RESUABLE HOT BIOPSY FORCEPS

K972505 · United States Endoscopy Group, Inc. · KGE · Sep 18, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K972505
• Device Name: RESUABLE HOT BIOPSY FORCEPS
• Applicant: United States Endoscopy Group, Inc.
• Product Code: KGE · Gastroenterology, Urology
• Decision Date: Sep 18, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Reusable Hot Biopsy Forceps are intended for use in flexible endoscopy procedures to biopsy, grasp, dissect and transect tissue.

Device Story

Reusable hot biopsy forceps used during flexible endoscopy to biopsy, grasp, dissect, and transect gastrointestinal tissue. Device consists of forceps jaws used to grasp lesions or polyps; tissue is lifted from the intestinal wall and ablated using monopolar electric current. Operated by physicians in clinical settings. Output is the physical removal and cauterization of tissue samples for diagnostic purposes. Benefits include simultaneous tissue sampling and hemostasis during endoscopic procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Reusable monopolar biopsy forceps. Materials certified to standards appropriate for use. Quality assurance procedures based on MIL-STD-9858. Device functions via mechanical grasping and monopolar electrosurgical ablation.

Indications for Use

Indicated for use in flexible endoscopy procedures to biopsy, grasp, dissect, and transect tissue in the upper or lower gastrointestinal tract for the diagnosis of malignancies and other disorders. Contraindicated in patients with coagulopathy, potential for bleeding, current use of anticoagulants, or recent ingestion of non-steroidal anti-inflammatory drugs or ASA-containing drugs (unless bleeding is verified as normal), or other physician-determined contraindications.

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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K972505-

### SECTION II Pini SAFETY AND EFFECTIVENESS SUMMARY

## SEP 1 8 1997 SAFETY AND EFFECTIVENESS MONOPOLAR BIOPSY FORCEPS SUMMARY

Safety and Effectiveness on the endoscopic Summary of The procedures for biopsy of upper or lower gastrointestinal tract and the Monopolar Biopsy Forceps used reflects data available and presented at the time the submission was prepared, but, caution should be exercised in interpreting the data. The results of future studies may require alterations of the conclusions or recommendations set forth.

## Procedure/Product Overview

The Reusable hot biopsy forceps are intended for use in flexible endoscopy procedures to biopsy, grasp, dissect and transect tissue.

Lesions/polyps of the lower or upper gastrointestinal tract may be biopsied for the purpose of diagnosing malignancies and other disorders.

The lesion/polyp is grasped between the jaws of the biopsy forceps; the forceps are then lifted from the intestinal wall and the tissue is ablated with electric current.

# Contraindications for Biopsy Procedure

The use of Monopolar Biopsy Forceps is contraindicated and is not appropriate in cases where patients have or are present with:

- Coaqulopathy
- Potential for bleeding
- Current use of anticoaqulants .
- Recent ingestion of non-steroidal anti-inflammatory or ASA-.
- containing drug (unless bleeding is verified as normal)
- Other contraindications as determined by physician

## Manufacturing Overview

manufactures and tests the product to performance ប. S.E. specifications based on predicate and/or substantially equivalent devices.

U.S.E. manufacturing processes and procedures are based on good manufacturing practices. Quality assurance methods and procedures based on MIL-STD-9858 are utilized to assure conformance to design specifications.

Materials used in the manufacturing process are certified to standards appropriate for their use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Gretchen Younker Cohen United States Endoscopy Group, Inc. 9330 Progress Parkway Mentor, Ohio 44060

18 1997

Re: K972505 Reusable Hot Biopsy Forceps Dated: June 30, 1997 Received: July 3, 1997 Regulatory class: II 21 CFR §876.4300/Product code: 78 KGE

Dear Ms. Cohen:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, 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 misbranion.

If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

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 vour 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

Sincerely yours,

Lillian Yin, Ph.D.

Lillian Yin. Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number if Known_K 972505 Reusable Biopsy Forceps, Hot Device Name:_

Indications for Use:

The Reusable Hot Biopsy Forceps are intended for use in flexible endoscopy procedures to biopsy, grasp, dissect and transect tissue.

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CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-the Counter Use__________________________________________________________________________________________________________________________________________________________

Robert R. Satting/

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 2505 510(k) Number