The DePuy Restore Orthobiologic Soft Tissue Implant is intended to reinforce soft tissue where weakness exists, specifically for the reinforcement of soft tissue repaired by sutures or suture anchors during tendon repair surgery, including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, and other tendons. The device is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps or other tendons. Sutures used to repair the tear, and sutures or bone anchors used to attach the tissue to the bone, provide biomechanical strength for the tendon repair. The DePuy Restore Orthobiologic Soft Tissue Implant is also intended for use during general tissue reconstruction of the periosteum. The device reinforces soft tissue and provides a resorbable scaffold that is replaced by the patient's own soft tissue.

Device Description

The DePuy Restore Orthobiologic Soft Tissue Implant is manufactured from porcine small intestinal submucosa (SIS), comprised predominantly of water and collagen, and will be supplied in a sheet or strand configuration in sterile form in a sealed double pouch system.

AI/ML Overview

The DePuy Restore Orthobiologic Soft Tissue Implant (K071016) is a surgical mesh made from porcine small intestinal submucosa (SIS), intended to reinforce soft tissue during tendon repair surgery and general tissue reconstruction of the periosteum. It is not intended to replace normal body structure or provide full mechanical strength, but rather to serve as a resorbable scaffold.

Here's an analysis of its acceptance criteria and the supporting study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes the device's characteristics and the types of tests performed rather than specific quantitative acceptance criteria or detailed performance metrics. The stated "acceptance criteria" appear to be meeting the requirements of the conducted tests to demonstrate suitability for use.

Acceptance Criteria Category	Reported Device Performance (as per submission)
Biocompatibility	Met the requirements of extensive biocompatibility testing.
Viral Inactivation	Met the requirements of viral inactivation testing.
Mechanical Strength	Met the requirements of mechanical testing.
Suitability for Use	Evidence of suitability for use in soft tissue repair.
Substantial Equivalence	Found substantially equivalent to predicate devices (K031969, K061892, K033671) in terms of intended use and technological characteristics, raising no new types of safety and effectiveness questions.

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

The document does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "extensive biocompatibility testing," "viral inactivation testing," and "mechanical testing." These tests were likely conducted on the device material itself rather than human clinical subjects.

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

This information is not provided. The testing described (biocompatibility, viral inactivation, mechanical) is typically laboratory-based and does not involve expert readers establishing ground truth in the same way as, for example, diagnostic imaging studies.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable given the nature of the tests described.

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 MRMC comparative effectiveness study was mentioned. This device is a surgical implant, not an AI-assisted diagnostic tool, so such a study would not be relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable, as the device is a physical surgical mesh and not an algorithm or software.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the specific tests mentioned:

Biocompatibility: Ground truth would be established by standardized toxicological and biological response assays, often with reference materials.
Viral Inactivation: Ground truth would be established through virological assays and controls.
Mechanical Testing: Ground truth would be established by standardized mechanical testing methods and material properties specifications.

These are objective, laboratory-derived ground truths rather than clinical ground truths requiring expert consensus or pathology.

8. The Sample Size for the Training Set

This information is not provided and is not applicable, as 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

This information is not provided and is not applicable, as this is a physical medical device, not an AI model.

Summary of the Study:

The "study" referenced in the 510(k) submission is a series of laboratory-based tests. The device underwent:

Extensive biocompatibility testing: This likely involved in vitro and/or in vivo tests to ensure the material does not cause adverse biological reactions.
Viral inactivation testing: This would have assessed the effectiveness of the manufacturing process in neutralising potential viral contaminants from the porcine source material.
Mechanical testing: This would have evaluated the physical strength and properties of the mesh to ensure it can perform its intended function of reinforcing soft tissue without providing full mechanical strength.

The conclusion drawn from these tests was that the device met the requirements, providing evidence of its suitability for use and substantial equivalence to legally marketed predicate devices (DePuy Restore Orthobiologic Soft Tissue Implant (K031969), CryoLife ProPatch Soft Tissue Repair Matrix (K061892), W.L. Gore Absorbable Mesh (K033671)). The basis for substantial equivalence primarily relies on its similar material (porcine SIS) to K031969 and similar intended use and indications to all listed predicate devices. No new safety or effectiveness questions were raised.

Summary

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510(k) Premarket Notification DePuv Restore Orthobiologic Soft Tissue Implant

K07/016
Page ① of ②

510(k) SUMMARY 7.0

NAME OF SPONSOR:

Depuy Orthopaedics, Incorporated 700 Orthopaedic Drive Warsaw, Indiana 46581

510(k) CONTACT: Kathy Harris Director of Regulatory Affairs

SEP - 4 2007

DATE: March 30, 2007

TRADE NAME: DePuy Restore Orthobiologic Soft Tissue Implant COMMOM NAME: Surgical Mesh 21 CFR §878.3300, Class II CLASSIFICATION: PRODUCT CODE: FTM

SUBSTANTIALLY EQUIVALENT DEVICES:

DePuy Restore Orthobiologic Soft Tissue Implant (K031969) .
CryoLife ProPatch Soft Tissue Repair Matrix (K061892) .
W.L. Gore Absorbable Mesh (K033671) .

DEVICE DESCRIPTION AND INTENDED USE:

The DePuy Restore Orthobiologic Soft Tissue Implant is intended to reinforce soft tissue where weakness exists, specifically for the reinforcement of soft tissue repaired by sutures or suture anchors during tendon repair surgery, including reinforcement of the rotator cuff, patella, Achilles, biceps, quadriceps, and other tendons. The device is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps or other tendons. Sutures used to repair the tear, and sutures or bone anchors used to attach the tissue to the bone, provide biomechanical strength for the tendon repair. The DePuy Restore Orthobiologic Soft Tissue Implant is also intended for use during general tissue reconstruction of the periosteum. The device reinforces soft tissue and provides a resorbable scaffold that is replaced by the patient's own soft tissue.

BASIS OF SUBSTANTIAL EQUIVALENCE:

The DePuy Restore Orthobiologic Soft Tissue Implant is substantially equivalent to the above listed devices (K031969, K061892, K033671) in that it is manufactured from the same material (SIS) as K031969, and has the same intended use and similar indications as K031969, K061892, and K033671, raising no new types of safety and effectiveness questions.

DISCUSSION OF TESTS AND TEST RESULTS:

The DePuy Restore Orthobiologic Soft Tissue Implant met the requirements of extensive biocompatibility testing, viral inactivation testing, and mechanical testing, demonstrating suitability for use.

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510(k) Premarket Notification DePuy Restore Orthobiologic Soft Tissue Implant

page ② of ②

CONCLUSIONS DRAWN FROM TESTS:

Outcomes from the evaluation of the DePuy Restore Orthobiologic Soft Tissue Implant provide evidence of its suitability for use in soft tissue repair and substantial equivalency to predicate devices in terms of intended use and technological characteristics.

0000019

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DePuy Orthopaedics, Inc % Ms. Kathy Harris Director Regulatory Affairs 700 Orthopaedic Drive PO Box 988 Warsaw, IN 46581-0988

SEP - 4 2007

Re: K071016

Trade/Device Name: DePuy Restore Orthobiologic Soft Tissue Implant Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: August 10, 2007 Received: August 13, 2007

Dear Ms. Harris:

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

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Page 2 - Mr. Stephen Meade

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. 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrb/industry/support/index.html.

Sincerely yours,

Neil R. Oslin

Mark N. Melkerson 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):

Device Name: DePuy Restore Orthobiologic Soft Tissue Implant

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neilson Odlum

Page 1 of 1

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

510(k) Number K071016

000029

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.