MPS450 MULTIPARAMETER SIMULATOR

K103336 · Fluke Biomedical · DRT · Apr 13, 2011 · Cardiovascular

Device Facts

• Record ID: K103336
• Device Name: MPS450 MULTIPARAMETER SIMULATOR
• Applicant: Fluke Biomedical
• Product Code: DRT · Cardiovascular
• Decision Date: Apr 13, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2

Intended Use

The MPS450 Multiparameter Simulator is an electronic signal source for determining that patient monitors are performing within their operating specifications. The MPS450 provides the following function categories: ECG Functions Arrhythmia Functions ECG-Performance Testing Respiration Blood Pressure Temperature Cardiac Output (Optional) Fetal/Maternal ECG & IUP (Optional) The intended user is a trained bioment technician, who is performing 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 a technically trained individual, specializing in medical instrumentation technology. 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. This device is not to replace clinical testing of waveform detecting devices such as patient monitors. MPS450 is intended for over-the counter use.

Device Story

MPS450 is a portable, battery-powered electronic signal simulator used by biomedical technicians in laboratory or clinical settings to verify patient monitor performance. It generates physiological signals including ECG (including arrhythmia, performance testing, fetal/maternal), respiration, blood pressure, temperature, and cardiac output. The device uses embedded processors and firmware to synthesize these signals, which are output to the patient monitor under test via physical cable connections (e.g., binding posts, Mini-DIN). Technicians use the device's LCD interface to select simulation parameters and verify that the monitor's readings match the generated signals. This process ensures patient monitors are functioning within specifications before clinical use. The device does not connect to patients; it serves as a reference signal source for maintenance and quality assurance.

Clinical Evidence

No clinical data. Bench testing only. Laboratory studies (NPI-10292010-00002) verified the device performs within published specifications using a representative patient monitor. Software validation (NPI-10292010-00002 and NPI-11012010-00001) confirmed device performance.

Technological Characteristics

Portable, battery-powered (2x 9V alkaline) or AC-powered simulator. Components: PCB assemblies with surface-mount components, plastic injection-molded case, 4x20 character LCD. Connectivity: ECG binding posts, Mini-DIN connectors for BP/Temp/Cardiac Output, RS-232 port. Firmware-based signal generation. Dimensions: 7.5" x 6" x 2". Weight: 1 lb 8 oz.

Indications for Use

Indicated for use by trained biomedical technicians to perform periodic preventive maintenance and verification of patient monitor operating specifications. Not for use on patients or while monitors are connected to patients.

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

• MedSim300B (K935817)

Submission Summary (Full Text)

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K103336

**FLUKE.**
Biomedical

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

APR :1 3: 2011

### Submitter:

Fluke Biomedical 6920 Seaway Blvd Everett WA. 98203 [phone] -Phone [phone]) - Fax John Nelson -Contact Person

#### Device Name:

- Trade Name MPS450 Multiparameter Simulator
- Common Name -Simulator
- Classification Name Cardiac monitor (including cardiotachometer and rate alarm), per 21 CFR & 870.2300
- Product Codes -DRT

#### Devices for Which Substantial Equivalence is Claimed:

- MedSim300B
#### Device Description:

## Principles of Operation

Fluke Biomedical's MPS450 Multiparameter Simulator (hereafter referred to as the MPS450) provides a basis to train, evaluate, and perform preventive maintenance for virtually all patient monitors found in the healthcare industry. This is accomplished with multiple physiological simulations for ECG, blood pressure, respiration, temperature, artifact, and arrhythmia conditions. The MPS450 is a lightweight, battery powered unit that is portable enough to test a patient monitor anywhere the monitor is being used.

#### Technological Characteristics

The MPS450 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) Two 9 V alkaline batteries for portable operation, giving user flexibility and portability.

#### Intended Use of the Device:

The MPS450 Multiparameter Simulator is an electronic signal source for determining that patient monitors are performing within their operating specifications.

The MPS450 provides the following function categories:

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**FLUKE**
Biomedical

ECG Functions Arrhythmia Functions ECG-Performance Testing Respiration Blood Pressure Temperature Cardiac Output (Optional) Fetal/Maternal ECG & IUP (Optional)

The intended user is a trained bioment technician, who is performing 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 a technically trained individual, specializing in medical instrumentation technology.

