(204 days)
- 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.
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.
This document describes the acceptance criteria and the studies performed for the TVC Imaging System (K163345).
Acceptance Criteria and Reported Device Performance
The provided text does not contain a specific table of acceptance criteria with corresponding performance metrics for the TVC Imaging System related to its imaging capabilities (like detection sensitivity or specificity for lipid-core plaques). Instead, the performance testing section indicates that the device "met all design specifications" and "passed all tests conducted and met specification." The focus of the 510(k) summary is on demonstrating substantial equivalence to a predicate device, not on presenting detailed performance metrics against specific quantitative acceptance criteria for the imaging function itself.
However, based on the performance testing descriptions, the implicit acceptance criteria would be that the device:
- Meets biocompatibility standards for external communicating devices in circulating blood with limited contact duration (≤ 24 hrs).
- Achieves sterility and maintains a 6-month shelf life.
- Performs its designated functions (NIRS and IVUS imaging) without safety concerns in an in-vivo model.
- Produces imaging results (e.g., apposition and malapposition of stents) equivalent to the predicate product in an in-vivo model.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meet Biocompatibility Standards (ASTM F756-13, ISO 10993-4, -5, -10, -11) | Results reported meet criteria; testing performed using GLP. |
| Meet Sterilization Standards (ISO 11135:2014) | Results reported meet criteria. |
| Achieve 6-month Shelf Life for Catheter and Accessories | All catheter and accessory specifications passed. |
| Meet all Design Specifications for Catheter and Controller | Passed all tests conducted and met specification. |
| Ensure Safety in In-Vivo Model | No safety concerns in the swine coronary artery model (6 days post-imaging). |
| Equivalence to Predicate Product in In-Vivo Imaging (e.g., stent apposition) | Determined to meet objectives and found to be equivalent to the predicate product. |
| Functional UI and Controller Software | Showed passing results for all specifications. |
Study Information
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size:
- Biocompatibility, Sterilization, Shelf Life, Bench Performance: Not explicitly stated, but assumed to be sufficient for GLP and ISO standard compliance. These are typically lab-based tests, not human data.
- In-vivo Swine Studies: One study involved multiple coronary arteries per animal (3 per animal) in an unspecified number of swine. Another study involved stented coronary arteries in swine, also an unspecified number of animals. These are prospective animal studies.
- Data Provenance: The animal studies were conducted in swine (country not specified but likely conducted by or for Infraredx, Inc. in the USA as it's a US company). These are prospective animal data. No human clinical data was provided.
- Test Set Sample Size:
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- For the in-vivo animal studies, the "ground truth" for evaluating imaging performance (e.g., stent apposition, safety) would typically be established by veterinary cardiologists, interventionalists, or pathologists experienced in animal models. The document does not specify the number or qualifications of experts involved in establishing this "ground truth" or interpreting the animal study results.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- The document does not describe any specific adjudication method for the in-vivo animal studies. Evaluations are generally described as "determined to meet the objectives" or "found to be equivalent," implying a direct assessment by the study investigators rather than an adjudicated consensus process.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC comparative effectiveness study was described. The device is for imaging, and the studies focused on its technical performance and equivalence to a predicate device, not on how human readers' interpretation might improve with or without AI (which is not explicitly defined as part of this device in the given text). The device descriptions focus on displaying a "Chemogram" for lipid core plaques and IVUS images, which are direct outputs for interpretation.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The document describes performance testing of the "TVC Imaging System™ with the TVC Catheter and Controller" and "Commercial UI Software and Controller Software." This implies testing the integrated system, which can be considered standalone performance in the sense of the algorithm and hardware producing outputs, but it's not explicitly framed as an "algorithm-only" performance evaluation separate from the full device operation. The NIRS component involves algorithms for detecting lipid core-containing plaques and displaying them in a Chemogram, representing a standalone algorithmic output.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the in-vivo animal studies, the ground truth for safety would be assessed through pathological examination post-procedure (e.g., histological analysis of coronary arteries for tissue damage). For assessing stent apposition, the predicate device's output was used as a comparative "ground truth" for the new device's findings. No human pathology or outcomes data were used, as no clinical study was performed.
-
The sample size for the training set
- No training set is mentioned as this 510(k) summary focuses on demonstrating substantial equivalence through non-clinical performance and a limited animal study, not on the development or training of an AI algorithm within the device. While the device does have "Commercial UI Software and Controller Software" and outputs like a "Chemogram" (which implies underlying algorithms), details about any machine learning models or their training data are not provided.
-
How the ground truth for the training set was established
- Not applicable, as no training set or machine learning model training details were provided.
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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 20993-0002
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)
- 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.
