(24 days)
The HEALIX ADVANCE Anchor with DYNA+TAPE Sutures is indicated for use in soft tissue to bone fixation in association with post-operative immobilization as follows:
Shoulder: Rotator Cuff Repair, Bankart 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 Collateral Ligament Reconstruction , Radial Collateral Ligament Reconstruction
Hip: Capsular Repair, Acetabular Labral Repair
The HEALIX ADVANCE Anchor with DYNA+TAPE Sutures is a threaded suture anchor preloaded on a disposable inserter assembly intended for soft tissue fixation with one strand of #2 DYNACORD Suture and one strand of PERMATAPE Suture to bone. HEALIX ADVANCE with DYNA+TAPE Anchors are available in absorbable Biocryl Rapide® (BR) and non-absorbable PEEK materials. The HEALIX ADVANCE with DYNA+TAPE Sutures is provided sterile and is for single use only.
This document describes the regulatory clearance of the HEALIX ADVANCE™ Anchor with DYNA+TAPE™ Sutures, a medical device for soft tissue to bone fixation. This 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report as typically seen for AI/ML-based devices. Therefore, much of the requested information regarding AI/ML study specifics will not be available in this document.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., tensile strength, pull-out force) for the proposed device against its predicates. Instead, it refers to "performance testing included evaluation of fixation strength following cyclic loading." The reported device performance is broadly stated as: "Results of performance testing have demonstrated that the proposed devices are suitable for their intended use."
The comparison is primarily qualitative, asserting that the proposed device has "the same anchor materials, design, principle of operation, intended use, sterilization method, and shelf life, as the predicate HEALIX ADVANCE with DYNACORD Anchors (K173859) and the predicate HEALIX ADVANCE with PERMATAPE Anchors (K170639)."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide details on the sample size for any specific mechanical testing. It merely states "Verification activities were performed on the proposed device and / or its predicates." There is no mention of data provenance (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. The device is a physical medical implant, not an AI/ML diagnostic or prognostic tool that requires expert-established ground truth from medical images or clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this refers to adjudication for human-in-the-loop or AI/ML evaluations.
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 not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For this type of physical implant, "ground truth" typically relates to objective mechanical properties and biological responses, measured through engineering tests (e.g., universal testing machines for strength) and potentially biological compatibility studies, rather than expert consensus on medical images or pathology. The document indicates "performance testing included evaluation of fixation strength following cyclic loading."
8. The sample size for the training set
Not applicable. This device does not involve an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device does not involve an AI/ML algorithm.
Summary of what is available from the document regarding acceptance criteria and study:
The provided document describes a 510(k) Premarket Notification for a medical device (suture anchor). The primary goal of a 510(k) is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. This is typically achieved by showing that the new device has "the same technological characteristics" or "different technological characteristics but is as safe and effective as the predicate device, and the differences do not raise different questions of safety and effectiveness."
In this case, the acceptance criteria and study are defined by the need to demonstrate substantial equivalence:
- Acceptance Criteria (Implied): The proposed device's mechanical performance (specifically fixation strength following cyclic loading) and material properties must be comparable to or better than the identified predicate devices, and the device must be non-pyrogenic as per specified standards. No specific quantitative thresholds are provided in this summary.
- Study Proving Acceptance: The document refers to "Verification activities... on the proposed device and / or its predicates. Performance testing included evaluation of fixation strength following cyclic loading." It also mentions pyrogenicity testing: "The proposed device has been determined to be non-pyrogenic per the requirements set forth in ANSI/AAMI ST-72:2011, United States Pharmacopeia (USP), and European Pharmacopeia (EP) using the bacterial endotoxin testing (BET) method."
The conclusion is that the "results of performance testing have demonstrated that the proposed devices are suitable for their intended use." This suitability, coupled with the assertion of "similarities in the indications for use, technological characteristics, and performance in comparison to the predicate devices," forms the basis of the substantial equivalence determination.
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Image /page/0/Picture/0 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 - USA logo. To the right of that is the FDA logo, which 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 % Ashley Goncalo Project Manager - Regulatory Affairs DePuy Synthes Mitek, a Johnson and Johnson Company 325 Paramount Drive Raynham, Massachusetts 02767
Re: K191483
Trade/Device Name: HEALIX ADVANCE™ Anchor with DYNA+TAPE™ Sutures Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI, MAI Dated: June 3, 2019 Received: June 4, 2019
Dear Ashley Goncalo:
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.
