BMC RADIO FREQUENCY PERFORATION GENERATOR, MODELS RFP-100-115 AND RFP-100-230

K013904 · Baylis Medical Co., Inc. · GEI · Feb 12, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K013904
• Device Name: BMC RADIO FREQUENCY PERFORATION GENERATOR, MODELS RFP-100-115 AND RFP-100-230
• Applicant: Baylis Medical Co., Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Feb 12, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BMC Radio Frequency Perforation Generator; Model RFP-100-115 (For Domestic Use) and The BMC Radio Frequency Perforation Generator, Model RFP-100-230 (For International Use) is indicated for use in general surgical procedures to cut and coagulate soft tissue.

Device Story

The BMC Radio Frequency Perforation Generator (Models RFP-100-115 and RFP-100-230) is an electrosurgical device designed for cutting and coagulating soft tissue. It functions by delivering radio frequency (RF) energy to the surgical site. The device is intended for use by clinicians in general surgical procedures. By applying RF energy, the generator enables precise tissue cutting and hemostasis through coagulation, assisting surgeons in managing tissue during operations. The device is operated by medical professionals in a clinical or surgical setting.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electrosurgical generator for cutting and coagulation; RF energy source; models differentiated by voltage/regional power standards (115V vs 230V).

Indications for Use

Indicated for use in general surgical procedures to cut and coagulate soft tissue in patients requiring such surgical intervention.

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

FEB 1 2 2002

Mr. Kris Shah Vice-President, Product Development Baylis Medical Company, Inc. 5160 Explorer Drive, Unit 33 Mississauga, Ontario L4W 4T7 Canada

Re: K013904

Trade Name: BMC Radio Frequency Perforation Generator Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories; Regulatory Class: II Product Code: GEI Dated: November 19, 2001 Received: November 26, 2001

Dear Mr. Shah:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bourse et ermined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to Indications for use stated in the ensires of the Medical Device Amendments, or to devices that have May 26, 1970, the chacement date of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, marker the devices to expect to equirements for annual registration, listing of devices, controls provisions or the recements square squares misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it II your device is classifica (see above) the existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations and may be subject to such additional controliations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ood of I outstal Integraing your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease oe advised that I Dri 3 ibsounce or our device complies with other requirements of the Act that IDA has made a decommandions administered by other Federal agencies. You must of any Federal statutes and regulations administred to: registration and listing (21 comply with an the Hot of requirements, and manufacturing practice requirements as set CITY at 807), adomig (21 OFRT arrown), good if god if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Kris Shah

This letter will allow you to begin marketing your device as described in your Section 510(k)
The first of the may of the of a local starticle spiralence of your device to le I his letter will anow you to begin makemily of substantial equivalence of your device to a legally premarket notification. The FDA iniding of substanted by and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFF Part 801 and If you desire specific advice for your do vited diagnostic devices), please contact the Office of additionally 21 CFR Part 809.10 till With Creenstions on the promotion and advertising of
Compliance at [phone]. Additionally, for questions on the promotion and adve Compliance at [phone]. Additionally, for quest.25 (594-4639. Also, please note the your device, prease comace the Office of eene to premarket notification (21CFF Part 807.97).
regulation entitled, "Misbranding by reference to premarket notification the regulation entitled, Millsoranding of references to proder the Act may be obtained from the Other general information on your responsional and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

uriam C. Provost

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

Enclosure

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013904

Page 1 of 1

um 510(k) Number (if known):

3 10(K) Nambor (1 1 1 - 1 - 1 - 1 - 1 - 1 - Frqeuency Perforation Generator
Device Name: _____________________________________________________________________________________

Indications For Use:

indications Por Use.
The BMC Radio Frequency Perforation Generator; Model RFP-100-115 (For Domestic Use) and The BMC Radio Frequency Perforation Generalor, Model REP-200-2007 (11:45)
Model RFP-100-230 (For International Use) is indicated for use in general surgical procedures to cu and coagulate soft tissue.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Perscription use: X

(Optional Format 3-10-98)

Muriam C. Provost

sion Sign-Off Division of General, Restorative and Neurological Devices

510(k) Number K013904