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)

Device Description

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.

AI/ML Overview

The provided document describes the Fluke Biomedical MPS450 Multiparameter Simulator, a device intended to test the operation of patient monitors by simulating various physiological parameters. The submission focuses on demonstrating substantial equivalence to a predicate device, the MedSim300B.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the MPS450 are implicitly defined by comparing its performance specifications to those of the predicate device, the MedSim300B. The differences highlight where the MPS450 either meets or exceeds the predicate's capabilities or where features were deemed "not needed by customers."

Feature/Parameter	Acceptance Criteria (Predicate - MedSim300B)	Reported Device Performance (MPS450)	Notes
Physical Characteristics
Construction	Aluminum case	Plastic case	MPS450 is Lighter.
Size	10 L x 7 W x 3 H inches	7.5 L x 6 W x 2 H inches	MPS450 is Smaller.
Weight	3.55 lbs	1 lbs 8 oz	MPS450 is Lighter.
Display	2 by 24 character LCD	4 by 20 character LCD	MPS450 has More lines on display.
High level ECG connection	¼" standard phone jack w/ lead II waveform at .2V/mV of ECG lead II signal	0.2 V/mV +/- 5% of the ECG amplitude setting available on the BP3 connector	Different type of connector – same functionality.
Battery test	Yes, 8.4V or 9V, low battery signal if < 6.2V	No	Not needed by customers in MPS450 ("nice to have, but not Must have feature").
Lead test	Yes	No	Not a needed feature on MPS450.
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	+/- 5%, 2Hz @ 1.0 mV p-p SQ wave Lead II	+/- 2% setting lead II	MPS450 is More accurate.
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	Normal, horizontal and vertical	No	Feature not needed by end-user customers.
Pediatric ECG	Yes, R Wave width reduced to 40 ms	Yes, R Wave width reduced to 40 ms	None.
Functional Operation - Performance Testing
Square wave	2 Hz	2 Hz, 0.125 Hz	2 selections rather than 1 in MPS450.
Pulse	4.0 sec.	60ms	Faster pulse in MPS450.
Sine waves	Various -0.05 to 1000 Hz	Various -0.5 to 100 Hz	Only narrower range of sine waves needed in MPS450.
Triangle wave	2 Hz	2 Hz and 2.5Hz	2 selections in MPS450.
R Wave detector	Yes	Yes	None.
Pacemaker	0.1 to 2.0 msec pulse duration, -700 to +700 mV pulse amplitude	0.1 to 2.0 msec pulse duration, -10 to +10 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.
Functional Operation - Respiration Simulation
Normal baseline impedances	500 to 2000 ohms ref. to RL	500 to 2000 ohms ref. to RL	None.
Lead selections	I, II, and RL-LL	LA or LL	Reference ECG leads only 2 choices in MPS450.
Impedance variation	0, 0.1, 0.2, 0.5, 1.0, and 3.0 ohms	0.2, 0.5, 1.0, and 3.0 ohms	Simplified selection of Impedance variables in MPS450.
Respiration rates	15, 20, 30, 40, 60, 120 brpm	15, 20, 30, 40, 60, 80, 100, 120 brpm	Added 80 and 100 brpm in MPS450.
Apnea	Off, continuous, momentary, 12 & 32 s	Off, continuous, momentary, 12, 22 & 32 s	Added 22 second Apnea in MPS450.
Functional Operation - Cardiac Output
Catheter size	Fixed, 7F injectate vol. 10 cc	Fixed, 7F injectate vol. 10 cc	None.
Blood temperatures	36.0 to 38.0C; and user programmable	37.0	Single selection for temp. of blood in cardiac output.
Injectate temp	Chilled (2C)	Chilled (0C) or 24 C	2 selections for injectate temp.
Fixed blood flow rate	3, 5, 7 L/min	2.5, 5, 10 L/min	Selection of blood flow rates widened in MPS450.
Curves	Normal, interrupt, slow, L/R shunt	Normal, faulty and L/R shunt	Different curves for simulating different cardiac flow conditions in MPS450.
Output trend	1 normal, 2 defective	No.	Feature not needed by customers in MPS450.
Functional Operation - Blood Pressure
I/O impedance	300 ohms	300 ohms	None.
Exciter range	2 to 16 V/DC to 4 kHz	2 to 16 V/DC to 5kHz	Higher frequency in MPS450.
Transducer Sensitivity	5 or 40 uV/V/mmHg	5 or 40 uV/V/mmHg	None.
Level accuracy	+/- 1% full scale; +/- 1mmHg	+/- (2% setting + 2mmHg)	Different ranges on MPS450 resulted in different accuracy specification.
Static pres. selection	Manual and automatic	Manual	Only Manual in MPS450.
BP selections - Dynamic	Arterial, left and right ventricle, pulmonary artery, pulmonary wedge, Swan-Ganz	Arterial, Radial artery, left and right ventricle, pulmonary artery, pulmonary wedge, right atrium, left atrium and Swan-Ganz	More BP simulation types in MPS450.
BP selections - Static	-10, -5, 0, 20, 30, 40, 80, 100, 200, 250, 300 mmHg	-10, -5, 0, 20, 40, 50, 60, 80, 100, 150, 160, 200, 240, 320 and 400 mmHg	More static IBP pressures simulated in MPS450.
BP cable connector	DIN style	Mini-DIN	Different connector uses different set of IBP cables – mini-DIN is smaller, but DIN style is more rugged.
Functional Operation - Temperature Simulation
Temperature points	34, 37, 40C	0, 24, 37 and 40C	Additional temp simulation points in MPS450.
Dynamic trends	Hypothermia, spike and hyperthermia	No	Feature not implemented in MPS450 – not useful to end user customers.
Probe compatibility	Series 400 and 700	Series 400 and 700	None.
Temp cable connector	DIN Style	Mini-Din	Different connector uses different set of IBP cables – mini-DIN is smaller, but DIN style is more rugged.

