RAPISEAL PATCH

K964857 · Fusion Medical Technologies, Inc. · FTL · Feb 18, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K964857
• Device Name: RAPISEAL PATCH
• Applicant: Fusion Medical Technologies, Inc.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Feb 18, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The RapiSeal Patch is intended to provide a temporary matrix during the natural tissue repair process, resulting in the additional benefit of hemostatic tamponade.

Device Story

RapiSeal Patch is a bioresorbable gelatin-based thin film; supplied sterile/non-pyrogenic for single-use. Applied by clinicians during surgery to provide temporary matrix for tissue repair and hemostatic tamponade. Mechanical attachment via standard electrosurgery unit. Acts as physical barrier to stop bleeding and seal air leaks. Benefits include reduced bleeding and successful sealing of surgical wounds/air leaks. Evaluated in splenic injury models and lung air leak clinical cases.

Clinical Evidence

Clinical evaluation in 48 patients treating lung air leaks; demonstrated successful intraoperative reduction/sealing of air leaks with no reported device-related complications. Nonclinical evidence includes porcine splenic injury model (n=12) showing significantly reduced bleeding compared to controls and biocompatibility at 7 and 28 days.

Technological Characteristics

Bioresorbable gelatin film; absorbable in <28 days. Mechanical attachment via standard electrosurgery unit. Supplied sterile and non-pyrogenic. Biocompatibility verified per ISO 10993.

Indications for Use

Indicated for hemostatic tamponade in patients requiring temporary matrix support during natural tissue repair.

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

• Dexon "S" Polyglycolic Acid Mesh (Davis & Geck)

Submission Summary (Full Text)

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K964857

Appendix E--Revised January 31, 1997
FEB 18 1997

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: January 31, 1997

2. Device Name:

Trade Name: RapiSeal™ Patch
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:

Dexon "S" Polyglycolic Acid Mesh
Davis &amp; Geck

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 RapiSeal Patch is intended to provide a temporary matrix during the natural tissue repair process, resulting in the additional benefit of hemostatic tamponade.

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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.

The SURGICAL PATCH Comparison to Predicate Device

| | FUSION PATCH | Dexon Mesh |
| --- | --- | --- |
| Intended Use: | Provide a temporary matrix during the natural tissue repair process | Provide temporary support during the natural tissue repair process |
| Indications for Use: | Hemostatic tamponade | Hemostatic tamponade |
| Product Form: | Thin film | Mesh |
| Materials: | Gelatin | Polyglycolic Acid |
| Absorbable: | Yes (<28 days) | Yes (60-90 days) |
| Method of Attachment: | Mechanical; standard electrosurgery unit | Mechanical; the mesh is sutured in place |

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7. Performance Data

7.1 Nonclinical Tests

7.1.1 Biocompatibility

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

7.1.2 Effectiveness

Twelve pigs (6 untreated control animals and 6 Patch treated animals) underwent surgery to mimic splenic injury and bleeding. The Patch was effective in providing a means to approximate and close surgically created wounds in the spleen. In addition, the tamponade provided by the Patch resulted in complete cessation of bleeding at the wound site. Moreover, the reduction in bleeding after Patch application was significantly better than that for the untreated controls. Gross and histological examination at 7 and 28 days post-implant showed no abnormal responses to the Patch in the splenic tissue or in the abdomen, showing the Patch material to be biocompatible. No adhesions associated with Patch use were observed.

7.2 Clinical Tests

The RapiSeal Patch was used to treat air leaks in the lung in a total of 48 patients during the pre-commercial phase of the product. No Patch-related complications were reported during this clinical evaluation. In addition, the study demonstrated that the Patch was capable of successfully reducing or sealing air leaks intraoperatively.

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.