The CinchLock Knotless Suture Anchor and the NanoTack Suture Anchor 1.4mm are intended for the fixation of soft tissue to bone in the hip, shoulder, foot/ankle, hand/wrist, elbow, and knee. Please see individual indications for use statements.

The NanoTack® Suture Anchor, previously cleared under 510(k) K110473 and K130351, is intended for fixation of soft tissue to bone in the hip, shoulder, foot/ankle, hand/wrist, elbow, and knee, in the following procedures: Hip capsule repair, Acetabular labrum reattachment, Capsular stabilization (Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstructions), Acromilavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs, Biceps tenodesis, Hallux valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repairs/reconstructions, Bunionectomy, Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair, Extra-capsular repairs (Medial collateral ligament, Lateral collateral ligament, Posterior oblique ligament), Patellar realignment and tendon repairs (Vastus medialis obliquous advancement), Iliotibial band tenodesis.

The CinchLock™ Knotless Anchor, previously cleared under 510(k) K123651, is intended for fixation of soft tissue to bone in the hip, shoulder, foot/ankle, hand/wrist, elbow, and knee, in the following procedures: Hip capsule repair, Acetabular labrum reattachment, Capsular stabilization, Bankart repair, Anterior shoulder Instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstructions, Acromilavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs, Biceps tenodesis, Hallux valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repairs/reconstructions, Bunionectomy, Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair, Extra-capsular repairs, Medial collateral ligament, Lateral collateral ligament, Posterior oblique ligament, Patellar realignment and tendon repairs, Vastus medialis obliquous advancement, Iliotibial band tenodesis.

Device Description

The Pivot Suture Anchors which are part of this expanded indications submission are as follows: Pivot CinchLock Knotless Suture Anchor, Pivot NanoTack Suture Anchor 1.4mm. These anchors are non-degradable suture anchors manufactured from PEEK-OPTIMA® LT1 polymer. The CinchLock and NanoTack Anchors are attached to / pre-assembled to a stainless steel Inserter. Non-degradable ultra-high molecular weight polyethylene (UHMWPE) blue co-braid #1 suture is provided in the sterile package with the CinchLock Knotless Suture Anchor and Inserter. The Pivot NanoTack Suture Anchor incorporates a non-degradable ultra high molecular weight polyethylene (UHMWPE) blue co-braid #1 suture. The CinchLock Knotless Suture Anchor and NanoTack Suture Anchor 1.4mm devices are provided as a single use sterile devices.

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information required to describe the acceptance criteria and the study proving the device meets those criteria, as it focuses on a medical device clearance (510(k) for suture anchors) rather than an AI/ML device.

Specifically, the document discusses:

Device Names: CinchLock Knotless Suture Anchor, NanoTack Suture Anchor 1.4mm
Classification: Bone Anchor, Class II, Product Code MBI
Predicate Device: Smith and Nephew BioRaptor 2.3PK Suture Anchor - K071586
Device Description: Non-degradable suture anchors made from PEEK-OPTIMA® LT1 polymer, pre-assembled to a stainless steel Inserter, with UHMWPE suture.
Intended Use: Fixation of soft tissue to bone in various anatomical regions (hip, shoulder, foot/ankle, hand/wrist, elbow, and knee) for specified procedures.
Technological Characteristics: Identical to previous submissions; the current submission is for expanded indications.
Performance Testing: Mentions "insertion strength, anchor strength, suture strength, and biocompatibility testing" demonstrating substantial equivalence to the predicate device.
Substantial Equivalence: Claimed based on indications for use, technological characteristics, and comparison to the predicate device.
FDA Clearance: A letter from the FDA confirming substantial equivalence and providing clearance.
Expanded Indications for Use: Detailed lists of procedures for the NanoTack and CinchLock anchors across various joints.

This information pertains to a traditional medical device (suture anchors) and its mechanical and biological performance, not an AI/ML diagnostic or prognostic device. Therefore, the questions regarding acceptance criteria in terms of performance metrics like sensitivity, specificity, AUC, sample sizes for test/training sets, ground truth establishment, expert consensus, MRMC studies, or standalone algorithm performance are not applicable to this document.

Summary

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Premarket Notification - Traditional 510(k)

Section 5. 510(k) Summary

510(k) Owner

Pivot Medical Inc. 247 Humboldt Court Sunnyvale CA 94089 Phone: 408-774-1452 Fax: 408-739-4199 Jon Cook Director Regulatory Affairs and Quality Assurance

FDA Contact

Jon Cook Director Regulatory Affairs and Quality Assurance Pivot Medical 247 Humboldt Court Sunnyvale CA 94089 Telephone: (408) 774-1452 Facsimile: (408) 739-4199 Email: icook@pivotmedical.com

OCT 07 2013

Date Summary Prepared: June 12, 2013

Device Names

Trade Names:	CinchLock Knotless Suture Anchor
	NanoTack Suture Anchor 1.4mm
Common Name:	Bone Anchor
Classification Name:	Smooth or threaded metallic bone fixation fastener
Regulation number:	21 CFR 888.3040
Product Code:	MBI

