This document is a 510(k) summary for the Olympus Unipolar Optical Biopsy Forceps. It does not contain information about acceptance criteria or a study proving device performance against such criteria.

The provided text from the regulatory submission focuses on:

Device Identification: Name, common name, classification.
Predicate Devices: A list of previously cleared devices considered similar.
Submitter Information: Company and contact details.
Summary Preparation Date: December 8, 1998.
Intended Use Statement: "The Olympus Unipolar Optical Biopsy Forceps has been designed for endoscopic biopsy and coagulation within the urinary tract."
FDA Clearance Letter: Confirming substantial equivalence to predicate devices and allowing marketing.
Indications for Use Statement (CDR): Reinforcing the intended use.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

Medical device regulatory submissions like 510(k)s often do not publicly detail the specific performance acceptance criteria and study results in the summary section. Instead, they refer to internal testing performed by the manufacturer to demonstrate substantial equivalence to predicate devices, which may include bench testing for performance characteristics relevant to the device's function (e.g., biopsy sample size, coagulation effectiveness, mechanical integrity). These details are typically reserved for the full 510(k) submission, which is not fully provided here.

Summary

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DEC 24 1998

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VC983811

510(k) Summary

Olympus Unipolar Optical Biopsy Forceps

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Olympus Unipolar Optical Biopsy Forceps Device Name:

Common/Usual Name:Unipolar Optical Biopsy Forceps

Endoscopic Electrosurgical Unit and Accessories Classification Name:

Classification: CFR 876.4300 Class II

Predicate Devices:

Olympus	O5106	Rigid biopsy forceps with spoon jaw	K790071
Olympus	O5105	Rigid biopsy forceps, insulated	K790071
Olympus	O3109/A	Biopsy forceps with sharp cutting jaws	K790071
Olympus	O0115	Coagulation Electrode	K790071
Karl Storz		Biopsy Forceps, through cutting, double action jaws,for unipolar coagulation	unknown
Richard Wolf		Coagulating biopsy forceps by Tauber Type 8650.62	unknown

Prepared & Submitted by:	Laura Storms-Tyler
	Olympus America Inc.
	Two Corporate Center Drive
	Melville, NY 11747-3157
	Phone: (516) 844-5688
	Fax: (516) 844-5416

Summary Preparation Date: December 8, 1998

Statement of Intended Use:

The Olympus Unipolar Optical Biopsy Forceps has been designed for endoscopic biopsy and coagulation within the urinary tract.

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Rockville MD 20850

Food and Drug Administration 9200 Corporate Boulevard

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, representing the department's focus on people and health.

DEC 2 4 1998

Ms. Laura Storms-Tyler Olympus Winter & Ibe GmbH c/o Olympus America, Inc. 2 Corporate Center Drive Melville, NY 11747

Re: K983811

Unipolar Optical Biopsy Forceps Dated: October 27, 1997 Received: October 28, 1998 Regulatory Class: II 21 CFR 876,4300/Procode: 78 KGE

Dear Ms. Storms-Tyler:

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 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). 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 III (Special Controls) or class III (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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 the Electronic Product 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 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 and additionally 809.10 for in witted diagnostic devices), please contact the Office of Compilance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,


Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, 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):

Device Name:

OL YMPUS Unipolar Optical Biopsy Forceps

# Indication for Use:

The OL YMPUS Unipolar Optical Biopsy Forceps has been designed for endoscopic biopsy and coagulation within the urinary tract.

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use    | <span style="text-decoration: overline;">✓</span> | OR | Over-the Counter Use ______ |
|---------------------|---------------------------------------------------|----|-----------------------------|
| (per 21CFR 801.109) |                                                   |    | (Optional Format 1-2-96)    |

  

(Division Sign-Off)
Division of General Restorative Devices

| 510(k) Number | [K983811](https://510k.innolitics.com/search/K983811) |
|---------------|---------|
|---------------|---------|

Regulation Number and Section

§ 876.4300 Endoscopic electrosurgical unit and accessories.

(a)
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.(b)
Classification. Class II (performance standards).