(26 days)
The GRYPHON BR Anchor is intended 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, 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 GRYPHON PEEK Anchor is intended for:
Shoulder: Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Elbow: Ulnar or Radial Collateral Ligament Reconstruction
Hip: Capsular Repair, Acetabular Labral Repair
The Gryphon™ Anchor with Permacord™ is a suture anchor preloaded on a disposable inserter assembly intended for fixation of suture to bone. Gryphon Anchors are available in absorbable BR and non-absorbable PEEK materials. Permacord suture is non-absorbable. The Gryphon Anchor with Permacord suture is supplied sterile and is for single use only.
This looks like a 510(k) submission for a medical device, specifically a suture anchor, and not an AI/ML device. Therefore, the typical acceptance criteria and study design for AI/ML performance evaluation do not apply here.
The document describes the Gryphon™ Anchor with Permacord™ as a suture anchor preloaded on a disposable inserter assembly, available in absorbable BR and non-absorbable PEEK materials with non-absorbable Permacord suture.
Here's an analysis based on the provided text, focusing on the information available and noting where AI/ML specific criteria are not applicable:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is not an AI/ML device, the "acceptance criteria" are not related to diagnostic accuracy metrics (e.g., sensitivity, specificity). Instead, they relate to safety and performance specifications for a medical implant like a suture anchor. The document states:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Performance (e.g., pull-out strength, in-vitro testing) | "Results of performance testing have demonstrated that the proposed devices are suitable for their intended use." |
| Material Equivalence | "The proposed Gryphon Anchors with Permacord suture have the same anchor materials and design as predicate Gryphon Anchors (K090124, K100012, K103712)." |
| Functional Equivalence | "The proposed device principal operation is the same as predicate Gryphon Anchors (K090124, K100012, K103712)." |
| Suture Equivalence | "The Permacord suture is the same suture as referenced in predicate Healix Advance ™ Anchor with Permacord™ (K133794)." |
The study that "proves" the device meets the acceptance criteria is described as "Verification activities were performed on the implant and / or its predicates. Testing assessments include pull out testing and in-vitro testing." This non-clinical testing demonstrated that the device is "substantially equivalent" to predicate devices.
2. Sample Size for Test Set and Data Provenance:
This information is not applicable as the described testing is non-clinical performance and material testing for a physical medical device, not an AI/ML diagnostic or predictive model. There isn't a "test set" in the context of patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not applicable. Ground truth, in the context of AI/ML, refers to clinically verified labels or outcomes. For a physical device, testing involves engineering and materials science experts conducting physical tests, not clinical evaluations of patient data for ground truth.
4. Adjudication Method for the Test Set:
This information is not applicable for the same reasons as points 2 and 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
This information is not applicable. MRMC studies are used to evaluate the impact of AI on human reader performance, which isn't relevant for a physical implant device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This information is not applicable. This device is a physical implant, not an algorithm.
7. The Type of Ground Truth Used:
For the performance testing, the "ground truth" would be the objective measurement of mechanical properties (e.g., maximum load at failure for pull-out strength) under controlled laboratory conditions, compared against pre-defined engineering specifications or predicate device performance. It is not expert consensus, pathology, or outcomes data in the AI/ML sense.
8. Sample Size for the Training Set:
This information is not applicable as there is no AI/ML algorithm being trained.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no AI/ML algorithm being trained.
In summary, the provided document describes a 510(k) submission for a physical medical device (suture anchor) and focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing and material characterization. The concepts of acceptance criteria, test sets, ground truth, and studies as typically applied to AI/ML devices are not relevant to this submission.
