TVC Imaging System, TVC Catheter

K163345 · Infraredx, Inc. · OGZ · Jun 21, 2017 · Cardiovascular

Device Facts

• Record ID: K163345
• Device Name: TVC Imaging System, TVC Catheter
• Applicant: Infraredx, Inc.
• Product Code: OGZ · Cardiovascular
• Decision Date: Jun 21, 2017
• 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. 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

Device performs dual-modality intravascular imaging using near-infrared spectroscopy (NIRS) and intravascular ultrasound (IVUS); catheter inserted into coronary arteries during angiography. System inputs: NIRS light signals and RF ultrasound echoes. System transforms inputs into Chemogram (lipid-core plaque map) and high-resolution IVUS images (transverse/longitudinal views). Used in cath lab by interventional cardiologists/physicians. Output displayed on console monitor; assists clinicians in identifying lipid-core plaques and assessing vessel structure/stent apposition. Benefits include improved visualization of coronary pathology to guide interventional decision-making.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing (biocompatibility per ISO 10993/ASTM F756, sterilization per ISO 11135, shelf-life validation) and in vivo swine studies. Swine studies assessed safety and imaging performance (stent apposition/malapposition) compared to predicate, demonstrating equivalent performance.

Technological Characteristics

Dual-modality system: TVC Catheter, Controller (Pullback/Rotation Device), and Console. Imaging: 50MHz IVUS transducer and swept-source semiconductor laser for NIRS. Connectivity: Standalone console. Sterilization: EtO. Materials: External communicating, limited contact (<24 hrs). Software: Commercial UI and Controller software.

Indications for Use

Indicated for patients undergoing invasive coronary angiography or candidates for transluminal coronary interventional procedures requiring near-infrared examination of coronary arteries for lipid-core-containing plaque detection/burden assessment and intravascular ultrasound examination of coronary 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

• TVC Imaging System (K141682)

Submission Summary (Full Text)

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### 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

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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

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## 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)

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# Section 5: Traditional 510(k) Summary

| Submitted by: | Infraredx, Inc. |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Stephen Sum<br>Sr. VP of Technology Innovation and Regulatory Affairs<br>Infraredx, Inc.<br>34 Third Ave.<br>Burlington, MA 01803<br>Tel: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date of Summary: | November 28, 2016 |
| Device Trade Name: | TVC Imaging System™, TVC-MC-10 / TVC-MC-10i<br>TVC Catheter, TVC-C195-42 |
| Common or Usual Name: | Ultrasonic Pulsed Echo Imaging System<br>Diagnostic Intravascular Catheter |
| Classification: | 21 CFR 892.1560<br>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<br>ability to simultaneously assess vessel composition and structure using near-<br>infrared spectroscopy (NIRS) and intravascular ultrasound (IVUS). This<br>dual-modality instrument performs near-infrared spectroscopic analysis of<br>the vessel to detect lipid core-containing plaques of interest (LCP) displayed<br>in a map called a Chemogram, and simultaneously generates high resolution<br>IVUS images that display structural details of the vessel and plaque in<br>transverse and longitudinal views. |
| Indication for Use: | 1. The TVC Imaging System™ is intended for the near-infrared examination<br>of coronary arteries in patients undergoing invasive coronary<br>angiography.<br>a. The System is intended for the detection of lipid-core-containing<br>plaques of interest.<br>b. The System is intended for the assessment of coronary artery lipid core<br>burden.<br>2. The System is intended for ultrasound examination of coronary<br>intravascular pathology.<br>a. Intravascular ultrasound imaging is indicated in patients who are<br>candidates for transluminal coronary interventional procedures. |
| Technological<br>Characteristics: | The TVC Imaging System™ is composed of three main components: the<br>TVC Catheter, the TVC Controller (Pullback and Rotation Device (PBR)),<br>and the TVC Console. These three interconnected components work<br>together to produce dual images of NIRS and IVUS in a single scan of the<br>vessel. |

