LTM-RC SURGICAL MESH

K071986 · Lifecell Corp. · FTM · Oct 19, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K071986
• Device Name: LTM-RC SURGICAL MESH
• Applicant: Lifecell Corp.
• Product Code: FTM · General, Plastic Surgery
• Decision Date: Oct 19, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

LTM-RC 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. The implant is intended for the reinforcement of soft tissues repaired by sutures or suture anchors, during rotator cuff surgery. Indications for use also 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. The device is not intended to replace normal body structure or provide the full mechanical strength to repair the rotator cuff. Sutures used to repair the tear, and the sutures or bone anchors used to attach the tissue to the bone, provide biomechanical strength for the rotator cuff repair. LTM-RC is intended for single patient, one time use only.

Device Story

LTM-RC Surgical Mesh is a processed porcine dermal matrix used as a soft tissue patch. It is applied by surgeons during rotator cuff repair, hernia repair, or body wall defect surgery to reinforce tissue. The device does not provide primary mechanical strength; that is provided by sutures or bone anchors. It is a single-patient, one-time-use implant. The matrix is derived from porcine skin, processed, and terminally sterilized. It provides a scaffold for tissue reinforcement.

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 dermal matrix. Terminally sterilized sheet provided in prescribed geometric configurations and thicknesses. Packaged in double pouch configuration.

Indications for Use

Indicated for reinforcement of soft tissue where weakness exists, repair of damaged/ruptured soft tissue membranes, reinforcement of rotator cuff repairs (used with sutures/anchors), and repair of hernias or body wall defects requiring reinforcing/bridging material. Not intended to replace normal body structure or provide full mechanical strength for rotator cuff 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

• LTM Surgical Mesh (K070560)
• Permacol® Implant (K050355)
• Permacol® (K021056)

Submission Summary (Full Text)

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K071986 page1/2

#### III. 510(K) SUMMARY

## LifeCell Tissue Matrix-Rotator Cuff (LTM-RC) Surgical Mesh

# 007 1 9 2007

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

| LifeCell Corporation<br>One Millennium Way | |
|--------------------------------------------|--------------------------------------|
| Branchburg, NJ 08869 | |
| Phone: | [phone] |
| Facsimile: | [phone] |
| Contact Person: | Lorraine T. Montemurro, R.N., R.A.C. |
| Date Prepared: | July 19, 2007 |

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

LTM-RC Surgical Mesh

LifeCell Corporation One Millennium Way Branchburg, NJ 08876

#### Common or Usual Name

Surgical Mesh

#### Classification Name

Surgical Mesh

#### Predicate Devices

LTM Surgical Mesh (K070560)

Permacol® Implant (K050355)

Permacol® (K021056)

### Intended Use / Indications for Use

LTM-RC 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. The implant is intended for the reinforcement of soft tissues repaired by sutures or suture anchors, during rotator cuff surgery. Indications for use also 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.

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The device is not intended to replace normal body structure or provide the full
mechanical strength to repair the rotator cuff. Sutures used to repair the tear, and the sutures or
bone anchors used to attach the tissue to the bone, provide biomechanical strength for the rotator
cuff repair.

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

#### Technological Characteristics

The LTM-RC is a surgical mesh that is derived from porcine skin. The LTM-RC 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-RC 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-RC matrix possesses sufficient strength and suture retention for the intended use.

#### Substantial Equivalence

LTM-RC is substantially equivalent to legally marketed predicate devices, such as the LTM Surgical Mesh (K070560) and Permacol® Implant (K050355) surgical mesh devices. LTM-RC 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-RC functions equivalently to the predicate devices. Thus, LTM-RC is substantially equivalent.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is presented in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# OCT 1 9 2007

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

Re: K071986

Trade/Device Name: LifeCell Tissue Matrix-Rotator Cuff (LTM-RC) Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: September 24, 2007 Received: September 26, 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 - Lorraine T. Montemurro, R.N, R.A.C.

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]. 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 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 your

For
Mark N. Melkerson
DEB
D.R
1.19.07

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### II. INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K071986

Device Name: LifeCell Tissue Matrix-Rotator Cuff (LTM-RC) Surgical Mesh

Indications for Use:

LTM-RC 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. The implant is intended for the reinforcement of soft tissues repaired by sutures or suture anchors during rotator cuff repair surgery. Indications for use also 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.

The device is not intended to replace normal body structure or provide full mechanical strength to repair the rotator cuff. Sutures used to repair the tear and the sutures or bone anchors used to attach the tissue to the bone, provide biomechanical strength for the rotator cuff repair.

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

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

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

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE) Sion Sign-Division of General, Restorative, Page _________________________________________________________________________________________________________________________________________________________________________ of and Neurological Devices

**510(k) Number** L01194