(28 days)
The Hemashield Gold ™ Woven Double Velour Vascular Graft is 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 Branch Graft Configurations is different from the rest of the Hemashield Gold Woven Double Velour Vascular Graft product line only in the 1-4 branch configuration in which the grafts are sewn. The modified vascular grafts have the following similarities to those which previously received 510(k) concurrence: Identical indications for use, Identical labeling, Identical manufacturing processes, Identical operating principle, Incorporate identical materials, Have the identical shelf-life (5 years), Are packaged and sterilized using identical packaging materials and processes.
The provided submission for the Hemashield Gold Woven Double Velour Branch Graft is a Special 510(k) for a device modification, focusing on the branch configuration. The document explicitly states that there is "no change to these tests or to their acceptance criteria for the Branch Graft line extension" and that "all testing was done with standard test methods for these parameters". This indicates that the device's performance for these criteria was demonstrated to meet existing standards, rather than new studies being conducted specifically for this modification.
Due to the nature of this submission being a device modification to an already approved device and the stated lack of change in acceptance criteria for the branch graft line extension, detailed new studies with specific sample sizes, ground truth establishment, or multi-reader multi-case analyses are not part of this document. The performance is assumed to be in compliance with the established methods for the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Visual Inspection - Stains | $\le$ 0.05mm² | Met (Implied by "Pass" for related categories) |
| Visual Inspection - Foreign Matter | $\le$ 0.03mm² | Met (Implied by "Pass" for related categories) |
| Water Permeability | Accept: if $\le$ 4.0 mL $\cdot$ cm $^{-2}\cdot$ min $^{-1}$ | |
| Reject: if > 4.5 mL $\cdot$ cm $^{-2}\cdot$ min $^{-1}$ | ||
| Repeat test if > 4.0 and $\le$ 4.5 mL $\cdot$ cm $^{-2}\cdot$ min $^{-1}$ | ||
| If re-test values are all 399.9 lb/inch² | Met | |
| Crimp | 12.0 turns/inch - circular | Met |
| Usable Length | Main Graft - 45 ± 5cm | |
| Head Branches - 17.5 ± 2.5cm | ||
| Perfusion Branch - 22.5 ± 2.5cm | Met | |
| Inner Diameter | $\le$ 10.0 mm sizes; nominal diameter ± 0.5 mm |
10.0 mm sizes; nominal diameter ± 1.0 mm | Met |
| Visual Inspection - Sewing | No sewing defects | Met (Implied by "Pass" for related categories) |
| Air Permeability | $\le$ 24.5 - 43.5 l/m (depending upon size) | Met |
| Pyrogenicity: Rabbit Pyrogen | Pass | Pass |
| Acute Systemic Toxicity: Acute Systemic Injection | Pass | Pass |
| Irritation: Acute Intracutaneous Reactivity | Pass | Pass |
| Hemocompatibility: Hemolysis | Pass | Pass |
| Cytotoxicity: ISO L929 MEM Elution | Pass | Pass |
| Mutagenicity: Ames Test (Saline extract) | Pass | Pass |
| Subchronic toxicity: 14 day IV injection in rats | Pass | Pass |
| Implantation: ISO Muscle Implantation with histopathology (2 week) | Pass | Pass |
| Implantation: ISO Muscle Implantation with histopathology (12 week) | Pass | Pass |
| Physiochemical | Pass | Pass |
| Shelf Life Testing | Meets Product Specification after aging | Met Product Specification after aging (Implied by "Pass") |
Information Not Applicable to this Submission:
The following information is not provided in the original text as the submission is for a device modification where existing acceptance criteria and methods were used, rather than a new de novo study with specific performance endpoints outlined in these categories. The emphasis is on substantial equivalence to the predicate device, confirming that the modified device continues to meet the established performance and safety characteristics of the existing product line.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not specified. The document indicates that "All testing was done with standard test methods for these parameters" and that "There is no change to these tests or to their acceptance criteria for the Branch Graft line extension." This suggests that the established test methods for the predicate device were applied, without specifying new sample sizes or data provenance for this specific modification.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This is a medical device for vascular repair, not an image analysis or diagnostic device requiring expert interpretation for ground truth.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is a medical device for vascular repair.
- 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 for vascular repair, not an AI or diagnostic device involving human reader performance.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a medical device for vascular repair, not an AI or diagnostic device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the physical and biological tests, "ground truth" is established by the specified acceptance criteria for each test (e.g., specific dimensions, permeability rates, "Pass" for biocompatibility).
- The sample size for the training set
- Not applicable. This is a medical device for vascular repair, not a machine learning model requiring a training set.
- How the ground truth for the training set was established
- Not applicable. This is a medical device for vascular repair.
§ 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.”