(451 days)
Not Found
No
The summary describes a vital data acquisition unit that collects and transmits data. While it performs analysis (like ECG interpretation and arrhythmia detection), the description focuses on conventional signal processing and standard medical device functions, with no mention of AI, ML, or related concepts like training/test sets for algorithmic development.
No
The device is a vital data acquisition unit, which means it acquires and transmits patient physiological data. It is used for monitoring and diagnosis, not for providing therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the ECG monitoring function "may be used for the diagnostic measurements, interpretation and arrhythmias detection." Additionally, the IBP section mentions it "may also be used to aid in medical diagnosis."
No
The device description explicitly states it is a "vital data acquisition unit" that "receives vital signals from the patient through external sensors". This indicates it includes hardware components for signal acquisition, not just software for processing.
Based on the provided information, the ARGUS PB-3000 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- ARGUS PB-3000 Function: The ARGUS PB-3000 acquires vital data directly from the patient's body through external sensors (ECG electrodes, blood pressure cuffs, temperature probes, etc.). It measures physiological parameters in vivo (within the living body).
- Lack of Specimen Analysis: The description does not mention the analysis of any biological specimens.
The ARGUS PB-3000 is a patient monitoring device that measures physiological parameters directly from the patient.
N/A
Intended Use / Indications for Use
The ARGUS PB-3000 is a vital data acquisition unit intended to be used within or connected to a medical device or a medical system (Host System) for acquiring, and transmission of patient vitals and other pertinent clinical data of following vital data of a patient.
Indicated for the following applications:
ECG monitoring and diagnostic - The ECG monitoring function provide a conventional information about the patient's ECG rhythm, heart rate, and may be used for the diagnostic measurements, interpretation and arrhythmias detection in a medical device or medical system (Host System).
Respiration rate and apnea monitoring is indicated for pneumatic issues.
IBP - Invasive blood pressure monitoring is indicated for use in patients who require continuous monitoring of physiological pressures in order to rapidly assess changes in the patient's condition or response to therapy. It may also be used to aid in medical diagnosis.
NIBP - NIBP measurement is indicated in patients who have a risk of developing high or low blood pressure.
SpO2 - These measurements are indicated for use in patients who are at risk of developing hypoxemia, carboxyhemoglobinemia, or methemoglobinemia. This monitoring may be used during no motion conditions, and in patients who are well or poorly perfused.
CO2 - The CO2 measurement is used to detect trends in the level of expired CO2. It is used for monitoring breathing efficacy and treatment effectiveness in acute cardiopulmonary care, for example, to determine if adequate compressions are being performed during CPR or to rapidly detect whether an endotracheal tube has been placed successfully.
Respiration rate and apnea monitoring is indicated for pneumatic issues.
Cardiac Output (CO) - Cardiac Output measurement is indicated for use in patients who require a non-continuous measurement of the stroke volume and 1/min volume of the heart.
Temperature - Temperature measurement is indicated in any patient that has a risk of high or low temperature.
Product codes
MHX
Device Description
The ARGUS PB-3000 is a vital data acquisition unit intended to be used within or connected to a medical device or a medical system (Host System) for acquiring, and transmission of patient vitals and other pertinent clinical data. It receives vital signals from the patient through external sensors and communicates with the Host System. Data is transmitted to the Host System via network connection and without storing vital data and patient demographic data on the PB-3000. Depending on the variant of the PB-3000, the device has different modules allowing measurement of the vital parameter for ECG (monitoring and diagnostic mode, and respiration), IBP, temperature, cardiac output (CO), Sp02, CO2, and/or NIBP measurements.
The Host System is designed by a 3rd party host system manufacturer who chooses the PB-3000 variant to be implemented in their Host System. The PB-3000 communication interface allows the Host System Manufacturer to setup and use the provided functions.
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 and pediatric (neonates to adolescent)
Intended User / Care Setting
The ARGUS PB-3000 may be used in the operating suite, intensive care unit, emergency medical services environment and road ambulances.
