(307 days)
Sulzer Vascutek Fluoropassiv™ Fabric is indicated for vascular patch grafting and for intracardiac patching. The Fluoropassiv™ Thin Wall Carotid Patch is, in addition, indicated for patch closure after endarterectomy, particularly of the carotid arteries.
The Sulzer Vascutek Fluoropassiv™ Cardiovascular Fabric product line consists of a non-crimped Gelseal™ patch, Gelsoft™ patch, and a Thin Wall Carotid patch. Each product line is fluoropolymer coated and gelatinsealed, knitted polyester, with a base fabric porosity of 1433 ml/cm²/min, and 3495 ml/cm²/min, respectively, and are available in various square or rectangular sizes. The polyester fabrics have been impregnated with an absorbable mammalian gelatin which seals the prostheses in the same manner as the fibrin deposited in traditional procedures. The gelatin sealant obviates the need for preclotting prior to implantation. The gelatin is of United States Pharmacopeia (USP) standard and is derived from bovine bone.
The Sulzer Vascutek Fluoropassiv™ Cardiovascular Fabric, including the Gelseal™ patch, Gelsoft™ patch, and Thin Wall Carotid patch, underwent comprehensive in vitro and in vivo testing to demonstrate its substantial equivalence to the predicate device, Sulzer Vascutek Cardiovascular Fabric (K963611).
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the statement that the testing "provides evidence that Sulzer Vascutek Fluoropassiv™ Fabric is substantially equivalent to the predicate fabric." While specific numerical acceptance criteria are not explicitly stated in the provided text, the device's performance across several key metrics was deemed acceptable compared to the predicate.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Burst Strength | Substantially equivalent to predicate fabric (K963611) | Acceptable in vitro performance |
| Suture Retention | Substantially equivalent to predicate fabric (K963611) | Acceptable in vitro performance |
| Tensile Strength | Substantially equivalent to predicate fabric (K963611) | Acceptable in vitro performance |
| Water Porosity | Substantially equivalent to predicate fabric (K963611) | Base fabric porosity of 1433 ml/cm²/min and 3495 ml/cm²/min |
| In Vivo Performance | Acceptable in vivo performance based on animal testing | Acceptable in vivo performance demonstrated in animal testing |
| Biocompatibility | Suitable for intended use | Thoroughly tested and characterized |
| Shelf-Life | Established shelf-life | 4 years |
Study Details:
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Sample sizes used for the test set and the data provenance:
- The document does not specify the precise sample sizes used for each in vitro test (burst strength, suture retention, tensile strength, water porosity) or for the animal testing.
- Data Provenance: The nature of the studies (in vitro performance testing and animal testing) suggests these were prospective studies conducted specifically for this 510(k) submission. No information is provided regarding the country of origin for the data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The study primarily relies on objective physical property measurements and animal model observations rather than expert consensus on subjective assessments.
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Adjudication method for the test set:
- This information is not provided. Given the nature of the tests (physical properties and animal studies), and the lack of human interpretation, a formal adjudication method as typically used for image-based or clinical diagnostic studies is unlikely to have been applied in this context.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. This type of study is not relevant for evaluating the performance of a cardiovascular fabric, which is an implantable medical device assessed through physical and biological property testing rather than human interpretation of data.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in a sense. The in vitro performance testing and animal testing are standalone assessments of the device's physical and biological properties, independent of human clinical application interpretation. There is no algorithm involved.
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The type of ground truth used:
- In vitro testing: The ground truth for performance metrics like burst strength, suture retention, tensile strength, and water porosity is based on direct physical measurements and established engineering standards, compared against the properties of the predicate device.
- Animal testing: The ground truth for in vivo performance and biocompatibility is established through direct observation and analysis of biological responses in animal models.
- Biocompatibility: The ground truth for biocompatibility is established through well-characterized materials and testing according to relevant standards to ensure suitability for intended use.
- Gelatin sealant: The safety and effectiveness of the gelatin sealant were previously established and approved through PMA# P890045 for the Sulzer Vascular Gelseal™ Vascular Graft.
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The sample size for the training set:
- This concept is not applicable here as this is not a machine learning or AI-based device. The device's performance is established through direct physical and biological testing, not through training on a dataset.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of medical device evaluation.
§ 870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
(a)
Identification. An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.(b)
Classification. Class II (performance standards).