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.

Device Description

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.

AI/ML Overview

The provided 510(k) summary for the SCHILLER AG Argus PB-1000 System primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (Cardiovit CS-200 K970879) through non-clinical testing for safety and effectiveness.

Here’s a breakdown of the information requested, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are primarily based on compliance with specific international
standards for electrical safety and electromagnetic compatibility, and the device performance is reported as meeting these standards. Because this is a 510(k) submission, the device performance is primarily judged in comparison to the predicate device.

Acceptance Criteria (from EN Standards/Predicate Comparison)	Reported Device Performance
Electrical Safety:
EN 60601-1:1990 (General requirements)	Passed
EN 60601-1-1:1993 (Medical electrical systems)	Passed
EN 60601-1-4:1996 (Programmable electrical medical systems)	Passed
EN60601-2-25:1996 (Safety of electrocardiographs)	Passed
EN 60601-2-27:1996 (Safety of ECG monitoring equipment)	Passed
EN 60601-2-30:1995 (Safety of automatic cycling indirect blood pressure monitoring equipment)	Passed
Electromagnetic Compatibility (EMC):
EN 60601-1-2 (General EMC standard)	Passed
ESD: Fully functional below 4 kV (Open Air)	Passed (same as predicate)
ESD: No damage below 8 kV (Open Air)	Passed (same as predicate)
Radiated Emissions: Less than 30 dB Microvolts	Passed (same as predicate)
Radiated Immunity: Less than 3 Volts per meter	Passed (same as predicate)
Environmental Conditions:
Operating temperature: +10° - 40° C	Same as predicate
Storage temperature: -10° - +50° C	Same as predicate
Relative humidity: 25% - 95% (non condensing)	Same as predicate
Software Quality:	Reviewed according to "reviewer guidance for computer controlled medical devices undergoing 510 (k) review," with requirements, structure, development, revision, identification, verification, validation, and testing described in attached data.
Equivalence to Predicate Device (Cardiovit CS-200 K970879):	"We consider the submitted device to be as safe and effective as the Predicate Cardiovit CS-200 (K970879) device." (Based on non-clinical tests and comparison of technical specifications, with no safety-relevant differences identified).

Study Information:

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- The document does not describe a clinical test set or data provenance for performance evaluation. The testing described is non-clinical (electrical safety, EMC, software quality).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable. There is no mention of a test set requiring expert ground truth establishment for clinical performance.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. There is no mention of a test set requiring adjudication.
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:
- Not applicable. This device is a monitoring system, not an AI-assisted diagnostic tool, and no MRMC study is mentioned.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The document implies standalone testing of various electrical and EMC parameters as per the standards listed. However, "standalone" in the context of an "algorithm only" performance study typically refers to diagnostic accuracy of an AI model, which is not relevant here. The device itself (PB-1000) performs the parameter measurements and calculations, and these are presumably tested for accuracy and reliability as part of the standards compliance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests, the "ground truth" is adherence to the specified engineering and safety standards (e.g., standard electrical safety limits, electromagnetic compatibility thresholds, expected physical behavior of components).
The sample size for the training set:
- Not applicable. This document describes a medical device, not a machine learning algorithm that requires a "training set" in the conventional sense. The "software quality" section refers to software development and verification processes, not statistical training of an AI model.
How the ground truth for the training set was established:
- Not applicable, as there is no mention of a training set for an AI model. The software quality assurance processes adhere to established guidelines and involve verification and validation against requirements.

Summary

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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.

{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%(non condensing)	same
Electrostatic Discharge /Electromagnetic Compatibility:	EN 60601-1-2	same
ESD	Fully functional below 4 kV(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.

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K01226
page 3 of 3.

B1 Non-Clinical Tests

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.

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

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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.

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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 (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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

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SCHILLERSWITZERLAND	Indications for UseARGUS 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.

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

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.