Sepramesh™ IP Bioresorbable Barrier - Permanent Mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.

Device Description

Sepramesh™ IP Bioresorbable Coating/Permanent Mesh (Sepramesh™ IP) is a dualcomponent (absorbable and non-absorbable), sterile prosthesis designed for the reconstruction of soft tissue deficiencies. Sepramesh™ IP is co-knitted using polypropylene and polyglycolic acid (PGA) fibers to result in a two-sided mesh with a polypropylene surface and PGA surface. Genzyme will offer two versions of the device. The first version, previously cleared through K040868 utilizes violet dyed PGA fibers. The second version described in this submission utilizes natural beige PGA fibers. The mesh is coated on the PGA surface with a bioresorbable barrier of chemically modified sodium hyaluronate (HA), carboxymethylcellulose (CMC) and a polyethylene glycol (PEG) based hydrogel.

The uncoated side of the mesh allows a prompt fibroblastic response through the interstices of the mesh, encouraging tissue ingrowth, similar to polypropylene mesh alone. The coated side of the mesh provides a hydrophilic bioresorbable layer, separating the mesh from underlying tissue and organ surfaces during the critical wound-healing period resulting in minimal tissue attachment and visceral adhesions to the mesh. Shortly after placement, the biopolymer coating becomes a hydrated gel that is resorbed from the site in less than 30 days. The absorption of the PGA fibers is essentially complete between 50 and 80 days. The polypropylene mesh is permanent and allows for tissue ingrowth.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the Sepramesh™ IP Bioresorbable Coating/Permanent Mesh, based on the provided text:

Important Note: The provided document is a 510(k) summary for a medical device. This type of document focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing independent clinical efficacy or presenting detailed acceptance criteria and performance data in the same way a clinical trial report would. Therefore, the information provided below will reflect this context.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) summary, explicit "acceptance criteria" for precise numerical performance metrics are not typically presented in the same way as a full clinical study with predefined endpoints. Instead, the acceptance criterion for a 510(k) is usually substantial equivalence to predicate devices. The performance is reported in terms of comparability to these predicates.

Acceptance Criterion (Based on Substantial Equivalence to Predicates)	Reported Device Performance (Sepramesh™ IP)
Biocompatibility and Safety	Considered non-toxic, non-mutagenic, non-sensitizing, biocompatible, and safe. (Based on ISO 10993 and GLP studies)
Adhesion Formation	Performed substantially equivalent or better than Bard® Composix® E/X Mesh and Bard® Mesh. Demonstrated minimal tissue attachment and visceral adhesions during the critical wound-healing period due to the coated side.
Tissue Ingrowth	Overall performance, including tissue ingrowth, was substantially equivalent to Bard® Composix® E/X Mesh and Bard® Mesh. The uncoated side allows a prompt fibroblastic response through the interstices of the mesh, encouraging tissue ingrowth. Cellular response and tissue ingrowth were comparable to predicates.
Physical and Mechanical Characteristics	Substantially equivalent to currently marketed predicate devices for: Mesh thicknessMesh knit characteristicsPore sizeMesh mass/areaSuture retention strengthTear propagation strengthBurst strength

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document mentions an in vivo study in a rabbit hernia repair model. However, the specific number of animals (sample size) used in this animal study is not provided in the excerpt.
Data Provenance: The study was an in vivo animal study conducted specifically for this submission to evaluate the device's performance. The country of origin is not explicitly stated, but Genzyme Corporation is based in Cambridge, MA (USA). The study is prospective in nature for the purpose of demonstrating substantial equivalence.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document does not detail the number of experts or their qualifications for evaluating the in vivo rabbit study. In animal studies, assessments like adhesion formation, tissue ingrowth, and cellular response are typically performed by veterinary pathologists or other experts in tissue analysis, but this specific information is absent.

4. Adjudication Method for the Test Set

The adjudication method for the in vivo rabbit study is not specified in the provided text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was NOT done. This document pertains to a medical device (surgical mesh), not an imaging or diagnostic AI system. MRMC studies are typically used to assess the performance of diagnostic aids (like AI algorithms) in improving human reader interpretation of images. The study described here is an in vivo animal study evaluating the physical and biological interaction of the mesh in a living system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the device is a physical surgical mesh and not an algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant here. The in vivo rabbit study evaluates the device itself, not an algorithm's performance.