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 Performance Data:
- Electrical Safety: IEC 60601-1:2005, AMD1:2012 (ed. 3.1), ANSI AAMI ES60601-1:2005/ (R)2012
- EMC: IEC 60601-1-2:2020 (ed. 4.1)
- Additional Standards Testing and V&V:
- IEC 60601-1-6:2010 + A1 2013 (ed. 3.1) - Usability
- IEC 60601-1-12:2014 (ed. 1.0) - Emergency medical services environment
- IEC 60601-2-25:2011 (ed. 2.0) - Electrocardiographs
- IEC 60601-2-27:2011 (ed. 3.0) - Electrocardiographic Monitoring Equipment
- IEC 80601-2-30:2018 (ed. 2.0) - Automated non-invasive sphygmomanometers
- IEC 60601-2-34:2011 (ed. 3.0) - Invasive blood pressure monitoring equipment
- IEC 80601-2-49:2018 (ed. 1) - Multifunction patient monitors
- ISO 80601-2-55:2018 (ed. 2.0) - Respiratory gas monitors
- ISO 80601-2-56:2017, AMD1: 2018 (ed. 2.0) - Clinical thermometers for body temperature measurement
- ISO 80601-2-61:2017 (ed. 2), COR1:2018 - Pulse oximeter equipment
- IEC 62366-1 :2015 (ed. 1) / COR1: 2016 - Application of usability engineering
- ANSI/AAMI EC57:2012 - Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms
- ISO 14971:2019 (ed. 3) - Application of risk management
- EN ISO 81060-2:2018 (ed. 3) - Non-invasive sphygmomanometers - Clinical investigation
Key results from non-clinical performance data include:
- Testing of the ECG module using standard ANSI/AAMI EC57:2012 to verify the sensitivity and positive predictivity of the QRS detection and heart rate calculation.
- Performance testing of ECG-based respiration measurement accuracy in the ARGUS PB-3000 to support performance equivalence compared to the predicate device.
- Performance testing for the cardiac output measurement function (accuracy).
- Compatibility testing and verification for all compatible temperature sensors, IBP accessories, and NIBP cuffs.
- Standards-based testing and system level testing for the SpO2 and CO2 modules to verify module functionality as implemented in PB-3000.
Software Verification and Validation Testing:
- IEC 62304:2006 + A1:2015 (ed. 1.1) - Medical device software Software life-cycle processes.
- Software Verification and Validation testing was performed at the unit, integration and system levels for the ARGUS PB-3000 software to ensure it meets all specifications. In all instances, ARGUS PB-3000 functioned as intended and the observed results demonstrate substantial equivalence with the predicate device.
No clinical testing was performed for ARGUS PB-3000.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.
July 6, 2023
SCHILLER AG Stefan Bigler Head of Regulatory Affairs Altgasse 68 CH-6341 Baar Switzerland
Re: K221056
Trade/Device Name: ARGUS PB-3000 Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector And Alarm (Including ST-Segment Measurement And Alarm) Regulatory Class: Class II Product Code: MHX Dated: July 6, 2023 Received: July 6, 2023
Dear Stefan Bigler:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shruti N. Mistry -S
for
Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221056
Device Name ARGUS PB-3000
Indications for Use (Describe)
The ARGUS PB-3000 is a vital data acquisition unit intended to be used within or connected to a medical device or a medical system (Host System) for acquiring, and transmission of patient vitals and other pertinent clinical data of following vital data of a patient.
Indicated for the following applications:
ECG monitoring and diagnostic - The ECG monitoring function provide a conventional information about the patient's ECG rhythm, heart rate, and may be used for the diagnostic measurements, interpretation and arrhythmias detection in a medical device or medical system (Host System).
Respiration rate and apnea monitoring is indicated for pneumatic issues.
IBP - Invasive blood pressure monitoring is indicated for use in patients who require continuous monitoring of physiological pressures in order to rapidly assess changes in the patient's condition or response to therapy. It may also be used to aid in medical diagnosis.
