(110 days)
Shoulder: Bankart Repair, SLAP Lesion Repair, Capsular Shift or Capsulolabral Reconstruction Hip: Capsular Repair, Acetabular Labral Repair
The proposed device is a suture-anchor to be used for soft tissue fixation to bone. The Gryphon Anchor is a cannulated, ribbed anchor, made of either non-absorbable PEEK (Polyetheretherketone) or absorbable Biocry18 Rapide " (composite of ß-TCP and PLGA copolymer). Orthocord suture (absorbable polydioxanone (PDS®) and non-absorbable polyethylene braided composite suture) is preloaded on the anchor. The suture incorporates a pre-tied sliding knot (ProKnot knot). The device is provided as sterile; the device is for single patient use only.
The provided text describes a 510(k) summary for the GRYPHON™ ANCHOR w/PROKNOT™ TECHNOLOGY. This is a medical device, specifically a suture-anchor for soft tissue fixation to bone. The summary details its classification, predicate devices, and indications for use.
However, the document focuses on demonstrating substantial equivalence to predicate devices rather than providing specific acceptance criteria and detailed study results as would be typical for a new, non-equivalent device. The information available about performance testing is limited.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Sufficient fixation force to secure soft tissue to bone | "Fixation force testing was conducted under in vitro condition throughout two times of healing period, and substantial equivalence of fixation performance to the predicate device has been confirmed." |
| Biocompatibility of materials | "Material biocompatibility has been also confirmed." |
| No new issues of safety and efficacy compared to predicate devices | "The proposed device raises no new issue of safety and efficacy." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified. The document only mentions "fixation force testing was conducted." The number of samples tested is not quantified.
- Data Provenance: The testing was "in vitro." The country of origin for the data is not specified, but the applicant is DePuy Mitek, a Johnson & Johnson company, located in Raynham, MA, USA, suggesting the testing was likely conducted in the US or by a contracted lab. The testing is non-clinical.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of experts or ground truth establishment in the context of clinical studies for this device. The documentation focuses on non-clinical performance testing and comparison to predicate devices, which does not typically involve expert review of clinical cases.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this was non-clinical testing, not a clinical study involving adjudication of clinical cases.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a surgical implant (suture anchor), not an AI-powered diagnostic device. Therefore, MRMC studies and AI assistance are not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable, as this is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- For fixation force testing: The "ground truth" would be the measured physical properties of the device (e.g., pull-out strength, stiffness) compared against pre-defined engineering specifications or the performance of the predicate device. This is based on objective measurement rather than expert consensus or pathology in a clinical sense.
- For material biocompatibility: This typically involves established biocompatibility testing standards (e.g., ISO 10993 series) which determine if the material elicits an adverse biological response.
8. The Sample Size for the Training Set
Not applicable. There is no concept of a "training set" for this type of physical medical device submission, as it does not involve machine learning or AI models.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
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K132241 (1/2)
MITER SPORTS MEDIC
NOV - 5 2013
510(k) SUMMARY GRYPHON™ ANCHOR w/PROKNOT™ TECHNOLOGY
| Date SummaryPrepared | July 17, 2013 | |
|---|---|---|
| Submitter'sName andAddress | DePuy Miteka Johnson & Johnson company325 Paramount DriveRaynham, MA 02767 | |
| Contact Person | Yayoi FujimakiRegulatory Affairs Senior AssociateDePuy Miteka Johnson & Johnson company325 Paramount DriveRaynham, MA 02767, USA | Telephone: 508-828-3541Facsimile: 508-977-6911e-mail: yfujimal@its.jnj.com |
| Name ofMedical Device | Trade Name:GRYPHON™ Anchor w/PROKNOT™ Technologyfastener, fixation, biodegradable, soft tissueCommon Name: | |
| DeviceClassification | MAI - Single/multiple component metallic bone fixation appliances and미accessories, classified as Class II, regulated per 21 CFR 888.3030.HWC - Smooth or threaded metallic bone fixation fastener, Classified as●Class II, regulated per CFR 888.3040.Orthopedic panel요 | |
| PredicateDevice | BIORAPTOR® Knotless Suture Anchor (K121018, K093428)트GRYPHON™ P BR Anchor (K090124, K100012)다GRYPHON™ PEEK Anchor (K103712)E | |
| Indications forUse | Shoulder: Bankart Repair, SLAP Lesion Repair, Capsular Shift or CapsulolabralReconstructionHip: Capsular Repair, Acetabular Labral Repair | |
| DeviceDescription | The proposed device is a suture-anchor to be used for soft tissue fixation tobone. The Gryphon Anchor is a cannulated, ribbed anchor, made of either non-absorbable PEEK (Polyetheretherketone) or absorbable Biocry18 Rapide "(composite of ß-TCP and PLGA copolymer). Orthocord suture (absorbablepolydioxanone (PDS®) and non-absorbable polyethylene braided compositesuture) is preloaded on the anchor. The suture incorporates a pre-tied slidingknot (ProKnot knot). The device is provided as sterile; the device is for singlepatient use only. |
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( ) DePuy Synthes MITEK SPORTS MEDICINE
comments or folonion gobseries
1
| Comparison ofTechnologicalCharacteristics | Substantial equivalence to the predicate devices has been justified by similarityof indications, design, material, operation principle and device performance data.Performance testing ensured that there is no new issue of safety and efficacy. |
|---|---|
| Safety andPerformance | Non-clinical TestingPerformance requirement of the proposed device is to secure soft tissue to boneto heal. Fixation force testing was conducted under in vitro condition throughouttwo times of healing period, and substantial equivalence of fixation performanceto the predicate device has been confirmed. Material biocompatibility has beenalso confirmed. The proposed device raises no new issue of safety and efficacy. |
| SubstantialEquivalence | Based on technological characteristics comparison and performance evaluation,the proposed device is concluded to be substantially equivalent to the predicatedevices. |
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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 features the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of an eagle or bird-like figure, with three curved lines extending from its body.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 5, 2013
DePuy Mitek, a Johnson and Johnson company Ms. Yavoi Fujimaki Regulatory Affairs Senior Associate 325 Paramount Drive Raynham, Massachusetts 02767
- Re: K132241
Trade/Device Name: GRYPHON™ ANCHOR w/PROKNOT™ TECHNOLOGY 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: September 25, 2013 Received: September 26, 2013
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-interstatecommerce 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 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,
Erin詞為Keith
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DePuySynthes
MITEK SPORTS MEDICINE
Indications for Use
510(k) Number (if known): K132241
Device Name: GRYPHON™ ANCHOR w/PROKNOT™ TECHNOLOGY
Indications for Use:
GRYPHON ANCHOR w/PROKNOT TECHNOLOGY is indicated for followings.
Shoulder: Bankart Repair, SLAP Lesion Repair, Capsular Shift or Capsulolabral Reconstruction Hip: Capsular Repair, Acetabular Labral Repair
Prescription Use _____________________________________________________________________________________________________________________________________________________________
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)
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices
Page I of 1
§ 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.