Who is the manufacturer of HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCH?

Meadox Medicals, Div. Boston Scientific Corp. filed the 510(k) submission for HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCH (K962342).

What is the FDA product code for HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCH?

DXZ. It is classified under 21 CFR 870.3470 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCH?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCH?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCH

Q: What are the predicate devices for HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCH?

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

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)

Related Devices

K101740 — ALBOSURE POLYESTER VASCULAR PATCH · LeMaitre Vascular, Inc. · Sep 20, 2010
K963611 — VASCUTEK CARDIOVASCULAR FABRIC: VASCUTEK GELSEAL PATCH,VASCUTEK GELSOFT PATCH,VASCUTEK THIN WALL CAROTID PATCH · Vascutek, Ltd. · Nov 21, 1996
K172660 — Duravess bovine pericardial vascular patch · Edwards Lifesciences, LLC · Nov 17, 2017
K182493 — Bovine Pericardial Tissue Patch · Tisgenx · Jun 18, 2019
K972201 — PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENE · Sulzer Carbomedics, Inc. · Apr 14, 1998

Submission Summary (Full Text)

{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.