The Welch Allyn® 1500 Patient Monitor patient monitoring unit is designed for the monitoring of vital parameters such as ECG, SpO2, etCO2, non invasive blood pressure (NIBP), invasive blood pressure (IBP), temperature and respiration of a patient.
The device is intended to be used by qualified doctors or trained medical personnel.
The device is not suitable for transport.
There is no danger for patients with pacemaker.
The device is intended for the monitoring of one patient at a time.
The device is not designed for sterile use nor is it designed for outdoor use.
Do not use this monitor in areas where there is any danger of explosion or in the presence of flammable gases.
The device is classified CF. It is defibrillation protected when the original accessories are used. However, as a safety precaution when possible, remove the electrodes before defibrillation.
This product is not designed for direct cardiac application.
The arrhythmia module is not intended for use with neonatal patients.
The ST-analysis module is not intended for use with neonatal patients.

Device Description

The Welch Allyn 1500 Patient Monitor is an ultra-flat patient monitor designed for neonates, children, adult and paediatric use. It has a LCD screen for comprehensive vital data monitoring. Mains power supply is used for stationary use. The Welch Allyn 1500 Patient Monitor also provides full vital data monitoring during transport with the built-in battery.

AI/ML Overview

The SCHILLER Welch Allyn 1500 Patient Monitor is a patient monitoring unit designed for monitoring vital parameters such as ECG, SpO2, etCO2, non-invasive blood pressure (NIBP), invasive blood pressure (IBP), temperature, and respiration of a patient.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state quantitative acceptance criteria or performance metrics for the Welch Allyn 1500 Patient Monitor. Instead, it relies on demonstrating substantial equivalence to previously FDA-cleared predicate devices. The "performance" is implicitly tied to compliance with various medical device standards, indicating that the device meets the safety and performance levels expected under those standards.

Parameter/Aspect	Acceptance Criteria (Implied)	Reported Device Performance
12-lead Rest-ECG Analysis	Substantial equivalence to SCHILLER ARGUS LCM (K053207)	The 12-lead Rest-ECG Analysis algorithm used in the 1500 Patient Monitor has been FDA-cleared in the SCHILLER ARGUS LCM (K053207).
Patient Temperature	Substantial equivalence to SCHILLER ARGUS LCM (K053207)	The Patient Temperature parameter circuitry and algorithm used has been FDA-cleared in the SCHILLER ARGUS LCM (K053207).
Respiration	Substantial equivalence to SCHILLER ARGUS LCM (K053207)	The Respiration parameter circuitry and algorithm used has been FDA-cleared in the SCHILLER ARGUS LCM (K053207).
Non-Invasive Blood Pressure (NIBP)	Substantial equivalence to SCHILLER BP-200plus (K063814)	The NIBP parameter circuitry and algorithm used has been FDA-cleared in the SCHILLER BP-200plus (K063814).
Invasive Blood Pressure (IBP)	Substantial equivalence to SCHILLER ARGUS LCM (K053207)	The Invasive Blood Pressure parameter circuitry and algorithm used has been FDA-cleared in the SCHILLER ARGUS LCM (K053207).
Pulse Oximetry (SpO2)	Substantial equivalence to Nellcor Oximax NPB-40 (K051352)	The SpO2 parameter circuitry and algorithm used has been FDA-cleared in the Nellcor Oximax NPB-40 Pulse Oximeter (K051352).
ECG Arrhythmia / ST-segment Analysis	Substantial equivalence to Datascope Passport 2 (K020550)	The Mortara ECG Arrhythmia and ST-segment analysis algorithm used has been FDA-cleared in the Datascope Passport 2 Vital Signs Monitor (K020550).
End-tidal CO2 (etCO2)	Substantial equivalence to Oridion Capnostream10 (K060065)	The end-tidal CO2 parameter circuitry and algorithm used has been FDA-cleared in the Oridion Capnostream10 Bedside Monitor (K060065).
Electrical Safety	Compliance with IEC 60601-1, IEC 60601-1-4, IEC 60601-1-6, etc.	Tested and found to comply with IEC 60601-1 (Protection Class I Type CF), IEC 60601-1-4, IEC 60601-1-6, IEC 60601-2-27, IEC 60601-2-30, IEC 60601-2-34, IEC 60601-2-49, ISO 9919.
EMC (Electromagnetic Compatibility)	Compliance with IEC/EN 60601-1-2 (class A)	Tested and found to comply with IEC/EN 60601-1-2 (class A).
Software Quality	Compliance with "reviewer guidance for computer controlled medical devices undergoing 510 (k) review"	Software development process reviewed, and device software requirements, structure, development, revision, identification, verification, validation, and testing are described in attached data. The Quality System conforms to 21 CFR 820 and is Certified to ISO 9001:2008 and ISO 13485:2003.
Risk Analysis	Hazards identified, mitigated, verified/validated	A risk analysis, identifying potential hazards and documenting mitigation, has been developed and verified/validated as part of SCHILLER AG product development procedures.

