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 Description

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.

AI/ML Overview

The document is a 510(k) premarket notification for the LTM-Perforated Surgical Mesh. It focuses on demonstrating substantial equivalence to a predicate device, LTM-Surgical Mesh (K070560), rather than providing acceptance criteria and a study proving the device meets those criteria in the traditional sense of a clinical trial for diagnostic AI.

However, based on the provided text, I can extract information related to "acceptance criteria" (in this case, performance specifications for substantial equivalence) and the "study" (bench testing) used to support the claim.

Here's a breakdown of the requested information based on the document:

1. Table of acceptance criteria and the reported device performance

The document doesn't provide specific numerical acceptance criteria or performance values for the LTM-Perforated Surgical Mesh. Instead, it states that the device "maintains similar mechanical properties and meets the established specifications as the predicate device." The "acceptance criteria" are implied by the listed bench tests and the goal to be "substantially equivalent" to the predicate.

Test / Evaluation	Acceptance Criteria (Implied)	Reported Device Performance
Mesh Thickness	Comparable to predicate device LTM-Surgical Mesh (K070560)	Maintains similar mechanical properties and meets established specifications of the predicate.
Tensile Strength	Comparable to predicate device LTM-Surgical Mesh (K070560)	Maintains similar mechanical properties and meets established specifications of the predicate.
Device Stiffness	Comparable to predicate device LTM-Surgical Mesh (K070560)	Maintains similar mechanical properties and meets established specifications of the predicate.
Suture Pull-Out Strength	Comparable to predicate device LTM-Surgical Mesh (K070560)	Maintains similar mechanical properties and meets established specifications of the predicate.
Tear Resistance	Meets ASTM D5735-95 standard and comparable to predicate device.	Meets ASTM D5735-95 standard and maintains similar mechanical properties as the predicate.
Burst Strength	Meets ASTM D6797-07 standard and comparable to predicate device.	Meets ASTM D6797-07 standard and maintains similar mechanical properties as the predicate.
Biocompatibility	Biocompatible	Demonstrated as biocompatible (based on predicate testing, due to shared materials/process).
Viral Inactivation	Manufacturing process capable of viral inactivation	Demonstrated (based on predicate testing, due to shared materials/process).

2. Sample size used for the test set and the data provenance

Sample Size: The document does not specify the sample size for the bench testing performed. It refers to "relevant elements" of the FDA guidance for test performance.
Data Provenance: The bench testing was performed on the "subject LTM-Perforated Surgical Mesh device." It implies in-house testing by the manufacturer (LifeCell Corporation). The type of data is physical/mechanical test results.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a medical device (surgical mesh), not an AI/diagnostic device where expert assessment of "ground truth" (e.g., image interpretation) would be relevant. The "ground truth" for this device's performance is established by objective physical and mechanical tests against defined standards and comparison to a predicate device.

4. Adjudication method for the test set

Not applicable. This is a medical device (surgical mesh), not an AI/diagnostic device requiring expert 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 a medical device (surgical mesh) and not an AI-assisted diagnostic tool.

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

Not applicable. This is a medical device (surgical mesh) and not an AI algorithm.

7. The type of ground truth used

For the bench testing, the "ground truth" is established by:

Objective physical and mechanical measurements.
Adherence to recognized industry standards (ASTM D5735-95 for Tear Resistance, ASTM D6797-07 for Burst Strength).
Comparison to the established performance specifications and characteristics of the legally marketed predicate device (LTM-Surgical Mesh K070560).
Prior biocompatibility and viral inactivation data from the predicate device, which is deemed applicable due to identical raw materials and manufacturing processes (except for the perforations).

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

Not applicable.

Summary

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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

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

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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 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.

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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: (908) 947-1661 Fax: (908) 947-1095

Mira Leiwant Director, Quality Engineering and Regulatory Affairs Phone: (908) 809-7747 Fax: (908) 947-1095

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)

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DEVICE DESCRIPTION 4.

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.

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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).

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.