← Product Code [FTL](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FTL) · K961440 # SURGICAL PATCH, SURGICAL MEMBRANE, SURGICAL MESH (K961440) _Fusion Medical Technologies, Inc. · FTL · May 31, 1996 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FTL/K961440 ## Device Facts - **Applicant:** Fusion Medical Technologies, Inc. - **Product Code:** [FTL](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FTL.md) - **Decision Date:** May 31, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.3300 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Indications for 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. ## Regulatory 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) > 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} 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. {1} 164 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 | {2} 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. --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FTL/K961440](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FTL/K961440) **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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