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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<br>TVC-C195-32 and TVC-<br>MC9, MC9i (K141682) | New Device<br>TVC-C195-42 and TVC-<br>MC10, MC10i | Comparison with<br>Predicate Device |
| Product Function | Near Infrared and Ultrasound<br>Imaging System | Near Infrared and Ultrasound<br>Imaging System | Same |
| Intended Use | The TVC Imaging SystemTM is<br>intended for the near-infrared<br>examination of coronary arteries<br>in patients undergoing invasive<br>coronary angiography. The<br>System is intended for the<br>detection of lipid-core-<br>containing plaques of interest.<br>The System is intended for the<br>assessment of coronary artery<br>lipid core burden.<br>The System is intended for<br>ultrasound examination of<br>coronary intravascular<br>pathology. Intravascular<br>ultrasound imaging is indicated<br>in patients who are candidates<br>for transluminal coronary<br>interventional procedures. | The TVC Imaging SystemTM is<br>intended for the near-infrared<br>examination of coronary arteries<br>in patients undergoing invasive<br>coronary angiography. The<br>System is intended for the<br>detection of lipid-core-<br>containing plaques of interest.<br>The System is intended for the<br>assessment of coronary artery<br>lipid core burden.<br>The System is intended for<br>ultrasound examination of<br>coronary intravascular<br>pathology. Intravascular<br>ultrasound imaging is indicated<br>in patients who are candidates<br>for transluminal coronary<br>interventional procedures. | Same |
| Where Used | Coronary | Coronary | Same |
| System<br>Components | NIR/IVUS Catheter<br>Portable or Fixed Console<br>(Laser, SBC, power supply) and<br>Controller | NIR/IVUS Catheter<br>Portable or Fixed Console<br>(Laser, SBC, power supply) and<br>Controller | Same |
| Classification | Catheter -<br>Product Code OGZ<br>21 CFR 870.1200<br>System<br>Product Code IYO<br>21 CFR 892.1560 | Catheter -<br>Product Code OGZ<br>21 CFR 870.1200<br>System<br>Product Code IYO<br>21 CFR 892.1560 | Same |
| Clinical data in<br>510(k) | No | No | Same |
| Catheter Characteristics: | | | |
| Characteristic | Predicate<br>TVC-C195-32 and TVC-<br>MC9, MC9i (K141682) | New Device<br>TVC-C195-42 and TVC-<br>MC10, MC10i | Comparison with<br>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<br>(0.5cm from distal tip) | 1 RO marker<br>(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<br>catheter<br>Priming accessory<br>Controller sterile barrier | Intravascular NIR/IVUS<br>catheter<br>Priming accessory<br>Controller sterile barrier | Same |
| Transducer Center<br>Frequency | 50MHz | 50MHz | Same |
| Controller and Console Characteristics: | | | |
| Characteristic | Predicate<br>TVC-C195-32 and TVC-MC9,<br>MC9i (K141682) | New Device<br>TVC-C195-42 and TVC-<br>MC10, MC10i | Comparison with<br>Predicate Device |
| Imaging Mode | Near Infrared light Ultrasound | Near Infrared light Ultrasound | Same |
| Output | NIR light<br>RF Ultrasound | NIR light<br>RF Ultrasound | Same |
| Hardware<br>Components | CPU with 4GB RAM<br>1 Monitor and 1 Touchscreen<br>Monitor<br>Swept Source Laser | CPU with 16GB RAM<br>1 Monitor and 1 Touchscreen<br>Monitor<br>Swept Source Laser | Substantially equivalent |
| Laser Type | Swept Source Semiconductor<br>Laser | Swept Source Semiconductor<br>Laser | Same |
| Imaging element<br>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<br>Interface | LED lights | LCD screen | Substantially equivalent |

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| <b>Performance Testing</b> |
|----------------------------|
| (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

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