The ESU-1 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 ESU-1 Electrosurgical Generator is a high frequency isolated generator that utilizes electrical current via an assortment of surgical devices to cut and coagulate different types of tissue. The ESU-1 Electrosurgical Generator features cutting up to 300 watts with 2 cut modes, including "Cut T", a blend mode with 4 levels, 3 coagulation modes and 4 bipolar modes with Auto Bipolar option. "Cut T" mode is a new feature that includes a timing feature which automatically ceases RF activation after a user selectable period of time that can be altered between 0.1 and 3.0 seconds. The RF activation for Cut T mode is initially pre-set at 2 seconds (Note: if the operator changed these settings, the generator will powerup with the mode and setting in which the operator last activated the generator). The generator offers 2 monopolar headpiece outputs, monopolar foot controlled output, bipolar handpiece output, and bipolar foot controlled output. The generator has a return electrode sensing feature allows the user to use either a split or solid return electrode site. The padsensing feature allows the user to use either a split or solid return electrode.

The device consists of a generator and power cord and is packaged with a User's Guide in a cardboard shipping box with protective foam inserts. The main device components are a front panel containing the power button, wattage selection buttons, LED numeric display, 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 fuse, and internal components (printed circuit boards, speakers, cabling).

AI/ML Overview

The provided FDA 510(k) summary for the ESU-1 Electrosurgical Generator focuses on demonstrating substantial equivalence to a predicate device (Bovie® IDS-310 Electrosurgical Generator) through engineering and performance testing. It does not describe acceptance criteria or a study proving that the device meets those criteria in the context of clinical efficacy or diagnostic accuracy.

This document outlines a regulatory clearance process based on establishing similarity and safety/performance equivalence to a previously cleared device, rather than a de novo clinical study proving a specific performance benefit or diagnostic criterion.

Therefore, many of the requested categories (like sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size) are not applicable to the information provided in this 510(k) summary.

Here's an analysis of what is available:

1. Table of Acceptance Criteria and Reported Device Performance (as far as discernible from the document):

Acceptance Criteria Category	Reported Device Performance (Summary from Document)
Safety & Essential Performance (Standards Compliance)	The ESU-1 complies with IEC60601-1 (third edition), IEC60601-2 (electromagnetic compatibility), and IEC60601-2-2 standard for the safety of electrosurgical equipment.
Design Specifications	Bench testing was performed to demonstrate that the generator met its design specifications. The results from these tests demonstrate that the technological characteristics and performance criteria of the ESU-1 are adequate for the intended use of the device.
Technological Equivalence to Predicate Device	The ESU-1 has the same intended use/indications for use as the Bovie IDS-310. Each device is identical in size, weight, construction, uses high-frequency RF current, offers monopolar and bipolar output modes, offers the same waveforms, output frequencies, and maximum output power for all monopolar modes and for Micro, Standard, and Bovie Bipolar modes. Both have AutoBipolar Feature, same Return Electrode Monitoring System, same chassis, interconnections, internal PCBs, electrical components, and rated duty cycle. The RF output for both generators is identical.
New Feature Performance (Cut T mode)	"Cut T" mode includes a timing feature which automatically ceases RF activation after a user selectable period of time (0.1 to 3.0 seconds). Initially pre-set at 2 seconds. This mode replaces the Cut II function on the IDS-310. Specific performance values for Cut T mode are not explicitly stated beyond its functional description.

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

Not applicable. This summary refers to "bench testing" and "design verification and validation" on the ESU-1 or "devices representative of its design." This is not a clinical study with human subjects, so there is no "test set" in the sense of patient data.

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

Not applicable. No expert ground truth typical of diagnostic or clinical performance studies is mentioned. The "ground truth" here is compliance with engineering standards and design specifications.

4. Adjudication method for the test set:

Not applicable. No expert review or adjudication process for a test set is mentioned.

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 document pertains to an electrosurgical generator, not an AI-assisted diagnostic or therapeutic device that would involve human readers or AI improvement studies.

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

Not applicable. This device is an electrosurgical generator; it does not involve algorithms for standalone performance in the context of diagnostic AI. The software for the ESU-1 was "verified and validated based on its moderate level of concern," which refers to software functionality and safety within the device, not a performant algorithm.

7. The type of ground truth used:

For the performance testing, the "ground truth" seems to be compliance with engineering design specifications and recognized international safety and performance standards (e.g., IEC 60601 series). It also includes demonstrating functional equivalence to the predicate device.

