PROSIM 4, PROSIM 6, PROSIM 8

• K Number: K110429
• Device Name: PROSIM 4, PROSIM 6, PROSIM 8
• Manufacturer: FLUKE BIOMEDICAL
• Date Cleared: 2011-09-02 ( 199 days)
• Product Code: DRT
• Regulation Number: 870.2300
• Type: Traditional
• Panel: Cardiovascular
• Reference & Predicate Devices: K933519 , K974293 , K935817
• Predicate For: N/A

Intended Use

The intended us of ProSim 4 is to test and verify the basic operation of patient monitoring devices or systems used to monitor various physiological parameters of a patient, including ECG, Respiration, Invasive blood pressure and Non-invasive blood pressure.

The ProSim 4 Vital Signs Simulator provides electronic and pneumatic simulation of physiological parameters for determining that patient monitoring devices or systems are performing within their operating specifications. The device includes the following physiological simulations:

• ECG adult or neonatal
• Invasive and non-invasive blood pressure
• Respiration

The intended us of ProSim 6 and ProSim 8 is to test and verify the basic operation of patient monitoring devices or systems used to monitor various physiological parameters of a patient, including ECG, Respiration, Invasive blood pressure, Non-invasive blood pressure and Cardiac output. Additionally, the devices provide an optical signal to verify that the electronics within the pulse oximeter probe are functional.

The ProSim 6 and ProSim 8 Vital Signs Simulators provide electronic and pneumatic simulation of physiological parameters for determining that patient monitoring devices or systems are performing within their operating specifications. The devices provide the following physiological simulations:

• ECG adult or pediatric
• Invasive and non-invasive blood pressure
• Respiration
• Temperature
• Cardiac Output
• Fetal Simulation includes fetal, maternal ECG, & uterine contractions (ProSim 8 only)
  Additionally, the devices provide an optical signal to verify that the electronics within the pulse oximeter probe are functional

Device Description

Fluke Biomedical's ProSim 4 (hereafter referred to as the ProSim) 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 electrical signals, respiration electrical signals, invasive blood pressure (IBP) electrical signals and non-invasive blood pressure pulses. The ProSim is a lightweight, battery powered unit that is portable enough to test a patient monitor anywhere the monitor is being used.

ProSim vital signs simulator consists of the following components:

1. Printed Circuit Board Assemblies using surface mount components and firmware loaded in embedded processors.
2. Plastic iniection molded case parts.
3. Stepper Motor and piston pump for pneumatic simulation that makes reliable pressure pulses.
4. Liquid Crystal Touch Screen Display for user interface. User interface follows modern and ergonomic concepts.
5. Lithium Ion rechargeable battery for portable operation, giving user flexibility and portability.

Fluke Biomedical's ProSim 6 and ProSim 8 (hereafter referred to as the ProSim) 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 electrical signals, respiration electrical signals, invasive blood pressure (IBP) electrical signals, non-invasive blood pressure (NIBP) pressure pulses, temperature electrical signal, cardiac output electrical signal, and pulse oximetry SPO2 optical simulated light attenuation. The ProSim is a lightweight, battery powered unit that is portable enough to test a patient monitor anywhere the monitor is being used.

ProSim vital signs simulator consists of the following components:
l ) Printed Circuit Board Assemblies using surface mount components and firmware loaded in embedded processors.

• 2) Plastic injection molded case parts.
• 3. Stepper Motor and piston pump for pneumatic simulation that makes reliable pressure pulses.
• 4. Liquid Crystal Display for user interface. User interface follows modern and ergonomic concepts.
• 5. Lithium Ion rechargeable battery for portable operation, giving user flexibility and portability.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Fluke Biomedical ProSim 4, ProSim 6, and ProSim 8 devices:

Executive Summary:

The Fluke Biomedical ProSim 4, ProSim 6, and ProSim 8 are vital signs simulators designed to test and verify the basic operation of patient monitoring devices. The devices function by providing electronic and pneumatic simulations of various physiological parameters. Extensive non-clinical bench testing was conducted to demonstrate that the ProSim devices perform within their published specifications and are substantially equivalent to their predicate devices (MedSim300B, Cufflink, and Index 2MF SPO2 for ProSim 6/8). Clinical testing was not performed, as the devices are intended for laboratory use for preventative maintenance and not for direct patient use or medical equipment calibration. The ground truth for the testing was the published specifications of the device itself, verified through laboratory measurements.

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1. Table of Acceptance Criteria and the Reported Device Performance:

The document provides a detailed comparison table between the ProSim devices and their predicate devices, indicating various performance characteristics. Since the acceptance criteria are essentially the published specifications and the study aims to show the device performs within those specifications, the "reported device performance" is implicitly that the device met these specifications, thus demonstrating substantial equivalence.

Below is a summarized table consolidating key features and their performance (or range of performance), with the acceptance criteria being that the ProSim meets or improves upon the predicate device's comparable specification or meets its own stated specifications if it's a new feature or different range.