Study Information:

Sample size used for the test set and the data provenance:
- The document states "Laboratory studies have been conducted with a representative patient monitor to verify and validate the MPS450 will perform within its' published specifications."
- It also mentions "The MPS450 software has been successfully validated to confirm the performance of the device."
- However, specific numbers for the sample size of "patient monitors" or detailed data provenance (e.g., country of origin, retrospective/prospective) are not provided. The studies are described as "Non-Clinical Test Data" and were conducted in a laboratory setting.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. As "non-clinical test data" performed in a laboratory, the "ground truth" would likely be established by comparing the MPS450's output against known, highly accurate reference signals or measurements from calibrated laboratory equipment, rather than expert human interpretation.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided. Given the nature of a simulator, the "adjudication" would be a technical verification process against defined specifications, not a consensus-based method typically seen in image interpretation or diagnostic studies.
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:
- No, an MRMC comparative effectiveness study was not done. This type of study relates to AI-assisted human performance in diagnostic tasks, which is not applicable to a device like the MPS450, designed as a simulator for equipment testing. The MPS450 does not involve "human readers" or "AI assistance" in the diagnostic sense.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance evaluation was done. The "Non-Clinical Test Data" section explicitly states: "Laboratory studies have been conducted with a representative patient monitor to verify and validate the MPS450 will perform within its' published specifications" and "The MPS450 software has been successfully validated to confirm the performance of the device." This describes the device's inherent functional performance without human intervention in the signal generation process.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for this device would be established by known, precise electrical and physiological signal characteristics generated by the simulator itself and verified against highly accurate measurement equipment. It's a technical "ground truth" based on physics and engineering specifications, not clinical outcomes or expert labels.
The sample size for the training set:
- This device is a simulator, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. Therefore, the concept of a training set sample size is not applicable. The device's "training" refers to its design, programming, and rigorous testing against engineering specifications.
How the ground truth for the training set was established:
- As explained above, there is no "training set" in the context of machine learning. The device's "ground truth" is based on the fundamental electronic and physiological parameters it is designed to simulate, which are derived from established medical and engineering standards. Its performance is verified against these standards in laboratory testing.

Summary

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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 (440) 498-2579 -Phone (440-349-2307) - 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

Technological Characteristics

The MPS450 consists of the following components:

1. 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.

