(77 days)
No
The device description and intended use are purely mechanical/material-based for soft tissue to bone fixation. There is no mention of any computational or analytical functions that would involve AI/ML.
No
The device is an anchor used for soft tissue to bone fixation and is considered a surgical implant, not a therapeutic device that delivers treatment or therapy.
No
The device is described as an anchor for soft tissue to bone fixation and is used for orthopedic repairs, not for diagnosing conditions.
No
The device description clearly describes a physical, threaded suture anchor made of absorbable or non-absorbable materials, preloaded on a disposable inserter assembly. It also mentions suture and optional needles, all of which are hardware components. The performance studies section also details physical testing like pull-out testing and insertion/failure torque, further indicating a hardware device.
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. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The HEALIX ADVANCE Anchor is a surgical implant used for fixing soft tissue to bone. It is a physical device implanted into the body during surgery.
- Lack of Diagnostic Function: The description and intended use clearly indicate a mechanical function (fixation) within the body, not an analysis of biological samples for diagnostic purposes.
Therefore, the HEALIX ADVANCE Anchor falls under the category of a surgical implant or medical 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 PERMATAPETM Suture consists of a threaded suture anchor preloaded on a disposable inserter assembly intended for fixation of one strand of #2 PERMACORDTM suture and one strand of PERMATAPETM suture to bone. HEALIX ADVANCETM Anchors with PERMATAPETM 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 PERMATAPETM 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
Prescription Use
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
Verification activities were performed on the proposed device and / or its predicates. Testing assessments include pull out testing, insertion and failure torque and in-vitro testing. Results of performance testing have demonstrated that the proposed devices are suitable for their intended use. Bacterial endotoxin testing has been completed and results have demonstrated that the proposed devices meet the endotoxin limits.
Key Metrics
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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DEPARTMENT OF HEALTH & HUMAN SERVICES
May 18, 2017
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Medos International SARL % Ms. Julie Vafides Project Lead, Regulatory Affairs Depuv Mitek, a Johnson and Johnson Company 325 Paramount Drive Raynham, Massachusetts 02767
Re: K170639
Trade/Device Name: HEALIX ADVANCE™ Anchor with PERMATAPE™ 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: February 28, 2017 Received: March 2, 2017
Dear Ms. Vafides:
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
1
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known)
Device Name
HEALIX ADVANCE™ Anchor with PERMATAPE™ 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) |
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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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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510(k) SUMMARY
HEALIX ADVANCE™ Anchor with PERMATAPE™ Suture
| Submitter's
Name and
Address | DePuy Mitek
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767
Date Prepared: February 28, 2017 | |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Julie Vafides
Project Lead, Regulatory Affairs
DePuy Mitek, Inc.
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767, USA
Telephone: 508-977-6645
e-mail: jvafides@its.jnj.com | |
| Name of
Medical Device | Proprietary Name: a) HEALIX ADVANCE™ BR Anchor with PERMATAPE™
Suture
b) HEALIX ADVANCE™ PEEK Anchor with
PERMATAPE™ 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 PERMATAPE™ Suture is substantially
equivalent to:
■ K133794 HEALIX ADVANCE™ Anchor with PERMACORD™ Suture
■ K100012, K073412 Gryphon™ BR Anchor with Orthocord® Suture
Reference devices:
■ K162247 PERMATAPE™ Suture
■ K120449 HEALIX ADVANCE™ PEEK Anchor | |
| Device
Classification | > HEALIX ADVANCE™ BR Anchor with PERMATAPE™ 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 PERMATAPE™ 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 PERMATAPETM Suture consists of a
threaded suture anchor preloaded on a disposable inserter assembly intended for
fixation of one strand of #2 PERMACORDTM suture and one strand of
PERMATAPETM suture to bone. HEALIX ADVANCETM Anchors with
PERMATAPETM 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 PERMATAPETM Suture is provided sterile and
is for single use only. | |
| Technological
Characteristics | The proposed HEALIX ADVANCETM Anchors with PERMATAPETM Suture are
similar to the predicate HEALIX ADVANCETM Anchors with PERMACORDTM
Suture (K133794) in that they share the same intended use, anchor design and
materials, PERMACORD suture design and materials, device assembly, sterilization
method, and shelf life. The proposed devices are similar to the predicate Gryphon™
BR Anchor with Orthocord® Suture in that they share the same indications for use,
same anchor materials, similar anchor / device assembly design and principle of
operation. The proposed devices are similar to the reference device, PERMACORDTM
Suture (K162247), in that they share the same suture design and material. The
proposed devices are similar to the reference device, HEALIX ADVANCETM PEEK
Anchor (K120449), in that both are offered with or without needles to facilitate suture
passage through tissue. | |
| Indications for
Use | The HEALIX ADVANCE Anchor is indicated for use in soft tissue to bone fixation in
association with post-operative immobilization as follows: | |
| | Shoulder:
Foot/Ankle:
Knee:
Elbow:
Hip: | Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps
Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair,
Capsular Shift or Capsulolabral Reconstruction
Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair
Medial Collateral Ligament Repair, Lateral Collateral Ligament
Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Biceps Tendon Reattachment, Ulnar Collateral Ligament
Reconstruction , Radial Collateral Ligament Reconstruction
Capsular Repair, Acetabular Labral Repair |
| Non clinical
Testing | Verification activities were performed on the proposed device and / or its predicates.
Testing assessments include pull out testing, insertion and failure torque and in-vitro
testing. | |
| Safety and
Performance | Results of performance testing have demonstrated that the proposed devices are
suitable for their intended use.
Bacterial endotoxin testing has been completed and results have demonstrated that the
proposed devices meet the endotoxin limits.
Based on similarities in the indications for use, technological characteristics, and
performance in comparison to the predicate devices, the proposed HEALIX
ADVANCETM Anchor with PERMATAPETM Suture has shown to be substantially | |
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