(14 days)
The HEMASHIELD Vascular Grafts are indicated for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease. The prosthesis is also recommended for use in patients requiring systemic heparinization prior to, or during, surgery.
The HEMASHIELD Vascular Grafts are Woven Double Velour polvester grafts impregnated with highly purified collagen. The HEMASHIELD Vascular Grafts are designed to reduce . bleeding at implant and thereby eliminate the operative preclotting step. The collagen is designed to be gradually resorbed by the patient. In addition to collagen, the grafts also contain glycerol as a softening agent.
HEMASHIELD Woven Vascular Grafts - Acceptance Criteria and Study Details
The provided document describes the acceptance criteria and study performed to demonstrate substantial equivalence for the HEMASHIELD Woven Vascular Grafts. As this is a 510(k) submission for a predicate device modification, the focus is on non-clinical bench testing rather than clinical trials with human readers or AI algorithms.
1. Acceptance Criteria and Reported Device Performance
The document states that the results of non-clinical tests meet the specified acceptance criteria and are substantially equivalent to the predicate device. However, the exact quantitative acceptance criteria for each test and the reported numerical performance values for the proposed device are not explicitly provided in the given text. The tests performed are listed as:
| Acceptance Criteria (Explicit values not provided) | Reported Device Performance |
|---|---|
| Water Permeability | Met acceptance criteria |
| Longitudinal Tensile Strength | Met acceptance criteria |
| Factory Anastomotic Strength | Met acceptance criteria |
| Burst Strength | Met acceptance criteria |
| Usable Length | Met acceptance criteria |
| Relaxed Internal Diameter | Met acceptance criteria |
| Pressurized Internal Diameter | Met acceptance criteria |
| Wall Thickness | Met acceptance criteria |
| Suture Retention Strength (Suture Pull Out) | Met acceptance criteria |
| Guideline | Met acceptance criteria |
2. Sample Size and Data Provenance for Test Set
- Sample Size: The document does not specify the exact sample size (number of grafts) used for each of the bench tests.
- Data Provenance: The data is from bench testing conducted by MAQUET Cardiovascular LLC. The context of a 510(k) submission implies this testing was done internally by the manufacturer to support regulatory submission. No country of origin is explicitly stated, but the company address is in Wayne, New Jersey, USA. The testing is prospective in the sense that it was conducted specifically to evaluate the modified device against predetermined criteria.
3. Number of Experts and Qualifications for Ground Truth of Test Set
- Not Applicable. This study is a non-clinical bench test evaluating physical properties of a vascular graft, not a diagnostic or AI device that requires expert review for ground truth establishment.
4. Adjudication Method for Test Set
- Not Applicable. As this is a non-clinical bench test, there is no need for expert adjudication of results. Each test would have objective measurement outcomes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study was not performed. This type of study is relevant for diagnostic devices involving human readers and potentially AI assistance, which is not the nature of this vascular graft evaluation.
6. Standalone (Algorithm Only) Performance Study
- No. This is not an AI algorithm or software-only device. The evaluation focuses on the physical properties of a medical implant.
7. Type of Ground Truth Used
- The "ground truth" for the bench tests would be the objective measurements obtained from established testing standards and methodologies (e.g., ISO or ASTM standards, or equivalent internal validated methods). The results of these measurements were then compared against predetermined acceptance criteria, likely derived from the predicate device's performance or relevant standards.
8. Sample Size for Training Set
- Not Applicable. This is a non-clinical bench test, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set, this question is not relevant.
§ 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.”