Permacol™ - Crosslinked Porcine Dermal Collagen Surgical Mesh ("Permacol™ ") is intended to be used for reinforcement of the soft tissues which are repaired by suture or suture anchors limited to the supraspinatus during rotator cuff repair surgery.

Device Description

Permacol™ is available in sheet form.

AI/ML Overview

The provided text describes a 510(k) submission for a surgical mesh, Permacol™ - Crosslinked Porcine Dermal Collagen Surgical Mesh. The submission focuses on demonstrating substantial equivalence to predicate devices rather than a study proving the device meets specific acceptance criteria based on detailed performance metrics.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states "Mechanical testing of Permacol™ has been performed in accordance with FDA's Surgical Mesh 510(k) Guidance. The results demonstrate that Permacol™ provides appropriate tensile strength, elasticity, stiffness, suture pullout strength, tear resistance, and puncturability, for use in soft tissue repair."

However, specific quantitative acceptance criteria (e.g., minimum tensile strength of X MPa, elasticity range of Y-Z%) or the exact reported performance values are NOT provided in the submission summary. The FDA's 510(k) summary only states that the device "provides appropriate" values, implying that it met internal or guidance-recommended criteria without listing them.

Acceptance Criteria (Quantitative)	Reported Device Performance (Quantitative)
Not explicitly stated in the 510(k) summary (e.g., specific thresholds for tensile strength, elasticity)	Not explicitly stated in the 510(k) summary (e.g., actual measured tensile strength, elasticity values)
Qualitative statements from the document:	Qualitative statements from the document:
Appropriate tensile strength	Permacol™ provides appropriate tensile strength
Appropriate elasticity	Permacol™ provides appropriate elasticity
Appropriate stiffness	Permacol™ provides appropriate stiffness
Appropriate suture pullout strength	Permacol™ provides appropriate suture pullout strength
Appropriate tear resistance	Permacol™ provides appropriate tear resistance
Appropriate puncturability	Permacol™ provides appropriate puncturability

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

Sample Size: The document does not specify the sample size used for the mechanical testing.
Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It only mentions "Mechanical testing of Permacol™ has been performed..."

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

This information is not applicable as the "test set" in this context refers to mechanical properties of a medical device, not a diagnostic or clinical performance study requiring expert ground truth for interpretation (e.g., radiology images or pathology slides). The assessment is based on physical material properties.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as #3. Mechanical testing results are objective measurements, not subject to expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret cases with and without AI assistance. This submission is for a surgical mesh, a physical implant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This information is not applicable. The device is a surgical mesh, not an algorithm. The performance described relates to the physical characteristics of the mesh itself.

7. The Type of Ground Truth Used:

The "ground truth" here would be the objective measurements of the physical and mechanical properties of the Permacol™ mesh. This would involve laboratory-based testing methods to determine:
* Tensile strength
* Elasticity
* Stiffness
* Suture pullout strength
* Tear resistance
* Puncturability

These are intrinsic material properties and do not rely on expert consensus, pathology, or outcomes data in the way a diagnostic device would.

8. The Sample Size for the Training Set:

This information is not applicable. The Permacol™ mesh is a manufactured medical device, not an AI or algorithm that requires a "training set" in the computational sense. The document refers to its manufacturing process and testing of its final product properties.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable for the same reasons as #8.

Summary

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021056 (hlopd)

510(k) SUMMARY

OCT 31 2002

Tissue Science Laboratories, PLC's Permacol™ - Crosslinked Porcine Dermal Collagen Surgical Mesh

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

Howard M. Holstein, Esq. Hogan & Hartson, L.L.P. 555 Thirteenth Street, N.W. Washington, DC 20004-1109 (202) 637-5813 Phone: Facsimile: (202) 637-5910 E-mail: hmholstein@hhlaw.com

Contact Person: Howard M. Holstein

April 1, 2002 Date Prepared:

Name of Device and Name/Address of Sponsor

Tissue Science Laboratories, PLC 7th Floor, Victoria House Victoria Road Aldershot Hants GU11 1EJ United Kingdom

Common or Usual Name

Surgical Mesh

Classification Name

Surgical Mesh

Predicate Devices

DePuy, Inc.'s Restore® Orthobiologic Soft Tissue Implant (K001738) ("Restore®"), Organogenesis, Inc.'s Fortaflex Surgical Mesh (K011025) ("Fortaflex"); and Cook Biotech's SurgiSIS™ (K980431) ("SurgiSIS™).

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K02/1056 (P.2 of 2)

tended Use

echnological Characteristics and Substantial Equivalence

Permacol™ is substantially equivalent to its predicates because it has the same intended use and very similar technological characteristics. Permacol™ and its predicates are intended for use in a broad range of surgical procedures for soft tissue repair/reinforcement. Permacol™ and Restore® are specifically indicated for reinforcement of the soft tissues which are repaired by suture or suture anchors limited to the supraspinatus during rotator cuff repair surgery.

The technological characteristics of Permacol™ are very similar to its predicate devices. For example, Permacol™ is available in sheet form, like Fortaflex and SurgiSIS™. All of the devices also share similar dimensions, thickness, and composition. Finally, Permacol™ and Restore® present the same questions of safety and effectiveness with regard to mechanical strength and durability. Thus, Permacol™ is substantially equivalent to its oredicate devices.

Performance Data

Mechanical testing of Permacol™ has been performed in accordance with FDA's Surgical Mesh 510(k) Guidance. The results demonstrate that Permacol™ provides appropriate tensile strength, elasticity, stiffness, suture pullout strength, tear resistance, and puncturability, for use in soft tissue repair.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 31 2002

Tissue Science Laboratories, PLC c/o Hogan & Hartson, L.L.P. Howard M. Hostein, Esq. 555 Thirteenth Street, N.W. Washington, D.C. 20004-1109

Re: K021056

Trade/Device Name: Permaco[™ Crosslinked Porcine Dermal Collagen Surgical Mesh Regulation Number: 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTM Dated: August 20, 2002 Received: August 21, 2002

Dear Mr. Holstein:

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.

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 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); 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

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket 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" (21 CFR 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) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam d'Prevost

for 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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INDICATIONS FOR USE FORM

510(k) Number (if known):_KO31056

Device Name: Mesh

Indications for Use: Permacol™ - Crosslinked Porcine Dermal Collagen Surgical Mesh is indicated for use in the reinforcement of the soft tissues which are repaired by suture or suture anchors limited to the supraspinatus during rotator cuff repair surgery.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 C.F.R. 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

Muriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K021054

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.