The ESA620 Electrical Safety Analyzer is an electronic signal source and measurement device for verifying the electrical safety of medical devices. The ESA620 also provides ECG simulation and performance waveforms to verify patient monitors are performing within their operating specifications.

The ESA620 provides following function categories:

ECG Functions .
ECG-Performance Testing ●

Device Description

Fluke Biomedical's ESA620 Electrical Safety Analyzer (hereafter referred to as the ESA620) provides a basis for verifying the electrical safety of medical devices. The Product also provides ECG simulation and performance waveforms to verify patient monitors are performing within their operating specifications.

The ESA620 consists of the following components:

Printed Circuit Board Assemblies using surface mount components and firmware loaded in embedded processors.
Plastic injection molded case parts.
Liquid Crystal Display for user interface.
Power cord for powering the unit at 120V and 60Hz.

AI/ML Overview

This document describes the regulatory submission for the Fluke Biomedical ESA620 Electrical Safety Analyzer. It focuses on demonstrating substantial equivalence to a predicate device (MPS450), rather than proving that a device meets and acceptance criteria via a study. As such, many of the requested details about a study to prove acceptance criteria are not present in the provided text.

Here is an analysis based on the provided document:

Study Type and Purpose:
The document describes non-clinical testing performed to verify and validate the ESA620. The primary purpose of this testing was to demonstrate substantial equivalence to the predicate device (MPS450), not to meet predefined acceptance criteria in a robust clinical or standalone AI study.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" in the traditional sense of a performance study with specific target metrics for accuracy, sensitivity, specificity, etc. Instead, it compares the technological characteristics and intended use of the ESA620 against its predicate device, the MPS450, to establish substantial equivalence.

The "differences" column in the provided table implicitly represents areas where the ESA620's performance or features might be considered against the predicate. However, these are presented as factual differences rather than "acceptance criteria" where a specific pass/fail threshold is defined for each.

Feature	Predicate (MPS450) Performance/Characteristic	ESA620 Performance/Characteristic	Acceptance Criteria/Target (Implied)	Reported Device Performance (ESA620)	Meets Criteria?
Intended Use	Test and verify basic operation of patient monitoring devices (ECG, Respiration, Invasive BP, Cardiac Output). Lab environment, not patient-connected, not for calibration, not OTC.	Electronic signal source and measurement for electrical safety; ECG simulation, performance waveforms for patient monitors. Lab environment, not patient-connected, not for calibration, OTC.	Similar intended use, with some functional differences (less functionality in some areas, added electrical safety).	As described, fulfills the stated intended use.	Yes (demonstrated substantial equivalence)
Construction	Plastic Case	Plastic Case	Same	Plastic Case	Yes
Size	5.5" W x 7.5" D x 1.8" H	12.5" W x 9.5" D x 5" H	Can be larger	Larger	Yes (accepted difference as not impacting safety/effectiveness for the stated use)
Weight	2 lbs	9.5 lbs	Can be heavier	Heavier	Yes (accepted difference)
Display	4 line x 20-character super twist LCD	5.2" diagonal screen Monochrome STN transflective	Larger screen	Larger screen	Yes (accepted difference)
Function Key	Soft	Soft	Same	Soft	Yes
ECG Leads	10 binding posts; compatible with snaps, 3.2mm/4mm electrodes, banana plugs	10 binding posts; compatible with snaps, 3.2mm/4mm electrodes, banana plugs (with/without adapter)	Same	As described	Yes
Communications Port	RS232	USB	Advancement in technology (USB equivalent/better)	USB	Yes (accepted as an advancement)
Power	9V alkaline battery or AC transformer	AC line powered only	No battery due to higher power requirements (accepted)	AC line powered only	Yes (accepted as a functional difference)
ECG Lead Config	12 leads	12 leads	Same	12 leads	Yes
Amplitude Accuracy	$\pm$ 2% of setting (MPS450)	$\pm$ 5% of 1mV setting (ESA620)	Potentially less stringent, but acceptable for intended use.	$\pm$ 5% of 1mV setting	Yes (difference noted, accepted for equivalence)
Rate Accuracy	$\pm$ 1% setting (MPS450)	$\pm$ 2% of setting (ESA620)	Potentially less stringent, but acceptable for intended use.	$\pm$ 2% of setting	Yes (difference noted, accepted for equivalence)
Normal Sinus Rhythm	More options (30-300 bpm, 14 settings)	Fewer options (30-240 bpm, 5 settings)	Fewer options are acceptable for the device's purpose.	Fewer NSR waves	Yes (accepted difference)
Sine Wave	More options (0.5-100 Hz, 7 settings)	Fewer options (10-100 Hz, 5 settings)	Fewer frequencies are acceptable.	Fewer frequencies	Yes (accepted difference)
Square Wave	0.125, 2.0 Hz	0.125, 2.0 Hz	Same	0.125, 2.0 Hz	Yes
Triangle Wave	2.0, 2.5 Hz	2.0 Hz	Fewer frequencies are acceptable.	Fewer frequencies	Yes (accepted difference)
Pulse Wave	30, 60 bpm, 60 ms pulse width	30, 60 bpm, 63 ms pulse width	Slight difference in pulse width, accepted.	Wider pulse width	Yes (accepted difference)
Cable Connector	ECG leads, 10 binding postings	ECG leads, 10 binding postings	Same	ECG leads, 10 binding postings	Yes
Electrical Safety Analysis	Not present	Present	Added functionality	Present	N/A (new feature, not compared)
Respiration, BP, Cardiac Output	Present	Not present	Removed functionality, but still equivalent for overall purpose due to other new features.	Not present	N/A (removed feature)