NIBP - NIBP measurement is indicated in patients who have a risk of developing high or low blood pressure.
SpO2 - These measurements are indicated for use in patients who are at risk of developing hypoxemia, carboxyhemoglobinemia, or methemoglobinemia. This monitoring may be used during no motion conditions, and in patients who are well or poorly perfused.
CO2 - The CO2 measurement is used to detect trends in the level of expired CO2. It is used for monitoring breathing efficacy and treatment effectiveness in acute cardiopulmonary care, for example, to determine if adequate compressions are being performed during CPR or to rapidly detect whether an endotracheal tube has been placed successfully.
Respiration rate and apnea monitoring is indicated for pneumatic issues.
Cardiac Output (CO) - Cardiac Output measurement is indicated for use in patients who require a non-continuous measurement of the stroke volume and 1/min volume of the heart.
Temperature - Temperature measurement is indicated in any patient that has a risk of high or low temperature. Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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4
510(k) Summary
1. Submitter's Name, Address, Contact Information
| Name | SCHILLER AG |
|---|---|
| Address | Altgasse 68, CH-6341 Baar, Switzerland |
| Phone | +41 41 766 42 42 |
| Contact person | Stefan Bigler |
| Head of Regulatory Affairs | |
| SCHILLER AG, Altgasse 68, CH-6341 Baar, Switzerland | |
| Phone | +41 41 766 42 42 |
| regulatory@schiller.ch |
- July 5, 2023 Date prepared:
2. Subject Device and Predicate Device
2.1. Subject Device
| Device Trade Name | ARGUS PB-3000 |
|---|---|
| Common / Usual Name | Monitoring system |
| Classification Name | Monitor, Physiological, Patient |
| (With Arrhythmia Detection or Alarms) | |
| Device Class | II |
| Product code | MHX |
| Regulation Number | 21 CFR 870.1025 |
2.1. Predicate Device
| Device Name | ARGUS PB-1000 System |
|---|---|
| 510(k) number | K012226 |
| Device Class | II |
| Product code | MHX |
| Regulation Number | 21 CFR 870.1025 |
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3. Device Description
The ARGUS PB-3000 is a vital data acquisition unit intended to be used within or connected to a medical device or a medical system (Host System) for acquiring, and transmission of patient vitals and other pertinent clinical data. It receives vital signals from the patient through external sensors and communicates with the Host System. Data is transmitted to the Host System via network connection and without storing vital data and patient demographic data on the PB-3000. Depending on the variant of the PB-3000, the device has different modules allowing measurement of the vital parameter for ECG (monitoring and diagnostic mode, and respiration), IBP, temperature, cardiac output (CO), Sp02, CO2, and/or NIBP measurements.
The Host System is designed by a 3rd party host system manufacturer who chooses the PB-3000 variant to be implemented in their Host System. The PB-3000 communication interface allows the Host System Manufacturer to setup and use the provided functions.
4. Intended Use and Indications for Use
4.1.Intended Use
The ARGUS PB-3000 is a vital data acquisition unit intended to be used within or connected to a medical device or a medical System (Host System) for acquiring, analysing, and transmission of patient vitals and other pertinent clinical data of following vital data of a patient:
ECG and Respiration
ECG, heart rate, asystole time, respiration rate and apnoea time for monitoring and diagnostic purpose.
IBP
The IBP measurement is intended for continuously invasive measurement of a patient's arterial and/or venous blood pressure in different locations.
NIBP
The NIBP measurement is intended for non-invasive measure blood pressure with different cuffs in different locations.
SpO2
The SpO2 measurement is intended for non-invasive measuring of a patient's oxygen saturation level and other parameters (e.g. SpCO, SpMet).
CO2 and Respiration
6
The CO2 measurement is intended for the non-invasive monitoring of a patient's in and exhaled carbon dioxide, anaesthesia gases and to provide a respiration rate.
Cardiac Output (CO)
The Cardiac Output measurement is intended for measuring continuously blood and injected fluid temperature for calculating the current Cardiac Output of a patient in the medical system (Host System).
