The Bovie ICON GI Generator is used to deliver high frequency radiofrequency energy in conjunction with other surgical devices to cut and coagulate different kinds of tissues.

Device Description

The Bovie ICON GI (the Generator) operates by delivering high frequency radiofrequency (RF) energy which, when used in conjunction with other electrosurgical accessories, is used to cut and coagulate tissue. There is a characteristic electrical wave form associated with each mode. The electrical properties of the waveform (frequency and duration) produce the clinical effect (i.e. cut, coagulation). The shape and duration of waveforms are comparable between the generator and predicate devices. The Generator functions in any of seven user selectable modes: Cut, Blend, Smart Cut, Pinpoint Coagulation, Soft Coagulation, Bipolar Coagulation, Gentle Bipolar Coagulation. The generator is designed to comply with applicable Medical Electrical Equipment safety standards, including electromagnetic compatibility and other safety standards. The Generator uses technology substantially equivalent to the predicate devices, the Aaron IDS-300 (K022856) and the ERBE USA ERBOTOM ICC 200 (K933157). The generator incorporates an ergonomically designed user interface screen for the selection of device settings.

AI/ML Overview

The provided text describes the Bovie ICON GI Electrosurgical Generator and its intended use, but it does not contain information about acceptance criteria or a study proving the device meets those criteria.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device for FDA clearance. It describes the device's operation, compares it to predicate devices, and outlines its intended use.

Therefore, I cannot fulfill the request for information regarding acceptance criteria and a study proving their achievement. The provided text does not include any of the following details:

Table of acceptance criteria and reported device performance
Sample size for the test set or its provenance
Number of experts and their qualifications for ground truth establishment
Adjudication method for the test set
Multi-reader multi-case (MRMC) comparative effectiveness study or effect size
Standalone algorithm performance study
Type of ground truth used
Sample size for the training set
How ground truth for the training set was established

Summary

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KO61884

SEP - 6 2006

510(k) SUMMARY (As Required per 21 CFR 807.92(c))

GENERAL INFORMATION:

510k Owner's NameAddress	Bovie Medical3200 Tyrone Boulevard, Suite ASt. Petersburg, Florida 33710-2902
Contact Person	Richard A. KozloffVice-President; Quality Assurance/Regulatory AffairsTelephone #: (727) 803-8513FAX Number: (727) 347-9144
Date Prepared:	June 30, 2006
DEVICE DESCRIPTION:
Trade Name:	Bovie ICON GI Electrosurgical Generator
Common Name:	Electrosurgical Generator
Classification Name:	Electrosurgical Cutting and Coagulation Devicesand Accessories (21CFR 878.4400; Class II; ProductCode GEI)
Predicate Devices:
Aaron Medical	IDS-300 High FrequencyElectrosurgical Generator	K022856
ERBE USA, Inc.	Erbotom ICC 200	K933157

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K061884

DEVICE OPERATION:

The Generator functions in any of seven user selectable modes:

Cut a)
Blend b)
c) Smart Cut
d) Pinpoint Coagulation
Soft Coagulation e)
Bipolar Coagulation f)
Gentle Bipolar Coagulation g)

The generator is designed to comply with applicable Medical Electrical Equipment safety standards, including electromagnetic compatibility and other safety standards.

The Generator uses technology substantially equivalent to the predicate devices, the Aaron IDS-300 (K022856) and the ERBE USA ERBOTOM ICC 200 (K933157). The generator incorporates an ergonomically designed user interface screen for the selection of device settings. Although different from the user interface of the predicate devices, the difference does not affect the safety and effectiveness and may provide improved visualization of the device settings.

There are no new hazards presented with the use of the Bovie ICON GI generator as compared with the named predicate devices.

INTENDED USE:

The Bovie ICON GI Generator is used to deliver high frequency radiofrequency. energy in conjunction with other surgical devices to cut and coagulate different kinds of tissues.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a stylized representation of a human figure. The figure is composed of three abstract profiles facing to the right, symbolizing the department's focus on health and human well-being. The seal is in black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Bovie Medical % Mr. Richard Kozloff 3200 Tyrone Boulevard, Suite A St. Petersburg, Florida 33710

Re: K061884

Trade/Device Name: Bovie ICON GI Generator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting coagulation device and accessories Regulation Class: Class II Product Code: GEI Dated: June 30, 2006 Received: July 3, 2006

Dear Mr. Kozloff:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) 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 controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

SEP - 6 2006

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Richard Kozloff

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K061884

Device Name: Bovie ICON GI Generator

Indications for Use:

The Bovie ICON GI Generator is used to deliver high frequency radiofrequency energy in conjunction with other surgical devices to cut and coagulate different kinds of tissues.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number K061 8842

Regulation Number and Section

§ 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.