Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromioclavicular; 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. Patellar Tendon repair and secondary fixation in ACL/PCL reconstruction repair:

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction;

Hip: Capsular repair, Acetabular Labral Repair.

Device Description

The HEALIX TiTM Anchor with DYNACORDTM Suture is a threaded suture anchor preloaded on a disposable inserter assembly intended for fixation of soft tissue to bone. HEALIX TiTM Anchors with DYNACORDTM Suture is available in Titanium material, which is a common material used on existing Depuy Mitek devices. Devices with needles will be offered to facilitate suture passage through tissue. The HEALIX TiTM Anchor with DYNACORDTM Suture is provided sterile and is for single use only.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the HEALIX Ti™ ANCHOR with DYNACORD™. It establishes substantial equivalence to a predicate device, meaning it does not require a new study to prove its safety and effectiveness in the same way a novel device would. Therefore, the information typically found in an AI/Software as a Medical Device (SaMD) submission regarding acceptance criteria, training/test sets, expert adjudication, and MRMC studies is not applicable here.

The provided text focuses on the non-clinical testing performed to demonstrate the device's substantial equivalence to a predicate, rather than a clinical study evaluating the performance of an AI/SaMD.

Here's an analysis based on the provided document:

1. A table of acceptance criteria and the reported device performance:

The document describes non-clinical testing, not performance against specific clinical acceptance criteria of an AI/SaMD. The "acceptance criteria" here relate to engineering and material performance for a physical implant.

Acceptance Criteria (Type of Test)	Reported Device Performance (Summary)
Anchor fixation testing	Performed; results demonstrated suitability for intended use
Torque testing	Performed; results demonstrated suitability for intended use
Suture testing (per USP)	Performed; results demonstrated suitability for intended use
Approximation force testing	Performed; results demonstrated suitability for intended use
Biological evaluation	Conducted
Sterility	Conducted
Packaging	Conducted
Shelf-life testing	Conducted
Bacterial endotoxin testing	Met endotoxin limits

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

Sample Size: Not specified in terms of number of anchors tested, but general non-clinical testing was conducted.
Data Provenance: Not applicable in the context of clinical data for AI/SaMD. This refers to lab-based testing of physical properties.

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

Not applicable as this is not an AI/SaMD and does not involve human expert labeling of data. The "ground truth" for these tests would be the established engineering and materials science standards.

4. Adjudication method for the test set:

Not applicable for non-clinical engineering 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 is a physical medical device, not an AI/SaMD.

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

Not applicable. This is a physical medical device, not an AI/SaMD.

7. The type of ground truth used:

For the non-clinical testing, the "ground truth" is defined by established engineering standards, USP specifications for suture materials, and biological safety standards (e.g., ISO standards for biocompatibility, endotoxin limits).

8. The sample size for the training set:

Not applicable. This is not an AI/SaMD.

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

Not applicable. This is not an AI/SaMD.

In summary, the provided document is a regulatory submission for a physical medical device (suture anchor) based on demonstrating substantial equivalence to an existing predicate device through non-clinical performance and safety testing, not through clinical trials or evaluations of an AI/SaMD.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized representation of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG" are on the top line, and the word "ADMINISTRATION" is on the bottom line.

February 21, 2019

Medos International SARL % Leslie Coney Regulatory Affairs Specialist DePuy Mitek, a Johnson & Johnson Company 325 Paramount Drive Raynham, Massachusetts 02767

Re: K183279

Trade/Device Name: HEALIX TiTM ANCHOR with DYNACORD™ Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI, HWC Dated: November 19, 2018 Received: November 23, 2018

Dear Leslie Coney:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Laurence D. Coyne -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K183279

Device Name HEALIX Ti™ ANCHOR with DYNACORD™

Indications for Use (Describe) The HEALIX TiTM Anchors with DYNACORD™ is intended for:

Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromioclavicular; Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction:

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair;

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction;

Hip: Capsular repair, Acetabular Labral Repair.

Type of Use (Select one or both, as applicable)

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

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510(k) SUMMARY

HEALIX Ti™ Anchor with DYNACORD™ Suture

Date Prepared: January 23, 2019

Submitter'sName andAddress	DePuy Miteka Johnson & Johnson company325 Paramount DriveRaynham, MA 02767
Contact Person	Leslie ConeyRegulatory Affairs SpecialistDePuy Mitek, Inc.a Johnson & Johnson company325 Paramount DriveRaynham, MA 02767, USATelephone: 508-977-2618e-mail: lconey@its.jnj.com
Name ofMedical Device	Proprietary Name:-HEALIX TI™ ANCHOR with DYNACORD™-HEALIX TI™ 3 SUTURE ANCHOR withDYNACORD™-HEALIX TI™ ANCHOR with DYNACORD™ ANDNEEDLESClassification Name: Smooth or threaded metallic bone fixation fastenersCommon Name: Suture Anchor
SubstantialEquivalence	The HEALIX Ti™ Anchor with DYNACORD™ Suture is substantially equivalentto:K082282 HEALIX Ti® Anchor with ORTHOCORD®Reference devices:K173859 HEALIX ADVANCE® Anchors with DYNACORD® SutureK021434, K041553 FIBERWIRE® (Arthrex)K181809 GRYPHON ANCHOR® with DYNACORD®K082282 DYNACORD®
DeviceClassification	> HEALIX Ti™ Anchor with DYNACORD™ Suture is classified as:Single/multiple component metallic bone fixation appliances and accessories,classified as Class II, product code MBI, regulated under 21 CFR 888.3040.Single/multiple component metallic bone fixation appliances and accessories,
DeviceDescription	The HEALIX TiTM Anchor with DYNACORDTM Suture is a threaded suture anchorpreloaded on a disposable inserter assembly intended for fixation of soft tissue tobone. HEALIX TiTM Anchors with DYNACORDTM Suture is available in Titaniummaterial, which is a common material used on existing Depuy Mitek devices.Devices with needles will be offered to facilitate suture passage through tissue. TheHEALIX TiTM Anchor with DYNACORDTM Suture is provided sterile and is forsingle use only.
TechnologicalCharacteristics	The proposed HEALIX TiTM Anchor with DYNACORDTM Suture has the sameanchor materials, design, principle of operation, as well as device assembly,sterilization method, and shelf life, as predicate HEALIX TiTM Anchor withORTHOCORD® Suture (K082282). The DYNACORD® Suture component is anon-absorbable suture that conforms to USP, except for oversized diameter.
Indications forUse	The HEALIX TiTM Anchors with DYNACORDTM is intended for:Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, BicepsTenodesis, 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, Patella tendon repairand secondary fixation in ACL / PCL reconstruction repair.Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral LigamentReconstruction.Hip: Capsular repair, acetabular labral repair
Non clinicalTestingSafety andPerformance	Non-clinical testing has been performed on the proposed device and /or itspredicates. Performance testing included anchor fixation testing, torque testing,suture testing per USP and approximation force testing. Safety evaluations wereconducted to address biological, sterility, packaging and shelf-life testing. Bacterialendotoxin testing has been completed and results have demonstrated that theproposed devices meet the endotoxin limits.Results of performance testing have demonstrated that the proposed devices aresuitable for their intended use. Based on similarities in the indications for use,technological characteristics, and performance in comparison to the predicatedevices, the proposed HEALIX TiTM Anchor with DYNACORDTM Suture hasshown to be substantially equivalent to the predicate devices under the FederalFood, Drug and Cosmetic Act.

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Regulation Number and Section

N/A