(112 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 intended for fixation of soft tissue to bone. 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 describes the HEALIX ADVANCE™ Anchor with DYNACORD™ Suture, which is a medical device for soft tissue to bone fixation. However, the document does not contain information about specific acceptance criteria or a dedicated study providing quantitative performance metrics by which the device's performance can be explicitly measured against pre-defined criteria.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (K133794 HEALIX ADVANCE™ Anchor with PERMACORD™ Suture) through non-clinical testing. This type of submission relies on showing that the new device has similar technological characteristics and performs comparably to a device already cleared by the FDA, rather than conducting a de novo study against specific acceptance criteria.
Therefore, many of the requested details cannot be extracted from this document. Below is a summary of what is available and what is not:
HEALIX ADVANCE™ Anchor with DYNACORD™ Suture Device Performance Summary
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Not Explicitly Stated) | Device Performance (Based on Non-Clinical Testing and Equivalence) |
|---|---|
| Mechanical Performance: | Demonstrated suitability for intended use through: |
| - Anchor fixation strength | - Anchor fixation testing |
| - Torque strength | - Torque testing |
| - Suture tensile strength | - Suture testing per USP (non-absorbable, oversized diameter) |
| - Suture approximation force | - Suture approximation force testing |
| Biocompatibility: | Pass |
| - Biocompatibility evaluation | - In-vivo testing |
| Sterility: | Pass |
| - Sterility | - Sterility testing |
| Endotoxins: | Pass |
| - Endotoxin limits | - Bacterial endotoxin testing |
| Packaging Integrity/Shelf-life: | Demonstrated |
| - Packaging and shelf-life stability | - Packaging and shelf-life testing |
| _(Specific quantitative thresholds for "Pass" | |
| are not provided in this document)_ |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not specified in the document. The non-clinical testing refers to "anchor fixation testing," "in-vitro testing," "torque testing," "suture testing per USP," "suture approximation force testing," and "in-vivo testing," but the number of samples or specimens for each test is not provided.
- Data Provenance: The testing was "performed on the proposed device and/or its predicates." No information on country of origin or whether it was retrospective or prospective is given. Given the nature of mechanical/biocompatibility testing, it would generally be prospective laboratory testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable for this type of submission. This device is a physical implant, and its performance is evaluated through mechanical, chemical, and biological testing, not by expert review of data like in an AI/imaging study. Ground truth is established by standardized testing methods and measurements.
4. Adjudication Method for the Test Set:
- Not applicable. As noted above, this device's performance is determined by objective physical and biological tests, not by human expert adjudication of interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This is a physical medical device, not an AI or imaging diagnostic tool. MRMC studies are not relevant for this product.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
- Not applicable. This phrase typically refers to the performance of an AI algorithm in isolation. This is a physical device, and its performance is assessed directly through non-clinical testing.
7. The Type of Ground Truth Used:
- Objective Test Results / Standardized Measurements: Ground truth for this device's performance is established by the results of various non-clinical tests (e.g., tensile strength in Newtons, torque in Nm, presence/absence of bacterial endotoxins within specified limits, biocompatibility as determined by in-vivo models). These are direct measurements or observations against established material and biological standards (e.g., USP standards).
8. The Sample Size for the Training Set:
- Not applicable. This submission does not involve machine learning or AI, so there is no "training set."
9. How the Ground Truth for the Training Set was Established:
- Not applicable. As there is no training set for this device.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
April 11. 2018
Medos International SARL % Tatyana Korsunsky Regulatory Affairs Project Manager DePuy Mitek, a Johnson & Johnson company 325 Paramount Drive Raynham, Massachusetts 02767
Re: K173859
Trade/Device Name: HEALIX ADVANCE™ 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: March 14, 2018 Received: March 15, 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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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Page 2 - Tatyana Korsunsky
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
Mark N. Melkerson -S
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) K173859
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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SECTION 2 - 510(k) SUMMARY
HEALIX ADVANCE™ Anchor with DYNACORD™ Suture
Date Prepared: December 18, 2017
| 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 with DYNACORD™ Sutureb) HEALIX ADVANCE™ PEEK Anchor with DYNACORD™ Suture | ||
| Classification Name: a) Single/multiple component metallic bone fixation appliances and accessoriesb) Smooth or threaded metallic bone fixation fasteners | |||
| Common Name: Suture Anchor | |||
| SubstantialEquivalence | The HEALIX ADVANCE™ Anchor with DYNACORD™ Suture is substantiallyequivalent to:• K133794 HEALIX ADVANCE™ Anchor with PERMACORD™ SutureReference devices:• K120078/K120449 HEALIX ADVANCE™ Anchors with ORTHOCORD® Suture• K021434, K041553 FiberWire® (Arthrex) | ||
| 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 classified as:Smooth or threaded metallic bone fixation fasteners, classified as Class II,product code MBI, regulated under 21 CFR 888.3040. |
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| DeviceDescription | The HEALIX ADVANCETM Anchor with DYNACORDTM Suture is a threadedsuture anchor preloaded on a disposable inserter assembly intended for fixation ofsoft tissue to bone. HEALIX ADVANCETM Anchors with DYNACORDTM Sutureare available in absorbable BR and non-absorbable PEEK materials. Devices withneedles will be offered to facilitate suture passage through tissue. The HEALIXADVANCETM Anchor with DYNACORDTM Suture is provided sterile and is forsingle use only. |
|---|---|
| TechnologicalCharacteristics | The proposed HEALIX ADVANCETM Anchor with DYNACORDTM Suture has thesame anchor materials, design, principle of operation, as well as device assembly,sterilization method, and shelf life, as predicate HEALIX ADVANCETM Anchorwith PERMACORDTM Suture (K133794). The DYNACORDTM Suture componentis a non-absorbable suture that conforms to USP, except for oversized diameter. |
| 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 ReconstructionHip: Capsular Repair, Acetabular Labral Repair | |
| Non clinicalTesting | Non-clinical testing has been performed on the proposed device and / or itspredicates. Performance testing included anchor fixation testing, in-vitro testing,torque testing, suture testing per USP, suture approximation force testing, in-vivotesting. Safety evaluations were conducted to address biological, sterility,packaging, shelf-life and included in-vivo testing. Bacterial endotoxin testing hasbeen completed and results have demonstrated that the proposed devices meet theendotoxin limits. |
| Safety andPerformance | 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 ADVANCETM Anchor with DYNACORDTM Suturehas shown to be substantially equivalent to the predicate devices under the FederalFood, Drug and Cosmetic Act. |
§ 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.