HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE Suture by Medos International Sarl

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.

Device Description

The proposed HEALIX TiTM Dual Threaded Suture Anchor with DYNATAPETM Suture is a line extension to the currently marketed HEALIX TiTM Anchor family. The HEALIX Ti Anchor is a non-absorbable dual threaded suture anchor comprised of Titanium material. The threaded anchor comes preloaded on a disposable inserter assembly and is intended for fixation of one strand of #2 DYNACORD Suture and one strand of 2.5 mm DYNATAPE Suture to bone. The HEALIX TiTM Dual Threaded Suture Anchor with DYNATAPETM Suture is provided sterile via Ethylene Oxide (EO) sterilization and is for single use only.

AI/ML Overview

This is a 510(k) premarket notification for a medical device (HEALIX Ti™ Dual Threaded Suture Anchor with DYNATAPE™ Suture), not a traditional AI/ML software as a medical device (SaMD) submission. Therefore, much of the requested information (like acceptance criteria for AI performance, sample sizes for AI training/test sets, expert ground truth establishment, MRMC studies, and standalone AI performance) is not applicable or present in this document.

The document focuses on demonstrating substantial equivalence to predicate devices through material, design, and performance testing, typical for hardware medical devices.

However, I can extract the relevant "acceptance criteria" and "study results" related to the device's mechanical performance:

1. Table of Acceptance Criteria and Reported Device Performance (Non-AI related)

Acceptance Criteria Category	Specific Test/Evaluation	Acceptance Criteria (Implied)	Reported Device Performance	Comments
Mechanical Performance	Fixation strength following cyclic loading	Sufficient strength to perform intended soft-tissue-to-bone fixation	Demonstrated "sufficient" strength	This is implied, as the conclusion states the device is "suitable for their intended use." Specific numeric criteria and results are not provided in this summary.
	Knot tensile strength	Sufficient strength for binding tissues	Demonstrated "sufficient" strength	Implied as above.
	Suture approximation testing	Effective tissue approximation	Demonstrated "effective" approximation	Implied as above.
Sterilization	Sterilization validation (Ethylene Oxide)	Sterility Assurance Level (SAL) of 1 x 10-6	Validated to SAL of 1 x 10-6 per ANSI/AAMI/ISO 11135:2014	Meets the specified standard.
Biocompatibility/Safety	EO residuals	Compliant levels of ethylene oxide residuals	Tested per AAMI/ANSI/ISO 10993-7:2008 and found compliant	Meets the specified standard.
	Non-pyrogenicity	Non-pyrogenic	Determined to be non-pyrogenic per ANSI/AAMI ST-72:2011, USP, and EP using Bacterial Endotoxin Testing (BET) method	Meets the specified standards.
Substantial Equivalence	Similar indications for use, technological characteristics, and performance to predicates	Device characteristics and performance are comparable to the identified predicate devices, demonstrating safe and effective use.	Demonstrated substantial equivalence to K183279 and K200949 based on similarities in indications for use, technological characteristics, and performance.	This is the overarching "acceptance criterion" for a 510(k) submission.

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

This document does not specify a "test set" in the context of an AI/ML device. The "Non-clinical Testing" section refers to verification activities performed on the proposed device and its predicates.
No details on sample sizes (e.g., number of anchors tested) for the mechanical or biocompatibility tests are provided in this summary.
Data provenance (e.g., country of origin, retrospective/prospective) is not applicable or specified for these types of engineering and laboratory tests.

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

Not applicable. This device does not involve expert ground truth for a diagnostic or prognostic AI algorithm. The "ground truth" for its performance is derived from standardized engineering and laboratory testing methods.

4. Adjudication method for the test set:

Not applicable. There is no human reading or diagnostic task requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No. This is not an AI/ML diagnostic or assistive device.

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

Not applicable. This is a hardware medical device; it does not have a standalone algorithm component.

7. The type of ground truth used:

For mechanical performance tests (fixation strength, tensile strength, approximation): The "ground truth" is defined by the physical properties and performance measured against engineering specifications and industry standards.
For sterilization and biocompatibility: The "ground truth" is established by adherence to validated international standards (e.g., ISO 11135, ISO 10993-7, ANSI/AAMI ST-72, USP, EP) and laboratory testing demonstrating compliance.

8. The sample size for the training set:

Not applicable. There is no "training set" in the context of an AI/ML algorithm.

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

Not applicable.

