K Number

Device Name

ESA615

Manufacturer

FLUKE BIOMEDICAL

Date Cleared

2013-01-25

(213 days)

Product Code

DRT

Regulation Number

870.2300

Intended Use

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.

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 electrical safety analyzer and ECG simulator. There is no mention of AI, ML, or any related concepts in the intended use, device description, or performance studies.

Therapeutic

No.

The device is an analyzer used to verify the electrical safety and performance of other medical devices, not to provide therapy directly to patients.

Diagnostic

The device is an electrical safety analyzer and ECG simulator used to verify the safety and performance of medical devices and patient monitors, not to diagnose a patient's medical condition. It is used in a laboratory setting by trained technicians, outside of patient care.

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 information, the ESA615 Electrical Safety Analyzer is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The primary intended use is to verify the electrical safety of medical devices and to test the performance of patient monitors. This involves testing the equipment itself, not analyzing biological samples from a patient.
Device Description: The description focuses on the electronic components and functions for testing medical equipment.
Intended User / Care Setting: The intended user is a trained biomedical equipment technician working in a laboratory environment, outside of patient care areas. The device is explicitly stated as "not intended for use on patients, or to test devices while connected to patients."
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions, or providing information for diagnosis, treatment, or prevention of disease.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. The ESA615's function is to test the performance and safety of other medical devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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 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

Product codes

DRT

Device Description

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.

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

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.

Key Metrics

Not Found

Predicate Device(s)

MPS450

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

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 provides the following function categories:

ECG Functions .
ECG-Performance Testing .

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 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
biomedical equipment	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
equipment manufacturer or
equipment	Fewer functions,
Respiration,
Invasive Blood
Pressure, Cardiac
Output
			Biomedical
	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. It is
intended for over the counter
use.	independent service companies
that repair and service medical
equipment. The end user is
technically trained individual,
specializing in medical
instrumentation technology.
The MPS450 is intended to be
used in the laboratory
environment and is not intended
for use on patients, or to test
devices while connected to
patients. The MPS450 is not
intended to be used to calibrate
medical equipment and not
intended for over the counter
use.	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 screen
Monochrome STN
transflective	4 line x 20-character super twist
LCD display	Larger screen
Function Key	Soft	Soft	None
ECG Leads	5 applied parts jacks and easy
ECG snap connection with
optional expander box	10 binding posts; compatible
with disposable snaps, 3.2 mm
or 4 mm electrodes, and banana
plugs	Fewer applied
parts on ESA615
Communication
s Port	USB	RS232	Change from
RS232 to USB
data port with
advancement in
technology
Power	No Battery - AC line powered
only	9V alkaline battery with low
battery indicator; or battery
eliminator; transformer certified
to CSA	No battery because
of higher power
requirements

000144

Blomedica

0001455

・・

FLuke.
Biomedical

000146

| Lead

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

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.

DEPARTMENT OF HEALTH & HUM AN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread.

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.

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

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_