MULTITAK SUTURE SNAP SYSTEM

K013177 · Bonutti Research, Inc. · GAM · Dec 19, 2001 · General, Plastic Surgery

Device Facts

• Record ID: K013177
• Device Name: MULTITAK SUTURE SNAP SYSTEM
• Applicant: Bonutti Research, Inc.
• Product Code: GAM · General, Plastic Surgery
• Decision Date: Dec 19, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4493
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the Multitak Suture Snap System is in general soft tissue approximation and/or ligation. The system is indicated in securing soft tissue in arthroscopic and open surgical procedures where USP Size No. 2-0 through Size 2 nonabsorbable suture is used.

Device Story

Multitak Suture Snap System secures soft tissue in arthroscopic and open surgical procedures; replaces manual surgical knots. System comprises ultrasonic generator, handpiece, and resorbable poly-L-lactic acid (PLA) crimp. Operator triggers ultrasonic energy via handpiece to weld crimp onto suture at wound site. Crimp degrades into lactic acid, excreted as CO2 and water. Used by surgeons in clinical settings. Output is secured suture; provides mechanical strength equivalent to traditional knots. Benefits include simplified knotless fixation.

Clinical Evidence

Bench testing only. Comparison of mechanical strength between knotted nonabsorbable braided polyester suture and suture secured with Multitak Suture Snap 2 Resorbable Crimp. In vitro degradation study performed. Results demonstrated no statistical difference in strength between crimp-secured and knotted suture.

Technological Characteristics

Resorbable poly-L-lactic acid (PLA) crimp; ultrasonic energy source; generator and handpiece assembly. Dimensions/form factor not specified. Standalone system. Sterilization method not specified.

Indications for Use

Indicated for general soft tissue approximation and ligation in arthroscopic and open surgical procedures using USP Size No. 2-0 through Size 2 nonabsorbable suture.

Regulatory Classification

Identification

An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached.

Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.

Predicate Devices

• Axya Medical, Inc., Suture Welding System and Kit
• Innovasive Devices, Inc., Y-Knot Suture Clip

Reference Devices

• Mitek BTB Absorbable (PLA) Cross Pin
• Genzyme Surgical Products, Inc., nonabsorbable suture

Submission Summary (Full Text)

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K013177

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DEC 1 9 2001

## Bonutti Research, Inc. Multitak Suture Snap System 510(k) Premarket Notification

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

The following information is submitted in accordance with the requirements of 21 CFR 807.92:

Patrick Balsmann, MS, RAC, Contact Person: Director, Regulatory/Clinical Affairs & QA Bonutti Research, Inc., P.O. Box 1367, Effingham, Illinois 62401 Phone: [phone], ext. 321

Date Prepared: September 21, 2001

Proprietary Name: Multitak Suture Snap System

Common Name: Resorbable Crimp

Classification Name: Fastener, Fixation, Biodegradable, Soft Tissue.

Device Description: The Multitak Suture Snap System is designed for approximating and securing soft tissue in arthroscopic and open surgical procedures. The resorbable poly-L securing our assue in tasonically welded to secure suture at the wound repair site and takes the place of tying arthroscopic and open surgical repair knots. The system consists of a generator that provides ultrasonic energy to a handpiece. The energy applied to the handpiece is used to ultrasonically weld a resorbable crimp and secure suture during general tissue wound repair. The resorbable poly-L-lactic acid crimp is gradually degraded into lactic acid and excreted as carbon dioxide and water.

Intended Use: The intended use of the Multitak Suture Snap System is in general soft tissue approximation and/or ligation. The system is indicated in securing soft tissue in arthroscopic and open surgical procedures where USP Size No. 2-0 through Size 2 nonabsorbable suture is used.

316

2600 S. Raney St. Effingham, II 62401 Phone: [phone] [phone] (USA only)

Facsimile: (217) 347-338 www.BonuttiResearch.com

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Predicate Device(s): The Multitak Suture Snap System is similar in intended use and principle of operation to Axya Medical, Inc., Suture Welding System and Kit. Both systems principle of operation to secure suture without tying a knot. The Multitak Suture Snap aso annousonio oneigy to becare salare to Innovasive Devices, Inc., Y-Knot Suture Clip. Both Systems use a two-piece crimp component to secure suture without tying a knot. The Systems as a the proov system resorbable crimp is similar to currently marketed poly-L-lactic acid devices including the Mitek BTB Absorbable (PLA) Cross Pin.

Predicate Comparison: Performance testing comparing the mechanical strengths of knotted nonalsorbable braided polyester suture to the same type of suture secured with the Multitak Suture Snap 2 Resorbable Crimp was conducted to demonstrate substantial equivalence. Genzyme Surgical Products, Inc., nonabsorbable suture was used as the predicate comparison device. Results of bench testing and an in vitro degradation study demonstrated no statistical difference in suture secured with the resorbable crimp and knotted suture. The results demonstrate that the Multitak Suture Snap Resorbable Crimp provides an alternative means to tying surgical knots with nonabsorbable suture.

Submitted by:

Richard Baldwin

Patrick Balsmann Director, Regulatory/Clinical Affairs & QA

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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" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus, with three diagonal lines curving into a wavy base.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 9 2001

Patrick G. Balsmann Director, Regulatory/Clinical Affairs and QA Bonutti Research, Inc. P.O. Box 1367 Effingham, Illinois 62401

Re: K013177

Trade Name: Multitak Suture Snap System Regulation Number: 878.4493; 888.3040 Regulation Name: Absorbable PGL Suture; Bone Anchor Regulatory Class: II Product Code: GAM; MAI Dated: September 21, 2001 Received: September 24, 2001

Dear Mr. Balsmann:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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## Page 2 - Mr. Patrick Balsmann

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter with anow you to begin maing of substantial equivalence of your device to a legally prematicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and IT you desire specific acrise for for in vitro diagnostic devices), please contact the Office of additionally 21 CF 1 F ar 857. Additionally, for questions on the promotion and advertising of Comphance at [phone] office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). I guiation chittived, "Miooranang on responsibilities under the Act may be obtained from the Oincr general information currers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Neil R.P. Ogden fr
Celia M. Witten, Ph.D., M.D. CMW

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): K013177

Multitak Suture y stem Device Name: Sna

Indications for Use: The intended use of the Multitak Suture Snap System is in general soft tissue approximation and/or ligation. The system is indicated in securing soft tissue in arthroscopic and open surgical procedures where USP Size No. 2-0 through Size 2 nonabsorbable suture is used.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

NRO for cmw

(Division Sign-Of Division of General, Restorative and Neurological Devices

510(k) Number K013177

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)