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 Description

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.

AI/ML Overview

The document describes the LTM-Laparoscopic Surgical Mesh, a device intended for surgical repair of hernias and body wall defects. The submission focuses on demonstrating substantial equivalence to a predicate device, LTM Surgical Mesh (K070560), and discusses its performance relative to established specifications.

Here's an analysis of the provided information, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Tensile Strength	Meets specifications established for predicate device (K070560) after laparoscopic conditioning.
Tear Resistance	Meets specifications established for predicate device (K070732) after laparoscopic conditioning.
Suture Pull-out Strength	Meets specifications established for predicate device (K070732) after laparoscopic conditioning.
Burst Strength	Meets specifications established for predicate device (K070732) after laparoscopic conditioning.
Biocompatibility	Device is biocompatible, based on extensive testing of the predicate LTM Surgical Mesh (K070560).
Viral Inactivation	Manufacturing process is capable of inactivating viral components, based on testing of the predicate LTM Surgical Mesh (K070560).
Biomechanical Integrity (after laparoscopic conditioning)	Maintains biomechanical integrity before and after laparoscopic conditioning (rolling, introduction into abdomen, grasper interface), consistent with reference laparoscopic meshes.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the numerical sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It refers to "extensive biocompatibility testing, animal testing, viral inactivation testing, and biomechanical testing" of the predicate device (K070560). For the LTM-Laparoscopic Surgical Mesh itself, it states that it "went through the same biomechanical testing after laparoscopic handling (Attachment 1)."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The study primarily relies on physical and manufacturing consistency with a previously cleared device and biomechanical testing, rather than expert evaluation of the device in a clinical or diagnostic context.

4. Adjudication Method for the Test Set

This information is not applicable/provided as the study focuses on physical and mechanical properties rather than subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC study was not done. This device is a surgical mesh, not an AI-powered diagnostic tool, so such a study would not be relevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

A standalone performance study of an algorithm was not done. This is a physical surgical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through biomechanical specifications and performance data derived from the predicate device (LTM Surgical Mesh K070560) and further confirmed through specific tests on the LTM-Laparoscopic Surgical Mesh after simulated laparoscopic handling. This includes:

Tensile Strength
Tear Resistance
Suture Pull-out Strength
Burst Strength
Biocompatibility data (from predicate)
Viral inactivation data (from predicate)

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to this submission, as it concerns a physical surgical device, not a machine learning algorithm.

9. How the Ground Truth for the Training Set was Established

This information is not applicable as there is no training set for a machine learning algorithm.

Summary

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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: (908) 809-7719 Facsimile: (908) 947-1095 Or Sadhana Kalinani Phone: (908) 947-1114 Facsimile: (908) 947-1095

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 single patient one-time use only.

Technological Characteristics

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 (800) 638-2041 or (301) 796-7100 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 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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Regulation Number and Section

§ 878.3300 Surgical mesh.

(a)
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.(b)
Classification. Class II.