(112 days)
No
The device description and performance studies focus on the mechanical properties and biological compatibility of a suture anchor, with no mention of AI or ML technologies.
Yes.
The device is an anchor used for soft tissue to bone fixation, which is a therapeutic intervention aimed at repairing injuries and restoring function.
No
The device description clearly states its purpose is for "fixation of soft tissue to bone," which is a surgical repair function, not a diagnostic one.
No
The device description clearly states it is a threaded suture anchor preloaded on a disposable inserter assembly, available in absorbable and non-absorbable materials, and provided sterile. These are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The HEALIX ADVANCE Anchor is a surgical implant used to fix soft tissue to bone within the body. It is a physical device used during surgery, not a tool for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological specimens, laboratory procedures, or diagnostic purposes.
Therefore, the HEALIX ADVANCE Anchor is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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
Product codes
MAI, MBI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Foot/Ankle, Knee, Elbow, Hip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing has been performed on the proposed device and / or its predicates. Performance testing included anchor fixation testing, in-vitro testing, torque testing, suture testing per USP, suture approximation force testing, in-vivo testing. Safety evaluations were conducted to address biological, sterility, packaging, shelf-life and included in-vivo testing. Bacterial endotoxin testing has been completed and results have demonstrated that the proposed devices meet the endotoxin limits. Results of performance testing have demonstrated that the proposed devices are 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 ADVANCETM Anchor with DYNACORDTM Suture has shown to be substantially equivalent to the predicate devices under the Federal Food, Drug and Cosmetic Act.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K133794 HEALIX ADVANCE™ Anchor with PERMACORD™ Suture
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K120078/K120449 HEALIX ADVANCE™ Anchors with ORTHOCORD® Suture, K021434, K041553 FiberWire® (Arthrex)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
2
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-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)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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3
SECTION 2 - 510(k) SUMMARY
HEALIX ADVANCE™ Anchor with DYNACORD™ Suture
Date Prepared: December 18, 2017
| Submitter's
Name and
Address | DePuy Mitek
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767 | | |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Contact Person | Tatyana Korsunsky
Regulatory Affairs Project Manager
DePuy Mitek, Inc.
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767, USA
Telephone: 508-828-3122
e-mail: tkorsuns@its.jnj.com | | |
| Name of
Medical Device | Proprietary Name: a) HEALIX ADVANCE™ BR Anchor with DYNACORD™ Suture
b) HEALIX ADVANCE™ PEEK Anchor with DYNACORD™ Suture | | |
| | Classification Name: a) Single/multiple component metallic bone fixation appliances and accessories
b) Smooth or threaded metallic bone fixation fasteners | | |
| | Common Name: Suture Anchor | | |
| Substantial
Equivalence | The HEALIX ADVANCE™ Anchor with DYNACORD™ Suture is substantially
equivalent to:
• K133794 HEALIX ADVANCE™ Anchor with PERMACORD™ Suture
Reference devices:
• K120078/K120449 HEALIX ADVANCE™ Anchors with ORTHOCORD® Suture
• K021434, K041553 FiberWire® (Arthrex) | | |
| Device
Classification | > 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. | | |
4
| Device
Description | 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. |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics | The proposed HEALIX ADVANCETM Anchor with DYNACORDTM Suture has the
same anchor materials, design, principle of operation, as well as device assembly,
sterilization method, and shelf life, as predicate HEALIX ADVANCETM Anchor
with PERMACORDTM Suture (K133794). The DYNACORDTM Suture component
is a non-absorbable suture that conforms to USP, except for oversized diameter. |
| Indications for
Use | The HEALIX ADVANCETM Anchor is indicated for use in soft tissue to bone
fixation in association 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 |
| Non clinical
Testing | Non-clinical testing has been performed on the proposed device and / or its
predicates. Performance testing included anchor fixation testing, in-vitro testing,
torque testing, suture testing per USP, suture approximation force testing, in-vivo
testing. Safety evaluations were conducted to address biological, sterility,
packaging, shelf-life and included in-vivo testing. Bacterial endotoxin testing has
been completed and results have demonstrated that the proposed devices meet the
endotoxin limits. |
| Safety and
Performance | Results of performance testing have demonstrated that the proposed devices are
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 ADVANCETM Anchor with DYNACORDTM Suture
has shown to be substantially equivalent to the predicate devices under the Federal
Food, Drug and Cosmetic Act. |