The IDS-310 High Frequency Electrosurgical Generator is used to deliver RF energy via an assortment of surgical devices to cut and coagulate different kinds of tissue.

Device Description

The IDS-310 Electrosurgical Generator is an electrosurgical device that utilizes High Frequency electrical current, via an assortment of surgical devices to cut and coagulate different kinds of tissue.

The IDS-310 Generator is a high frequency isolated generator featuring cutting up to 300 watts, 4 blend modes, 3 coagulation modes and 4 bipolar modes with an Auto Bipolar option. 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 offers 2 monopolar handpiece outputs, monopolar foot controlled output, bipolar handpiece output, and bipolar foot controlled output. The generator has a return electrode contact and quality monitoring system (NEM) to reduce the risk of patient burns at the return electrode site. The pad-sensing feature allows the user to use either a split or solid return electrode.

The generator is designed to comply with applicable Medical Electrical Equipment safety standards, including electromagnetic compatibility and other safety standards. It is also designed to meet the requirements of the European RoHS directive.

The device consists of a generator, power cord, and a User's Guide. The main device components are a front panel containing the power button, wattage selection buttons, LED numeric displays, alarm and return electrode indicator lights, and connector ports for accessories, a back panel consisting of footswitch ports, volume controls, a power cord outlet, and internal components (printed circuit boards, speakers, cabling).

AI/ML Overview

The provided document describes a 510(k) summary for the Bovie® IDS-310 High Frequency Electrosurgical Generator, focusing on establishing substantial equivalence to predicate devices rather than detailing a study with specific acceptance criteria for performance measures like sensitivity, specificity, or reader improvement.

Therefore, many of the requested sections about acceptance criteria and study design elements (like sample size for test sets, expert qualifications, MRMC studies, or training sets) are not applicable or not present in this type of regulatory submission.

This submission primarily relies on bench testing and comparison to predicates to demonstrate that the device meets design specifications and is substantially equivalent to existing legally marketed devices.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Demonstrated via compliance with standards & similarity to predicates)	Reported Device Performance
Safety Standards Compliance:	Compliant:
- IEC 60601-1 (General requirements for basic safety and essential performance)	The generator is designed to comply with applicable Medical Electrical Equipment safety standards. Device testing and evaluation demonstrated compliance with IEC 60601-1: 2005.
- IEC 60601-1-2 (Electromagnetic Compatibility - Requirements and Tests)	Device testing and evaluation demonstrated compliance with IEC 60601-1-2: 2007.
- IEC 60601-2-2 (Particular requirements for high frequency surgical equipment)	Device testing and evaluation demonstrated compliance with IEC 60601-2-2: 2007.
- RoHS Directive Compliance (Restriction of Hazardous Substances)	The IDS-310 was designed compliant with the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (RoHS) Directive.
Intended Use:	Same Intended Use as Predicate Devices:
- To deliver RF energy via surgical devices to cut and coagulate tissue	The IDS-310 "is used to deliver RF energy via an assortment of surgical devices to cut and coagulate different kinds of tissue," which is identical to the primary predicate (Bovie IDS-300) and very similar to the secondary predicate (ERBE VIO300D). The Bovie IDS-310 has the same intended use as the predicate devices.
Technology / Principle of Operation:	Same Technology and Principles of Operation:
- High Frequency (RF) energy	Uses High Frequency (RF) electrical current. The Bovie IDS-310 utilizes the same technology and principles of operation as the predicate devices.
- Monopolar and Bipolar output	Offers Monopolar and Bipolar output.
- Waveform characteristics (frequency, duration, shape) producing clinical effect	Characteristic electrical waveforms 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 Cut I/II, Blend, Pinpoint Coagulation, and Spray Coagulation modes of the IDS-310 and primary predicate IDS-300 have the same waveform and maximum output power. The Bovie Bipolar mode of the IDS-310 has a similar waveform and the same output power as the VIO 300D BiClamp mode. Other IDS-310 Bipolar modes are similar to VIO 300D Bipolar modes but have lower output power.
Safety Features:	Equivalent Safety Features:
- Return electrode contact and quality monitoring system (NEM)	Has a return electrode contact and quality monitoring system (NEM) to reduce the risk of patient burns. The pad-sensing feature allows the use of split or solid return electrodes.
No New Safety/Efficacy Issues:	No New Issues Identified:
- Device does not raise additional issues of safety or efficacy	The Bovie IDS-310 does not raise additional issues of safety or efficacy compared to the predicate devices.

2. Sample size used for the test set and the data provenance:

Not Applicable. This submission is for an electrosurgical generator, not an AI or diagnostic device that uses "test sets" in the typical sense of medical image analysis or similar diagnostic applications. The "testing" involved bench testing to verify compliance with engineering and safety standards.
Data Provenance: Not relevant for this type of device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. Ground truth in the context of expert consensus is not applicable here as the device is not a diagnostic tool or an AI algorithm requiring human interpretation for validation. The device's performance is assessed against engineering specifications and safety standards.

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

Not Applicable. Adjudication methods are not relevant for this type of device submission.

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:

No. This is not an AI-assisted device subject to an MRMC study.

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

Not Applicable. This is not an algorithm. The device, an electrosurgical generator, operates as intended based on its design and validated performance against standards.

