Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a vital signs simulator that generates electronic and pneumatic signals to test patient monitors. There is no mention of AI or ML being used for analysis, simulation generation, or any other function. The device description focuses on hardware components and firmware for embedded processors, which are standard for such simulators.

Therapeutic

No
The device simulates physiological parameters to test and verify the operation of patient monitoring devices, not to provide therapy to a patient. The document explicitly states it "is not intended for use on patients".

Diagnostic

No

This device is not a diagnostic device. It is a vital signs simulator used to test and verify the basic operation of patient monitoring devices, not to diagnose medical conditions in patients. The text explicitly states it is "not intended for use on patients, or to test devices while connected to patients."

SaMD (Software as a Medical Device)

No

The device description explicitly lists multiple hardware components including printed circuit boards, plastic case parts, a stepper motor and piston pump, a touch screen display, and a battery. While it contains firmware and software, it is not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, the ProSim 4, ProSim 6, and ProSim 8 devices are not IVDs (In Vitro Diagnostics).

Here's why:

Intended Use: The intended use is clearly stated as testing and verifying the basic operation of patient monitoring devices or systems. These simulators provide electronic and pneumatic simulations of physiological parameters to ensure the monitoring equipment is functioning correctly. They are used for training, evaluation, and preventive maintenance of medical equipment.
Device Description: The description details the components of a simulator that generates electrical and pneumatic signals. It does not describe a device that analyzes biological samples (blood, urine, tissue, etc.) to provide diagnostic information about a patient's health.
Intended User / Care Setting: The intended user is a trained biomedical equipment technician in a laboratory environment. The document explicitly states the device is not intended for use on patients, or to test devices while connected to patients. This is a key distinction from IVDs, which are used to obtain information from patient samples for diagnostic purposes.
Lack of Biological Sample Analysis: There is no mention of the device interacting with or analyzing any biological samples.

In summary, the ProSim devices are medical device simulators used to test and maintain other medical devices (patient monitors). They do not perform diagnostic tests on patient samples, which is the defining characteristic of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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

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

Product codes (comma separated list FDA assigned to the subject device)

DRT, DXN

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:

Printed Circuit Board Assemblies using surface mount components and firmware loaded in embedded processors.
Plastic iniection molded case parts.
Stepper Motor and piston pump for pneumatic simulation that makes reliable pressure pulses.
Liquid Crystal Touch Screen Display for user interface. User interface follows modern and ergonomic concepts.
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:

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Adult, neonatal (ProSim 4)
Adult, pediatric (ProSim 6 and 8). ProSim 8 specifically mentions fetal simulation.

Intended User / Care Setting

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.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

MedSim300B Submitted as MedSim300 under 510(k) K935817, Cufflink

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

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)
Index 2 (K 933519)

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).

Summary

0

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

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

1

Image /page/1/Picture/0 description: The image shows the logo for Fluke Biomedical. The word "FLUKE" is in large, bold, sans-serif font on a gray background. Below the word "FLUKE" is the word "Biomedical" in a smaller, bold, sans-serif font. There is a black line above the word "Biomedical".

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 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 or
independent service
companies that repair
and service medical | To test operation
of patient monitors
by simulating
physiological
parameters,
including: ECG,
respiration, blood
pressure,
temperature and
cardiac output. | To test operation of
Non-Invasive Blood
Pressure (automated
Sphygmomanometers
simulator). | None |
| | equipment. The end
user is a technically
trained individual,
specializing in medical
instrumentation
technology.
The ProSim product line
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 and
not intended for over the
counter use. | | | |
| Construction | Plastic case. | Aluminum case. | Aluminum case. | Lighter more
compact plastic
casing. |
| Size | ProSim 4: 7.1 L x 3.7 W
x 2.2 H inches. | 10 L x 7 W x 3 H
inches. | 15 L x 12.5 W x 5 H
inches. | Combination
instrument
smaller than
sum of
predicate
devices. |
| Weight | ProSim 4: 1.9 lbs. | 3.55 lbs. | 15 lbs. | Lighter. |
| Display | ¼ VGA graphic LCD
Touch Color Display. | 2 by 24 character
LCD. | 8 by 20 character
alphanumeric
display & 64 by 240
graphical display. | More display,
Touch Screen
and Color. |
| Function Key | ProSim 4: Touchscreen. | Soft. | Soft. | ProSim 4:
Touchscreen. |
| ECG leads | 10 binding posts;
compatible w/
disposable snaps, 3.2
mm or 4.0 mm
electrodes, and banana
plugs (with or without
adapter). | 10 binding posts;
compatible w/
disposable snaps.
3.2 mm or 4.0 mm
electrodes, and
banana plugs. | N/A | None. |
| IBP Channels | Independent BP
channels w/ sensitivity
control (5 or 40
uV/V/mmHg); cable
interface w/ monitors.
ProSim 4: 1 channel. | 4 independent BP
channels w/
sensitivity control
(5 or 40
uV/V/mmHg);
cable interface w/
monitors. | N/A | Number of
channels
reduced per
market
requirements
and use. |
| Communications
Port | USB. | RS232. | RS232. | Change from
RS232 to USB
data port with
advancement in
technology. |
| 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. |
| Respiration
rates | ProSim 4: 10, 20, 30,
40, 50, 60, 70, 80, 90 &
100 brpm. | 15, 20, 30, 40, 60,
120 brpm. | N/A | More
Respiration
rates due to
market
requirements
and use. |
| Apnea | ProSim 4: Off &
Continuous. | Off, Continuous,
momentary, 12 &
32 s. | N/A | ProSim 4: Less
apneas for
basic simulation
and target
market. |
| Cable connector | ECG leads, binding
posts. | 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 4
kHz | N/A | Higher
frequency
range driven by
market trend
and technology. |
| Transducer
Sensitivity | ProSim 4: 5 uV/V/mmHg | 5 or 40
uV/V/mmHg. | N/A | ProSim 4:
Fewer
selections for
basic simulation
and target
market. |
| Level accuracy | +/- (1% setting +
1mmHg). | +/- 1% full scale;
+/- 1mmHg. | N/A | None. |
| Static pres.
Selection | Manual. | Manual and
automatic. | N/A | Limited
selection mode
per target
market and use. |
| Dynamic BP
selections | ProSim 4: Arterial and
left ventricle. | Arterial, left and
right ventricle,
pulmonary artery,
pulmonary wedge,
Swan-Ganz. | N/A | ProSim 4:
Fewer
selections for
basic simulation
and target
market. |
| Static BP
selections | ProSim 4: 0, 80, 160 &
250 mmHg | -10, -5, 0, 20, 30,
40, 80, 100, 200,
250 & 300 mmHg. | N/A | ProSim 4:
Fewer
selections for
basic simulation
and target
market. |
| Cable connector | DIN style. | DIN style. | N/A | None. |
| Manometer | 0 to 400 mmHg | N/A | Max. 499.75 mmHg | Lower range
following
market
requirements. |
| Leak Test | Source pressure, seal
off, measure change in
pressure over time. | N/A | Source pressure,
seal off, measure
change in pressure
over time. | None. |
| Over Pressure
Test | Increase pressure until
device under tests vents
to atmosphere. | N/A | Increase pressure
until device under
tests vents to
atmosphere. | None. |
| Simulation | ProSim 4:
Systolic/Diastolic Adult –
60/30, 120/80, 150/100
& 200/150; Neonatal
35/15 & 70/40. | N/A | Systolic/Diastolic
simulations. Adult
60/30 to 255/195. | ProSim 4:
Fewer
selections for
basic
simulation.
Adult and
Neonatal. |
| Synchronization
to ECG | ProSim 4: Up to 150
BPM | N/A | 30 to 240 BPM | ProSim 4:
Limited for
basic
simulation. |

