TYRX SURGICAL MESH, MODEL SMPC-0501

K052864 · Tyrx Pharma, Inc. · FTL · Dec 22, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K052864
• Device Name: TYRX SURGICAL MESH, MODEL SMPC-0501
• Applicant: Tyrx Pharma, Inc.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Dec 22, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

TyRx Surgical Mesh is intended for the repair of hernias and other abdominal fascial deficiencies requiring the addition of a reinforcing or bridging material to obtain the desired surgical result. Examples of applications where TyRx Surgical Mesh may be used include, but are not limited to: inguinal, femoral, umbilical, abdominal, incisional and intramuscular hernias and muscle flap reinforcement.

Device Story

TyRx Surgical Mesh is a sterile, dual-component prosthesis for soft tissue reconstruction. It consists of a non-resorbable polypropylene mesh coated with a bioresorbable polyarylate polymer. The coating, comprising approximately 10% of the device weight, provides stiffness to facilitate intraoperative handling. Once implanted, the coating resorbs within approximately 90 days, leaving a permanent, lightweight polypropylene mesh. The device is used by surgeons in clinical settings for hernia repair and fascial reinforcement. It provides mechanical support to the surgical site, promoting tissue ingrowth as demonstrated in animal studies. The benefit is a combination of ease of handling during placement and long-term tissue reinforcement.

Clinical Evidence

No clinical data. Evidence consists of non-clinical laboratory testing performed in accordance with FDA guidance for surgical mesh and animal testing. Animal studies demonstrated satisfactory tissue ingrowth compared to control devices via histopathology.

Technological Characteristics

Dual-component sterile prosthesis. Materials: knitted polypropylene filaments and bioresorbable polyarylate coating. Coating represents ~10% of total device weight. Resorption time: ~90 days. Form factor: surgical mesh. Intended for permanent implantation.

Indications for Use

Indicated for patients requiring repair of hernias and abdominal fascial deficiencies, including inguinal, femoral, umbilical, abdominal, incisional, and intramuscular hernias, and muscle flap reinforcement.

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

• VYPRO Mesh VICRYL-PROLENE partially absorbable synthetic surgical mesh (K002672)
• PROLENE polypropylene mesh nonabsorbable synthetic mesh (K962530)
• GORE POLYPROPYLENE HERNIA Mesh (K043081)

Submission Summary (Full Text)

{0}------------------------------------------------

TyRx Pharma Inc.
TyRx Surgical Mesh - Premarket Notification [510(k)] Submission

K052864 Page
November 9, 2005 1/2

# SECTION 2. 510(K) SUMMARY

510(k) Summary (as required by 21 CFR 807.92)

Pursuant to Section 12, Part (a)(i)3A of the Safe Medical Devices Act of 1990, TyRx Pharma, Inc. is providing a summary of the safety and effectiveness information available for TyRx Surgical Mesh, as well as the substantial equivalence decision making process used for TyRx Surgical Mesh.

Sponsor/Applicant Name and Address: TyRx Pharma, Inc. 1 Deer Park Drive, Suite G Monmouth Junction, NJ 08852

Sponsor Contact Information: Mason Diamond, DDS Vice President, Clinical and Regulatory Affairs Phone: [phone] Fax: [phone] E-mail: [e-mail]

Date of Preparaton of 510(k) Summary: October 6, 2005

New Device Trade/Proprietary Name: TyRx Surgical Mesh

Device Common/Classification Name: Polymeric Surgical Mesh

Predicate Devices Name and 510(k) Numbers: VYPRO Mesh VICRYL-PROLENE partially absorbable synthetic surgical mesh (K002672) PROLENE polypropylene mesh nonabsorbable synthetic mesh (K962530) GORE POLYPROPYLENE HERNIA Mesh (K043081)

Device Description:

