CONMED ABC PROBE FOR FLEXIBLE ENDOSCOPES

K990586 · Conmedcorp · GEI · May 17, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K990586
• Device Name: CONMED ABC PROBE FOR FLEXIBLE ENDOSCOPES
• Applicant: Conmedcorp
• Product Code: GEI · General, Plastic Surgery
• Decision Date: May 17, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Sterile, single-use electrosurgical accessory used in conjunction with an ABC® generator for delivery of agron gas and electrosurgical current through a flexible endoscope to perform coagulation.

Device Story

ConMed ABC® Probe for Flexible Endoscopes; sterile, single-use electrosurgical accessory. Used with ABC® generator; delivers argon gas and electrosurgical current to tissue via flexible endoscope. Enables endoscopic coagulation. Operated by physicians in clinical settings. Benefits include precise, non-contact coagulation during endoscopic procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Sterile, single-use electrosurgical accessory; designed for compatibility with flexible endoscopes and ABC® generators; delivers argon gas and electrosurgical current.

Indications for Use

Indicated for use as a sterile, single-use electrosurgical accessory for the delivery of argon gas and electrosurgical current through a flexible endoscope to perform coagulation in patients requiring endoscopic electrosurgical procedures.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 17 1999

Mr. Ira D. Duesler, Jr. Quality Engineer ConMed Corporation 310 Broad Street Utica. New York 13501

Re: K990586

> Trade Name: ConMed ABC® Probe for Flexible Endoscopes Regulatory Class: II Product Code: GEI Dated: February 22,1999 Received: February 23, 1999

Dear Mr. Duesler:

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 - Mr. Ira D. Duesler, Jr.

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,

f
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices

Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): __ K 990586

ConMED ABC® Probe for Flexible Endoscopes Device Name:

Indications for Use:

Sterile, single-use electrosurgical accessory used in conjunction with an ABC® generator for delivery of agron gas and electrosurgical current through a flexible endoscope to perform coagulation.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K990586

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter