The Bovie IDS-400 Electrosurgical Generator is a non-sterile, reusable multi-purpose electrosurgical generator that is designed to perform monopolar and bipolar functions in the operating arena.

Device Description

The Bovie IDS-400 Electrosurgical Generator is a non-sterile, reusable multi-purpose electrosurgical generator that is designed to perform monopolar and bipolar functions in the operating arena. 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 arc comparable between the generator and predicate devices. The Generator functions in any of six user selectable modes: Monopolar Cut I/II, Blend, Coagulation (Pinpoint), Fulguration (Spray Coagulation), and Bipolar.

AI/ML Overview

The provided text describes a 510(k) submission for the Bovie IDS-400 Electrosurgical Generator. This type of regulatory submission establishes substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria through a clinical study with performance metrics in the way a novel therapeutic or diagnostic device might.

Therefore, the requested information elements (1 through 9) related to a study proving acceptance criteria are largely not applicable in this context. The document focuses on demonstrating that the new device operates similarly to an already cleared device and presents no new safety risks.

Here's a breakdown of why and what information can be gleaned:

1. A table of acceptance criteria and the reported device performance

Not Applicable. The document does not define specific performance acceptance criteria for the Bovie IDS-400 in terms of clinical outcomes or diagnostic accuracy. Instead, it states that the device's electrical waveforms (frequency and duration) "produce the clinical effect (i.e. cut, coagulation)" and are "comparable between the generator and predicate devices." This implies that the 'acceptance criteria' are functional equivalence to the predicate, verified through engineering design and testing, rather than clinical performance metrics.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. This document does not describe a clinical study with a test set of patients or data samples. The "testing" mentioned would typically involve engineering verification and validation (V&V) on the device itself (e.g., measuring output parameters, safety testing, electromagnetic compatibility) to ensure it meets its own design specifications and is comparable to the predicate. No patient data is involved.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. As no clinical "test set" or diagnostic evaluation is described, there's no ground truth established by experts in this context. The validation involves engineering expertise to compare device parameters and performance to the predicate.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. There's no clinical test set requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This is an electrosurgical generator, not an AI-assisted diagnostic or interpretive device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not Applicable. This device is a surgical tool, operated by humans to perform electrosurgery. It is not an algorithm running in standalone mode.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable. For this type of device, the "ground truth" for substantial equivalence is the established and safe performance of the predicate device. The Bovie IDS-400 is compared against the Aaron IDS-300's known operational characteristics and safety profile.

8. The sample size for the training set

Not Applicable. There is no "training set" in the context of an electrosurgical generator's regulatory submission. There is no machine learning model involved.

9. How the ground truth for the training set was established

Not Applicable. No training set is involved.

Summary of Device Performance (from the document):

The Bovie IDS-400 Electrosurgical Generator's performance is established through equivalence to its predicate device, the Aaron IDS-300. The key performance claims are:

Operation: Delivers high-frequency radiofrequency (RF) energy.
Clinical Effect: Electrical waveform properties (frequency and duration) produce cutting and coagulation effects.
Comparability: "The shape and duration of waveforms are comparable between the generator and predicate devices."
Modes of Operation: Functions in six user-selectable modes: Monopolar Cut I/II, Blend, Coagulation (Pinpoint), Fulguration (Spray Coagulation), and Bipolar.
Safety: Designed to comply with applicable Medical Electrical Equipment safety standards, including electromagnetic compatibility. "There are no new hazards presented with the use of the Bovie IDS-400 Electrosurgical Generator as compared with the predicate device."

Conclusion:

This document is a 510(k) summary, which aims to demonstrate substantial equivalence to a legally marketed predicate device (Aaron IDS-300) rather than presenting a clinical study with detailed performance acceptance criteria and associated study data as might be seen for a novel diagnostic or therapeutic device. The "acceptance criteria" here are effectively met by demonstrating that the new device functions similarly to the predicate and introduces no new safety or effectiveness concerns.

Summary

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

DEVICE OPERATION:

The Bovie IDS-400 (the Generator) operates by dclivering 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 arc comparable between the generator and predicate devices.

The Generator functions in any of six user selectable modes:

Monopolar Cut I/II The cut modes allow the user to utilize electrosurgical current to vaporize or cut tissue.

Blend: The monopolar cutting speed and degree of hemostasis is controlled by the Monopolar blend control.

Coagulation (Pinpoint): Coagulation, also referred to as pinpoint coagulation, is used with forceps, blade, or needle electrodes and endoscopic devices. Coagulation is intended for use of small defined tissue areas. Coagulation is used to activate the generator prior to contacting tissue. Once the desired effect is achieved, the electrode is removed from the tissue area and deactivated. This coagulation mode provides precise control of bleeding in localized areas.

Fulguration (Spray Coagulation): Fulguration, also referred to as spray coagulation provides greater control of bleeding in highly vascularized tissues over broad surface areas. This mode is used with all types of pencil electrodes, endoscopic devices and clamps. Areas are repeatedly sprayed until desired hemostasis is established and can be used on all types of tissue.

The bipolar procedure is activated when performing coagulation with bipolar Bipolar: forceps.

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 cquivalent to the Aaron IDS-300 Electrosurgical Generator (K022856). There are no new hazards presented with the use of the Bovie IDS-400 Electrosurgical Generator as compared with the predicate device.

INTENDED USE:

The Bovie IDS-400 Electrosurgical Generator is a non-sterile, reusable multi-purpose electrosurgical generator that is designed to perform monopolar and bipolar functions in the operating arena.

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K072041 p. 2 of 2

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

GENERAL INFORMATION:

510k Owner's Name	Bovie Medical
Address	3200 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:	July 23, 2007

DEVICE DESCRIPTION:

Trade Name:

Common Name: Classification Name: Bovie IDS-400 Electrosurgical Generator

Electrosurgical Generator

Electrosurgical Cutting and Coagulation Devices and Accessories (21CFR 878.4400; Class II; Product Code GEI)

Predicate Devices: Aaron Medical

IDS-300 High Frequency Electrosurgical Generator

K022856

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The eagle is black, and the text is in a smaller font size.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 0 2008

Bovie Medical % Mr. Richard A. Kozloff Vice President, Quality Assurance/Regulatory Affairs 3200 Tyrone Boulevard, Suite A Saint Petersburg, Florida 33710-2902

Re: K072041

Trade/Device Name: Bovie IDS-400 Electrosurgical Generator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories. Regulatory Class: II Product Code: GEI Dated: March 31, 2008 Received: April 1, 2008

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.

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 A. 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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. Millerson

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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KO72041

Indications for Use

07204 510(k) Number (if known):

Bovie IDS-400 Electrosurgical Generator Device Name:

Indications for Use:

The Bovie IDS-400 Electrosurgical Generator is a non-sterile, reusable multi-purpose electrosurgical generator that is designed to perform monopolar and bipolar functions in the operating arena.

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)

ence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number K07204 4-2

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.