ProSim 4 (compared to MedSim 300B and Cufflink)

Feature	Predicate Devices (Range/Specification)	ProSim 4 (Reported Performance/Specification)	Acceptance Criteria
Display	2x24 char LCD (MedSim); 8x20 char alpha & 64x240 graphics (Cufflink)	¼ VGA graphic LCD Touch Color Display	More display, Touch Screen, and Color – Met/Exceeded
IBP Channels	4 channels (MedSim)	1 channel	Reduced per market requirements and use – Met
Comm Port	RS232	USB	Advancement in technology – Met
Battery Test	Limited low battery indication (MedSim); No battery (Cufflink)	Multiple levels of battery life indication	Predicate checks at one level, ProSim checks at multiple levels – Met/Exceeded
Power	2x9V alkaline (MedSim); AC line (Cufflink)	Li-Ion rechargeable battery w/ low battery indicator; battery eliminator (115VAC)	Longer operating life with modern battery technology – Met/Exceeded
Amplitude accuracy (ECG)	+/- 5%, 2Hz @ 1.0 mV p-p SQ wave Lead II (MedSim)	+/- 2% setting lead II	More accurate on newer devices – Met/Exceeded
NSR rates (ECG)	30 to 300 BPM (MedSim)	30 to 320 BPM	Wider range due to market preferences – Met/Exceeded
NSR amplitudes (ECG)	50 uV to 5.5mV (MedSim)	1mV	Limited amplitude for basic simulation – Met
Pacemaker	0.1 to 2.0 ms width, -700 to +700 mV (MedSim)	1 ms width, 3mV	Basic simulation for targeted market – Met
Impedance variation (Resp)	0 to 3 ohms (MedSim)	1.0 ohm	Basic simulation for targeted market – Met
Respiration rates	15, 20, 30, 40, 60, 120 brpm (MedSim)	10, 20, 30, 40, 50, 60, 70, 80, 90 & 100 brpm	More Respiration rates – Met/Exceeded
Apnea (Resp)	Off, Continuous, momentary, 12 & 32 s (MedSim)	Off & Continuous	Less apneas for basic simulation – Met
Transducer Sensitivity (IBP)	5 or 40 uV/V/mmHg (MedSim)	5 uV/V/mmHg	Fewer selections for basic simulation – Met
Static pres. Selection (IBP)	Manual and automatic (MedSim)	Manual	Limited selection mode per target market and use – Met
Dynamic BP selections (IBP)	Arterial, left and right ventricle, pulmonary artery, pulmonary wedge, Swan-Ganz (MedSim)	Arterial and left ventricle	Fewer selections for basic simulation – Met
Static BP selections (IBP)	-10, -5, 0, 20, 30, 40, 80, 100, 200, 250 & 300 mmHg (MedSim)	0, 80, 160 & 250 mmHg	Fewer selections for basic simulation – Met
Manometer (NIBP)	N/A (MedSim); Max. 499.75 mmHg (Cufflink)	0 to 400 mmHg	Lower range per market requirements – Met
Simulation (NIBP)	N/A (MedSim); Systolic/Diastolic simulations. Adult 60/30 to 255/195 (Cufflink)	Systolic/Diastolic Adult – 60/30, 120/80, 150/100 & 200/150; Neonatal 35/15 & 70/40	Fewer selections for basic simulation; Adult and Neonatal – Met
Synchronization to ECG (NIBP)	N/A (MedSim); 30 to 240 BPM (Cufflink)	Up to 150 BPM	Limited for basic simulation – Met

ProSim 6 & 8 (compared to MedSim 300B, Index 2, and Cufflink)