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 SumSr. VP of Technology Innovation and Regulatory AffairsInfraredx, Inc.34 Third Ave.Burlington, MA 01803Tel: 781.345.9651Fax: 781.345.9551Email: ssum@infraredx.com |
| Date of Summary: | November 28, 2016 |
| Device Trade Name: | TVC Imaging System™, TVC-MC-10 / TVC-MC-10iTVC Catheter, TVC-C195-42 |
| Common or Usual Name: | Ultrasonic Pulsed Echo Imaging SystemDiagnostic Intravascular Catheter |
| Classification: | 21 CFR 892.156021 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 theability to simultaneously assess vessel composition and structure using near-infrared spectroscopy (NIRS) and intravascular ultrasound (IVUS). Thisdual-modality instrument performs near-infrared spectroscopic analysis ofthe vessel to detect lipid core-containing plaques of interest (LCP) displayedin a map called a Chemogram, and simultaneously generates high resolutionIVUS images that display structural details of the vessel and plaque intransverse and longitudinal views. |
| Indication for Use: | 1. The TVC Imaging System™ is intended for the near-infrared examinationof coronary arteries in patients undergoing invasive coronaryangiography.a. The System is intended for the detection of lipid-core-containingplaques of interest.b. The System is intended for the assessment of coronary artery lipid coreburden.2. The System is intended for ultrasound examination of coronaryintravascular pathology.a. Intravascular ultrasound imaging is indicated in patients who arecandidates for transluminal coronary interventional procedures. |
| TechnologicalCharacteristics: | The TVC Imaging System™ is composed of three main components: theTVC Catheter, the TVC Controller (Pullback and Rotation Device (PBR)),and the TVC Console. These three interconnected components worktogether to produce dual images of NIRS and IVUS in a single scan of thevessel. |
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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 | PredicateTVC-C195-32 and TVC-MC9, MC9i (K141682) | New DeviceTVC-C195-42 and TVC-MC10, MC10i | Comparison withPredicate Device |
| Product Function | Near Infrared and UltrasoundImaging System | Near Infrared and UltrasoundImaging System | Same |
| Intended Use | The TVC Imaging SystemTM isintended for the near-infraredexamination of coronary arteriesin patients undergoing invasivecoronary angiography. TheSystem is intended for thedetection of lipid-core-containing plaques of interest.The System is intended for theassessment of coronary arterylipid core burden.The System is intended forultrasound examination ofcoronary intravascularpathology. Intravascularultrasound imaging is indicatedin patients who are candidatesfor transluminal coronaryinterventional procedures. | The TVC Imaging SystemTM isintended for the near-infraredexamination of coronary arteriesin patients undergoing invasivecoronary angiography. TheSystem is intended for thedetection of lipid-core-containing plaques of interest.The System is intended for theassessment of coronary arterylipid core burden.The System is intended forultrasound examination ofcoronary intravascularpathology. Intravascularultrasound imaging is indicatedin patients who are candidatesfor transluminal coronaryinterventional procedures. | Same |
| Where Used | Coronary | Coronary | Same |
| SystemComponents | NIR/IVUS CatheterPortable or Fixed Console(Laser, SBC, power supply) andController | NIR/IVUS CatheterPortable or Fixed Console(Laser, SBC, power supply) andController | Same |
| Classification | Catheter -Product Code OGZ21 CFR 870.1200SystemProduct Code IYO21 CFR 892.1560 | Catheter -Product Code OGZ21 CFR 870.1200SystemProduct Code IYO21 CFR 892.1560 | Same |
| Clinical data in510(k) | No | No | Same |
| Catheter Characteristics: | |||
| Characteristic | PredicateTVC-C195-32 and TVC-MC9, MC9i (K141682) | New DeviceTVC-C195-42 and TVC-MC10, MC10i | Comparison withPredicate 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/IVUScatheterPriming accessoryController sterile barrier | Intravascular NIR/IVUScatheterPriming accessoryController sterile barrier | Same |
| Transducer CenterFrequency | 50MHz | 50MHz | Same |
| Controller and Console Characteristics: | |||
| Characteristic | PredicateTVC-C195-32 and TVC-MC9,MC9i (K141682) | New DeviceTVC-C195-42 and TVC-MC10, MC10i | Comparison withPredicate Device |
| Imaging Mode | Near Infrared light Ultrasound | Near Infrared light Ultrasound | Same |
| Output | NIR lightRF Ultrasound | NIR lightRF Ultrasound | Same |
| HardwareComponents | CPU with 4GB RAM1 Monitor and 1 TouchscreenMonitorSwept Source Laser | CPU with 16GB RAM1 Monitor and 1 TouchscreenMonitorSwept Source Laser | Substantially equivalent |
| Laser Type | Swept Source SemiconductorLaser | Swept Source SemiconductorLaser | Same |
| Imaging elementpullback 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 UserInterface | LED lights | LCD screen | Substantially equivalent |
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| 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
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| equivalent to the predicate product. | |
|---|---|
| Performance Testing(Clinical): | None Provided |
| Substantial EquivalenceRationale: | There are no proposed changes to the intended use of this product, nor anychanges to the scientific principles of operation, principal technologicalcharacteristics, or safety. The non-clinical and pre-clinical testing performedon the proposed device indicates that it is safe and effective, and issubstantially equivalent to the predicate device. |
§ 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).