(75 days)
No
The description focuses on standard physiological measurement techniques (Korotkoff sounds, optical sensor) and microprocessor control, with no mention of AI or ML.
No.
The device is intended to measure and display physiological parameters (blood pressure, heart rate, SpO2) which provides diagnostic/monitoring information but it does not treat or directly alleviate a medical condition.
No
The device is intended to measure and display physiological parameters (blood pressure, heart rate, SpO2, pulse rate) during stress tests, serving as an adjunct to exercise stress testing devices. It provides quantitative values of these parameters, but the text does not indicate that it interprets these measurements to diagnose a medical condition.
No
The device description explicitly mentions hardware components such as a microprocessor, electric pump, valve, measurement cuff, optical ear sensor, and external power supply. It also details power options and battery requirements, indicating it is a physical device with integrated software, not a software-only device.
Based on the provided information, the BP-200 plus is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The BP-200 plus measures physiological parameters (blood pressure, heart rate, SpO2, pulse rate) directly from the patient's body (upper arm and ear) without analyzing biological samples like blood, urine, or tissue.
- The intended use and device description clearly indicate direct patient measurement. The device uses a cuff on the arm and an ear sensor, which are external to the body and do not involve the collection or analysis of in vitro specimens.
Therefore, the BP-200 plus falls under the category of in vivo diagnostic or monitoring devices, not in vitro diagnostics.
N/A
Intended Use / Indications for 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 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.
Product codes (comma separated list FDA assigned to the subject device)
DXN, DQA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper right arm of the patient
Indicated Patient Age Range
adult or adolescent patients. The BP-200 plus should not be used with neonates.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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 68 |
| P.O. Box | |
| Ch-6341 Baar | |
| Switzerland | |
| Telephone: | +41-41-766 42 52 |
| Contact Person: | Reto Kuetel |
| Altgasse 68 | |
| P.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 System |
| with 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
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.
1
SCHILLER
SWITZERLAND
Page 2 of 2
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
2
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.
3
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
4
Indications for Use
510(k) Number (if known): K063814
Device Name: BP-200 plus
Indications For 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 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.
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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