TyRx Surgical Mesh is dual component (resorbable and non-resorbable), sterile prosthesis designed for the reconstruction of soft tissue deficiencies. TyRx Surgical Mesh is constructed of a non-resorbable mesh comprised of knitted filaments of polypropylene and a bioresorbable polyarylate coating on the mesh. The resorbable coating represents approximately 10% of the total weight of the device. The purpose of the resorbable coating is to provide additional stiffness to the mesh in order to facilitate interoperative handling during placement. Once placed, the polymer resorbs in approximately 90 days leaving a lighter permanent mesh incorporated into the tissue. In

{1}------------------------------------------------

TyRx Pharma Inc. TyRx Surgical Mesh - Premarket Notification [510(k)] Submission

K052864 Page

November 9, 2005 2/2

addition, animal testing demonstrated that TyRx Surgical Mesh would achieve satisfactory tissue ingrowth compared to commercial surgical mesh.

#### Intended Use:

TyRx Surgical Mesh is intended for the repair of hernias and other abdominal fascial deficiencies requiring the addition of a reinforcing or bridging material to obtain the desired surgical result. Examples of applications where TyRx Surgical Mesh may be used include, but are not limited to: inguinal, femoral, umbilical, abdominal, incisional and intramuscular hernias and muscle flap reinforcement.

#### Performance Data:

Non-clinical laboratory testing was performed in accordance with the FDA guidance document "Guidance for the Preparation of a Premarket Notification for a Surgical Mesh" demonstrating that the device is comparable to standard surgical mesh devices that are indicated for hernia repair and other abdominal fascial or muscular deficiencies requiring the addition of a reinforcing or bridging material to obtain the desired surgical result. The TyRx Surgical Mesh and the polyarylate polymer have been demonstrated to be biocompatible. In addition, animal testing demonstrated that TyRx Surgical Mesh will achieve satisfactory tissue ingrowth compared to control as evidenced by histopathology.

### Conclusions:

Based on the 510(k) summaries (21 CFR 807) and the information provided herein, we conclude that the new device is substantially equivalent to the Predicate Device under the Federal Food Drug and Cosmetic Act.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the caduceus symbol.

DEC 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Mason W. Diamond, D.D.S. Vice President, Clinical & Regulatory Affairs TyRx Pharma, Inc. 1 Deer Park Drive, Suite G Monmouth Junction, New Jersey 08852

Re: K052864

Trade/Device Name: TyRx Surgical Mesh, Model SMPC-0501 Regulatory Number: 21 CFR 878.3300 Regulatory Name: Implantable clip Regulatory Class: II Product Code: FTL Dated: December 2, 2005 Received: December 6, 2005

Dear Dr. Diamond:

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, 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.

{3}------------------------------------------------

Page 2 – Dr. Diamond

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis icher will anow you to ough marketing of substantial equivalence of your device to a legally premits to the are month 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 at [phone]. Also, please note the regulation entitled, Contact the Office of Compullier as (21 the Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general miorination on Jour respumer 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 Richards

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

Enclosure

{4}------------------------------------------------

November 9, 2005

TyRx Pharma Inc. TyRx Surgical Mesh - Premarket Notification [510(k)] Submission

## SECTION 1. INDICATION FOR USE STATEMENT

Indications for Use

510(k) Number (if known): K052864

Device Name: _________________ TyRx Surgical Mesh

Indications for Use:

Is intended for the repair of hernias and other abdominal fascial deficioncies requiring the addition of a reinforcing or bridging material to obtain the desired surgical result. . Examples of applications where TyRx Surgical Mesh may be used include, but are not limited to: inguinal, femoral, umbilical, abdominal, incisional and intramuscular hernias and muscle flap reinforcement.

Prescription Use X (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 OF NEEDED)

# Concurrence of CDRH, Office of Device Evaluation (ODE)

Anbare Bnchmp for Xxm
Division Sign Off

Page 1 of \

Division of General. Restorative. and Neurological Devices

510(k) Number K052864

CONFIDENTIAL - PROPRIETARY INFORMATION