MONITORING SYSTEM,MODEL ARGUS PB-1000

K012226 · Schiller AG · MHX · Apr 8, 2002 · Cardiovascular

Device Facts

• Record ID: K012226
• Device Name: MONITORING SYSTEM,MODEL ARGUS PB-1000
• Applicant: Schiller AG
• Product Code: MHX · Cardiovascular
• Decision Date: Apr 8, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2

Intended Use

The Monitoring System ARGUS PB-1000 is for the monitoring of vital parameters such as: ECG: Heartrate, Asystolic Time, Respiration Rate Invasive Blood Pressure: systolic, distolic and mean pressure Temperature: temperature and AT Non Invasive Blood Pressure: systolic, distolic and mean pressure CO2, etCO2 and CO2ins SpO2: SpO2 and pulse rate on humans and for the evaluation of Resting ECG, Arrhythmias, ST-Segments and Cardiac Output. There is alarm handling for all parameters except ST-Segments. The system comprises the Parameter Box PB-1000 and the Visualisation Unit AR-GUS PRO. The two units are connected via a serial interface. All vital parameters and evaluations are registered and calculated in the PB-1000. This data is then transmitted to the visualisation unit ARGUS PRO or another generally used PC via the serial interface. All data can be shown and monitored on the ARGUS PRO. The PB-1000 operated using an internal battery and an external power input (RS 232/12V), which is, like the data transmission, completely separate from the visualisation unit. The ARGUS PRO is powered via the normal mains connection 230V/110V. The system is inteded for use in the Intensive Care Unit, in the Recovery Room, in the Operation Room and during hospital internal transport.

Device Story

Argus PB-1000 is a multi-parameter patient monitoring system consisting of a Parameter Box (PB-1000) and a Visualization Unit (ARGUS PRO). The PB-1000 collects physiological signals (ECG, BP, temperature, CO2, SpO2) from patients; performs signal processing and calculations for vital signs and cardiac evaluations; and transmits data via serial interface to the ARGUS PRO or a standard PC for display. The system provides alarm handling for monitored parameters (excluding ST-segments). Designed for use in ICU, recovery, OR, and hospital transport environments. Healthcare providers use the visualized data to monitor patient status and make clinical decisions regarding patient care.

Clinical Evidence

No clinical data. Bench testing only, including electrical safety and electromagnetic compatibility testing per EN 60601-1, EN 60601-1-1, EN 60601-1-2, EN 60601-1-4, EN 60601-2-25, EN 60601-2-27, and EN 60601-2-30.

Technological Characteristics

System comprises a Parameter Box (PB-1000) and Visualization Unit (ARGUS PRO) connected via serial interface. PB-1000 powered by internal battery/external 12V; ARGUS PRO powered by mains (110V/230V). Complies with EN 60601-1, 1-1, 1-2, 1-4, 2-25, 2-27, and 2-30 standards. Software-controlled medical device.

Indications for Use

Indicated for monitoring vital parameters (ECG, invasive/non-invasive BP, temperature, CO2, SpO2) and evaluating resting ECG, arrhythmias, ST-segments, and cardiac output in humans. Used in ICU, recovery, OR, and during hospital transport.

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

• Cardiovit CS - 200 (K970879)

Submission Summary (Full Text)

{0}------------------------------------------------

K012226
page 1 of 3

# 510 K Summary

APR - 8 2002

according to 21 CFR 807.92

- A1 Address
SCHILLER AG Altgasse 68 CH-6341 Baar Switzerland

| Contact Name: | Mr. Markus Buetler |
|---------------|--------------------|
| Tel: | 001 41 41 766 4252 |
| Date: | 02.th April 2002 |

- A2 Device Name

| 1. Trade Name: | Argus PB-1000 System | |
|-----------------|----------------------|--|
| 2. Common Name: | Monitoring System | |

#### A3 Legally Marketed Device

Legally Marketed Device to which this submitted device is compared:

Cardiovit CS - 200 K 970879

#### Intended Use A4

The Monitoring System ARGUS PB-1000 is for the monitoring of vital parameters such as:

ECG: Heartrate, Asystolic Time, Respiration Rate

Invasive Blood Pressure: systolic, distolic and mean pressure

Temperature: temperature and AT

Non Invasive Blood Pressure: systolic, distolic and mean pressure CO2, etCO2 and CO2ins

SpO2: SpO2 and pulse rate

on humans and for the evaluation of Resting ECG, Arrhythmias, ST-Segments and Cardiac Output. There is alarm handling for all parameters except ST-Segments. The system comprises the Parameter Box PB-1000 and the Visualisation Unit AR-GUS PRO. The two units are connected via a serial interface.

All vital parameters and evaluations are registered and calculated in the PB-1000. This data is then transmitted to the visualisation unit ARGUS PRO or another generally used PC via the serial interface. All data can be shown and monitored on the ARGUS PRO.

The PB-1000 operated using an internal battery and an external power input (RS 232/12V), which is, like the data transmission, completely separate from the visualisation unit. The ARGUS PRO is powered via the normal mains connection 230V/110V.

