(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
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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:
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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.
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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.
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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.
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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.
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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.
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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.
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How the ground truth for the training set was established
- Not applicable, as no training set or machine learning model training details were provided.
§ 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).