{0}------------------------------------------------
JUN 1 0 2014
・ :
SECTION 2 - 510(k) SUMMARY
l
Gryphon™ Anchor with Permacord™
| Submitter'sName andAddress | DePuy Miteka Johnson & Johnson company325 Paramount DriveRaynham, MA 02767Date Prepared: May 14, 2014 |
|---|---|
| Contact Person | Julie VafidesRegulatory Affairs SpecialistDePuy Mitek, Inc.a Johnson & Johnson company325 Paramount DriveRaynham, MA 02767, USATelephone: 508-977-6645Facsimile: 508-977-6911e-mail: jvafides@its.jnj.com |
| Name ofMedical Device | Proprietary Name: a) Gryphon™ BR Anchor with Permacord™b) Gryphon™ PEEK Anchor with Permacord™Classification Name: a) Single/multiple component metallic bone fixation appliances and accessoriesb) Smooth or threaded metallic bone fixation fastenersCommon Name: Suture Anchor |
| SubstantialEquivalence | The Gryphon™ Anchor with Permacord™ is substantially equivalent to:■ K090124, K100012 Gryphon™ P BR Anchor with Orthocord®■ K103712 Gryphon™ PEEK Anchor with Orthocord®■ K133794 Healix Advance™ Anchor with Permacord™ |
| DeviceClassification | ➤ Gryphon™ BR Anchors with Permacord™ are classified as:Single/multiple component metallic bone fixation appliances and accessories, classified as Class II, product code MAI, regulated under 21 CFR 888.3030.➤ Gryphon™ PEEK Anchors with Permacord™ are classified as:Smooth or threaded metallic bone fixation fasteners, classified as Class II, product code MBI, regulated under 21 CFR 888.3040. |
{1}------------------------------------------------
| DeviceDescription | The Gryphon™ Anchor with Permacord™ is a suture anchor preloaded on a disposableinserter assembly intended for fixation of suture to bone. Gryphon Anchors areavailable in absorbable BR and non-absorbable PEEK materials. Permacord suture isnon-absorbable. The Gryphon Anchor with Permacord suture is supplied sterile and isfor single use only. |
|---|---|
| TechnologicalCharacteristics | The proposed Gryphon Anchors with Permacord suture have the same anchormaterials and design as predicate Gryphon Anchors (K090124, K100012, K103712).The proposed device principal operation is the same as predicate Gryphon Anchors(K090124, K100012, K103712). The Permacord suture is the same suture asreferenced in predicate Healix Advance ™ Anchor with Permacord™ (K133794). |
| Indications forUse | The GRYPHON BR Anchor is intended for: |
| Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, BicepsTenodesis, 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 LigamentReconstruction | |
| Hip: Capsular Repair, Acetabular Labral Repair | |
| The GRYPHON PEEK Anchor is intended for: | |
| Shoulder: Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift orCapsulolabral Reconstruction | |
| Foot/Ankle: Lateral Stabilization, Medial Stabilization | |
| Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair,Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis | |
| Elbow: Ulnar or Radial Collateral Ligament Reconstruction | |
| Hip: Capsular Repair, Acetabular Labral Repair |
2 of 3
/
{2}------------------------------------------------
.
.
| Non clinicalTesting | Verification activities were performed on the implant and / or its predicates. Testinassessments include pull out testing and in-vitro testing. |
|---|---|
| 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 Gryphon Anchorwith Permacord suture has shown to be substantially equivalent to the predicatedevices under the Federal Food, Drug and Cosmetic Act. |
.
:
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 10, 2014
DePuy Mitek, Incorporated Ms. Julie Vafides Regulatory Affairs Specialist 325 Paramount Drive Raynham, Massachusetts 02767
Re: K141259
Trade/Device Name: Gryphon™ BR and PEEK with Permacord™ 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: May 14, 2014 Received: May 15, 2014
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 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-
{4}------------------------------------------------
Page 2 - Ms. Julie Vafides
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 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/Resourcesfor You/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/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 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/Resourcesfor You/Industry/default.htm.
..
:
.
Sincerely yours.
Lori A. Wiggins
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K141259
Device Name
Gryphon BR and PEEK with Permacord
Indications for Use (Describe)
The GRYPHON BR Anchor is intended for:
Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Sepair, Shoulder: Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair Foot/Ankle: Knee: Medial Collateral Ligament Repair, Lateral 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 GRYPHON PEEK Anchor is intended for:
Shoulder: Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Sepair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Foot/Ankle: Lateral Stabilization, Medial Stabilization Knee: Medial Collateral Ligament Repair. Lateral Ligament Repair. Posterior Oblique Ligament Repair. Nigilbial Band Tenodesis
- Elbow: Ulnar or Radial Collateral Ligament Reconstruction
- Hip: Capsular Repair, Acetabular Labral Repair
Type of Use (Select one or both, as applicable)
X 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.
CHANGE ON FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR CONSTITU Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Casey L. Hanley, Ph.D.
§ 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.