Feature	Predicate Devices (Range/Specification)	ProSim 6 & 8 (Reported Performance/Specification)	Acceptance Criteria
Intended Use	MedSim: ECG, Resp, BP, Temp, CO; Index 2: SpO2; Cufflink: NIBP	ECG, Resp, IBP, NIBP, Temp, CO, SpO2 (Fetal Sim for ProSim 8)	Additional functions of noninvasive blood pressure and pulse oximetry simulation. – Met/Exceeded
Display	MedSim: 2x24 char LCD; Index 2: 2x24 char LCD; Cufflink: 8x20 char alpha & 64x240 graphics	¼ VGA graphic LCD Color Display	More display, Color. – Met/Exceeded
High level ECG	¼" standard phone jack w/ lead II waveform at .2V/mV (MedSim)	BNC jack for 0.5V/mV output into 50 Ohm impedance	Output to oscilloscope via BNC is preferred by customers. – Met/Exceeded
IBP Channels	4 independent BP channels (MedSim)	2 channels	Number of channels reduced per market requirements and use. – Met
Comm Port	RS232 (all predicates)	USB	Change from RS232 to USB data port with advancement in technology. – Met/Exceeded
Battery Test	Limited low battery indication (MedSim, Index 2); No battery (Cufflink)	Multiple levels of battery life indication	Predicate devices only check at one level. ProSim checks battery status at multiple charge levels. – Met/Exceeded
Amplitude accuracy (ECG)	+/- 5%, 2Hz @ 1.0 mV p-p SQ wave Lead II (MedSim)	+/- 2% setting lead II	More accurate on newer devices due to market preferences and technology improvements. – Met/Exceeded
NSR rates (ECG)	30 to 300 BPM (MedSim)	30 to 360 BPM	Wider range due to market preferences. – Met/Exceeded
Square and/or Pulse waves	Square at 2 Hz and 0.125 Hz (MedSim)	Square at 2.5, 2 & 0.125 Hz. Pulse at 60ms / 60 and 30 BPM	More choices. – Met/Exceeded
Sine waves	0.05 to 100 Hz (MedSim)	0.05 to 150 Hz	More choices. – Met/Exceeded
Triangle wave	2 Hz (MedSim)	0.125, 2 and 2.5 Hz	More choices. – Met/Exceeded
R Wave detector	Yes (MedSim)	Yes	None. – Met
QRS Detection and Tall T-wave rejection	No (MedSim)	Yes	Improved capability. – Met/Exceeded
Impedance variation (Resp)	0 to 3 ohms (MedSim)	0 to 5 ohms	Expanded capability to meet new market requirements. – Met/Exceeded
Respiration rates	15, 20, 30, 40, 60, 120 brpm (MedSim)	15 to 120 brpm in incremental steps	More Respiration rates due to market requirements and use. – Met/Exceeded
Apnea (Resp)	Off, Continuous, momentary, 12 & 32 s (MedSim)	Off, Continuous, momentary, 12, 22 & 32 S	Additional apneas. – Met/Exceeded
Blood temperatures (CO)	36C to 38C and user programmable (MedSim)	36C to 38C in incremental steps	User programmable not included due to market requirements and use. – Met
Injective temp (CO)	Chilled (2C) (MedSim)	Chilled (0C) or 24 C	More selections per market requirements. – Met/Exceeded
Fixed blood flow rate (CO)	3, 5, 7 L/min (MedSim)	2.5, 5, 10 L/min	Different selections per market requirements. – Met
Output trend (CO)	1 normal, 2 defective (MedSim)	No	Not included due to market requirements and use. – Met
Exciter range (IBP)	2 to 16 V/DC to 4 kHz (MedSim)	2 to 16 V/DC to 5kHz	Higher frequency range driven by market trend and technology. – Met/Exceeded
Static pres. Selection (IBP)	Manual and automatic (MedSim)	Manual	Limited selection mode per target market and use. – Met
Dynamic BP selections (IBP)	Arterial, left and right ventricle, pulmonary artery, pulmonary wedge, Swan-Ganz (MedSim)	Arterial, radial artery, left and right ventricle, pulmonary artery, pulmonary wedge, right atrium, left atrium and Swan-Ganz	More selections. – Met/Exceeded
Static BP selections (IBP)	-10, -5, 0, 20, 30, 40, 80, 100, 200, 250 & 300 mmHg (MedSim)	-10 to 300 mmHg in incremental steps	More selections. – Met/Exceeded
Temperature (Sim)	0, 24, 37 and 40C (MedSim)	30C to 42C in incremental steps	Different selections per market requirements. – Met
SpO2 Accuracy	Select 50% to 100% in 1% increments - accuracy: 75%to 100% ± 1% plus the accuracy of the pulse oximeter under test. 50%-75%, ± 2% plus accuracy of the oximeter under test. Under 50%, unspecified. (Index 2)	Select 30% to 100% in 1% increments w/ oximeter manufacturer's R-curve or Fluke Biomedical R-curves (91-100% ±(3 counts + UUT accuracy), 81-90% ±(5 counts + UUT accuracy), 71-80% ±(7 counts + UUT accuracy), <70% monotonic unfilled accuracy)	More selections per market requirements. – Met/Exceeded
SpO2 Test features	Transmission Light Control (TLC) feature for different light attenuation (Index 2)	Transmission of light selected through selection of finger type: light finger, thick dark finger or neonate.	Better user interface and understanding of transmission with ProSim selection of light transmission levels. – Met/Exceeded
Magnetic Holder	N/A (Index 2)	Yes	Includes tested magnetic holder for SPO2 module. – Met/Exceeded
Simulation (NIBP)	Systolic/Diastolic simulations. Adult 60/30 to 255/195 (Cufflink)	Systolic/Diastolic Adult 60/30 to 255/195; Neonatal 35/15 to 255/195	Adult and Neonatal available. – Met/Exceeded
Arrhythmias (NIBP)	Premature atrial contraction, Premature ventricular contraction, Atrial fibrillation, Missed Beat, aberrant Sinus conduction (Cufflink)	Premature atrial contraction, Premature ventricular contraction, Atrial fibrillation, Missed Beat.	No aberrant Sinus conduction. Not needed per market use. – Met
Synchronization to ECG (NIBP)	30 to 240 BPM (Cufflink)	30 to 240 BPM	None. – Met

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2. Sample Size Used for the Test Set and the Data Provenance:

• Sample Size: The document does not specify a numerical sample size for individual tests (e.g., how many measurements were taken for each parameter). It states that "Laboratory studies have been conducted with a representative patient monitor..." and "The ProSim [4/6/8] software has been successfully validated..." This implies that the testing involved a single representative device (the ProSim itself) undergoing various tests against its own specifications or in comparison to predicate devices.
• Data Provenance: The studies were non-clinical laboratory studies conducted by Fluke Biomedical. The location of the laboratory is likely the manufacturer's facility in the USA (Fluke Biomedical, Everett, WA, or Solon, OH). The data is retrospective in the sense that it's a summary of completed bench tests demonstrating performance.

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3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

• Number of Experts: The document does not specify the number of experts.
• Qualifications of Experts: The ground truth for this type of device, a vital signs simulator, is typically based on electrical and pneumatic engineering principles and established medical device standards for physiological parameter simulation (e.g., AAMI, IEC standards for ECG, BP). The testing would be performed by trained technicians or engineers proficient in metrology and test equipment, verifying the device's output against known, calibrated reference standards. While not explicitly stated, it's implied these are qualified personnel within Fluke Biomedical's R&D or Quality Assurance departments.

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4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable in the traditional sense of human consensus for, say, image interpretation. The "adjudication" is based on objective measurement against defined performance specifications and comparison to predicate devices. The results are summarized by the manufacturer.

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5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

• No, an MRMC study was not done. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data. The ProSim devices are test equipment for patient monitors, not diagnostic tools. Their effectiveness is measured by their ability to accurately simulate physiological signals for verification and maintenance, not by improving human diagnostic performance.

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6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Yes, a standalone study was done. The entire "Non-Clinical Test Data" section describes rigorous bench testing of the ProSim devices themselves, which are algorithmic-driven instruments, to verify their performance within published specifications. The statement "The ProSim [4/6/8] software has been successfully validated to confirm the performance of the device" directly supports this. The device's function is standalone simulation; there isn't a "human-in-the-loop" once the simulation parameters are set.

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7. The Type of Ground Truth Used:

• Engineering Specifications and Calibrated Reference Standards: The ground truth used is the device's own published specifications (e.g., amplitude accuracy, rate ranges, impedance values) and the measured performance of predicate devices. Performance was verified against these using calibrated test equipment and established metrology practices.

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8. The Sample Size for the Training Set:

• Not applicable. The ProSim devices are simulators, not AI/machine learning models that require a training set. They are designed based on established physiological principles and engineering design.

