(151 days)
The ProBP 2400 is a non-invasive digital blood pressure device using oscillometric technique and an upper-arm blood pressure cuff to measure systolic and diastolic blood pressures, pulse rate and mean arterial pressure (MAP).
The device detects the appearance of irregular heartbeat during measurement, and gives a warning signal with the reading once the irregular heartbeat is detected.
The device can accurately measure in pregnant patients including those with known or suspected preeclampsia.
ProBP 2400 Digital Blood Pressure Device is designed to measure systolic and diastolic blood pressure, pulse rate and mean arterial pressure (MAP) of an individual by using a non-invasive technique in which one inflatable cuff is wrapped around the single upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but use two resistive pressure sensors rather than a stethoscope and mercury manometer. The sensors convert tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well known technique in the market called the "oscillometric method".
The device can accurately measure blood pressure in pregnant patients including those with known or suspected pre-eclampsia.
The device has 1x, 3x, and MANUAL measurement modes and has irregular heartbeat detection function, inflation pressure setting function, measurement intervals setting function etc.
The 1x mode is selected to perform single blood pressure measurement of patients.
The 3x mode is selected to complete a fully-automated triple measurements. Taking fewer than three measurements can be stopped by pressing the Start/Stop button.
The MANUAL mode is selected for blood pressure measurement of patients to confirm if a patient is suitable for the oscillometric method.
The provided document is a 510(k) summary for the Microlife ProBP 2400 Digital Blood Pressure Device. It discusses the device's technical specifications, intended use, and substantial equivalence to predicate devices, supported by non-clinical and clinical testing.
Here's the information requested based on the document's content:
1. Table of Acceptance Criteria and Reported Device Performance:
The document bases its acceptance on demonstrating substantial equivalence to predicate devices and adherence to relevant standards. Specific numerical acceptance criteria for BP measurement accuracy are not explicitly detailed for the ProBP 2400 itself in this summary, but rather referenced through compliance with standards and equivalence to a clinically validated predicate.
| Acceptance Criterion (Implicit based on Standards) | Reported Device Performance (via Equivalence & Standards Adherence) |
|---|---|
| Blood Pressure Measurement Accuracy (General, for non-invasive sphygmomanometers) | The device is from the technical point of view, identical to predicate device Model WatchBP Office Afib (TWIN200 AFS). The measurement algorithm remains unchanged. Complies with ANSI/AAMI ISO 81060-2 (Blood Pressure Measurement Accuracy) via clinical validation results of the predicate device. |
| Blood Pressure Measurement Accuracy in Pregnant/Preeclamptic Patients | The accuracy measurement in pregnancy and pre-eclampsia for the ProBP 2400 is from the technical point of view, identical to what is utilized in predicate device Model BP3MW1-4X(R). The clinical test report of BP3MW1-4X(R), K140572 in pregnancy and preeclampsia, is applicable. |
| Safety and Essential Performance (Electrical, Mechanical, Environmental) | Demonstrated through reliability testing (storage, operating, vibration, drop, life testing) and compliance with various IEC, AAMI/ANSI, and EN standards (IEC 60601-1, IEC 60601-1-2, AAMI/ANSI SP10, EN 1060-1, EN 1060-3, ISO 14971, AAMI/ANSI/ISO 10993-1-1, AAMI/ANSI/ISO 10993-5, AAMI/ANSI/ISO 10993-10, AAMI/ANSI/IEC 80601-2-30). No design characteristics violated requirements or resulted in safety hazards. |
| Software Validation (for Software Contained in Medical Devices and Off-The-Shelf Software) | Software validation conducted in accordance with "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (November 2005) and "Guidance for Off-The-Shelf Software Use in Medical Devices" (September 1999) for the PC-link function. |
| Irregular Heartbeat Detection Function | The device detects the appearance of irregular heartbeat during measurement and gives a warning signal. (Details of accuracy for IHD not quantified in this summary, but the function is part of the device's capabilities). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for BP Measurement Accuracy (General): Not explicitly stated for the ProBP 2400 itself, as it relies on the clinical validation of a predicate device (WatchBP Office Afib(TWIN200 AFS)) in accordance with ANSI/AAMI IEC 81060-2. The standard mandates specific minimum sample sizes per demographic group.
- Sample Size for BP Measurement Accuracy in Pregnant/Preeclamptic Patients: Not explicitly stated for the ProBP 2400 itself, as it relies on the clinical test report of predicate device Model BP3MW1-4X(R). This clinical test determined the accuracy in pregnancy and pre-eclampsia.
- Data Provenance: Not specified in this document. The manufacturer is Microlife Intellectual Property GmbH, Switzerland.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the supplied text. The document refers to compliance with standards like ANSI/AAMI IEC 81060-2, which dictates methodology for validation studies including reference measurements, but does not detail the personnel involved in establishing ground truth for the predicate device studies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the supplied text. Adjudication methods are typically part of detailed clinical study protocols, which are not fully reproduced here.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This device is a standalone blood pressure monitor and does not involve "human readers" or "AI assistance" in the context of diagnostic interpretation. Its function is to provide direct measurements.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, in essence, standalone performance was assessed through the clinical validation of its predicate devices. The device's performance, being "identical" to its predicate devices in terms of its measurement algorithm, means its standalone accuracy was established by the predicate devices adhering to standards like ANSI/AAMI IEC 81060-2. This standard focuses on the accuracy of the automated device against reference measurements, which is an assessment of its "algorithm only" performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For blood pressure measurement accuracy (general and in special populations), the ground truth in studies adhering to standards like ANSI/AAMI IEC 81060-2 is typically established by simultaneous or near-simultaneous measurements by trained observers using a reference standard (e.g., auscultatory mercury sphygmomanometer). This is a form of expert reference measurement, but not "expert consensus" in the sense of multiple experts interpreting an image.
8. The sample size for the training set:
- Not applicable / Not provided. The document describes a medical device, not an AI/Machine Learning model that would typically have a distinct "training set." The oscillometric algorithm for blood pressure measurement is a well-established technique. If any embedded software was developed using machine learning, the details are not included here. The "training" for such devices is based on established physiological models and statistical methods validated through clinical studies.
9. How the ground truth for the training set was established:
- Not applicable / Not provided. See explanation for point 8.
§ 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).