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

L TM-Laparoscopic Surgical Mesh is a surgical mesh that is derived from porcine dermis and is processed and preserved in a phosphate buffered aqueous solution containing matrix stabilizers. This device is designed to perform as a surgical mesh for soft tissue repair while presenting a scaffold to the patient. The device consists of a terminally sterilized sheet of the processed porcine dermal matrix provided in prescribed geometric configurations and thicknesses and is packaged in a double pouch configuration. The proposed device has the same scientific technology, principles of operation, Intended Use, and Indications for Use as the cleared predicate device, LTM-Laparoscopic Surgical Mesh (K121289).

The only change described in this submission is a minor modification to the Instructions for Use. There have been no changes made to the physical LTM-Laparoscopic Surgical Mesh device. The Instructions for Use have been modified to describe fixation of the device by sutures and surgical tacks, according to surgeon preference. The Instructions for Use previously provided as part of the cleared predicate device (K121289) described suturing LTM-Laparoscopic Surgical Mesh into position.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called LTM-Laparoscopic Surgical Mesh. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove the device meets acceptance criteria in the typical sense of measuring performance against predefined metrics (e.g., sensitivity, specificity, accuracy for an AI/diagnostic device).

Here's an analysis based on the provided text, addressing your points where applicable, and noting where information is not present for this type of submission:

1. A table of acceptance criteria and the reported device performance

For this type of device (surgical mesh) and submission (510(k) for a minor modification), acceptance criteria are primarily related to safety and efficacy not being negatively impacted by the change, and the device continuing to perform its intended use. The "performance" reported is less about statistical metrics and more about confirming functionality under the new condition.

Acceptance Criteria (Implied)	Reported Device Performance
Fixation using surgical tacks does not affect safety and efficacy.	"Testing included laparoscopic fixation of LTM-Laparoscopic Surgical Mesh by surgical tacks under simulated conditions, and the results have demonstrated that this method of fixation did not affect safety and efficacy of the device or raise any new questions of safety or efficacy."
Device continues to perform its intended use.	"Thus, the proposed LTM-Laparoscopic Surgical Mesh continues to perform its intended use as a soft tissue patch to reinforce soft tissue where weakness exists and for the repair of damaged or ruptured soft tissue membranes and is substantially equivalent to the predicate device LTM-Laparoscopic Surgical Mesh (K121289)."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The text describes "testing included laparoscopic fixation of LTM-Laparoscopic Surgical Mesh by surgical tacks under simulated conditions." However, it does not specify:

The sample size of the test set (e.g., number of meshes tested, number of fixation points).
Data provenance (country of origin), although it's a submission to the US FDA.
Whether the study was retrospective or prospective, but "simulated conditions" implies a controlled experimental setup.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This type of information is not applicable to the study described. The study involves a physical device and its fixation method, not an AI or diagnostic tool requiring expert interpretation for ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not an observational study requiring adjudication of expert opinions. The "results have demonstrated" implies objective measurements or observations in the simulated conditions, rather than subjective interpretation that would need 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

Not applicable. This is not an AI/diagnostic device, and no MRMC study was performed.

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

Not applicable. This is a physical surgical mesh, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" here is implied to be the successful and safe fixation of the mesh under simulated conditions, and the maintenance of the device's intended function. It's based on technical assessment and potentially engineering testing rather than medical "ground truth" like pathology or clinical outcomes in patients for this specific modification.

8. The sample size for the training set

Not applicable. There is no training set for this type of device modification.

9. How the ground truth for the training set was established

Not applicable. There is no training set.

Summary of the Study:

The study described is a design validation testing for a minor modification to the Instructions for Use of LTM-Laparoscopic Surgical Mesh. The modification allows for fixation of the mesh using surgical tacks in addition to sutures.

Objective: To ensure that using surgical tacks for fixation does not negatively impact the safety and efficacy of the device.
Methodology: Laparoscopic fixation of the mesh using surgical tacks was performed under "simulated conditions."
Findings: The results "demonstrated that this method of fixation did not affect safety and efficacy of the device or raise any new questions of safety or efficacy."
Conclusion: The device continues to perform its intended use and is substantially equivalent to the predicate device.

This submission is a 510(k), which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical trials, especially for minor modifications like this one. The "study" here is a targeted engineering/performance test to address the specific change.

Summary

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K130817 page 1/2

APR 1 7 2013

510(k) Summary LTM-Laparoscopic Surgical Mesh

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

LifeCell Corporation One Millennium Way Branchburg, NJ 08876

Contact Person: John Blewitt Senior Regulatory Affairs Associate Phone: (908) 947-1432 Fax: (908) 947-1095

Date Prepared:

March 21, 2013

Name of Device and Name and Address of Sponsor

LTM-Laparoscopic Surgical Mesh-Strattice Reconstructive Tissue Matrix (RTM) LifeCell Corporation One Millennium Way Branchburg, NJ 08876

Common or Usual Name

Surgical Mesh

Classification Name

Surgical Mesh-(21 C.F.R. §878.3300)

Device Class

Product Code OXK, FTM

OAK, TMI

Predicate Devices

LTM-Laparoscopic Surgical Mesh (K121289)—LifeCell Corporation

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K130817 page 2/2

Intended Use/ Indications for Use

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

Device Description and Technological Characteristics

Performance Data

The addition of language in the device Instructions for Use describes fixation the device using sutures and surgical tacks. Additional validation of the design was performed to ensure fixation using surgical tacks could be achieved. Testing included laparoscopic fixation of LTM-Laparoscopic Surgical Mesh by surgical tacks under simulated conditions, and the results have demonstrated that this method of fixation did not affect safety and efficacy of the device or raise any new questions of safety or efficacy . Thus, the proposed LTM-Laparoscopic Surgical Mesh continues to perform its intended use as a soft tissue patch to reinforce soft tissue where weakness exists and for the repair of damaged or ruptured soft tissue membranes and is substantially equivalent to the predicate device LTM-Laparoscopic Surgical Mesh (K121289).

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized graphic of an abstract human figure with outstretched arms, positioned to the right. Encircling the graphic is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

April 17, 2013

LifeCell Corporation % Mr. John Blewitt Senior Regulatory Affairs Associate One Millennium Way Branchburg, New Jersey 08876

Re: K130817

Trade/Device Name: LTM - Laparoscopic Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: OXK, FTM Dated: March 22, 2013 Received: March 25, 2013

Dear Mr. Blewitt:

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. Isting 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 (reporting of medical

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Page 2 - Mr. John Blewitt

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/ResourcesforYou/Industry/default.htm.

Sincerely yours, FOR

Peter D清影视mm -S

Mark. N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K130817

Device Name: LTM-Laparoscopic Surgical Mesh

Indications 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 Exemption (ODE)

David Krause

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K130817

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.