Permacol™ tissue 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 where weakness exists and for the surgical repair of damaged or ruptured soft tissue in plastic and reconstructive surgery of the face and head.

Device Description

Permacol™ consists of a sterile, tough, off-white, moist, flexible, fibrous flat sheet comprised of acellular crosslinked porcine dermal collagen and elastin. Each impermeable inner pack contains a small quantity of saline to maintain its moistness and flexibility. The product is available in thicknesses of 0.5-1.5 mm and dimensions of 0.8 x 0.8 to 4 x 6 inches.

AI/ML Overview

The provided 510(k) summary for Permacol™ Crosslinked Porcine Dermal Collagen Surgical Mesh does not contain the information requested regarding acceptance criteria or a study proving the device meets said criteria.

The document is a premarket notification for a Class II medical device, essentially asserting its substantial equivalence to previously cleared predicate devices. It focuses on:

Device Identification and Classification: Naming the device, its sponsor, and its classification.
Predicate Devices: Listing similar devices already on the market.
Intended Use: Stating the purpose of the device (soft tissue repair/reinforcement in plastic and reconstructive surgery of the face and head).
Technological Characteristics: Describing the material, form, and how it is used.
Summary Basis for Substantial Equivalence: Arguing that the new device is sufficiently similar to existing ones and does not raise new questions of safety or effectiveness. This is the core of a 510(k) submission.

The information about specific acceptance criteria, performance data from a study, sample sizes, expert involvement, ground truth, or comparative effectiveness studies (MRMC) is typically not included in a 510(k) summary. These details would be part of a more extensive submission to the FDA, which is not publicly available in this format, or would appear in a full study report.

Therefore, for each of your requested points, the answer based solely on the provided text is:

A table of acceptance criteria and the reported device performance: Not provided. The document states "these differences do not raise any new questions of safety or effectiveness, as confirmed by preclinical and clinical evaluation," but does not give specific criteria or performance metrics.
Sample sizes used for the test set and the data provenance: Not provided. The document mentions "preclinical and clinical evaluation" in a general sense but gives no details on studies, test sets, or data provenance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
Adjudication method for the test set: Not provided.
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 document describes a surgical mesh, not an AI-assisted diagnostic or imaging device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided.
The sample size for the training set: Not applicable (not an AI/ML device) and not provided if referring to a general study.
How the ground truth for the training set was established: Not applicable and not provided.

Summary

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JAN 1 7 2002

510(k) Summary

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

Tissue Sciences Laboratories PLC Submitter: 7th Floor, Victoria House Victoria Road Aldershot Hants GU11 1SJ United Kingdom Tel. (011) 44 125 233 3002 Fax (011) 44 125 233 3010
Submission Correspondent:

Howard M. Holstein, Esq. Hogan & Hartson, LLP 555 Thirteenth St. N.W. Washington, DC 20004 Tel. (202) 637-5813 Fax (202) 637-5910

Date Prepared: October 26, 2001

Name of Device and Name/Address of Sponsor

Permacol™ Crosslinked Porcine Dermal Collagen Surgical Mesh

Sponsor:

Tissue Sciences Laboratories PLC 7th Floor, Victoria House Victoria Road Aldershot Hants GU11 1SJ United Kingdom Tel. (011) 44 125 233 3002 Fax (011) 44 125 233 3010

Common or Usual Name

Permacol™

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Classification Name

Surgical Mesh

Predicate Devices

1. Tissue Science Laboratories, PLC's Permacol™ Crosslinked Porcine Dermal Collagen Mesh (K992556) ("Permacol")
1. Tissue Technologies, Inc.'s Soft Form Facial Implant (K002071, K000849, K973462) ("Soft Form")
1. Organogenesis, Inc.'s Fortaflex Surgical Mesh (K011025) ("Fortaflex")
1. S. Jackson, Inc.'s Sterile SupraFOIL Smooth Nylon Foil Sheets (K973379) ("SupraFOIL")

Intended Use

Permacol™ is indicated for use to provide soft tissue repair or reinforcement in plastic and reconstructive surgery of the face and head.

Technological Characteristics

To use Permacol™ for soft tissue repair, the surgeon first removes damaged or necrotic tissue. Permacol™ can be cut to the desired

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size and shape required to reinforce or repair the tissue. It is flexible and can conform to the complex surface shapes of human anatomy. Once the product is cut to the desired dimensions, it can be sutured in position if desired. Permacol™ provides sufficient mechanical strength to secure sutures to the surrounding healthy tissue until healing occurs. Similar procedures are used with other surgical mesh devices.

Summary Basis for the Finding of Substantial Equivalence

Permacol™ has the same intended use and substantially the same indications for use as the predicates, which have previously been cleared for use in the face and in reconstructive procedures in the head. Furthermore, the technological features of Permacol™ are substantially similar to the predicates. Although there are minor differences between the products, i.e., with respect to the dimensions and form, method of securement, and materials, these differences do not raise any new questions of safety or effectiveness, as confirmed by preclinical and clinical evaluation. Therefore, Permacol™ is substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping lines forming its body and wings. The eagle faces right and is positioned within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 7 2002

Tissue Science Laboratories, PLC c/o Howard M. Holstein, Esq. Hogan & Hartson, LLP 555 Thirteenth Street, NW Washington, DC 20004-1109

Re: K013625

Trade/Device Name: Permacol Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTM Dated: November 01, 2001 Received: November 05, 2001

Dear Mr. Holstein:

We have reviewed your Section 510(k) premarket notification of intent to market the We have fevenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices the increations for abo 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 with the provisions of the Posts. application (PMA). You may, therefore, market the approval or a promiser applicontrols provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, provisions facturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations (Frid I), It may or san be found in the Code of Federal Regulations, Title 21, Parts arroomig your 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 I loase on that FDA has made a determination that your device complies with other not intoun that I DTP has or any Federal statutes and regulations administered by other requirements on the Free of any For all the Act's requirements, including, but not I carreral agencies: " or and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.

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Page 2 - Mr. Howard M. Holstein, Esq

This letter will allow you to begin marketing your device as described in your Section Find four market notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, (Misbranding by reference to premarket notification( (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 6382041 or (301) 4436597 or at its Internet address HYPERLINK http://www.fda.gov/cdrh/dsma/dsmamain.html http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. Milken

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Permacol™ Porcine Collagen Surgical Mesh

Indications For Use:

Permacol™ tissue is intended for use as a soft tissue patch to reinforce soft tissue r crimator - trebute is the surgical repair of damaged or ruptured soft where weakness calow and of the our plastic and reconstructive surgery of the face and head.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluati

e Evaluation (QPE)
Mark n millhuss
(Div on Sign-Off)

Divison of General, Restorative and +++rological Devices

Prescription Use_ X

Over - The 510(to) telubber -(Per 21 CFR 801.109)

(Optional Format 1-2-96)

013625

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.