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 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.

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.

AI/ML Overview

The provided FDA 510(k) summary for the ARGUS PB-3000 device does not explicitly provide a table of acceptance criteria and reported device performance values in a quantifiable manner that is typically requested for AI/ML device submissions. This document is a premarket notification for a traditional medical device (a vital data acquisition unit), not a software as a medical device (SaMD) with an AI/ML component requiring a detailed performance study with ground truth and expert adjudication.

However, based on the non-clinical performance data section, we can infer some of the testing performed and the standards met, which serve as the implicit acceptance criteria for this type of device. The study described focuses on demonstrating substantial equivalence to a predicate device (ARGUS PB-1000 System, K012226) through compliance with recognized electrical safety, EMC, and performance standards for physiological monitoring equipment.

Here's an attempt to structure the available information regarding acceptance criteria and the "study" (non-clinical testing) that proves the device meets them, while acknowledging the limitations of the provided document in the context of typical AI/ML device performance reporting:

1. Table of Acceptance Criteria and Reported Device Performance

Since specific numerical acceptance criteria and "reported device performance" (e.g., sensitivity, specificity, accuracy metrics as would be seen for an AI algorithm) are not presented in this document for the overall device, the table below reflects the standards that the device met. Compliance with these standards is the "reported performance" and the fulfillment of the "acceptance criteria" in this context.

Parameter/Function Tested	Acceptance Criteria (Reference Standard)	Reported Device Performance (Compliance)
Electrical Safety	IEC 60601-1:2005, AMD1:2012 (ed. 3.1) ANSI AAMI ES60601-1:2005/(R)2012	Complies (implied by submission and clearance)
Electromagnetic Compatibility (EMC)	IEC 60601-1-2:2020 (ed. 4.1)	Complies (implied by submission and clearance)
Risk Management	ISO 14971:2019 (ed. 3)	Complies (implied by submission and clearance)
Usability Engineering	IEC 62366-1:2015 (ed. 1) / COR1:2016 IEC 60601-1-6:2010 + A1 2013 (ed. 3.1)	Complies (implied by submission and clearance)
Software Life Cycle Processes	IEC 62304:2006 + A1:2015 (ed. 1.1)	Complies (Software V&V performed; functioned as intended)
General Requirements for Patient Monitors	IEC 80601-2-49:2018 (ed. 1)	Complies (implied by submission and clearance)
Emergency Medical Services Environment Use	IEC 60601-1-12:2014 (ed. 1.0)	Complies (implied by submission and clearance)
ECG Performance	IEC 60601-2-25:2011 (ed. 2.0) (Diagnostic ECGs) IEC 60601-2-27:2011 (ed. 3.0) (Monitoring ECG) ANSI/AAMI EC57:2012 (QRS detection, HR calculation)	Complies (Performance testing performed; meets requirements)
NIBP Performance	IEC 80601-2-30:2018 (ed. 2.0) EN ISO 81060-2:2018 (ed. 3)	Complies (Compatibility testing performed; implied by clearance)
IBP Performance	IEC 60601-2-34:2011 (ed. 3.0)	Complies (Compatibility testing performed; implied by clearance)
Pulse Oximeter (SpO2) Performance	ISO 80601-2-61:2017 (ed. 2), COR1:2018	Complies (Standards-based testing; module functionality verified)
Respiratory Gas Monitors (CO2) Performance	ISO 80601-2-55:2018 (ed. 2.0)	Complies (Standards-based testing; module functionality verified)
Clinical Thermometers (Temperature) Performance	ISO 80601-2-56:2017, AMD1: 2018 (ed. 2.0)	Complies (Compatibility testing performed; implied by clearance)
Cardiac Output Measurement (Accuracy)	Not explicitly stated but "Performance testing for the cardiac output measurement function (accuracy)" was performed.	Accuracy confirmed (implied by successful testing)
ECG-based Respiration Measurement Accuracy	Not explicitly stated but "Performance testing of ECG-based respiration measurement accuracy [...] to support performance equivalence compared to the predicate device" was performed.	Accuracy confirmed and equivalent to predicate (implied by successful testing)

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

Test Set Sample Size: Not explicitly stated in terms of patient data. The testing referenced are primarily benchmarking against recognized standards using test equipment, simulators, and potentially some limited physiological setups, rather than a "test set" of patient data in the way an AI/ML model would use it. For physical device performance, compliance with standards usually involves predefined test methods and specific numbers of readings or operational cycles, but not a "sample size" of diverse patient cases as would be relevant for an algorithm's performance.
Data Provenance: Not applicable in the context of this type of non-clinical, standards-based testing. The testing is laboratory-based and simulated, focusing on hardware and software functionality and safety according to engineering standards. There is no mention of country of origin for patient data or whether it was retrospective or prospective, as no clinical data was used for direct performance evaluation for this 510(k) submission.

