SERFAS ENERGY SYSTEM

K041810 · Stryker Endoscopy · GEI · Dec 21, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K041810
• Device Name: SERFAS ENERGY SYSTEM
• Applicant: Stryker Endoscopy
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Dec 21, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The SERFAS Energy System is indicated for resection ablation and coagulation of soft tissue and hemostasis of blood vessels in orthopedic and arthroscopic procedures of joints such as the knee, shoulder, elbow, hip, ankle and wrist.

Device Story

SERFAS Energy System is a bipolar high-frequency electrosurgical system; consists of electrosurgical generator, disposable single-use probes, and footswitch. Used in orthopedic and arthroscopic procedures; operated by surgeons. Device delivers bipolar RF energy to soft tissue for resection, ablation, and coagulation; provides hemostasis of blood vessels. Surgeon controls energy delivery via footswitch; output allows precise tissue management during joint surgery. Benefits include controlled tissue removal and bleeding management in minimally invasive orthopedic settings.

Technological Characteristics

Bipolar high-frequency electrosurgical system. Components: electrosurgical generator, disposable single-use probes, footswitch. Energy source: RF electrical energy. Intended for orthopedic/arthroscopic soft tissue management.

Indications for Use

Indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels during orthopedic and arthroscopic joint procedures (knee, shoulder, elbow, hip, ankle, wrist). Prescription use only.

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.

Predicate Devices

• Stryker Endoscopy Radio Frequency Ablation System (SERFAS) (K991960)
• ArthroCare System (K001588, K011634, K020832, K032504)
• ArthroCare ArthroWands (K011083, K013463, K020557, K030551, K033584)
• Mitek VAPR System (K974022)

Submission Summary (Full Text)

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DEC 2 1 2004

5900 Optical Court San Jose, CA 95138 t: 408 754 2000 f: 408 754 2505 www.stryker.com

stryker

Endoscopy

# 041810

### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

December 2, 2004 Date

#### Device Name

| Classification Name: | Electrosurgical Cutting and Coagulation Device and<br>Accessories (21 CFR 878.4400) |
|------------------------|-------------------------------------------------------------------------------------|
| Common and Usual Name: | RF System |
| Proprietary Name: | SERFAS Energy System |

#### Product Description

The SERFAS Energy System is a bipolar high frequency electrosurgical system comprised of an electrosurgical generator, a series of disposable, single use, probe styles, and a footswitch.

#### Intended Use

The SERFAS Energy System is indicated for resection ablation and coagulation of soft tissue and hemostasis of blood vessels in orthopedic and arthroscopic procedures of joints such as the knee, shoulder, elbow, hip, ankle and wrist.

#### Predicate Devices

Stryker Endoscopy Radio Frequency Ablation System (SERFAS): K991960 ArthroCare System: K001588, K011634, K020832, K032504 ArthroCare ArthroWands: K011083, K013463, K020557, K030551, K033584 Mitek VAPR System: K974022

#### Substantial Equivalence

When compared to the predicated devices listed above the SERFAS Energy System has the same intended use and the technological differences do not raise new questions of safety and effectiveness. Therefore, the SERFAS Energy System is substantially equivalent to the predicate marketed devices.

#### Contact

Christopher Earley Senior Design Engineer Stryker Endoscopy

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Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of a stylized eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 21 2004

Stryker Endoscopy c/o Mr. Nishith Desai TÜV Rheinland of North America, Inc. 12 Commerce Road Newtown, Connecticut 06470

Re: K041810

Trade/Device Name: SERFAS Energy System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: December 13, 2004 Received: December 15, 2004

Dear Mr. Desai:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed your becerer of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to commerce prior to rial 2011-12-12 in accordance with the provisions of the Federal Food, Drug, de neces may been require approval of a premarket approval application (PMA). and Cosmotion Free (110) and the device, subject to the general controls provisions of the Act. The r ou may, cherefore, mailes of the Act include requirements for annual registration, listing of general voltable profice, 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 If your device is exassinou (tional 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 or any x 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. Nishith Desai

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]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director 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

510(k) Number (if known): K041810

Device Name: SERFAS Energy System

Indications for Use:

The SERFAS Energy System is indicated for resection, ablation and coagulation of soft tissue and hemostasis of blood vessels in orthopedic and arthroscopic procedures of joints such as the knee, shoulder, elbow, hip, ankle, and wrist.

Prescription Use _ X (Per 21 CFR 801.109) OR

Over-The-Counter-Use__________________________________________________________________________________________________________________________________________________________

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Misiam C. Provost

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

K041810 510(k) Number___