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

Sample Size: The document states "Laboratory studies have been conducted with a representative patient monitor to verify and validate the ESA620 will perform within its' published specifications -Document: NPI-05012012-00002". This indicates a very limited "sample size" of only one representative patient monitor for the non-clinical tests. This is typical for a device meant for testing other equipment, where the focus is on the device's output accuracy and stability, rather than diverse patient data.
Data Provenance: The studies were conducted in a laboratory setting ("Non-Clinical Test Data"). The country of origin for the data is not specified, but given the submitter (Fluke Biomedical) is US-based and the submission is to the FDA, it is highly likely to be U.S.-based. The data is prospective in the sense that it was generated specifically for this submission to validate the new device.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not provided in the document. For a technical device like an electrical safety analyzer, "ground truth" would typically refer to the accuracy of its measurements and simulations compared to established standards and calibrated reference equipment, rather than expert human interpretation. The "validation" likely refers to engineering design verification and validation by qualified engineers rather than clinical experts.

4. Adjudication Method for the Test Set:

This information is not applicable/not provided as the validation described is non-clinical performance testing of measurement parameters against specifications, not an assessment requiring multiple human readers and adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC study was not done. This type of study is specifically designed for assessing the impact of AI assistance on human reader performance, typically in diagnostic imaging. The ESA620 is a test and measurement device, not a diagnostic tool requiring human interpretation.

6. Standalone (Algorithm Only) Performance Study:

The document implies a standalone performance assessment of the device, but not in the context of an "algorithm" as would be found in AI/ML devices. The "Non-Clinical Test Data" section states "The ESA620 software has been successfully validated to confirm the performance of the device." This confirms that the device's technical performance (measurements, simulations) was evaluated independently against its specifications.

7. Type of Ground Truth Used:

The "ground truth" for this device would be established engineering specifications, calibrated reference standards, and potentially a "golden standard" or master device that has been proven accurate. The statement "to verify and validate the ESA620 will perform within its' published specifications" indicates that the ground truth was the published specifications themselves, which are derived from metrology standards.

8. Sample Size for the Training Set:

This information is not applicable/not provided. The ESA620 is a hardware device with embedded firmware; it is not an AI/ML device that requires a "training set" in the context of machine learning. The validation described is traditional software and hardware verification.

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

This information is not applicable. As it's not an AI/ML device, there's no "training set" or corresponding ground truth establishment process in that sense. The "ground truth" for the device's function (e.g., whether it accurately outputs a 1mV ECG signal) would be based on fundamental electrical engineering principles, national/international standards (e.g., IEC 60601 for medical electrical equipment safety), and calibration to a higher-level physical standard.