{1}------------------------------------------------

K012226
page 2 of 3

The system is inteded for use in the Intensive Care Unit, in the Recovery Room, in the Operation Room and during hospital internal transport.

#### A5 Table of Comparison

| | CS-200 (K970879) | PB-1000 |
|-------------------------------------------------------------|-------------------------------------------|-----------------|
| Dimensions: | 600x620x1530mm | 210x115x45mm 1) |
| Weight: | 71 kg | 980 g 2) |
| Environmental Conditions: | | |
| Operating temperature | +10° - 40° C | same |
| Storage temperature | -10° - +50° C | same |
| Relative humidity | 25% - 95%<br>(non condensing) | same |
| Electrostatic Discharge /<br>Electromagnetic Compatibility: | EN 60601-1-2 | same |
| ESD | Fully functional below 4 kV<br>(Open Air) | same |
| | No damage below 8 kV (Open Air) | same |
| Radiated Emissions | Less than 30 dB Microvolts | same |
| Radiated Immunity | Less than 3 Volts per meter | same |

Discussion of Differences:

None of the above differences (1 or 2) can be considered as safety relevant differences.

We consider the submitted device to be as safe and effective as the Predicate Cardiovit CS-200 (K970879) device.

{2}------------------------------------------------

K01226
page 3 of 3.

#### B1 Non-Clinical Tests

1. Electrical Safety and Reliability

The device has been tested to be in accordance with the following standards:

EN 60601-1:1990: Safety of Medical Electrical Equipment part 1, General requirements.

EN 60601-1-1:1993 Safety requirements for medical electrical systems. EN 60601-1-2: Electromagnetic Compatibility Test, Electrostatic Discharge, Radio Frequency Electromagnetic Field, Fast Transients.

EN 60601-1-4:1996 Collateral Standard: Programmable electrical medical systems.

EN60601-2-25:1996 Particular requirements for the safety of electrocardiographs.

EN 60601-2-27:1996 Particular Requirements for the safety of electrocardiographic monitoring equipment.

EN 60601-2-30:1995 Particular requirements for the safety of automatic cycling indirect blood pressure monitoring equipment.

All tests are passed.

4) Data related to software quality

SCHILLER has reviewed its software development process following the auideline

" reviewer guidance for computer controlled medical devices undergoing 510 (k) review". Device software requirements, software structure chart, software development, software revision/ modification, software identification, software verification, validation and testing are described in the data attached.

- Clinical Tests B2
n.a.

#### Conclusions from Tests B3

The fulfilling of the above standards ensures the safety and effectiveness of the submitted device. We consider the submitted device to be as safe and effective as the Predicate Cardiovit CS-200 (K970879) Device.

Date: 02.04.2002

Markus Buetler Quality Assurance Manager SCHILLER AG

{3}------------------------------------------------

Image /page/3/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping bodies, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 8 2002

Mr. Markus Buetler Quality Assurance Manager SCHILLER AG Altgasse 68, Postfach CH-6341 Baar SWITZERLAND

Re: K012226

Trade Name: Argus PB-1000 System Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detection or Alarms Regulatory Class: Class III (three) Product Code: MHX Dated: March 8, 2002 Received: March 11, 2002

Dear Mr. Buetler:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

{4}------------------------------------------------

## Page 2 - Mr. Markus Buetler

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

W. Dale Tell

Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

| SCHILLER<br>SWITZERLAND | Indications for Use<br>ARGUS PB - 1000 | Nr. | : |
|-------------------------|----------------------------------------|-------|------------|
| | | Issue | : 07.03.02 |
| | | Page | : 1/1 |

# ARGUS PB-1000 System

## Indications for Use

The Monitoring System ARGUS PB-1000 is for the monitoring of vital parameters such as:

ECG: Heartrate, Asystolic Time, Respiration Rate

Invasive Blood Pressure: systolic, distolic and mean pressure

Temperature: temperature and AT

Non Invasive Blood Pressure: systolic, distolic and mean pressure

CO2, etCO2 and CO2ins

SpO2: SpO2 and pulse rate

on humans and for the evaluation of Resting ECG, Arrhythmias, ST-Segments and Cardiac Output. There is alarm handling for all parameters except ST-Segments.

The system comprises the Parameter Box PB-1000 and the Visualisation Unit ARGUS PRO. The two units are connected via a serial interface.

All vital parameters and evaluations are registered and calculated in the PB-1000. This data is then transmitted to the visualisation unit ARGUS PRO or another generally used PC via the serial interface. All data can be shown and monitored on the ARGUS PRO.

The PB-1000 operated using an internal battery and an external power input (RS 232/12V), which is, like the data transmission, completely separate from the visualisation unit. The ARGUS PRO is powered via the normal mains connection 230V/110V.

The system is inteded for use in the Intensive Care Unit, in the Recovery Room, in the Operation Room and during hospital internal transport.

07.03.2002 M. Bo. He.

**Prescription Use**
(Per 21 CFR 801.109)

Division of Cardiovascular & Respiratory Devices
K Number: K012229