The BP-200 plus is intended to be used as an adjunct to exercise stress testing devices. It is intended to measure and display diastolic and systolic blood pressure, heart rate, percentage of oxygen saturation in arterial blood (SpO2) and pulse rate in adult or adolescent patients during stress tests. The measurement cuff of the BP-200 plus in intended to be placed on the upper right arm of the patient. The BP-200 plus can be used for patients of both sexes and all races. The BP-200 plus should not be used with neonates.

Device Description

The BP-200 plus, a microprocessor based non invasive blood pressure monitor and oxygen saturation measurement system intended to be used with stress-test systems, uses Korotkoff sounds to determine blood pressure and an optical ear sensor for oxygen saturation. An internal electric pump is used to inflate the cuff, and deflation is controlled by a valve. The BP-200 plus has the ability to make blood pressure at predetermined intervals (normally from a schedule determined by the physician), or on demand. Saturation measurements are updated once per second.

The BP-200 plus is powered by an external power supply (input: 230/110 V; output: 9V dc), and as an option by using four "AA" rechargeable batteries (≥ 2500 mAh). The batteries must be recharged with an external battery charger.

AI/ML Overview

The SCHILLER BP-200 plus is an automated non-invasive blood pressure monitor system with an oxygen saturation measurement option, intended for use as an adjunct to exercise stress testing devices. It measures and displays diastolic and systolic blood pressure, heart rate, percentage of oxygen saturation in arterial blood (SpO2), and pulse rate in adult or adolescent patients during stress tests. It is not to be used with neonates.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the BP-200 plus has satisfactorily passed all tests according to the listed standards. While quantitative acceptance criteria (e.g., specific error margins for blood pressure measurements) are not explicitly stated in the provided text, the reference to these standards implies that the device achieved compliance with their respective requirements.

Acceptance Criterion (via Standard Adherence)	Reported Device Performance
ANSI/AAMI SP10 (Blood Pressure Accuracy)	Passed satisfactorily
EN 60601-2-30 (Blood Pressure Monitors)	Passed satisfactorily
EN 1060-1 (Non-invasive sphygmomanometers)	Passed satisfactorily
EN 1060-3 (Non-invasive sphygmomanometers - Electro-mechanical blood pressure measuring systems)	Passed satisfactorily
ISO 9919 (Pulse Oximeters - Medical Electrical Equipment)	Passed satisfactorily
EN 60601-1 (General Requirements for Basic Safety and Essential Performance)	Passed satisfactorily
EN 60601-1-2 (Electromagnetic Compatibility)	Passed satisfactorily
International Test Protocol for validation of blood pressure measuring devices in adults" of the European Society of Hypertension	Passed satisfactorily

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

The document does not explicitly state the sample size (number of patients) used for the clinical test set. The provenance of the data is implied to be clinical studies conducted in adherence to international standards. The country of origin of the data is not specified directly, but the device manufacturer is SCHILLER AG in Switzerland, and the standards are international (ANSI/AAMI, EN, ISO, European Society of Hypertension). The studies are clinical tests, and based on the context of premarket notification for a new device, they would be considered prospective in nature.

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

The document states that the measurements of the BP-200 plus were "compared with manual auscultatory measurements." This implies that human experts (e.g., trained medical professionals) performed the manual auscultatory measurements, which served as the ground truth. However, the number of experts, their qualifications, or any specific details about the individuals establishing the ground truth are not provided.

4. Adjudication Method for the Test Set

The document indicates that the BP-200 plus measurements were "compared with manual auscultatory measurements." This likely means that the manual measurements served as the reference standard. However, the specific adjudication method (e.g., if multiple human readers took manual measurements and how discrepancies were resolved, such as 2+1, 3+1, or none) is not described.

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

A MRMC comparative effectiveness study, particularly one involving AI assistance, is not described in the provided text. The device is a blood pressure monitor, not an AI-assisted diagnostic tool for image interpretation or similar tasks that would typically involve MRMC studies in this context. The comparison is between the device's automated measurements and traditional manual measurements.

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

Yes, the primary clinical test described is a standalone performance evaluation of the BP-200 plus device. The device's measurements (algorithm only, as it's an automated monitor) are compared against the gold standard of manual auscultatory measurements. There is no indication of a human-in-the-loop interaction where an operator's performance is 'assisted' by the device in the way an AI would assist a radiologist.

