ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM

K022543 · Arthrocare Corp. · FAS · Aug 30, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K022543
• Device Name: ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM
• Applicant: Arthrocare Corp.
• Product Code: FAS · Gastroenterology, Urology
• Decision Date: Aug 30, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ArthroCare® Bipolar Loop Electrosurgery System is a bipolar electrosurgical device intended for use in patients requiring endoscopic surgery for general urological procedures. Urological tissue can be resected using this System, such as the prostate, in procedures including transurethral prostatectomy (TURP) and transurethral incisions in the prostate (TUIP), as well as non-malignant tumors of the bladder wall. The System has been shown to be effective in tissue resection, ablation, and excision, as well as in hemostasis of blood vessels. It is intended for endoscopic procedures using saline solution. Ringer's lactate, or other conductive solutions as irrigants, under direct or video-assisted fiberoptic visualization.

Device Story

Bipolar electrosurgical system for endoscopic urological procedures; comprises electrosurgical generator (Controller), disposable bipolar Wands, and reusable Patient Cable. Operates via high-frequency energy in conductive irrigation fluids (saline, Ringer's lactate). Used by physicians in clinical settings under direct or video-assisted fiberoptic visualization. Enables tissue resection, ablation, excision, and hemostasis of blood vessels. System modifications involve performance and dimensional specifications.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and performance specification modifications.

Technological Characteristics

Bipolar high-frequency electrosurgical system. Components: Controller (generator), disposable bipolar Wands, reusable Patient Cable. Operates in conductive irrigation media (saline, Ringer's lactate).

Indications for Use

Indicated for patients requiring endoscopic urological surgery, including transurethral prostatectomy (TURP), transurethral incisions in the prostate (TUIP), and resection of non-malignant bladder wall tumors. Used for tissue resection, ablation, excision, and hemostasis.

Regulatory Classification

Identification

An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.

Predicate Devices

• ArthroCare® Bipolar Loop Electrosurgery System (K955531)
• ArthroCare® Bipolar Loop Electrosurgery System (K010568)

Submission Summary (Full Text)

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X022543
pg 1 of 2

AUG 3 0 2002

# 510(k) Summary

# ArthroCare Corporation ArthroCare® Bipolar Loop Electrosurgery System

# General Information

| Submitter Name/Address: | ArthroCare Corporation<br>680 Vaqueros Avenue<br>Sunnyvale, CA 94085-2936 |
|-------------------------|---------------------------------------------------------------------------------------------|
| Phone Number: | [phone] |
| Contact Person: | Bruce Prothro<br>Vice President,<br>Operational Planning, Quality and<br>Regulatory Affairs |
| Date Prepared: | July 30, 2002 |

Device Description

| Trade Name: | ArthroCare® Bipolar Loop Electrosurgery<br>System |
|----------------------|-------------------------------------------------------------------------------------|
| Generic/Common Name: | Electrosurgical Device and Accessories |
| Classification Name: | Electrosurgical Cutting and Coagulation<br>Device and Accessories (21 CFR 878.4400) |
| Predicate Devices | ArthroCare® Bipolar Loop<br>Electrosurgery System<br>K955531 and K010568 |

## Product Description

The ArthroCare® Bipolar Loop Electrosurgery System is a bipolar, high frequency electrosurgical system consisting of three components: an electrosurgical generator called the Controller; a family of disposable, bipolar, single use Wands; and a reusable Patient Cable.

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#### Intended Uses

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The ArthroCare® Bipolar Loop Electrosurgery System is a bipolar electrosurgical device intended for use in patients requiring endoscopic surgery for general urological procedures. Urological tissue can be resected using this System, such as the prostate, in procedures including transurethral prostatectomy (TURP) and transurethral incisions in the prostate (TUIP), as well as non-malignant tumors of the bladder wall. The System has been shown to be effective in tissue resection, ablation, and excision, as well as in hemostasis of blood vessels. It is intended for endoscopic procedures using saline solution. Ringer's lactate, or other conductive solutions as irrigants, under direct or video-assisted fiberoptic visualization.

#### Substantial Equivalence

This Special 510(k) proposes a modification in the performance specifications, dimensional specifications, and labeling for the Bipolar Loop Electrosurgery System, which was previously cleared in K955531 on February 21, 1996 and K010568 on March 27, 2001. The indications for use, technology, principle of operation, materials, packaging, and sterilization parameters of the ArthroCare Bipolar Loop Electrosurgery System remain the same as in the predicate cleared 510(k).

#### Summary of Safety and Effectiveness

The modified Bipolar Loop Electrosurgery System, as described in this Special 510(k), is substantially equivalent to the predicate device. The proposed modifications in performance specifications, dimensional specifications, and labeling are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the System.

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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 stylized eagle with three tail feathers, enclosed in a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the circle.

# Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# AUG 3 0 2002

Re: K022543

Trade/Device Name: ArthroCare® Bipolar Loop Electrosurgery System Regulation Number: 21 CFR §876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II

Product Codes: 78 FAS and KNS Dated: July 30, 2002 Received: August 1, 2002

Dear Ms. Defiesta-Ng:

Ms. Valerie Defiesta-Ng

ArthroCare® Corporation

SUNNYVALE CA 94085

680 Vaqueros Avenue

Director, Regulatory Affairs

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 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

This letter will allow you to begin marketing your device as described in your 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 one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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" (21 CFR 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.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy Cbrogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use Statement

ArthroCare® Bipolar Loop Electrosurgery System Device Name

K022543 510(k) Number:

Indications for Use:

The ArthroCare® Bipolar Loop Electrosurgery System is a bipolar electrosurgical device intended for use in patients requiring endoscopic surgery for general urological procedures. Urological tissue can be resected using this System, such as the prostate, in procedures including transurethral prostatectomy (TURP) and transurethral incisions in the prostate (TUIP), as well as non-malignant turnors of the bladder wall. The System has been shown to be effective in tissue resection, ablation, and excision, as well as in hemostasis of blood vessels. It is intended for endoscopic procedures using saline solution. Ringer's lactate, or other conductive solutions as irrigants, under direct or video-assisted fiberoptic visualization.

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|--------------------------------------------------------|
|--------------------------------------------------------|

| Prescription Use | <b>X</b> | OR | Over-the-Counter Use |
|------------------|----------|----|----------------------|
|------------------|----------|----|----------------------|

(Per 21 CFR 801.109)

Nancy Brogdon

(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number K022543