(50 days)
Not Found
No
The 510(k) summary describes a physical suture anchor and its intended uses, with no mention of AI or ML in the device description, intended use, performance studies, or key metrics.
No.
The device is described as an absorbable threaded suture anchor intended for fixation of soft tissue to bone, which is a surgical implant rather than a therapeutic device that administers therapy.
No
The device description clearly states its purpose as "fixation soft tissue to bone," indicating it is an implant used for repair, not diagnosis. The indications for use list various surgical repairs, not diagnostic procedures.
No
The device description explicitly states it is an "absorbable threaded suture anchor preloaded on a disposable inserter assembly," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The description clearly states the device is an "absorbable threaded suture anchor preloaded on a disposable inserter assembly intended for fixation soft tissue to bone." This is a surgical implant used to physically attach soft tissue to bone.
- Intended Use: The intended uses listed are all surgical procedures involving the repair of ligaments, tendons, and labrums in various joints. These are not diagnostic tests.
The device is a surgical implant used for repair and reconstruction, not for diagnosing conditions based on in vitro analysis of biological samples.
N/A
Intended Use / Indications for Use
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 or Radial Collateral Ligament Reconstruction:
Hip: Capsular repair, Acetabular Labral Repair.
Product codes
MAI
Device Description
The HEALIX ADVANCE BR Anchor is absorbable threaded suture anchor preloaded on a disposable inserter assembly intended for fixation soft tissue to bone. The suture options may include needles to facilitate suture passage through tissue. HEALIX ADVANCE BR Anchor is provided sterile and is for single patient 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
Design verification activities, such as Anchor Torque, Anchor Pull Out (at T=0 and in vitro testing throughout the healing period) were performed against pre-defined acceptance criteria according to the intended use,
Results of performance testing have demonstrated that the proposed devices are suitable for their intended use.
Based on the indications for use, technological characteristics, and comparison to the predicate devices, the proposed HEALIX ADVANCE BR Anchor 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)
Reference Device(s)
Not Found
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.
0
پ
SECTION 2 - 510(k) SUMMARY
HEALIX ADVANCE™ BR Anchor
| Submitter's
Name and
Address | DePuy Mitek
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767 |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Yayoi Fujimaki
Regulatory Affairs Senior Associate
DePuy Mitek, Inc.
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767, USA
Telephone: 508-828-3541
Facsimile: 508-977-6911
e-mail: yfujimal@its.jnj.com |
| Name of
Medical Device | Proprietary Name: HEALIX ADVANCE™ BR Anchor
Classification Name: Single/multiple component metallic bone fixation appliances and accessories
Common Name: Bone Anchor |
| Substantial
Equivalence
Facility | The HEALIX ADVANCE BR Anchor is substantially equivalent to:
■ K073412: Healix BR Anchor and Gryphon BR Anchor
■ K100012: Gryphon T and P BR Anchor |
| Device
Classification | Single/multiple component metallic bone fixation appliances and accessories,
classified as Class II, product code MAI regulated under 21 CFR 888.3030. |
1
| Device
Description | The HEALIX ADVANCE BR Anchor is absorbable threaded suture anchor preloaded
on a disposable inserter assembly intended for fixation soft tissue to bone. The suture
options may include needles to facilitate suture passage through tissue. HEALIX
ADVANCE BR Anchor is provided sterile and is for single patient use only. | | |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Indications for
Use | Shoulder: | Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps
Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair,
Capsular Shift or Capsulolabral Reconstruction; | |
| | Foot/Ankle:
Knee: | Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair;
Medial Collateral Ligament Repair, Lateral Collateral Ligament
Repair, Posterior Oblique Ligament Repair, Iliotibial Band
Tenodesis; | |
| | Elbow: | Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament
Reconstruction: | |
| | Hip: | Capsular repair, Acetabular Labral Repair. | |
| Safety and
Performance | Non-clinical Testing
Design verification activities, such as Anchor Torque, Anchor Pull Out (at T=0 and in
vitro testing throughout the healing period) were performed against pre-defined
acceptance criteria according to the intended use, | | |
| | Results of performance testing have demonstrated that the proposed devices are
suitable for their intended use.
Based on the indications for use, technological characteristics, and comparison to the
predicate devices, the proposed HEALIX ADVANCE BR Anchor has shown to be
substantially equivalent to the predicate devices under the Federal Food, Drug and
Cosmetic Act. | | |
2
Image /page/2/Picture/1 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" arranged around the perimeter. Inside the circle is a stylized graphic of three curved shapes, resembling a person embracing another person, which is the symbol of the department.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
FEB 2 9 2012
DePuy Mitek Inc. % Ms. Yayoi Fujimaki Regulatory Affairs Senior Associate 325 Paramount Drive Raynham, Massachusetts 02767
Re: K120078
Trade/Device Name: HEALIX ADVANCE™ BR Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI Dated: January 9, 2012 Received: January 10, 2012
Dear Ms. Fujimaki:
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 (reporting of medical
3
Page 2 – Ms. Yayoi Fujimaki
device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: HEALIX ADVANCE™ BR Anchor
Indications for Use:
The HEALIX ADVANCE™ BR Anchor is indicated 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, Mediał 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 or Radial Collateral Ligament Reconstruction; |
| Hip: | Capsular Repair, Acetabular Labral Repair. |
Prescription Use _ x
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of 1
长)20078 510(k) Number_
Premarket Notification: Traditional HEALIX ADVANCE™ BR Anchor