ARGUS PB-3000

K221056 · Schiller AG · MHX · Jul 6, 2023 · Cardiovascular

Device Facts

• Record ID: K221056
• Device Name: ARGUS PB-3000
• Applicant: Schiller AG
• Product Code: MHX · Cardiovascular
• Decision Date: Jul 6, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

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 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.

Device Story

ARGUS PB-3000 is a vital data acquisition unit; integrates into 3rd-party Host Systems for patient monitoring. Inputs: ECG, respiration (thorax impedance), IBP, NIBP, SpO2, CO2, Cardiac Output (thermodilution), and temperature sensors. Device processes raw signals; transmits data to Host System via network. Host System performs visualization, alarm handling, and advanced analysis (e.g., arrhythmia, ST-segment). Used in OR, ICU, EMS, and ambulances by clinicians. Benefits: enables continuous/non-continuous physiological monitoring to assess patient condition and therapy response.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via standards-based testing (IEC 60601-1, 60601-1-2, 60601-2-25, 60601-2-27, 80601-2-30, 60601-2-34, 80601-2-49, ISO 80601-2-55, ISO 80601-2-56, ISO 80601-2-61) and ANSI/AAMI EC57:2012 for ECG/ST-segment algorithms.

Technological Characteristics

Vital data acquisition unit; no display. Modules: ECG (5/10 wire), Respiration (impedance), IBP, NIBP, SpO2 (Masimo MX5), CO2, Cardiac Output (thermodilution), Temperature. Power: 100-240 VAC or 15 VDC from Host. Connectivity: Networked to Host System. Standards: IEC 60601-1, 60601-1-2, 60601-2-25, 60601-2-27, 80601-2-30, 60601-2-34, 80601-2-49, ISO 80601-2-55, ISO 80601-2-56, ISO 80601-2-61. Software: IEC 62304 compliant.

Indications for Use

Indicated for adult and pediatric (neonates to adolescent) patients of all genders/races requiring monitoring of ECG, respiration, IBP, NIBP, SpO2 (hypoxemia/carboxyhemoglobinemia/methemoglobinemia risk), CO2 (breathing efficacy/CPR/tube placement), Cardiac Output, or temperature. Used in OR, ICU, EMS, and ambulances.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• ARGUS PB-1000 System (K012226)

Reference Devices

• Masimo MX5 (K193242)
• MASIMO SET MS-1 (K962603)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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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# 510(k) Summary

#### 1. Submitter's Name, Address, Contact Information

| Name | SCHILLER AG |
|----------------|-----------------------------------------------------|
| Address | Altgasse 68, CH-6341 Baar, Switzerland |
| Phone | [phone] |
| Contact person | Stefan Bigler |
| | Head of Regulatory Affairs |
| | SCHILLER AG, Altgasse 68, CH-6341 Baar, Switzerland |
| Phone | [phone] |
| E-mail | [e-mail] |

- 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<br>(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

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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

