ENDO WINDOW HIGH FREQUENCY ELECTROCAUTERY DEVICE, MODEL EW018

K021266 · Ethicon Endo-Surgery, Inc. · KNS · Sep 27, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K021266
• Device Name: ENDO WINDOW HIGH FREQUENCY ELECTROCAUTERY DEVICE, MODEL EW018
• Applicant: Ethicon Endo-Surgery, Inc.
• Product Code: KNS · Gastroenterology, Urology
• Decision Date: Sep 27, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

EndoWindow™ High Frequency Electrocautery Device is indicated for the transendoscopic electrocautery of tissue in the upper gastrointestinal tract such as Barrett's esophagus.

Device Story

EndoWindow is a sterile, single-use, disposable bipolar electrosurgical device; fits over flexible endoscopes (max diameter 8.7mm). Electrodes located distally on exterior surface deliver electrical current to cauterize tissue. Cauterization creates white coagulum visible to user through a rectangular window between electrodes. Used by physicians in clinical settings during endoscopic procedures. Provides localized tissue cauterization in upper GI tract; benefits patient by enabling targeted treatment of conditions like Barrett's esophagus.

Clinical Evidence

Bench and animal testing performed. Biocompatibility assessment conducted per ISO 10993-1 with satisfactory results.

Technological Characteristics

Bipolar electrosurgical device; sterile, single-use, disposable. Designed to fit over flexible endoscopes up to 8.7mm diameter. Features distal electrodes and a viewing window for cauterization monitoring. Biocompatibility tested per ISO 10993-1.

Indications for Use

Indicated for transendoscopic electrocautery of upper gastrointestinal tract tissue, including Barrett's esophagus.

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

• Microvasive Gold Probe

Submission Summary (Full Text)

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K021266

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

| Company | Ethicon Endo-Surgery, Inc.<br>4545 Creek Road<br>Cincinnati, OH 45242 |
|------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Ken Charak, MBA, RAC<br>Manager Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared | April 18, 2002 |
| Device Name | Trade Name: EndoWindowTM High Frequency Electrocautery Device<br>Classification Name: Electrosurgical Device |
| Predicate Device | Microvasive Gold Probe |

#### Device Description

EndoWindow™ is a sterile, single-use, disposable bipolar device that is intended to cauterize tissue in the esophagus. EndoWindow fits around a flexible endoscope and contains electrodes located distally on the exterior surface of the device. When positioned and activated, the electrodes deliver electrical current to cauterize tissue. Cauterization of tissue manifests as a white coagulum and occurs in full view of the user in the narrow rectangular window located between the electrodes. The inner diameter of EndoWindow is designed to accommodate an endoscope having a maximum diameter of 8.7mm.

#### Indications for Use

EndoWindow High Frequency Electrocautery Device is indicated for the transendoscopic electrocautery of tissue in the upper gastrointestinal tract such as Barrett's esophagus.

#### Technological Characteristics

While the basic design of EndoWindow is different than Gold Probe, a comprehensive assessment of the differences versus Gold Probe does not raise any new issues relating to safety and effectiveness.

#### Performance Data

Laboratory and animal testing was performed to verify performance and safety. A biocompatibility assessment was conducted in accordance with ISO 10993-1 with satisfactory results.

#### Conclusion

EndoWindow is substantially equivalent to Gold Probe. The information provided in this submission provides assurance that EndoWindow will meet the requirements for its intended use.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# SEP 2 7 2002

Re: K021266

Trade/Device Name: EndoWindow™ High-Frequency Electrocautery Device Regulation Number: 21 CFR §876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: 78 KNS Dated: July 31, 2002 Received: August 1, 2002

Dear Mr. Charak:

Mr. Ken Charak

4545 Creek Road

Manager of Regulatory Affairs

CINCINNATI OH 45242-2839

Ethicon Endo-Surgery, Inc.

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 (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.

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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 vour 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 C Brogdon

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

510 (k) Number (if known): _____________________________

EndoWindow™ High Frequency Electrocautery Device Device Name:

Indications for Use:

EndoWindow™ High Frequency Electrocautery Device is indicated for the transendoscopic electrocautery of tissue in the upper gastrointestinal tract such as Barrett's esophagus.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

*Prescription Use*

(Optional Format 3-10-98)

David A. Ayres

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number