(127 days)
The Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter is intended for intravascular imaging and is indicated for use in coronary arteries in patients who are candidates for transluminal interventional procedures. The Vis-Rx Micro-Imaging Catheter is intended for use in vessels 1.3 to 6.0 mm in diameter. The Vis-Rx Micro-Imaging Catheter is not intended for use in a target vessel that has undergone a previous bypass procedure.
The Gentuity® Imaging System provides images of the coronary arteries in patients who are candidates for transluminal interventional procedures. The system utilizes fiber-optic technology to deliver near-infrared light and receive light reflected from coronary tissue to produce images. The Gentuity Imaging System consists of the Gentuity Imaging Console, Vis-Rx® Micro-Imaging Catheter, and optional Gentuity Review Station. The console houses the Optical Engine, Computer and application software, and Probe Interface Module (PIM). The Vis-Rx catheter is a sterile, single-use catheter with an external sheath and an optical imaging core. The Gentuity Review Station is an optional stand-alone computer for analysis and review.
This document, K192922, is a 510(k) Premarket Notification for the Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter. It establishes substantial equivalence to a predicate device, rather than providing a detailed clinical study demonstrating the device's meeting of specific acceptance criteria.
While the document references "performance testing" and "design verification and validation," it does not present a formal clinical study with a predefined test set, ground truth establishment, or specific acceptance criteria for diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) typical of AI/CADe submissions. Instead, the performance testing focuses on engineering specifications, physical properties of the catheter, and a comparison of image quality with a predicate device.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics cannot be directly extracted from this 510(k) summary. The document focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than establishing de novo performance thresholds.
However, based on the provided text, here's an attempt to address the points where information is available or can be inferred:
1. Table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria for diagnostic accuracy or clinical performance metrics in the way a de novo device with AI might. Instead, performance testing focused on engineering specifications, physical characteristics, and image quality comparison to a predicate device.
| Category | Acceptance Criteria (Implied/Inferred) | Reported Device Performance |
|---|---|---|
| General Safety | Compliance with relevant electrical safety (IEC 60601 series), laser safety (IEC 60825-1, 21 CFR 1040.10, 1040.11), and software standards (IEC 62304, DICOM). | "The Gentuity® Imaging System has been tested and is in compliance with general safety requirements...The results of this testing conclude the software has met these requirements." |
| Bench Testing | System meets its performance specifications (scan range, axial resolution, optical sensitivity, A-line rate, dynamic range, frame rate, pullback rate and range, FORJ characteristics; catheter: visual/dimensional, tensile strength, leakage, corrosion, torque, particulates, coating, lubricity/friction, flexibility/kink). Bench testing successfully demonstrates the product meets specifications and raises no new safety/effectiveness issues. | "Comprehensive verification and validation activities were successfully completed, raising no new issues of safety or effectiveness. All testing passed the acceptance criteria." Specific metrics are not provided in the summary but were presumably documented in the submission. |
| Biocompatibility | Compliance with ISO 10993-1 for cytotoxicity, sensitization, intracuraneous reactivity, acute systemic toxicity, material mediated pyrogenicity, hemolysis, complement SC5b-9 and C3a, in vivo thrombogenicity. | "The Vis-Rx was subjected to a series of biocompatibility tests in accordance with FDA guidance, using International Standard ISO 10993-1." (Implied: Passed, as it concluded substantial equivalence). |
| Sterilization | Achieve a Sterility Assurance Level (SAL) of $10^{-6}$ according to international sterilization standards. | "Sterilization and sterilization were performed to ensure a SAL of 106, according to international sterilization standards." (Assuming "106" in the text means $10^{-6}$). |
| Packaging & Shelf Life | Packaging integrity (visual inspection, bubble leak, seal strength) maintained after sterilization, environmental conditioning, and simulated shipping/distribution. | "Testing was conducted after sterilization, environmental conditioning including aging, and simulated shipping and distribution." (Implied: Passed, as it concluded substantial equivalence). |
| System Performance (Console, SW, PIM, Catheter) | Successful performance in simulated use (tortuous path model), automatic flush detection, lumen segmentation, NURD (Non-Uniform Rotational Distortion), image brightness, lateral resolution, measurement accuracy. (Implied: Acceptable performance for intended use). | Described as tested. (Implied: Passed, as it concluded substantial equivalence). |
