(17 days)
The Healix Advance Knotless Anchors are indicated for use in the following procedures for reattachment of soft tissue to bone:
Shoulder
Rotator Cuff .
. Biceps Tenodesis
The proposed Healix Advance Knotless Anchor is a one piece implantable cannulated, threaded anchor designed to secure soft tissue to bone. The anchor is provided loaded on a disposable inserter driver device. The proposed anchors will be offered in a 6.5 mm size. The proposed 6.5 mm Healix Advance Knotless PEEK Anchor is manufactured from PEEK (Polyetheretherketone) material.
The DePuy Mitek HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5mm) is a medical device designed for reattachment of soft tissue to bone. This submission (K131683) is for a larger version (6.5mm) of previously cleared predicate devices (4.75mm and 5.5mm Healix Advance Knotless PEEK Anchors).
Acceptance Criteria and Device Performance Study:
Since this FDA submission is a Special 510(k) based on substantial equivalence to predicate devices, formal acceptance criteria and a single study proving the device meets them in the traditional sense (e.g., a clinical trial with specific performance endpoints) are not presented in the provided documents. Instead, the submission focuses on demonstrating that the new device has the same design, technological characteristics, and safety/performance profile as the predicate devices, despite the size change.
The "Substantial Equivalence" framework in 510(k) submissions relies on showing that the new device is as safe and effective as a legally marketed predicate device. The "acceptance criteria" here can be inferred as showing that the new device performs equivalently or comparably to the predicate in non-clinical tests relevant to its function.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Inferred fromPredicate Equivalence) | Reported Device Performance (Non-clinical Testing) |
|---|---|
| Similar Mechanical Properties: | |
| - Insertion Torque (comparable to predicate) | Performed; demonstrated substantial equivalence |
| - Torque to Failure (comparable to predicate) | Performed; demonstrated substantial equivalence |
| - Anchor Pullout Strength (comparable to predicate) | Performed; demonstrated substantial equivalence |
| Biocompatibility: | Manufactured from PEEK material, same as predicate; inherently considered biocompatible based on predicate. |
| Sterility: | Not explicitly mentioned but assumed to meet standards for implantable devices. |
Explanation: The "acceptance criteria" are implied by the need to demonstrate substantial equivalence to the predicate devices (4.75mm and 5.5mm Healix Advance Knotless PEEK Anchors). The non-clinical testing performed (Insertion Torque, Torque to Failure, Anchor Pullout) aimed to show that the 6.5mm anchor's mechanical performance is comparable to the predicate devices, thus meeting the "acceptance criteria" for safety and effectiveness in the context of a Special 510(k).
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated. The document mentions "Product Design Verification and Design Validation activities," but does not detail the number of samples used for each test (Insertion Torque, Torque to Failure, Anchor Pullout).
- Data Provenance: The testing was "Non-clinical Testing" performed by the manufacturer, DePuy Mitek. The country of origin of the data is not specified, but it would have been generated in a controlled laboratory setting by the company. It is retrospective in the sense that the testing was conducted prior to submission to demonstrate equivalency.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable in this context. The "ground truth" for non-clinical mechanical testing is derived from the physical properties and performance characteristics of the devices themselves, measured through established engineering and biomechanical methods. No human experts are used to interpret the "ground truth" of these test results; rather, engineers and scientists conduct and analyze the tests against predetermined specifications or predicate performance.
4. Adjudication Method for the Test Set:
- Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or image-based diagnostic evaluations where human interpretation of outcomes is involved. For non-clinical mechanical testing, results are quantitative and objective, and thus do not require an adjudication process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of images or data (e.g., radiologists reading mammograms with and without AI assistance). The Healix Advance Knotless PEEK Anchor is an implantable surgical device, and its performance is evaluated through biomechanical testing and clinical outcomes, not through human reader interpretation of data.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- No, a standalone (algorithm only) study was not done. This type of study is specifically for evaluating the performance of AI algorithms. The device described is a physical surgical implant, not an algorithm.
7. Type of Ground Truth Used:
- The "ground truth" for the non-clinical testing was based on objective, quantitative mechanical measurements (e.g., torque values, force measurements for pullout strength). These measurements establish the intrinsic performance characteristics of the device. The comparison of these measurements to the predicate device's known performance serves as the basis for the substantial equivalence claim.
