ARGUS, MODEL LCM

K053207 · Schiller AG · MHX · May 19, 2006 · Cardiovascular

Device Facts

• Record ID: K053207
• Device Name: ARGUS, MODEL LCM
• Applicant: Schiller AG
• Product Code: MHX · Cardiovascular
• Decision Date: May 19, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2

Intended Use

The Monitoring System ARGUS LCM is for the monitoring of vital parameters such as: - ECG: Heartrate, Respiration Rate . - Invasive Blood Pressure: systolic, diastolic and mean pressure - - Temperature: temperature - - Non Invasive Blood Pressure: systolic, diastolic and mean pressure - - CO2, etCO2 and CO2ins and respiration rate. - - SpO2: SpO2 and pulse rate - There is alarm handling for all parameters except temperature. The ARGUS LCM is powered via the normal mains connection 230V/110V, and using an internal battery and an external power input. 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 LCM is a multi-parameter patient monitoring system; inputs include ECG leads, invasive blood pressure transducers, temperature probes, NIBP cuffs, CO2 sensors, and SpO2 sensors. Device processes physiological signals to display real-time vital signs and provide alarm handling for all parameters except temperature. Used in ICU, recovery, OR, and during hospital transport; operated by clinicians. Output provides continuous monitoring data to assist healthcare providers in clinical decision-making and patient status assessment. Powered by mains, internal battery, or external input.

Clinical Evidence

Bench testing only. No clinical data provided. Device compliance verified against recognized national and international performance, safety, and electromagnetic compatibility standards (IEC 60601-1, 60601-1-2, 60601-2-27, 60601-2-30, 60601-2-34, 60601-2-49, EN 865). Risk analysis and software validation performed per 21 CFR 820 and ISO standards.

Technological Characteristics

Modular patient monitor; dimensions 290x275x180mm; weight 4.6kg. Power: 110V/230V mains, internal battery, external input. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-4, IEC 60601-2-2, IEC 60601-2-3, EN 12470-4, EN 865. Integrates OEM modules for SpO2 (Masimo/Nellcor) and CO2 (Welch Allyn).

Indications for Use

Indicated for monitoring vital parameters including ECG (heart rate, respiration), invasive/non-invasive blood pressure, temperature, CO2 (etCO2, CO2ins), and SpO2 (pulse rate) in patients in the ICU, recovery room, operating room, or 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

• ARGUS PB-1000 System (K012226)
• Cardiovit AT-102 (K031557)

Reference Devices

• Masimo SET 2000 (K990966)
• Nellcor N-550 Pulse Oximeter (K021090)
• Welch Allyn Atlas Monitor (K022084)

Submission Summary (Full Text)

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# 510 K Summary of Safety and Effectiveness

according to 21 CFR 807.92

MAY 1 9 2006

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

Contact Name: Tel: Date:

Mr. Markus Buetler 001 41 41 766 4252 02." May 2006

#### Device Name A2

| 1. Trade Name: | Argus LCM (Basic / Plus) |
|-----------------|--------------------------|
| 2. Common Name: | Monitoring System |

### Legally Marketed Device A3

Legally Marketed Device to which this submitted device is compared:

| ARGUS PB-1000 System | K012226 |
|----------------------|---------|
| Cardiovit AT-102 | K031557 |

#### A4 Intended Use

The Monitoring System ARGUS LCM is for the monitoring of vital parameters such as:

- ECG: Heartrate, Respiration Rate .
- Invasive Blood Pressure: systolic, diastolic and mean pressure -
- Temperature: temperature -
- Non Invasive Blood Pressure: systolic, diastolic and mean pressure -
- CO2, etCO2 and CO2ins and respiration rate. -
- SpO2: SpO2 and pulse rate

There is alarm handling for all parameters except temperature.

The ARGUS LCM is powered via the normal mains connection 230V/110V, and using an internal battery and an external power input.

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

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K053207
P2/4

### Table of Comparison (1) A5

| | Argus PB-1000 System<br>(K012226) | ARGUS LCM |
|---------------------------|-----------------------------------|-------------------|
| Dimensions: | 210x115x45mm | 290x275x180mm1) |
| Weight: | 980 g | 4.6 kg / 9.2lbs2) |
| Environmental Conditions: | | |
| Operating temperature | +10° - 40° C | same |
| Storage temperature | -10° - +50° C | same |
| Relative humidity | 25% - 95%<br>(non condensing) | 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 ARGUS PB-1000 (K 012226) device.

