The EM3 AEM Monitor is an accessory for use with electrosurgical generators and electrodes that is designed to safely deliver electrosurgical energy and to prevent injury caused by insulation failure and capacitive coupling.

The EM3 AEM Monitor performs two distinct functions:

Active electrode monitoring is intended to control stray monopolar energy caused by insulation failure and capacitive coupling in surgical instruments on the shaft of the instrument.
End point monitoring is intended to aid the surgeon in determining the end point of bipolar electrosurgical desiccation.

Device Description

The EM3 AEM Monitor is the "nerve center" and interface to the electrosurgical generator and instruments for AEM monitoring, a safety system for minimally-invasive electrosurgery.

For monopolar electrosurgery. AEM technology prevents unanticipated or undetected burns from stray energy along the instrument outside the surgeon's field of view
In bipolar electrosurgery, the EM3 displays the measurement of high-frequency current flowing through the instrument and tissue as an aid in determining the endpoint of bipolar desiccation

The EM3 AEM Monitor system comprises two components

The Monitor or electronic unit.
A specific or standard ESU Adapter.

An ESU Adapter is an accessory to the Monitor containing cords and connectors, which connect the Monitor to the electrosurgical generator (ESU). Multiple models of ESU Adapters are required due to the wide variety of electrosurgical generators in the marketplace and in use in the hospitals.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the EM3 AEM Monitor, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Metric	Acceptance Criteria (Predicate EM2 AEM Monitor)	Reported Performance (EM3 AEM Monitor)
Intended Use	Monopolar active-electrode stray-energy shunting and monitoring and bipolar desiccation end-point monitoring	Identical to EM2
Operating Principle	Monopolar high-frequency current shunting, measuring, threshold detection, and alarming; Bipolar high-frequency ammeter measuring and indicating current; Interruption of electrosurgical current under fault condition by tripping ESU contact quality monitor alarm	Monopolar high-frequency current shunting, measuring, threshold detection, and alarming; Bipolar high-frequency ammeter measuring and indicating current; Direct interruption of electrosurgical current to active electrode under fault condition
Materials	Typical electronic wires, connectors, analog and logic components, circuit boards, and enclosures	Same as EM2
Energy Source	Mains power	Identical to EM2
Technology	Discrete logic components, PAL logic device, analog electronics, logic-level relay	FPGA logic device, analog electronics, HF power relays
Sterilization	None	None
Performance: Shield circuit to ESU return potential impedance	< 55 pF	< 55 pF
Performance: Alarm threshold current	350 mA	400 mA
Performance: Visual/audible indication from monitor (Alarm response time)	< 150 ms	< 150 ms
Performance: Power delivery cessation (Alarm response time)	> 300 ms (dependent on ESU circuit)	< 150 ms
Performance: Fault indication	Simultaneous active and return faults alarmed: active on EM2, return on ESU	Singular active fault indication from monitor
Performance: Current graph granularity	~30 mA	~120 mA
EMC and Electrical Safety	Internal design control assurances, IEC 60601-1 (2nd ed) compliant, IEC 60601-1-2 compliance, IEC 60601-2-2 compliance	Internal design control assurances, IEC 60601-1 (3rd ed) compliant, IEC 60601-1-2 compliance, IEC 60601-2-2 compliance

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "Complete verification and validation tests were performed in accordance with Design Control requirements per 21 CFR 820.30 for all essential specifications demonstrating substantial equivalence of the EM3 AEM Monitor to the predicate system." However, specific sample sizes for a test set (e.g., number of cases, number of devices) are not provided. The provenance of the data is not explicitly stated as retrospective or prospective, nor is the country of origin mentioned beyond the manufacturer being located in Boulder, CO, US.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. The study appears to be a bench test focused on the technical performance compared to a predicate device, rather than a clinical study requiring expert ground truth for interpretation (e.g., image analysis).

4. Adjudication Method for the Test Set

This information is not applicable/not provided as the study described is a technical bench test and verification, not a study involving human interpretation 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

No MRMC comparative effectiveness study was done or mentioned. This device is a safety monitoring system for electrosurgery, not an AI-powered diagnostic tool that human readers would use in conjunction with.