7. The Type of Ground Truth Used

The ground truth for the in vivo animal study appears to be based on:

Direct Observation/Measurement: Evaluation of adhesion formation and tissue ingrowth in the rabbit hernia repair model.
Histopathological Analysis: Assessment of cellular response.
Standardized Physical Testing: Measurement of mesh thickness, knit characteristics, pore size, mass/area, suture retention strength, tear propagation strength, and burst strength.

8. The Sample Size for the Training Set

Not applicable. The device is a surgical mesh, not an AI algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This device does not involve an AI algorithm with a training set.

Summary

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Ko53066 1/5

genzyme

DEC 1 9 2005

Sepramesh™ IP Bioresorbable Coating/Permanent Mesh

PART 2

510(K) SUMMARY AS REQUIRED BY 21 CFR 807.92

Per Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, Genzyme Corporation is providing a summary of the safety and effectiveness information available for Sepramesh™ IP Bioresorbable Barrier - Permanent Mesh (Sepramesh™ IP), as well as the substantial equivalence decision making process used for SeprameshTM.

Sponsor/Applicant Name and Address: 1.1

Genzyme Corporation 500 Kendall Street Cambridge, MA 02142

Sponsor Contact Information: 1.2

Lisa D. Crockett Sr. Regulatory Affairs Associate Phone: 617.591.5548 FAX: 617.761.8414 email: lisa.crockett(@genzyme.com

Date of Preparation of 510(k) Summary: 1.3

October 27, 2005October 26, 2005

Device Trade or Proprietary Name: 1.4

Sepramesh™ IP Bioresorbable Coating/Permanent Mesh

Device Common/Usual or Classification Name: 1.5

Surgical Mesh (21 CFR 878.3300, Product Code FTM)

Identification of the Legally Marketed Devices to which Equivalence 1.6 is Being Claimed:

Name of Predicate Device	Name of Manufacturer(Town, State)	510(k) Number
Sepramesh™ IP	Genzyme Corporation,Cambridge, MA	K040868
Sepramesh™	Genzyme Corporation,	K994328

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K053066 2/5

Image /page/1/Picture/1 description: The image shows the word "genzyme" in a simple, sans-serif font. The letters are all lowercase and evenly spaced. The word appears to be a company or brand name, given its presentation as a single word.

Sepramesh™ IP Bioresorbable Coating/Permanent Mesh

	Cambridge, MA
Bard® Composix® E/X Mesh	Davol Inc., Cranston, RI	K002684
Bard® Mesh	Davol Inc., Cranston, RI	Pre-Amendment
Vicryl™ Knitted Mesh	Ethicon Inc., Somerville, NJ	K810428
Dexon® PGA Mesh	Davis & Geck Inc., Norwalk,CT	K830889

Device Description: 1.7

Intended Use: 1.8

Sepramesh™ IP Bioresorbable Coating/Permanent Mesh is indicated for use in the reconstruction of soft tissue deficiencies such as for the repair of hernias.

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Comparison of Technological Characteristics of Sepramesh™ IP with 1.9 Legally Marketed Devices:

Table 16 is the Table of Similarities and Differences between Genzyme's Sepramesh™ IP Bioresorbable Coating/Permanent Mesh and the legally marketed devices identified in Section 1.6.