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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 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 (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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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K191483
Device Name
HEALIX ADVANCE™ Anchor with DYNA+TAPE™ Sutures
Indications for Use (Describe)
The HEALIX ADVANCE Anchor with DYNA+TAPE Sutures is indicated for use in soft tissue to bone fixation in association with post-operative immobilization as follows:
Shoulder: Rotator Cuff Repair, Bankart 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 Collateral Ligament Reconstruction , Radial Collateral Ligament Reconstruction
Hip: Capsular Repair, Acetabular Labral 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™ Anchor with DYNA+TAPE™ Sutures
| 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 | Ashley GoncaloProject Manager, Regulatory AffairsDePuy Synthes Mitek Sports Medicinea Johnson & Johnson company325 Paramount DriveRaynham, MA 02767Telephone: 508-977-3907Email: agoncalo@its.jnj.com |
| Name of MedicalDevice | Proprietary Name: HEALIX ADVANCE Anchor with DYNA+TAPE Suturesa) HEALIX ADVANCE BR Anchor with DYNA+TAPESuturesb) HEALIX ADVANCE PEEK Anchor withDYNA+TAPE SuturesClassification Name: a) Single/multiple component metallic bone fixationappliances and accessoriesb) Smooth or threaded metallic bone fixation fastenersCommon Name: Suture Anchor |
| SubstantialEquivalence | The HEALIX ADVANCE Anchor with DYNA+TAPE Sutures is substantiallyequivalent to the predicates:• K170639 - HEALIX ADVANCE Anchor with PERMATAPE™ Suture(Primary)• K173859 - HEALIX ADVANCE Anchor with DYNACORD™ Suture |
| DeviceClassification | a) HEALIX ADVANCE BR Anchor with DYNA+TAPE Sutures is classified as:Single/multiple component metallic bone fixation appliances and accessories,classified as Class II, product code MAI, regulated under 21 CFR 888.3030. |
| b) HEALIX ADVANCE PEEK Anchor with DYNA+TAPE Sutures is classifiedas: Smooth or threaded metallic bone fixation fasteners, classified as Class II,product code MBI, regulated under 21 CFR 888.3040. | |
| DeviceDescription | The HEALIX ADVANCE Anchor with DYNA+TAPE Sutures is a threadedsuture anchor preloaded on a disposable inserter assembly intended for soft tissuefixation with one strand of #2 DYNACORD Suture and one strand ofPERMATAPE Suture to bone. HEALIX ADVANCE with DYNA+TAPEAnchors are available in absorbable Biocryl Rapide® (BR) and non-absorbablePEEK materials. The HEALIX ADVANCE with DYNA+TAPE Sutures isprovided sterile and is for single use only. |
| TechnologicalCharacteristics | The proposed HEALIX ADVANCE Anchor with DYNA+TAPE Sutures has thesame anchor materials, design, principle of operation, intended use, sterilizationmethod, and shelf life, as the predicate HEALIX ADVANCE with DYNACORDAnchors (K173859) and the predicate HEALIX ADVANCE with PERMATAPEAnchors (K170639). The PERMATAPE Suture, which is preloaded on theproposed anchor, is identical to the PERMATAPE Suture which is preloaded onthe predicate HEALIX ADVANCE with PERMATAPE Suture (K170639).The DYNACORD Suture, which is preloaded on the proposed anchor, is identicalto the suture that is pre-loaded on the predicate HEALIX ADVANCE withDYNACORD Suture (K173859). |
| Indications forUse | The HEALIX ADVANCE Anchor with DYNA+TAPE Sutures is indicated for usein soft tissue to bone fixation in association with post-operative immobilization asfollows:Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, BicepsTenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shiftor Capsulolabral ReconstructionFoot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon RepairKnee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair,Posterior Oblique Ligament Repair, Iliotibial Band TenodesisElbow: Biceps Tendon Reattachment, Ulnar Collateral Ligament Reconstruction,Radial Collateral Ligament ReconstructionHip: Capsular Repair, Acetabular Labral Repair |
| Non-clinicalTesting | Verification activities were performed on the proposed device and / or itspredicates. Performance testing included evaluation of fixation strength followingcyclic loading. |
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The proposed device has been determined to be non-pyrogenic per the requirements set forth in ANSI/AAMI ST-72:2011, United States Pharmacopeia (USP), and European Pharmacopeia (EP) using the bacterial endotoxin testing (BET) method.
Safety and Results of performance testing have demonstrated that the proposed devices are Performance suitable for their intended use. Based on similarities in the indications for use, technological characteristics, and performance in comparison to the predicate devices, the proposed HEALIX ADVANCE with DYNA+TAPE Anchors has shown to be substantially equivalent to the predicate devices under the Federal Food, Drug and Cosmetic Act.
§ 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.