The study described is primarily a substantial equivalence demonstration to predicate devices for each specific parameter. This means the performance of the Welch Allyn 1500 Patient Monitor's individual components (e.g., ECG analysis, SpO2 sensor) is considered acceptable because they utilize algorithms and circuitry that have previously received FDA clearance in other devices.

General safety and performance acceptance criteria for the entire device assembly are met through compliance with various national and international performance, safety, and electromagnetic compatibility standards, as listed in the "Non-Clinical Tests B1" section.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a specific sample size for a test set used to evaluate the overall Welch Allyn 1500 Patient Monitor. Instead, it relies on the pre-existing FDA clearances of the embedded components and their respective studies.

For the predicate devices/algorithms:

Data Provenance: Not explicitly stated for each predicate device's original clearance, but these devices would have undergone their own testing, likely including both clinical and non-clinical studies. Given the context of medical devices, data would generally originate from diverse patient populations to ensure broad applicability. The submitting company (SCHILLER AG) is based in Switzerland.
Retrospective or Prospective: Not specified.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document as it describes a substantial equivalence submission relying on previously cleared components and adherence to standards, rather than a de novo clinical study with new ground truth establishment for the combined device. For the individual predicate devices, this information would have been part of their original 510(k) submissions.

4. Adjudication Method for the Test Set

Since a specific test set and ground truth establishment for the Welch Allyn 1500 Patient Monitor itself (beyond component equivalence and standard compliance) are not detailed, an adjudication method is not mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no mention of an MRMC comparative effectiveness study being performed for the Welch Allyn 1500 Patient Monitor. The submission focuses on device parameters being substantially equivalent to existing FDA-cleared devices, meaning it's not comparing human readers with and without AI assistance specific to this new integrated monitor.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The submission details that the algorithms for 12-lead Rest-ECG Analysis, Patient Temperature, Respiration, NIBP, IBP, SpO2, ECG Arrhythmia/ST-segment Analysis, and etCO2 are the same as those present in previously FDA-cleared devices. This implies that the standalone performance of these algorithms would have been established during the original clearance of those predicate devices. The current submission focuses on the integration and overall safety/effectiveness of the combined unit.

For instance, the ECG Arrhythmia and ST-segment analysis algorithm is the "Mortara ECG Arrhythmia and ST-segment analysis algorithm used in the 1500 Patient Monitor has been FDA-cleared in the Datascope Passport 2 Vital Signs Monitor (K020550)." This indicates a standalone performance study (without human in the loop) for that algorithm would have been conducted as part of the K020550 submission.

7. Type of Ground Truth Used

The type of ground truth used for the underlying algorithms in the predicate devices is not explicitly stated in this document. However, for physiological monitoring devices, ground truth for parameters like ECG interpretation, arrhythmia detection, blood pressure, SpO2, and CO2 typically involves:

Expert Consensus: For ECG and arrhythmia interpretation by cardiologists.
Reference Standards/Devices: Calibrated reference instruments for parameters like blood pressure, temperature, SpO2, and CO2.
Pathology/Clinical Outcomes Data: Less direct for these specific vital signs but could be relevant for validating the clinical significance of detected arrhythmias or ST changes.

8. Sample Size for the Training Set

The document does not provide information regarding the sample size of training sets for any of the algorithms. This information would have been part of the original 510(k) submissions for the predicate devices where these algorithms were first cleared.

9. How the Ground Truth for the Training Set Was Established

Similar to point 8, the document does not provide information on how the ground truth for the training sets of the constituent algorithms was established. This would have been detailed in the respective 510(k) submissions for the predicate devices.