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9. How the Ground Truth for the Training Set Was Established:

• Not applicable. As stated above, there is no "training set" in the context of an AI/ML model for these devices.

Summary

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K110429

SEP - 2 2011

Image /page/0/Picture/2 description: The image shows the logo for Fluke Biomedical. The word "FLUKE" is in large, bold, sans-serif font. Below the word "FLUKE" is the word "Biomedical" in a smaller, bold, sans-serif font. There is a line above the word "Biomedical".

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

Submitter:

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

Device Name:

• ◆ Trade Name - ProSim 4
• . Common Name -Vital Signs Simulator
• Classification Name Monitor, Cardiac /System, Measurement, Blood-Pressure, Non-Invasive per . 21 CFR 870.2300/870.1130
• Product Codes -DRT, DXN .

Devices for Which Substantial Equivalence is Claimed:

• MedSim300B Submitted as MedSim300 under 510(k) K935817 ◆
• Cufflink .

Device Description:

Principles of Operation

Fluke Biomedical's ProSim 4 (hereafter referred to as the ProSim) 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 electrical signals, respiration electrical signals, invasive blood pressure (IBP) electrical signals and non-invasive blood pressure pulses. The ProSim is a lightweight, battery powered unit that is portable enough to test a patient monitor anywhere the monitor is being used.

Technological Characteristics

ProSim vital signs simulator consists of the following components:

1. Printed Circuit Board Assemblies using surface mount components and firmware loaded in embedded processors.

2. Plastic iniection molded case parts.

3. Stepper Motor and piston pump for pneumatic simulation that makes reliable pressure pulses.

4. Liquid Crystal Touch Screen Display for user interface. User interface follows modern and ergonomic concepts.

5. Lithium Ion rechargeable battery for portable operation, giving user flexibility and portability.

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Intended Use of the Device:

The intended us of ProSim 4 is to test and verify the basic operation of patient monitoring devices or systems used to monitor various physiological parameters of a patient, including ECG, Respiration, Invasive blood pressure and Non-invasive blood pressure.

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 manufacturers and independent service companies that repair and service medical equipment. The end user is a technically trained individual, specializing in medical instrumentation technology.

The ProSim 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 product line is not intended to be used to calibrate medical equipment.

ProSim is intended for over-the counter use.

Summary of Technological Characteristics:

The ProSim 4 is substantially equivalent to one other legally marketed device in the United States. The ProSim functions in a manner similar to and is intended for the same use as the MedSim300B and Cufflink manufactured by Fluke Biomedical.

The ProSim 4 is similar to the MedSim300B and Cufflink 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 ProSim differs from the MedSim300B and Cufflink in that the ProSim combines the features of each of these devices into one device and is touch screen operated.