Summary

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121722

Section III -510(k) Summarv of Safety and Effectiveness

OCT 11 2012

Biomedica

000115

Submitter:

Fluke Biomedical 6920 Seaway Blvd Everett WA. 98203 (440) 498-2579 -Phone (440-349-2307) - Fax John Nelson -Contact Person

Device Name:

Trade Name ESA620 Electrical Safety Analyzer
Common Name -Analyzer
Classification Name Cardiac monitor (including cardiotachometer and rate alarm), per 21 CFR & 870.2300
Product Codes -DRT

Devices for Which Substantial Equivalence is Claimed:

MPS450 .

Device Description:

Principles of Operation

Technological Characteristics

The ESA620 consists of the following components:

Printed Circuit Board Assemblies using surface mount components and firmware loaded in embedded processors.
Plastic injection molded case parts.
Liquid Crystal Display for user interface.
Power cord for powering the unit at 120V and 60Hz.

Intended Use of the Device:

The Product is an electronic signal source and measurement device for verifying the electrical safety of medical devices. The Product also provides ECG simulation and performance waveforms to verify patient monitors are performing within their operating specifications.

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The Product provides the following function categories:

o ECG Functions
ECG-Performance Testing o

The intended user is a trained biomedical equipment technician who performs periodic preventative maintenance checks on patient monitors in service. Users can be associated with hospitals, clinics, original equipment manufacturers and independent service companies that repair and service medical equipment.

The end user is an individual, trained in medical instrumentation technology. This Product is intended to be used in the laboratory environment, outside of the patient care area, and is not intended for use on patients, or to test devices while connected to patients. This Product is not intended to be used to calibrate medical equipment.

ESA620 is intended for over the counter use.

Summary of Technological Characteristics:

The ESA620 is substantially equivalent to one other legally marketed and FDA approved device in the United States. The ESA620 functions in a manner similar to and is intended for the similar use as the MPS450 manufactured by Fluke Biomedical. The ESA620 is similar to MPS450 in that it uses LCD display, and allows user to simulate physiological parameter to verify the operation of patient monitors. The ESA620 differs from MPS450 in that ESA620 works only using AC power cord and has additional options of performing electrical safety analysis.

Features	ESA620	MPS450	Difference
Intended Use	The Product is an electronicsignal source and measurementdevice for verifying theelectrical safety of medicaldevices. The Product alsoprovides ECG simulation andperformance waveforms toverify patient monitors areperforming within theiroperating specifications.The Product provides thefollowing function categories:• ECG Functions• ECG-PerformanceTestingThe intended user is a trained	The intended use of MPS450 isto test and verify the basicoperation of patient monitoringdevices or systems used tomonitor various physiologicalparameters of patient, includingECG, Respiration, InvasiveBlood Pressure, and CardiacOutput.The intended user is a trainedbiomedical equipment technicianwho is performing periodicpreventative maintenance checkson patient monitors in service.Users can be associated withHospitals, clinics, original	Fewer functions,ESA 620 does notperformRespiration,Invasive BloodPressure orCardiac Output

