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.

Device Description

The Healix Advance" Anchor with Permacord™ suture is a threaded suture anchor preloaded on a disposable inserter assembly intended for fixation soft tissue to bone. Healix Advance Anchors are available in absorbable BR and non-absorbable PEEK materials. Permacord suture is a non-absorbable suture that conforms to USP, except for oversized diameter. Healix Advance Anchors with Permacord are provided sterile and is for single use only.

AI/ML Overview

The provided text describes the Healix Advance™ Anchor with Permacord™ suture and its substantial equivalence to predicate devices, but it does not detail specific acceptance criteria or a study proving the device meets those criteria in the typical format you've requested for AI/software-based medical devices.

Instead, the submission focuses on demonstrating safety and effectiveness through substantial equivalence to already legally marketed devices, which is a common pathway for predicate-based medical devices. The "study" here refers to non-clinical testing performed to show that the new device performs comparably to its predicates.

Here's an interpretation based on the provided text, formatted to align with your request where possible, but with clear indications where the information is not present in the document.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Performance:
Pull out testing adequate	Performed (results not detailed)
Insertion torque adequate	Performed (results not detailed)
Failure torque adequate	Performed (results not detailed)
In-vitro testing successful	Performed (results not detailed)
Suture testing per USP	Performed (results not detailed)
Material Equivalence:
Anchor materials same as predicates (K120078, K120449)	Confirmed: "The proposed Healix Advance Anchors with Permacord suture have the same anchor materials and design as predicate Healix Advance Anchors (K120078, K120449)."
Permacord suture materials same as Force Fiber suture (K070673, K092533, K100506)	Confirmed: "The Permacord suture has the same design and materials as Teleflex's Force Fiber suture (K070673, K092533, K100506), and conforms to USP, except for oversized diameter."
Design Equivalence:
Anchor design same as predicates (K120078, K120449)	Confirmed: "The proposed Healix Advance Anchors with Permacord suture have the same anchor materials and design as predicate Healix Advance Anchors (K120078, K120449)."
Permacord suture design same as Force Fiber suture	Confirmed: "The Permacord suture has the same design and materials as Teleflex's Force Fiber suture..."
Functional Equivalence:
Principal operation same as predicates (K120078, K120449, K100012)	Confirmed: "The proposed device principal operation is the same as predicate Healix Advance Anchors (K120078. K120449) and Gryphon™ BR (K100012) anchors."
Intended Use:
Suitable for intended use	Confirmed: "Results of performance testing have demonstrated that the proposed devices are suitable for their intended use."
Sterility:
Provided sterile	Confirmed: "Healix Advance Anchors with Permacord are provided sterile and is for single use only."
Biocompatibility:	Not explicitly mentioned, but typically covered by material equivalence to predicates or standard biocompatibility testing for new materials.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified. The document states "Verification activities were performed on the implant and / or its predicates" and "Testing assessments include pull out testing, insertion and failure torque, in-vitro testing and suture testing per USP." This implies engineering bench testing, which would involve a certain number of samples, but the exact count is not provided.
Data Provenance: The testing appears to be internal lab testing ("Verification activities were performed"), not necessarily in a country of origin context. It is non-clinical/bench testing. It is retrospective in the sense that it's evaluating a final design against pre-defined performance metrics, but the data itself is generated prospectively for the submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is a medical device for physical implantation, not an AI/software device that requires human expert review for "ground truth" labels. The "ground truth" for this device's performance is established by engineering specifications and material standards (like USP) as well as the performance of predicate devices.

4. Adjudication Method for the Test Set

Not applicable. As this is not an AI/software device requiring human judgment for data labeling, there is no adjudication method in the context described. Performance is measured against engineering and material specifications.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a physical medical device (suture anchor), not an AI system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device.

7. The type of ground truth used

For this type of device, the "ground truth" is defined by:
- Engineering Specifications: Specific quantifiable values for pull-out strength, torque, etc.
- Material Specifications: Adherence to established standards such as USP (United States Pharmacopeia) for sutures.
- Predicate Device Performance: The demonstrated safe and effective performance of the predicate devices. The new device is shown to be substantially equivalent to these devices.

8. The Sample Size for the Training Set

Not applicable. This product is a physical medical device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. This product is a physical medical device, not an AI/ML algorithm that requires a training set and associated ground truth establishment.