Features	ProSim 4	MedSim 300B(K935817)	Cufflink(K942546)	Difference
Intended Use	The intended use ofProSim 4 is to test andverify the basicoperation of patientmonitoring devices orsystems used to monitorvarious physiologicalparameters of a patient,including ECG,Respiration, Invasiveblood pressure andNon-Invasive bloodpressure.The intended user is atrained biomedicalequipment technicianwho is performingperiodic preventativemaintenance checks onpatient monitors inservice. Users can beassociated withHospitals, clinics,original equipmentmanufacturers orindependent servicecompanies that repairand service medical	To test operationof patient monitorsby simulatingphysiologicalparameters,including: ECG,respiration, bloodpressure,temperature andcardiac output.	To test operation ofNon-Invasive BloodPressure (automatedSphygmomanometerssimulator).	None
	equipment. The enduser is a technicallytrained individual,specializing in medicalinstrumentationtechnology.The ProSim product lineis intended to be used inthe laboratoryenvironment and is notintended for use onpatients, or to testdevices while connectedto patients. This productline is not intended to beused to calibratemedical equipment andnot intended for over thecounter use.
Construction	Plastic case.	Aluminum case.	Aluminum case.	Lighter morecompact plasticcasing.
Size	ProSim 4: 7.1 L x 3.7 Wx 2.2 H inches.	10 L x 7 W x 3 Hinches.	15 L x 12.5 W x 5 Hinches.	Combinationinstrumentsmaller thansum ofpredicatedevices.
Weight	ProSim 4: 1.9 lbs.	3.55 lbs.	15 lbs.	Lighter.
Display	¼ VGA graphic LCDTouch Color Display.	2 by 24 characterLCD.	8 by 20 characteralphanumericdisplay & 64 by 240graphical display.	More display,Touch Screenand Color.
Function Key	ProSim 4: Touchscreen.	Soft.	Soft.	ProSim 4:Touchscreen.
ECG leads	10 binding posts;compatible w/disposable snaps, 3.2mm or 4.0 mmelectrodes, and bananaplugs (with or withoutadapter).	10 binding posts;compatible w/disposable snaps.3.2 mm or 4.0 mmelectrodes, andbanana plugs.	N/A	None.
IBP Channels	Independent BPchannels w/ sensitivitycontrol (5 or 40uV/V/mmHg); cableinterface w/ monitors.ProSim 4: 1 channel.	4 independent BPchannels w/sensitivity control(5 or 40uV/V/mmHg);cable interface w/monitors.	N/A	Number ofchannelsreduced permarketrequirementsand use.
CommunicationsPort	USB.	RS232.	RS232.	Change fromRS232 to USBdata port withadvancement intechnology.
Battery test	Multiple levels of battery life indication.	Limited low battery indication.	No battery.	Predicate devices only check at one level. ProSim checks battery status at multiple charge levels.
Power	Li-Ion rechargeable battery w/ low battery indicator; or battery eliminator (115VAC) transformer certified to CSA.	2 X 9V alkaline battery w/ low battery indicator; or battery eliminator (115VAC) transformer certified to CSA C22.2. 231 series M89).	No Battery- AC line powered only.	Longer operating life with modern battery technology.
Lead configuration	12 leads.	12 leads.	N/A	None.
Output impedances	500 to 2000ohms to RL.	500 to 2000ohms to RL.	N/A	None.
Amplitude accuracy	+/- 2% setting lead II.	+/- 5%, 2Hz @ 1.0 mV p-p SQ wave Lead II.	N/A	More accurate on newer devices due to market preferences and technology improvements.
NSR rates	ProSim 4: 30 to 320 BPM.	30 to 300 BPM.	N/A	Wider range due to market preferences.
NSR amplitudes	ProSim 4: 1mV	50 uV to 5.5mV.	N/A	ProSim 4: Limited amplitude for basic simulation.
Pediatric or Neonatal ECG	R Wave width reduced to 40 ms.	R Wave width reduced to 40 ms.	N/A	None.
Square and/or Pulse waves	ProSim 4: Pulse at 60ms / 2Hz.	Square at 2 Hz and 0.125 Hz.	N/A	ProSim 4: Provides what is required for a basic simulation.
Pacemaker	ProSim 4: 1 ms width, 3mV.	0.1 to 2.0 ms width, -700 to +700 mV	N/A	ProSim 4: Basic simulation for targeted market.
Cable connector	ECG leads, 10 binding postings.	ECG leads, 10 binding postings.	N/A	None.
Normal baseline impedances	500 to 2000 ohms ref. to RL.	500 to 2000 ohms ref. to RL.	N/A	None.
Lead selections	LA or LL.	I or II (LA or LL).	N/A	None.
Impedance variation	ProSim 4: 1.0 ohm	0 to 3 ohms.	N/A	ProSim 4: Basic simulation for targeted market.
Respirationrates	ProSim 4: 10, 20, 30,40, 50, 60, 70, 80, 90 &100 brpm.	15, 20, 30, 40, 60,120 brpm.	N/A	MoreRespirationrates due tomarketrequirementsand use.
Apnea	ProSim 4: Off &Continuous.	Off, Continuous,momentary, 12 &32 s.	N/A	ProSim 4: Lessapneas forbasic simulationand targetmarket.
Cable connector	ECG leads, bindingposts.	ECG leads,binding posts.	N/A	None
I/O impedance	300 ohms.	300 ohms.	N/A	None.
Exciter range	2 to 16 V/DC to 5kHz.	2 to 16 V/DC to 4kHz	N/A	Higherfrequencyrange driven bymarket trendand technology.
TransducerSensitivity	ProSim 4: 5 uV/V/mmHg	5 or 40uV/V/mmHg.	N/A	ProSim 4:Fewerselections forbasic simulationand targetmarket.
Level accuracy	+/- (1% setting +1mmHg).	+/- 1% full scale;+/- 1mmHg.	N/A	None.
Static pres.Selection	Manual.	Manual andautomatic.	N/A	Limitedselection modeper targetmarket and use.
Dynamic BPselections	ProSim 4: Arterial andleft ventricle.	Arterial, left andright ventricle,pulmonary artery,pulmonary wedge,Swan-Ganz.	N/A	ProSim 4:Fewerselections forbasic simulationand targetmarket.
Static BPselections	ProSim 4: 0, 80, 160 &250 mmHg	-10, -5, 0, 20, 30,40, 80, 100, 200,250 & 300 mmHg.	N/A	ProSim 4:Fewerselections forbasic simulationand targetmarket.
Cable connector	DIN style.	DIN style.	N/A	None.
Manometer	0 to 400 mmHg	N/A	Max. 499.75 mmHg	Lower rangefollowingmarketrequirements.
Leak Test	Source pressure, sealoff, measure change inpressure over time.	N/A	Source pressure,seal off, measurechange in pressureover time.	None.
Over PressureTest	Increase pressure untildevice under tests ventsto atmosphere.	N/A	Increase pressureuntil device undertests vents toatmosphere.	None.
Simulation	ProSim 4:Systolic/Diastolic Adult –60/30, 120/80, 150/100& 200/150; Neonatal35/15 & 70/40.	N/A	Systolic/Diastolicsimulations. Adult60/30 to 255/195.	ProSim 4:Fewerselections forbasicsimulation.Adult andNeonatal.
Synchronizationto ECG	ProSim 4: Up to 150BPM	N/A	30 to 240 BPM	ProSim 4:Limited forbasicsimulation.

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Non-Clinical Test Data:

Laboratory studies have been conducted with a representative patient monitor to verify and validate the ProSim 4 will perform within its' published specifications.

• NPI-02042011-00001 ProSim 4 Bench test summary and results. .
  The ProSim 4 software has been successfully validated to confirm the performance of the device.

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 devices, and successful validation of the ProSim 4 software, the performance of the ProSim 4 is deemed to be substantially equivalent to the MedSim300B and Cufflink.

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Device Name:

• Trade Name -ProSim 6, ProSim 8 .
• . Common Name -Vital Signs Simulator
• Classification Name Monitor, Cardiac /System, Measurement, Blood-Pressure, Non-Invasive per . 21 CFR 870.2300/870.1130
• Product Codes -- DRT, DXN .

Devices for Which Substantial Equivalence is Claimed:

• MedSim300B Submitted as MedSim300 under 510(k) K935817 .
• Index 2MF SPO2 Originally submitted and cleared under 510(k) K933519. Currently marketed . as Index 2MF which was ruled as a general purpose device on Feb 11, 1998 (K974293)
• . Cufflink

Device Description:

Principles of Operation

Fluke Biomedical's ProSim 6 and ProSim 8 (hereafter referred to as the ProSim) 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 electrical signals, respiration electrical signals, invasive blood pressure (IBP) electrical signals, non-invasive blood pressure (NIBP) pressure pulses, temperature electrical signal, cardiac output electrical signal, and pulse oximetry SPO2 optical simulated light attenuation. The ProSim is a lightweight, battery powered unit that is portable enough to test a patient monitor anywhere the monitor is being used.

