K Number
K051368
Device Name
BR 102 PLUS BLOOD PRESSURE HOLTER SYSTEM
Manufacturer
Date Cleared
2005-08-09

(76 days)

Product Code
Regulation Number
870.1130
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 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. 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.
More Information

Not Found

No
The description mentions a "microprocessor based" device that "analysed" signals to determine blood pressure. This analysis is described as based on auscultatoric and oscillometric signals and comparison to manual measurements for validation, which are standard signal processing techniques for blood pressure monitors, not indicative of AI/ML. There is no mention of AI, ML, deep learning, neural networks, or any related terms. The performance studies focus on standard device validation against established protocols and predicate devices, not on the performance of an AI/ML algorithm.

No.
The device is used as "an aid or adjunct to diagnosis and treatment" by measuring and monitoring blood pressure. While it supports treatment by providing diagnostic information, it does not directly perform a therapeutic action.

Yes
Explanation: The "Intended Use / Indications for Use" section states that "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 phrase "aid or adjunct to diagnosis" explicitly indicates its diagnostic purpose.

No

The device description clearly outlines hardware components including a portable monitor, cuff, electrical pump, microprocessor, and batteries. While there is associated PC software, the core medical device functionality relies on the physical hardware.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
  • Device Function: The BR-102 plus is a non-invasive device that measures blood pressure directly from the patient's upper arm using physical signals (auscultatoric and oscillometric). It does not analyze samples taken from the body.
  • Intended Use: The intended use is to measure blood pressure over an extended period as an aid or adjunct to diagnosis and treatment. This is a physiological measurement, not an in vitro test.

Therefore, the BR-102 plus falls under the category of a non-invasive medical device for physiological monitoring, not an in vitro diagnostic device.

N/A

Intended Use / Indications for 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.

Product codes (comma separated list FDA assigned to the subject device)

DXN

Device 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.

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

upper arm

Indicated Patient Age Range

adult or adolescent patient, not to 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 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.

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.

Accutracker DX, K913844, Oscar 2 Model 222, K003004

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.

Not Found

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

14:10 | 14:10

Image /page/0/Picture/2 description: The image shows the word "SCHILLER" in large, bold, sans-serif font. Below the word "SCHILLER" is a horizontal line. Below the line is the word "SWITZERLAND" in a smaller, sans-serif font. The text is black on a white background.

6051368

BR-102 plus 510(k) Summary

BR-102 plus 510(k) Summary1
Submitter Information2
Name of Device2
Legally-marketed predicate devices2
Description2
Intended Use3
Performance Data3
Conclusion3

Image /page/0/Picture/6 description: The image contains the number 064. The numbers are written in a slightly slanted, handwritten style. The '0's are rounded, and the '6' and '4' are distinct and easily readable.

1

Submitter Information

Name:SCHILLER AG
Adress:Altgasse 68
P.O. Box
Ch-6341 Baar
Switzerland
Telephone:+41-41-766 42 52
Contact Person:Markus Buetler
Altgasse 68
P.O. Box
Ch-6341 Baar
Switzerland
+41-41-766 42 52

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.

2

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.

3

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is placed to the right of the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA", which is arranged in a circular fashion around the top and left side of the symbol.

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.

4

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 (800) 638-2041 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

5

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