COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE WITH HIGH STRENGTH SUTURE

K091016 · Surgical Devices, A Global Business Unit Covidien · GAT · May 4, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K091016
• Device Name: COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE WITH HIGH STRENGTH SUTURE
• Applicant: Surgical Devices, A Global Business Unit Covidien
• Product Code: GAT · General, Plastic Surgery
• Decision Date: May 4, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.5000
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Covidien Sports Surgery AS Meniscal Repair Device with High Strength Suture is intended to be used to approximate soft tissue such as during the repair of meniscal tear injuries.

Device Story

The Covidien Sports Surgery AS Meniscal Repair Device is a sterile, single-use surgical instrument designed for meniscal tear repair. The device features a suture-passing needle mechanism pre-loaded with Size 2/0 Force Fiber Ultra High Molecular Weight (UHMW) non-absorbable polyethylene suture and a pre-tied knot. The distal end is available in various angular configurations to facilitate access to specific meniscal anatomy. Used by surgeons in an operating room setting, the device enables the delivery of a pre-tied knot to approximate soft tissue. By providing a high-strength suture delivery system, the device assists in the mechanical stabilization of meniscal tears, potentially improving healing outcomes for patients.

Clinical Evidence

Bench testing only. Performance testing was conducted to verify that the device is safe, effective, and performs as intended. Materials were evaluated in accordance with ISO 10993-1.

Technological Characteristics

Single-use, sterile surgical device. Components consist of a suture-passing needle mechanism and Size 2/0 Force Fiber UHMW non-absorbable polyethylene suture. Distal end features various angular configurations. Materials evaluated per ISO 10993-1. Mechanical delivery of pre-tied knot.

Indications for Use

Indicated for the approximation of soft tissue, specifically for the repair of meniscal tear injuries.

Regulatory Classification

Identification

Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed 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

• Covidien Sport Surgery AS Meniscal Repair Device

Submission Summary (Full Text)

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## K091016

:

## 510(k) Summary of Safety and Effectiveness

| SUBMITTER: | Surgical Devices, a global business unit of Tyco Healthcare<br>Group LP (d/b/a Covidien)<br>60 Middletown Avenue<br>North Haven, CT 06473<br>Tel. No.: [phone]<br>MAY - 4 2009 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Tim M. Lohnes, Manager, Regulatory Affairs |
| DATE PREPARED: | April 7, 2009 |
| TRADE/PROPRIETARY NAME: | Covidien Sport Surgery AS Meniscal Repair Device with<br>High Strength Suture |
| PREDICATE DEVICE(S): | Covidien Sport Surgery AS Meniscal Repair Device |
| DEVICE DESCRIPTION: | The Covidien Sports Surgery AS Meniscal Repair Device<br>with High Strength Suture is a sterile single use device for<br>the approximation of soft tissue such as the repair of<br>meniscal tears. The disposable single use Device is<br>comprised of a suture-passing needle mechanism which is<br>pre-loaded with Size 2/0 Force Fiber Ultra High Molecular<br>Weight (UHMW) Non Absorbable Polyethylene suture<br>(K040472), inclusive of a pre-tied knot. The distal end of the<br>device will be offered in various angular configurations to<br>enable access to areas of the meniscal anatomy, and to<br>allow for user preference. |
| INTENDED USE | The Covidien Sports Surgery AS Meniscal Repair Device<br>with High Strength Suture is intended to be used to<br>approximate soft tissue such as during the repair of meniscal<br>tear injuries. |
| TECHNOLOGICAL<br>CHARACTERISTICS | The Covidien Sports Surgery AS Meniscal Repair Device<br>with High Strength Suture is substantially equivalent to the<br>predicate device with regard to passing suture in order to<br>deliver a pre-tied knot for the repair of meniscal tear injuries. |
| MATERIALS: | All components of the Covidien Sports Surgery AS Meniscal<br>Repair Device with High Strength Suture are comprised of<br>materials which are evaluated in accordance with ISO |

- Performance testing was conducted to verify that the Meniscal PERFORMANCE DATA: Repair Device with High Strength Suture is safe and effective and performs as intended.
Standard 10993-1.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The logo is black and white.

MAY - 4 2009

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Covidien % Mr. Tim M. Lohnes Manager, Regulatory Affairs 60 Middletown Avenue North Haven, Connecticut 06473

Re: K091016

Trade/Device Name: Covidien Sports Surgery All Suture (AS) Meniscal Repair Device with High Strength Suture

Regulation Number: 21 CFR 878.5000

Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: II Product Code: GAT Dated: April 8, 2009 Received: April 9, 2009

Dear Mr. Lohnes:

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 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 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.

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Page 2 - Mr. Tim M. Lohnes

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at [phone]. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Neil R. Pogle

Mark N. Melkerson & Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications For Use

14091016 510(k) Number (if known):

Device Name:

## Covidien Sports Surgery All Suture (AS) Meniscal Repair Device with High Strength Suture

Indications For Use:

"The Covidien Sports Surgery AS Meniscal Repair Device with High Strength Suture is intended for use for approximation of soft tissue such as the repair of meniscal tear infuries".

Prescription Use × (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)

David Krane fa mxu

(Division of General, Restor Division on on one and Neurological Devic

**510(k) Number** K091066

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