ETI BIPOLAR HEMOSTATIC PROBE

K031026 · Endo-Therapeutics, Inc. · KNS · Jun 27, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K031026
• Device Name: ETI BIPOLAR HEMOSTATIC PROBE
• Applicant: Endo-Therapeutics, Inc.
• Product Code: KNS · Gastroenterology, Urology
• Decision Date: Jun 27, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ETI Hemostatic Probe is intended for use during endoscopic procedures where electrosurgery is required to cauterize tissue of actual or potentially bleeding sites in the gastrointestinal tract. The device also can be used for irrigation.

Device Story

ETI Bipolar Hemostatic Probe is an endoscopic electrosurgical accessory; used to cauterize bleeding or potentially bleeding sites in the gastrointestinal tract. Device delivers bipolar electrosurgical energy to target tissue; also provides irrigation capability. Operated by physicians during endoscopic procedures. Output is thermal coagulation of tissue; aids in hemostasis. Benefits include effective control of GI bleeding during endoscopy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Bipolar electrosurgical probe; endoscopic form factor; provides irrigation and electrosurgical energy delivery. Class II device (21 CFR 876.4300).

Indications for Use

Indicated for use in patients undergoing endoscopic procedures requiring electrosurgical cauterization of bleeding or potentially bleeding gastrointestinal tissue; also indicated for irrigation.

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.

Submission Summary (Full Text)

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JUN 2 7 2003

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Todd Adkisson Endo-Therapeutics, Inc. 1183 Cedar St. SAFETY HARBOR, FL 34695 Re: K031026 Trade/Device Name: ETI Bipolar Hemostatic Probe Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: 78 KNS Dated: March 26, 2003 Received: March 31, 2003

Dear Mr. Adkisson:

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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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 one of the following numbers, based on the regulation number at the top of the letter:

| 8xx. Ixxx | [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" (21CFR Part 807.97) you may obtain. 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 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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## 510(k) INDICATIONS FOR USE STATEMENT

KOSIO26. 510(k) Number (If KNOWN):

ETI Hemostatic Probe Device Name:

Endo-Therapeutics, Inc Applicant Name:

Indications for Use: The ETI Hemostatic Probe is intended for use during endoscopic procedures where electrosurgery is required to cauterize tissue of actual or potentially bleeding sites in the gastrointestinal tract. The device also can be used for irrigation.

Signature:

President

**Date:** 3/26/03

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David Lymann

Division of Reprodu 510(k) Nun

*Prescription Use*