(76 days)
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.
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.
Here's an analysis of the provided text to extract the requested information about the BR-102 plus NIBP Holter System's acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the BR-102 plus has "satisfactory passed all tests" according to specific standards but does not provide a table of numerical acceptance criteria or the reported device performance against those criteria. It refers to:
- Standards Met: ANSI/AAMI SP10, EN 60601-1, EN 60601-1-2, EN 60601-2-30, EN 1060-1, EN 1060-3.
- Clinical Test Protocol: "International Test Protocol for validation of blood pressure measuring devices in adults" of the European Society of Hypertension.
- Performance Claim: "The BR-102 plus has satisfactory passed all tests."
Without a direct table of acceptance criteria and performance from the document, I cannot create one as specifically requested. The document primarily asserts compliance with established standards. ANSI/AAMI SP10 and the ESH protocol contain specific accuracy requirements for blood pressure devices (e.g., mean difference and standard deviation between device and reference measurements), but these values are not explicitly stated in the provided text as the device's acceptable performance or actual performance.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the clinical test set. It mentions the "International Test Protocol for validation of blood pressure measuring devices in adults" by the European Society of Hypertension, which typically specifies sample sizes (e.g., usually 33 subjects) for validation studies, but this specific detail is not present in the provided text regarding the BR-102 plus study.
The country of origin for the data is not explicitly stated in relation to the clinical tests, but the submitter (SCHILLER AG) is located in Switzerland. The study type (retrospective or prospective) is also not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document mentions that the BR-102 plus measurements are compared with "manual auscultatory measurements as described in the SP10." The SP10 standard itself outlines requirements for expert observers (e.g., two trained observers) for auscultatory reference measurements. However, the exact number of experts used for this specific study and their qualifications (e.g., radiologist with 10 years of experience) are not explicitly stated in the provided text.
4. Adjudication Method for the Test Set
The document states that the comparison is made against "manual auscultatory measurements as described in the SP10." The SP10 standard generally prescribes comparison to two trained observers with specific disagreement criteria for valid measurements. However, the specific adjudication method (e.g., 2+1, 3+1, none) used in the BR-102 plus study, beyond referencing the SP10 method, is not explicitly detailed in the text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not conducted or reported in this document. The device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone study was performed. The clinical tests involve comparing the device's measurements (algorithm only) to a reference standard (manual auscultation). The description of the device as a "microprocessor based ambulatory blood pressure monitor" that "determines the blood pressure" indicates its standalone function without human interpretation of raw signals for diagnosis.
7. The Type of Ground Truth Used
The ground truth used for comparison in the clinical tests was manual auscultatory measurements. This is explicitly stated: "To verify the overall system efficiency the measurments of BR-102 plus are compared with manual auscultatory measurements as discribed in the SP10."
8. The Sample Size for the Training Set
The document does not provide any information regarding a training set sample size. This type of device (a blood pressure monitor) based on established measurement principles (auscultation and oscillometry) typically would not have a "training set" in the sense of a machine learning algorithm that requires extensive labelled data for supervised learning. Its algorithms are usually pre-programmed based on physiological models and engineering principles, then validated against clinical standards.
9. How the Ground Truth for the Training Set Was Established
As no training set is described or implied for this device in the context of machine learning, the question of how its ground truth was established is not applicable based on the provided text. The device's functioning is based on physical measurement principles, not a data-driven training process in the AI sense.
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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) Summary | 1 |
|---|---|
| Submitter Information | 2 |
| Name of Device | 2 |
| Legally-marketed predicate devices | 2 |
| Description | 2 |
| Intended Use | 3 |
| Performance Data | 3 |
| Conclusion | 3 |
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.
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Submitter Information
| Name: | SCHILLER AG |
|---|---|
| Adress: | Altgasse 68P.O. BoxCh-6341 BaarSwitzerland |
| Telephone: | +41-41-766 42 52 |
| Contact Person: | Markus BuetlerAltgasse 68P.O. BoxCh-6341 BaarSwitzerland+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.
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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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Image /page/3/Picture/1 description: The image contains the words "Public Health Service". The text is in a simple, sans-serif font and is left-aligned. The words are stacked on top of each other, with "Public" on the top line, "Health" on the second line, and "Service" on the third line.
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.
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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 (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
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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
§ 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).