(50 days)
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.
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.
The provided document describes a medical device, the HEALIX ADVANCE™ BR Anchor, and its substantial equivalence to previously marketed predicate devices. However, the document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of a diagnostic or AI-based device.
This document is a 510(k) summary for a bone anchor, which is a physical medical device (implant) used for fixation of soft tissue to bone. The "Safety and Performance" section states: "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."
This indicates that mechanical performance testing was done for the physical implant, but the details of the acceptance criteria, specific study results, sample sizes for these tests, or any form of "ground truth" or expert adjudication are not included in this regulatory summary. These details would typically be found in the full 510(k) submission or design verification reports, which are not provided here.
Therefore, I cannot fulfill the request as it pertains to acceptance criteria and a study proving a diagnostic device's performance, an AI-based device's performance, or a multi-reader multi-case (MRMC) comparative effectiveness study. The request's questions are geared towards the evaluation of diagnostic algorithms or software, which is not the subject of this document.
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SECTION 2 - 510(k) SUMMARY
HEALIX ADVANCE™ BR Anchor
| Submitter'sName andAddress | DePuy Miteka Johnson & Johnson company325 Paramount DriveRaynham, MA 02767 |
|---|---|
| Contact Person | Yayoi FujimakiRegulatory Affairs Senior AssociateDePuy Mitek, Inc.a Johnson & Johnson company325 Paramount DriveRaynham, MA 02767, USATelephone: 508-828-3541Facsimile: 508-977-6911e-mail: yfujimal@its.jnj.com |
| Name ofMedical Device | Proprietary Name: HEALIX ADVANCE™ BR AnchorClassification Name: Single/multiple component metallic bone fixation appliances and accessoriesCommon Name: Bone Anchor |
| SubstantialEquivalenceFacility | The HEALIX ADVANCE BR Anchor is substantially equivalent to:■ K073412: Healix BR Anchor and Gryphon BR Anchor■ K100012: Gryphon T and P BR Anchor |
| DeviceClassification | Single/multiple component metallic bone fixation appliances and accessories,classified as Class II, product code MAI regulated under 21 CFR 888.3030. |
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| DeviceDescription | The HEALIX ADVANCE BR Anchor is absorbable threaded suture anchor preloadedon a disposable inserter assembly intended for fixation soft tissue to bone. The sutureoptions may include needles to facilitate suture passage through tissue. HEALIXADVANCE BR Anchor is provided sterile and is for single patient use only. | ||
|---|---|---|---|
| Indications forUse | Shoulder: | Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, BicepsTenodesis, 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 LigamentRepair, Posterior Oblique Ligament Repair, Iliotibial BandTenodesis; | ||
| Elbow: | Biceps Tendon Reattachment, Ulnar or Radial Collateral LigamentReconstruction: | ||
| Hip: | Capsular repair, Acetabular Labral Repair. | ||
| Safety andPerformance | Non-clinical TestingDesign verification activities, such as Anchor Torque, Anchor Pull Out (at T=0 and invitro testing throughout the healing period) were performed against pre-definedacceptance criteria according to the intended use, | ||
| Results of performance testing have demonstrated that the proposed devices aresuitable for their intended use.Based on the indications for use, technological characteristics, and comparison to thepredicate devices, the proposed HEALIX ADVANCE BR Anchor has shown to besubstantially equivalent to the predicate devices under the Federal Food, Drug andCosmetic Act. |
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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
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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
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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 orCapsulolabral Reconstruction; |
|---|---|
| Foot/Ankle: | Lateral Stabilization, Mediał Stabilization, Achilles Tendon Repair; |
| Knee: | Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, PosteriorOblique 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
§ 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.