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.

This device is not to replace clinical testing of waveform detecting devices such as patient monitors.

MPS450 is intended for over-the counter use.

#### Summary of Technological Characteristics:

MPS450 is substantially equivalent to another legally marketed device in the United States. MPS450 functions in a manner similar to and is intended for the same use as MedSim300B that is currently marketed by Fluke Biomedical.

| Features | MPS450 | MedSim 300B<br>(K935817) | Difference |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Intended Use | To test operation of<br>patient monitors by<br>simulating physiological<br>parameters, including:<br>ECG, respiration, blood<br>pressure, temperature<br>and cardiac output | To test operation of<br>patient monitors by<br>simulating physiological<br>parameters, including:<br>ECG, respiration, blood<br>pressure, temperature<br>and cardiac output | None |
| Device Description | | | |
| Physical characteristics. | | | |
| construction | Plastic case | Aluminum case | Lighter |
| Size | 7.5 L x 6 W x 2 H<br>inches | 10 L x 7 W x 3 H inches | Smaller |
| Weight | 1lbs 8 oz | 3.55 lbs | Lighter |
| Operating panel<br>characteristics | | | |
| Display | 4 by 20 character LCD | 2 by 24 character LCD | More lines on display of<br>MPS450 |
| ECG leads | 10 binding posts;<br>compatible w/<br>disposable snaps, 3.2<br>mm or 4.0 mm<br>electrodes, and banana<br>plugs. | 10 binding posts;<br>compatible w/<br>disposable snaps, 3.2<br>mm or 4.0 mm<br>electrodes, and banana<br>plugs. | None |
| | | | |
| High level ECG | 0.2 V/mV +/- 5% of the<br>ECG amplitude setting<br>available on the BP3<br>connector | ¼" standard phone jack<br>w/ lead II waveform at<br>.2V/mV of ECG lead II<br>signal. Use w/ analog<br>input, high level, central<br>station monitors or<br>recorders | Different type of<br>connector- same<br>functionality |
| BP Channels | 4 independent BP<br>channels w/ sensitivity<br>control (5 or 40<br>uV/V/mmHg); cable<br>interface w/ monitors | 4 independent BP<br>channels w/ sensitivity<br>control (5 or 40<br>uV/V/mmHg); cable<br>interface w/ monitors | None |
| Respiration | Baseline Impedance<br>(500 - 2000) control;<br>lead select control | Baseline Impedance<br>(500 - 2000) control;<br>lead select control | None |
| Temperature | Yes, fixed temp. probe<br>select control (400 or<br>700 YSI) series probes | Yes, fixed or variable<br>temp. probe select<br>control (400 or 700 YSI)<br>series probes | Fixed temp probe use<br>only for MPS450 |
| Cardiac output | Yes, cable connect w/<br>monitor | Yes, cable connect w/<br>monitor | None |
| RS -232 port | Yes | Yes | None |
| Battery test | No | Yes, 8.4V or 9V, low<br>battery signal if < 6.2V | Not needed by<br>customers in MPS 450-<br>a "nice to have, but not<br>Must have feature" |
| Lead test | No | Yes | Same as above- not a<br>needed feature on MPS<br>450 |
| Function Key control | Yes | Yes | None |
| Power | 2 X 9V alkaline<br>batteries w/ low battery<br>indicator; or battery<br>eliminator (115VAC)<br>transformer certified to<br>CSA C22.2. 231 series | 2 X 9V alkaline batteries<br>w/ low battery indicator;<br>or battery eliminator<br>(115VAC) transformer<br>certified to CSA C22.2.<br>231 series M89) | None |