Technological Characteristics

ProSim vital signs simulator consists of the following components:

l ) Printed Circuit Board Assemblies using surface mount components and firmware loaded in embedded processors.

• 2. Plastic injection molded case parts.
• 3. Stepper Motor and piston pump for pneumatic simulation that makes reliable pressure pulses.
• 4. Liquid Crystal Display for user interface. User interface follows modern and ergonomic concepts.
• 5. Lithium Ion rechargeable battery for portable operation, giving user flexibility and portability.

Intended Use of the Device:

The intended us of ProSim 6 and ProSim 8 is to test and verify the basic operation of patient monitoring devices or systems used to monitor various physiological parameters of a patient, including ECG, Respiration, Invasive blood pressure, Non-invasive blood pressure and Cardiac output. Additionally, the devices provide an optical signal to verify that the electronics within the pulse oximeter probe are functional.

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, cliginal 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,

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The ProSim 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 product line is not intended to be used to calibrate medical equipment.

ProSim is intended for over-the counter use.

Summary of Technological Characteristics:

The ProSim is substantially equivalent to one other legally marketed device in the United States. The ProSim functions in a manner similar to and is intended for the same use as the MedSim300B, Index 2 and Cufflink manufactured by Fluke Biomedical.

The ProSim is similar to the MedSim300B, Index 2 and Cufflink 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 ProSim differs from the MedSim300B, Index 2 and Cufflink in that the ProSim combines the features of each of these devices into one device.

