(75 days)
"bypass or reconstruction of peripheral arterial blood vessels".
The Vascutek Cobrahood™ vascular grafts are still intended for prescription use only.
Vascuteks ePTFE vascular grafts were originally cleared by FDA in 1999 (K992832: unsealed and K993667: gelatin sealed). In 2004, Vascutek received clearance for the application of an external ePTFE wrap to the original FDA cleared ePTFE vascular graft range (K041528). As a result of development in line with design control procedures, it became possible to flare the end of a standard wrapped ePTFE graft to create the Cobrahood™ design as shown in Figures 1a and 1b of this submission. The intended use is, "bypass or reconstruction of peripheral arterial blood vessels".
All Vascutek ePTFE grafts are manufactured from virgin expanded polytetrafluoroethylene resin, including the ePTFE external wrap. Cobrahood™ ePTFE vascular grafts are not sealed, i.e. do not have an external gelatin coating. The grafts are available with or without an external support constructed of PTFE. This is identical to the support present on the predicate devices, cleared by FDA in 2005 (K041528).
All Vascutek ePTFE vascular grafts are supplied sterile. The method of sterilization is Ethylene Oxide. A shelf-life of five years has been established. All related parameters remain unchanged to the predicate grafts.
The Cobrahood™ ePTFE vascular graft range is detailed fully in Table 2 of this submission. Manufacturing drawings are provided in Attachment I.
The document provided is a 510(k) summary for the Vascutek Cobrahood™ ePTFE Vascular Grafts and the FDA's clearance letter. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than explicit acceptance criteria and performance against those criteria in a typical clinical study.
Therefore, the information regarding acceptance criteria and a study proving the device meets those criteria will be interpreted in the context of a 510(k) submission, specifically focusing on bench testing for substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Bench Testing for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Mechanical/Physical Properties: Tests to ensure Cobrahood™ grafts meet established standards for ePTFE vascular grafts and are comparable to predicate devices. (Specific tests or quantitative criteria are not detailed in the summary, but implied by "physical testing"). | All samples tested passed the relevant acceptance criteria. Results demonstrated that the Cobrahood™ ePTFE vascular grafts are substantially equivalent to the predicate devices (Vascutek MAXIFLO™ Wrap Grafts and IMPRA Inc. Distaflo Bypass Grafts). |
| Material Composition: Use of virgin expanded polytetrafluoroethylene resin for both graft and external wrap. | The device uses the same materials of construction (virgin expanded polytetrafluoroethylene resin, including the ePTFE external wrap) as the predicate devices. |
| Sterilization Method: Ethylene Oxide. | The device is supplied sterile via Ethylene Oxide. Method unchanged from predicate. |
| Shelf-Life: 5 years. | A shelf-life of five years has been established, and all related parameters remain unchanged to the predicate grafts. |
| Intended Use: Bypass or reconstruction of peripheral arterial blood vessels. | The intended use is "bypass or reconstruction of peripheral arterial blood vessels," identical to the predicate. |
| Technological Characteristics: No changes to materials, sterilization, packaging, or shelf life compared to predicates. | The device has the same technological characteristics as the predicates; no changes to materials of construction, sterilization, packaging, or shelf life. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "All samples tested" for bench testing, but does not provide the number of Cobrahood™ grafts or predicate grafts used.
- Data Provenance: The bench testing was conducted by Vascutek Ltd. in Scotland. It is a retrospective comparison against previously cleared predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable in the context of this 510(k) submission. The "ground truth" for demonstrating substantial equivalence against predicate devices is established through engineering and performance specifications, and comparison of physical characteristics and bench test results, rather than expert consensus on clinical outcomes or images. The "ground truth" is effectively the established performance and characteristics of the predicate devices.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human interpretation or clinical adjudication. Substantial equivalence is determined by comparing design, materials, and performance data from bench tests.
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 device is a vascular graft, not an AI-powered diagnostic or interpretive tool. No MRMC study was conducted.
6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not applicable. This device is a physical medical implant, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the bench testing was primarily the engineering specifications and established performance characteristics of the predicate devices, against which the Cobrahood™ graft's physical and performance data were compared. The objective was to show that the new design (flared outflow) did not alter the safety and effectiveness, and that the performance remained unchanged, thereby achieving substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable.
§ 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.”