Temperature
The Temperature measurement is intended for non-invasive and invasive measurement of a patient's temperature in different locations.
4.2. Indications for Use
The ARGUS PB-3000 is a vital data acquisition unit intended to be used within or connected to a medical device or a medical system (Host System) for acquiring, analysing, and transmission of patient vitals and other pertinent clinical data of following vital data of a patient.
Indicated for the following applications:
ECG monitoring and diagnostic
The ECG monitoring function provide a conventional information about the patient's ECG rhythm, heart rate, and may be used for the diagnostic measurements, interpretation and arrhythmias detection in a medical device or medical system (Host System).
Respiration rate and apnea monitoring is indicated for pneumatic issues.
IBP
Invasive blood pressure monitoring is indicated for use in patients who require continuous monitoring of physiological pressures in order to rapidly assess changes in the patient's condition or response to therapy. It may also be used to aid in medical diaqnosis.
NIBP
NIBP measurement is indicated in patients who have a risk of developing high or low blood pressure.
SpO2
These measurements are indicated for use in patients who are at risk of developing hypoxemia, carboxyhemoglobinemia, or methemoglo-binemia. This monitoring
7
may be used during no motion and motion conditions, and in patients who are well or poorly perfused.
CO2
The CO2 measurement is used to detect trends in the level of inspired or expired CO2. It is used for monitoring breathing efficacy and treatment effectiveness in acute cardiopulmonary care, for example, to determine if adequate compressions are being performed during CPR or to rapidly detect whether an endotracheal tube has been placed successfully.
Respiration rate and apnea monitoring is indicated for pneumatic issues.
Cardiac Output (CO)
Cardiac Output measurement is indicated for use in patients who require a noncontinuous measurement of the stroke volume and I/min volume of the heart.
Temperature
Temperature measurement is indicated in any patient that has a risk of high or low temperature.
5. Comparison of Indications
Both the predicate device and the subject device are patient monitoring systems intended to be used in healthcare facilities under the direction of clinical professionals.
The PB-3000 is a vital signs data acquisition unit, lacking a display, and intended to be used within or connected to a medical device or a medical system (Host System); the PB-1000 was cleared with its own monitoring system as a complete patient monitoring system, and the parameter unit of PB-1000 could also be integrated in compatible Host Systems.
When the PB-3000 is integrated into compatible host systems, the host provides the visual display, can perform analysis on the PB-3000 acquired data, and perform alarm handling.
The predicate and subject are substantially equivalent because the PB-3000 must integrate with a Host System that then will manage the alarm system, and uses PB-3000 data further analyses (e.g., arrythmia or ST segments, trending) – which is equivalent to the function of the PB-1000 with both a parameter box and a visualization unit which is a system that includes both a parameter box and a visualization unit.
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6. Comparison of Technological Characteristics with the Predicate Device
| Description | Subject Device
ARGUS PB-3000 | Predicate Device
K012226 - ARGUS PB-1000 | Comparison |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Target
population | The Argus PB-3000 is used in
medical device or medical
system (Host System) and
intended to be used for the
patient target group:
• Adult and pediatric (neonates
to adolescent)
• Both sexes and all races | Measuring ranges, alarm limits and
sensors can be selected for the
individual requirements of the
patient (neonates, children,
adults).
NIBP Sensors: Different cuff sizes
for adults, children and neonates
Pulsoximetry SpO2Finger clip
sensor, adhesive sensors for
adults, children and neonates
etCO2Sensors: Mainstream:
Airway adapter for adults and
neonates (low dead space) | The PB-3000 and the PB-1000
have the same target
population. |
| Where used | The ARGUS PB-3000 may be
used in the operating suite,
intensive care unit, emergency
medical services environment
and road ambulances. It is
fixed to a wall, the patient bed,
a trolley, or is incorporated
into a medical device or
medical system (Host System)
upwards or at a 90° position. | The system is intended for use in
the Intensive Care Unit, in the
Recovery Room, in the Operation
Room and during hospital internal
transport. | The PB-3000 is substantially
equivalent to the PB-1000: The
PB-3000 additionally can be
used in road ambulances.
