← Product Code [DXZ](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXZ) · K962342 # HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCH (K962342) _Meadox Medicals, Div. Boston Scientific Corp. · DXZ · Sep 10, 1996 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXZ/K962342 ## Device Facts - **Applicant:** Meadox Medicals, Div. Boston Scientific Corp. - **Product Code:** [DXZ](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXZ.md) - **Decision Date:** Sep 10, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.3470 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular - **Attributes:** Therapeutic ## Indications for 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. ## Regulatory 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](/device/K955349.md)) - Gore-Tex® Peripheral Vascular Patch ([K821717](/device/K821717.md)) - Gore-Tex® Cardiovascular Patch ([K811841](/device/K811841.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 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. --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXZ/K962342](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXZ/K962342) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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