8. Sample Size for the Training Set:
- Not applicable. This device is a physical product, not an AI/ML algorithm that requires a training set. The concept of a "training set" is relevant to machine learning models.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for this device.
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| K131683 (1/2) | |||||
|---|---|---|---|---|---|
| PRODUCT:SUBMISSION TYPE: SPECIAL | HEALIX ADVANCE KNOTLESSPEEK ANCHOR (6.5mm)SUBMISSION DATE: June 6, 2013 | ||||
| 510(k) SUMMARY | JUN 2 7 2013 | ||||
| Submitter: | DePuy Miteka Johnson & Johnson company325 Paramount DriveRaynham, MA 02767 | ||||
| Contact Person | Kristine ChristoManager, Regulatory AffairsDePuy Miteka Johnson & Johnson company325 Paramount DriveRaynham, MA 02767, USA | Facsimile: | Telephone: 508-828-3359508-977-6911e-mail: kchristo@its.jnj.com | ||
| Date Prepared | June 6, 2013 | ||||
| Name of MedicalDevice | Proprietary Name:Classification Name:Common Name: | Bone Anchor | Fastener, Fixation, Biodegradable, Soft tissue | HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5mm) | |
| SubstantialEquivalence | The HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5mm) is substantially equivalent to:1/120520 } Ctole Llacky Advance Kmatlegg DDCV Amabon (4,76 and 5,5 mm) |
■ K130539 Mitek Healix Advance Knotless PEEK Anchor (4.75 and 5.5mm)
Device Fastener, Fixation, Nondegradable, Soft Tissue, classified as Class II, product code MBI regulated Classification under 21 CFR 888.3040.
Device The proposed Healix Advance Knotless Anchor is a one piece implantable cannulated, threaded Description anchor designed to secure soft tissue to bone. The anchor is provided loaded on a disposable inserter driver device. The proposed anchors will be offered in a 6.5 mm size. The proposed 6.5 mm Healix Advance Knotless PEEK Anchor is manufactured from PEEK (Polyetheretherketone) material.
Indications for The Healix Advance Knotless Anchors are indicated for use in the following procedures for Use reattachment of soft tissue to bone:
Shoulder
- Rotator Cuff .
- . Biceps Tenodesis
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| Image: DePuy logo | K131683 (2/2) | |
|---|---|---|
| never stop moving | PRODUCT: | HEALIX ADVANCE KNOTLESSPEEK ANCHOR (6.5mm) |
| SUBMISSION DATE: | June 6, 2013 | |
| SUBMISSION TYPE: | SPECIAL |
| Comparison ofTechnologicalCharacteristics | The proposed Healix Advance Knotless PEEK Anchors will have the same design as compthe predicate devices (4.75mm and 5.5mm) but will be larger in size (6.5mm). Both the prand predicate Healix Advance Knotless PEEK Anchors are molded from the same(polyetheretherketone) material. No new technological characteristics were introduces asof the proposed changes. |
|---|---|
| Safety andPerformance | Non-clinical TestingProduct Design Verification and Design Validation activities, such as, Insertion Torque, Torque toFailure and Anchor Pullout were performed on the proposed implant device. Results ofperformance and safety testing have demonstrated that the proposed device is substantiallyequivalent to the predicate devices.Based on the indications for use, technological characteristics, and comparison to predicatedevices, the proposed 6.5mm Healix Advance Knotless Anchors have been shown to besubstantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act. |
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002
June 27, 2013
Depuy Mitek Incorporated, a Johnson & Johnson Company % Ms. Kristine Christo Manager, Regulatory Affairs 325 Paramount Drive Raynham, Massachusetts 02767
Re: K131683
Trade/Device Name: Healix Advance Knotless PEEK Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: June 7, 2013 Received: June 10, 2013
Dear Ms. Christo:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Kristine Christo
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 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" (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/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.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Erif Dkeith
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): K131683
Device Names: Healix Advance Knotless PEEK Anchor
Indications for Use: The Healix Advance Knotless Anchors are indicated for use in the following procedures for reattachment of soft tissue to bone:
Shoulder
Rotator Cuff .
Biceps Tenodesis .
Prescription Use ﮯ 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)
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.