(58 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 indicated for use in soft tissue to bone fixation with post-operative immobilization for various repairs across multiple anatomical sites, which is a therapeutic function.
No
Explanation: This device, the HEALIX ADVANCE Anchor, is described as a threaded suture anchor used for soft tissue to bone fixation. Its purpose is to repair and stabilize tissues, not to diagnose medical conditions or analyze patient data.
No
The device description clearly states it is a threaded suture anchor made of absorbable or non-absorbable materials, preloaded on a disposable inserter assembly, and provided sterile. This describes 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 a surgical implant used for soft tissue to bone fixation in various anatomical locations. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The description details a physical implant (anchor and suture) and its materials, designed for surgical implantation. This is consistent with a medical device used in surgery, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
- Performance Studies: The performance studies focus on the mechanical properties, fixation strength, biocompatibility, and sterility of the implant, which are relevant to a surgical device, not a diagnostic test.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The HEALIX ADVANCE Anchor does not fit this description.
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. 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)
Device safety and effectiveness is supported by non-clinical testing on the proposed device and / or its predicate. Testing included suture diameter, knot tensile, suture approximation force and chemical characterization. Anchor fixation, in-vitro anchor fixation, torque testing, in-vivo testing, biocompatibility, sterility, packaging, shelf-life, and bacterial endotoxin testing of the predicate device were included by reference (K173859).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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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-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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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SECTION 2 - 510(k) SUMMARY
HEALIX ADVANCE™ Anchor with DYNACORD™ Suture
| 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:
K173859 HEALIX ADVANCE™ Anchor with DYNACORD™ Suture
Reference devices:
K021434, K041553 FiberWire® (Arthrex)
K133794 HEALIX ADVANCE™ Anchors with PERMACORD™ Suture |
| 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. |
| Device
Description | 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. |
| Technological
Characteristics | The HEALIX ADVANCETM Anchor with DYNACORDTM Suture is intended for
fixation of soft tissue to bone, where anchor is inserted into the bone and sutures are
utilized to hold soft tissue. |
| | When DYNACORD™ Suture is placed in an aqueous environment, the salt particles
within the silicone core elute out, leaving behind a micro-porous structure within the
silicone core. These small voids are consequently filled with surrounding fluid as the
core hydrates, resulting in a radial expansion of the suture. If laxity is present, this
radial 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 to
the Predicate
Devices | The proposed HEALIX ADVANCETM Anchor with DYNACORD™ Suture is an
update to the predicate HEALIX ADVANCETM Anchor with DYNACORDTM
Suture (K173859). The outer sheath of white/black DYNACORD is updated with
black UHMWPE, and removal of black Nylon. |
| 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 | Device safety and effectiveness is supported by non-clinical testing on the proposed
device and / or its predicate. Testing included suture diameter, knot tensile, suture
approximation force and chemical characterization. Anchor fixation, in-vitro
anchor fixation, torque testing, in-vivo testing, biocompatibility, sterility,
packaging, shelf-life, and bacterial endotoxin testing of the predicate device were
included by reference (K173859). |
| Safety and
Performance | Results of performed testing have demonstrated that the proposed device is suitable
for its intended use. Based on the similarities in the indications for use,
technological characteristics, and performance in comparison to the predicate
devices, the proposed HEALIX ADVANCE™ Anchor with DYNACORD™ Suture
has shown to be substantially equivalent to the predicate devices under the Federal
Food, Drug and Cosmetic Act. |
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