Summary

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February 1, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Medos International SARL % Elizabeth Messana Regulatory Affairs Specialist II Depuy Synthes Mitek, a Johnson & Johnson Company 325 Paramount Drive Raynham, Massachusetts 02767

Re: K203794

Trade/Device Name: HEALIX Ti™ Dual Threaded Suture Anchor with DYNATAPE™ Suture Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: December 30, 2020 Received: January 4, 2020

Dear Elizabeth Messana:

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, 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

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K203794

Device Name

HEALIX Ti™ Dual Threaded Suture Anchor with DYNATAPE™ Suture

Indications for Use (Describe)

The HEALIX Ti™ Dual Threaded Suture Anchor is intended for soft-tissue-to-bone fixation with postoperative immobilization.

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;

Type of Use (Select one or both, as applicable)
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X 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™ Dual Threaded Suture Anchor with DYNATAPE™ Suture Date Prepared: 12/21/2020

Submitter's Name and Address	DePuy Synthes Mitek Sports Medicinea Johnson & Johnson company325 Paramount DriveRaynham, MA 02767
	On behalf of:Medos International SARLChemin-Blanc 38, Le Locle NeuchatelCH 2400, Switzerland
Contact Person	Elizabeth MessanaRegulatory Affairs Specialist IIDePuy Synthes Mitek Sports Medicinea Johnson & Johnson company325 Paramount DriveRaynham, MA 02767
	Telephone: 508-828-3150Email: emessan1@its.jnj.com
Name of Medical Device	Trade Name / Proprietary Name:HEALIX Ti™ Dual Threaded Suture Anchor with DYNATAPE™ SutureCommon Name:Suture Anchor

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SubstantialEquivalence	The HEALIX TiTM Dual Threaded Suture Anchor with DYNATAPETMSuture is substantially equivalent to the predicates:K183279, HEALIX TiTM ANCHORS with DYNACORDTMSuture (Primary Predicate) K200949, HEALIX ADVANCETM Anchor withDYNATAPETM Suture (Reference Predicate)
DeviceClassification	HEALIX TiTM Dual Threaded Suture Anchor with DYNATAPETM Sutureis classified as:Smooth or threaded metallic bone fixation fasteners, classifiedas Class II, product code MBI, regulated under 21 CFR888.3040.
Device Panel	Orthopedic Devices
DeviceDescription	The proposed HEALIX TiTM Dual Threaded Suture Anchor withDYNATAPETM Suture is a line extension to the currently marketedHEALIX TiTM Anchor family. The HEALIX Ti Anchor is a non-absorbable dual threaded suture anchor comprised of Titanium material.The threaded anchor comes preloaded on a disposable inserter assemblyand is intended for fixation of one strand of #2 DYNACORD Sutureand one strand of 2.5 mm DYNATAPE Suture to bone.The HEALIX TiTM Dual Threaded Suture Anchor with DYNATAPETMSuture is provided sterile via Ethylene Oxide (EO) sterilization and isfor single use only.
TechnologicalCharacteristics	The suture anchor design and principal of operation are identical to thepredicate device HEALIX TiTM ANCHORS with DYNACORDTMSuture (K183279), while the indications for use are similar to thepredicate as only a subset is pursued.
Indications forUse	The HEALIX TiTM Dual Threaded Suture Anchor is intended for soft-tissue-to-bone fixation in association with postoperativeimmobilization.Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair,Biceps Tenodesis, Acromioclavicular Separation Repair, DeltoidRepair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, AchillesTendon Repair; Knee: Medial Collateral Ligament Repair, Lateral CollateralLigament Repair, Posterior Oblique Ligament Repair, Iliotibial BandTenodesis, Patellar Tendon repair and secondary fixation inACL/PCL reconstruction repair; Elbow: Biceps Tendon Reattachment, Ulnar or Radial CollateralLigament Reconstruction.
Non-clinicalTesting	Verification activities were performed on the proposed device and itspredicates. Performance testing included evaluation of fixation strengthfollowing cyclic loading, knot tensile strength and suture approximationtesting.Ethylene Oxide Sterilization was validated according toANSI/AAMI/ISO 11135: 2014 to a SAL of 1 x 10-6.EO residuals were tested per AAMI/ANSI/ISO 10993-7:2008The proposed device has been determined to be non-pyrogenic per therequirements set forth in ANSI/AAMI ST-72:2011, United StatesPharmacopeia (USP), and European Pharmacopeia (EP) using thebacterial endotoxin testing (BET) method.
Safety andPerformance	Results of performance testing have demonstrated that the proposeddevices are suitable for their intended use.Based on similarities in the indications for use, technologicalcharacteristics, and performance in comparison to the predicate devices,the proposed HEALIX TiTM Dual Threaded Suture Anchor withDYNATAPETM Suture has shown to be substantially equivalent to thepredicate devices under the Federal Food, Drug and Cosmetic Act.

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Regulation Number and Section

N/A