Summary

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SCHILLER AG
Altgasse 68, Postfach
CH-6341 Baar
Tel: +41 (41) 766 42 42
Fax: +41 (41) 761 08 80

MWST Nr. 212858 sales@schiller.ch buving@schiller.ch http://www.schiller.ch

SCHILLER

101619

NOV 1 2 2010

510 (k) Summary of Safety and Effectiveness

according to 21 CFR 807.92

Address A1

SCHILLER AG Altgasse 68 CH-6341 Baar Switzerland

Contact Name:	Serkan Sezer
Tel:	+ 41 41 766 4252
Date:	28. th May 2010

A2 Device Name

1. Trade Name:	Welch Allyn 1500 Patient Monitor
2. Common Name:	Monitoring System

Legally Marketed Device АЗ

Legally Marketed Device to which this submitted device is compared:

Parameters – 12-lead Rest-ECG Analysis

The 12-lead Rest-ECG Analysis algorithm used in the 1500 Patient Monitor has been FDAcleared in the SCHILLER ARGUS LCM K053207).

Parameters - Temperature

The Patient Temperature parameter circuitry and algorithm used in theWelch Allyn 1500 Patient Monitor has been FDA-cleared in the SCHILLER ARGUS LCM K053207).

Parameters - Respiration

The Respiration parameter circuitry and algorithm used in the 1500 Patient Monitor has been FDA-cleared in the SCHILLER ARGUS LCM K053207).

Parameters --NIBP and Invasive Blood Pressure

The Not Invasive Blood Pressure parameter circuitry and algorithm used in the 1500 Patient Monitor has been FDA-cleared in the SCHILLER BP-200plus (K063814).

Parameters -Invasive Blood Pressure

The Invasive Blood Pressure parameter circuitry and algorithm used in the 1500 Patient Monitor has been FDA-cleared in the SCHILLER ARGUS LCM K053207).

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Parameters - Temperature

The Patient Temperature parameter circuitry and algorithm used in the 1500 Patient Monitor has been FDA-cleared in the SCHILLER ARGUS LCM K053207).Parameters - Pulse Oximetry (SpO2)

The SpO2 parameter circuitry and algorithm used in the 1500 Patient Monitor has been FDAcleared in the Nellcor Oximax NPB-40 Pulse Oximeter (K051352).

Parameters - ECG Arrhythmia / ST-segment Analysis

The Mortara ECG Arrhythmia and ST-segment analysis algorithm used in the 1500 Patient Monitor has been FDA-cleared in the Datascope Passport 2 Vital Signs Monitor (K020550).

Parameters - end-tidal CO2

The end-tidal CO2 parameter circuitry and algorithm used in the 1500 Patient Monitor has been FDA-cleared in the Oridion Capnostream10 Bedside Monitor (K060065).

A4 Intended Use

The device is intended to be used by qualified doctors or trained medical personnel.
The device is not suitable for transport.
公 There is no danger for patients with pacemaker.
The device is intended for the monitoring of one patient at a time. A
A The device is not designed for sterile use nor is it designed for outdoor use.
Do not use this monitor in areas where there is any danger of explosion or in the presence of flammable gases.
The device is classified CF. It is defibrillation protected when the original accessories are used. However, as a safety precaution when possible, remove the electrodes before defibrillation.
This product is not designed for direct cardiac application.
The arrhythmia module is not intended for use with neonatal patients. A
The ST-analysis module is not intended for use with neonatal patients. A

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SCHILLER AG Altgasse 68, Postfach CH-6341 Baar Tel: +41 (41) 766 42 42
Fax: +41 (41) 761 08 80

MWST Nr. 212858 sales@schiller.ch buying@schiller.ch http://www.schiller.ch

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A5 Table of Comparison (1)

		ARGUS LCM	WA1500PM
1	Dimensions:	290x275x180mm 1)	396 x 284 x 81 mm
2	Weight:	4.6 kg / 9.2lbs 2)	4.6 kg / 9.2lbs 2)
3	Environmental Conditions:	Indoor use	Indoor use
4	Operating temperature	+10° - 40° C	+10° - 40° C
5	Storage temperature	-10° - +50° C	-10° - +50° C
6	Relative humidity	25% - 95%(non condensing)	25% - 95%(non condensing)

Discussion of Difference:

None of the above difference (1 ) can be considered as safety relevant difference.

We consider the submitted device to be as safe and effective as the Predicate SCHILLER ARGUS LCM (K 053207) device.

