(112 days)
Not Found
No
The device description and summary of performance studies focus on the mechanical properties and function of a suture anchor, with no mention of AI or ML capabilities.
Yes
The device is described as being used for "reattachment of soft tissue to bone for Rotator Cuff Repairs," which is a therapeutic intervention aimed at treating an injury or condition.
No
The device is a suture anchor used for reattachment of soft tissue to bone, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines a physical suture anchor and driver, which are hardware components.
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 Rotator Cuff Repairs." This is a surgical procedure performed in vivo (within the living body).
- Device Description: The device is a "suture anchor device for reattachment of soft tissue to bone." It's a physical implant used to secure tissue during surgery.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
The device is a surgical implant used directly on the patient's body during a procedure, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
The Cayenne Medical, Inc. CuffLink™ Suture Anchors are intended for use for the reattachment of soft tissue to bone for Rotator Cuff Repairs.
Product codes (comma separated list FDA assigned to the subject device)
MBI, HWC
Device Description
The CuffLink™ Suture 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. There are two sutures loaded through the center of the anchor around, an eyelet at the distal tip of the anchor and back through the center. The suture anchor is mounted on a driver. The CuffLink Suture 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 CuffLink Suture Anchor is offered in two different sizes with four suture color options. The anchor sizes are 5.5 x 16 mm and 6.5 x 16 mm. Sutures used in the anchor are size # 2 nonabsorbable surgical sutures. The CuffLink driver has a working length of 14 cm with an outer shaft diameter of 3 mm.
Mechanical testing was performed on the CuffLink Suture Anchor and a predicate device. Testing showed ultimate pull-out strength was equivalent to the predicate device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone (for reattachment of soft tissue to bone, specifically for Rotator Cuff Repairs)
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 Suture Anchor and a predicate device. Testing showed ultimate pull-out strength was equivalent to the 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.
K061863, K040472, K070673, K100506, K092533
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
Cayenne Medical, Inc. CuffLink™ Suture Anchor
| K112814 |
|---|
| --------- |
ADMINISTRATIVE INFORMATION
Manufacturer Name:
510(k) Number:
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
January 17, 2012
DEVICE NAME
| Classification Names: | Smooth or threaded metallic bone fixation fastener |
|---|---|
| Trade/Proprietary Name: | CuffLink™ Suture Anchor |
Common Name: Suture Anchor
DEVICE CLASSIFICATION
FDA has classified bone screws as Class II devices (21 CFR 888.3040). The product codes for screw, fixation, bone are MBI and HWC. These devices are reviewed by the Orthopedic Joint Devices Branch.
INTENDED USE
The Cayenne Medical, Inc. CuffLink™ Suture Anchors are intended for use for the reattachment of soft tissue to bone for Rotator Cuff Repairs.
Revised Page 17 of 156
l, l
Page 1 of 2
1
K.II 2814
DEVICE DESCRIPTION
The CuffLink™ Suture 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. There are two sutures loaded through the center of the anchor around, an eyelet at the distal tip of the anchor and back through the center. The suture anchor is mounted on a driver. The CuffLink Suture 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 CuffLink Suture Anchor is offered in two different sizes with four suture color options. The anchor sizes are 5.5 x 16 mm and 6.5 x 16 mm. Sutures used in the anchor are size # 2 nonabsorbable surgical sutures. The CuffLink driver has a working length of 14 cm with an outer shaft diameter of 3 mm.
Mechanical testing was performed on the CuffLink Suture Anchor and a predicate device. Testing showed ultimate pull-out strength was equivalent to the predicate device.
EQUIVALENCE TO MARKETED PRODUCT
Cayenne Medical, Inc. demonstrated that, for the purposes of FDA's regulation of medical devices, the CuffLink™ Suture Anchor is substantially equivalent in indication and design principles to predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices: Arthrex Corkscrew™ Suture Anchors (K061863), Force Fiber Blue Co-Braid Polyethylene non-absorbable surgical suture (K040472), Force Fiber Black Co-Braid Polyethylene non-absorbable surgical suture (K070673), Force Fiber Green Co-Braid Polyethylene non-absorbable surgical suture (K100506), and Force Fiber Blue Polyethylene nonabsorbable surgical suture (K092533).
Revised Page 18 of 156
Page 2 of 2
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN 1 7 2012
Cavenne Medical, Inc. % Ms. Kereshmeh Shahriari 16597 N.92nd St. Suite 101 Scottsdale, AZ 85260 US
Re: K112814
Trade/Device Name: Cufflink Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI, HWC Dated: December 15, 2011 Received: December 16, 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 10 more 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 rou may, alerely morely miss 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 additeration. Thease now , 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 Of ICP at 007); acomig (21 CFR 803); good manufacturing practice requirements as set
3
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/CDRHOffices/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
ely yours,
for
N. Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic & Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
K112814 510(k) Number (if known): _
Device Name: CuffLink™ Suture Anchor
Indications for Use:
The Cayenne Medical, Inc. CuffLink™ Suture Anchors are intended for use for the reattachment of soft tissue to bone for 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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
K
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number
Page 1 of 1
Revised Page 15 of 156
Cayenne Medical, Inc.