LTM-LABAROSCOPIC SURGICAL MESH

K121289 · Lifecell Corp. · OXK · Aug 3, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K121289
• Device Name: LTM-LABAROSCOPIC SURGICAL MESH
• Applicant: Lifecell Corp.
• Product Code: OXK · General, Plastic Surgery
• Decision Date: Aug 3, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

LTM-Laparoscopic 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 during open or laparoscopic procedures. LTM-Laparoscopic Surgical Mesh is intended for single patient one-time use only.

Device Story

LTM-Laparoscopic Surgical Mesh is a terminally sterilized, porcine-derived dermal tissue matrix; used as a soft tissue patch for hernia repair and body wall defects. Device is implanted by surgeons during open or laparoscopic procedures to reinforce or bridge damaged tissue. Biomechanical integrity is maintained during laparoscopic handling, including rolling and grasper interface. Device provides sufficient strength and suture retention for surgical repair. Benefits include reinforcement of weakened soft tissue to achieve desired surgical outcomes. Single-patient, one-time use.

Clinical Evidence

Bench testing only. Biomechanical testing confirmed the mesh maintains tensile strength, tear resistance, suture pull-out strength, and burst strength after simulated laparoscopic handling (rolling, introduction, and grasper interface). Data supports equivalence to predicate K070560.

Technological Characteristics

Surgical mesh derived from porcine dermal tissue. Provided in geometric configurations ranging from 2 cm x 2 cm to 20 cm x 30 cm. Terminally sterilized; packaged in double pouch configuration. Biocompatible, non-synthetic matrix.

Indications for Use

Indicated for patients requiring soft tissue reinforcement or repair of hernias and body wall defects during open or laparoscopic surgical procedures.

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)

Reference Devices

• Restorelle Polypropolene Mesh (K103568)
• Surgimesh XD (K092233)
• Surgimesh WN (K061445)

Submission Summary (Full Text)

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K121289

LTM-Laparoscopic Surgical Mesh - 510(k) Pre Market Notification

#### III. 510(K) SUMMARY

- 3 2012 AUG

# LifeCell Corporation's LTM-Laparoscopic Surgical Mesh

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

LifeCell Corporation One Millennium Way Branchburg, NJ 08876

Contact Persons: Mark R. Jakubowski Phone: [phone] Facsimile: [phone] Or Sadhana Kalinani Phone: [phone] Facsimile: [phone]

Date Prepared: April 27, 2012

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

LTM-Laparoscopic 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 LTM Surgical Mesh (K070560) – LifeCell Corporation

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K121289

LTM-Laparoscopic Surgical Mesh - 510(k) Pre Market Notification

### Reference Devices

Restorelle Polypropolene Mesh (K103568) -- C.R. Bard Surgimesh XD (K092233) - Aspide Medical Surgimesh WN (K061445) - Aspide Medical

#### Intended Use / Indications for Use

LTM-Laparoscopic 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 during open or laparoscopic procedures.

LTM-Laparoscopic Surgical Mesh is intended for single patient one-time use only.

#### Technological Characteristics

The LTM-Laparoscopic Surgical Mesh is a surgical mesh that is derived from porcine dermal tissue. The LTM-Laparoscopic Surgical Mesh device consists of a terminally sterilized sheet of the processed porcine dermal matrix provided in prescribed geometric configurations and sizes ranging from 10 cm x 16 cm to 20 cm x 20 cm, with future sizes planned ranging from 2 cm x 2 cm to 20 cm x 30 cm. It will be packaged in double pouch configuration.

#### Performance Data

LTM-Laparoscopic Surgical Mesh is within the existing specification window and is manufactured with, the same process as LTM Surgical Mesh (K070560) (e.g., material source, processing methods to ensure purity, and packaging). LTM Surgical Mesh (K070560) has undergone extensive biocompatibility testing, animal testing, viral inactivation testing, and biomechanical testing. The data indicates 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 LTM-Laparoscopic Surgical Mesh went through the same biomechanical testing after laparoscopic handling (Attachment 1) and possesses sufficient strength and suture retention for the intended use. This fully supports use during open or laparoscopic procedures.

#### Substantial Equivalence.

LTM-Laparoscopic Surgical Mesh is substantially equivalent to the legally marketed predicate device, LifeCell Corporation's LTM Surgical Mesh (K070560), which has been cleared by the FDA for use as a surgical mesh to be implanted to reinforce soft tissue where weakness exists in abdominal wall procedures.

LTM-Laparoscopic Surgical Mesh is technologically similar to LifeCell's recently cleared LTM Surgical Mesh (K070560). The laparoscopic conditioning data (Attachment 1) show that LTM-Laparoscopic Surgical Mesh meets Tensile Strength, Tear Resistance, Suture Pull-out Strength, and Burst Strength specifications as

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established for the predicate device (K070560). The laparoscopic conditioning of LTM-Laparoscopic Surgical Mesh (rolling, introduction into abdomen, and grasper interface) is consistent with the handling of the reference laparoscopic surgical meshes (i.e. Restorelle Polypropolene Mesh (K 103568), Surgimesh XD (K092233), and Surgimesh WN (K061445), which have all been cleared for the laparoscopic use indication). LTM-Laparoscopic Surgical Mesh maintains its biomechanical integrity before and after laparoscopic conditioning making it substantially equivalent for open or laparoscopic procedures.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

> 3 2012 AUG

Lifecell Corporation % Mr. Mark R. Jakubowski 1 Millenium Way Branchburg, New Jersey 08876

Re: K121289

Trade/Device Name: LTM-Laparoscopic Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: OXK Dated: June 27, 2012 Received: June 28, 2012

Dear Mr. Jakubowski:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 or any I vathar sthates act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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## Page 2 - Mr. Mark R. Jakubowski

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,
Mark A. Millican

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative 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):

Device Name: LTM-Laparoscopic Surgical Mesh

Indication for Use:

LTM-Laparoscopic 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 during open or laparoscopic procedures.

LTM-Laparoscopic Surgical Mesh is intended for single patient one-time use only.

Prescription Use XX (21 CFR Part 801 Subpart D) AND/OR

Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Kramer MM
Division Sign Off

(Division Sign-Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K121289

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