(113 days)
The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 6 inches to 8 inches (15.0 cm to 20.5 cm).
The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.
The Omron HEM-6400T-Z Wrist Blood Pressure Monitor is a battery- powered automatic non-invasive blood pressure system intended for home use. The device is powered by a rechargeable lithium-polymer battery. There is no connection to external power. The device inflates a wrist cuff with an integral pump, then deflates the cuff via an electric valve. During inflation, the wrist cuff pressure is monitored and pulse waveform data is extracted. The extracted pulse waveform data is then analyzed by software which determines pulse rate, as well as systolic and diastolic blood pressure. The systolic and diastolic blood pressures are measured using the oscillometric method. The cuff pressure range is 0 to 299mmHg and the pulse rate range is 30 to 199 beats/min.
HEM-6400T-Z is intended for use in adult patient population with wrist circumference ranging from 6 inches to 8 inches (15.0 cm to 20.5 cm). The device also detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings. The device displays the latest blood pressure reading, while up to 100 readings can be stored in memory. In addition, the device includes an Advanced Positioning Sensor (APS) as an aid to the user to determine if the wrist cuff is at the correct height in relation to the heart. It makes this determination based on the reading of an accelerometer (to measure the angle of the arm in relation to the table) integral to the device. The APS feature is similar to the predicate device. The operation of the device is intended for home use. Functions and other features that are controlled by the end user include applying the wrist cuff to the wrist, powering on/off the system, starting or stopping the BP and pulse measurement cycle, and charging the batteries as needed. As an optional feature, the user can also pair the HEM-6400T-Z to a smartphone when employing the "Omron connect" app. This app is an optional feature and is only intended to display trend graphs of measured systolic and diastolic blood pressure, and pulse rate. This app does not provide any diagnostic or measurement functions, and does not interpret or analyze the data for medical decision making. Unlimited readings can be stored in the app for archiving and review by the user. Aside from this optional app for smartphones, HEM-6400T-Z does not connect with other collateral devices.
The document relates to the 510(k) premarket notification for the Omron HEM-6400T-Z Wrist Blood Pressure Monitor. The primary study presented is a clinical investigation to validate the accuracy of blood pressure measurements.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria (Standard) | Reported Device Performance (Omron HEM-6400T-Z) |
|---|---|---|
| Blood Pressure Accuracy | Within ±3mmHg | Performed equivalently to the auscultation method (details of deviation not explicitly provided, but compliance with standard expected) |
| Pulse Rate Accuracy | Within ±5% of reading | Not explicitly stated in the clinical testing summary, but "Performance characteristics related to BP measurement and pulse rate are comparable between the two devices" implies it meets the predicate's ±5% criteria. |
| Measurement Method | Cuff oscillometric method | Cuff oscillometric method |
| Cuff Pressure Range | 0 to 299mmHg | 0 to 299mmHg |
| Pulse Rate Range | 30 to 199 beats/min | 30 to 199 beats/min (predicate was 40 to 180 beats/min, but this difference was deemed not to impact safety or effectiveness) |
| Wrist Circumference | 6 to 8 inches (15.0 cm to 20.5 cm) | 6 to 8 inches (15.0 cm to 20.5 cm) (predicate accommodated 13.5cm to 21.5cm, difference deemed minor) |
| Irregular Heartbeat Detection | Yes | Yes |
| Body Movement Detection | Yes | Yes |
| Biocompatibility | ISO 10993-1 requirements | Met ISO 10993-1 requirements |
| Electrical Safety, EMC, ESD | Relevant standards | Met relevant standards |
| Software Verification & Validation | Relevant standards | Performed |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Clinical Investigation): Not explicitly stated in the provided text. The document mentions "A clinical investigation was conducted," but does not specify the number of subjects.
- Data Provenance: Not specified. The document does not indicate the country of origin or whether the study was retrospective or prospective, though general clinical investigations for device validation are typically prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not explicitly stated. The ground truth was established using an "auscultation method using a calibrated sphygmomanometer by trained medical staff."
- Qualifications of Experts: Referred to as "trained medical staff." Specific qualifications (e.g., physician, nurse, years of experience, specialty) are not detailed.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly stated. The description mentions "auscultation method using a calibrated sphygmomanometer by trained medical staff," implying direct measurement as the ground truth, rather than an adjudication process between multiple independent readings or interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study was a clinical investigation validating the device's accuracy against a recognized measurement method, not assessing human reader improvement with or without AI assistance.
- Effect Size: Not applicable, as no MRMC study was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Yes, the clinical investigation described is a standalone performance study. It validated the accuracy of the Omron HEM-6400T-Z (an automated device operating on its own) against an auscultation method. There is no human-in-the-loop component for the device's measurement function itself; the "human" aspect is purely for establishing ground truth.
7. The Type of Ground Truth Used
- Ground Truth Type: Expert consensus from "trained medical staff" using the auscultation method with a calibrated sphygmomanometer. This is a direct measurement by trained human operators, serving as the clinical gold standard for blood pressure measurement in many validation studies.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. Wrist blood pressure monitors like the Omron HEM-6400T-Z typically use established algorithms based on oscillometric principles, which are not "trained" in the machine learning sense on a dataset but rather designed and calibrated. The document does not mention any machine learning or AI training processes that would require a training set.
9. How the Ground Truth for the Training Set Was Established
- Training Set Ground Truth: Not applicable, as there is no mention of a training set or machine learning/AI training process for this device.
§ 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).