(96 days)
No
The description focuses on the mechanical aspects of a suture anchor and its inserter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as a "suture anchor device for reattachment of soft tissue to bone for shoulder procedures," which directly addresses and treats a medical condition (soft tissue detachment), thus making it a therapeutic device.
No
The device is a suture anchor intended for the reattachment of soft tissue to bone, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines a physical, manually operated suture anchor and inserter, which are hardware components. The performance studies also focus on mechanical testing of the physical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The LabraLink™ Suture Anchor is a surgical implant used to reattach soft tissue to bone within the body during shoulder procedures. It is a mechanical device, not a diagnostic tool that analyzes biological samples.
The description clearly indicates it's a surgical device for physical repair, not for diagnostic testing of biological specimens.
N/A
Intended Use / Indications for Use
The Cayenne Medical, Inc. LabraLink™ Suture Anchor is intended for the reattachment of soft tissue to bone for shoulder procedures such as Bankart repair and SLAP lesion repair.
Product codes
MBI
Device Description
The LabraLink™ Suture Anchor is a sterile, manually operated, single procedure suture anchor device for reattachment of soft tissue to bone for shoulder procedures such as Bankart repair and SLAP lesion repair. The anchor has two suture eyelets allowing for one or two sutures to be loaded through the eyelets. The suture anchor is mounted on an inserter. The LabraLink Suture Anchor incorporates design features that facilitate suture anchor placement under arthroscopic, open, or limited access conditions in soft tissue to bone for shoulder procedures such as Bankart repair and SLAP lesion repair.
The LabraLink Suture Anchor is offered in one size, 2.9 x 15 mm with four suture color options. The anchors are offered in two configurations, single loaded or double loaded sutures. Suture(s) used on the anchor are size # 2 non-absorbable surgical sutures. The LabraLink inserter has a working length of 25.8 cm with an outer shaft diameter of 3.2 mm.
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 LabraLink Suture Anchor and a predicate device. Testing showed ultimate pull-out strength was significantly higher than the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K040472, K070673, K100506, K092533
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
LabraLink™ Suture Anchor
510(k) Summary
Cayenne Medical, Inc.
LabraLink™ Suture Anchor
Telephone (480) 502-3661 FAX (480) 502-3670
K112960 510(k) Number:
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 |
DEVICE NAME
| Classification Names: | Smooth or threaded metallic bone fixation fastener |
|---|---|
| Trade/Proprietary Name: | LabraLink™ Suture Anchor |
| Common Name: | Suture Anchor |
DEVICE CLASSIFICATION
FDA has classified bone screws as Class II devices (21 CFR 888.3040). The product code for screw, fixation, bone is MBI. These devices are reviewed by the Orthopedic Joint Devices Branch.
INTENDED USE
The Cayenne Medical, Inc. LabraLink™ Suture Anchor is intended for the reattachment of soft tissue to bone for shoulder procedures such as Bankart repair and SLAP lesion repair.
1
510(k) Summary
LabraLink™ Suture Anchor
DEVICE DESCRIPTION
The LabraLink™ Suture Anchor is a sterile, manually operated, single procedure suture anchor device for reattachment of soft tissue to bone for shoulder procedures such as Bankart repair and SLAP lesion repair. The anchor has two suture eyelets allowing for one or two sutures to be loaded through the eyelets. The suture anchor is mounted on an inserter. The LabraLink Suture Anchor incorporates design features that facilitate suture anchor placement under arthroscopic, open, or limited access conditions in soft tissue to bone for shoulder procedures such as Bankart repair and SLAP lesion repair.
The LabraLink Suture Anchor is offered in one size, 2.9 x 15 mm with four suture color options. The anchors are offered in two configurations, single loaded or double loaded sutures. Suture(s) used on the anchor are size # 2 non-absorbable surgical sutures. The LabraLink inserter has a working length of 25.8 cm with an outer shaft diameter of 3.2 mm.
Mechanical testing was performed on the LabraLink Suture Anchor and a predicate device. Testing showed ultimate pull-out strength was significantly higher than the predicate device.
EQUIVALENCE TO MARKETED PRODUCT
Cayenne Medical, Inc. demonstrated that, for the purposes of FDA's regulation of medical devices, the LabraLink™ 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: Smith & Nephew BIORAPTOR 2.3 PK Suture Anchor (K071586), Force Fiber Blue Co-Braid Polvethylene 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 non-absorbable surgical suture (K092533).
Cayenne Medical, Inc.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Cayenne Medical, Inc. % Mr. Kereshmeh Shahriari 16597 N. 92nd Street Suite 101 Scottsdale, AZ 85260
JAN - 9 2012
Re: K112960
Trade/Device Name: LabraLink™ Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: December 26, 2011 Received: December 28, 2011
Dear Mr. Shahriari:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your would the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the 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 I va may, alerty, and of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adviteration. 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 If your dovied to additional controls. Existing major regulations affecting your device can be finay of subject to additions, 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 r teast be deviced that I Dr Dr device complies with other requirements of the Act that I Dri has made a aond regulations administered by other Federal agencies. You must of any I cacial statutes and regaranents, including, but not limited to: registration and listing (21 Comply with an the Prev Prequil Part 801); medical device reporting (reporting of medical CI K Fat 607), laboring (21 CFR 803); good manufacturing practice requirements as set
3
Page - 2 - Mr. Kereshmeh Shahriari
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality bystems (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 IT you desire specific advice to: your co ntersoffices/CDRH/CDRHOffices/ucm115809.htm for go to intp://www.lua.gov/iller.com/ Radiological Health's (CDRH's) Office of Compliance. Also, please the Conter for Devices and Nationshing by reference to premarket notification" (21CFR Part note the regulation onlined, "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 I ou inay of amall Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address (600) 030-2011 01 (30 (30 cm) Medical Devices for You/Industry/default.htm.
Sincerely vours,
Mark N. Melkerson
SOCCA O.A Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Premarket Notification
LabraLink™ Suture Anchor
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: LabraLink™ Suture Anchor
Indications for Use:
The Cayenne Medical, Inc. LabraLink™ Suture Anchor is intended for the reattachment of soft tissue to bone for shoulder procedures such as Bankart repair and SLAP lesion repair.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (Over-The-Counter Use
(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)
Ulyiluk Frat
ivision of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112960
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