Differences do not raise new
questions on safety and
effectiveness. |
| Display
Information | No display provided. Must
integrate into compatible Host
System (subject to further
V&V and regulatory
authorization) | PB-1000 Display Unit | Substantially Equivalent.
Testing demonstrates that the
PB-3000 performs appropriate
vital signs data acquisition and
transfers these data to a
compatible host system for a
display equivalent to predicate. |
| Power | Main input: Power supply with
100-240 VAC
Output: 15V
or guaranteed medical power
supply 15 VDC ±5% supplied
by OEM host system
Back-up Internal rechargeable
battery | Main input: Argus PRO (100-240
VAC)
Output: 7 to 12 VDC
Power consumption: 5 kV | Fully isolated, defibrillation
protected >5 kV | Substantially Equivalent |
| Cardiac
Output | Thermodilution
Injectate temperature
waveform and catheter
temperature | Thermodilution
Injectate temperature waveform
and catheter temperature | Substantially Equivalent |
| Temperature | Direct temperature operating
mode Sensors for rectal use,
skin, ear, esophageal | Direct temperature operating
mode; and includes temperature
differential
Sensors for rectal use, skin, ear | Substantially Equivalent. PB-
3000 is part of a compatible
host system that can provide
temperature differential. |
| Alarms | Acquires data that are
transferred to Host, provides
technical states, and audio
communication | Visual and audible alarms | Substantially Equivalent. In
PB-3000, alarm handling is
implemented on the host
system using data and event
states acquired by the PB-
3000. |
9
10
The ARGUS PB-3000 and ARGUS PB-1000 Unit (Parameter Box) are part of a medical devices system: Both units have modules for acquiring, and transmission of patient vital data and the ability to communicate with the medical device system (Host System). They receive vital signs from the patient through external sensors for ECG/respiration, IBP, body temperature, cardiac output (CO), SpO2, CO2, and/or NIBP measurement.
7. Non-Clinical Performance Data
7.1.Electrical Safety
| Rec.# | Standard Year (ed.) | Title |
|---|---|---|
| N/A | IEC 60601-1:2005, | |
| AMD1:2012 (ed. 3.1) | Medical Electrical Equipment Part 1: General requirements | |
| for basic safety and essential performance | ||
| 19-4 | ANSI AAMI ES60601- | |
| 1:2005/ (R)2012 | Medical electrical equipment—Part 1: General requirements | |
| for basic safety and essential performance |
7.2. EMC
| Rec.# | Standard Year (ed.) | Title |
|---|---|---|
| 19-36 | IEC 60601-1-2:2020 | |
| (ed. 4.1) | Medical electrical equipment - Part 1-2: General | |
| requirements for basic safety and essential performance - | ||
| Collateral Standard: Electromagnetic disturbances - | ||
| Requirements and tests |
7.3. Additional Standards Testing and V&V
| Rec.# | Standard Year (ed.) | Title |
|---|---|---|
| 5-89 | IEC 60601-1-6:2010 |
- A1 2013 (ed. 3.1) | Medical electrical equipment Part 1-6 General requirements
for safety - Collateral Standard: Usability |
| 19-15 | IEC 60601-1-12:2014
(ed. 1.0) | Medical electrical equipment-Part 1-12: General
requirements for basic safety and essential performance -
Collateral Standard: Requirements for medical electrical
equipment and medical electrical systems intended for use in
the emergency medical services environment |
| 3-105 | IEC 60601-2-25:2011
(ed. 2.0) | MEDICAL ELECTRICAL EQUIPMENT – Medical electrical
equipment Part 2: Particular requirements for the basic
safety and essential performance of electrocardiographs |
11
| Rec.# | Standard Year (ed.) | Title |
|---|---|---|
| 3-126 | IEC 60601-2-27:2011 | |
| (ed. 3.0) | Medical electrical equipment Part 2: Particular Requirements | |
| for the Safety, Including Essential Performance of | ||
| Electrocardiographic Monitoring Equipment | ||
| 3-123 | IEC 80601-2-30:2018 | |
