HEALIX ADVANCE PEEK ANCHOR by Depuy Mitek

The HEALIX ADVANCE™ PEEK Anchor is indicated for:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction;
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair;
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis;
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction;
Hip: Capsular repair, Acetabular Labral Repair.

Device Description

The HEALIX ADVANCE PEEK Anchor is non-absorbable threaded suture anchor manufactured of PEEK material. The anchor comes preloaded on a disposable inserter assembly and is intended for fixation of size 2 suture to bone. The suture options may include needles to facilitate suture passage through tissue. HEALIX ADVANCE PEEK Anchor is provided sterile and is for single patient, use only.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the HEALIX ADVANCE™ PEEK Anchor. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting a full clinical trial to establish new safety and effectiveness.

Therefore, the study described is a non-clinical, design verification study. The information required for an AI/CADe medical device, such as expert consensus, MRMC studies, or training set details, is not applicable to this type of device and submission.

Here's an analysis of the provided information within the context of a non-clinical device:

1. Table of acceptance criteria and the reported device performance:

Test	Acceptance Criteria	Reported Device Performance
Anchor Torque	Pre-defined acceptance criteria (not specified)	Demonstrated suitability for intended use (meets criteria)
Anchor Pull Out	Pre-defined acceptance criteria (not specified)	Demonstrated suitability for intended use (meets criteria)

Explanation: The document states, "Design verification activities, such as Anchor Torque and Anchor Pull Out were performed against pre-defined acceptance criteria according to the indicated use. Results of performance testing have demonstrated that the proposed devices are suitable for their intended use." However, the specific numerical acceptance criteria and the quantitative results of these tests are not provided in this summary. These details would typically be found in the full test reports submitted to the FDA, not in the 510(k) summary.

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated for specific tests. The description implies multiple anchors were tested for design verification.
Data Provenance: Not applicable in the context of human data. These are laboratory-based, non-clinical tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable: For non-clinical tests like anchor torque and pull-out strength, "ground truth" is established by engineering specifications and objective measurements, not expert human interpretation.

4. Adjudication method for the test set:

Not Applicable: No human interpretation or adjudication is involved in these types of physical performance tests.

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 device is a physical surgical anchor and not an AI/CADe device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

Not Applicable: This device is a physical surgical anchor and not an algorithm.

7. The type of ground truth used:

Engineering Specifications/Objective Measurements: For mechanical tests like torque and pull-out, the "ground truth" is derived from relevant engineering standards, material properties, and mechanical test methodologies. These tests objectively measure the physical properties of the anchor.

8. The sample size for the training set:

Not Applicable: This is a non-clinical device, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established:

Not Applicable: This is a non-clinical device, not an AI/ML algorithm that requires a training set and corresponding ground truth.

In summary: The K120449 PEEK Anchor submission relies on non-clinical, mechanical design verification tests to demonstrate substantial equivalence to a predicate device. The information requested pertaining to AI/CADe devices (such as expert reads, MRMC studies, and training set details) is not relevant to this type of medical device submission.

Summary

{0}------------------------------------------------

K120449 (pg1/2)

SECTION 2 - 510(k) SUMMARY

HEALIX ADVANCE™ PEEK Anchor

MAY 1 1 2012

ﺴﺮ ﺑﺎﻟﻤﺮﺍﺟﻊ -

Submitter'sName andAddress	DePuy Miteka Johnson & Johnson company325 Paramount DriveRaynham, MA 02767
Contact Person	Yayoi FujimakiRegulatory Affairs Senior AssociateDePuy Mitek, Inc.a Johnson & Johnson company325 Paramount DriveRaynham, MA 02767, USATelephone: 508-828-3541Facsimile: 508-977-6911e-mail: yfujimal@its.jnj.com
Name ofMedical Device	Proprietary Name: HEALIX ADVANCE™ PEEK AnchorClassification Name: Smooth or threaded metallic bone fixation fastenersCommon Name: Bone Anchor
SubstantialEquivalenceFacility	The HEALIX ADVANCE PEEK Anchor is substantially equivalent to:• K071481: Healix PEEK Anchor
DeviceClassification	Smooth or threaded metallic bone fixation fasteners, classified as Class II, productcode HWC, regulated under 21 CFR 888.3040.

Premarket Notification: Traditional
HEALIX ADVANCE™ PEEK Anchor

, i

{1}------------------------------------------------

DeviceDescription	The HEALIX ADVANCE PEEK Anchor is non-absorbable threaded suture anchormanufactured of PEEK material. The anchor comes preloaded on a disposable inserterassembly and is intended for fixation of size 2 suture to bone. The suture options mayinclude needles to facilitate suture passage through tissue. HEALIX ADVANCEPEEK Anchor is provided sterile and is for single patient, use only.
Indications forUse	Shoulder:	Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, BicepsTenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair,Capsular Shift or Capsulolabral Reconstruction;
	Foot/Ankle:	Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair;
	Knee:	Medial Collateral Ligament Repair, Lateral Collateral LigamentRepair, Posterior Oblique Ligament Repair, Iliotibial BandTenodesis;
	Elbow:	Biceps Tendon Reattachment, Ulnar or Radial Collateral LigamentReconstruction;
	Hip:	Capsular repair, Acetabular Labral Repair.
Safety andPerformance	Non-clinical TestingDesign verification activities, such as Anchor Torque and Anchor Pull Out wereperformed against pre-defined acceptance criteria according to the indicated use.Results of performance testing have demonstrated that the proposed devices aresuitable for their intended use.Based on the indications for use, technological characteristics, and comparison to thepredicate devices, the proposed HEALIX ADVANCE PEEK Anchor have shown to besubstantially equivalent to the predicate devices under the Federal Food, Drug andCosmetic Act.

・

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized eagle in flight, rendered in blue lines. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

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

DePuy Mitek, Inc a Johnson and Johnson Company % Ms. Yayoi Fujimaki Regulatory Affairs Senior Associate 325 Paramount Drive Raynham, MA 02767

JUL - 2 2012

Re: K120449

Trade/Device Name: HEALIX ADVANCE™ PEEK Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: May 11, 2012 Received: May 11, 2012

Dear Ms. Fujimaki:

This letter corrects our substantially equivalent letter of May 11, 2012.

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 (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 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

{3}------------------------------------------------

Page 2 - Ms. Yayoi Fujimaki

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 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/CDRH/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 A. Milkeron

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

{4}------------------------------------------------

Indications for Use

KIZD449 (pa 1/1) 510(k) Number (if known): Device Name: HEALIX ADVANCE™ PEEK Anchor Indications for Use:

The HEALIX ADVANCE™ PEEK Anchor is indicated for:

Shoulder:	Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis,Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift orCapsulolabral Reconstruction;
Foot/Ankle:	Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair;
Knee:	Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis;
Elbow:	Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction;
Hip:	Capsular repair, Acetabular Labral Repair.

Prescription Use ____x

AND/OR

Over-The-Counter Use _

(Pari 21 CFR 801 Subpart D)

(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)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K120449

Page 1 of 1

Premarket Notification: Traditional HEALIX ADVANCE™ PEEK Anchor

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.