7. The type of ground truth used:

For this device, the "ground truth" is primarily based on established engineering and safety standards (e.g., IEC 60601 series) and functional specifications derived from the predicate devices. Bench testing demonstrated that the generator met its design specifications and complied with these standards. The clinical effectiveness is inferred from its similarity in operating principles, waveforms, and intended use to already-marketed and accepted predicate devices.

8. The sample size for the training set:

Not Applicable. This is not a machine learning or AI device that requires a training set.

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

Not Applicable. As there is no training set mentioned, this question is not applicable.

Summary

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MAR 1 7 2014

K134054

page 1 of 4

510(k) SUMMARY

(Submitted As Required per 21 CFR 807.92(c))

GENERAL INFORMATION:

510k Owner's Name

Bovie Medical Corporation

Establishment Registration Number: 3007593903

Address

5115 Ulmerton Road Clearwater, Florida 33760-4004 United States of America

Telephone Number: FAX Number:

Contact Person:

Richard A. Kozloff Vice-President; Quality Assurance/Regulatory Affairs

Date Prepared:

December 27, 2013

(727) 384-2323

(727) 322-4465

DEVICE IDENTIFICATION:

Trade Name/Model Number:

Common Name:

Classification Name:

Classification:

Legally Marketed Predicate Device(s): Bovie® IDS-310 High Frequency Electrosurgical Generator

Electrosurgical Generator (ESU)

Electrosurgical Cutting and Coagulation Device and Accessories

21CFR 878.4400; Class II; Product Code GEI

510(k) Number: K022856

Primary Predicate Device Name:

Bovie IDS-300 High Frequency Electrosurgical Generator

Manufacturer: Bovie Medical Corporation

510(k) Number: K083452

Secondary Predicate Name: ERBE VIO ESU (Model VIO 300D) Manufacturer: ERBE USA, INC.

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K134054

510(k) SUMMAR Y

(Submitted As Required per 21 CFR 807.92(c))

Device Description:

Bench testing was performed to demonstrate that the generator met design specifications and to establish substantial equivalence with predicate devices. Device testing and evaluation demonstrated compliance with the following:

IEC 60601-1: 2005

Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance

IEC 60601-1-2: 2007

Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility -Requirements and Tests

IEC 60601-2-2: 2007

Medical Electrical Equipment - Part 2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

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K134054

510(k) SUMMARY

(Submitted As Required per 21 CFR 807.92(c))

Substantial Equivalence:

Characteristic	Bovie® IDS-310(This Submission)	Bovie IDS-300High FrequencyElectrosurgicalGenerator(K022856)Primary Predicate	ERBE ESUVIO300D(K083452)Secondary Predicate
Regulation andProduct Code	21 CFR 878.4400 /GEI	Same	Same
Intended Use	Is used to deliver RFenergy via anassortment of surgicaldevices to cut andcoagulate differentkinds of tissue	Same	Is intended to deliverhigh frequency (HF)electrical current forthe cutting and/orcoagulation of tissue.
Energy Type	High Frequency (RF)	High Frequency (RF)	High Frequency (RF)
Output	Monopolar andBipolar	Monopolar andBipolar	Monopolar andBipolar

Similarities

Each device Uses high frequency RF current to deliver a desired clinical effect.

Each device offers monopolar and bipolar output modes.

The Cut I/II, Blend, Pinpoint Coagulation, and Spray Coagulation modes of the IDS-310 and IDS-300 predicate devices have the same waveform and maximum output power. The Bovie Bipolar mode of the IDS-310 has a similar waveform and the same output power as the VIO 300D BiClamp mode. Other IDS-310 Bipolar modes are similar to VIO 300D Bipolar modes but have lower output power.

Differences

The IDS-310 was designed compliant with both IEC 60601-1 Third Edition and the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (RoHS) Directive.

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K134054.

510(k) SUMMARY

(Submitted As Required per 21 CFR 807.92(c))

Conclusions

The Bovie IDS-310 High Frequency Electrosurgical Generator has the same intended use, operating procedures, principles of operation, and utilizes the same technology as the predicate devices. The Bovie IDS-310 does not raise additional issues of safety or efficacy compared to the predicate devices.

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Public Health Service

Food und Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MID 20993-0002

DEPARTMENT OF HEALTH & HUMAN SERVICES

March 17, 2014

Bovie Medical Corporated Mr. Richard A. Kozlofí Vice President, Quality Assurance/Regulatory Affairs 5115 Ulmerton Road Clearwater, Florida 33760

Re: K134054

Trade/Device Name: Bowie® IDS-310 High Frequency 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: December 27, 2014 Received: December 31, 2014

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 FIDA'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); medical device reporting of medical

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Page 2 - Mr. Richard A. Kozloff

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Felipe Aguel

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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Indications for Use

K134054 510(k) Number (if known):

Device Name: Bovie IDS-310 High Frequency Electrosurgical Generator

Indications for Use:

The IDS-310 High Frequency Electrosurgical Generator is used to deliver RF energy via an assortment of surgical devices to cut and coagulate different kinds of tissue.

Prescription Use __ V (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) Long H. -A 100.100.1.1 = 1300369054 for BSA (Division Sign-Off) Division of Surgical Devices 4-2 510 (K) Number: K134054

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.