(42 days)
The KIRWAN MODEL 28 1000 Generator is a general purpose solid state bipolar generator to supply the RF signal to electrosurgical handpieces used on soft body tissues where a wide range of tissue types, patient conditions, and load impedances are encountered.
A 0-50 digital display power setting indicator provides the operator a parallax free reading of the power setting (+/- Swatts, full scale (@ 100 ohms). A bar graph display output current monitor provides the operator a relative measure of the output current amplitude and to denote the presence of output energy during activation. The handswitch is powered by an independent low voltage (7 Vdc) isolated power supply. Audio and Visual monitors are in accord with IEC 601-1-2 and ANSI HF-18 guidelines. IF and Low Frequency leakages are well within IEC 601-1-2 and ANSI HF-18 safety guide lines for isolated (body floating) ipolar coagulators.
This document describes the Kirwan 28 1000 Coagulator, specifically a 510(k) premarket notification for a predicate device. It does not contain information about acceptance criteria or a study proving a device meets those criteria.
Therefore, I cannot provide the requested information. The provided text is a regulatory submission for a medical device, not a performance study.
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S. Food and Drug Administration 0K Document Mail Center HFZ-401 Center for Medical Devices 1390 Piccard Drive Rockville, Maryland 20850
MAY 2 2 1997
K 971341
To: Document Control Clerk
This summary of 510K safety and effectiveness for the Kirwan 28 1000 Coagulator is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807,92.
A 0-50 digital display power setting indicator provides the operator a parallax free reading of the power setting (+/- Swatts, full scale (@ 100 ohms).
A bar graph display output current monitor provides the operator a relative measure of the output current amplitude and to denote the presence of output energy during activation.
The handswitch is powered by an independent low voltage (7 Vdc) isolated power supply.
Audio and Visual monitors are in accord with IEC 601-1-2 and ANSI HF-18 guidelines.
IF and Low Frequency leakages are well within IEC 601-1-2 and ANSI HF-18 safety guide lines for isolated (body floating) ipolar coagulators.
This device is identical to an existing approved device.
Sincerely,
Kembra Pfahler
Kevin Prario Manager, Regulatiory Affairs Kirwan Surgical Products Inc. 180 Enterprise Drive Box 427 Marshfield, Massachusetts 02050
4/9/97
Date
Date
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 2 1997
Mr. Kevin Prario Manager, Regulatory Affairs Kirwan Surgical Products, Inc. 180 Enterprise Drive Marshfield, Massachusetts 02050
Re: K971341 Trade Name: Kirwan Model 28 1000 Biopolar Generator Regulatory Class: II Product Code: GEI Dated: April 9, 1997 Received: April 10, 1997
Dear Mr. Prario:
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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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. Kevin Prario
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 (301) 594-4595. 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/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
ﺍﻟﻤﺴﺘﻘ
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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Page__________________________________________________________________________________________________________________________________________________________________________
971341 510(k) Number (if known)
Device Name: KIRWAN MODEL 28 1000 BIPOLAR GENERATOR
Indications for use:
The KIRWAN MODEL 28 1000 Generator is a general purpose solid state bipolar generator to supply the RF signal to electrosurgical handpieces used on soft body tissues where a wide range of tissue types, patient conditions, and load impedances are encountered.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Divisier) Stan-
Division of General Restorative Devices (471341
510(k) Number
Prescription Use
X(Per 21 CFR 801.109)
OR
Over The Counter Use
(Optional Format 1-2-96)
5
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
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.(b)
Classification. Class II.