BIPOLAR GRASPING FORCEPS BIQ+

K984417 · Olympus America, Inc. · GEI · Feb 24, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K984417
• Device Name: BIPOLAR GRASPING FORCEPS BIQ+
• Applicant: Olympus America, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Feb 24, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Olympus Bipolar Forceps has been designed for grasping and coagulation of soft tissue and blood vessels during endoscopic treatment in laparoscopic and gynecological applications.

Device Story

The Olympus Bipolar Forceps is a surgical instrument used for grasping and coagulating soft tissue and blood vessels. It is intended for use during endoscopic procedures, specifically in laparoscopic and gynecological surgery. The device is operated by a physician or surgeon. It functions by delivering bipolar electrosurgical energy to the target tissue, enabling simultaneous grasping and hemostasis. The device is used in an operating room environment. By providing controlled coagulation, it assists the surgeon in managing tissue and vessels, potentially reducing bleeding and improving surgical efficiency during minimally invasive procedures.

Clinical Evidence

bench testing only

Technological Characteristics

Bipolar electrosurgical forceps; 5mm diameter; manual actuation; intended for use with compatible electrosurgical generators. Materials and design are consistent with previously cleared Olympus bipolar forceps (K955623) and HiQ hand instruments (K944201).

Indications for Use

Indicated for grasping and coagulation of soft tissue and blood vessels during endoscopic treatment in laparoscopic and gynecological applications.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

• BiCOAG® Bipolar Dissecting Forceps (K945975, K955001, K971565)
• A5380, A5382 Bipolar forceps, Ø5 mm, micro tweezers (K955623)
• A5384, A5386 Bipolar forceps, Ø5 mm, tweezers, thin (K955623)
• A5388, A5390 Bipolar forceps, Ø5 mm, tweezers, thick (K955623)
• A5392, A5394 Bipolar forceps, Ø5 mm, Hirsch (K955623)
• A6124, A6322 HiQ Handinstruments (K944201)

Submission Summary (Full Text)

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5/24/99

Image /page/0/Picture/2 description: The image shows the logo and contact information for Olympus Winter & IBE. The business address is Kuehnstr. 61, D-22045 Hamburg, and the mailing address is Postfach 70 17 09, D-22017 Hamburg. The telephone number is (040) 6 69 66-0, and the telefax number is (040) 6 68 15 91.

EU

984417

#### 510(k) SUMMARY

## OLYMPUS BIPOLAR FORCEPS

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

| Device Name: | Bipolar Grasping Forceps BiQ+ |
|----------------------|------------------------------------------------------------------|
| Common/Usual Name: | Bipolar Forceps |
| Classification Name: | DEVICE, ELECTROSURGICAL, CUTTING & COAGULATION &<br>ACCESSORIES. |
| Classification: | CFR 878.4400 Class II |

Predicate Devices:

| Manufacturer | Description | 510(k) |
|-----------------------|------------------------------------------------------|-------------------------------|
| Everest Medical Corp. | BiCOAG® Bipolar Dissecting Forceps | K945975<br>K955001<br>K971565 |
| Olympus | A5380, A5382 Bipolar forceps, Ø5 mm, micro tweezers | K955623 |
| Olympus | A5384, A5386 Bipolar forceps, Ø5 mm, tweezers, thin | K955623 |
| Olympus | A5388, A5390 Bipolar forceps, Ø5 mm, tweezers, thick | K955623 |
| Olympus | A5392, A5394 Bipolar forceps, Ø5 mm, Hirsch | K955623 |
| Olympus | A6124, A6322 HiQ Handinstruments | K944201 |

Prepared & Submitted By: (Contact Person)

Mrs. Laura Storms-Tyler Olympus America Inc. Endoscope Division Two Corporate Center Drive Melville, NY 11747-3157 Phone: [phone] Fax: [phone]

Summary Preparation Date: February 16, 1999

#### Statement of Intended Use:

The Olympus Bipolar Forceps has been designed for grasping and coagulation of soft tissue and blood vessels during endoscopic treatment in laparoscopic and gynecological applications.

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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular 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, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 4 1999

Ms. Laura Storms-Tyler Director, Regulatory Affairs Olympus America, Inc. Two Corporate Center Drive Melville, New York 11747-3157

Re: K984417

> Trade Name: OLYMPUS Bipolar Forceps BiQ* Regulatory Class: II Product Code: GEI Dated: November 26, 1998 Received: December 10, 1998

## 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 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 II (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 requirement, 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.

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# Page 2 - Ms. Laura Storms-Tyler

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 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,

Sathish Kumar, Ph.D., P.E.

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### K 984417 510(k) Number (if known):

Device Name:

OLYMPUS Bipolar Forceps BiQ*

# Indications for Use:

The Olympus Bipolar Forceps has been designed for grasping and coagulation of soft tissue and blood vessels during endoscopic treatment in laparoscopic and gynecological applications.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Presciption Use (per 21CFR 801.109)

OR

Over-the Counter Use

(Optional Format 1-2-96)

(Division Sign-Off) Division of General Restorative Device 510(k) Number _