HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCH

K962342 · Meadox Medicals, Div. Boston Scientific Corp. · DXZ · Sep 10, 1996 · Cardiovascular

Device Facts

• Record ID: K962342
• Device Name: HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCH
• Applicant: Meadox Medicals, Div. Boston Scientific Corp.
• Product Code: DXZ · Cardiovascular
• Decision Date: Sep 10, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The HEMASHIELD FINESSE™ Ultra-Thin, Knitted Cardiovascular Patch is indicated for cardiac and vascular patch grafting. The fabric is also recommended for use in patients requiring systemic heparinization prior to, or during, surgery.

Device Story

Knitted polyester fabric patch; impregnated with bovine collagen; contains glycerol softening agent. Used for cardiac and vascular patch grafting. Implanted by surgeons during cardiovascular procedures. Provides structural repair or reinforcement of cardiovascular tissues. Benefits include biocompatible material profile and suitability for heparinized patients.

Clinical Evidence

Bench testing only. Comparative analysis performed against predicate devices for burst strength, wall thickness, suture retention strength, tensile strength, water permeability, and suture hole elongation; all results equivalent to marketed predicate.

Technological Characteristics

Knitted polyester fabric; bovine collagen impregnated; glycerol softening agent. Dimensions: ultra-thin profile. Biocompatibility established via equivalence to predicate HEMASHIELD® fabrics tested per ISO 9000 standards.

Indications for Use

Indicated for cardiac and vascular patch grafting in patients, including those requiring systemic heparinization prior to or during surgery.

Regulatory Classification

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.

Predicate Devices

• HEMASHIELD® Cardiovascular Fabrics (K955349)
• Gore-Tex® Peripheral Vascular Patch (K821717)
• Gore-Tex® Cardiovascular Patch (K811841)

Submission Summary (Full Text)

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K960342
SEP 10 1996

# 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

**Sponsor:** Meadow Medicals, Inc.
A Division of Boston Scientific Corporation
112 Bauer Drive
Oakland, New Jersey 07436

**Contact Person:** Susan Eichler-Huston
Regulatory Affairs Specialist

**Submission Date:** June 14, 1996

**Device Name:** HEMASHIELD FINESSE™ Ultra-Thin, Knitted Cardiovascular Patch

**Predicate Devices:** HEMASHIELD® Cardiovascular Fabrics (K955349)
Gore-Tex® Peripheral Vascular Patch (K821717)
Gore-Tex® Cardiovascular Patch (K811841)

**Description of Device:** The HEMASHIELD FINESSE™ Ultra-Thin, Knitted Cardiovascular Patch is a knitted polyester fabric, impregnated with bovine collagen and contains glycerol as a softening agent.

**Intended Uses:** The HEMASHIELD FINESSE™ Ultra-Thin, Knitted Cardiovascular Patch is indicated for cardiac and vascular patch grafting. The fabric is also recommended for use in patients requiring systemic heparinization prior to, or during, surgery.

**Substantial Equivalence:** The HEMASHIELD FINESSE™ Ultra-Thin, Knitted Cardiovascular Patch is identical to the HEMASHIELD® Knitted Double Velour Cardiovascular Fabric in materials, manufacturing processes, packaging and sterilization. The only difference is that the HEMASHIELD FINESSE™ Patch is thinner than the HEMASHIELD® Knitted Fabric. Testing has been performed that shows that the HEMASHIELD FINESSE™ Patch is substantially equivalent to the predicate devices.

**Product Testing:** The following tests have been performed on the HEMASHIELD FINESSE™ Ultra-Thin, Knitted Cardiovascular Patch:

| Burst Strength - | equivalent to marketed product |
| --- | --- |
| Wall Thickness - | equivalent to marketed product |
| Suture Retention Strength - | equivalent to marketed product |
| Tensile Strength - | equivalent to marketed product |
| Water Permeability - | equivalent to marketed product |
| Suture Hole Elongation - | equivalent to marketed product |

**Biocompatibility Testing:** The HEMASHIELD FINESSE™ Ultra-Thin, Knitted Cardiovascular Patch is identical in materials, processing, packaging and sterilization as the predicate HEMASHIELD® Cardiovascular Fabrics. As such, it is reasonable to assume that the device is also identical in biocompatibility to the predicate, which has been shown through testing performed in accordance with ISO 9000 Standards to be safe for their intended use.