| Animal Testing (Safety) | Histomorphology findings similar between Gentuity System and predicate, and clinical usability (catheter handling, ease of use, radiopacity) similar to predicate. | "The Gentuity System performed as intended and the histomorphology findings were similar between the two treatment groups... Clinical usability assessment... was also performed and found to be similar to the predicate." |
| Third-Party Image Quality Assessment | Image quality attributes (image contrast, axial resolution, tissue depth penetration) and image artifacts (seam-line, NURD, saturation) were scored, with the two systems (Gentuity vs. predicate) demonstrating substantially equivalent imaging quality. | "The results of this test conclude that the two systems provide substantially equivalent imaging quality." |
| Usability | Meets the needs of intended users to perform OCT imaging safely and effectively according to ANSI/AAMI/IEC 62366-1:2015. | "Usability evaluation was conducted to establish that the Gentuity Imaging System meets the needs of the intended users to perform OCT imaging safely and effectively... The results... conclude the Gentuity Imaging System... is substantially equivalent to the... predicate device." |
2. Sample size used for the test set and the data provenance
- Test Set (Image Quality Assessment): While an exact number of images/cases is not specified for the "Third-Party Image Quality Assessment," it involved "cross-sectional images extracted from pullbacks with Vis-Rx and with the predicate device." The data provenance for this assessment is not specified (e.g., country of origin, retrospective/prospective), but the context of "animal studies" suggests it was likely derived from the animal testing conducted.
- Animal Testing: Two animal studies were conducted. No specific number of animals or cases is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- For the "Third-Party Image Quality Assessment," "Two independent end user reviewers viewed cross-sectional images." Their specific qualifications (e.g., number of years of experience, specific specialty like cardiology/interventional radiology) are not stated beyond being "end user reviewers."
- There's no mention of ground truth established by experts for algorithmic performance in terms of diagnostic accuracy, as this is not an AI/CADe device being assessed for diagnostic performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- No adjudication method is described for the image quality assessment. The document simply states "Each cross-sectional image was scored by each reviewer." It does not mention how disagreements were resolved or if a consensus mechanism was employed.
5. 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 a multi-reader multi-case (MRMC) comparative effectiveness study of human readers with vs. without AI assistance was reported. This device is an imaging system, not an AI/CADe device intended to assist human interpretation in that manner. The "Third-Party Image Quality Assessment" was a comparison of image quality between two devices, not an evaluation of human reader performance with or without AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable, as the device is an imaging system, not a standalone AI diagnostic algorithm. The software features mentioned (automatic lumen detection, lumen measurements, etc.) are image processing features within the system, not standalone diagnostic algorithms evaluated for their own performance metrics against ground truth.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the Third-Party Image Quality Assessment, the "ground truth" was essentially the subjective scores given by the two independent reviewers based on predefined attributes and artifacts. This is not a clinical ground truth like pathology or outcomes.
- For the Animal Testing (Safety), histomorphology findings (presumably from pathology of animal tissues) were used as the basis for comparison of safety and bio-response between the Gentuity system and the predicate. This could be considered a form of ground truth for safety evaluation.
- For Lumen Segmentation and Measurement Accuracy (under "System: Console, SW, PIM, Catheter"), the ground truth would likely be established through phantom studies or calibrated measurements where the true dimensions are known. This is a technical ground truth, not a clinical one.
8. The sample size for the training set
- The document does not detail any "training set" for an AI algorithm in the context of diagnostic performance. The software development and testing were performed in compliance with IEC 62304, which focuses on software lifecycle processes and safety, not on statistical performance of machine learning models.
9. How the ground truth for the training set was established
- As no training set for an AI algorithm (in the diagnostic sense) is described, this question is not applicable based on the provided document. The "ground truth" for verifying the system's various engineering functions would typically be established through calibrated instruments, known reference standards, or direct physical measurements during bench testing.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.