K Number

Device Name

ESA620 ELECTRICAL SAFETY ANALYZER

Manufacturer

FLUKE BIOMEDICAL

Date Cleared

2012-10-11

(121 days)

Product Code

DRT

Regulation Number

870.2300

Intended Use

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: 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

MPS450

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard electronic test and measurement device with embedded firmware, not mentioning any AI or ML capabilities.

Therapeutic

No
The device is used to verify the electrical safety of medical devices and to verify patient monitors are performing within their operating specifications. It is a testing and measurement device, not one that directly treats or diagnoses a medical condition.

Diagnostic

The ESA620 is an electrical safety analyzer and simulation device used to verify the electrical safety and performance of other medical devices, such as patient monitors. It is not used to diagnose a patient's condition.

SaMD (Software as a Medical Device)

The device description explicitly lists hardware components such as Printed Circuit Board Assemblies, plastic injection molded case parts, a Liquid Crystal Display, and a power cord.

IVD (In Vitro Diagnostic)

Based on the provided text, the ESA620 Electrical Safety Analyzer is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use is to verify the electrical safety of medical devices and to verify patient monitors are performing within their operating specifications. This involves testing the medical equipment itself, not analyzing samples from the human body.
Device Description: The description details an electronic signal source and measurement device for testing medical equipment. It does not mention any components or functions related to analyzing biological samples.
Intended User / Care Setting: The intended user is a trained biomedical equipment technician who performs maintenance checks on patient monitors in a laboratory environment, outside of the patient care area. The device is explicitly stated as "not intended for use on patients, or to test devices while connected to patients."
Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Diagnosing diseases or conditions
- Monitoring treatment
- Screening for medical conditions

The ESA620 is a piece of test and measurement equipment used to ensure the proper functioning and safety of other medical devices. It does not perform diagnostic tests on patient samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The ESA620 provides following function categories:

ECG Functions .
ECG-Performance Testing ●

Product codes (comma separated list FDA assigned to the subject device)

DRT

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

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.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

MPS450

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

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.

The Product provides the following function categories:

o ECG Functions
ECG-Performance Testing o

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 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.
The Product provides the
following function categories:
• ECG Functions
• ECG-Performance
Testing
The intended user is a trained	The intended use of MPS450 is
to test and verify the basic
operation of patient monitoring
devices or systems used to
monitor various physiological
parameters of patient, including
ECG, Respiration, Invasive
Blood Pressure, and Cardiac
Output.
The intended user is a trained
biomedical equipment technician
who is performing periodic
preventative maintenance checks
on patient monitors in service.
Users can be associated with
Hospitals, clinics, original	Fewer functions,
ESA 620 does not
perform
Respiration,
Invasive Blood
Pressure or
Cardiac 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
Lead
Configuration	12 leads	12 leads	None
Amplitude
Accuracy	$\pm$ 5% of 1mV setting	$\pm$ 2% of setting	Less accurate
Rate Accuracy	$\pm$ 2% of setting	$\pm$ 1% setting	Less accurate
Normal Sinus
Rhythm	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
Cable
Connector	ECG leads, 10 binding postings	ECG leads, 10 binding postings	None

. 000116

..............................................................................................................................................................................

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

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.

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

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