LRTM SURGICAL MESH

K070560 · Lifecell Corp. · FTM · Jun 11, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K070560
• Device Name: LRTM SURGICAL MESH
• Applicant: Lifecell Corp.
• Product Code: FTM · General, Plastic Surgery
• Decision Date: Jun 11, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

LTM Surgical Mesh (LTM) is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. Indications for use include the repair of hernias and /or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome. LTM is intended for single patient use only.

Device Story

LTM Surgical Mesh is a sterile, processed porcine dermal matrix used as a soft tissue patch. It is implanted by surgeons during procedures to reinforce weakened soft tissue or repair hernias and body wall defects. The device provides a structural scaffold for tissue repair. It is intended for single-patient use.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing, including biocompatibility, viral inactivation, and biomechanical testing (strength and suture retention) to demonstrate safety and performance.

Technological Characteristics

Porcine-derived dermal matrix; terminally sterilized; provided in various geometric configurations and thicknesses; packaged in double-pouch configuration. Biocompatible, non-synthetic material.

Indications for Use

Indicated for patients requiring soft tissue reinforcement or repair of damaged/ruptured soft tissue membranes, specifically for hernia repair and body wall defects requiring bridging or reinforcing material.

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

• Permacol® Implant (K050355)
• Surgisis® (K034039)

Submission Summary (Full Text)

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K070560

## 510(K) SUMMARY

# JUN 1 1 2007

## LifeCell Corporation's LTM Surgical Mesh

### Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

| LifeCell Corporation | |
|----------------------|--------------------------------------|
| One Millennium Way | |
| Branchburg, NJ 08869 | |
| Phone: | [phone] |
| Facsimile: | [phone] |
| Contact Person: | Lorraine T. Montemurro, R.N., R.A.C. |
| Date Prepared: | June 6, 2007 |

#### Name of Device and Name/Address of Sponsor

LTM Surgical Mesh

LifeCell Corporation One Millennium Way Branchburg, NJ 08869

## Common or Usual Name

Surgical Mesh

## Classification Name

Surgical Mesh

## Predicate Devices

Permacol® Implant (K050355)

Surgisis® (K034039)

## Intended Use / Indications for Use

LTM Surgical Mesh (LTM) is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. Indications for use include the repair of hernias and /or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome.

LTM is intended for single patient use only.

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### Technological Characteristics

The LTM is a surgical mesh that is derived from porcine skin. The LTM device consists of a terminally sterilized sheet of the processed porcine dermal matrix provided in prescribed geometric configurations and thicknesses, and packaged in double pouch configuration.

## Performance Data

The LTM has undergone extensive biocompatibility testing, animal testing, viral inactivation testing and biomechanical testing. The data indicate that the device is biocompatible and that the manufacturing process is capable of inactivating any viral components that may come with the starting material. The biomechanical data show that the LTM matrix possesses sufficient strength and suture retention for the intended use.

## Substantial Equivalence

LTM is substantially equivalent to legally marketed predicate devices, such as the Permacol@ Implant (K050355) and Surgisis® (K034039) surgical mesh devices. LTM has the same intended uses and the same or similar indications, technological characteristics, and principles of operation as these predicate devices. Performance data demonstrate that LTM functions equivalently to the predicate devices. Thus, LTM is substantially equivalent.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

LifeCell Corporation % Ms. Lorraine T. Montemurro, R.N., RAC Manager, Regulatory Affairs One Millennium Way Branchburg, New Jersey 08876

JUN 1 1 2007

Re: K070560

Trade/Device Name: LTM Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: May 7, 2007 Received: May 8, 2007

Dear Ms. Montemurro:

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.

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Page 2 - Ms. Lorraine T. Montemurro, R.N., 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 Iogally 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]. Also, please note (2) Cregulation over), pro "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 analy Manufacturers, International 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 vours.

P.R. DSDh

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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## INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name: LTM Surgical Mesh

Indications for Use:

LTM Surgical Mesh is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. Indications for use include the repair of hernias and /or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome.

LTM is intended for single patient use only.

Prescription Use (Part 21 C.F.R. 801 Subpart D)

AND/OR

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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