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

Number of Experts: Not applicable. For standards-based testing of a vital signs acquisition unit, the "ground truth" is defined by the reference values generated by calibrated test equipment or physiological simulators as specified in the relevant international or national standards (e.g., a known heart rate from an ECG simulator, a known pressure from a pressure calibrator).
Qualifications of Experts: Not applicable in this context. The testing would be performed by qualified engineers and technicians, not clinical experts establishing medical ground truth from patient data.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The "adjudication" is compliance with engineering standards and predefined test procedures. The results are compared against the specified limits or expected behaviors detailed in these standards (e.g., "within X% deviation," "detects QRS within Y ms").

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: No. This device is a vital data acquisition unit, not an AI-assisted diagnostic tool involving human readers or interpretation of complex medical imagery/signals by AI.
Effect Size: Not applicable.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: The device's performance, as evaluated against the listed standards, is inherently "standalone" in the sense that the device itself (hardware and embedded software) is tested to acquire, analyze (e.g., heart rate, respiration rate), and transmit vital signs. However, it's crucial to note its intended use: "to be used within or connected to a medical device or a medical system (Host System)." The PB-3000 acquires the data, and the Host System handles aspects like display, further analysis (e.g., arrhythmia or ST segments), and alarms. So, while its data acquisition is standalone, its full clinical function relies on integration with a Host System. No specific "algorithm only" performance metric (like for an AI model) is provided beyond general compliance with the standards for ECG, NIBP, etc.

7. The Type of Ground Truth Used

Type of Ground Truth: Reference values from calibrated test equipment and physiological simulators as defined by the referenced national and international performance standards (e.g., electrical safety standards, specific performance standards for ECG, NIBP, SpO2 modules).

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. Traditional medical devices like this typically do not have "training sets" in the AI/ML sense. The embedded software and algorithms are developed using traditional engineering methods and validated against specifications and standards, not through training on large datasets.

9. How the Ground Truth for the Training Set was Established

Ground Truth for Training Set: Not applicable. As there's no "training set" in the AI/ML context, there's no corresponding process for establishing ground truth for training. Development and validation rely on established engineering principles and adherence to standards.

Summary

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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.

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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)

Indicated for the following applications:

Respiration rate and apnea monitoring is indicated for pneumatic issues.

NIBP - NIBP measurement is indicated in patients who have a risk of developing high or low blood pressure.

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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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
E-mail	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

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

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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

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

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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 DeviceARGUS PB-3000	Predicate DeviceK012226 - ARGUS PB-1000	Comparison
Targetpopulation	The Argus PB-3000 is used inmedical device or medicalsystem (Host System) andintended to be used for thepatient target group:• Adult and pediatric (neonatesto adolescent)• Both sexes and all races	Measuring ranges, alarm limits andsensors can be selected for theindividual requirements of thepatient (neonates, children,adults).NIBP Sensors: Different cuff sizesfor adults, children and neonatesPulsoximetry SpO2Finger clipsensor, adhesive sensors foradults, children and neonatesetCO2Sensors: Mainstream:Airway adapter for adults andneonates (low dead space)	The PB-3000 and the PB-1000have the same targetpopulation.
Where used	The ARGUS PB-3000 may beused in the operating suite,intensive care unit, emergencymedical services environmentand road ambulances. It isfixed to a wall, the patient bed,a trolley, or is incorporatedinto a medical device ormedical system (Host System)upwards or at a 90° position.	The system is intended for use inthe Intensive Care Unit, in theRecovery Room, in the OperationRoom and during hospital internaltransport.	The PB-3000 is substantiallyequivalent to the PB-1000: ThePB-3000 additionally can beused in road ambulances.Differences do not raise newquestions on safety andeffectiveness.
DisplayInformation	No display provided. Mustintegrate into compatible HostSystem (subject to furtherV&V and regulatoryauthorization)	PB-1000 Display Unit	Substantially Equivalent.Testing demonstrates that thePB-3000 performs appropriatevital signs data acquisition andtransfers these data to acompatible host system for adisplay equivalent to predicate.
Power	Main input: Power supply with100-240 VACOutput: 15Vor guaranteed medical powersupply 15 VDC ±5% suppliedby OEM host systemBack-up Internal rechargeablebattery	Main input: Argus PRO (100-240VAC)Output: 7 to 12 VDCPower consumption: <15 WInternal rechargeable battery	Substantially Equivalent:Difference does not raise newquestions of safety oreffectiveness as demonstratedby 60601-1 testing
ElectricalSafety	IEC 60601-1:2005 + C1:2006+ C2:2007 + A1:2012 and USdeviations	60601-1	Substantially Equivalent
Description	Subject DeviceARGUS PB-3000	Predicate DeviceK012226 - ARGUS PB-1000	Comparison
EMC	IEC 60601-1-2:2020 (ed 4.1)	60601-1-2	Substantially Equivalent
ECG	Simultaneous recording ofall active electrode signals• Use with 5 and 10 wirepatient cableParametersHeart rate and Asystole	• Simultaneous recording of allactive electrode signals• Use with 3, 5 and 10 wire patientcableParametersHeart rate and AsystoleST segment analysisResting ECG and arrythmia	Substantially EquivalentPB-3000 complies with 60601-2-25 for diagnostic ECGsand compatible host systemshall be responsible for STanalysis, resting ECG, andarrythmia analysis, if indicated.
Respiration	Thorax impedance methodParameter Respiration rate,apnoea	Thorax impedance methodParameter Respiration rate,apnoea	Substantially Equivalent
IBPParameters	SYS, MEAN, DIA	SYS, MEAN, DIA	Substantially Equivalent
NIBPParameters	systolic, diastolic and meanpressure with different cuffsizes for adults, children, andneonates	systolic, diastolic and meanpressure with different cuff sizesfor adults, children, and neonates	Substantially Equivalent
SpO2	Masimo™ MX5 (K193242)Sensors: Finger clip sensor,adhesive sensors for adults,children and neonates	MASIMO™ SET MS-1(K962603)Sensors: Finger clip sensor,adhesive sensors for adults,children and neonates	Substantially Equivalent
CO2	Fully isolated, defibrillationprotected >5 kV	Fully isolated, defibrillationprotected >5 kV	Substantially Equivalent
CardiacOutput	ThermodilutionInjectate temperaturewaveform and cathetertemperature	ThermodilutionInjectate temperature waveformand catheter temperature	Substantially Equivalent
Temperature	Direct temperature operatingmode Sensors for rectal use,skin, ear, esophageal	Direct temperature operatingmode; and includes temperaturedifferentialSensors for rectal use, skin, ear	Substantially Equivalent. PB-3000 is part of a compatiblehost system that can providetemperature differential.
Alarms	Acquires data that aretransferred to Host, providestechnical states, and audiocommunication	Visual and audible alarms	Substantially Equivalent. InPB-3000, alarm handling isimplemented on the hostsystem using data and eventstates acquired by the PB-3000.

