HEALIX ADVANCE SP BIOCOMPOSITE Anchor by Medos International SARL

• Shoulder: Rotator cuff repair, biceps tenodesis, deltoid repair
• Knee: Posterior oblique repair, medial collateral ligament (MCL) reconstruction, lateral collateral ligament reconstruction, iliotibial (IT) band tenodesis
• Foot/Ankle: Achilles tendon repair

Device Description

The HEALIX ADVANCE SP BIOCOMPOSITE Anchor is a two-piece "self-punching" design consisting of a cannulated, threaded anchor and dilator which are permanently implanted into the body. The anchor- dilator are preloaded on a disposable inserter shaft with handle, held in place by a non-absorbable stay suture comprised of Ultra-High Molecular Weight Polyethylene (UHMWPE) and Green poly (ethylene terephthalate) (PET). The proposed HEALIX ADVANCE SP BIOCOMPOSITE Anchor is offered in two sizes, 4.9 mm and 5.5 mm and is molded from Absorbable Biocryl Biocomposite ((Polylactic Acid (PLA) and Tricalcium Phosphate (TCP)) material. The dilator is comprised of Non-absorbable PEEK (Polyetheretherketone). The HEALIX ADVANCE SP BIOCOMPOSITE Anchor is provided sterile via Ethylene Oxide (EO) sterilization and is for single use only.

AI/ML Overview

The provided text describes a medical device, the HEALIX ADVANCE™ SP BIOCOMPOSITE Anchor, and its substantial equivalence to predicate devices, but it does not contain acceptance criteria for device performance or a study demonstrating that the device explicitly meets such criteria with numerical performance data.

The "Non-clinical Testing" section outlines the types of tests performed and generally states that "Performance testing included evaluation of in-vitro fixation strength at zero, six and twelve weeks, insertion torque, torque to failure and cyclic migration at time zero." However, it does not provide:

Specific numerical acceptance criteria (e.g., minimum fixation strength, maximum cyclic migration).
Reported numerical performance results of the HEALIX ADVANCE™ SP BIOCOMPOSITE Anchor from these tests.
Details of any statistical study that would compare these numerical results against predefined acceptance criteria.

Therefore, I cannot populate the table or answer most of your detailed questions regarding acceptance criteria and study particulars because the necessary information is not present in the provided text.

Based on the available information, here's what can be inferred or explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (e.g., minimum tensile strength)	Reported Device Performance (e.g., actual tensile strength result)
Not specified in the provided text. The text mentions performance tests conducted (fixation strength, insertion torque, torque to failure, cyclic migration), but does not state the specific acceptance criteria for these tests nor the numerical results obtained.	Not specified in the provided text. The text merely states, "Results of performance testing have demonstrated that the proposed devices are suitable for their intended use," without providing quantitative outcomes.

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

Sample Size: Not specified.
Data Provenance: The tests are described as "in-vitro" and "non-clinical," which implies laboratory testing of the device itself rather than human or animal studies. The country of origin of the data is not specified, but the applicant (Medos International SARL) is based in Switzerland, and the testing was likely conducted in a similar regulated environment.

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

This question is not applicable as the "test set" described relates to in-vitro mechanical and material properties of the device, not a diagnostic or clinical outcome requiring expert consensus. The "ground truth" here would be the physical measurements and material properties of the device itself.

4. Adjudication method for the test set:

Not applicable for in-vitro mechanical testing.

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:

This question is not applicable. The device is a surgical anchor, not an AI-powered diagnostic or assistive tool.

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

This question is not applicable. The device is a physical surgical implant, not an algorithm.

7. The type of ground truth used:

For the non-clinical testing, the "ground truth" would be the objective physical and material properties of the device measured through standardized laboratory tests (e.g., force, torque, displacement).

8. The sample size for the training set:

This question is not applicable. The device is a physical surgical implant, which does not involve a "training set" in the context of machine learning or AI.

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

This question is not applicable for the same reason as above.

Additional Information from the text:

Sterilization Validation: Ethylene Oxide Sterilization was validated according to ANSI/AAMI/ISO 11135: 2014 to a SAL (Sterility Assurance Level) of 1 x 10^-6.
EO Residuals: Tested per AAMI/ANSI/ISO 10993-7:2008.
Non-pyrogenic: Determined to be non-pyrogenic per ANSI/AAMI ST-72:2011, USP, and EP using the bacterial endotoxin testing (BET) method.