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

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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 Device<br>ARGUS PB-3000 | Predicate Device<br>K012226 - ARGUS PB-1000 | Comparison |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Target<br>population | The Argus PB-3000 is used in<br>medical device or medical<br>system (Host System) and<br>intended to be used for the<br>patient target group:<br>• Adult and pediatric (neonates<br>to adolescent)<br>• Both sexes and all races | Measuring ranges, alarm limits and<br>sensors can be selected for the<br>individual requirements of the<br>patient (neonates, children,<br>adults).<br>NIBP Sensors: Different cuff sizes<br>for adults, children and neonates<br>Pulsoximetry SpO2Finger clip<br>sensor, adhesive sensors for<br>adults, children and neonates<br>etCO2Sensors: Mainstream:<br>Airway adapter for adults and<br>neonates (low dead space) | The PB-3000 and the PB-1000<br>have the same target<br>population. |
| Where used | The ARGUS PB-3000 may be<br>used in the operating suite,<br>intensive care unit, emergency<br>medical services environment<br>and road ambulances. It is<br>fixed to a wall, the patient bed,<br>a trolley, or is incorporated<br>into a medical device or<br>medical system (Host System)<br>upwards or at a 90° position. | The system is intended for use in<br>the Intensive Care Unit, in the<br>Recovery Room, in the Operation<br>Room and during hospital internal<br>transport. | The PB-3000 is substantially<br>equivalent to the PB-1000: The<br>PB-3000 additionally can be<br>used in road ambulances.<br>Differences do not raise new<br>questions on safety and<br>effectiveness. |
| Display<br>Information | No display provided. Must<br>integrate into compatible Host<br>System (subject to further<br>V&V and regulatory<br>authorization) | PB-1000 Display Unit | Substantially Equivalent.<br>Testing demonstrates that the<br>PB-3000 performs appropriate<br>vital signs data acquisition and<br>transfers these data to a<br>compatible host system for a<br>display equivalent to predicate. |
| Power | Main input: Power supply with<br>100-240 VAC<br>Output: 15V<br>or guaranteed medical power<br>supply 15 VDC ±5% supplied<br>by OEM host system<br>Back-up Internal rechargeable<br>battery | Main input: Argus PRO (100-240<br>VAC)<br>Output: 7 to 12 VDC<br>Power consumption: <15 W<br>Internal rechargeable battery | Substantially Equivalent:<br>Difference does not raise new<br>questions of safety or<br>effectiveness as demonstrated<br>by 60601-1 testing |
| Electrical<br>Safety | IEC 60601-1:2005 + C1:2006<br>+ C2:2007 + A1:2012 and US<br>deviations | 60601-1 | Substantially Equivalent |
| Description | Subject Device<br>ARGUS PB-3000 | Predicate Device<br>K012226 - ARGUS PB-1000 | Comparison |
| EMC | IEC 60601-1-2:2020 (ed 4.1) | 60601-1-2 | Substantially Equivalent |
| ECG | Simultaneous recording of<br>all active electrode signals<br>• Use with 5 and 10 wire<br>patient cable<br><br>Parameters<br>Heart rate and Asystole | • Simultaneous recording of all<br>active electrode signals<br>• Use with 3, 5 and 10 wire patient<br>cable<br><br>Parameters<br>Heart rate and Asystole<br>ST segment analysis<br>Resting ECG and arrythmia | Substantially Equivalent<br>PB-3000 complies with 60601-<br>2-25 for diagnostic ECGs<br>and compatible host system<br>shall be responsible for ST<br>analysis, resting ECG, and<br>arrythmia analysis, if indicated. |
| Respiration | Thorax impedance method<br>Parameter Respiration rate,<br>apnoea | Thorax impedance method<br>Parameter Respiration rate,<br>apnoea | Substantially Equivalent |
| IBP<br>Parameters | SYS, MEAN, DIA | SYS, MEAN, DIA | Substantially Equivalent |
| NIBP<br>Parameters | systolic, diastolic and mean<br>pressure with different cuff<br>sizes for adults, children, and<br>neonates | systolic, diastolic and mean<br>pressure with different cuff sizes<br>for adults, children, and neonates | Substantially Equivalent |
| SpO2 | Masimo™ MX5 (K193242)<br>Sensors: Finger clip sensor,<br>adhesive sensors for adults,<br>children and neonates | MASIMO™ SET MS-1<br>(K962603)<br>Sensors: Finger clip sensor,<br>adhesive sensors for adults,<br>children and neonates | Substantially Equivalent |
| CO2 | Fully isolated, defibrillation<br>protected >5 kV | Fully isolated, defibrillation<br>protected >5 kV | Substantially Equivalent |
| Cardiac<br>Output | Thermodilution<br>Injectate temperature<br>waveform and catheter<br>temperature | Thermodilution<br>Injectate temperature waveform<br>and catheter temperature | Substantially Equivalent |
| Temperature | Direct temperature operating<br>mode Sensors for rectal use,<br>skin, ear, esophageal | Direct temperature operating<br>mode; and includes temperature<br>differential<br>Sensors for rectal use, skin, ear | Substantially Equivalent. PB-<br>3000 is part of a compatible<br>host system that can provide<br>temperature differential. |
| Alarms | Acquires data that are<br>transferred to Host, provides<br>technical states, and audio<br>communication | Visual and audible alarms | Substantially Equivalent. In<br>PB-3000, alarm handling is<br>implemented on the host<br>system using data and event<br>states acquired by the PB-<br>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,<br>AMD1:2012 (ed. 3.1) | Medical Electrical Equipment Part 1: General requirements<br>for basic safety and essential performance |
| 19-4 | ANSI AAMI ES60601-<br>1:2005/ (R)2012 | Medical electrical equipment—Part 1: General requirements<br>for basic safety and essential performance |

