The Cayenne Medical, Inc. Quattro™ Link Knotless Anchors are intended for use for the reattachment of soft tissue to bone for the following indications:

Shoulder

Capsular stabilization
o Bankart repair
o Anterior shoulder instability
o SLAP lesion repairs
o Capsular shift or capsulolabral reconstructions
Acromioclavicular separation repairs t
Deltoid repairs
-Rotator cuff repairs
Bicep tenodesis |

Elbow, Wrist, and Hand

ו Biceps tendon reattachment
Ulnar or radial collateral ligament reconstruction |
-Lateral epicondylitis repair

Knee

Extra-capsular repairs ।
o Medial collateral ligament
o Lateral collateral ligament
o Posterior oblique ligament
। Patellar realignment and tendon repairs
o Vastus medials obliquous advancement
Illiotibial band tenodesis ।

Foot and Ankle

Hallux valgus repairs ।
-Medial or Lateral instability repairs/reconstructions
Achilles tendon repairs/reconstructions -।
Midfoot reconstructions l
Metatarsal ligament/tendon repairs/reconstructions 1
l Bunionectomy

Device Description

The Quattro™ Link Knotless Anchor is a sterile, manually operated, single procedure suture anchor device for reattachment of soft tissue to bone in shoulder, elbow, wrist, hand, knee, foot, and ankle procedures. The anchor is mounted on an inserter. The Quattro Link Knotless Anchor incorporates design features that facilitate suture anchor placement under arthroscopic or open, limited access conditions in soft tissue to bone reattachment procedures. 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 only). The all PEEK anchor is offered in three different sizes, 2.9mm, 4.5mm. The PEEK and titanium alloy tip anchor is offered in one size, 4.5mm.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Quattro™ Link Knotless Anchor, based on the provided document:

The document states that a non-clinical study for the device was performed but does not explicitly provide information such as acceptance criteria beyond establishing that the "maximum suture slip force (ultimate pull-out strength) is significantly higher than that of the predicate devices." It also states that "product dimensional analysis met the components and product specifications."

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implied)	Reported Device Performance
Mechanical Performance	Ultimate Pull-Out Strength (Suture Slip Force): Must be significantly higher than predicate devices.	"maximum suture slip force (ultimate pull-out strength) is significantly higher than that of the predicate devices."
Dimensional Analysis	Product Dimensions: Must meet specified components and overall product specifications.	"Product dimensional analysis met the components and product specifications."
Substantial Equivalence	Indications and Design Principles: Must be substantially equivalent to predicate devices.	"demonstrated that...the Quattro Link Knotless Anchor is substantially equivalent in indications and design principles to predicate devices."
Safety and Efficacy	Technological Characteristics: Any differences from predicate devices must not raise new issues of safety or efficacy.	"Any differences in the technological characteristics between the subject and predicate devices do not raise new issues of safety or efficacy."

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample size used for the mechanical testing or dimensional analysis test sets. It only mentions that "Mechanical testing was performed" and "Dimensional analysis was performed."

The data provenance is not explicitly stated in terms of country of origin. The study is a non-clinical study, specifically mechanical testing, and therefore doesn't involve human subject data (retrospective or prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This question is not applicable as the study described is a non-clinical, mechanical testing study. "Ground truth" in the context of expert consensus is typically relevant for studies involving image interpretation, diagnosis, or clinical outcomes, not for the physical properties of a medical device.

4. Adjudication Method for the Test Set

This question is not applicable as the study described is a non-clinical, mechanical testing study. Adjudication methods (like 2+1 or 3+1) are used for resolving disagreements among human experts, which is not relevant here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The described study is a non-clinical mechanical performance test, not a clinical study involving human readers or cases.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone study (in the context of an algorithm or AI) was not done. This device is a physical surgical anchor, not a software algorithm.

7. The Type of Ground Truth Used

For the mechanical testing, the "ground truth" would be the measured physical properties of the device (ultimate pull-out strength, dimensions) obtained through standardized engineering tests, not a clinical "ground truth" like pathology or expert consensus.

8. The Sample Size for the Training Set

This question is not applicable as the described study is a non-clinical, mechanical testing study of a physical device. There is no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the same reasons as #8.

Summary

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510(k) Summary

Quattro™ Link Knotless Anchor

510(k) Summary

OCT 31 2012

Cayenne Medical, Inc. Quattro™ Link Knotless Anchor

ADMINISTRATIVE INFORMATION

510(k) Number

K122314

Manufacturer Name:

Cayenne Medical, Inc. 16597 N. 92nd St., Suite 101 Scottsdale, AZ 85260 Telephone (480) 502-3661 FAX (888) 334-4079

16597 N. 92nd St., Suite 101 Scottsdale, AZ 85260

Telephone (480) 502-3661 FAX (888) 334-4079

kshahriari@cayennemedical.com

Kereshmeh Shahriari

Official Contact:

510(k) Summary Preparation Date

July 31, 2012

DEVICE NAME

Product Code

MBI

Classification Names:

Trade/Proprietary Name:

Quattro™ Link Knotless Anchor

Fastener, Fixation, Nondegradable, Soft Tissue

Suture Anchor Common Name:

DEVICE CLASSIFICATION

FDA has classified bone screws as Class II devices (21 CFR 888.3040). The product code is MBI, Fastener, Fixation, Nondegradable, Soft Tissue. These devices are reviewed by the Orthopedic Joint Devices Branch.