ArgusLCM	WA1500PM	Module	Standards	Different
X	X	Safety	IEC 60601-1	Same
	X	Software	IEC 60601-1-4	Same
X	X	EMC	IEC 60601-1-2	New Standard
X	X	ECG	IEC 60601-1IEC 60601-2-27	Same
X	X	Monitoring	IEC 60601-2-34IEC 60601-2-49	Same
X	X	SPO2	EN 9919	New Standard
X	X	NIBP	IEC 60601-2-30	Same
X	X	Temp.	EN 12470-4	Same
X	X	CO2	ISO 21647-1	New Standard
X	X	IBP	IEC 60601-2-34	Same

Table of Comparison (2)

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+41 (41) 761 08 80

MWST Nr 212858 http://www.schiller.ch

Non-Clinical Tests BT

1. Electrical Safety and Reliability:
IEC 60601-1: General requirements for basic safety and essential performance. Protection Class I Type CF
IEC 60601-1-4: General requirements for collateral standard: programmable electrical medical systems.
IEC 60601-1-6: General requirements for safety collateral standard usability A
IEC 60601-2-27: Particular requirements for the safety of electrocardiographic monitoring equipment
IEC 60601-2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment
IEC 60601-2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment
IEC 60601-2-49: Particular requirements for the safety of multifunction patient monitoring equipment
ISO 9919. Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use
- 1. Protection Class
Protection against electric shocks, Class I according to IEC/EN 60601-1 (with internal power)
- 1. IP- Protection
This device is not designed for outdoor use (IPX1)
- 1. EMC
IEC/EN 60601-1-2 (class A)
- 1. Additional Requirements
EN 1060-1 and 3 (non-invasive blood pressure recorders part 1)
- 1. Conformity
CE according to directive 93/42/EEC class Ilb

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.

Clinical Tests B2
- n.a.

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SCHILLER AG Altgasse 68 Postfach CH-6341 Baar +41 (41) 766 42 42 Fax: +41 (41) 761 08 80

MWST Nr. 212858 sales@schiller.ch buying@schiller.ch http://www.schiller.ch

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Summary of Performance Testing: ВЗ

The SCHILLER Welch Allyn 1500 Patient 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 SCHILLER Welch Allyn 1500 Patient Monitoring 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 9001:2008 and ISO 13485:2003

Conclusion

As stated above, SCHILLER AG conclusion is that the SCHILLER Welch Allyn 1500 Patient Monitor is safe, effective, comply with the appropriate medical device standards and equivalent to the SCHILLER ARGUS LCMK053207; SP02 Module Nelcor K051352; CO2 Module Oridien K072295; ECG Library Mortara K020550; NIBPNodule SCHILLER K063814 all parameters currently on the market.

Baar (Switzerland) 28" May 2010

SCHILLER AG
Aligasse 68
CH-6341 Baar/Switzerland
Serkan Sezer

SCHILLER AG Quality and Regulatory Affairs Manager

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Paze

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Serkan Sezer Quality and Regulatory Affairs Manager SCHILLER AG Altgasse 68 Baar, Zg SWITZERLAND 6341

NOV 1 2 2010

Re: K101619

Device Name: Welch Allyn® 1500 Patient Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Patient physiological monitor (with arrhythmia detection or alarms) Regulatory Class: Class II (Two) Product Codes: MHX Dated: October 19, 2010 Received: October 20, 2010

Dear Mr. Sezer:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Arlene B. Boan

for

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 known):_____________________________________________________________________________________________________________________________________________________ K101619

NOV 1 2 2010

Welch Allyn 1500 Patient Monitor Device Name:

Indications For Use:

The Welch Allyn 1500 Patient Monitor is an ultra-flat patient monitor designed for neonates, children, adult and paediatric use. It has a LCD screen for comprehensive vital data monitoring.

Mains power supply is used for stationary use. The Welch Allyn 1500 Patient Monitor also provides full vital data monitoring during transport with the built-in battery.

The device is intended to be used by qualified doctors or trained medical personnel.
The device is not suitable for transport.
There is no danger for patients with pacemaker.
The device is intended for the monitoring of one patient at a time.
The device is not designed for sterile use nor is it designed for outdoor use.
Do not use this monitor in areas where there is any danger of explosion or in the presence of flammable gases.
The device is classified CF. It is defibrillation protected when the original accessories are used. However, as a safety precaution when possible, remove the electrodes before defibrillation.
This product is not designed for direct cardiac application.
The arrhythmia module is not intended for use with neonatal patients.
The ST-analysis module is not intended for use with neonatal patients.

page 1 of 2

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Baar (Switzerland) 21th July 2010

SCHILLER AG

Altgasse 6

CH 6341 Baar/Switzerland

SCHILLER AG

Serkan Sezer

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)

Ahlley Bovans for BDZ

(Division Sidn-Off) Division of Cardiovascular Devices

510(k) Number K101619

Page 1 of _2

Page 2 of 2

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.