LTM-T SURGICAL MESH

K080353 · Lifecell Corp. · FTL · Apr 3, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K080353
• Device Name: LTM-T SURGICAL MESH
• Applicant: Lifecell Corp.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Apr 3, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LifeCell Tissue Matrix (LTM) Surgical Mesh is intended for the reinforcement of soft tissue repaired by sutures or suture anchors during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Indications for use also include the repair of body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome. The device is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Sutures, used to repair the tear, and sutures or bone anchors used to attach the tissue to the bone, provide biomechanical strength for the tendon repair. LTM is intended for single patient, one time use only.

Device Story

LTM Surgical Mesh; porcine-derived dermal matrix; terminally sterilized sheet. Used in surgical settings by physicians for soft tissue reinforcement during tendon repair or body wall defect repair. Device acts as scaffold; does not replace native tissue or provide primary biomechanical strength; sutures/anchors provide primary strength. Single-patient, one-time use. Benefits include reinforcement of surgical repair sites.

Clinical Evidence

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

Technological Characteristics

Surgical mesh derived from porcine skin; processed porcine dermal matrix. Terminally sterilized; provided in prescribed geometric configurations and thicknesses. Packaged in double pouch configuration.

Indications for Use

Indicated for reinforcement of soft tissue repaired by sutures/anchors during tendon repair (rotator cuff, patellar, Achilles, biceps, quadriceps) and repair of body wall defects requiring reinforcing/bridging material. Not intended to replace body structure or provide full mechanical strength for tendon repair.

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

• LifeCell Corporation's LTM Surgical Mesh (K070560)
• Pegasus Biologics, Inc.'s OrthADAPT™ (K071065)

Submission Summary (Full Text)

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K080353
Page 1/2

## 510(K) SUMMARY

ﭘﻮ

### LifeCell Corporation's LTM Surgical Mesh

APR - 3 2008

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

LifeCell Corporation One Millennium Way Branchburg, NJ 08876 [phone] Phone: [phone] Facsimile:

Lorraine T. Montemurro, R.N., R.A.C. Contact Person: February 08, 2008 Date Prepared:

## Name of Device and Name/Address of Sponsor

LTM Surgical Mesh

LifeCell Corporation One Millennium Way Branchburg, NJ 08876

## Common or Usual Name

Surgical Mesh

#### Classification Name

Surgical Mesh

#### Classification

Class II

#### Product Code

FTM

## Predicate Devices

LifeCell Corporation's LTM Surgical Mesh (K070560) Pegasus Biologics, Inc.'s OrthADAPT™ (K071065)

## Intended Use / Indications for Use

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K080353
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The LifeCell Tissue Matrix (LTM) Surgical Mesh is intended for the reinforcement of soft tissue repaired by sutures or suture anchors during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Indications for use also include the repair of body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome.

The device is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Sutures, used to repair the tear, and sutures or bone anchors used to attach the tissue to the bone, provide biomechanical strength for the tendon repair.

LTM is intended for single patient, one time use only.

### 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 the legally marketed predicate devices, LifeCell Corp.'s LTM Surgical Mesh (K070560) and Pegasus Biologics, Inc.'s OrthADAPT™ (K071065) 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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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

LifeCell Corporation % Ms. Lorraine T. Montemurro, R.N., R.A.C. Manager, Regulatory Affairs One Millennium Way Branchburg, New Jersey 08876-3876

APR - 3 2008

Re: K080353

Trade/Device Name: LTM Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: February 8, 2008 Received: February 11, 2008

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 r ou may yours is 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 he 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 1 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. Sharon Alexander

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

Mark M. Mulhausen

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:

The LifeCell Tissue Matrix (LTM) Surgical Mesh is intended for the reinforcement of soft tissue repaired by sutures or suture anchors during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Indications for use also include the repair of body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome.

The device is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Sutures, used to repair the tear, and sutures or bone anchors used to attach the tissue to the bone, provide biomechanical strength for the tendon repair.

LTM is intended for single patient, one time use only.

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

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R. Boyle for mxm

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

510(k) Number K080353