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510(k) Summary

INTENDED USE

The Cayenne Medical, Inc. Quattro Link Knotless Anchors are intended for use for the reattachment of soft tissue to bone for the following indications:

Shoulder

Capsular stabilization
- o Bankart repair
- o Anterior shoulder instability
- o SLAP lesion repairs
- o Capsular shift or capsulolabral reconstructions
Acromioclavicular separation repairs t
Deltoid repairs
-Rotator cuff repairs
Bicep tenodesis |

Elbow, Wrist, and Hand

ו Biceps tendon reattachment
Ulnar or radial collateral ligament reconstruction |
-Lateral epicondylitis repair

Knee

Extra-capsular repairs ।
- o Medial collateral ligament
- o Lateral collateral ligament
- o Posterior oblique ligament
। Patellar realignment and tendon repairs
- o Vastus medials obliquous advancement
Illiotibial band tenodesis ।

Foot and Ankle

Hallux valgus repairs ।
-Medial or Lateral instability repairs/reconstructions
Achilles tendon repairs/reconstructions -।
Midfoot reconstructions l
Metatarsal ligament/tendon repairs/reconstructions 1
l Bunionectomy

DEVICE DESCRIPTION

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K122314 (pg. 3 of 3)

510(k) Summary

Anchor incorporates design features that facilitate suture anchor placement under arthroscopic or open, limited access conditions in soft tissue to bone reattachment procedures. 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 only). The all PEEK anchor is offered in three different sizes, 2.9mm, 4.5mm. The PEEK and titanium alloy tip anchor is offered in one size, 4.5mm.

NON-CLINICAL TESTING

Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included. Mechanical testing was performed on the Quattro Link Knotless Anchor and Inserter. It was shown that maximum suture slip force (ultimate pull-out strength) is significantly higher than that of the predicate devices. Dimensional analysis was performed on the Quattro Link Knotless Anchor and Inserter. Product dimensional analysis met the components and product specifications.

EQUIVALENCE TO MARKETED PRODUCT

Cavenne Medical, Inc. demonstrated that, for the purposes of FDA's regulation of medical devices, the Quattro Link 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: Cayenne Medical Quattro Link (CuffLink ) Knotless Anchor (K112876), Smith & Nephew FOOTPRINT Ultra PK Suture Anchor (K093897) and Smith & Nephew Bioraptor Suture Anchor (K093428). The data included in this submission demonstrates substantial equivalence to the predicate devices listed above.

The subject device Quattro Link Knotless Anchor with Inserter has the same intended use, materials, manufacturing processes, packaging, sterilization method, and shelf life as the Cayenne Medical Quattro Link (CuffLink) Knotless Anchor (K112876). The subject device Quattro Link Knotless Anchor with Inserter has identical design and technology to the Cayenne Medical Quattro Link (CuffLink) Knotless Anchor (K112876). Any differences in the technological characteristics between the subject and predicate devices do not raise new issues of safety or efficacy.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The symbol is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Cayenne Medical, Incorporated % Ms. Keresheh Shahriari 16597 N. 92nd Street, Suite 101 Senior Director Regulatory Affairs and Quality Assurance Scottsdale, Arizona 85260

OCT 3 1 2012

Re: K122314

Trade/Device Name: Quattro™ Link Knotless Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: October 16, 2012 Received: October 18, 2012

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 use stared in the Merceans)77, the enactment date of the Medical Device Amendments, or to connineroo pror to tria) 20, 2012, 11:31 in accordance with the provisions of the Federal Food, DNG and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Coometic . Its ( . 10) leat the device, subject to the general controls provisions of the Act. The r ou may, moreleve, mains 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 adunction. Ticasonote. ODAC acce as a second as a secure 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 device to additional controls. Existing major regulations affecting your device can be may 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 teaso be action and a determination that your device complies with other requirements of the Act that I Driver Intacted and regulations administered by other Federal agencies. You must or any 1 occar Lances and 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) (21 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/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,

For Pt Lin
Nu

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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Quattro™ Link Knotless Anchor

Indications for Use

510(k) Number (if known): _K122314

Device Name: Quattro™ Link Knotless Anchor

Indications for Use:

The Cayenne Medical, Inc. Quattro™ Link Knotless Anchors are intended for use for the reattachment of soft tissue to bone for the following indications:

Shoulder

Capsular stabilization
- 0 Bankart repair
- o Anterior shoulder instability
- o SLAP lesion repairs
- o Capsular shift or capsulolabral reconstructions
Acromioclavicular separation repairs
Deltoid repairs -
Rotator cuff repairs -
Bicep tenodesis ﺳﮯ

Elbow, Wrist, and Hand.

Biceps tendon reattachment -
Ulnar or radial collateral ligament reconstruction -
Lateral epicondylitis repair -

Knee

Extra-capsular repairs ।
- 0 Medial collateral ligament
- o Lateral collateral ligament
- Posterior oblique ligament o
Patellar realignment and tendon repairs -
- Vastus medials obliquous advancement o
Illiotibial band tenodesis -

Foot and Ankle

Hallux valgus repairs ।
Medial or Lateral instability repairs/reconstructions -
Achilles tendon repairs/reconstructions

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K122314 (pg. 2 of 2)

510(k) Premarket Notification

Midfoot reconstructions
Metatarsal ligament/tendon repairs/reconstructions . I
Bunionectomy -

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)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K122314

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.