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	A-4777
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Feature	ProposedSepramesh™ IPBioresorbableCoating/Permanent Mesh	Sepramesh™ IPBioresorbableCoating/Permanent Mesh	Sepramesh™BiosurgicalComposite	Bard®Composix® E/XMesh	Bard® Mesh	Dexon®PGA Mesh	Comments onDifferences
510(k) No.	To be determined	K040868	K994328	K002684	Pre-Amendment	K830889	Not Applicable
Classification	Class II: Polymeric	Class II: Polymeric	Class II: PolymericSurgical Mesh	Class II: PolymericSurgical Mesh	Class II: PolymericSurgical Mesh	Class II: PolymericSurgical Mesh	SubstantiallyEquivalent
Indication	Reconstruction ofsoft tissuedeficiencies, suchas for the repair ofhernias	Reconstruction ofsoft tissuedeficiencies, suchas for the repair ofhernias	Reconstruction ofsoft tissuedeficiencies, suchas for the repairof hernias	Reconstruction ofsoft tissuedeficiencies, suchas for the repairof hernias andchest wall defects	Reinforce softtissue whereweaknessexists, i.e.,repair ofhernias andchest walldefects	Externalorgan supportand organarchitecturepreservation	SubstantiallyEquivalent
LabelingClaims	Biopolymer surfaceminimizes tissueand visceraladhesions to device	Biopolymer surfaceminimizes tissueand visceraladhesions to device	HA/CMC surfaceminimizes tissueand visceraladhesions to device	ePTFE minimizesadhesions todevice	None	None	SubstantiallyEquivalent
ProductDesign	Polypropylene/PGA mesh withbiopolymer coatingon one surface	Polypropylene/PGA mesh withbiopolymer coatingon one surface	Polypropylenemesh withHA/CMC coatingon one surface	Polypropylenemesh with anePTFE layerstitched on onesurface	Polypropylenemesh	PGA Mesh	Coated surfaceplaced facingviscera.

able 16: Table of Similarities and Differences/Substantial Equivalence to Predicate Devices

Proprietary and Confidential
Document Info: SEPRAMESH_IP_510K_FINAL WO APPENDICES I.DO

Kossokb

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Summary of Nonclinical Data: 1.10

The biocompatibility and safety tests conducted for Sepramesh™ IP were selected in accordance with the Blue Book Memorandum G95-1, "Use of International Standard ISO 10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing." All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices. Based on the results from these studies, Sepramesh™ IP is considered to be non-toxic, nonmutagenic, non-sensitizing, biocompatible and safe.

The effectiveness of Sepramesh™ IP was compared in vivo in a rabbit hernia repair model to Bard® Composix® E/X Mesh and Bard® Mesh. The overall performance of Sepramesh™ IP, including adhesion formation and tissue ingrowth, was substantially equivalent to these hernia repair products. Cellular response and tissue ingrowth for all three groups was comparable. Sepramesh™ IP performed substantially equivalent or better than Bard® Composix® E/X Mesh and Bard® Mesh in all of the evaluated adhesion reduction categories.

The physical and mechanical characteristics of Sepramesh™ IP, such as mesh thickness, mesh knit characteristics, pore size, mesh mass/area, suture retention strength, tear propagation strength and burst strength, are substantially equivalent to the currently marketed predicate devices.

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Image /page/5/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling an emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines representing the branches of the department. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 9 2005

Ms. Lisa D. Crockett Sr. Regulatory Affairs Associate Genzyme Corporation 55 Cambridge Parkway Cambridge, Massachusetts 02142

Re: K053066

Trade/Device Name: Sparamesh IP Bioresorbable Coating/Permanent Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: October 31, 2005 Received: December 1, 2005

Dear Ms. Crockett:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Crockett

This letter will allow you to begin marketing your device as described in your Section 510(k) I ins letter witi anow you to oegin maine of substantial equivalence of your device to a legally premarket notification: "The PDF interestion for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you utsire specific advice for your as (240) 276-0115. Also, please note the regulation entitled, Contact on Other of Compitante and ret notification (21CFR Part 807.97). You may obtain Of Small other general informational and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 443 6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barbara Buehl

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K053066

Device Name: Sepramesh™ IP Bioresorbable Barrier - Permanent Mesh

Indications For Use:

Sepramesh™ IP Bioresorbable Barrier - Permanent Mesh is indicated for use in the Sepramesn'" IP Bloresorbable Barns " Permanent of hernias.
reconstruction of soft tissue deficiencies, such as for the repair of hernias.

× Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

.. .

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Friedrich for MCM

(Division Division of Ge and Neurological D

Page 1 of 1_

510(k) Number K1053066

Regulation Number and Section

§ 878.3300 Surgical mesh.

(a)
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.(b)
Classification. Class II.