HPTM 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 which require the use of reinforcing material to obtain the desired surgical outcome. The implant is intended for reinforcement of soft tissue in plastic and reconstructive surgery.

HPTM is intended for single patient, one-time use only.

Device Description

HP Tissue Matrix 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. 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 device is considered a single use device which is to be used in a healthcare facility or hospital. It is sterilized via Gamma irradiation.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the HPTM surgical mesh. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving performance against defined acceptance criteria in a clinical context with human readers and ground truth.

Therefore, many of the requested sections about acceptance criteria, clinical study details, expert involvement, and reader performance cannot be extracted directly from this document. The document primarily details bench testing for material characteristics.

Here's an analysis of what can be extracted and what cannot:

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

The document provides a list of bench tests performed but does not explicitly state acceptance criteria or the specific numerical results of the device's performance for each test. It only states that "The results of the tests performed demonstrated that the modifications did not affect safety and efficacy of the device or raise any new questions of safety or efficacy."

Test or Evaluation	Acceptance Criteria	Reported Device Performance
Mesh Thickness	Not specified in document	"did not affect safety and efficacy"
Tensile Strength	Not specified in document	"did not affect safety and efficacy"
Suture Pullout Strength	Not specified in document	"did not affect safety and efficacy"
Tear Strength	Not specified in document (refers to ASTM D5735-95)	"did not affect safety and efficacy"
Burst Strength	Not specified in document (refers to ASTM D6797-07(2011))	"did not affect safety and efficacy"
Device Stiffness	Not specified in document	"did not affect safety and efficacy"
Biocompatibility	Not specified in document (refers to ISO 10993 -1, ISO 14971:2007)	"did not affect safety and efficacy"
Drape	Not specified in document	"did not affect safety and efficacy"

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

Sample Size: Not specified for the bench tests.
Data Provenance: Not applicable as this is bench testing on materials, not human data. There is no mention of country of origin.

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)

Not applicable. This document describes bench testing of a physical medical device, not an AI or diagnostic device requiring expert interpretation for ground truth.

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

Not applicable. There is no human interpretation or adjudication involved in the described bench testing.

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

No. The document explicitly states: "No clinical testing was included in this submission." This is a 510(k) submission for a surgical mesh, not a diagnostic AI device, so such a study would not be expected or relevant here.

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

Not applicable. This is not an algorithm or AI device. The "device" is a physical surgical mesh.

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

Not applicable. For the bench tests, the "ground truth" would be the measured physical properties of the material, compared to established material standards (like ASTM or ISO) or the predicate device.

8. The sample size for the training set

Not applicable. This is not an AI or algorithm device 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 is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is simple and clean, and it is easily recognizable.

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

December 23, 2014

LifeCell Corporation Ms. Mira Leiwant Director, Quality Engineering and Regulatory Affairs One Millennium Way Branchburg, New Jersey 08876

Re: K142326

Trade/Device Name: HPTM Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTM and OXH Dated: November 21, 2014 Received: November 24, 2014

Dear Ms. Leiwant:

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 (reporting of medical

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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 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/Resourcesfor You/Industry/default.htm. 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 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

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for 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

510(k) Number (if known) K142326

Device Name HPTM

Indications for Use (Describe)

HPTM 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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary K142326

I. SUBMITTER

LifeCell Corporation One Millennium Way Branchburg, NJ 08876

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

Prepared by and Date: Keira Jessop December 19, 2014

II. DEVICE

Name of Device: HP Tissue Matrix (HPTM) Common or Usual Name: Surgical Mesh Classification Name: Surgical Mesh-(21 C.F.R. §878.3300) Device Class: II Product Code: FTM

III. PREDICATE DEVICES

LTM-BPS Surgical Mesh (K082176)—LifeCell Corporation This predicate has not been subject to a design-related recall

IV. DEVICE DESCRIPTION

The changes described in this submission are the replacement and addition of solutions used during the processing of the LTM-BPS device.

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V. INDICATIONS FOR USE

HPTM 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 which require the use of reinforcing or bridging material to obtain the desired surgical outcome. The implant is intended for reinforcement of soft tissue in plastic and reconstructive surgery.

HPTM is intended for single patient one-time use only.

VI. COMPARISON OF TECHNOLOGICAL CHARCTERISTICS WITH THE PREDICATE DEVICE

The subject and predicate devices are both surgical meshes that are derived from porcine dermis and then processed and preserved in a phosphate buffered aqueous solution containing matrix stabilizers. Both devices are designed to perform as a surgical mesh for soft tissue repair. Both devices consist of a terminally sterilized sheet of the processed porcine dermal matrix provided in prescribed geometric configurations and thicknesses and are packaged in a double pouch configuration. The subject device has the same scientific technology, principles of operation, Intended Use, and Indications for Use as the cleared predicate device, LTM-BPS Surgical Mesh (K082176).

The changes described in the submission are the replacement and addition of solutions used during the processing of the LTM-BPS device.

VII. PERFORMANCE DATA

Performance Data

Bench testing was performed on the subject HPTM device to support substantial equivalence. Testing included relevant elements of the FDA "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh" Table 1 includes the applicable tests used to demonstrate substantial equivalence and applicable guidance documents or standard.

Table 1: Substantial Equivalence Testing Conducted
Test or Evaluation	Applicable guidance document or FDArecognized consensus standard
Mesh Thickness	N/A
Tensile Strength	N/A
Suture Pullout Strength	N/A
Tear Strength	ASTM D5735-95
Burst Strength	ASTM D6797-07(2011)
Device Stiffness	N/A
Biocompatibility	ISO 10993 -1, ISO 14971:2007
Drape	N/A

The results of the tests performed demonstrated that the modifications did not affect safety and efficacy of the device or raise any new questions of safety or efficacy.

Clinical Tests

No clinical testing was included in this submission.

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VIII. CONCLUSIONS

The subject device, HPTM, meets the requirements to perform its intended use as a soft tissue patch and is substantially equivalent to the predicate device LTM-BPS Surgical Mesh (K082176).

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.