LTM-Perforated Surgical Mesh

K150712 · Lifecell Corporation · FTM · Jul 2, 2015 · General, Plastic Surgery

Device Facts

• Record ID: K150712
• Device Name: LTM-Perforated Surgical Mesh
• Applicant: Lifecell Corporation
• Product Code: FTM · General, Plastic Surgery
• Decision Date: Jul 2, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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

Device Story

LTM-Perforated Surgical Mesh is a porcine-derived acellular dermal matrix used as a soft tissue patch for hernia and body wall defect repair. The device is processed in a phosphate-buffered aqueous solution with matrix stabilizers and provided in specific geometric configurations. It is a single-use, terminally sterilized sheet. The primary design modification from the predicate is the addition of a pre-defined pattern of perforations, created during the final die-cutting stage, to improve handling or integration while maintaining mechanical integrity. Used in healthcare facilities by surgeons, the mesh provides structural reinforcement to weakened or damaged tissue. The device is implanted to support the surgical repair, facilitating the desired clinical outcome for soft tissue reconstruction.

Clinical Evidence

No clinical testing was performed. Substantial equivalence is supported by bench testing comparing the subject device to the predicate. Bench evaluations included mesh thickness, tensile strength, device stiffness, suture pull-out strength, tear resistance (ASTM D5735-95), and burst strength (ASTM D6797-07). Results demonstrate that the perforated mesh maintains mechanical properties equivalent to the non-perforated predicate.

Technological Characteristics

Material: Porcine acellular dermal matrix. Preservation: Phosphate-buffered aqueous solution with matrix stabilizers. Form factor: Terminally sterilized sheet with pre-defined perforation pattern. Sterilization: Electron beam irradiation. Mechanical testing standards: ASTM D5735-95 (tear resistance), ASTM D6797-07 (burst strength).

Indications for Use

Indicated for patients requiring soft tissue reinforcement or repair of damaged/ruptured soft tissue membranes, including hernias and body wall defects.

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

• Biodesign® Hernia Graft, Cook Medical (K974540)
• Collamend TM FM Implant, Davol Inc. - subsidiary of C.R. Bard (K082687)
• SurgiMend™e, TEI Biosciences Inc. (K083898)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a stylized eagle with three human profiles incorporated into its design.

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

July 2, 2015

LifeCell Corporation Ms. Linda Scamardella Regulatory Affairs Specialist One Millennium Way Branchburg, New Jersey 08876

Re: K150712

Trade/Device Name: LTM-Perforated Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTM Dated: June 3, 2015 Received: June 4, 2015

Dear Ms. Scamardella:

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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related

{1}------------------------------------------------

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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# David Krause -S

for

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K150712

Device Name LTM-Perforated Surgical Mesh

### Indications for Use (Describe)

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

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------|---------------------------------------------|
| × Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |

# CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

K150712 Page 1 of 3

# 510(k) Summary

# 1. SUBMITTER

### Name and Address of Submitter

LifeCell Corporation One Millennium Way Branchburg, NJ 08876

# Contacts:

Linda Scamardella Regulatory Affairs Specialist Phone: [phone] Fax: [phone]

Mira Leiwant Director, Quality Engineering and Regulatory Affairs Phone: [phone] Fax: [phone]

# Prepared by and Date:

Linda Scamardella March 18, 2015

# 2. DEVICE

| Name of Device: | LTM-Perforated Surgical Mesh |
|-----------------------|--------------------------------------|
| Common or Usual Name: | Surgical Mesh |
| Classification Name: | Surgical Mesh (21 C.F.R. §878.3300) |
| Device Class: | Class II |
| Product Code: | FTM |

# 3. PREDICATE DEVICE

Predicate Device: LTM-Surgical Mesh (K070560) - LifeCell Corporation This predicate has not been subject to a design-related recall

Reference Devices: Biodesign® Hernia Graft, Cook Medical (K974540) Collamend TM FM Implant, Davol Inc. - subsidiary of C.R. Bard (K082687) SurgiMend™e, TEI Biosciences Inc. (K083898)

{4}------------------------------------------------

#### DEVICE DESCRIPTION 4.

LTM-Perforated Surgical Mesh is a surgical mesh that is derived from porcine dermis and then processed and preserved in a patented phosphate buffered aqueous solution containing matrix stabilizers. The device is designed to perform as a surgical mesh for soft tissue repair. The device consists of a terminally sterilized sheet of processed porcine dermal matrix provided in prescribed geometric configurations and thicknesses. The device is packaged in a double pouch configuration, and is sterilized via electron beam irradiation. The device is considered a single use device which is to be used in a healthcare facility or hospital.

