(90 days)
No
The summary describes a mechanical suture anchor and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended for the repair and reconstruction of soft tissues in various anatomical sites, which is a therapeutic purpose.
No
The device description and intended use clearly state that it is a surgical implant (a threaded suture anchor) for fixation of soft tissue to bone, not for diagnosis.
No
The device description clearly states it is a threaded suture anchor made of Titanium, preloaded on a disposable inserter assembly. This is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for surgical fixation of soft tissue to bone in various anatomical locations (Shoulder, Foot/Ankle, Knee, Elbow, Hip). This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as a "threaded suture anchor preloaded on a disposable inserter assembly." This is a physical implantable device used during surgery.
- Lack of Diagnostic Activity: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) outside of the body to diagnose a condition, monitor treatment, or screen for diseases.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical tool used for repair and reconstruction within the body.
N/A
Intended Use / Indications for Use
The HEALIX TiTM Anchors with DYNACORDTM is intended for:
Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromioclavicular; 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. Patellar Tendon repair and secondary fixation in ACL/PCL reconstruction repair:
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction;
Hip: Capsular repair, Acetabular Labral Repair.
Product codes
MBI, HWC
Device Description
The HEALIX TiTM Anchor with DYNACORDTM Suture is a threaded suture anchor preloaded on a disposable inserter assembly intended for fixation of soft tissue to bone. HEALIX TiTM Anchors with DYNACORDTM Suture is available in Titanium material, which is a common material used on existing Depuy Mitek devices. Devices with needles will be offered to facilitate suture passage through tissue. The HEALIX TiTM 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, torque testing, suture testing per USP and approximation force testing. Safety evaluations were conducted to address biological, sterility, packaging and shelf-life 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 TiTM 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)
K082282 HEALIX Ti® Anchor with ORTHOCORD®
Reference Device(s)
K173859 HEALIX ADVANCE® Anchors with DYNACORD® Suture, K021434, K041553 FIBERWIRE® (Arthrex), K181809 GRYPHON ANCHOR® with DYNACORD®, K082282 DYNACORD®
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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February 21, 2019
Medos International SARL % Leslie Coney Regulatory Affairs Specialist DePuy Mitek, a Johnson & Johnson Company 325 Paramount Drive Raynham, Massachusetts 02767
Re: K183279
Trade/Device Name: HEALIX TiTM ANCHOR with DYNACORD™ Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI, HWC Dated: November 19, 2018 Received: November 23, 2018
Dear Leslie Coney:
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
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/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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Indications for Use
510(k) Number (if known) K183279
Device Name HEALIX Ti™ ANCHOR with DYNACORD™
Indications for Use (Describe) The HEALIX TiTM Anchors with DYNACORD™ is intended for:
Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromioclavicular; 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. Patellar Tendon repair and secondary fixation in ACL/PCL reconstruction repair:
Elbow: Biceps Tendon Reattachment, Ulnar or 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) |
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510(k) SUMMARY
HEALIX Ti™ Anchor with DYNACORD™ Suture
Date Prepared: January 23, 2019
| Submitter's
Name and
Address | DePuy Mitek
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767 |
|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Leslie Coney
Regulatory Affairs Specialist
DePuy Mitek, Inc.
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767, USA
Telephone: 508-977-2618
e-mail: lconey@its.jnj.com |
| Name of
Medical Device | Proprietary Name:
-HEALIX TI™ ANCHOR with DYNACORD™
-HEALIX TI™ 3 SUTURE ANCHOR with
DYNACORD™
-HEALIX TI™ ANCHOR with DYNACORD™ AND
NEEDLES
Classification Name: Smooth or threaded metallic bone fixation fasteners
Common Name: Suture Anchor |
| Substantial
Equivalence | The HEALIX Ti™ Anchor with DYNACORD™ Suture is substantially equivalent
to:
K082282 HEALIX Ti® Anchor with ORTHOCORD®
Reference devices:
K173859 HEALIX ADVANCE® Anchors with DYNACORD® SutureK021434, K041553 FIBERWIRE® (Arthrex)K181809 GRYPHON ANCHOR® with DYNACORD®K082282 DYNACORD® |
| Device
Classification | > HEALIX Ti™ Anchor with DYNACORD™ Suture is classified as:
Single/multiple component metallic bone fixation appliances and accessories,
classified as Class II, product code MBI, regulated under 21 CFR 888.3040.
Single/multiple component metallic bone fixation appliances and accessories, |
| Device
Description | The HEALIX TiTM Anchor with DYNACORDTM Suture is a threaded suture anchor
preloaded on a disposable inserter assembly intended for fixation of soft tissue to
bone. HEALIX TiTM Anchors with DYNACORDTM Suture is available in Titanium
material, which is a common material used on existing Depuy Mitek devices.
Devices with needles will be offered to facilitate suture passage through tissue. The
HEALIX TiTM Anchor with DYNACORDTM Suture is provided sterile and is for
single use only. |
| Technological
Characteristics | The proposed HEALIX TiTM 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 TiTM Anchor with
ORTHOCORD® Suture (K082282). The DYNACORD® Suture component is a
non-absorbable suture that conforms to USP, except for oversized diameter. |
| Indications for
Use | The HEALIX TiTM Anchors with DYNACORDTM is intended for:
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, Patella tendon repair
and secondary fixation in ACL / PCL reconstruction repair.
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament
Reconstruction.
Hip: Capsular repair, acetabular labral repair |
| Non clinical
Testing
Safety and
Performance | Non-clinical testing has been performed on the proposed device and /or its
predicates. Performance testing included anchor fixation testing, torque testing,
suture testing per USP and approximation force testing. Safety evaluations were
conducted to address biological, sterility, packaging and shelf-life 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 TiTM Anchor with DYNACORDTM Suture has
shown to be substantially equivalent to the predicate devices under the Federal
Food, Drug and Cosmetic Act. |
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