| (ed. 2.0) | Medical electrical equipment Part 2: Particular requirements | |
| for the basic safety and essential performance of automated | ||
| non-invasive sphygmomanometers | ||
| 3-115 | IEC 60601-2-34:2011 | |
| (ed. 3.0) | Medical electrical equipment – Part 2-34: Particular | |
| requirements for the basic safety and essential performance | ||
| of invasive blood pressure monitoring equipment | ||
| N/A | IEC 80601-2-49:2018 | |
| (ed. 1) | Medical electrical equipment - Part 2-49: Particular | |
| requirements for the basic safety and essential performance | ||
| of multifunction patient monitors | ||
| 1-140 | ISO 80601-2-55:2018 | |
| (ed. 2.0) | Medical electrical equipment Part 2: Particular requirements | |
| for the basic safety and essential performance of respiratory | ||
| gas monitors | ||
| 6-421 | ISO 80601-2-56:2017, | |
| AMD1: 2018 (ed. 2.0) | Medical electrical equipment - Part 2-56: Particular | |
| requirements for basic safety and essential performance of | ||
| clinical thermometers for body temperature measurement | ||
| 1-139 | ISO 80601-2-61:2017 | |
| (ed. 2), COR1:2018 | Medical electrical equipment – Part 2-61: Particular | |
| requirements for basic safety and essential performance of | ||
| pulse oximeter equipment | ||
| 5-114 | IEC 62366-1 :2015 | |
| (ed. 1) / COR1: 2016 | Medical devices - Application of usability engineering to | |
| medical devices | ||
| 3-118 | ANSI/AAMI | |
| EC57:2012 | Testing and reporting performance results of cardiac rhythm | |
| and ST-segment measurement algorithms | ||
| 5-125 | ISO 14971:2019 | |
| (ed. 3) | Medical devices - Application of risk management to medical | |
| devices | ||
| 3-166 | EN ISO 81060-2:2018 | |
| (ed. 3) | Non-invasive sphygmomanometers - Part 2: Clinical | |
| investigation of intermittent automated measurement type |
- Testing of the ECG module using standard ANSI/AAMI EC57:2012 (FDA recognition # 3-118) to verify the sensitivity and positive predictivity of the QRS detection and heart rate calculation
- · Performance testing of ECG-based respiration measurement accuracy in the ARGUS PB-3000 to support performance equivalence compared to the predicate device.
- · Performance testing for the cardiac output measurement function (accuracy)
- · Compatibility testing and verification for all compatible temperature sensors, IBP accessories, and NIBP cuffs
- Standards-based testing and system level testing for the SpO2 and CO2 modules to verify module functionality as implemented in PB-3000
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7.4. Software Verification and Validation Testing
| Rec.# | Standard Year (ed.) | Title |
|---|---|---|
| 13-79 | IEC 62304:2006 + | |
| A1:2015 (ed. 1.1) | Medical device software Software life-cycle processes |
Software Verification and Validation testing was performed at the unit, integration and system levels for the ARGUS PB-3000 software to ensure it meets all specifications. In all instances, ARGUS PB-3000 functioned as intended and the observed results demonstrate substantial equivalence with the predicate device.
8. Clinical Testing
No clinical testing was performed for ARGUS PB-3000.
9. Conclusion
The ARGUS PB-3000, the subject device of this submission, is substantially equivalent to its predicate device, the ARGUS PB-1000 System (K012226). ARGUS PB-3000 has the same intended use and substantially equivalent indications for use, design, and functions as the predicate device. Non-clinical performance testing demonstrates that PB-3000 meets its requirements and is as safe and effective as its predicate device. The technological differences between ARGUS PB-3000 and its predicate device raise no new questions of safety or effectiveness. Thus, ARGUS PB-3000 is substantially equivalent to the previously cleared predicate device.