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, -

| Functional Operation | | | |
|----------------------|---------------------------------------|---------------------------------------------|---------------------------------------------|
| ECG simulation | | | |
| Lead configuration | 12 Leads | 12 leads | None |
| Output impedances | 500 to 2000ohms to RL | 500 to 2000ohms to RL | None |
| Amplitude accuracy | +/- 2% setting lead II | +/- 5%, 2Hz @ 1.0 mV<br>p-p SQ wave Lead II | More accurate in MPS<br>450 |
| NSR rates | 30 to 300 bpm | 30 to 300 bpm | None |
| NSR amplitudes | 50 uV to 5.5mV | 50 uV to 5.5mV | None |
| ST Segments | -0.8 to + 0.8 mV | -0.8 to + 0.8 mV | None |
| Axis deviation | No | Normal, horizontal and<br>vertical | Feature not needed by<br>end-user customers |
| Pediatric ECG | Yes, R Wave width<br>reduced to 40 ms | Yes, R Wave width<br>reduced to 40 ms | None |

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| Performance testing | | | | |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|------------------------------|
| Square wave | 2 Hz, 0.125 Hz | 2 Hz | 2 selections rather than 1 in MPS 450 | |
| Pulse | 60ms | 4.0 sec. | Faster pulse in MPS450 | |
| Sine waves | Various -0.5 to 100 Hz | Various -0.05 to 1000 Hz | Only narrower range of sine waves needed in MPS450 | |
| Triangle wave | 2 Hz and 2.5Hz | 2 Hz | 2 selections in MPS450 | |
| R Wave detector | Yes | Yes | None | |
| Pacemaker | Yes, 0.1 to 2.0 msec pulse duration, -10 to +10 mV pulse amplitude | Yes, 0.1 to 2.0 msec pulse duration, -700 to +700 mV pulse amplitude | Pacer pulse amplitude lower for MPS450-testing at lower level than Medsim300 | |
| Premature beat insertion | Yes, PVC, PNC or PAC | Yes, PVC, PNC or PAC | None | |
| Cable connector | ECG leads, 10 binding postings | ECG leads, 10 binding postings | None | |
| Respiration simul. | | | | |
| Normal baseline impedances | 500 to 2000 ohms ref. to RL | 500 to 2000 ohms ref. to RL | None | |
| Lead selections | LA or LL | I, II, and RL-LL | Reference ECG leads only 2 choices in MPS 450 | |
| Impedance variation | 0.2, 0.5, 1.0, and 3.0 ohms | 0, 0.1, 0.2, 0.5, 1.0, and 3.0 ohms | Simplified selection of Impedance variables in MPS450 | |
| Respiration rates | 15, 20, 30, 40, 60, 80, 100, 120 brpm | 15, 20, 30, 40, 60, 120 brpm | Added 80 and 100 brpm in MPS450 | |
| Apnea | Off, continuous, momentary, 12, 22 & 32 s | Off, continuous, momentary, 12 & 32 s | Added 22 second Apnea in MPS450 | |
| Cable connector | ECG leads, binding posts | ECG leads, binding posts | None | |
| Cardiac output | Yes | Yes | None | |
| Catheter size | Fixed, 7F injectate vol. 10 cc | Fixed, 7F injectate vol. 10 cc | None | |
| Blood temperatures | 37.0 | 36.0 to 38.0C; and user programmable | Single selection for temp. of blood in cardiac output. | |
| Injectate temp | Chilled (0C) or 24 C | Chilled (2C) | 2 selections for injectate temp. | |
| Fixed blood flow rate | 2.5, 5, 10 L/min | 3, 5, 7 L/min | Selection of blood flow rates widened in MPS 450 | |
| Curves | Normal, faulty and L/R shunt | Normal, interrupt, slow, L/R shunt | Different curves for simulating different cardiac flow conditions in MPS 450 | |
| Output trend | No. | 1 normal, 2 defective | Feature not needed by customers in MPS450 | |
| | | | | Image: Fluke Biomedical logo |
| | | | | |
| Bath/Injectate resistance | Continuously variable, 3<br>pin standard | Continuously variable, 3<br>pin standard | None | |
| Cable connector | | | | |
| - Blood temp | American Edward, 3 pin<br>standard | American Edward, 3 pin<br>standard | None | |
| - Injectate Temp | American Edward, 4 pin<br>standard | American Edward, 4 pin<br>standard | None | |
| Blood pressure | | | | |
| I/O impedance | 300 ohms | 300 ohms | None | |
| Exciter range | 2 to 16 V/DC to 5kHz | 2 to 16 V/DC to 4 kHz | Higher frequency in<br>MPS450 | |
| Transducer Sensitivity | 5 or 40 uV/V/mmHg | 5 or 40 uV/V/mmHg | None | |
| Level accuracy | +/- (2% setting +<br>2mmHg) | +/- 1% full scale; +/-<br>1mmHg | Different ranges on<br>MPS 450 resulted in<br>different accuracy<br>specification | |
| Static pres. Selection | Manual | Manual and automatic | Only Manual in<br>MPS450 | |
| BP selections | | | | |
| - Dynamic | Arterial, Radial artery,<br>left and right ventricle,<br>pulmonary artery,<br>pulmonary wedge, right<br>atrium, left atrium and<br>Swan-Ganz | Arterial, left and right<br>ventricle, pulmonary<br>artery, pulmonary<br>wedge, Swan-Ganz | More BP simulation<br>types in MPS450 | |
| - Static | -10, -5, 0, 20, 40, 50, 60,<br>80, 100, 150, 160, 200,<br>240, 320 and 400<br>mmHg | -10, -5, 0, 20, 30, 40, 80,<br>100, 200, 250, 300<br>mmHg | More static IBP<br>pressures simulated in<br>MPS450 | |
| - Cable connector | Mini-DIN | DIN style | Different connector uses<br>different set of IBP<br>cables- mini-DIN is<br>smaller, but DIN style is<br>more rugged. | |
| Temperature Simulation | Mini-DIN | DIN Style | Different connector uses<br>different set of IBP<br>cables-mini-DIN is<br>smaller, but DIN style is<br>more rugged. | |
| - Temperature | 0, 24, 37 and 40C | 34, 37, 40C | Additional temp<br>simulation points in<br>MPS450 | |
| - Dynamic trends | No | Hypothermia, spike and<br>hyperthermia | Feature not<br>implemented in<br>MPS450- not useful to<br>end user customers. | |
| Probe compatibility | Series 400 and 700 | Series 400 and 700 | None | |
| Cable connector | Mini-Din | DIN Style | | |
| | | | DIN<br>different<br>cable<br>small<br>more | |

