Invasive blood pressure: systolic, diastolic and mean pressure
s and controller Brings and/or sidestream Invasive blood pressure. Systems, main and/or sidestream FIO2

lt will extend the functionality of the existing Argus PB-1000 system (K0122Z6).
The function and the promoter her PB-1000 and the visualisation unit AR It will extend the functionality of the existing Algust PB-1000 (PB-100) (PB-100)
The system comprises the parameter box PB-1000 and the visualisation unit ARGUS
(PBS) and th

The system compilses the parcined via a serial interface. PRO. The two units are connected via a serial intenated and calculated in the PB-2200. This All vital parameters and evaluations are registered and calouaced manager generally used
data is then transmitted to the visualisation unit ARGUS PRO or another generally us data is then transmitted to the visuallsation und monitored on the ARGUS PRO.
PC via the serial interface. All data can be shown and monitored on the ARGUS PRO. PC via the serial interface. All data can be snown and monecessed power input (RS
The PB-2200 is operated using an internal battery and an external power input (RS
e and the The PB-2200 is operated using an internal battery alle an and the manate from the 232/12V), which is, like the data transmission, completely sop
visualisation unit. The ARGUS PRO is powered via the normal mains connection

230V/110V.
The system is intended for use in the intensive care unit, in the recovery room, in the The system is intended for ass internal transports.

Device Description

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.

AI/ML Overview

The provided 510(k) summary for the ARGUS PB-2200 Monitoring System indicates that no specific acceptance criteria or a dedicated study proving performance against such criteria were explicitly presented in the document. Instead, the submission relies on demonstrating substantial equivalence to a predicate device (ARGUS PB-1000 System, K012226) by showing that the ARGUS PB-2200 meets or exceeds various established safety and electromagnetic compatibility standards.

The key takeaway is that for this device, the "acceptance criteria" are the compliance with recognized medical device standards, and the "study" is the non-clinical testing performed against those standards.

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

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Standards Met)	Reported Device Performance
Electrical Safety:
EN 60601-1:1990 (General Safety)	All tests passed.
EN 60601-1-1:1993 (Medical Electrical Systems Safety)	All tests passed.
EN 60601-1-4:1996 (Programmable Medical Systems Safety)	All tests passed.
Electromagnetic Compatibility (EMC):
EN 60601-1-2 (EMC Test)	All tests passed.
- Electrostatic Discharge (ESD)	Fully functional below 4 kV (Open Air), No damage below 8 kV (Open Air)
- Radiated Emissions	Less than 30 dB Microvolts
- Radiated Immunity	Less than 3 Volts per meter
Specific Safety (Blood Pressure Monitoring):
EN 60601-2-34:1995 (Blood Pressure Monitoring Equipment Safety)	All tests passed.
Software Quality:	Reviewed according to "reviewer guidance for computer controlled medical devices undergoing 510 (k) review." Device software requirements, structure, development, revision, identification, verification, validation, and testing are described in attached data.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document relates to non-clinical testing of the device against standards. There is no mention of a "test set" in the context of patient data or clinical performance. Therefore, sample size for a test set is not applicable (N/A) for this type of submission. The data provenance is related to in-house or contracted laboratory testing for compliance with international standards, likely performed in Switzerland (country of origin of SCHILLER AG). The testing is prospective in the sense that the device was actively tested against the standards.

3. 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. This submission focuses on engineering and safety standards compliance, not on clinical performance evaluated by medical experts establishing ground truth from patient data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There was no "test set" in the context of clinical data requiring adjudication.

5. 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

No MRMC comparative effectiveness study was done. This device is a vital signs monitor, not an AI-assisted diagnostic tool for interpretation by human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device is a monitoring system for vital parameters. Its "performance" is its ability to accurately measure and display these parameters and comply with safety standards. The non-clinical tests described are essentially "standalone" performance evaluations against specified engineering and safety criteria. There is no mention of an algorithm in the sense of a diagnostic or interpretive AI, therefore, no standalone algorithm performance study as typically understood in AI/ML medical devices.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests, the "ground truth" is established by the defined parameters and tolerances within the referenced international standards (e.g., specific voltage levels for ESD, frequency ranges for emitted radiation, and safety requirements for medical electrical equipment). The device's performance is compared directly against these established standard requirements.

