VERSALOK PEEK ANCHOR WITH ORTHOCORD SUTURE, MODELS 210818, 210819 by DEPUY MITEK, A JOHNSON & JOHNSON COMPANY

VERSALOCK Anchor is indicated for use in the following: Shoulder: Rotor Cuff Repair, Biceps Tenodesis Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis; Joint Capsule Closure Elbow: Biceps Tendon Reattachment

Device Description

The Versalok Peek Anchor System includes the Versalok Peek Anchor, which will be presented sterile, pre-mounted on an inserter shaft w/anvil with a threader tab and suture. The System will be deployed with the use of a reusable Deployment Gun. The system is provided with and without a Orthocord#2 suture.

AI/ML Overview

Here's the breakdown of the acceptance criteria and study information for the Versalok Peek Anchor, based on the provided 510(k) summary:

This device is a bone anchor, not an AI/software device. Therefore, many of the typical AI-related study components (like expert ground truth, MRMC studies, training sets, etc.) are not applicable in this context. The "acceptance criteria" here refers to the performance standards demonstrably met by the device to prove substantial equivalence to existing predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Test Performed	Reported Device Performance (Summary)
Mechanical Performance	Pull Out Testing	Not explicitly detailed with numerical values, but stated that results "demonstrated that the modified device is substantially equivalent to the predicate devices."
Material Safety	Biocompatibility	Not explicitly detailed, but stated that results "demonstrated that the modified device is substantially equivalent to the predicate devices."
Product Stability	Shelf Life	Not explicitly detailed, but stated that results "demonstrated that the modified device is substantially equivalent to the predicate devices."
Sterility Assurance	Sterilization	Not explicitly detailed, but stated that results "demonstrated that the modified device is substantially equivalent to the predicate devices."

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

Sample Size for Test Set: The document does not specify the exact sample sizes (e.g., number of anchors, test specimens) used for the nonclinical testing (pull-out, shelf life, sterilization, biocompatibility).
Data Provenance: The data is generated from nonclinical testing of the device or its predicates. The country of origin for the data is not specified but is implicitly associated with the manufacturer (DePuy Mitek, Inc. in Raynham, MA, USA). The testing is prospective for the Versalok Peek Anchor to demonstrate its performance against established standards and predicate devices.

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

Not Applicable: For a physical medical device like a bone anchor, "ground truth" in the context of expert consensus (as used for imaging or diagnostic AI) is not relevant. The ground truth for mechanical and material properties is established by validated engineering and scientific testing standards and methodologies.

4. Adjudication Method for the Test Set:

Not Applicable: Adjudication is typically associated with human reviewer discrepancies (e.g., in medical image interpretation). For nonclinical testing of a physical device, the "adjudication" is inherent in the objective nature of the test results themselves against predefined pass/fail criteria or comparison to predicate performance.

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 an AI/software-specific study type. The Versalok Peek Anchor is a physical implantable medical device, not an AI or software product.

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

Not Applicable: This is an AI/software-specific study type. The Versalok Peek Anchor is a physical implantable medical device.

7. The Type of Ground Truth Used:

For the nonclinical studies, the "ground truth" is based on:
- Objective physical measurements and chemical analyses according to recognized standards (e.g., ASTM, ISO standards for pull-out strength, material characterization, biocompatibility testing guidelines).
- Performance of legally marketed predicate devices (Trident Anchor, Versalok Ti Anchor, Arthrex Pushlock Anchor) as benchmarks for substantial equivalence.

8. The Sample Size for the Training Set:

Not Applicable: This is an AI/software-specific concept. There is no "training set" for a physical medical device.

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

Not Applicable: As above, there is no "training set."

Summary of the Study Proving Acceptance Criteria:

The study proving the Versalok Peek Anchor meets acceptance criteria is a series of nonclinical performance and safety tests. These tests were conducted on the implant or its predicates and included:

Pull Out Testing: To evaluate the mechanical strength and fixation capability of the anchor.
Shelf Life Testing: To ensure the device maintains its properties over its intended storage duration.
Sterilization Testing: To confirm the effectiveness of the sterilization process and ensure the device remains sterile until use.
Biocompatibility Testing: To assess the biological safety of the materials in contact with body tissues.

