BP-200 PLUS

K063814 · Schiller AG · DXN · Mar 7, 2007 · Cardiovascular

Device Facts

• Record ID: K063814
• Device Name: BP-200 PLUS
• Applicant: Schiller AG
• Product Code: DXN · Cardiovascular
• Decision Date: Mar 7, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 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 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 Story

Microprocessor-based monitor for non-invasive blood pressure (NIBP) and oxygen saturation (SpO2) during exercise stress testing. Inputs: Korotkoff sounds via cuff for blood pressure; optical ear sensor for SpO2. Operation: Internal electric pump inflates cuff; valve controls deflation; SpO2 updated once per second. Used in clinical stress-test settings by healthcare professionals. Output: Displays systolic/diastolic blood pressure, heart rate, SpO2, and pulse rate. Assists clinicians in monitoring patient physiological status during exercise; enables automated interval or on-demand measurements. Benefits: Provides continuous/periodic hemodynamic monitoring during stress testing to assess patient response to exercise.

Clinical Evidence

Clinical validation performed comparing BP-200 plus measurements against manual auscultatory measurements per ANSI/AAMI SP10 and EN 60601-2-30 standards. Additionally, the device was validated using the International Test Protocol for validation of blood pressure measuring devices in adults (European Society of Hypertension). Results demonstrated satisfactory performance and equivalence to predicate devices.

Technological Characteristics

Microprocessor-based system. NIBP sensing via Korotkoff sounds; SpO2 sensing via optical ear sensor. Power: External supply (230/110V) or optional 4x AA rechargeable batteries. Standards: ANSI/AAMI SP10, EN 60601-1, EN 60601-1-2, EN 60601-2-30, EN 1060-1, EN 1060-3, ISO 9919. Connectivity: Integrated with stress-test systems.

Indications for Use

Indicated for adult and adolescent patients undergoing exercise stress testing. Contraindicated for neonates.

Regulatory Classification

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.

Predicate Devices

• Tango +, K053209, SunTech Medical Instruments Inc.

Reference Devices

• Masimo SET 2000 Oximeter (K012226)
• SCHILLER Microvit MT-100 (K973735)
• SCHILLER ARGUS PB-1000

Submission Summary (Full Text)

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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 68<br>P.O. Box<br>Ch-6341 Baar<br>Switzerland |
| Telephone: | [phone] |
| Contact Person: | Reto Kuetel<br>Altgasse 68<br>P.O. Box |

Ch-6341 Baar Switzerland [phone] MAR 0 7 2007

#### Name of Device

| Trade Name: | SCHILLER BP-200 plus |
|----------------------|---------------------------------------------------------------------------------------------------------|
| Common Name: | Automated Non-Invasive Blood Pressure Monitor System<br>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.

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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 [phone]. 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 [phone] or [phone] 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:

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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