The subject device shares the same underlying scientific design as a porcine derived acellular dermal matrix, and has the same Intended Use, Indications for Use, and principles of operation as the cleared predicate device, LTM-Surgical Mesh (K070560). This 510(k) premarket notification describes a new design feature of the subject device, which introduces a pre-defined pattern of perforations throughout the tissue matrix.

### 5. INDICATIONS FOR USE

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

### 6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The subject device, LTM-Perforated Surgical Mesh, and the predicate device, LTM-Surgical Mesh (K070560), are both derived from porcine dermis and then processed and preserved in a patented phosphate buffered aqueous solution containing matrix stabilizers. The material type for both devices can be described as a porcine acelluar dermal matrix. Both devices consist of a terminally sterilized sheet of the processed porcine dermal matrix provided in prescribed geometric configurations and thicknesses. Both are packaged in a double pouch configuration and sterilized via electron beam irradiation.

The subject device, LTM-Perforated, and the predicate device, LTM-Surgical Mesh (K070560) share the same underlying scientific design as a porcine derived acellular dermal matrix, and have the same Intended Use, Indications for Use, and principles of operation. The predicate introduces a new design feature, a pre-defined pattern of perforations in the tissue matrix. The spacing and size of the perforations were specifically designed to maintain mechanical properties and meet the same established performance specifications as the predicate device, LTM-Surgical Mesh. The subject device utilizes the existing manufacturing processes of the predicate LTM-Surgical Mesh. Perforations are added to the tissue during the final die cutting stage at the time the device is cut to its final dimensions.

{5}------------------------------------------------

#### 7. PERFORMANCE

The predicate device, LTM-Surgical Mesh (K070560) has undergone appropriate biocompatibility testing, animal testing, and viral inactivation testing. The data demonstrates that the device is biocompatible and that the manufacturing process is capable of viral inactivation. The subject device, LTM- Perforated Surgical Mesh and the predicate device, LTM-Surgical Mesh (K070560) utilize the same raw materials (porcine dermis), processing components/solutions and manufacturing processes, and are identical except for the presence of perforations. Therefore, no further biocompatibility testing, animal testing, or viral inactivation testing was performed given that the presence of perforations does not change the biochemical or material properties of the surgical mesh.

# Bench Testing:

Bench testing was performed on the subject LTM-Perforated Surgical Mesh device to support substantial equivalence. Testing and/or evaluations included relevant elements of the FDA "Guidance for the Preparation of a Premarket Notification for a Surgical Mesh'" issued March 2, 1999. Table I includes the applicable product characterization criteria used to demonstrate substantial equivalence.

| Table 1: Substantial Equivalence Criteria | |
|-------------------------------------------|---------------------|
| Bench Testing /Evaluation | Applicable Standard |
| Mesh Thickness | N/A |
| Tensile Strength | N/A |
| Device Stiffness | N/A |
| Suture Pull-Out Strength | N/A |
| Tear Resistance | ASTM D5735-95 |
| Burst Strength | ASTM D6797-07 |

Performance data demonstrates that LTM-Perforated maintains similar mechanical properties and meets the established specifications as the predicate device. In addition, the LTM-Perforated Surgical Mesh shares the technological characteristics of perforations with other legally marketed reference devices. This new technological characteristic does not affect safety and efficacy of the device or raise new questions of safety or efficacy. LTM-Perforated Surgical Mesh meets the requirements to perform its intended use as a soft tissue patch and is substantially equivalent to the predicate device, LTM-Surgical Mesh (K070560).

# Clinical Testing:

No clinical testing was included in this submission.

#### 8. CONCLUSIONS

The subject device, LTM-Perforated Surgical Mesh, meets the requirements to perform its intended use as a soft tissue patch and is substantially equivalent to the legally marketed predicate device, LTM-Surgical Mesh (K070560).