(88 days)
The Kirwan Model 28 1500 Generator is a general purpose solid state monopolar generator with independent 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.
An isolated output monopolar electrosurgery generator with independent bipolar electrosurgery generator. The monopolar generator has continuously adjustable 0-150 watts in three cut modes of cut, blend 1, blend 2 and two coagulation modes 0-75 watts. The bipolar generator is continuously adjustable 0-50. Outputs of both generators are independently controlled and RF isolated from each other. Each generator handswitch system is powered by independent low voltage (7 Vdc) isolated power supplies. Audio and Visual monitors are in accord with IEC 601-1-2 and ANSI HF-18 guidelines. RF and Low Frequency leakages are well within IEC 601-1-2 and ANSI HF-18 safety guide lines for isolated (body floating) monopolar electrosurgerygenerators and bipolar coagulators.
The document provided is a 510(k) summary for the Kirwan Model 28 1500 Electrosurgery Generator. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical study data with specific acceptance criteria and performance metrics described in your request.
Therefore, the provided text does not contain the information requested regarding:
- A table of acceptance criteria and reported device performance. The submission primarily discusses technical specifications and adherence to safety guidelines (IEC 601-1-2 and ANSI HF-18) for leakage and monitoring, but not performance metrics relative to clinical acceptance criteria.
- Sample size and data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size and ground truth establishment for a training set.
The document states that the device is an "isolated output monopolar electrosurgery generator with independent bipolar electrosurgery generator" and specifies power outputs for different modes (cut, blend, coagulation). It also mentions that "Audio and Visual monitors are in accord with IEC 601-1-2 and ANSI HF-18 guidelines" and "RF and Low Frequency leakages are well within IEC 601-1-2 and ANSI HF-18 safety guide lines." These are safety and technical specifications, not clinical performance acceptance criteria or results of a study designed to demonstrate such.
The FDA's review concludes that the device is "substantially equivalent" to legally marketed predicate devices, which is the primary criterion for 510(k) clearance. This determination is based on comparing the device's technical characteristics and intended use to those of existing devices, rather than on new clinical effectiveness studies with the specific details requested in your prompt.
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U.S. Food and Drug Administration 510K Document Mail Center HFZ-401 Center for Medical Devices 9200 Corporate Boulevard Rockville, Maryland 20850
To: Document Control Clerk
This summary of 510K safety and effectiveness for the Kirwan Model 28 1500 electrosurgery generator is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
An isolated output monopolar electrosurgery generator with independent bipolar electrosurgery generator. The monopolar generator has continuously adjustable 0-150 watts in three cut modes of cut, blend 1, blend 2 and two coagulation modes 0-75 watts. The bipolar generator is continuously adjustable 0-50. Outputs of both generators are independently controlled and RF isolated from each other.
Each generator handswitch system is powered by independent low voltage (7 Vdc) isolated power supplies.
Audio and Visual monitors are in accord with IEC 601-1-2 and ANSI HF-18 guidelines.
RF and Low Frequency leakages are well within IEC 601-1-2 and ANSI HF-18 safety guide lines for isolated (body floating) monopolar electrosurgerygenerators and bipolar coagulators.
Sincerely,
Kambhavi
6/12/98
Kevin Prario Manager, Quality Assurance Kirwan Surgical Products, Inc. 180 Enterprise Drive Marshfield, Massachusetts 02050 Date 06/12/98
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 8 1998
Mr. Kevin Prario Manager, Quality Assurance Kirwan Surgical Products, Inc. 180 Enterprise Drive Marshfield, Massachusetts 02050
Re: K982176
Trade Name: Kirwan Model 28 1500 Electrosurgery Generator Regulatory Class: II Product Code: GEI Dated: June 12, 1998 Received: June 22, 1998
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 legally marketed predicate 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 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/dsma/dsmamain.html".
Sincerely yours,
Elia Watt
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__________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known) K982126
Device Name: KIRWAN MODEL 1500 ELECTROSURGERY GENERATOR
Indications for use:
The Kirwan Model 28 1500 Generator is a general purpose solid state monopolar generator with independent 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.
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Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over The Counter Use (Per 21 CFR 801.109) (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.