MULTI-BITE HOT BIOPSY FORCEPS

K090796 · Endo-Therapeutics, Inc. · KGE · Nov 25, 2009 · Gastroenterology, Urology

Device Facts

• Record ID: K090796
• Device Name: MULTI-BITE HOT BIOPSY FORCEPS
• Applicant: Endo-Therapeutics, Inc.
• Product Code: KGE · Gastroenterology, Urology
• Decision Date: Nov 25, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4300
• Device Class: Class 2

Intended Use

Biopsy forceps are intended for use in collecting tissue samples for histological examination.

Device Story

Multi-bite Electric (Hot) Biopsy Forceps are endoscopic accessories used to collect tissue samples for histological examination. The device is operated by a physician during endoscopic procedures. It functions by capturing tissue and applying electrosurgical energy to facilitate the biopsy process. The output is a tissue sample retrieved for clinical analysis. The device is intended for use in a clinical or hospital setting.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Endoscopic electrosurgical accessory; manual operation; designed for tissue sampling; compatible with standard electrosurgical units. No specific materials or software algorithms described.

Indications for Use

Indicated for patients requiring tissue sample collection for histological examination via endoscopic procedures. Prescription use only.

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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Public Health Service

## NOV 25 2009

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Ms. Lisa Derrick Director of Quality Assurance and Regulatory Affairs Endo-Therapeutics, Inc. 15251 Roosevelt Blvd., #204 CLEARWATER FL 33760

Re: K090796

Trade/Device Name: Multi-bite Electric (Hot) Biopsy Forceps Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: KGE Dated: October 9, 2009 Received: October 15, 2009

Dear Ms. Derrick:

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); medical device reporting of medical

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device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

[signature]

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

## Enclosure

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Image /page/2/Picture/0 description: The image shows the logo and contact information for Endo-Therapeutics, Inc. The logo consists of the letters "ETI" in a stylized font. The address is listed as 15251 Roosevelt Blvd. #204 Clearwater FL 33760. The phone number is 727-538-9570 and the fax number is 727-524-4111.

## Indications for Use

510(k) Number (if known): K090796

Device Name: Multi-bite Electric (Hot) Biopsy Forceps

Indications for Use:

Biopsy forceps are intended for use in collecting tissue samples for histological examination.

× Over-The-Counter Use Prescription Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aran R. Whing

(Division Division of Reproductive, Abdominal and Radiological Devic 510(k) Number

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