	biomedical equipment	equipment manufacturer or
	technician who performs	independent service companies
	periodic preventative	that repair and service medical
	maintenance checks on patient	equipment. The end user is
	monitors in service. Users can	technically trained individual,
	be associated with hospitals,	specializing in medical
	clinics, original equipment	instrumentation technology.
	manufacturers and independent	The MPS450 is intended to be
	service companies that repair	used in the laboratory
	and service medical	environment and is not intended
	equipment.	for use on patients, or to test
	The end user is an individual,	devices while connected to
	trained in medical	patients. The MPS450 is not
	instrumentation technology.	intended to be used to calibrate
	This Product is intended to be	medical equipment and not
	used in the laboratory	intended for over the counter
	environment, outside of the	use.
	patient care area, and is not
	intended for use on patients, or
	to test devices while connected
	to patients. This Product is not
	intended to be used to calibrate
	medical equipment. It is
	intended for over the counter
	use.
Construction	Plastic Case	Plastic Case	None
	12.5" wide x 9.5" deep x 5"	5.5" wide x 7.5" deep x 1.8"	Bigger
Size	high	high
Weight	9.5 lbs	2lbs	Heavier
	5.2" diagonal screen	4 line x 20-character super twist	Larger screen
Display	Monochrome STN	LCD display
	transflective
Function Key	Soft	Soft	None
	10 binding posts; compatible	10 binding posts; compatible	None
	with disposable snaps, 3.2 mm	with disposable snaps, 3.2 mm
ECG Leads	or 4 mm electrodes, and	or 4 mm electrodes, and banana
	banana plugs (with or without	plugs
	adapter)
	USB	RS232	Change from
			RS232 to USB
Communication			data port with
s Port			advancement in
			technology
	No Battery - AC line powered	9V alkaline battery with low	No battery because
Power	only	battery indicator; or battery	of higher power
		eliminator or transformer certified	requirements
		to CSA
ECG
LeadConfiguration	12 leads	12 leads	None
AmplitudeAccuracy	$\pm$ 5% of 1mV setting	$\pm$ 2% of setting	Less accurate
Rate Accuracy	$\pm$ 2% of setting	$\pm$ 1% setting	Less accurate
Normal SinusRhythm	30, 60, 120, 180, 240 bpm	30, 40, 45, 60, 80, 90, 100, 120,140, 160, 180, 200, 220, 240,260, 280, 300 bpm	Fewer NSR waves
Sine wave	10, 40, 50, 60, 100 Hz	0.5, 5, 10, 40, 50, 60, 100 Hz	Fewer frequencies
Square wave	0.125, 2.0 Hz	0.125, 2.0 Hz	None
Triangle wave	2.0 Hz	2.0, 2.5 Hz	Fewer frequencies
Pulse wave	30, 60 bpm, 63 ms pulse width	30, 60 bpm, 60 ms pulse width	Wider pulse width
CableConnector	ECG leads, 10 binding postings	ECG leads, 10 binding postings	None

. 000116

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Substantial Equivalence:

The ESA620 is substantially equivalent to one other legally marketed device in the United States. The ESA620 functions in a manner similar to and is intended for the same use as the MPS450 manufactured by Fluke Biomedical.

The ESA620 is similar to the MPS450 in that it uses LCD display, and allows user to simulate ECG parameters to verify the operation of patient monitors. The ESA620 differs from the MPS450 in that the ESA620 is not battery operated; it performs Electrical Safety Analysis and does not perform respiration, blood pressure or cardiac output.

Non-Clinical Test Data:

Laboratory studies have been conducted with a representative patient monitor to verify and validate the ESA620 will perform within its' published specifications -Document: NPI-05012012-00002

The ESA620 software has been successfully validated to confirm the performance of the device. Document: NPI-04262012-00002 and NPI-02152012-00002

Clinical Test Data:

Clinical testing has not been conducted on this product.

Conclusion:

Based upon the laboratory studies, similar technological/performance characteristics as compared to the predicate device, and successful validation of the ESA620 software, the performance of the ESA620 is deemed to be substantially equivalent to the MPS450.

108118

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

OCT 11 2012

Fluke Biomedical c/o Mr. John Nelson Director of Regulatory/Quality Affairs 6045 Cochran Rd. Solon, OH 44139

Re: K121722

Trade/Device Names: ESA620 Regulatory Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including Cardiotachometer and Rate Alarm) Regulatory Class: Class II (Two) Product Code: DRT Dated: September 18, 2012 Received: September 19, 2012

Dear Mr. Nelson:

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 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.

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Page 2 - Mr. John Nelson

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1 1 5809.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 yours.

Bram D. Zuckerman, M.D.

Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

| 12 | 7 2 2 510(k) Number (if known):

Device Name: ESA 620 Electrical Safety Analyzer

Indications for Use:

The ESA620 provides following function categories:

ECG Functions .
ECG-Performance Testing ●

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Cardiovascular Devices	· 000004
510(k) Number	K121722

Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).