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.

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.

AI/ML Overview

The provided text is a 510(k) summary for the LabraLink™ Suture Anchor, a medical device. It does not describe acceptance criteria for a study, nor does it present results from a clinical study to prove the device meets such criteria. Instead, it details the device's technical specifications, intended use, and substantial equivalence to previously marketed predicate devices, which is the basis for its FDA clearance.

Therefore, I cannot extract the requested information as it is not present in the provided document. The document focuses on regulatory clearance based on substantial equivalence, primarily through mechanical testing comparisons with predicate devices, rather than a clinical study with detailed acceptance criteria and performance metrics against human expert ground truth.

If you have a different document that describes such a study, please provide it.

Summary

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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 101Scottsdale, AZ 85260Telephone (480) 502-3661FAX (480) 502-3670
Official Contact:	Kereshmeh Shahriari16597 N. 92nd St., Suite 101Scottsdale, AZ 85260kshahriari@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.

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510(k) Summary

LabraLink™ Suture Anchor

DEVICE DESCRIPTION

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.

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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 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

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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

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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

Page 15 of 159

Regulation Number and Section

§ 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.