KUGEL HERNIA PATCH

K963141 · Douglas Bueschel · FTL · Oct 11, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K963141
• Device Name: KUGEL HERNIA PATCH
• Applicant: Douglas Bueschel
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Oct 11, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the Kugel Hernia Patch™ is a surgical mesh for hernia repair. It is indicated for use in all forms of hernia repair. A few examples of hernia repair are Inguinal, Fermoral, Incisional and Ventral hernia repairs in the abdominal wall and the groin area.

Device Story

Surgical mesh for reinforcement of hernia defects; used in abdominal wall and groin hernia repairs. Device consists of polypropylene mesh; implanted by surgeons during hernia repair procedures. Provides structural reinforcement to tissue; facilitates repair of inguinal, femoral, incisional, and ventral hernias. Benefits include tissue support and defect closure.

Clinical Evidence

Bench testing only. Evidence includes biocompatibility per ANSI/AAMI/ISO 11135-1994, sterility validation per ANSI/AAMI/ISO 11135-1994, LAL testing, packaging integrity validation, and NTSB shipping durability testing.

Technological Characteristics

Material: Polypropylene mesh. Sterilization: Ethylene Oxide (EtO). Standards: Biocompatibility and sterility per ANSI/AAMI/ISO 11135-1994.

Indications for Use

Indicated for all forms of hernia repair, including inguinal, femoral, incisional, and ventral hernias in the abdominal wall and groin area.

Regulatory Classification

Identification

Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

Predicate Devices

• Atrium Polypropylene Mesh

Submission Summary (Full Text)

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OCT 11 1996
K963141

# Kugel Hernia Patch™ 510(k) Summary

In accordance with 21 CFR section 807.92 Surgical Sense, Inc. is submitting the following safety and effectiveness summary.

1) Submitter Information
- Surgical Sense, Inc.
- 2108 Scenic Bay Drive
- Arlington, TX 76103
- 817-457-7067
- Contact: J. Doug Inman
- Prepared: August 5, 1996

2) Name of Device
- Proprietary Name: Kugel Hernia Patch™
- Common Name: Surgical Mesh
- Classification Name: Surgical Mesh

3) Substantially equivalent to Atrium Polypropylene Mesh

4) The Kugel Hernia Patch™ is a surgical mesh for reinforcement of a hernia defect.

5) The intended use of the Kugel Hernia Patch™ is a surgical mesh for hernia repair. It is indicated for use in all forms of hernia repair. A few examples of hernia repair are Inguinal, Fermoral, Incisional and Ventral hernia repairs in the abdominal wall and the groin area.

6) The Kugel Hernia Patch™ is equivalent to the Atrium Polypropylene Mesh in that it has the same intended use (hernia repair), the same material (polypropylene mesh) and the same sterilization method (EtO).

The Kugel Hernia Patch™ has been designed using materials from existing medical devices. The following tests and validation have been or will be performed on the Kugel Hernia Patch™:

- Biocompatibility per ANSI/AAMI/ISO 11135-1994
- Sterility validation per ANSIAAMI/ISO 11135-1994
- Sterility testing per industry accepted protocols
- LAL testing per industry accepted test protocols
- Packaging integrity process validation
- NTSB shipping durability test

Kugel Hernia Patch™ 510(k)
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