COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE

K082535 · Surgical Devices, A Global Business Unit Covidien · GAT · Dec 1, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K082535
• Device Name: COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE
• Applicant: Surgical Devices, A Global Business Unit Covidien
• Product Code: GAT · General, Plastic Surgery
• Decision Date: Dec 1, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5000
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Sterile, single-use meniscal repair device; consists of suture-passing needle mechanism pre-loaded with Size 2/0 nonabsorbable polyethylene terephthalate surgical suture (TiCron) and pre-tied knot. Used by surgeons in clinical settings to approximate soft tissue during meniscal tear repair. Device delivers pre-tied knot to secure tissue; facilitates surgical repair; benefits patient through effective tissue approximation.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Materials comply with ISO 10993-1. Device is a manual surgical instrument; non-powered; single-use. Components include needle mechanism and nonabsorbable polyethylene terephthalate suture.

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

• TiCron surgical suture (K830591)
• Smith & Nephew Ultra Fast-Fix Meniscal Repair System (K072322)
• Stryker Mini-Mender Meniscal Repair System (K032901)

Submission Summary (Full Text)

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K082535
pg192

### 510(k) Summary of Safety and Effectiveness

SUBMITTER:

Surgical Devices, a global business unit of Tyco Healthcare Group LP (d/b/a Covidien) 60 Middletown Avenue North Haven, CT 06473 Tel. No .: [phone]

DEC 0 1 2008

CONTACT PERSON:

Tim M. Lohnes Manager, Regulatory Affairs

DATE PREPARED:

August 27, 2008

Covidien Sport Surgery AS Meniscal Repair Device TRADE/PROPRIETARY NAME:

PREDICATE DEVICE(S):

Classification Name:

Device Classification: Common and Usual Name: Proprietary Name: 510(k) Submitter/Holder:

510(k):

Classification Name:

Device Classification: Common and Usual Name: Proprietary Name:

510(k) Submitter/Holder: 510(k) no .:

Classification Name:

Device Classification:

Common and Usual Name:

Proprietary Name: 510/k) Submitter/Holder: 510(k) no .:

DEVICE DESCRIPTION:

Nonabsorbable poly(ethylene terephthalate) surgical suture CFR 878.5000 (GAT) Class II Polyester Nonabsorbable Surgical Sutures (GAT) TiCron™ surgical suture Surgical Devices, a global business unit of Tyco Healthcare Group LP (d/b/a Covidien) K830591

Suture Retention Device/Synthetic Nonabsorbable Polvethylene Suture 21 CFR 878.5000 (GAT) Class II Meniscal Repair Device Smith & Nephew Ultra Fast-Fix Meniscal Repair System Smith & Nephew, Inc. Endoscopy Div. K072322

Nonabsorbable poly(ethylene terephthalate) surgical suture CFR 878.5000 (GAT) Class II, 21 CFR 888.4540 (LXH) Class I Polyester Nonabsorbable Surgical Sutures, Orthopedic manual surgical instrument Stryker Mini-Mender Meniscal Repair System Stryker Endoscopv K032901

The Covidien Sports Surgery AS Meniscal Repair Device is a sterile single use device for the approximation of soft tissue such as for the repair of meniscal tears. The disposable single Device is comprised of a suture-passing use needle mechanism which is pre-loaded with a strand of Size 2/0 nonabsorbable polyethylene terephthalate surgical suture (TiCron™) which includes a pre-tied knot.

Surgical Devices, a global business unit of Tyco Healthcare Group LP (d/b/a Covidien) Premarket Notification

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K082535
pg 202

#### INTENDED USE

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

is substantially equivalent to the predicate devices with regard to passing suture in order to deliver a pre-tied knot for the

The Covidien Sports Surgery AS Meniscal Repair Device

repair of meniscal tear injuries.

TECHNOLOGICAL CHARACTERISTICS

MATERIALS:

PERFORMANCE DATA:

Repair Device are comprised of materials which are in accordance with ISO Standard 10993-1.

All components of the Covidien Sports Surgery AS Meniscal

Performance testing was conducted to verify that the Meniscal Repair Device is safe and effective and performs as intended.

Surgical Devices, a global business unit of Tyco Healthcare Group LP (d/b/a Covidien) Premarket Notification

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged around the upper portion of the circle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Surgical Devices % Mr. Tim M. Lohnes Manager, Regulatory Affairs 60 Middleton Avenue North Haven. Connecticuit 06473

## DEC 0 1 2008

Re: K082535

Trade/Device Name: Covidien Sports Surgery AS Meniscal Repair Device Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: II Product Code: GAT Dated: August 27, 2008 Received: September 2, 2008

Dear Mr. Lohnes:

We have reviewed vour Section 510(k) premarket notification of intent to market the device i 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.

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. Tim M. Lohnes

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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), 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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.

Mark N. Millican

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

Enclosure

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K082535
pg 191

# Indications For Use

510(k) Number (if known):

Device Name: Covidien Sports Surgery AS Meniscal Repair Device

Indications For Use:

"The Covidien Sports Surgery AS Meniscal Repair Device is Intended for use for approximation of soft tissue such as the repair of meniscal tear injuries"

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)

Nitke? Qal for mem

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

K082535 510(k) Number

Surgical Devices, a global business unit of Tyco Healthcare Group LP (d/b/a Covidien) Premarket Notification

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