(70 days)
The Perma-Pass™ Vascular Graft is intended for bypass or reconstruction of occluded or diseased arterial blood vessels, or the creation of subcutaneous arteriovenous conduits for blood access. The Graft is intended for use as a vascular prosthesis only.
- Thinwall Perma-Pass Grafts are not indicated for blood access. .
- Perma-Pass Grafts are not indicated for applications involving: pulmonary arteries; . ascending aorta; coronary arteries; common, external, or internal carotid arteries; cerebral arteries; brachiocephalic trunk; cardiac veins; pulmonary veins; or the inferior or superior vena cava.
The Perma-Pass™ Vascular Graft is manufactured from the following materials; polytetraflouroethylene (PTFE) resin, lubricant used as a manufacturing aid, and a black pigment used to create the orientation line. These grafts are available in a straight configuration with an internal diameter of 5mm, thin wall, and lengths sufficient to satisfy most vascular graft applications. The Perma-Pass Graft is constructed from the same materials used in manufacturing the tubing for the Perma-Flow® Coronary Bypass Graft, manufactured by Possis Medical, Inc. and approved under HDE H970005 dated 30 April, 1998. These grafts are supplied in the same packaging as the Perma-Flow Graft and are packaged, labeled and sterilized in the same manner.
The provided text describes a 510(k) premarket notification for the Perma-Pass™ Vascular Graft, comparing it to an existing predicate device (IMPRA ePTFE Vascular Graft). The core of the submission is to demonstrate substantial equivalence, rather than to establish new safety and effectiveness criteria through a standalone study with defined acceptance criteria and performance metrics.
Therefore, the information requested in your prompt regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not explicitly available in this document. This document focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device based on material, design, and performance characteristics, rather than proving performance against specific acceptance criteria for a new clinical claim.
However, I can extract the relevant information regarding the comparison and the non-clinical tests that implicitly serve as the "study" for this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a 510(k) submission seeking equivalence, explicit "acceptance criteria" for clinical performance are not stated in the traditional sense of a clinical trial. Instead, the acceptance is based on demonstrating that the Perma-Pass Graft's physical and functional properties are comparable to and exceed physiological requirements like the predicate device.
| Characteristic | Acceptance Criteria (Implied: Comparable to/Better than Predicate & Exceed Physiological Requirements) | Predicate Device Performance (IMPRA Graft) | Perma-Pass Graft Performance |
|---|---|---|---|
| Physical Properties | |||
| Pore volume | Comparable | 69% | 67% |
| Internodal distance (Inner) | Comparable | 21 um | 21 um |
| Internodal distance (Outer) | Comparable | 24 um | 21 um |
| Water entry pressure | Comparable to/Better than 276 mmHg | 276 mmHg | 309 mmHg |
| Kink diameter | Comparable to/Better than 14mm | 14mm | 13mm |
| Pressurized burst strength | Comparable to/Better than 325 kPa | 325 kPa | 381 kPa |
| Tensile Strength | |||
| Longitudinal | Comparable | 126 N | 121 N |
| Circumferential | Comparable to/Better than 3.10 N/mm | 3.10 N/mm | 3.50 N/mm |
| Suture Retention Strength | |||
| Longitudinal | Comparable to/Better than 283 g | 283 g | 535 g |
| Oblique | Comparable to/Better than 285 g | 285 g | 553 g |
Study Proving Device Meets Acceptance Criteria:
The "study" conducted for this 510(k) submission consisted of Non-Clinical Tests. The document states:
"Extensive testing of in vitro, functional, physical, and biocompatibility tests have been performed on the Perma-Pass Graft. These tests have shown that the Graft performs comparably to the predicate device. All performance results for the Graft and the predicate device exceed physiological requirements for the intended clinical use of the device. Where applicable, tests were conducted using USP or AAMI guidelines and standards. The results were acceptable in all cases."
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the document. The testing involves "extensive testing of in vitro, functional, physical, and biocompatibility tests," implying multiple samples of the Perma-Pass Graft and the predicate device were tested for each characteristic. The exact number of units per test or batch size is not reported.
- Data Provenance: The tests are "in vitro, functional, physical, and biocompatibility tests." This indicates laboratory-based testing, likely conducted by the manufacturer (Possis Medical, Inc.) in the USA. It is prospective testing designed to evaluate the properties of the manufactured devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This submission relies on objective physical and functional measurements, following established standards (USP or AAMI guidelines). There are no human "experts" establishing a subjective "ground truth" for the test results described. The "ground truth" is the measured value itself, derived from the test methodology.
4. Adjudication method for the test set:
- Not applicable as the tests are objective measurements, not subjective evaluations requiring adjudication.
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:
- Not applicable. This is a medical device (vascular graft), not an AI diagnostic tool. No MRMC studies were conducted as part of this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device.
7. The type of ground truth used:
- The "ground truth" for the performance claims in this submission is objective, quantitative measurements of physical properties (e.g., pore volume, water entry pressure, tensile strength) and functional performance, compared against the known properties of a legally marketed predicate device and physiological requirements. This is data derived from laboratory testing, not expert consensus, pathology, or outcomes data in the usual clinical sense.
8. The sample size for the training set:
- Not applicable. There is no "training set" as this is not a machine learning model. The device itself is manufactured using established processes.
9. How the ground truth for the training set was established:
- Not applicable. There is no training set for this type of medical device submission.
§ 870.3450 Vascular graft prosthesis.
(a)
Identification. A vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access. It is commonly constructed of materials such as polyethylene terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or collagen, or a synthetic coating, such as silicone. The graft structure itself is not made of materials of animal origin, including human umbilical cords.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular Prostheses 510(k) Submissions.”