ESA620 ELECTRICAL SAFETY ANALYZER

K121722 · Fluke Biomedical · DRT · Oct 11, 2012 · Cardiovascular

Device Facts

• Record ID: K121722
• Device Name: ESA620 ELECTRICAL SAFETY ANALYZER
• Applicant: Fluke Biomedical
• Product Code: DRT · Cardiovascular
• Decision Date: Oct 11, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2

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 Story

ESA620 is an electrical safety analyzer and signal source; used by biomedical technicians in laboratory environments for preventative maintenance of patient monitors. Device inputs include AC power; outputs include electrical safety measurements and simulated ECG waveforms (normal sinus rhythm, sine, square, triangle, pulse waves). Operation involves connecting the device to a patient monitor to verify performance against specifications. The device features an LCD interface and USB connectivity. It does not connect to patients. Benefits include ensuring medical equipment safety and operational accuracy through periodic testing.

Clinical Evidence

No clinical data. Bench testing and software validation were performed to confirm the device meets published specifications.

Technological Characteristics

Components: PCB assemblies with surface mount components, embedded processors, plastic injection molded case, LCD, power cord. Energy: 120V/60Hz AC. Connectivity: USB port. Dimensions: 12.5" x 9.5" x 5". Weight: 9.5 lbs. Interface: 10 binding posts compatible with disposable snaps, 3.2mm/4mm electrodes, and banana plugs.

Indications for Use

Indicated for use by trained biomedical equipment technicians in hospitals, clinics, OEMs, and independent service companies to perform periodic preventative maintenance checks on patient monitors. Not for use on patients, not for testing devices while connected to patients, and not for calibration of medical equipment.

Regulatory Classification

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.

Predicate Devices

• MPS450

Submission Summary (Full Text)

{0}------------------------------------------------

## 121722

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

OCT 11 2012

Biomedica

000115

#### Submitter:

Fluke Biomedical 6920 Seaway Blvd Everett WA. 98203 [phone] -Phone [phone]) - 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

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.

#### Technological Characteristics

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.

#### 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.

{1}------------------------------------------------

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 electronic<br>signal source and measurement<br>device for verifying the<br>electrical safety of medical<br>devices. The Product also<br>provides ECG simulation and<br>performance waveforms to<br>verify patient monitors are<br>performing within their<br>operating specifications.<br>The Product provides the<br>following function categories:<br>• ECG Functions<br>• ECG-Performance<br>Testing<br>The intended user is a trained | The intended use of MPS450 is<br>to test and verify the basic<br>operation of patient monitoring<br>devices or systems used to<br>monitor various physiological<br>parameters of patient, including<br>ECG, Respiration, Invasive<br>Blood Pressure, and Cardiac<br>Output.<br>The intended user is a trained<br>biomedical equipment technician<br>who is performing periodic<br>preventative maintenance checks<br>on patient monitors in service.<br>Users can be associated with<br>Hospitals, clinics, original | Fewer functions,<br>ESA 620 does not<br>perform<br>Respiration,<br>Invasive Blood<br>Pressure or<br>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<br>Configuration | 12 leads | 12 leads | None |
| Amplitude<br>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<br>Rhythm | 30, 60, 120, 180, 240 bpm | 30, 40, 45, 60, 80, 90, 100, 120,<br>140, 160, 180, 200, 220, 240,<br>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<br>Connector | ECG leads, 10 binding postings | ECG leads, 10 binding postings | None |

. 000116

{2}------------------------------------------------

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

{3}------------------------------------------------

#### 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

{4}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image contains the text "Public Health Service". The text is written in a simple, sans-serif font and is horizontally aligned. The text is likely a title or heading, possibly indicating the name of an organization or department.

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.

{5}------------------------------------------------

## 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 [phone] or [phone] 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

{6}------------------------------------------------

# Indications for Use

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

Device Name: ESA 620 Electrical Safety Analyzer

## Indications for 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 ●

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 |