The ESA615 Electrical Safety Analyzer is an electronic signal source and measurement device for verifying the electrical safety of medical devices. The ESA615 also provides ECG simulation and performance waveforms to verify patient monitors are performing within their operating specifications. The ESA615 provides following function categories: ECG Functions, ECG-Performance Testing.

Device Description

Fluke Biomedical's ESA615 Electrical Safety Analyzer (hereafter referred to as the ESA615) 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 ESA615 can be controlled by a suitably equipped computer to carry out tests, via either a cable or wirelessly. The ESA615 consists of the following components: 1) Printed Circuit Board Assemblies using surface mount components and firmware loaded in embedded processors. 2) Plastic injection molded case parts. 3) Liquid Crystal Display for user interface. 4) Power cord for powering the unit at 120V and 60Hz.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the ESA615 Electrical Safety Analyzer, based on the provided text:

Device: ESA615 Electrical Safety Analyzer

1. Table of Acceptance Criteria and Reported Device Performance

The submission claims substantial equivalence to the predicate device (MPS450) based on similar technological characteristics and performance, not against specific, quantifiable acceptance criteria. The "differences" column below highlights how ESA615 performance differs from the predicate.

Feature	Acceptance Criteria (Predicate: MPS450)	Reported Device Performance (ESA615)	Met Criteria? (Comparison to Predicate)
Intended Use	Test and verify basic operation of patient monitoring devices for ECG, Respiration, Invasive Blood Pressure, and Cardiac Output.	Verify electrical safety of medical devices; provide ECG simulation and performance waveforms.	Differs: Fewer functions (no Respiration, Invasive Blood Pressure, Cardiac Output), but adds Electrical Safety Analysis.
Construction	Plastic Case	Plastic Case	Yes
Size	5.5" wide x 7.5" deep x 1.8" high	6.94" wide x 3.3" deep x 11.2" high	Bigger
Weight	2 lbs	3.5 lbs	Heavier
Display	4 line x 20-character super twist LCD display	3" diagonal screen Monochrome STN transflective	Larger screen
Function Key	Soft	Soft	Yes
ECG Leads	10 binding posts	5 applied parts jacks (with optional expander box)	Fewer applied parts
Communications Port	RS232	USB	Change from RS232 to USB
Power	9V alkaline battery & battery eliminator	No Battery - AC line powered only	No battery due to higher power demands
Lead Configuration	12 leads	5 leads	Fewer leads
Amplitude Accuracy	±2% of setting	± 5% of 1mV setting	Less accurate
Rate Accuracy	±1% setting	± 2% of setting	Less accurate
Normal Sinus Rhythm	30, 40, 45, 60, 80, 90, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300 bpm	30, 60, 120, 180, 240 bpm	Fewer NSR waves
Sine wave	0.5, 5, 10, 40, 50, 60, 100 Hz	10, 40, 50, 60, 100 Hz	Fewer frequencies
Square wave	0.125, 2.0 Hz	0.125, 2.0 Hz	Yes
Triangle wave	2.0, 2.5 Hz	2.0 Hz	Fewer frequencies
Pulse wave	30, 60 bpm, 60 ms pulse width	30, 60 bpm, 63 ms pulse width	Wider pulse width
Cable Connector	ECG leads, 10 binding postings	ECG leads, 5 binding postings	Fewer binding postings

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

The document mentions "Laboratory studies have been conducted with a representative patient monitor..." but does not specify the sample size (number of "representative patient monitors" or tests performed) or the data provenance (country of origin, retrospective/prospective).

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

Not applicable. The device is an analyzer, not a diagnostic tool requiring expert interpretation. The "ground truth" for its performance is its physical and electronic output measurements compared against its published specifications.

4. Adjudication method for the test set

Not applicable, as this is a device performance verification, not a clinical study requiring human interpretation and multi-expert 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 device is an electrical safety analyzer and ECG simulator, not an AI-assisted diagnostic tool.

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

Yes, the testing described appears to be standalone performance verification of the ESA615 itself, against its published specifications. The description "Laboratory studies have been conducted with a representative patient monitor to verify and validate the ESA615 will perform within its' published specifications" indicates this.

7. The type of ground truth used

The ground truth for the test set appears to be its own published specifications, as verified by "Laboratory studies... to verify and validate the ESA615 will perform within its' published specifications."

8. The sample size for the training set

Not applicable. This is a hardware device with firmware, not a machine learning model that requires a training set.

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

Not applicable.

Summary

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K121860.

Image /page/0/Picture/1 description: The image shows the logo for Fluke Biomedical. The logo is black and white and features the word "FLUKE" in large, bold letters. Below the word "FLUKE" is the word "Biomedical" in smaller letters. In the upper right corner of the image is the fraction "1/4" written in black ink.