Predicate Devices

Smith and Nephew BioRaptor 2.3PK Suture Anchor - K071586

Device Description

The Pivot Suture Anchors which are part of this expanded indications submission are as follows:

Pivot CinchLock Knotless Suture Anchor Pivot NanoTack Suture Anchor 1.4mm

These anchors are non-degradable suture anchors manufactured from PEEK-OPTIMA® LT1 polymer. The CinchLock and NanoTack Anchors are attached to / pre-assembled to a stainless steel Inserter. Non-degradable ultra-high molecular weight polyethylene (UHMWPE) blue co-braid #1 suture is provided in the sterile package with the CinchLock Knotless Suture Anchor and Inserter. The Pivot NanoTack Suture Anchor incorporates

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Image /page/1/Picture/2 description: The image shows the logo for Pivot Medical. The logo consists of the word "pivot" in bold, sans-serif font, with a stylized sphere replacing the "o". Below the word "pivot" is the word "MEDICAL" in a smaller, sans-serif font. The sphere in the logo appears to be made up of several layers or segments.

a non-degradable ultra high molecular weight polyethylene (UHMWPE) blue co-braid #1 suture. The CinchLock Knotless Suture Anchor and NanoTack Suture Anchor 1.4mm devices are provided as a single use sterile devices.

Intended Use

Summary of Technological Characteristics

The technological characteristics of the Pivot anchors included in this submission remain identical to those initially submitted in the prior Pivot 510(k) submissions. The main difference between the original submissions and this 510(k) submission is the addition of indications for use. The predicate device with the expanded indications is the Smith & Nephew BioRaptor 2.3PK Suture Anchor - K071586.

Summary of Performance Testing

The performance testing conducted demonstrates that the insertion and fixation properties of the CinchLock Knotless Suture Anchor and the NanoTack Suture Anchor 1.4mm are substantially equivalent to the predicate device.

Pre-clinical testing includes insertion strength, anchor strength, suture strength, and biocompatibility testing.

Summary of Substantial Equivalence

Based upon the indications for use, technological characteristics, and comparison to the predicate device, the CinchLock Knotless Suture Anchor and NanoTack Suture Anchor 1.4mm are substantially equivalent to the predicate device, including the expanded indications for use.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and 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 symbol featuring three abstract shapes that resemble human figures or waves, stacked on top of each other.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

October 7, 2013

Pivot Medical, Incorporated Mr. Jon Cook Director, Regulatory Affairs and Quality Assurance 247 Humboldt Court Sunnyvale, California 94089

Re: K131769

Trade/Device Name: CinchLock" Knotless Anchor NanoTack® Suture Anchor 1.4mm Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: July 8, 2013 Received: July 9, 2013

Dear Mr. Cook:

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, listing 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

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Page 2 - Mr. Jon Cook

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resources/orYou/Industry/default.htm. 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.

Erin Keith

for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 4. Indications for Use

510(k) Number (if known): K131769

Device Name: NanoTack® Suture Anchor 1.4mm

Indications for Use:

Hip	Foot and Ankle
Hip capsule repair	Hallux valgus repairs
Acetabular labrum reattachment	Medial or lateral instability repairs/reconstructions
	Achilles tendon repairs/reconstructions
Shoulder	Midfoot reconstructions
Capsular stabilization	Metatarsal ligament/tendonrepairs/reconstructions
- Bankart repair	Bunionectomy
- Anterior shoulder instability
- SLAP lesion repairs
- Capsular shift or capsulolabral reconstructions	Elbow, Wrist, and Hand
Acromilavicular separation repairs	Biceps tendon reattachment
Deltoid repairs	Ulnar or radial collateral ligament reconstructions
Rotator cuff tear repairs	Lateral epicondylitis repair
Biceps tenodesis
	Knee
	Extra-capsular repairs
	- Medial collateral ligament
	- Lateral collateral ligament
	- Posterior oblique ligament
	Patellar realignment and tendon repairs
	- Vastus medialis obliquous advancement
	Iliotibial band tenodesis

Prescription Use __ X (Part 21 CFR 801 Subpart D)

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)

Elizabeth L. Frank -S

Division of Orthopedic Devices

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Indications for Use (continued): Section 4.

510(k) Number (if known): K i 31769

CinchLock™ Knotless Anchor Device Name:

Indications for Use:

Hip

Hip capsule repair Acetabular labrum reattachment

Shoulder

Capsular stabilization
Bankart repair
Anterior shoulder Instability
SLAP lesion repairs
Capsular shift or capsulolabral reconstructions Acromilavicular separation repairs

Deltoid repairs Rotator cuff tear repairs Biceps tenodesis

Foot and Ankle

Hallux valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Bunionectomy

Elbow, Wrist, and Hand

Biceps tendon reattachment Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair

Kuea

Extra-capsular repairs
Medial collateral ligament
Lateral collateral ligament
· Posterior oblique ligament

Patellar realignment and tendon repairs - Vastus medialis obliquous advancement Iliotibial band tenodesis

Prescription Use X ....... (Part 21 CFR 801 Subpart D)

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)

Elizabeth L. Frank -S

Division of Orthopedic Devices

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.