. 0000006

2

Image /page/2/Picture/0 description: The image shows the word "FLUKE" in a bold, sans-serif font. Below the word "FLUKE" is the word "Biomedical" in a smaller, sans-serif font. The word "Biomedical" is underlined with a thick, black line. The background of the image is a light gray color.

1/4

〜 000007

3

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1/4

Image /page/3/Picture/2 description: The image shows a sequence of numbers, specifically "000008". The numbers are printed in a bold, sans-serif font. The image appears to be a close-up of the numbers, with some minor imperfections or artifacts visible around the edges of the numbers.

4

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. په چهاچ پ

5/14

. 000009

5

Image /page/5/Picture/0 description: The image shows the word "FLUKE" in large, bold, black letters. Below the word "FLUKE" is the word "Biomedical" in a smaller font. The background of the image is a light color, and there are some dark spots around the letters.

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.

6

Image /page/6/Picture/0 description: The image shows the logo for Fluke Biomedical. The logo consists of the word "FLUKE" in a bold, sans-serif font, with the word "Biomedical" underneath it in a smaller font. The logo is surrounded by a textured background, which gives it a slightly distressed look. The image also contains a handwritten number, "7/".

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.

1. Plastic injection molded case parts.
1. Stepper Motor and piston pump for pneumatic simulation that makes reliable pressure pulses.
1. Liquid Crystal Display for user interface. User interface follows modern and ergonomic concepts.
1. 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,

000011

7

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 |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | The intended use 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,
Temperature,
Cardiac output and
SpO2.
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 or
independent service
companies that
repair and service
medical equipment.
The end user is a
technically trained
individual,
specializing in | To test operation
of patient monitors
by simulating
physiological
parameters,
including: ECG,
respiration, blood
pressure,
temperature and
cardiac output. | To test operation of
Pulse Oximeters by
simulating the visible
and infrared light
absorption. | To test operation
of
Non-Invasive Blood
Pressure (automated
Sphygmomanometers
simulator). | Additional
functions of
noninvasive
blood pressure
and pulse
oximetry
simulation |
| | medical
instrumentation
technology.

000012

Siomedic

8

・・・・

000013

:

9/14

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Biomedical

000014 :

10

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Biomedical

4

.

000015

: 1

11

Image /page/11/Picture/0 description: The image shows the word "FLUKE" in all caps and in a bold, sans-serif font. The letters are black, and there is a registered trademark symbol to the right of the letter "E". The background is a light gray color. The image is simple and clean, with a focus on the brand name.

Biomedical 174

000016 ﺍﻟ

12

Image /page/12/Picture/0 description: The image shows the logo for Fluke Biomedical. The word "FLUKE" is in large, bold, black letters on a gray background. Below the word "FLUKE" is the word "Biomedical" in smaller, bold, black letters.

174

s

13

Image /page/13/Picture/0 description: The image shows the word "FLUKE" in all caps and in a bold, sans-serif font. To the right of the word is a registered trademark symbol. The word and symbol are in black, and the background is a light gray with a textured pattern.

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.

000018

14

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

16

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

000012

X

510(k) Number K110429

17

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

000020

.