Features	ProSim 6 &ProSim 8	MedSim 300B(K935817)	Index 2(K 933519)	Cufflink(K942546)	Difference
IntendedUse	The intended use ofProSim 6 andProSim 8 is to testand verify the basicoperation of patientmonitoring devicesor systems used tomonitor variousphysiologicalparameters of apatient, includingECG, Respiration,Invasive bloodpressure, Non-invasive bloodpressure,Temperature,Cardiac output andSpO2.The intended user isa trained biomedicalequipmenttechnician who isperforming periodicpreventativemaintenance checkson patient monitorsin service. Users canbe associated withHospitals, clinics,original equipmentmanufacturers orindependent servicecompanies thatrepair and servicemedical equipment.The end user is atechnically trainedindividual,specializing in	To test operationof patient monitorsby simulatingphysiologicalparameters,including: ECG,respiration, bloodpressure,temperature andcardiac output.	To test operation ofPulse Oximeters bysimulating the visibleand infrared lightabsorption.	To test operationofNon-Invasive BloodPressure (automatedSphygmomanometerssimulator).	Additionalfunctions ofnoninvasiveblood pressureand pulseoximetrysimulation
	medicalinstrumentationtechnology.The ProSim productline is intended tobe used in thelaboratoryenvironment and isnot intended for useon patients, or totest devices whileconnected topatients. Thisproduct line is notintended to be usedto calibrate medicalequipment and notintended for overthe counter use.
Construction	Plastic case.	Aluminum case.	Plastic case.	Aluminum case.	Lighter morecompactplastic casing
Size	5.7 L x 11.9 W x 3.4H inches.	10 L x 7 W x 3 Hinches.	10 L x 10.5 W x 4 Hinches.	15 L x 12.5 W x 5 Hinches.	Combinationinstrumentsmaller thansum ofpredicatedevices.
Weight	4.1 lbs.	3.55 lbs.	4 lbs.	15 lbs.	Lighter.
Display	¼ VGA graphicLCD Color Display.	2 by 24 characterLCD.	2 by 24 characterLCD.	8 by 20 characteralphanumericdisplay & 64 by 240graphical display.	More display,Color.
FunctionKey	Soft.	Soft.	Soft.	Soft.	None.
ECG leads	10 binding posts;compatible w/disposable snaps,3.2 mm or 4.0 mmelectrodes, andbanana plugs (withor without adapter).	10 binding posts;compatible w/disposable snaps,3.2 mm or 4.0 mmelectrodes, andbanana plugs.	N/A	N/A	None.
High levelECG	BNC jack for0.5V/mV outputinto 50 Ohmimpedance.	¼" standard phonejack w/ lead IIwaveform at.2V/mV of ECGlead II signal. Usew/ analog input,high level, centralstation monitors orrecorders.	N/A	N/A	Output tooscilloscopevia BNC ispreferred bycustomers.
IBPChannels	Independent BPchannels w/sensitivity control (5or 40 uV/V/mmHg);cable interface w/monitors.2 channels.	4 independent BPchannels w/sensitivity control(5 or 40uV/V/mmHg);cable interface w/monitors.	N/A	N/A	Number ofchannelsreduced permarketrequirementsand use.
	(500 – 2000)control; lead selectcontrol.	Impedance (500 –2000) control; leadselect control.
Temperature	Yes, fixed temp.probe select control(400 or 700 YSI)series probes.	Yes, fixed orvariable temp.probe selectcontrol (400 or 700YSI) series probes.	N/A	N/A	None.
Cardiacoutput	Yes, cable connectw/ monitor.	Yes, cable connectw/ monitor.	N/A	N/A	None.
Communications Port	USB.	RS232.	RS232.	RS232.	Change fromRS232 toUSB data portwithadvancementin technology.
Battery test	Multiple levels ofbattery lifeindication.	Limited lowbattery indication.	Limited low batteryindication.	No battery.	Predicatedevices onlycheck at onelevel. ProSimchecks batterystatus atmultiplecharge levels.
Power	Li-Ion rechargeablebattery w/ lowbattery indicator; orbattery eliminator(115VAC)transformer certifiedto CSA.	2 X 9V alkalinebattery w/ lowbattery indicator; or batteryeliminator(115VAC)transformercertified to CSAC22.2. 231 seriesM89).	Rechargeable LeadAcid battery.	No Battery- AC linepowered only.	Longeroperating lifewith modernbatterytechnology.
ECG
Leadconfiguration	12 leads.	12 leads.	N/A	N/A	None.
Outputimpedances	500 to 2000ohms to RL.	500 to2000ohmsto RL.	N/A	N/A	None.
Amplitudeaccuracy	+/- 2% setting lead II.	+/- 5%,2Hz @ 1.0mV p-p SQwave LeadII.	N/A	N/A	More accurateon newerdevices due tomarketpreferences andtechnologyimprovements.
NSR rates	30 to 360 BPM.	30 to 300BPM.	N/A	N/A	Wider range dueto marketpreferences.
NSRamplitudes	50 uV to 5.0mV.	50 uV to5.5mV.	N/A	N/A	None.
ST Segments	-0.8 to +0.8 mV.	-0.8 to +0.8 mV.	N/A	N/A	None.
Axis deviation	Intermediate, horizontaland vertical.	Intermediate,horizontalandvertical.	N/A	N/A	None.
Pediatric orNeonatal ECG	R Wave width reduced to40 ms.	R Wavewidthreduced to40 ms.	N/A	N/A	None.
Performance Test
Square and/orPulse waves	Square at 2.5, 2 & 0.125Hz. Pulse at 60ms / 60and 30 BPM	Square at 2Hz and0.125 Hz.	N/A	N/A	More choices.
Sine waves	0.05 to 150 Hz.	0.05 to 100Hz.	N/A	N/A	More choices.
Triangle wave	0.125, 2 and 2.5 Hz.	2 Hz.	N/A	N/A	More choices.
R Wavedetector	Yes.	Yes.	N/A	N/A	None
QRS Detectionand Tall T-wave rejection.	Yes	No	N/A	N/A	None
Pacemaker	0.1 to 2.0 ms width, -700to +700 mV	0.1 to 2.0ms width, -700 to +700mV	N/A	N/A	None
Cableconnector	ECG leads, 10 bindingpostings.	ECG leads,10 bindingpostings.	N/A	N/A	None.
Respiration
Normalbaselineimpedances	500 to 2000 ohms ref. toRL.	500 to 2000ohms ref. toRL.	N/A	N/A	None.
Leadselections	LA or LL.	I or II (LAor LL).	N/A	N/A	None.
Impedancevariation	0 to 5 ohms.	0 to 3ohms.	N/A	N/A	Expandedcapability tomeet newmarketrequirements.
Respirationrates	15 to 120 brpm inincremental steps.	15, 20, 30,40, 60, 120brpm.	N/A	N/A	MoreRespiration ratesdue to marketrequirementsand use.
Apnea	Off, Continuous,momentary, 12, 22 & 32S.	Off,Continuous,momentary,12 & 32 s.	N/A	N/A	Additionalapneas.
Cableconnector	ECG leads, binding posts.	ECG leads,bindingposts.	N/A	N/A	None
Cardiac Output
Catheter size	Fixed, 7F injective vol.10 cc.	Fixed, 7Finjectivevol. 10 cc.	N/A	N/A	None.
Bloodtemperatures	36C to 38C inincremental steps.	36C to 38Cand userprogrammable.	N/A	N/A	Userprogrammablenot included dueto marketrequirementsand use.
Injective temp	Chilled (0C) or 24 C.	Chilled(2C).	N/A	N/A	More selectionsper marketrequirements.
Fixed bloodflow rate	2.5, 5, 10 L/min.	3, 5, 7L/min.	N/A	N/A	Differentselections permarketrequirements.
Curves	Normal, faulty and L/Rshunt.	Normal,interrupt,slow, L/Rshunt.	N/A	N/A	None.
Output trend	No.	1 normal, 2defective.	N/A	N/A	Not includeddue to marketrequirementsand use.
Bath/Injectiveresistance	Continuously variable, 3pin standard.	Continuously variable,3 pinstandard.	N/A	N/A	None.
Cableconnector	Blood Temp - AmericanEdward, 3 pin standard;Injective Temp -American Edward, 4 pinstandard.	BloodTemp -AmericanEdward, 3pinstandard;InjectiveTemp -AmericanEdward, 4pinstandard.	N/A	N/A	None
Invasive Blood Pressure.
I/O impedance	300 ohms.	300 ohms.	N/A	N/A	None.
Exciter range	2 to 16 V/DC to 5kHz.	2 to 16V/DC to 4kHz	N/A	N/A	Higherfrequency rangedriven by markettrend andtechnology.
TransducerSensitivity	5 or 40 uV/V/mmHg.	5 or 40uV/V/mmHg.	N/A	N/A	None.
Level accuracy	+/- (1% setting +1mmHg).	+/- 1% fullscale; +/-1mmHg.	N/A	N/A	None.
Static pres.Selection	Manual.	Manual andautomatic.	N/A	N/A	Limitedselection modeper target marketand use.
Dynamic BPselections	Arterial, radial artery, leftand right ventricle,pulmonary artery,pulmonary wedge, rightatrium, left atrium andSwan-Ganz.	Arterial,left andrightventricle,pulmonaryartery,pulmonarywedge,Swan-Ganz.	N/A	N/A	More selections.
Static BPselections	-10 to 300 mmHg inincremental steps.	-10, -5, 0,20, 30, 40,80, 100,200, 250 &300 mmHg.	N/A	N/A	More selections.
Cableconnector	DIN style.	DIN style.	N/A	N/A	None.
Temperature	30C to 42C inincremental steps.	0, 24, 37and 40C.	N/A	N/A	Differentselections permarketrequirements.
Probecompatibility	Series 400 and 700.	Series 400and 700.	N/A	N/A	None.
Cableconnector	DIN Style.	DIN Style.	N/A	N/A	None.
Oximeter SPO2 optical emitter and detector
SpO2 R-Curveselection	Select R-Curve frommenu of choices.	N/A	Select R-Curvefrom menu ofchoices.	N/A	None.
SpO2 Pulserate selection	Select BPM rate in 1BPM increments.	N/A	Select BPM ratein 1 BPMincrements.	N/A	None.
SpO2accuracy	Select 30% to 100% in1% incrementsWith oximetermanufacturer's R-curveSaturationwithin UUT specificrange ±(1 count +specified accuracy of theUUT)Saturationoutside UUT specificrange monotonic withunspecified accuracyWith Fluke BiomedicalR-curves91 to 100 %±(3 counts + specifiedaccuracy of the UUT)81 to 90 % ±(5counts + specifiedaccuracy of the UUT)71 to 80 % ±(7counts + specifiedaccuracy of the UUT)Below 70 %monotonic withunspecified accuracy	N/A	Select 50% to100% in 1%increments-accuracy: 75%to100% ± 1%plus theaccuracy of thepulse oximeterunder test. 50%-75%, ± 2% plusthe accuracy ofthe oximeterunder test.Under 50%,unspecified.	N/A	More selectionsper marketrequirements.
SpO2 Test	Optical.	N/A	Probe electricalsimulation test.	N/A	Electricalsimulation of thefinger probe isnot needed withmodernoximeters.
SpO2 testfeatures	Transmission of lightselected through selectionof finger type: lightfinger, thick dark fingeror neonate.	N/A	TransmissionLight Control(TLC) feature inIndex 2 is aquantity thatsimulatesdifferent light	N/A	Better userinterface andunderstanding oftransmissionwith ProSimselection of lighttransmission
			attenuation.		levels.
MagneticHolder	Yes	N/A	No	N/A	Includes testedmagnetic holderfor SPO2module.
Non-Invasive Blood Pressure
Manometer	0 to 400 mmHg	N/A	N/A	Max. 499.75 mmHg	Lower rangefollowingmarketrequirements.
Leak Test	Source pressure, seal off,measure change inpressure over time.	N/A	N/A	Source pressure, sealoff, measure changein pressure overtime.	None.
Over PressureTest	Increase pressure untildevice under tests ventsto atmosphere.	N/A	N/A	Increase pressureuntil device undertests vents toatmosphere.	None.
Simulation	Systolic/Diastolic Adult60/30 to 255/195;Neonatal 35/15 to255/195.	N/A	N/A	Systolic/Diastolicsimulations. Adult60/30 to 255/195.	Adult andNeonatalavailable.
Arrhythmias	Premature atrialcontraction, Prematureventricular contraction,Atrial fibrillation, MissedBeat.	N/A	N/A	Premature atrialcontraction,Prematureventricularcontraction, Atrialfibrillation, MissedBeat, aberrant Sinusconduction.	No aberrantSinusconduction. Notneeded permarket use.
Synchronization to ECG	30 to 240 BPM	N/A	N/A	30 to 240 BPM	None.