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

The study described is essentially a standalone performance evaluation of the device's technical specifications. The "algorithm" here refers to the device's built-in logic (FPGA firmware) for monitoring and alarm functions. The performance metrics listed (e.g., impedance, alarm threshold, response time) are intrinsic to the device's function and were tested independently of a human operator, though the device's output (alarms, current display) interacts with the human surgeon.

7. The Type of Ground Truth Used

The ground truth for the bench tests appears to be established technical specifications and engineering requirements, along with the performance characteristics of the predicate device (EM2 AEM Monitor). For example, the "alarm threshold current" has a defined value (400 mA).

8. The Sample Size for the Training Set

Not applicable. This device is hardware with embedded firmware, and the testing described is verification and validation against specifications, not a machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for a machine learning algorithm. The "ground truth" for the device's design and testing is based on engineering principles, safety standards (e.g., IEC 60601-1), and the performance of the predicate device.

Summary

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K122383

Image /page/0/Picture/1 description: The image shows the word "ENCISION" in bold, black letters. There is a logo to the right of the word that looks like a sphere with lines on it. Underneath the word is some smaller text that is difficult to read.

AECOM LANDMARK GRAPHIC INSTRUMENTS

510(k) Summary

JAN 1 0 2013

Device	EM3 AEM® Monitor
Owner	Encision, Inc.
	6797 Winchester Circle
	Boulder, CO 80301
	Phone: (303) 444-2600
	Fax: (303) 444-2693
Contact	James W LewisVP RAQA
Date of Summary	4 January 2013
Subject Device	Trade name	EM3 AEM Monitor
	Common name	Electrosurgical, Cutting & Coagulation &Accessories
	Classification	(21 CFR 878.4400, Class II,Product Code: GEI)
Predicate Device	Trade Names	EM2 AEM Monitor
	Market Clearance	510(k): K093622 (2010)
	Common name	Electrosurgical, Cutting & Coagulation &Accessories
	Classification	(21 CFR 878.4400, Class II,Product Code: GEI)

Device Description

The EM3 AEM Monitor is the "nerve center" and interface to the electrosurgical generator and instruments for AEM monitoring, a safety system for minimally-invasive electrosurgery.

. For monopolar electrosurgery. AEM technology prevents unanticipated or undetected burns from stray energy along the instrument outside the surgeon's field of view
In bipolar electrosurgery, the EM3 displays the measurement of high-frequency . current flowing through the instrument and tissue as an aid in determining the endpoint of bipolar desiccation

The EM3 AEM Monitor system comprises two components

The Monitor or electronic unit .
A specific or standard ESU Adapter .

Page 1 of 4

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Technological Characteristics

The AEM monitor performs different functions for the two types of electrosurgery.

Monopolarelectrosurgery	• Monitor connections shunt stray energy, attempting to pass throughthe insulated shaft of an AEM instrument by insulation breakdown orcapacitive coupling, back to the ESU
	• Monitor shuts down the electrosurgical procedure if the level of strayenergy reaches dangerous levels
Bipolarelectrosurgery	• Monitor displays the level of flow of electrosurgical current in real-time. (This information aids surgeons in determining the end pointof bipolar desiccation.)

The EM3 AEM Monitor is the third generation of AEM monitor; updating, simplifying and improving the features of the second-generation monitor, the EM2, while serving identical indications and uses.