The document states that the "results of performance and safety testing have demonstrated that the modified device is substantially equivalent to the predicate devices." This substantial equivalence, based on these verified tests and comparison to the predicate devices (Trident Anchor, Versalok Ti Anchor, and Arthrex Pushlock Anchor), forms the basis for the FDA's clearance. The "acceptance criteria" are implicitly met by confirming these performance and safety characteristics are comparable or equivalent to the already cleared predicate devices.

Summary

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510(k) SUMMARY

KI00532

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Versalok Peek Anchor

Submitter's Name and Address:	DePuy Mitek, Inc.a Johnson & Johnson company325 Paramount DriveRaynham, MA 02767
	MAR 1 7 2010
Contact Person	Kristine ChristoRegulatory Affairs Project ManagerDePuy Mitek, Inc.a Johnson & Johnson company325 Paramount DriveRaynham, MA 02767Telephone: 508-828-3359Facsimile: 508-977-6911e-mail: kchristo@its.jnj.comPrepared: 2/24/10
Name of Medical Device	Classification Name: Fastener, Fixation, Nondegradable, SoftTissue Smooth or threaded metallic bonefixation fastenersCommon/Usual Name: Bone AnchorProprietary Name: Versalok Peek Anchor
Substantial Equivalence	Versalok Peek Anchor is substantially equivalent to:Trident Anchor (K060914)Versalok Ti Anchor (K063478)Arthrex Pushlock Anchor (K063479)
Device Classification	This device carries an FDA product code MBI and HWC, and isclassified as Fastener, Fixation, Nondegradable, Soft Tissue Smooth orthreaded metallic bone fixation fasteners under 21 CFR 888.3040.
Device Description	The Versalok Peek Anchor System includes the Versalok Peek Anchor,which will be presented sterile, pre-mounted on an inserter shaft w/anvil

510(k) Premarket Notification: Special
Versalok Peek Anchor ConfidentialVersalok Peek Anchor

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with a threader tab and suture. The System will be deployed with the use of a reusable Deployment Gun. The system is provided with and without a Orthocord#2 suture.

The VERSALOK Anchor System offers several additional clinical benefits as the anchor allows the surgeon to fix the tissue without tying knots and the delivery system allows the surgeon to control the tension placed on the tissue with the tension wheel of the deployment gun.

Technologies characteristics including material, design, packaging and indications are the same as the predicate cleared devices and use similar or identical material and packaging as the predicates.

Indications for Use

Nonclinical testing:

Safety and Performance

Predicate Comparison

The Versalok Peek Anchor is indicated for use in the following: Shoulder: Rotator Cuff Repair, Biceps Tenodesis, Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis; Joint Capsule Closure Elbow: Biceps Tendon Reattachment

Verification activities were performed on the implant or its predicates. Testing includes pull out testing, shelf life, sterilization and biocompatibility.

Results of performance and safety testing have demonstrated that the modified device is substantially equivalent to the predicate devices.

Based on the indications for use, technological characteristics, and comparison to predicate devices, the Versalok Peek Anchor has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.

The proposed Versalok Peek Anchor is compared to the predicate Trident Anchor (K063478), Versalok Anchor (K060914) and Arthrex Pushlock (K063479) below.

510(k) Premarket Notification: Special Versalok Peek Anchor

Confidential

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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-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

MAR 1 7 2010

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

DePuy Mitek % Ms. Kristine Christo Regulatory Affairs Project Manager 325 Paramount Drive Raynham, Massachusetts 02767

Re: K100532 Trade/Device Name: VERSALOCK Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC, MBI Dated: February 24, 2010 Received: February 25, 2010

Dear Ms. Christo:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Kristine Christo

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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,

Mark N. Melkerso Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

K100537

Device Name:

VERSALOCK Anchor is indicated for use in the following:

Shoulder: Rotor Cuff Repair, Biceps Tenodesis Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis; Joint Capsule Closure Elbow: Biceps Tendon Reattachment

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Krone for MXM
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K100532

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.