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 Mosh (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. The mesh is coated on the PGA surface with a bioresorbable, chemically modified sodium hyaluronate (HA), carboxymethylcellulose (CMC) and a polyethylene glycol (PEG) based hydrogel.

The fascial side of the mesh allows a prompt fibroblastic response through the interstices of the mesh, encouraging tissue ingrowth, similar to polypropylene mesh alone. The visceral 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 submission describes a medical device, Sepramesh™ IP Bioresorbable Coating - Permanent Mesh, seeking 510(k) clearance. This type of submission focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than proving specific performance against an acceptance criterion in a clinical study. Therefore, the information requested regarding acceptance criteria and a study proving device performance in the context of an AI/human-in-the-loop study is not applicable.

Here's a breakdown of why this information isn't present in this specific document:

Device Type: Sepramesh™ IP is a surgical mesh for soft tissue repair, not an AI or diagnostic imaging device. Its clearance pathway is based on material properties, design, and intended use comparison to existing devices.
510(k) Clearance: The 510(k) process is about demonstrating "substantial equivalence," meaning that the new device is as safe and effective as a legally marketed device. It typically relies on comparisons of technological characteristics, materials, and intended use, often supported by bench testing and sometimes animal studies, rather than large-scale clinical trials with specific performance endpoints like those seen in AI device submissions.

Therefore, many of the requested categories related to AI performance, human reader studies, and large-scale test datasets do not apply to this specific 510(k) submission.

Here is the information that can be extracted from the provided text, recognizing the nature of a 510(k) for a surgical mesh:

1. A table of acceptance criteria and the reported device performance:

This document does not present a table of specific acceptance criteria in the way one might see for an AI device (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" for a 510(k) of this nature involve demonstrating substantial equivalence to predicate devices, focusing on:

Materials: Comparison of polypropylene, PGA, HA, CMC, PEG.
Design: Dual-component mesh with two sides (fibroblastic response side and bioresorbable separation layer).
Intended Use: Reconstruction of soft tissue deficiencies, such as hernia repair.
Performance (General): Bioresorption profile of coating and PGA fibers, permanent nature of polypropylene mesh, tissue ingrowth, minimal tissue attachment/adhesions.

The document states: "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..." This statement from the FDA serves as the "reported device performance" in the context of the 510(k) process – that it meets the "acceptance criteria" of being substantially equivalent.

2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI device or a diagnostic device; therefore, there isn't a "test set" in the sense of patient data for performance evaluation. The substantial equivalence is based on component comparison and intended use.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for the reasons stated above.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for the reasons stated above.

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. Sepramesh™ IP is a surgical implant, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate devices and the demonstration that the new device shares similar technological characteristics and performs similarly.

8. The sample size for the training set: Not applicable. This is not a machine learning or AI device.

9. How the ground truth for the training set was established: Not applicable. This is not a machine learning or AI device.

Summary

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K040868

510(K) SUMMARY (as required by 21 CFR 807.92) 10.0

Pursuant to 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 Coating - Permanent Mesh (Sepramesh™ IP), as well as the substantial equivalence decision making process used for Sepramesh™.

10.1 Sponsor/Applicant Name and Address:

Genzyme Corporation 500 Kendall Street Cambridge, MA 02142

10.2 Sponsor Contact Information:

Michael G. Halpin Director, Regulatory Affairs Phone: 617.591.5836 FAX: 617.761.8414 email: michael.halpin@genzyme.com

10.3 Date of Preparation of 510(k) Summary:

May 25, 2004

10.4 Device Trade or Proprietary Name:

Sepramesh™ IP Bioresorbable Coating -- Permanent Mesh

10.5 Device Common/Usual or Classification Name:

Surgical Mesh

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Name of Predicate Device	Name of Manufacturer(Town, State)	510(k) Number
Sepramesh™	Genzyme Corporation,Cambridge, MA	K994328
Bard® Mesh	Davol Inc., Cranston, RI	Pre-amendment
Bard® Composix® E/XMesh	Davol Inc., Cranston, RI	KK002684
Vicryl™ Knitted Mesh	Ethicon Inc., Somerville, NJ	K810428
Dexon® PGA Mesh	Davis & Geck Inc., Norwalk, CT	K830889

Identification of the Legally Marketed Devices to which Equivalence is Being Claimed: 10.6

10.7 Device Description:

10.8 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.

2/3

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K040864

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

Table 15 is the Table of Similarities and Differences between Genzyme's Sepramesh™ IP Bioresorbable Coating - Permanent Mesh and the legally marketed devices identified in Section 10.6.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 4 2004

Mr. Michael G. Halpin Director, Regulatory Affairs Genzyme Corporation 500 Kendall Street Cambridge, Massachusetts 02142

Re: K040868

Trade/Device Name: Sepramesh™ IP Bioresorbable Coating - Permanent mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: April 1, 2004 Received: April 5, 2004

Dear Mr. Halpin:

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 for use surfally in the encreated of 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, do hoosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and coometre fore, 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 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. Michael G. Halpin

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter with and w yourse FDA finding of substantial equivalence of your device to a legally premaired predicated 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 if you desire specific acrepliance at (301) 594-4659. 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 other general michhaal 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/dsma/dsmamain.html

Sincerely yours,

Mark A. Milhousen

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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16040868

Indications for Use Form

510(k) Number (if known): K040868

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.

Prescription 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)

Mark N. Millhurn

Division Sign=Off Division of General, Restorative, and Neurological Devices

Page I of I

1040868 510(k) Number_

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.