Sepramesh™ IP Bioresorbable Coating/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 utilizes violet dyed PGA fibers. The second version utilizes natural beige PGA fibers instead of the original violet version. The mesh is coated on the PGA surface with a bioresorbable coating 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

The provided text is a 510(k) summary for a medical device called Sepramesh™ IP Bioresorbable Coating - Permanent Mesh. This document is a premarket notification to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device.

The 510(k) summary does not contain a study proving the device meets acceptance criteria in the way described in your request. A 510(k) submission typically focuses on demonstrating substantial equivalence to a predicate device, often through a comparison of technological characteristics, materials, and intended use, rather than presenting a new clinical study with specific performance metrics against pre-defined acceptance criteria.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment are not present in this type of regulatory submission. The document explicitly states: "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™M IP Bioresorbable Coating - Permanent Mesh (Sepramesh™ IP)." This indicates a review of existing information and a comparison, not a de novo clinical trial with new performance data.

Here's a breakdown of what can be extracted from the provided text, and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the 510(k) summary. The document does not describe specific acceptance criteria (e.g., a certain percentage reduction in adhesions, a specific tensile strength after implantation) or present new performance data from a clinical study to meet such criteria. Instead, it justifies substantial equivalence by comparing the Sepramesh™ IP with a predicate device (K053066) based on broad characteristics like classification, indication, labeling claims, product design, materials, and sizes.

The "Performance" of the device is described qualitatively:

"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."

These are descriptive statements about the device's function, not quantitative performance metrics against acceptance criteria from a specific study.

2. Sample size used for the test set and the data provenance:

Not applicable/Not provided. This document does not describe a "test set" in the context of an AI/algorithm performance study. It's a regulatory submission for a physical medical device (surgical mesh).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not provided. This document does not involve expert review or ground truth establishment for a test set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable/Not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable/Not provided. This is not an AI/software device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable/Not provided. This is not an AI/software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable/Not provided.

8. The sample size for the training set:

Not applicable/Not provided. This is not a machine learning device, so there is no "training set."

9. How the ground truth for the training set was established:

Not applicable/Not provided.

In summary: The provided document is a 510(k) premarket notification for a surgical mesh, demonstrating substantial equivalence to a previously cleared device. It does not contain the details of a study with acceptance criteria, sample sizes, expert involvement, or ground truth establishment as would be found in a performance study for, for example, a diagnostic AI device. The comparison provided (Table 5) focuses on the device's features, intended use, and materials to argue for equivalence, not on quantitative performance metrics.

Summary

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PART 2

K063739
page 1 of 3

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™M IP Bioresorbable Coating - Permanent Mesh (Sepramesh™ IP).

1.1 Sponsor/Applicant Name and Address:

Genzyme Corporation

500 Kendall Street

Cambridge, MA 02142

1.2 Sponsor Contact Information:

Matthew Hibbert

Senior Associate, Regulatory Affairs

T: (617) 374-7463

F: (617) 761-8414

matthew.hibbert@genzyme.com

1.3 Date of Preparation of 510(k) Summary:

December 15, 2006

1.4 Device Trade or Proprietary Name:

Sepramesh™ IP Bioresorbable Coating/Permanent Mesh

1.5 Device Common/Usual or Classification Name:

Surgical Mesh (21 CFR 878.3300, Product Code FTL)

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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	K053066

1.7 Device Description:

1.8 Intended Use:

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 5 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.

Feature	Sepramesh™ IP BioresorbableCoating/Permanent Mesh	Proposed Sepramesh™ IPBioresorbable Coating/PermanentMesh
Classification	Class II: Polymeric Surgical Mesh	Same
Indication	Reconstruction of soft tissuedeficiencies, such as for the repair ofhernias	Same
LabelingClaims	Biopolymer surface minimizes tissue andvisceral adhesions to device	Same
ProductDesign	Polypropylene/PGA mesh withbiopolymer coating on one surface	Same
Materials	Polypropylene, PGA (violet dyed fibersor natural beige fibers), HA/CMC, PEGbased hydrogel	Same
Sizes	3"x6" to 8"x12"	Add 12"x14"

Table 5: Table of Similarities and Differences/Substantial Equivalence to Predicate Devices

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, composed of four intertwined lines. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 7 2007

Genzyme Biosurgery % Mr. Matthew Hibbert Senior Associate, Regulatory Affairs 55 Cambridge Parkway Cambridge, Massachusetts 02142

Re: K063739

Trade/Device Name: Sepramesh™ IP Bioresorbable Coating - Permanent Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: December 15, 2006 Received: December 18, 2006

Dear Mr. Hibbert:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to 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. Iisting 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 comply 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 – Mr. Matthew Hibbert

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely you

Fik

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

Enclosure

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genzyme

Sepramesh™ IP Bioresorbable Coating/Permanent Mesh

Indications for Use Form

510(k) Number (if known): To be determined KO63739

Device Name: Sepramesh™ IP Bioresorbable Coating – Permanent Mesh

Indications for Use:

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

Presciption Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21. CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Kestorative, and Neurological Devices

510(k) Number K063739

Proprietary and Confidential DOCUMENT INFO: SEPRAMESH IP 510K LARGER SIZE.DOC

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.