ARTHREX OPES ELECTRODES AND ACCESSORIES

K023986 · Arthrex, Inc. · GEI · Dec 17, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K023986
• Device Name: ARTHREX OPES ELECTRODES AND ACCESSORIES
• Applicant: Arthrex, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Dec 17, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Arthrex electrosurgical ablation devices and accessories are intended for use in resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels and tissue in general, arthroscopic, and orthopedic procedures. Specifically, these devices and their accessories will be used for general surgeries, and open and arthroscopic surgery of the shoulder, wrist, hand, elbow, hip, knee, and ankle.

Device Story

Monopolar electrosurgical cutting and coagulation devices; used for soft tissue resection, ablation, and hemostasis. Operated by surgeons in general, arthroscopic, and orthopedic surgical settings. Devices are sterile, single-use electrodes. Function involves delivery of high-frequency electrical energy to target tissue to achieve desired surgical effect. Output allows for precise tissue management during open or arthroscopic procedures. Benefits include controlled tissue removal and bleeding management.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and intended use characteristics.

Technological Characteristics

Monopolar electrosurgical electrodes; sterile, single-use; high-frequency energy source; intended for soft tissue resection, ablation, and coagulation.

Indications for Use

Indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in general, arthroscopic, and orthopedic surgical procedures, including shoulder, wrist, hand, elbow, hip, knee, and ankle surgeries.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Submission Summary (Full Text)

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KO23986

## DEC 1 7 2002

# 510(k) Summary

| 510(k) Number: | |
|----------------|-----------------------------------------|
| Company: | Arthrex, Inc. |
| Address: | 2885 S. Horseshoe Dr., Naples, FL 34104 |
| Telephone: | [phone] |
| Facsimile: | [phone] |
| Contact: | Ann Waterhouse |
| Trade Name: | Arthrex OPES Electrodes and Accessories |

Product Code: GEI

Common Name: High Frequency Devices and Accessories

#### Description:

The Arthrex electrosurgical cutting and coagulation devices and accessories are monopolar in structure, allowing for a range of surgical repairs. The electrodes are sold sterile, single use in a pouch/pouch configuration.

### Indications for Use:

The Arthrex electrosurgical ablation devices and accessories are intended for use in resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels and tissue in general, arthroscopic, and orthopedic procedures. Specifically, these devices and their accessories will be used for general surgeries, and open and arthroscopic surgery of the shoulder, wrist, hand, elbow, hip, knee, and ankle.

### Substantial Equivalence;

By definition, substantial equivalence means that a device has the same intended use and technical characteristics as the predicate device, or has the same intended use and different technological characteristics, but can be demonstrated to be as safe and effective as the predicate device. The difference between the Arthrex product line and the predicate devices with similar indications do not raise any questions regarding the safety and effectiveness. Furthermore, the device and accessories are well characterized and have been used in surgical applications with similar indications. The devices, as designed, are as safe and effective as predicate devices.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

## DEC 1 7 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

TUV Product Service · Mark Job . 1775 Old Highway 8 New Brighton, Minnesota 55112-1891

Re: K023986

Trade/Device Name: Arthrex Opes Electrodes and Accessories Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: November 29, 2002 Received: December 2, 2002

Dear Mr. Job:

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.

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

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Page 2 -- Mr. Mark Job

the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Celia M. Witten, Ph.D., MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### K023986 510(k) Number (if known):

## Device Name: Arthrex OPES Electrodes and Accessories

### Indications for Use:

The Arthrex electrosurgical cutting and coagulation devices and accessories are monopolar in structure, allowing for use in a range of surgical procedures. The Arthrex electrosurgical ablation devices and accessories are intended for use in resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels and tissue in general, arthroscopic, and orthopedic procedures. Specifically, these devices and their accessories will be used for general surgeries, and open and arthroscopic surgery of the shoulder, wrist, hand, elbow, hip, knee, and ankle.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Option Format 3-10-98)

Prescription use

Clara Wells

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

510(k) Number _K023986

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