The Monitoring System ARGUS LCM is for the monitoring of vital parameters such as: ECG, Invasive Blood Pressure, Temperature, Non Invasive Blood Pressure, CO2, etCO2, CO2ins, 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 intended for use in the Intensive Care Unit, in the Recovery Room, in the Operation Room and during hospital internal transport.

AI/ML Overview

The provided document is a 510(k) summary for the SCHILLER AG Argus LCM Monitoring System, comparing it to predicate devices. It states that the device is "as safe and effective as" the predicate devices and passed relevant electrical safety and software quality tests. However, it does not contain the specific information requested about acceptance criteria and a study proving those criteria are met in the format of the output.

Specifically:

Acceptance Criteria and Reported Device Performance Table: The document lists standards passed for various components (e.g., IEC 60601-1 for System, IEC 60601-2-2 for ECG). However, it does not provide specific acceptance criteria values (e.g., accuracy +/- X%) or numerical reported device performance against those criteria. Instead, it generally states "All tests are passed" or refers to compliance with standards.
Sample size and data provenance for test set: Not available. The document states "B2 Clinical Tests: n.a." (not applicable), indicating no clinical tests were performed for this submission. The non-clinical tests mentioned are electrical safety and software quality.
Number of experts and qualifications for ground truth: Not applicable, as no clinical study with ground truth established by experts is described.
Adjudication method for test set: Not applicable.
MRMC comparative effectiveness study: Not applicable.
Standalone (algorithm-only) performance: Not applicable, as the device is a monitoring system and the performance evaluation focuses on hardware components and electrical safety, not an algorithm's standalone diagnostic performance.
Type of ground truth used: Not applicable, as no clinical study is described. The "ground truth" for the non-clinical tests would be the specifications and requirements of the standards themselves.
Sample size for training set: Not applicable, as no machine learning algorithm development is described in detail that would require a 'training set'. The software quality section refers to software requirements, development, verification, validation, and testing, but not in the context of a machine learning model.
How ground truth for training set was established: Not applicable.

Therefore, since the document pertains to a medical device submission primarily focused on demonstrating substantial equivalence through non-clinical testing and comparison to predicate devices, the requested clinical study-centric details are not present.

Summary

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

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.

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

K053207
P2/4

Table of Comparison (1) A5

	Argus PB-1000 System(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%(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.

LCMPlus	LCMBasic	Module	Description	Reference	Standards
X	X	System	Schiller AT-102	K031557, SchillerAT-102	IEC 60601-1IEC 60601-1-2IEC 60601-2-4
X		ECG	Schiller AT-102	K031557, SchillerAT-102	IEC 60601-1IEC 60601-2-2
	X	ECG 3p	New Schiller ECGHardware amplifierAmplifier FirmwareFilteringAlgorithm	K031557, SchillerAT-102	IEC 60601-1IEC 60601-2-2
X	X	SPO2	Masimo OEM SpO2Module MS-7	K990966, MasimoSET 2000	Verification andTest Documer
X	X	SPO2	Nellcor OEM SpO2 ModuleMP-100	K021090, Nellcor N-550 Pulse Oximeter	Verification andTest Documer
X	X	NIBP	Schiller NIBP ModuleARGUS PB-1000	K012216, SchillerARGUS PB-1000System	IEC 60601-2-3
X	X	Temp.	Schiller TemperatureModule ARGSU PB-1000	K012216, SchillerARGUS PB-1000System	EN 12470-4
X	X	CO2	Welch Allyn OEM CO2Module LC101	K022084, WelchAllyn Atlas Monitor	SpecificationsDeclaration
X	X	IBP	Schiller IBP ModuleARGUS PB-1000	K012216, SchillerARGUS PB-1000System	IEC 60601-2-3

Table of Comparison (2)

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

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

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

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

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

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.

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

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 (301) 594-4646. 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 (800) 638-2041 or (301) 443-6597 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

{6}------------------------------------------------

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

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.