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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 requirementsfor basic safety and essential performance
19-4	ANSI AAMI ES60601-1:2005/ (R)2012	Medical electrical equipment—Part 1: General requirementsfor 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: Generalrequirements 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 requirementsfor safety - Collateral Standard: Usability
19-15	IEC 60601-1-12:2014(ed. 1.0)	Medical electrical equipment-Part 1-12: Generalrequirements for basic safety and essential performance -Collateral Standard: Requirements for medical electricalequipment and medical electrical systems intended for use inthe emergency medical services environment
3-105	IEC 60601-2-25:2011(ed. 2.0)	MEDICAL ELECTRICAL EQUIPMENT – Medical electricalequipment Part 2: Particular requirements for the basicsafety and essential performance of electrocardiographs

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Rec.#	Standard Year (ed.)	Title
3-126	IEC 60601-2-27:2011(ed. 3.0)	Medical electrical equipment Part 2: Particular Requirementsfor the Safety, Including Essential Performance ofElectrocardiographic Monitoring Equipment
3-123	IEC 80601-2-30:2018(ed. 2.0)	Medical electrical equipment Part 2: Particular requirementsfor the basic safety and essential performance of automatednon-invasive sphygmomanometers
3-115	IEC 60601-2-34:2011(ed. 3.0)	Medical electrical equipment – Part 2-34: Particularrequirements for the basic safety and essential performanceof invasive blood pressure monitoring equipment
N/A	IEC 80601-2-49:2018(ed. 1)	Medical electrical equipment - Part 2-49: Particularrequirements for the basic safety and essential performanceof multifunction patient monitors
1-140	ISO 80601-2-55:2018(ed. 2.0)	Medical electrical equipment Part 2: Particular requirementsfor the basic safety and essential performance of respiratorygas monitors
6-421	ISO 80601-2-56:2017,AMD1: 2018 (ed. 2.0)	Medical electrical equipment - Part 2-56: Particularrequirements for basic safety and essential performance ofclinical thermometers for body temperature measurement
1-139	ISO 80601-2-61:2017(ed. 2), COR1:2018	Medical electrical equipment – Part 2-61: Particularrequirements for basic safety and essential performance ofpulse oximeter equipment
5-114	IEC 62366-1 :2015(ed. 1) / COR1: 2016	Medical devices - Application of usability engineering tomedical devices
3-118	ANSI/AAMIEC57:2012	Testing and reporting performance results of cardiac rhythmand ST-segment measurement algorithms
5-125	ISO 14971:2019(ed. 3)	Medical devices - Application of risk management to medicaldevices
3-166	EN ISO 81060-2:2018(ed. 3)	Non-invasive sphygmomanometers - Part 2: Clinicalinvestigation 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.

Regulation Number and Section

§ 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.