The ICON VS Electrosurgical Generator is intended to be used with Bovie Seal and Cut Instruments for sealing vessels and cutting tissues. 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, and seal). The shape and duration of waveforms are comparable between the generator and the predicate device. The Generator functions in any of the following user selectable modes: Pure Cut, Blend Mode 1, Blend Mode 2, Blend Mode 3, Special Cut, Laparoscopic Cut, Pinpoint Coagulation, Gentle Coagulation, Spray Coagulation, Laparoscopic Coagulation, Macro Bipolar, Micro Bipolar, Gentle Bipolar, Auto Stop Bipolar, Vessel Seal with Optional Power Cut. The generator is designed to comply with applicable Medical Electrical Equipment safety standards, including electromagnetic compatibility and other safety standards. Like the predicate device, the ICON VS incorporates an ergonomically designed user interface screen for the selection of device settings. The ICON VS uses identical technology to the predicate device and the waveform profiles for all cut, coagulation, and bipolar modes are identical. The ICON VS differs from the predicate device in that 1) it is designed to work with Bovie Seal and Cut Instruments (K-092208 pending review), 2) the vessel sealing mode on the ICON VS is less aggressive than the predicate device (90 watts of power versus 400 watts of power), and 3) the power cut mode on the ICON VS delivers 100 watts of power versus the predicate device which delivers 80 watts of power.

AI/ML Overview

The provided text is a 510(k) summary for the Bovie ICON VS Electrosurgical Generator. It focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a performance study with specific acceptance criteria and detailed quantitative results. Therefore, I cannot extract the requested information as it is not present in the document.

Here's why I cannot fulfill your request based on the provided text:

No Acceptance Criteria or Reported Performance Data: The document does not specify any quantitative acceptance criteria (e.g., "device must achieve 90% accuracy" or "power output must be within +/- 5% of target"). Similarly, it does not present reported device performance in terms of metrics like sensitivity, specificity, accuracy, or power output measurements compared against specific targets.
No Formal Study Design or Results: The text describes the device, its operation, and its intended use, and compares it to a predicate device. It states that "The ICON VS uses identical technology to the predicate device and the waveform profiles for all cut, coagulation, and bipolar modes are identical." It also notes differences in power output for vessel sealing and power cut modes. However, these are descriptive comparisons, not the results of a formal study with statistical analysis, sample sizes, ground truth establishment, or expert reviews as you've outlined for AI/diagnostic devices.
Focus on Substantial Equivalence: The primary objective of a 510(k) submission, as reflected in this summary, is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing technological characteristics, intended use, and performance characteristics qualitatively or through engineering tests, rather than clinical trials or reader studies that would generate the type of data you're asking for.
Device Type: This is an electrosurgical generator, a medical device that cuts and coagulates tissue using electrical current. The "acceptance criteria" and "study" framework you've described (e.g., MRMC studies, ground truth establishment by experts, pathology, training/test sets) are highly relevant for diagnostic devices, particularly those involving image analysis or AI. For electrosurgical generators, performance evaluation typically involves electrical safety testing, electromagnetic compatibility (EMC) testing, power output accuracy measurements, and functional testing to ensure the device performs its intended cutting and coagulation actions effectively and safely, often through bench testing or animal studies, not reader studies.

In summary, the provided 510(k) summary is a regulatory document focused on demonstrating substantial equivalence by comparing technological features and intended use, not a detailed report of a performance study with the specific metrics and methodologies you have requested for a diagnostic or AI-driven device.

Summary

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

383

GENERAL INFORMATION:

け

MAR 1 0 2010

. . . .

510k Owner's Name	Bovie Medical
Address	5115 Ulmerton RoadClearwater, Florida 33760-4004
Contact Person	Richard A. KozloffVice-President; Quality Assurance/Regulatory AffairsTelephone #: (727) 803-8513FAX Number: (727) 322-4465
Date Prepared:	07/31/2009
DEVICE DESCRIPTION:
Trade Name:	Bovie ICON VS Electrosurgical Generator
Common Name:	Electrosurgical Generator
Classification Name:	Electrosurgical Cutting and Coagulation Devices andAccessories (21CFR 878.4400; Class II; Product Code GEI)
Predicate Devices:

Bovie Medical

Bovie ICON GP General Purpose RF Generator (K-082109)

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

DEVICE OPERATION:

The ICON VS Electrosurgical Generator is intended to be used with Bovie Seal and Cut Instruments for sealing vessels and cutting tissues.

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, and seal). The shape and duration of waveforms are comparable between the generator and the predicate device.

The Generator functions in any of the following user selectable modes:

1. Pure Cut 2. Blend Mode 1
1. Blend Mode 2 4. Blend Mode 3
1. Special Cut 6. Laparoscopic Cut
1. Pinpoint Coagulation 8. Gentle Coagulation
Spray Coagulation 9. 10. Laparoscopic Coagulation
1. Macro Bipolar 12. Micro Bipolar
1. Gentle Bipolar 14. Auto Stop Bipolar
1. Vessel Seal with Optional Power Cut

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

Like the predicate device, the ICON VS incorporates an ergonomically designed user interface screen for the selection of device settings. The ICON VS uses identical technology to the predicate device and the waveform profiles for all cut, coagulation, and bipolar modes are identical. The ICON VS differs from the predicate device in that 1) it is designed to work with Bovie Seal and Cut Instruments (K-092208 pending review), 2) the vessel sealing mode on the ICON VS is less aggressive than the predicate device (90 watts of power versus 400 watts of power), and 3) the power cut mode on the ICON VS delivers 100 watts of power versus the predicate device which delivers 80 watts of power.

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

INTENDED USE:

The ICON VS Electrosurgical Generator is intended to be used with Bovie Seal and Cut Instruments for sealing vessels and cutting tissues.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of a bird or abstract human figures, with flowing lines suggesting movement or connection.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Bovie Medical Corporation % Mr. Richard A. Kozloff Vice President, Quality Assurance/ Regulatory Affairs 5115 Ulmerton Road Clearwater, Florida 33760-4004

MAR 1 0 2010

Re: K092383

Trade/Device Name: Bovie ICON VS Electrosurgical Generator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: February 05, 2010 Received: February 12, 2010

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Mr. Richard A. Kozloff

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Sincerely yours,

Mark N. Melkerson
Director

Division of Surgical, Orthopedic

DED DIRECTOR
3/10/0

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

Enclosure

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Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Bovie ICON VS Electrosurgical Generator

Indications for Use:

The ICON VS Electrosurgical Generator is intended to be used with Bovie Seal and Cut Instruments for sealing vessels and cutting tissues.

イ 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)

Neil R. Osada Csr mxm

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K092383

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.