## 7.2. EMC

| Rec.# | Standard Year (ed.) | Title |
|-------|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 19-36 | IEC 60601-1-2:2020<br>(ed. 4.1) | Medical electrical equipment - Part 1-2: General<br>requirements for basic safety and essential performance -<br>Collateral Standard: Electromagnetic disturbances -<br>Requirements and tests |

## 7.3. Additional Standards Testing and V&V

| Rec.# | Standard Year (ed.) | Title |
|-------|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 5-89 | IEC 60601-1-6:2010<br>+ A1 2013 (ed. 3.1) | Medical electrical equipment Part 1-6 General requirements<br>for safety - Collateral Standard: Usability |
| 19-15 | IEC 60601-1-12:2014<br>(ed. 1.0) | Medical electrical equipment-Part 1-12: General<br>requirements for basic safety and essential performance -<br>Collateral Standard: Requirements for medical electrical<br>equipment and medical electrical systems intended for use in<br>the emergency medical services environment |
| 3-105 | IEC 60601-2-25:2011<br>(ed. 2.0) | MEDICAL ELECTRICAL EQUIPMENT – Medical electrical<br>equipment Part 2: Particular requirements for the basic<br>safety and essential performance of electrocardiographs |

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| Rec.# | Standard Year (ed.) | Title |
|-------|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 3-126 | IEC 60601-2-27:2011<br>(ed. 3.0) | Medical electrical equipment Part 2: Particular Requirements<br>for the Safety, Including Essential Performance of<br>Electrocardiographic Monitoring Equipment |
| 3-123 | IEC 80601-2-30:2018<br>(ed. 2.0) | Medical electrical equipment Part 2: Particular requirements<br>for the basic safety and essential performance of automated<br>non-invasive sphygmomanometers |
| 3-115 | IEC 60601-2-34:2011<br>(ed. 3.0) | Medical electrical equipment – Part 2-34: Particular<br>requirements for the basic safety and essential performance<br>of invasive blood pressure monitoring equipment |
| N/A | IEC 80601-2-49:2018<br>(ed. 1) | Medical electrical equipment - Part 2-49: Particular<br>requirements for the basic safety and essential performance<br>of multifunction patient monitors |
| 1-140 | ISO 80601-2-55:2018<br>(ed. 2.0) | Medical electrical equipment Part 2: Particular requirements<br>for the basic safety and essential performance of respiratory<br>gas monitors |
| 6-421 | ISO 80601-2-56:2017,<br>AMD1: 2018 (ed. 2.0) | Medical electrical equipment - Part 2-56: Particular<br>requirements for basic safety and essential performance of<br>clinical thermometers for body temperature measurement |
| 1-139 | ISO 80601-2-61:2017<br>(ed. 2), COR1:2018 | Medical electrical equipment – Part 2-61: Particular<br>requirements for basic safety and essential performance of<br>pulse oximeter equipment |
| 5-114 | IEC 62366-1 :2015<br>(ed. 1) / COR1: 2016 | Medical devices - Application of usability engineering to<br>medical devices |
| 3-118 | ANSI/AAMI<br>EC57:2012 | Testing and reporting performance results of cardiac rhythm<br>and ST-segment measurement algorithms |
| 5-125 | ISO 14971:2019<br>(ed. 3) | Medical devices - Application of risk management to medical<br>devices |
| 3-166 | EN ISO 81060-2:2018<br>(ed. 3) | Non-invasive sphygmomanometers - Part 2: Clinical<br>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 +<br>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.