SURGICAL PATCH, SURGICAL MEMBRANE, SURGICAL MESH

K961440 · Fusion Medical Technologies, Inc. · FTL · May 31, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K961440
• Device Name: SURGICAL PATCH, SURGICAL MEMBRANE, SURGICAL MESH
• Applicant: Fusion Medical Technologies, Inc.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: May 31, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Patch reinforces the soft tissue of the lung thereby sealing or reducing air leaks that occur during pulmonary surgery.

Device Story

Bioresorbable gelatin film; used in thoracic surgery to reinforce lung soft tissue; seals/reduces air leaks. Applied mechanically via standard electrosurgery unit. Used by surgeons in OR. Provides physical barrier to air leakage; facilitates tissue reinforcement. Benefits patient by reducing post-operative air leaks.

Clinical Evidence

Multi-center, open-label study; 26 patients; 52 treated air leaks. Primary endpoint: successful closure of air leaks. Result: 96% success rate. No product-related adverse effects reported. Biocompatibility testing performed per ISO-10993, including hemocompatibility, cytotoxicity, systemic toxicity, irritation, genotoxicity, and sensitization.

Technological Characteristics

Bioresorbable gelatin film; thin film form factor. Mechanical attachment via standard electrosurgery unit. Absorbable (<28 days). Supplied sterile and non-pyrogenic.

Indications for Use

Indicated for sealing or reducing air leaks in thoracic surgery for patients undergoing pulmonary surgery.

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

• Peri-Strips® (Bio-Vascular, Inc.)

Submission Summary (Full Text)

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K961440 163
MAY 31 1996

# 510(k) Summary
Fusion Medical Technologies, Inc.
The Patch

1. Sponsor: Fusion Medical Technologies, Inc.
1615 Plymouth Street
Mountain View, CA 94043

Contact Person: Debera Brown
Vice President, Regulatory and Clinical Affairs

Date of Summary Preparation: April 10, 1996

2. Device Name:

Trade Name: To be determined
Common/Usual Name: Surgical Patch, Surgical Membrane, Surgical Mesh
Classification Name: Surgical Mesh

3. Identification of the Predicate or Legally Marketed Devices to Which Equivalence is being Claimed:

Peri-Strips®
Bio-Vascular, Inc.

4. Device Description

The Patch is a bioresorbable film containing gelatin. Each Patch is supplied sterile and non-pyrogenic in a single-use package.

5. Intended Use

The Patch reinforces the soft tissue of the lung thereby sealing or reducing air leaks that occur during pulmonary surgery.

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6. A Statement of How the Technological Characteristics of the Device Compare to Those of the Predicate or Legally Marketed Device(s) Cited

Fusion Medical Technologies, Inc.
The PATCH
Comparison to Predicate Device

| | The PATCH | Peri-strip® |
| --- | --- | --- |
| Intended Use: | • Reinforce soft tissue of the lung | • Reinforce soft tissue of the lung under staple lines |
| Indications for Use: | • Seal or reduce air leaks in thoracic surgery | • Seal or reduce air leaks in thoracic surgery |
| Product Form: | Thin film | Thin film |
| Materials: | Gelatin | Pericardium |
| Absorbable: | Yes (<28 days) | Yes (2 years) |
| Method of Attachment: | Mechanical; standard electrosurgery unit | Mechanical; staples |

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165

## 7. Performance Data

### 7.1 Nonclinical Tests

Standard biocompatibility testing was performed according to the FDA-modified matrix recommended in FDA memorandum #G95-1 entitled, “Use of International Standard ISO-10993, Biological Evaluation of Medical Device Part-1: Evaluation and Testing”.

The product passed all of the following biocompatibility tests:

- Hemocompatibility
- Cytotoxicity--ISO agarose overlay
- Cytotoxicity--ISO elution method
- Acute Systemic Toxicity
- Irritation--Intracutaneous Reactivity
- Genotoxicity--Ames mutagenesis
- Genotoxicity--Sister chromatid exchange
- Genotoxicity--Chromosomal aberration
- Sensitization--Magnusson and Kligman
- Implantation/Subchronic Toxicity

### 7.2 Clinical Tests

Twenty six patients were enrolled in a multi-center, open label study in which the Patch was used to seal air leaks that occur during pulmonary surgery. Of the 52 leaks that were treated with the Patch, 96% were deemed to have successful closure. No product related adverse effects were noted during the study.

### 7.3 Conclusions Drawn from Nonclinical and Clinical Testing

The conclusions drawn from the nonclinical and clinical testing were that the product is biocompatible and functional for the intended use.