Summary

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FEB - 4 2014

SECTION 2 - 510(k) SUMMARY

Healix Advance"" Anchor with Permacord™

Submitter'sName andAddress	DePuy Miteka Johnson & Johnson company325 Paramount DriveRaynham, MA 02767Date Prepared: December 11, 2013
Contact Person	Tatyana KorsunskyRegulatory Affairs SpecialistDePuy Mitek, Inc.a Johnson & Johnson company325 Paramount DriveRaynham, MA 02767, USATelephone: 508-828-3122Facsimile: 508-977-6911e-mail: tkorsuns@its.jnj.com
Name ofMedical Device	Proprietary Name: a) Healix Advance™ BR Anchor with Permacord™b) Healix Advance™ PEEK Anchor with Permacord™Classification Name: a) Single/multiple component metallic bone fixationappliances and accessoriesb) Smooth or threaded metallic bone fixation fastenersCommon Name: Suture Anchor
SubstantialEquivalence	The Healix Advance™ Anchor with Permacord™ is substantially equivalent to:• K120078 Healix Advance™ BR Anchor with Orthocord® suture• K120449 Healix Advance™ PEEK Anchor with Orthocord® suture• K100012, K073412 Gryphon™ T BR Anchor with Orthocord® sutureThe following predicate devices were referenced:• K070673 Force Fiber® White/Black Co-Braid. Teleflex• K092533 Force Fiber® Blue Braid. Teleflex• K100506 Force Fiber® White/Green Co-Braid. Teleflex
DeviceClassification	➤ Healix Advance BR anchor 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 is classified as:Smooth or threaded metallic bone fixation fasteners, classified as Class II, productcode HWC, regulated under 21 CFR 888.3040.
DeviceDescription	The Healix Advance" Anchor with Permacord™ suture is a threaded suture anchorpreloaded on a disposable inserter assembly intended for fixation soft tissue to bone.Healix Advance Anchors are available in absorbable BR and non-absorbable PEEKmaterials. Permacord suture is a non-absorbable suture that conforms to USP, exceptfor oversized diameter. Healix Advance Anchors with Permacord are provided sterileand is for single use only.
TechnologicalCharacteristics	The proposed Healix Advance Anchors with Permacord suture have the same anchormaterials and design as predicate Healix Advance Anchors (K120078, K120449). Theproposed device principal operation is the same as predicate Healix Advance Anchors(K120078. K120449) and Gryphon" BR (K100012) anchors. The Permacord suturehas the same design and materials as Teleflex's Force Fiber suture (K070673,K092533, K100506), and conforms to USP, except for oversized diameter.
Indications forUse	The HEALIX ADVANCE Anchor is indicated for use in soft tissue to bone fixation inassociation with post-operative immobilization as follows:
	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.
Non clinicalTesting	Verification activities were performed on the implant and / or its predicates. Testingassessments include pull out testing, insertion and failure torque, in-vitro testing andsuture testing per USP.
Safety andPerformance	Results of performance testing have demonstrated that the proposed devices aresuitable for their intended use.
	Based on similarities in the indications for use, technological characteristics, andperformance in comparison to the predicate devices, the proposed Healix AdvanceAnchor with Permacord suture has shown to be substantially equivalent to thepredicate devices under the Federal Food, Drug and Cosmetic 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 emblem resembling an eagle or bird with three wing-like shapes.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 4, 2014

DePuy Mitek, a Johnson & Johnson company Ms. Tatyana Korsunsky Regulatory Affairs Specialist 325 Paramount Drive Raynham, Massachusetts 02767

Re: K133794

Trade/Device Name: Healix Advance™ Anchor with Permacord™ 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, HWC Dated: December 11, 2013 Received: December 13, 2013

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. 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. Tatyana Korsunsky

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 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.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Vincent訂房Devlin -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): K133794

Device Name: Healix Advance™ Anchor with Permacord™suture

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:	Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or CapsulolabralReconstruction;
Foot/Ankle:	Lateral Stabilization, Medial 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
(Part 21 CFR 801 Subpart D)
Over-The-Counter Use
(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)

Casey L. Hanley, Ph.D.

Division of Orthopedic Devices

Page 1 of_1

Regulation Number and Section

§ 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.