BR 102 PLUS BLOOD PRESSURE HOLTER SYSTEM

K051368 · Schiller AG · DXN · Aug 9, 2005 · Cardiovascular

Device Facts

• Record ID: K051368
• Device Name: BR 102 PLUS BLOOD PRESSURE HOLTER SYSTEM
• Applicant: Schiller AG
• Product Code: DXN · Cardiovascular
• Decision Date: Aug 9, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The BR-102 plus is a non-invasive ambulatory blood pressure monitor. It uses auscultatoric and oscillometric signals to measure the blood pressure of human beings, or uses purely the oscillometric signals. Systolic, mean arterial pressure and the heart rate are measured. The BR-102 plus is intended for use as an aid or adjunct to diagnosis and treatment when it is necessary to measure an adult or adolescent patient's blood pressure over an extended period of time (up to 48h). The BR-102 plus can be used for patients of both sexes and all races. The BR-102 plus should not be used with neonates.

Device Story

Portable, microprocessor-based ambulatory blood pressure monitor; worn by patient with upper arm cuff. Operates via auscultatory and oscillometric signals or purely oscillometric method; electrical pump generates cuff pressure. Measurements initiated by predetermined schedule (set by physician via MT-300 PC software) or on-demand via start key. Readings stored in device memory; downloaded to PC post-study for analysis, tabular/graphic reporting, and statistical review. Used in clinical settings or home environments under physician guidance. Provides objective blood pressure data to assist clinicians in diagnosis and treatment monitoring.

Clinical Evidence

Bench testing performed per ANSI/AAMI SP10, EN 60601-1, EN 60601-1-2, EN 60601-2-30, EN 1060-1, and EN 1060-3. Clinical validation conducted via comparison to manual auscultatory measurements per SP10 and the European Society of Hypertension International Test Protocol for validation of blood pressure measuring devices in adults. Device passed all tests.

Technological Characteristics

Portable, microprocessor-based monitor; powered by two AA NiMH rechargeable batteries. Sensing via auscultatory and oscillometric methods. Connectivity via PC interface for data download. Software-based measurement scheduling and analysis. Complies with ANSI/AAMI SP10, EN 60601-1, EN 60601-1-2, EN 60601-2-30, EN 1060-1, and EN 1060-3.

Indications for Use

Indicated for adult and adolescent patients requiring ambulatory blood pressure monitoring (systolic, diastolic, mean arterial pressure, heart rate) for up to 48 hours as an aid to diagnosis and treatment. 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

• Accutracker DX (K913844)
• Oscar 2 Model 222 (K003004)

Submission Summary (Full Text)

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6051368

# BR-102 plus 510(k) Summary

| BR-102 plus 510(k) Summary | 1 |
|------------------------------------|---|
| Submitter Information | 2 |
| Name of Device | 2 |
| Legally-marketed predicate devices | 2 |
| Description | 2 |
| Intended Use | 3 |
| Performance Data | 3 |
| Conclusion | 3 |

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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: | Markus Buetler<br>Altgasse 68<br>P.O. Box<br>Ch-6341 Baar<br>Switzerland<br>[phone] |

### Name of Device

Trade Name: BR-102 plus NIBP Holter System Common Name: Classification Name: Non-Invasive Blood Pressure Measurement System, 21 CFR §870.1130 , DXN, Class II

# Legally-marketed predicate devices

Accutracker DX, K913844, SunTech Medical Instruments Inc.

Oscar 2 Model 222, K003004, SunTech Medical Instruments Inc.

The BR-102 plus is substantially equivalent to the above mentioned devices.

# Description

The BR-102 plus is a portable, compact, lightweight, microprocessor based ambulatory blood pressure monitor. Two versions are available:

- Using auscultatoric and oscillometric signals. During cuff delfation auscultatoric and . oscillometric signals are analysed by the microprocessor to determine the blood pressure, where the oscillometric measurement is used as a backup.
- Purely oscillometric method to use the device without a microphone. The oscillometric . signals are analysed by the microprocessor to determine the blood pressure.

The device is worn or carried by the patient. The cuff is borne on the upper arm. An electrical pump inside the device generates the pressure in the cuff. The BR-102 plus is powered from two AA size recharchable NiMH batteries. The BR-102 plus initialises blood pressure measurements depending on a predetermined shedule (normally predetermined by a physician), or on demand (by using the start key). Each reading is stored in memory, allowing the physician to download all the results obtained during the study period after the study has concluded, to be analysed by the PC software. The readings are displayed on the display for a short time.