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Biomedical

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Biomedical

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Biomedical 174

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Biomedical

Non-Clinical Test Data:

Laboratory studies have been conducted with a representative patient monitor to verify and validate the ProSim 6 and ProSim 8 will perform within its' published specifications.

• NPI-01282011-00007 ProSim 6_8 Bench test summary and results .
  The ProSim 6 and ProSim 8 software has been successfully validated to confirm the performance of the device.

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 devices, and successful validation of the ProSim 8 software, the performance of the ProSim 6 and ProSim 8 is deemed to be substantially equivalent to the MedSim300B, Index 2 and Cufflink.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/14/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

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, RAC Director of Regulatory/Quality Affairs 6045 Cochran Rd. Solon, OH 44139

2 2011

Re: K110429

Trade/Device Names: ProSim 4, 6 and 8 Regulatory Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including Cardiotachometer and Rate Alarm) Regulatory Class: Class II (Two) Product Code: DRT Dated: August 26, 2011 Received: August 29, 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, RAC

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 (OS) 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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

R. D. Zadeh, M.D.

Bran D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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FLUKE
Biomedical

Indications for Use

ProSim 4

510(k) Number (if known): K110429

Device Name: ProSim4

Indications for Use:

The ProSim 4 Vital Signs Simulator provides electronic and pneumatic simulation of physiological parameters for determining that patient monitoring devices or systems are performing within their operating specifications. The device includes the following physiological simulations:

• ECG adult or neonatal .
• Invasive and non-invasive blood pressure .
• Respiration .

Prescription Use

(Part 21 CFR 801 Subpart D)	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)

AND/OR

Over-The-Counter Use

(Division Sign-Off) Division of Cardiovascular Devices

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X

510(k) Number K110429

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FLUKE.
Biomedical

Indications for Use

ProSim 6/8

510(k) Number (if known): K110429

Device Name: ProSim6/8

Indications for Use:

The ProSim 6 and ProSim 8 Vital Signs Simulators provide electronic and pneumatic simulation of physiological parameters for determining that patient monitoring devices or systems are performing within their operating specifications. The devices provide the following physiological simulations:

• · ECG adult or pediatric
• Invasive and non-invasive blood pressure .
• Respiration ●
• Temperature �
• � Cardiac Output
• Fetal Simulation includes fetal, maternal ECG, & uterine contractions (ProSim . 8 only)

Additionally, the devices provide an optical signal to verify that the electronics within the pulse oximeter probe are functional

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (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)
Division of Cardiovascular Devices

510(k) Number K110427

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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).