(76 days)
The Cayenne Medical, Inc. CuffLink Knotless Anchors are intended for use for the reattachment of soft tissue to bone for shoulder procedures such as Rotator Cuff Repairs.
The CuffLink™ Knotless Anchor is a sterile, manually operated, single procedure suture anchor device for reattachment of soft tissue to bone in procedures such as shoulder rotator cuff repair. The anchor is mounted on an inserter. The CuffLink Knotless Anchor incorporates design features that facilitate suture anchor placement under arthroscopic or open, limited access conditions in soft tissue to bone reattachment procedures such as shoulder rotator cuff repair. The anchor is offered in two different configurations, with or without a self-punching (SP) metal tip (PEEK anchor body and titanium alloy tip and PEEK anchor is offered in two different sizes. 4.5mm and 5.5mm. The PEEK and titanium alloy anchor is offered in one size, 4.5mm.
The provided text is a 510(k) summary for the Cayenne Medical, Inc. CuffLink™ Knotless Anchor. This document describes a medical device, its intended use, and its substantial equivalence to previously marketed products. However, it does not include information about acceptance criteria or a study that proves the device meets specific performance criteria in the way typically discussed for AI/ML device evaluations.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance. This means showing that the new device is as safe and effective as a legally marketed device, not necessarily that it meets specific performance thresholds against a predefined acceptance criterion in a clinical study setting.
Here's a breakdown based on the provided text, addressing your questions where possible and noting where information is absent:
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Table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for a diagnostic or AI device. The "acceptance criteria" here is implicitly "demonstrate substantial equivalence to predicate devices."
- Device Performance: The document states, "Mechanical testing was performed on the CuffLink Knotless Anchor and Inserter. It was shown that ultimate pull-out strength is significantly higher than that of a predicate device." This is a mechanical performance claim, not an AI/ML performance claim.
Since this is a physical medical device (suture anchor) and not an AI/ML diagnostic tool, the typical "acceptance criteria" for AI/ML are not relevant here. The "performance" described is related to mechanical strength, not diagnostic accuracy.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
Not applicable (N/A). The document refers to "mechanical testing," not a clinical "test set" for diagnostic performance. No details on the sample size for this mechanical testing or data provenance are provided beyond the general statement. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
N/A. This concept of expert-established ground truth for a test set is not relevant for the mechanical testing of a suture anchor. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
N/A. This is relevant for AI/ML diagnostic studies, not for the mechanical testing of a physical device. -
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:
N/A. This is a physical device, not an AI system. No human readers or AI assistance are involved in its primary function. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
N/A. This is a physical device, not an algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
N/A. For the described mechanical testing, the "ground truth" would be the direct measurement of physical properties like pull-out strength, as determined by engineering standards and validated testing methods. It's not a diagnostic "ground truth." -
The sample size for the training set:
N/A. This device is not an AI/ML model that requires a training set. -
How the ground truth for the training set was established:
N/A. This device is not an AI/ML model.
In summary:
The provided 510(k) summary focuses on demonstrating "substantial equivalence" of a physical medical device (a suture anchor) to existing predicate devices based on its intended use, design principles, and mechanical properties. It explicitly states that "Mechanical testing was performed... [and] ultimate pull-out strength is significantly higher than that of a predicate device."
The questions posed are primarily relevant for the evaluation of Artificial Intelligence (AI) or Machine Learning (ML) medical devices, which involve diagnostic performance, ground truth establishment, expert reviews, and reader studies. The CuffLink™ Knotless Anchor is not an AI/ML device, and thus, most of the requested information (related to AI acceptance criteria, test sets, ground truth for AI, MRMC studies, etc.) is not present in this document.
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510(k) Summary
510(k) Summary
Cayenne Medical, Inc. CuffLink™ Knotless Anchor
510(k) Number:
K112876
ADMINISTRATIVE INFORMATION
| Manufacturer Name: | Cayenne Medical, Inc.16597 N. 92nd St., Suite 101Scottsdale, AZ 85260Telephone (480) 502-3661FAX (480) 502-3670 |
|---|---|
| Official Contact: | Kereshmeh Shahriari16597 N. 92nd St., Suite 101Scottsdale, AZ 85260kshahriari@cayennemedical.comTelephone (480) 502-3661FAX (480) 502-3670 |
| 510(k) Summary PreparationDate | September 22nd, 2011 |
| DEVICE NAME | |
| Classification Names: | Smooth or threaded metallic bone fixation fastener |
| Trade/Proprietary Name: | CuffLink™ Knotless Anchor |
| Common Name: | Suture Anchor |
DEVICE CLASSIFICATION
FDA has classified bone screws as Class II devices (21 CFR 888.3040). The product code for CuffLink Knotless Anchor is MBI. The subsequent product code is HWC. These devices are reviewed by the Orthopedic Joint Devices Branch.
INTENDED USE
The Cayenne Medical, Inc. CuffLink Knotless Anchors are intended for use for the reattachment Revised Page 17 of 142
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112876
510(k) Summary
of soft tissue to bone for shoulder procedures such as Rotator Cuff Repairs.
DEVICE DESCRIPTION
The CuffLink™ Knotless Anchor is a sterile, manually operated, single procedure suture anchor device for reattachment of soft tissue to bone in procedures such as shoulder rotator cuff repair. The anchor is mounted on an inserter. The CuffLink Knotless Anchor incorporates design features that facilitate suture anchor placement under arthroscopic or open, limited access conditions in soft tissue to bone reattachment procedures such as shoulder rotator cuff repair. The anchor is offered in two different configurations, with or without a self-punching (SP) metal tip (PEEK anchor body and titanium alloy tip and PEEK anchor is offered in two different sizes. 4.5mm and 5.5mm. The PEEK and titanium alloy anchor is offered in one size, 4.5mm.
Mechanical testing was performed on the CuffLink Knotless Anchor and Inserter. It was shown that ultimate pull-out strength is significantly higher than that of a predicate device.
EQUIVALENCE TO MARKETED PRODUCT
Cavenne Medical. Inc. demonstrated that, for the purposes of FDA's regulation of medical devices, the CuffLink Knotless Anchor is substantially equivalent in indications and design principles to predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices: Smith & Nephew FOOTPRINT Ultra PK Suture Anchor (K093897) and DePuy Mitek GII Anchors (K041115).
Revised Page 18 of 142
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
Cayenne Medical, Inc. % Ms. Kereshmeh Shahriari Senior Directory of Regulatory Affairs, Quality Assurance and Compliance 16597 North 92nd Street, Suite 101 Scottsdale, Arizona 85260
DEC 1 5 2011
Re: K112876
Trade/Device Name: Cufflink™ Knotless Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI. HWC Dated: October 18, 2011 Received: October 31, 2011
Dear Ms. Shahriari:
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. Ilsting 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) (2 i CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Kereshmeh Shahriari
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/CDRHQffices/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/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/ResourcesforYou/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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510(k) Premarket Notification
CuffLink™ Knotless Anchor
Indications for Use
510(k) Number (if known): K112876
Device Name: CuffLink™ Knotless Anchor
Indications for Use:
The Cayenne Medical, Inc. CuffLink Knotless Anchors are intended for use for the reattachment of soft tissue to bone for shoulder procedures such as Rotator Cuff Repairs.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
March Links and Children Marcel Comments of the Children Comments on the Children and Childred Children and Children Children Children Children Childer Children Childer Child
Concurrence of CDRH, Office of Device Evaluation (ODE)
BBlake for MKM
vision Sign-Off Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number
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§ 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.