. . . .

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Biomedical

#### Substantial Equivalence:

The MPS450 is substantially equivalent to one other legally marketed device in the United States. The MPS450 functions in a manner similar to and is intended for the same use as the MedSim300B manufactured by Fluke Biomedical.

The MPS450 is similar to the MedSim300B in that it is a cordless battery-operated device, uses LCD display, and allows user to simulate physiological parameters to verify the operation of patient monitors. The MPS450 differs from the MedSim300B in that the MPS450 is lighter, smaller does not contain a battery test feature, improved accuracy and a wider range of performance testing characteristics than the MedSim300B.

#### Non-Clinical Test Data:

Laboratory studies have been conducted with a representative patient monitor to verify and validate the MPS450 will perform within its' published specifications -Document: NPI-10292010-00002

The MPS450 software has been successfully validated to confirm the performance of the device. Document: NPI-10292010-00002 and NPI-11012010-00001

#### 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 MPS450 software, the performance of the MPS450 is deemed to be substantially equivalent to the MedSim300B.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized symbol resembling a person with outstretched arms, with three lines representing the body and arms. The symbol is enclosed within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle.

#### Public Health Service

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

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

APR 1 3 2011

Re: K103336

Trade/Device Names: MPS450 Multiparameter Simulator Regulatory Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including Cardiotachometer and Rate Alarm) Regulatory Class: Class II (Two) Product Code: DRT Dated: March 24, 2011 Received: April 4, 2011

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 (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/CDRH0ffices/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.hum.

Sincerely yours,

Bram D. Zuckerman, M.D.

Sin 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

510(k) Number (if known): K103336

Device Name: MPS450 Multiparameter Simulator

Indications for Use:

The MPS450 Multiparameter Simulator is an electronic signal source for determining that patient monitors are performing within their operating specifications.

The MPS450 provides the following function categories: .

ECG Functions Arrhythmia Functions ECG-Performance Testing Respiration Blood Pressure Temperature Cardiac Output (Optional) Fetal/Maternal ECG & IUP (Optional)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use X AND/OR . (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | 000099 |
|------------------------------------|----------|
| Division of Cardiovascular Devices | |
| 510(k) Number | K10 3336 |