Update	• Electronics/logic system modernized: circuits redesigned using identical analog elements/components while updating firmware to FPGA (field programmable gate array) logic
	• Alarm visuals—Visual alarms amber in color, per international standard
	• ESU adapter designs—Redesigned monopolar and bipolar adapters
	• ESU compatibility—Designed to accommodate new-generation ESU
Simplify	• Connections for hand-control instruments incorporated into monitor
	• Monopolar ESU adapters with fewer connections and wires
Improve	• Power-interruption response time by interrupting energy delivery directly rather than relying on ESU patient-electrode circuitry
	• Power measurement accuracy across the spectrum of possible electrosurgical waveforms with increased logic capacity of FPGA
	• Logic maintenance and support flexibility
	• Alarm discernment by presenting active-electrode-related alarms (monitor alarms) independent of return-electrode alarms (ESU alarm)

Intended Use

The EM3 AEM Monitor performs two distinct functions:

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Active electrode monitoring is intended to control stray monopolar energy caused by . insulation failure and capacitive coupling in surgical instruments on the shaft of the instrument.
End point monitoring is intended to aid the surgeon in determining the end point of . bipolar electrosurgical desiccation.

Equivalence:

Based on operating principle, intended use, technology, safety, and performance; the EM3 AEM Monitor is substantially equivalent to its predicate device, the EM2 AEM Monitor.

	EM3 AEM Monitor	EM2 AEM Monitor
Intended Use	Identical to EM2	Monopolar active-electrode stray-energyshunting and monitoring and bipolardesiccation end point monitoring
Operatingprinciple	• Monopolar high frequency currentshunting, measuring, threshold detection,and alarming	• Monopolar high frequency currentshunting, measuring, threshold detection,and alarming
	• Bipolar high frequency ammetermeasuring and indicating current	• Bipolar high frequency ammetermeasuring and indicating current
	• Direct interruption of electrosurgicalcurrent to active electrode under faultcondition	• Interruption of electrosurgical currentunder fault condition by tripping ESUcontact quality monitor alarm
Materials	Same as EM2	Typical electronic wires, connectors, analogand logic components, circuit boards, andenclosures
Energysource	Identical to EM2	Mains power
Technology	• FPGA logic device	• Discrete logic components
	• Analog electronics	• PAL logic device
	• HF power relays	• Analog electronics
		• Logic-level relay
Sterilization	None	None
Performance	• Shield circuit to ESU return potentialimpedance: < 55 pF	• Shield circuit to ESU return potentialimpedance: < 55 pF
	• Alarm threshold current: 400 mA	• Alarm threshold current: 350 mA
	• Alarm response time	• Alarm response time
	• Visual/audible indication frommonitor: < 150 ms	• Visual/audible indication frommonitor: < 150 ms
	• Power delivery cessation: < 150 ms	• Power delivery cessation: > 300 ms(dependent on ESU circuit)
	• Singular active fault indication frommonitor	• Simultaneous active and return faultsalarmed: active on EM2, return on ESU
	• Current graph granularity: ~ 120 mA	• Current graph granularity: ~30 mA

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	EM3 AEM Monitor	EM2 AEM Monitor
EMC andElectricalSafety	• Internal design control assurances	• Internal design control assurances
	• IEC 60601-1 (3rd ed) compliant	• IEC 60601-1 (2nd ed) compliant
	• IEC 60601-1-2 compliance	• IEC 60601-1-2 compliance
	• IEC 60601-2-2 compliance	• IEC 60601-2-2 compliance

Bench Tests:

Complete verification and validation tests were performed in accordance with Design Control requirements per 21 CFR 820.30 for all essential specifications demonstrating substantial equivalence of the EM3 AEM Monitor to the predicate system.

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

Letter dated: January 10, 2013

Encision, Inc. % Jim Lewis 6797 Winchester Cir. Boulder, CO 80301 US

Re: K122383

Trade Name: EM3 AEM Monitor AEM Connectors Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: December 14, 2012 Received: December 17, 2012

Dear Mr. Lewis:

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 (reporting of medical 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.

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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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K122383

Device Name: EM3 AEM Monitor

Indications for Use:

The EM3 AEM Monitor performs two distinct functions:

Active electrode monitoring is intended to control stray monopolar energy caused by . insulation failure and capacitive coupling in surgical instruments on the shaft of the instrument.
· End point monitoring is intended to aid the surgeon in determining the end point of bipolar electrosurgical desiccation.

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)

Brian D. Pullin -S

Division of Surgical Devices 510(k) Number: K122383

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.