| LCM<br>Plus | LCM<br>Basic | Module | Description | Reference | Standards |
|-------------|--------------|--------|----------------------------------------------------------------------------------------|----------------------------------------------|-----------------------------------------------|
| X | X | System | Schiller AT-102 | K031557, Schiller<br>AT-102 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-4 |
| X | | ECG | Schiller AT-102 | K031557, Schiller<br>AT-102 | IEC 60601-1<br>IEC 60601-2-2 |
| | X | ECG 3p | New Schiller ECG<br>Hardware amplifier<br>Amplifier Firmware<br>Filtering<br>Algorithm | K031557, Schiller<br>AT-102 | IEC 60601-1<br>IEC 60601-2-2 |
| X | X | SPO2 | Masimo OEM SpO2<br>Module MS-7 | K990966, Masimo<br>SET 2000 | Verification and<br>Test Documer |
| X | X | SPO2 | Nellcor OEM SpO2 Module<br>MP-100 | K021090, Nellcor N-<br>550 Pulse Oximeter | Verification and<br>Test Documer |
| X | X | NIBP | Schiller NIBP Module<br>ARGUS PB-1000 | K012216, Schiller<br>ARGUS PB-1000<br>System | IEC 60601-2-3 |
| X | X | Temp. | Schiller Temperature<br>Module ARGSU PB-1000 | K012216, Schiller<br>ARGUS PB-1000<br>System | EN 12470-4 |
| X | X | CO2 | Welch Allyn OEM CO2<br>Module LC101 | K022084, Welch<br>Allyn Atlas Monitor | Specifications<br>Declaration |
| X | X | IBP | Schiller IBP Module<br>ARGUS PB-1000 | K012216, Schiller<br>ARGUS PB-1000<br>System | IEC 60601-2-3 |

## Table of Comparison (2)

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### 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. IEC60601-1-2: Electromagnetic Compatibility Test, Electrostatic Discharge, Radio Frequency Electromagnetic Field, Fast Transients. IEC60601-2-27:1996 Particular Requirements for the safety of electrocardiographic monitoring equipment.

IEC60601-2-30:1995 Particular requirements for the safety of automatic cycling indirect blood pressure monitoring equipment. IEC60601-2-34:1995 Particular requirements for the safety of the blood pressure monitoring equipment. IEC60601-2-49:2001 Particular Requirements for the safety of multifunction patient monitoring equipment EN865:1997 Pulse Oximeters-Particular Requirements

All tests are passed.

### 4) Data related to software quality

SCHILLER has reviewed its software development process following the guideline * 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.

#### B2 Clinical Tests

n.a.

### B3 Summary of Performance Testing:

The Argus LCM Monitoring and associated accessories have been tested and found to comply with recognized national and international performance, safety and electromagnetic compatibility standards for medical devices and product specifications listed in the Argus LCM labeling.

A risk analysis, identifying potential hazards and documenting mitigation of the hazards. has been developed and verified/validated as part of SCHILLER AG. product development procedures. SCHILLER AG Quality System conforms to 21 CFR 820 and is Certified to ISO 9001:2000 and ISO 13485:2003

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### Conclusion

As stated above, SCHILLER AG conclusion is that the Argus LCM Monitoring is safe, effective, comply with the appropriate medical device standards and equivalent to the Argus PB-1000 System (K012226) and Cardiovit AT-102 (K031557) currently on the market.

Baar (Switzerland) 02™ May 2006

A. Bi. Ree

Markus Buetler SCHILLER AG Quality Assurance and Regulatory Affairs Manager

Section and Career of

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 9 2006

Mr. Markus Buetler Quality and Regulatory Department Schiller AG Altgasse 68 Baar, ZG, Switzerland 6341

Re: K053207

Trade/Device Name: Argus, Model LCM 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: November 11, 2005 Received: November 16, 2005

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 10 mo beared or 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.

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### Page 2 - Mr. Markus Buetler

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r toase of acribed alla I termination that your device complies with other requirements of the Act that I Dr Amal statutes and regulations administered by other Federal agencies. You must or any I caster that to t'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 (21 CFR Part 807), accems (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. product faction control provided in arketing your device as described in your Section 510(k) I mis lotter will and w Jown FDA finding of substantial equivalence of your device to a legally premated predicated with 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), please If you active of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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,

Duna R. hochner

Image /page/5/Picture/5 description: The image shows a handwritten symbol or character. It appears to be a combination of curved and angular lines, possibly resembling a stylized letter or a unique design. The lines are thick and dark, suggesting they were drawn with a pen or marker. The overall impression is abstract and artistic.

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

Enclosure

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## Indications for Use

510(k) Number (If know): KOS3207

Device Name: Argus LCM

Indications for Use:

The Monitoring System ARGUS LCM is for the monitoring of vital parameters such as:

- ECG: Heartrate, Respiration Rate ・
- Invasive Blood Pressure: systolic, diastolic and mean pressure -
- Temperature: temperature ー
- Non Invasive Blood Pressure: systolic, diastolic and mean pressure -
- CO2, etCO2 and CO2ins -
- SpO2: SpO2 and pulse rate -

There is alarm handling for all parameters except temperature.

The ARGUS LCM is powered via the normal mains connection 230V/110V, and using an internal battery and an external power input.

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

SCHILLER AG
Altgasse 68

341 Baar/Switzerland

10////0√

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

ovascular Devices

510(k) Number k053207