8. The sample size for the training set

The document does not describe a "training set" as it is commonly understood for AI/ML models. This device is a hardware monitoring system, not an AI/ML product that undergoes a training phase with a dataset.

9. How the ground truth for the training set was established

Not applicable. No training set for an AI/ML model was used or described.

Summary

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Image /page/0/Picture/1 description: The image shows a handwritten text string that appears to be a combination of letters and numbers. The string reads 'K033738' on the first line, and 'P 1/3' on the second line. The handwriting is somewhat rough, and the characters are not perfectly formed.

510 K Summary

AUG 2 4 2004

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:	21.th November 2003

A2 Device Name

1. Trade Name:	ARGUS PB-2200
2. Common Name:	Monitoring System

A3 Legally Marketed Device Legally Marketed Device to which this submitted device is compared:
ARGUS PB-1000 System K 012226

A4 Intended Use

The Monitoring System ARGUS PB-2200 is for the monitoring of vital parameters such as:

Invasive Blood Pressure: systolic, distolic and mean pressure CO2, etCO2 and CO2ins, main and/or sidestream FIO2

It will extend the functionality of the existing Argus PB -1000 System (K012226) 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 intended for use in the Intensive Care Unit, in the Recovery Room, in the Operation Room and during hospital internal transport.

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

KO 33729
P.L.

Table of Comparison A5

	Argus PB-1000 System(K012226)	ARGUS PB-2200
Dimensions:	210x115x45mm	210x115x64.5mm 1)
Weight:	980 g	1200g 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:ESD	EN 60601-1-2	same
	Fully functional below 4 kV(Open Air)	same
	No damage below 8 kV (OpenAir)	same
Radiated Emissions	Less than 30 dB Microvolts	same
Radiated Immunity	Less than 3 Volts per meter	same
Safety StandardsSafety of Medical Electrical Equipmentpart1. General requirements	EN 60601-1:1990	same
Safety requirements for medicalsystems	EN 60601-1-1:1993	same
Safety requirements for programmableelectrical medical systems	EN 60601-1-4:1996	same
Requirements for the safety of theblood pressure monitoring equipment	EN 60601-2-34:1995	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 System (K012226) device.

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Non-Clinical Tests B1

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.

EN 60601-2-34:1995 Particular requirements for the safety of the blood pressure monitoring equipment.

All tests are passed.

1. Data related to software quality
  SCHILLER has reviewed its software development process following the quideline

" 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.
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 ARGUS PB-1000 System Device. (K 012226)

Date: 21.11.2003

K. R. Ze.

Martin Roth

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 and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of three wavy lines, resembling a bird or a symbol representing health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 4 2004

Mr. Markus Buetler Quality Assurance Manager SCHILLER AG Altgasse 68 CH-6341 Baar Switzerland

Re: K033738

Trade Name: ARGUS PB-2200 Patient Monitoring System Regulation Number: 21 CFR 870.1110 Regulation Name: Blood Pressure Computer Regulatory Class: Class II (two) Product Code: DSK Dated: August 2, 2004 Received: August 4, 2004

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), please contact the Office 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 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,

N.W.R.S. Oplien

Barry D. Zuckerman, M.D.

Bram D. Zuckern 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 known): K033738 _

Device Name: Monitoring System ARGUS PB-2200

Indications For Use:
The monitoring system ARGUS PB-2200 is for the monitoring of vital parameters such as:

Invasive blood pressure: systolic, diastolic and mean pressure
s and controller Brings and/or sidestream Invasive blood pressure. Systems, main and/or sidestream FIO2

230V/110V.
The system is intended for use in the intensive care unit, in the recovery room, in the The system is intended for ass internal transports.

SCHILLER AG
Altgasse 68
CH-6341 Baar/Switzerland

Prescription Use X
(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)

Nake. Spleen to B, Page 1 of 1

(Division Sian-Off) Jivision of Cardiovascular Devices

510(k) Number KD33738

Regulation Number and Section

§ 870.1110 Blood pressure computer.

(a)
Identification. A blood pressure computer is a device that accepts the electrical signal from a blood pressure transducer amplifier and indicates the systolic, diastolic, or mean pressure based on the input signal.(b)
Classification. Class II (performance standards).