(76 days)
Not Found
No
The device description and performance studies focus on mechanical properties and surgical technique, with no mention of AI or ML.
No.
The device is described as a "suture anchor device" intended for "reattachment of soft tissue to bone," which falls under the category of surgical implants or fixation devices, not therapeutic devices that directly treat a disease or condition.
No
Explanation: The device description clearly states that the CuffLink Knotless Anchor is intended for "reattachment of soft tissue to bone for shoulder procedures such as Rotator Cuff Repairs." This indicates a surgical or restorative function, not a diagnostic one. There is no mention of the device being used to identify, detect, or monitor a medical condition.
No
The device description clearly describes a physical suture anchor and inserter, which are hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "reattachment of soft tissue to bone for shoulder procedures such as Rotator Cuff Repairs." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "suture anchor device for reattachment of soft tissue to bone." This is a physical implant used during surgery.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
This device is clearly a surgical implant used in vivo (within the living body), not a device used to test samples in vitro (in a lab setting).
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MBI, HWC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 101
Scottsdale, AZ 85260
Telephone (480) 502-3661
FAX (480) 502-3670 |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Kereshmeh Shahriari
16597 N. 92nd St., Suite 101
Scottsdale, AZ 85260
kshahriari@cayennemedical.com
Telephone (480) 502-3661
FAX (480) 502-3670 |
| 510(k) Summary Preparation
Date | 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
4
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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