8. The sample size for the training set:

Not applicable. This document does not describe the development of a machine learning algorithm with a training set. The "bench testing" would involve testing the physical device and its software's adherence to specifications.

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

Not applicable. As no training set for an AI algorithm is mentioned, this question is not relevant.

Summary

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

November 10, 2016

TVA Medical, Inc. Ms. Katherine Kumar VP of Regulatory & Clinical Affairs 7000 Bee Caves Rd., Suite 250 Austin, Texas 78746

Re: K162656

Trade/Device Name: ESU-1 Electrosurgical Generator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: September 21, 2016 Received: September 23, 2016

Dear Ms. Kumar:

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 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 devicerelated 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,

Jennifer R. Stevenson -A

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K162656

Device Name ESU-1 Electrosurgical Generator

Indications for Use (Describe)

The ESU-1 Electrosurgical Generator is used to deliver RF energy via an assortment of surgical devices to cut and coagulate different kinds of tissue.

Type of Use (Select one or both, as applicable)	Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY (K162656)

ESU-1 Electrosurgical Generator

510(k) Owner

TVA Medical, Inc. 7000 Bee Caves Rd., Suite 250 Austin, TX 78746

Official Correspondent

Katherine Kumar, PhD, RAC TVA Medical, Inc. VP of Regulatory & Clinical Affairs 7000 Bee Caves Rd., Suite 250 Austin, TX 78746

Email: kkumar@tvamedical.com Phone: 612-716-5578 (cell) Fax: 612-435-0292

Date Prepared: September 8, 2016

Subject Device Name

Trade Name	ESU-1 Electrosurgical Generator
Common or usual name	Electrosurgical Generator
Classification name	Electrosurgical Cutting and CoagulationDevice and Accessories [21 CFR 878.4400product code GEI]
Class	II
Classification Panel	General and Plastic Surgery (79)

Predicate Device

Bovie® IDS-310 Electrosurgical Generator [Bovie Medical Corporation; K134054]

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Device Description

Indications for Use

The ESU-1 Electrosurgical Generator [ESU-1] is used to deliver RF energy via an assortment of surgical devices to cut and coagulate different kinds of tissue.

Comparison of Indications for Use to Predicate Device

The ESU-1 has the same indications for use as the Bovie IDS-310.

Comparison of Technological Characteristics to Predicate Device

The ESU-1 has the following similarities to the Bovie IDS-310:

Both devices have the same intended use/indications for use
. Each device is identical in size, weight and construction.
Each device uses high frequency RF current to deliver a desired clinical effect.
Each device offers monopolar and bipolar output modes.
Each device offers the same waveforms, output frequencies and maximum output . power for all monopolar modes.

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. Each device offers the same waveforms, output frequencies and maximum output power for Micro. Standard and Bovie Bipolar modes.
Each device offers the AutoBipolar Feature.
Each device offers the same Return Electrode Monitoring System.
. Each device has the same chassis.
Each device has the same interconnections, internal printed circuit boards and electrical components.
. Each device has the same rated duty cycle.

The RF output for both generators is identical and both generators have identical modes with the exception that the ESU-1 has a "Cut T" mode, which includes a timing feature which automatically ceases RF activation after a user selectable period of time that can be altered between 0.1 and 3.0 seconds. The RF activation for Cut T mode is initially pre-set at 2 seconds. The Cut T mode replaces the Cut II function on the IDS-310. The RF output for both generators is identical.

Performance testing

The software for the ESU-1 has been verified and validated based on its moderate level of concern. The ESU-1 complies with IEC60601-1 (third edition), IEC60601-2 (electromagnetic compatibility), and IEC60601-2-2 standard for the safety of electrosurgical equipment. Bench testing was performed to demonstrate that the generator met its design specifications. The testing consisted of Mechanical Verification Testing, Inspection Verification Testing, Electrical Verification Testing, Shipping Study, FPGA Validation for Main Board, FPGA Validation for Display Board and was conducted on the ESU-1 or devices representative of its design.

The results from these tests demonstrate that the technological characteristics and performance criteria of the ESU-1 are adequate for the intended use of the device and that the device can perform in a manner equivalent to devices currently on the market with the same intended use.

Sterilization

The ESU-1 Electrosurgical Generator is a non-sterile device.

Biocompatibility

The ESU-1 Electrosurgical Generator is not a patient contacting device.

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Conclusion

The ESU-1 met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs. The ESU-1 is substantially equivalent to legally marketed predicate devices.

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.