7. The Type of Ground Truth Used

The ground truth used for the clinical tests was manual auscultatory measurements. This is a well-established clinical standard for blood pressure measurement.

8. The Sample Size for the Training Set

The document does not provide information about a separate "training set" or its sample size. As this device is a medical monitoring instrument and not an AI/machine learning algorithm that requires extensive data for model training in the conventional sense, the concept of a training set as understood in AI/ML is not directly applicable. The device's internal algorithms and calibration would have been developed and refined through engineering and validation processes, but these details are not specified as a "training set" in this context.

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

Since a "training set" in the context of AI/ML is not mentioned or implied for this device, information on how its ground truth was established is not applicable/provided. The development and calibration of the device's algorithms would have relied on engineering principles and potentially internal testing, but not explicitly on an external "training set" with established ground truth as described for AI models.

Summary

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Image /page/0/Picture/2 description: The image shows the word "SCHILLER" in large, bold, black letters. Below the word is a horizontal line, and below the line is the word "SWITZERLAND" in smaller, black letters. The text appears to be a logo or brand name.

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Submitter Information

Name:	SCHILLER AG
Adress:	Altgasse 68P.O. BoxCh-6341 BaarSwitzerland
Telephone:	+41-41-766 42 52
Contact Person:	Reto KuetelAltgasse 68P.O. Box

Ch-6341 Baar Switzerland +41-41-766 42 52 MAR 0 7 2007

Name of Device

Trade Name:	SCHILLER BP-200 plus
Common Name:	Automated Non-Invasive Blood Pressure Monitor Systemwith Oxygen Saturation Measurement as an option
Classification Name:	System, measurement, blood pressure, non-invasive
Product Code:	DXN
Regulatory Class:	Class II (two)
Regulation Number:	21 CFR 870.1130

Legally-marketed predicate devices

Tango +, K053209, SunTech Medical Instruments Inc.

The SCHILLER BP-200 plus is substantially equivalent to the above mentioned device.

The following modules are used as an option:

Oximeter: Masimo SET 2000 Oximeter Kagoa66 . ECG Amplifier: SCHILLER Microvit MT-100 K973735 .
K012226
QRS Trigger: SCHILLER ARGUS PB-1000 �

Description

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SCHILLER

SWITZERLAND

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Intended Use

The BP-200 plus is intended to be used as an adjunct to exercise stress testing devices. It is intended to measure and display diastolic and systolic blood pressure, heart rate, percentage of oxygen saturation in arterial blood (SpO2) and pulse rate in adult or adolescent patients during stress tests. The BP-200 plus can be used for patients of both sexes and all races. The BP-200 plus should not be used with neonates.

Performance Data

Non-clinical tests:

The BP-200 plus has passed the tests according to the following standards:

ANSI/AAMI SP10 .
EN 60601-1
EN 60601-1-2
EN 60601-2-30 .
EN 1060-1
EN 1060-3
150 9919 .

Clinical tests:

To verify the overall system efficiency the measurments of BP-200 plus are compared with manual auscultatory measurements as discribed in the ANSI/AAMI SP10 and the EN 60601-2-30. For the same reason the "International Test Protocol for validation of blood pressure measuring devices in adults" of the European Society of Hypertension has been carried out.

The BP-200 plus has satisfactory passed all tests.

Conclusion

The results of the above mentioned tests demonstrates that the BP-200 plus is equivalent in safety and efficiancy to the legally-marketed predicate devices.

007

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 0 7 2007

Schiller AG c/o Reto Kuettel Altgasse 68 Baar, ZG SWITZERLAND 6341

Re: K063814

Trade Name: BP 200 Plus Regulation Numbers: 21 CFR 870.1130 and 21 CFR 870.2700 Regulation Names: Noninvasive Blood Pressure Measurement System, and Oximeter Regulatory Class: Class II Product Codes: DXN, DQA Dated: December 14, 2006 Received: December 22, 2006

Dear Mr. Kuettel:

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. Reto Kuettel

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 (240) 276-0120. 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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

C. R. Zalesky, MD

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): K063814

Device Name: BP-200 plus

Indications For Use:

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)

C. Mesamur
District Size: 28

510(k) Number K063814

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Regulation Number and Section

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).