(58 days)
The HEALIX ADVANCE Anchor is indicated for use in soft tissue to bone fixation with post-operative immobilization as follows:
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 Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
Hip: Capsular Repair, Acetabular Labral Repair
The HEALIX ADVANCETM Anchor with DYNACORDTM Suture is a threaded suture anchor preloaded on a disposable inserter assembly. HEALIX ADVANCETM Anchors with DYNACORDTM Suture are available in absorbable BR and non-absorbable PEEK materials. Devices with needles will be offered to facilitate suture passage through tissue. The HEALIX ADVANCETM Anchor with DYNACORDTM Suture is provided sterile and is for single use only.
The provided text is a 510(k) summary for the HEALIX ADVANCE™ Anchor with DYNACORD™ Suture. It describes the device, its intended use, and substantial equivalence to predicate devices, supported by non-clinical testing. However, it does not contain information related to a study proving a device meets acceptance criteria for an AI/algorithm-based medical device performance.
Specifically, the document discusses a suture anchor (a physical medical device used in orthopedic surgery), not an image-based AI or algorithm. Therefore, the requested information (acceptance criteria for an AI, sample sizes for AI test/training sets, expert ground truth establishment, MRMC studies, standalone AI performance) is not applicable to this document.
The "studies" mentioned in the document are non-clinical physical tests of the suture anchor and suture, such as:
- suture diameter
- knot tensile strength
- suture approximation force
- chemical characterization
- anchor fixation (in-vitro and in-vivo)
- torque testing
- biocompatibility
- sterility
- packaging
- shelf-life
- bacterial endotoxin testing
These tests are to demonstrate the physical properties and safety of the orthopedic implant and suture, not the performance of an AI algorithm.
Therefore, I cannot provide the requested table or details about an AI study based on the provided text.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the word "ADMINISTRATION".
February 14, 2019
Medos International SARL % Tatyana Korsunsky Regulatory Affairs Project Manager DePuy Mitek, a Johnson and Johnson company 325 Paramount Drive Raynham, Massachusetts 02767
Re: K183506
Trade/Device Name: HEALIX ADVANCETM Anchor with DYNACORD™ Suture Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI, MBI Dated: December 17, 2018 Received: December 18, 2018
Dear Ms. Korsunsky:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 (OS) 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 mediation-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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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVIGES Food and Drug Administration
Indications for Use
510(k) Number (if known) K183506
Device Name
HEALIX ADVANCETM Anchor with DYNACORD™ Suture
Indications for Use (Describe)
The HEALIX ADVANCE Anchor is indicated for use in soft tissue to bone fixation with post-operative immobilization as follows:
| Shoulder: | Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-ClavicularSeparation 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 LigamentRepair, Iliotibial Band Tenodesis |
| Elbow: | Biceps Tendon Reattachment, Ulnar Collateral Ligament Reconstruction, Radial Collateral LigamentReconstruction |
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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SECTION 2 - 510(k) SUMMARY
HEALIX ADVANCE™ Anchor with DYNACORD™ Suture
| Submitter'sName andAddress | DePuy Miteka Johnson & Johnson company325 Paramount DriveRaynham, MA 02767 |
|---|---|
| Contact Person | Tatyana KorsunskyRegulatory Affairs Project ManagerDePuy Mitek, Inc.a Johnson & Johnson company325 Paramount DriveRaynham, MA 02767, USATelephone: 508-828-3122e-mail: tkorsuns@its.jnj.com |
| Name ofMedical Device | Proprietary Name: a) HEALIX ADVANCE™ BR Anchor withDYNACORD™ Sutureb) HEALIX ADVANCE™ PEEK Anchor withDYNACORD™ SutureClassification 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 DYNACORD™ Suture is substantiallyequivalent to:K173859 HEALIX ADVANCE™ Anchor with DYNACORD™ SutureReference devices:K021434, K041553 FiberWire® (Arthrex)K133794 HEALIX ADVANCE™ Anchors with PERMACORD™ Suture |
| DeviceClassification | HEALIX ADVANCE™ BR Anchor with DYNACORD™ Suture 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.HEALIX ADVANCE™ PEEK Anchor with DYNACORD™ Suture 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 ADVANCETM Anchor with DYNACORDTM Suture is a threadedsuture anchor preloaded on a disposable inserter assembly. HEALIX ADVANCETMAnchors with DYNACORDTM Suture are available in absorbable BR and non-absorbable PEEK materials. Devices with needles will be offered to facilitate suturepassage through tissue. The HEALIX ADVANCETM Anchor with DYNACORDTMSuture is provided sterile and is for single use only. |
| TechnologicalCharacteristics | The HEALIX ADVANCETM Anchor with DYNACORDTM Suture is intended forfixation of soft tissue to bone, where anchor is inserted into the bone and sutures areutilized to hold soft tissue. |
| When DYNACORD™ Suture is placed in an aqueous environment, the salt particleswithin the silicone core elute out, leaving behind a micro-porous structure within thesilicone core. These small voids are consequently filled with surrounding fluid as thecore hydrates, resulting in a radial expansion of the suture. If laxity is present, thisradial expansion of the braid causes an axial shortening of the total suture length.The DYNACORD™ Suture is designed to resist laxity and minimize gap formation,by maintaining approximation force (compression). | |
| Comparison tothe PredicateDevices | The proposed HEALIX ADVANCETM Anchor with DYNACORD™ Suture is anupdate to the predicate HEALIX ADVANCETM Anchor with DYNACORDTMSuture (K173859). The outer sheath of white/black DYNACORD is updated withblack UHMWPE, and removal of black Nylon. |
| Indications forUse | The HEALIX ADVANCETM Anchor is indicated for use in soft tissue to bonefixation in association with post-operative immobilization as follows: |
| 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 RepairKnee: Medial Collateral Ligament Repair, Lateral Collateral LigamentRepair, Posterior Oblique Ligament Repair, Iliotibial BandTenodesis | |
| Elbow: Biceps Tendon Reattachment, Ulnar Collateral LigamentReconstruction , Radial Collateral Ligament Reconstruction | |
| Hip: Capsular Repair, Acetabular Labral Repair | |
| Non clinicalTesting | Device safety and effectiveness is supported by non-clinical testing on the proposeddevice and / or its predicate. Testing included suture diameter, knot tensile, sutureapproximation force and chemical characterization. Anchor fixation, in-vitroanchor fixation, torque testing, in-vivo testing, biocompatibility, sterility,packaging, shelf-life, and bacterial endotoxin testing of the predicate device wereincluded by reference (K173859). |
| Safety andPerformance | Results of performed testing have demonstrated that the proposed device is suitablefor its intended use. Based on the similarities in the indications for use,technological characteristics, and performance in comparison to the predicatedevices, the proposed HEALIX ADVANCE™ Anchor with DYNACORD™ Suturehas shown to be substantially equivalent to the predicate devices under the FederalFood, Drug and Cosmetic Act. |
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N/A