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

Submitter:

JAN 2 5 2013

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

Device Name:

Trade Name - ESA615 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 ESA615 consists of the following components:

Printed Circuit Board Assemblies using surface mount components and firmware loaded in embedded processors.
Plastic injection molded case parts.

1. Liquid Crystal Display for user interface.
1. 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:

ECG Functions .
ECG-Performance Testing .

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.

ESA615 is intended for over the counter use.

Summary of Technological Characteristics:

The ESA615 is substantially equivalent to one other legally marketed and FDA approved device in the United States. The ESA615 functions in a manner similar to and is intended for the similar use as the MPS450 manufactured by Fluke Biomedical. The ESA615 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 ESA615 differs from MPS450 in that ESA615 works only using AC power cord and has additional options of performing electrical safety analysis.

Features	ESA615	MPS450V	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 trainedbiomedical equipment	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, originalequipment manufacturer orequipment	Fewer functions,Respiration,Invasive BloodPressure, CardiacOutput
			Biomedical
	technician who performsperiodic preventativemaintenance checks on patientmonitors in service. Users canbe associated with hospitals,clinics, original equipmentmanufacturers and independentservice companies that repairand service medicalequipment.The end user is an individual,trained in medicalinstrumentation technology.This Product is intended to beused in the laboratoryenvironment, outside of thepatient care area, and is notintended for use on patients, orto test devices while connectedto patients. This Product is notintended to be used to calibratemedical equipment. It isintended for over the counteruse.	independent service companiesthat repair and service medicalequipment. The end user istechnically trained individual,specializing in medicalinstrumentation technology.The MPS450 is intended to beused in the laboratoryenvironment and is not intendedfor use on patients, or to testdevices while connected topatients. The MPS450 is notintended to be used to calibratemedical equipment and notintended for over the counteruse.	3/4
Construction	Plastic Case	Plastic Case	None
Size	6.94" wide x 3.3" deep x 11.2"high	5.5" wide x 7.5" deep x 1.8"high	Bigger
Weight	3.5 lbs	2lbs	Heavier
Display	3" diagonal screenMonochrome STNtransflective	4 line x 20-character super twistLCD display	Larger screen
Function Key	Soft	Soft	None
ECG Leads	5 applied parts jacks and easyECG snap connection withoptional expander box	10 binding posts; compatiblewith disposable snaps, 3.2 mmor 4 mm electrodes, and bananaplugs	Fewer appliedparts on ESA615
Communications Port	USB	RS232	Change fromRS232 to USBdata port withadvancement intechnology
Power	No Battery - AC line poweredonly	9V alkaline battery with lowbattery indicator; or batteryeliminator; transformer certifiedto CSA	No battery becauseof higher powerrequirements

000144

Blomedica

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0001455

・・

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FLuke.
Biomedical

000146

LeadConfiguration	5 leads	12 leads	None
AmplitudeAccuracy	± 5% of 1mV setting	±2% of setting	Less accurate
Rate Accuracy	± 2% of setting	±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, 5 binding postings	ECG leads, 10 binding postings	Fewer bindingpostings

Substantial Equivalence:

The ESA615 is substantially equivalent to one other legally marketed device in the United States. The ESA615 functions in a manner similar to and is intended for the same use as the MPS450 manufactured by Fluke Biomedical.

The ESA615 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 ESA615 differs from the MPS450 in that the ESA615 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 ESA615 will perform within its' published specifications -- Document: NPI-05012012-00002

The ESA615 software has been successfully validated to confirm the performance of the device. Document: NPI-03012012-00001 and NPI-05042012-00001

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 ESA615 software, the performance of the ESA615 is deemed to be substantially equivalent to the MPS450.

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DEPARTMENT OF HEALTH & HUM AN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

JAN 2 5 2013

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

Re: K121860

Trade/Device Names: ESA615 Regulatory Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including Cardiotachometer and Rate Alarm) Regulatory Class: Class II (Two) Product Code: DRT Dated: January 7, 2013 Received: January 8, 2013

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. 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.

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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 (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/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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Owen P. Faris -S

for 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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K12if60

Image /page/6/Picture/1 description: The image shows the Fluke Biomedical logo. The logo consists of the word "FLUKE" in large, bold, sans-serif font, with a stylized design above the letters. Below the word "FLUKE" is the word "Biomedical" in a smaller, bold, sans-serif font. The image is black and white.

Indications for Use

510(k) Number (if known): 长しさした 6 0

Device Name: ESA 615 Electrical Safety Analyzer

Indications for Use:

The ESA615 provides following function categories:

ECG Functions .
ECG-Performance Testing

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (21 CFR 807 Subpart C)

000004

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

Concurryal; goff CDRJL Office_of Device Evaluation (ODE)

(Division Sign-Off) Division of Cardiovascular Devices

Kr21860 510(k) Number_

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).