(149 days)
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No
The document describes a multiparameter simulator for testing patient monitors, focusing on generating physiological signals. There is no mention of AI or ML in the intended use, device description, or any other section.
No
The device is a multiparameter simulator used for testing and performing maintenance on patient monitors, not for treating patients.
No
The device is a multiparameter simulator used to test and perform preventive maintenance on patient monitors, not to diagnose medical conditions in patients. It's explicitly stated that it is "not intended for use on patients".
No
The device description explicitly states it is a "lightweight, battery powered unit" and a "portable unit," indicating it is a physical hardware device that generates electronic signals. While it has software, it is not solely software.
Based on the provided information, the MPS450 Multiparameter Simulator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "determine that patient monitors are performing within their operating specifications" by providing electronic signals. This is a quality control and maintenance function for medical equipment, not a diagnostic test performed on biological samples.
- Device Description: It's described as an "electronic signal source" and a "simulator" for training, evaluating, and performing preventive maintenance on patient monitors.
- Intended User / Care Setting: The intended user is a "trained bioment technician" in a "laboratory environment," and it is explicitly stated that the device is "not intended for use on patients, or to test devices while connected to patients."
- Lack of Biological Sample Interaction: The device simulates physiological signals electronically; it does not interact with or analyze biological samples (like blood, urine, tissue, etc.), which is a core characteristic of IVD devices.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The MPS450 does not perform this function.
N/A
Intended Use / 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)
Product codes
DRT
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.
The MPS450 consists of the following components:
-
- Printed Circuit Board Assemblies using surface mount components and firmware loaded in embedded processors.
-
- Plastic injection molded case parts.
-
- Liquid Crystal Display for user interface.
-
- Two 9 V alkaline batteries for portable operation, giving user flexibility and portability.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
MedSim300B (K935817)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
0
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
Fluke Biomedical's MPS450 Multiparameter Simulator (hereafter referred to as the MPS450) provides a basis to train, evaluate, and perform preventive maintenance for virtually all patient monitors found in the healthcare industry. This is accomplished with multiple physiological simulations for ECG, blood pressure, respiration, temperature, artifact, and arrhythmia conditions. The MPS450 is a lightweight, battery powered unit that is portable enough to test a patient monitor anywhere the monitor is being used.
Technological Characteristics
The MPS450 consists of the following components:
-
- Printed Circuit Board Assemblies using surface mount components and firmware loaded in embedded processors.
- Plastic injection molded case parts.
-
- 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:
1
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 of
patient monitors by
simulating physiological
parameters, including:
ECG, respiration, blood
pressure, temperature
and cardiac output | To test operation of
patient monitors by
simulating physiological
parameters, including:
ECG, respiration, blood
pressure, temperature
and cardiac output | None |
| Device Description | | | |
| Physical characteristics. | | | |
| construction | Plastic case | Aluminum case | Lighter |
| Size | 7.5 L x 6 W x 2 H
inches | 10 L x 7 W x 3 H inches | Smaller |
| Weight | 1lbs 8 oz | 3.55 lbs | Lighter |
| Operating panel
characteristics | | | |
| Display | 4 by 20 character LCD | 2 by 24 character LCD | More lines on display of
MPS450 |
| ECG leads | 10 binding posts;
compatible w/
disposable snaps, 3.2
mm or 4.0 mm
electrodes, and banana
plugs. | 10 binding posts;
compatible w/
disposable snaps, 3.2
mm or 4.0 mm
electrodes, and banana
plugs. | None |
| | | | |
| High level ECG | 0.2 V/mV +/- 5% of the
ECG amplitude setting
available on the BP3
connector | ¼" standard phone jack
w/ lead II waveform at
.2V/mV of ECG lead II
signal. Use w/ analog
input, high level, central
station monitors or
recorders | Different type of
connector- same
functionality |
| BP Channels | 4 independent BP
channels w/ sensitivity
control (5 or 40
uV/V/mmHg); cable
interface w/ monitors | 4 independent BP
channels w/ sensitivity
control (5 or 40
uV/V/mmHg); cable
interface 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. probe
select control (400 or
700 YSI) series probes | Yes, fixed or variable
temp. probe select
control (400 or 700 YSI)
series probes | Fixed temp probe use
only 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, low
battery signal if