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#### BR-102 plus

**SCHILLER**

SWITZERLAND

The associated MT-300 PC software provides the setup of the system. A measurement shedule can be defined with the MT-300 program and up-loaded into the BR-102 plus. All the settings can also be made on the device. After the ambulatory blood pressure study has been completed (up to 48h) the stored readings in the BR-102 plus are downloaded to the PC using the MT-300 program. The MT-300 programm provides the data in tabular and graphic form, as well as a patient report and statistical values.

## Intended Use

The BR-102 plus is a non-invasive ambulatory blood pressure monitor. It uses auscultatoric and oscillometric signals to measure the blood pressure of human beings, or uses purely the oscillometric signals. Systolic, mean arterial pressure and the heart rate are measured. The BR-102 plus is intended for use as an aid or adjunct to diagnosis and treatment when it is necessary to measure an adult or adolescent patient's blood pressure over an extended period of time (up to 48h). The BR-102 plus can be used for patients of both sexes and all races.

The BR-102 plus should not be used with neonates.

## Performance Data

#### Non-clinical tests:

The BR-102 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 .

#### Clinical tests:

.

To verify the overall system efficiency the measurments of BR-102 plus are compared with manual auscultatory measurements as discribed in the SP10. 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 BR-102 plus has satisfactory passed all tests.

## Conclusion

The results of the above mentioned tests demonstrates that the BR-102 plus is equivalent in safety and efficiancy to the legally-marketed predicate devices.

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AUG 9 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Schiller AG, Switzerland c/o Mr. Markus Buetler Quality Assutance and Regulatory Affairs Altgassa 68 P.O Box Ch-6341 Baar Switzerland

Re: K051368

Trade/Device Name: NIBP Holter System Regulation Number: 21 CFR 870.1130 Regulation Name: Non- Invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: July 22, 2005 Received: July 29, 2005

Dear Mr. Buetler:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 3 rotty premainer is substantially equivalent (for the indications
referenced above and have determined the device is substantial in interestate for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regally manation in the Medical Device Ameral Food Drug commerce prior to May 20, 1770, the enacting with the provisions of the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of the Peder devices that have been icclassified in assessment of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval oppor and Cosment Act (Act) that to not require appro the general controls provisions of the Act. The You may, therefore, market the device, subject to the genirements for annual registration, listing of the general controls provisions of the rest labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in If your device is classified (sec above) mis existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations FD may be subject to such additional controller and the may be of 898. In addition, FDA may be found in the Ood of I sacra engerning 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 and mean Please be advised that FDA s issualles of a successions with other reguirements of the Act
that FDA has made a determination that your device complies with other worth that FDA has made a determination administered by other Federal agencies. You must or any Federal Statutes and regulations daministered of registration and listing (21)
comply with all the Act's requirements, including, but not limited to: registration and comply with an the Act 3 requirements, news 801); good manufacturing practice requirements as set CFK Part 807), labeling (21 CFR Part 820); and 1f applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (occircis or a described in your Section 510(k) I his letter will anow you to begin maneting your and equivalence of your device it a legally premarket nothcation. The PDA midning of backlessification 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 11 you desire specific advice ion your acon 276-0295. Also, please note the regulation entitled, contact the Office of Computible at (210) 215 cart 807.97). You may obtain " Misbranding by relevelec to premanter to the Act from the Division of Small other gelleral information on your responses are at its toll-free number [phone] or Manufacturers, International and Consailter of the world thindustry/support/index.html.

Sincerely yours,

Bhimmar for

Bran D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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# Indications for Use

510(k) Number (if known): K051368

Device Name: BR-102 plus

Indications For Use:

The BR-102 plus is a non-invasive ambulatory blood pressure monitor. It uses The BR-102 plus is a non invasive anialatery would pressure of human beings, auscultations and oscillometric signals. Systolic, diastolic, mean arterial pressure and or uses purely the oschildrions signaler of the intended for use as an aid or adjunct
the heart rate are measured. The BR-102 plus is intended on adolesant the nean rate are measured. The Dir Tecessary to measure an adult or adolescent.
to diagnosis and treatment when it is necessary to measure and 1958. The PR 102 t lo diagnosis and treatment when it is noodbary to time (up to 48h). The BR-102 plus pationt o broofer patients of both sexes and all races.

The BR-102 plus should not be used with neonates.

× 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)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K051368