XYLOS SURGICAL MESH

K023237 · Xylos Corporation · FTM · Mar 18, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K023237
• Device Name: XYLOS SURGICAL MESH
• Applicant: Xylos Corporation
• Product Code: FTM · General, Plastic Surgery
• Decision Date: Mar 18, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

XYLOS™ Surgical Mesh is intended for implantation to reinforce soft tissue including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, prolapse repair, reconstruction of the pelvic floor, hernias, suture line reinforcement and reconstructive procedures. The device is intended for one-time use.

Device Story

XYLOS™ Surgical Mesh is a sterile, implantable device derived from microbial cellulose. It undergoes chemical processing, including solvent dehydration, to achieve desired mechanical properties. The mesh provides tensile strength and suture retention for soft tissue reinforcement. It is supplied in various sizes, double-pouched, and gamma-sterilized for single-use. Surgeons implant the mesh during reconstructive or hernia repair procedures to support or reinforce weakened tissue. The device functions as a permanent or semi-permanent scaffold to facilitate tissue repair.

Clinical Evidence

Bench testing only. Evidence includes safety, biocompatibility, toxicity, pyrogenicity, sterility, and mechanical strength testing.

Technological Characteristics

Material: Microbial-derived cellulose. Processing: Solvent dehydration. Sterilization: Gamma radiation. Form factor: Cut-to-size mesh. Properties: Tensile strength, suture retention, consistent thickness.

Indications for Use

Indicated for soft tissue reinforcement in patients requiring repair of abdominal/thoracic wall defects, muscle flaps, pelvic floor reconstruction, prolapse repair, hernia repair, or suture-line 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

• Bio-Vascular, Inc. Peri-Guard® Pericardium (K983162)
• Ethicon, Inc. Prolene Polypropylene Mesh, Nonabsorbable (K962530)
• XYLOS™ XCell® Wound Dressing (K974251)

Submission Summary (Full Text)

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K023237

# 510(k) Summary

#### DATE PREPARED:

09SEP2002

#### SUBMITTED BY:

XYLOS Corporation 41 University Drive, Suite 400 Newtown, PA 18940

## CONTACT PERSON:

Patsy J. Trisler, J.D., RAC Senior Director, Medical Device Consulting PharmaNet, Inc. 815 Connecticut Avenue, NW, Suite 800 Washington, D.C. 20006 202-835-1346 (direct dial) 609-520-8107 (fax)

### DEVICE:

Mesh, Surgical Classification Name: Common/Usual Name: Surgical Mesh XYLOS™ Surgical Mesh Proprietary Name:

## DEVICE CLASSIFICATION:

Product Code/Classification Number: FTM (878.3300) Requlatory Class:

#### PREDICATE DEVICES:

Bio-Vascular, Inc. Peri-Guard® Pericardium K983162 Ethicon, Inc. Prolene Polypropylene Mesh, Nonabsorbable K962530 XYLOS™ XCell® Wound Dressing K974251

#### STATEMENT OF SUBSTANTIAL EQUIVALENCE:

XYLOS™ Surgical Mesh is substantially equivalent to the predicate devices, having similar intended use, technological characteristics, and performance.

#### INTENDED USE:

XYLOS™ Surgical Mesh is intended for implantation to reinforce soft tissue including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, prolapse repair, reconstruction of the pelvic floor, hernias, suture line reinforcement and reconstructive procedures. The device is intended for one-time use.

## DEVICE DESCRIPTION:

XYLOS™ Surqical Mesh is prepared from microbial derived cellulose that undergoes chemical processing inclusive of solvent dehydration. Units are cut in various sizes to meet surgical needs. Each unit is double-pouched, labeled, and gamma sterilized surgical mesh exhibits excellent tensile strength, suture retention and consistent thickness.

## PERFORMANCE DATA:

XYLOS™ Surgical Mesh functions as intended when subjected to safety, biocompatibility, toxicity, pyrogenicity, sterility and mechanical strength testing.

MAR 1 8 2003

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MAR 1 8 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Xylos Corporation c/o Ms. Patsy J. Trisler, J.D., RAC Senior Director, Medical Device Consulting PharmaNet, Inc. 815 Connecticut Avenue NW, Suite 800 Washington, D.C. 20006

Re: K023237

Trade/Device Name: XYLOS™ Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: FTM Dated: February 5, 2003 Received: February 7, 2003

Dear Ms. Trisler:

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 (OS) 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. Patsy J. Trisler, J.D., RAC

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Muriam C. Provost

Po/ 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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## Indications for Use FORM

# Page 1 of 1

**510(k) Number (if known)** KC23237

Device Name:

XYLOS™ Surgical Mesh

This device is intended for implantation to Indications for Use: reinforce soft tissue including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, prolapse repair, reconstruction of the pelvic floor, hernias, suture-line reinforcement and reconstructive procedures. The device is intended for one-time use.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21CFR 801.109)

OR

Over-the-Counter-Use Optional Format 1-2-96

Muriam C. Provost

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

000037

510(k) Number K023237