(22 days)
The Distaflo Bypass Graft is intended for bypass or reconstruction of peripheral arterial blood vessels.
Distaflo™ Bypass Grafts are intended for bypass or reconstruction of peripheral arterial blood vessels.
The Distaflo Bypass Graft is an expanded polytetrafluoroethylene (ePTFE) vascular graft with a cuffed distal end. The Distaflo Bypass Graft can be manufactured with or without Flex beading and with or without a carbon lining.
Here's a breakdown of the acceptance criteria and study findings for the IMPRA Distaflo™ Bypass Graft, based on the provided document:
Acceptance Criteria and Device Performance
The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it states that the testing aimed to demonstrate "substantial equivalence" to predicate devices. The "Performance Data" section indicates:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Predicate Device Performance / Standard(s) Used | Distaflo Bypass Graft Performance | Outcome |
|---|---|---|---|
| Mechanical/Physical Properties of Cuffed Portion | IMPRA Carboflo Vascular Graft & Venaflo Graft with Carbon (using methods from ANSI/AAMI VP20-1994 and 1993 FDA Draft Guidance for Vascular Graft Prostheses) | Suitable for bypass/reconstruction of peripheral arterial blood vessels under anticipated conditions of use. | Met - Substantially Equivalent |
| Biocompatibility/Material Equivalence | Use of same materials as predicate devices (IMPRA Carboflo Vascular Graft, Venaflo Graft with Carbon, and Venaflo ePTFE Vascular Graft and Venaflo Graft with Carbon). | Same materials as predicate devices. | Met - Substantially Equivalent |
| Manufacturing Process Equivalence | Use of same processes as predicate devices. | Same processes as predicate devices. | Met - Substantially Equivalent |
| Design Equivalence (Distal Cuff) | Modeled after the Miller Vein Cuff. | Modeled after the Miller Vein Cuff. | Met - Substantially Equivalent |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the exact sample size for the "test set" (i.e., the number of Distaflo Bypass Grafts or their components tested). It mentions "Device testing was performed on the cuffed portion of the Distaflo Bypass Graft."
- Data Provenance: The document does not provide information on the country of origin of the data or whether the study was retrospective or prospective. Given the nature of medical device testing for regulatory approval in the US (FDA 510(k)), it is generally assumed that the testing was conducted in a controlled lab environment by the manufacturer.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not applicable and not provided in the document. The "ground truth" for this type of device (vascular graft) is established through engineering and biocompatibility testing against predefined standards and performance characteristics, rather than expert consensus on diagnostic images or clinical outcomes in humans at this stage of approval.
4. Adjudication Method for the Test Set:
Not applicable. As described above, the evaluation relies on direct physical and mechanical testing against recognized standards and comparison to predicate devices, not on expert adjudication of observations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret results, and an AI algorithm might assist them. The Distaflo Bypass Graft is a physical implantable device, and its evaluation does not involve human readers interpreting AI output.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. The device is not an algorithm. Its "performance" is inherently standalone, as it's a physical product assessed directly through testing, not an AI model.
7. The Type of Ground Truth Used:
The "ground truth" for the Distaflo Bypass Graft's performance is based on:
- Engineering and Material Standards: Compliance with methods recommended in ANSI/AAMI VP20-1994: Cardiovascular Implants - Vascular Prostheses and the 1993 FDA Draft Guidance: Guidance for the Preparation of Research and Marketing Applications for Vascular Graft Prostheses.
- Predicate Device Performance: Direct comparison of test results to the established performance of legally marketed predicate devices (IMPRA Carboflo Vascular Graft and Venaflo Graft with Carbon).
- Design and Manufacturing Equivalence: Verification that the device uses the same materials, processes, and a design concept (Miller Vein Cuff) found in established devices.
8. The Sample Size for the Training Set:
Not applicable. The Distaflo Bypass Graft is a manufactured medical device, not an AI model requiring a training set of data.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
§ 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.”