SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESH

K053066 · Genzyme Corporation · FTL · Dec 19, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K053066
• Device Name: SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESH
• Applicant: Genzyme Corporation
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Dec 19, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Sepramesh™ IP is a sterile, dual-component surgical mesh for soft tissue reconstruction; composed of co-knitted polypropylene and polyglycolic acid (PGA) fibers. One side features a bioresorbable barrier coating of chemically modified sodium hyaluronate (HA), carboxymethylcellulose (CMC), and polyethylene glycol (PEG) hydrogel. The uncoated polypropylene side facilitates fibroblastic tissue ingrowth; the coated side provides a hydrophilic barrier to minimize visceral adhesions during wound healing. The coating resorbs in <30 days; PGA fibers resorb in 50-80 days; polypropylene remains as a permanent scaffold. Used by surgeons in clinical settings for hernia repair. The device is placed with the coated side facing viscera to prevent adhesions. Benefits include reduced adhesion formation while maintaining structural support for tissue repair.

Clinical Evidence

No human clinical data. Evidence based on nonclinical biocompatibility testing per ISO 10993 and an in vivo rabbit hernia repair model. Rabbit study compared Sepramesh™ IP to Bard® Composix® E/X Mesh and Bard® Mesh, showing comparable cellular response, tissue ingrowth, and superior or equivalent adhesion reduction performance.

Technological Characteristics

Dual-component surgical mesh; polypropylene and polyglycolic acid (PGA) fibers. Bioresorbable coating: sodium hyaluronate (HA), carboxymethylcellulose (CMC), and polyethylene glycol (PEG). Sterile, Class II surgical mesh. Mechanical properties: mesh thickness, pore size, mass/area, suture retention, tear propagation, and burst strength.

Indications for Use

Indicated for reconstruction of soft tissue deficiencies, including hernia repair. No specific age or gender restrictions provided.

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

• Sepramesh™ IP (K040868)
• Sepramesh™ (K994328)

Reference Devices

• Bard® Composix® E/X Mesh (K002684)
• Bard® Mesh (Pre-Amendment)
• Vicryl™ Knitted Mesh (K810428)
• Dexon® PGA Mesh (K830889)

Submission Summary (Full Text)

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Ko53066 1/5

genzyme

1

## 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: [phone] FAX: [phone] 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<br>(Town, State) | 510(k) Number |
|--------------------------|---------------------------------------|---------------|
| Sepramesh™ IP | Genzyme Corporation,<br>Cambridge, MA | K040868 |
| Sepramesh™ | Genzyme Corporation, | K994328 |

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K053066 2/5

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## 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,<br>CT | K830889 |

### Device Description: 1.7

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.

### 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 |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| ----- | |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
| | |

| Feature | Proposed<br>Sepramesh™ IP<br>Bioresorbable<br>Coating/Permanent Mesh | Sepramesh™ IP<br>Bioresorbable<br>Coating/Permanent Mesh | Sepramesh™<br>Biosurgical<br>Composite | Bard®<br>Composix® E/X<br>Mesh | Bard® Mesh | Dexon®<br>PGA Mesh | Comments on<br>Differences |
|--------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|---------------------------------------------|
| 510(k) No. | To be determined | K040868 | K994328 | K002684 | Pre-<br>Amendment | K830889 | Not Applicable |
| Classification | Class II: Polymeric | Class II: Polymeric | Class II: Polymeric<br>Surgical Mesh | Class II: Polymeric<br>Surgical Mesh | Class II: Polymeric<br>Surgical Mesh | Class II: Polymeric<br>Surgical Mesh | Substantially<br>Equivalent |
| Indication | Reconstruction of<br>soft tissue<br>deficiencies, such<br>as for the repair of<br>hernias | Reconstruction of<br>soft tissue<br>deficiencies, such<br>as for the repair of<br>hernias | Reconstruction of<br>soft tissue<br>deficiencies, such<br>as for the repair<br>of hernias | Reconstruction of<br>soft tissue<br>deficiencies, such<br>as for the repair<br>of hernias and<br>chest wall defects | Reinforce soft<br>tissue where<br>weakness<br>exists, i.e.,<br>repair of<br>hernias and<br>chest wall<br>defects | External<br>organ support<br>and organ<br>architecture<br>preservation | Substantially<br>Equivalent |
| Labeling<br>Claims | Biopolymer surface<br>minimizes tissue<br>and visceral<br>adhesions to device | Biopolymer surface<br>minimizes tissue<br>and visceral<br>adhesions to device | HA/CMC surface<br>minimizes tissue<br>and visceral<br>adhesions to device | ePTFE minimizes<br>adhesions to<br>device | None | None | Substantially<br>Equivalent |
| Product<br>Design | Polypropylene/<br>PGA mesh with<br>biopolymer coating<br>on one surface | Polypropylene/<br>PGA mesh with<br>biopolymer coating<br>on one surface | Polypropylene<br>mesh with<br>HA/CMC coating<br>on one surface | Polypropylene<br>mesh with an<br>ePTFE layer<br>stitched on one<br>surface | Polypropylene<br>mesh | PGA Mesh | Coated surface<br>placed facing<br>viscera. |

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

4/5

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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 [phone]. 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 [phone] or [phone] 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

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**510(k) Number** K1053066