter Characteristics:
Characteristic	Predicate
TVC-C195-32 and TVC-
MC9, MC9i (K141682)	New Device
TVC-C195-42 and TVC-
MC10, MC10i	Comparison with
Predicate Device
Usable Length	160 cm	160 cm	Same
Sheath Distal Tip Profile	2.4 F	2.4 F	Same
Guidewire rail length	2.5 cm	1.2 cm	Substantially equivalent
Imaging window profile	3.2 F	3.2 F	Same
Imaging core pullback	12 cm	15 cm	Substantially equivalent
Number of RO Marker Bands	1 RO marker
(0.5cm from distal tip)	1 RO marker
(0.5cm from distal tip)	Same
Maximum guidewire OD	0.014 in.	0.014 in.	Same
Minimum guide catheter I.D.	6 F	6 F	Same
Method of Sterilization	EtO	EtO	Same
Packaging	Sealed tray/pouch	Card/pouch	Substantially equivalent
Materials supplied in sterile packaging	Intravascular NIR/IVUS
catheter
Priming accessory
Controller sterile barrier	Intravascular NIR/IVUS
catheter
Priming accessory
Controller sterile barrier	Same
Transducer Center
Frequency	50MHz	50MHz	Same
Controller and Console Characteristics:
Characteristic	Predicate
TVC-C195-32 and TVC-MC9,
MC9i (K141682)	New Device
TVC-C195-42 and TVC-
MC10, MC10i	Comparison with
Predicate Device
Imaging Mode	Near Infrared light Ultrasound	Near Infrared light Ultrasound	Same
Output	NIR light
RF Ultrasound	NIR light
RF Ultrasound	Same
Hardware
Components	CPU with 4GB RAM
1 Monitor and 1 Touchscreen
Monitor
Swept Source Laser	CPU with 16GB RAM
1 Monitor and 1 Touchscreen
Monitor
Swept Source Laser	Substantially equivalent
Laser Type	Swept Source Semiconductor
Laser	Swept Source Semiconductor
Laser	Same
Imaging element
pullback speed	0.5 mm/s	0.5, 1.0, and 2.0 mm/s	Substantially equivalent
Pullback Distance	120mm	150mm	Substantially equivalent
Controller Housing	No handle	Handle	Substantially equivalent
Controller User
Interface	LED lights	LCD screen	Substantially equivalent

5

6

Performance Testing
(Bench):

Biocompatibility

The biocompatibility evaluation was conducted for an external communicating device in circulating blood, with a limited contact duration of ≤ 24 hrs. The series of testing was conducted using the TVC Catheter and utilizing Good Laboratory Practice (GLP). The testing procedures are based on the requirements of:

• . ASTM F756-13 Standard Practices for Assessment of Hemolytic Properties of Materials
• . ISO 10993-4: 2002: Biological evaluation of medical devices -Part 4: Selection of tests for interaction with blood, as amended 2006
• . ISO 10993-5: 2009: Biological Evaluation of Medical Devices -Part 5: Tests for Cytotoxicity, in vitro methods
• . ISO 10993-10: 2010: Biological Evaluation of Medical Devices -Part 10: Tests for Irritation and skin sensitization
• . ISO 10993-11: 2006: Biological evaluation of medical devices -Part 11: Tests for systemic toxicity

Sterilization and Shelf Life

This sterilization re-qualification was conducted using the TVC Catheter and packaging. Results reported meet the criteria defined in ISO 11135: 2014.

The shelf life evaluation conducted on the TVC Catheter passed all catheter and accessory specifications. The data obtained support a 6 month shelf life for the TVC Catheter.

Performance Testing

Verification and validation testing was performed on the TVC Imaging System™ with the TVC Catheter and Controller to demonstrate that the new catheter and modified controller met all design specifications. The results of the tests showed the TVC Catheter (TVC-C195-42) and Controller passed all tests conducted and met specification.

Validation testing of the Commercial UI Software and Controller Software with the modifications listed above showed passing results for all specifications.

Performance Testing An in vivo assessment was conducted where swine underwent a single surgical procedure on Day 0 in which the Infraredx TVC Catheter was placed (Animal): and a pullback was performed in each of 3 coronary arteries per animal. There were no safety concerns in the swine coronary artery model 6 days after imaging with the Infraredx TVC Catheter.

An additional in vivo assessment was conducted where swine underwent a single interventional procedure in which stents were implanted in the coronary arteries in such a manner as to appose a portion of the stent to the vessel wall and malappose another portion of the stent. Infraredx TVC Catheter imaging was performed through the implanted stent to determine apposition and malapposition of the stent with each of the test and predicate catheters. The Infraredx TVC Catheter and MC10 Console and Controller (PBR) were determined to meet the objectives of this study and found to be

7

	equivalent to the predicate product.
Performance Testing
(Clinical):	None Provided
Substantial Equivalence
Rationale:	There are no proposed changes to the intended use of this product, nor any
changes to the scientific principles of operation, principal technological
characteristics, or safety. The non-clinical and pre-clinical testing performed
on the proposed device indicates that it is safe and effective, and is
substantially equivalent to the predicate device.