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(K935817)	Difference
Intended Use	To test operation ofpatient monitors bysimulating physiologicalparameters, including:ECG, respiration, bloodpressure, temperatureand cardiac output	To test operation ofpatient monitors bysimulating physiologicalparameters, including:ECG, respiration, bloodpressure, temperatureand cardiac output	None
Device Description
Physical characteristics.
construction	Plastic case	Aluminum case	Lighter
Size	7.5 L x 6 W x 2 Hinches	10 L x 7 W x 3 H inches	Smaller
Weight	1lbs 8 oz	3.55 lbs	Lighter
Operating panelcharacteristics
Display	4 by 20 character LCD	2 by 24 character LCD	More lines on display ofMPS450
ECG leads	10 binding posts;compatible w/disposable snaps, 3.2mm or 4.0 mmelectrodes, and bananaplugs.	10 binding posts;compatible w/disposable snaps, 3.2mm or 4.0 mmelectrodes, and bananaplugs.	None

High level ECG	0.2 V/mV +/- 5% of theECG amplitude settingavailable on the BP3connector	¼" standard phone jackw/ lead II waveform at.2V/mV of ECG lead IIsignal. Use w/ analoginput, high level, centralstation monitors orrecorders	Different type ofconnector- samefunctionality
BP Channels	4 independent BPchannels w/ sensitivitycontrol (5 or 40uV/V/mmHg); cableinterface w/ monitors	4 independent BPchannels w/ sensitivitycontrol (5 or 40uV/V/mmHg); cableinterface w/ monitors	None
Respiration	Baseline Impedance(500 - 2000) control;lead select control	Baseline Impedance(500 - 2000) control;lead select control	None
Temperature	Yes, fixed temp. probeselect control (400 or700 YSI) series probes	Yes, fixed or variabletemp. probe selectcontrol (400 or 700 YSI)series probes	Fixed temp probe useonly for MPS450
Cardiac output	Yes, cable connect w/monitor	Yes, cable connect w/monitor	None
RS -232 port	Yes	Yes	None
Battery test	No	Yes, 8.4V or 9V, lowbattery signal if < 6.2V	Not needed bycustomers in MPS 450-a "nice to have, but notMust have feature"
Lead test	No	Yes	Same as above- not aneeded feature on MPS450
Function Key control	Yes	Yes	None
Power	2 X 9V alkalinebatteries w/ low batteryindicator; or batteryeliminator (115VAC)transformer certified toCSA C22.2. 231 series	2 X 9V alkaline batteriesw/ low battery indicator;or battery eliminator(115VAC) transformercertified to CSA C22.2.231 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 mVp-p SQ wave Lead II	More accurate in MPS450
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 andvertical	Feature not needed byend-user customers
Pediatric ECG	Yes, R Wave widthreduced to 40 ms	Yes, R Wave widthreduced 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, 3pin standard	Continuously variable, 3pin standard	None
Cable connector
- Blood temp	American Edward, 3 pinstandard	American Edward, 3 pinstandard	None
- Injectate Temp	American Edward, 4 pinstandard	American Edward, 4 pinstandard	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 inMPS450
Transducer Sensitivity	5 or 40 uV/V/mmHg	5 or 40 uV/V/mmHg	None
Level accuracy	+/- (2% setting +2mmHg)	+/- 1% full scale; +/-1mmHg	Different ranges onMPS 450 resulted indifferent accuracyspecification
Static pres. Selection	Manual	Manual and automatic	Only Manual inMPS450
BP selections
- Dynamic	Arterial, Radial artery,left and right ventricle,pulmonary artery,pulmonary wedge, rightatrium, left atrium andSwan-Ganz	Arterial, left and rightventricle, pulmonaryartery, pulmonarywedge, Swan-Ganz	More BP simulationtypes in MPS450
- Static	-10, -5, 0, 20, 40, 50, 60,80, 100, 150, 160, 200,240, 320 and 400mmHg	-10, -5, 0, 20, 30, 40, 80,100, 200, 250, 300mmHg	More static IBPpressures simulated inMPS450
- Cable connector	Mini-DIN	DIN style	Different connector usesdifferent set of IBPcables- mini-DIN issmaller, but DIN style ismore rugged.
Temperature Simulation	Mini-DIN	DIN Style	Different connector usesdifferent set of IBPcables-mini-DIN issmaller, but DIN style ismore rugged.
- Temperature	0, 24, 37 and 40C	34, 37, 40C	Additional tempsimulation points inMPS450
- Dynamic trends	No	Hypothermia, spike andhyperthermia	Feature notimplemented inMPS450- not useful toend user customers.
Probe compatibility	Series 400 and 700	Series 400 and 700	None
Cable connector	Mini-Din	DIN Style
			DINdifferentcablesmallmore

. . . .

: : : : :

000103

edical

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ferent connector uses erent set of IBP les- mini-DIN is aller, but DIN style is re rugged:

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 (800) 638-2041 or (301) 796-7100 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

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).