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 image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

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

Re: K191242

Trade/Device Name: HEALIX ADVANCE™ SP BIOCOMPOSITE Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI Dated: July 11, 2019 Received: July 15, 2019

Dear Ms. 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

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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/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 medical devices and radiation-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,

Laurence D. Coyne, 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) K191242

Device Name HEALIX ADVANCE™ SP BIOCOMPOSITE Anchor

Indications for Use (Describe)

The HEALIX ADVANCE SP BIOCOMPOSITE Anchor is indicated for use in the following procedures for reattachment of soft tissue to bone:

· Shoulder: Rotator cuff repair, biceps tenodesis, deltoid repair

· Knee: Posterior oblique repair, medial collateral ligament (MCL) reconstruction, lateral ligament reconstruction, iliotibial (IT) band tenodesis

· Foot/Ankle: Achilles tendon repair

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

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 ADVANCE™ SP BIOCOMPOSITE Anchor Date Prepared: 05/7/2019

Submitter'sName andAddress	DePuy Synthes Mitek Sports Medicinea Johnson & Johnson company325 Paramount DriveRaynham, MA 02767On 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 MedicalDevice	Proprietary Name: HEALIX ADVANCE™ SP BIOCOMPOSITEAnchorClassification Name: Single/multiple component metallic bone fixationappliances and accessoriesProduct Code: MAICommon Name: Suture Anchor
SubstantialEquivalence	The HEALIX ADVANCE SP BIOCOMPOSITE Anchor issubstantially equivalent to:K101679, K082810, K071177, K061863, K051219 Arthrex PushLock Anchors Reference Devices: K182941, HEALIX ADVANCE™ SP PEEK Anchor K032167, Bio-INTRAFIX Tibial Tapered Screws and Sheaths K161638, SPEEDTRAP™ Graft Preparation System
DeviceClassification	HEALIX ADVANCE SP BIOCOMPOSITE Anchor is classified as:
	Single/multiple component metallic bone fixation appliances andaccessories, classified as Class II, product code MAI, regulated under21 CFR 888.3030.
Device Panel	Orthopedic Devices
DeviceDescription	The HEALIX ADVANCE SP BIOCOMPOSITE Anchor is a two-piece"self-punching" design consisting of a cannulated, threaded anchor anddilator which are permanently implanted into the body. The anchor-dilator are preloaded on a disposable inserter shaft with handle, held inplace by a non-absorbable stay suture comprised of Ultra-HighMolecular Weight Polyethylene (UHMWPE) and Green poly (ethyleneterephthalate) (PET). The proposed HEALIX ADVANCE SPBIOCOMPOSITE Anchor is offered in two sizes, 4.9 mm and 5.5 mmand is molded from Absorbable Biocryl Biocomposite ((Polylactic Acid(PLA) and Tricalcium Phosphate (TCP)) material. The dilator iscomprised of Non-absorbable PEEK (Polyetheretherketone). TheHEALIX ADVANCE SP BIOCOMPOSITE Anchor is provided sterilevia Ethylene Oxide (EO) sterilization and is for single use only.
TechnologicalCharacteristics	The suture anchor design, anchor materials, principal of operation andindications for use are similar when compared to the predicate ArthrexPushLock Anchors (K101679, K082810, K071177, K061863,K051219).
	The suture anchor design, principal of operation and indications for useare identical when compared to the reference device- HEALIXADVANCE™ SP PEEK Anchor (K182941)
	The Biocryl (PLA/ ß-TCP) Biocomposite material of the anchor isidentical to the Biocryl in the reference device- Bio-INTRAFIX TibialTapered Screws and Sheaths (K032167).
	The PEEK (Polyetheretherketone) design and material of the dilatorcomponent is identical to the PEEK dilator in the reference device-HEALIX ADVANCE™ SP PEEK Anchor (K182941).
	The stay-suture material (UHMWPE/PET) is identical to the windingsuture present in the reference device- SPEEDTRAPTM GraftPreparation System (K161638).
Indications for Use	The HEALIX ADVANCE SP BIOCOMPOSITE Anchor is indicatedfor use in the following procedures for reattachment of soft tissue tobone:• Shoulder: Rotator cuff repair, biceps tenodesis, deltoid repair• Knee: Posterior oblique repair, medial collateral ligament (MCL)reconstruction, lateral collateral ligament reconstruction, iliotibial(IT) band tenodesis• Foot/Ankle: Achilles tendon repair
Non-clinical Testing	Verification activities were performed on the proposed device and / orits predicates. Performance testing included evaluation of in-vitrofixation strength at zero, six and twelve weeks, insertion torque, torqueto failure and cyclic migration at time zero.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 and Performance	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 ADVANCE SP BIOCOMPOSITE Anchor hasshown to be substantially equivalent to the predicate devices under theFederal Food, Drug and Cosmetic Act.

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Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.