BIPOLAR ARTHROSCOPIC PROBE, STRAIGHT, BIOPOLAR ARTHROSCOPIC PROBE, ANGLED, BIPOLAR ARTHROSCOPIC PROBE, STRAIGHT,

K973682 · Electroscope, Inc. · GEI · Dec 18, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K973682
• Device Name: BIPOLAR ARTHROSCOPIC PROBE, STRAIGHT, BIOPOLAR ARTHROSCOPIC PROBE, ANGLED, BIPOLAR ARTHROSCOPIC PROBE, STRAIGHT,
• Applicant: Electroscope, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Dec 18, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Bipolar Arthroscopic Probe is an electrosurgical device designed to be used in Arthroscopic procedures involving cutting and coagulation of soft body tissue. The Bipolar Arthroscopic Probe is indicated for use in patients requiring ine bipolar neurossoppf the joint i.e., wrist, knee, shoulder, ankle, and elbow.

Device Story

Bipolar Arthroscopic Probe is an electrosurgical instrument for cutting and coagulation of soft tissue during arthroscopic procedures. Device features integrated suction and irrigation capabilities. Operated by surgeons in clinical/OR settings. Device delivers electrical energy to target tissue to achieve desired surgical effect. Benefits include precise tissue management within joints (wrist, knee, shoulder, ankle, elbow) during minimally invasive surgery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Bipolar electrosurgical probe; includes suction and irrigation channels; straight and angled configurations; intended for soft tissue cutting and coagulation.

Indications for Use

Indicated for patients requiring bipolar electrosurgical cutting and coagulation of soft tissue during arthroscopic joint procedures, including wrist, knee, shoulder, ankle, and elbow.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that form the shape of the bird's body and wings. The logo is simple and recognizable, and it is often used to represent the U.S. Department of Health and Human Services.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Jane Johnson Regulatory Affairs & Quality Assurance Manager Electroscope, Incorporated 4828 Sterling Drive Boulder, Colorado 80301

DEC 1 8 1997

Re: K973682

> Trade Name: Bipolar Arthroscopic Probe, Straight/Angled, with Suction/ Irrigation Capabilities Regulatory Class: II Product Code: GEI Dated: September 22, 1997 Received: September 26, 1997

Dear Ms. Johnson:

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 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

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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 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.

focall

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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510(k) Number (if known): K973682

Device Name:__________________________________________________________________________________________________________________________________________________________________ capabilities.

Indications For Usc:

The Bipolar Arthroscopic Probe is an electrosurgical device designed to be used in Arthroscopic procedures involving cutting and coagulation of soft body tissue. The Bipolar Arthroscopic Probe is indicated for use in patients requiring ine bipolar neurossoppf the joint i.e., wrist, knee, shoulder, ankle, and elbow.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sian-Off)
Division of General Restorative Devices K973682
510(k) Number

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The Counter Use

(Optional Forust 1-2-96)