(115 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 5 1/4 inches to 8 1/2 inches (13.5 cm to 21.5 cm). The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.
The device is an automatic non-invasive blood pressure system. The device is battery powered by 2 "AAA" batteries, there is no connection to external power. The device inflates a wrist cuff with an integral pump, then deflates the cuff via an electronically controllable valve. During inflation the 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 pressure. The algorithm used to determine pulse rate, systolic and diastolic pressure is identical to the predicate. The device has a memory function that automatically stores up to 90 of the latest measurements. It can also display an average of the last three values. The device also detects the appearance of irregular heartbeats during measurement.
Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria (from predicate/standards) | Reported Device Performance (HEM-6221) |
|---|---|---|
| Indications for Use | Measuring BP & pulse rate in adults, wrist circumference 5.25"-8.5" (13.5-21.5cm), irregular heartbeat detection. | Identical. Device is a digital monitor for measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 5 1/4 inches to 8 1/2 inches (13.5 cm to 21.5 cm) and detects irregular heartbeats. |
| Patient Population | Adult | Adult |
| Environment of Use | Home | Home |
| Accuracy of Pressure Indicator | +/- 3 mmHg (from predicate HEM-609N) | +/- 3 mmHg or 2% of reading (similar to predicate, and evaluated against ANSI/AAMI/ISO 81060-2) |
| Accuracy of Pulse Rate | +/- 5% | +/- 5% |
| Standards Compliance | IEC 60601-1, IEC 60601-1-2, AAMI SP10, ANSI/AAMI/ISO 81060-2 | Met all requirements specifications and standards requirements; testing performed for all listed standards. |
| Biocompatibility (Cuff Materials) | ISO 10993-1 and FDA Guidance (Cytotoxicity, Sensitization, Intracutaneous Reactivity) | Tested in accordance with ISO 10993-1 and FDA Guidance; included Cytotoxicity, Sensitization, and Intracutaneous Reactivity. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 85 patients (43 males and 42 females)
- Data Provenance: Not explicitly stated, but the clinical accuracy testing was conducted "in accordance with ANSI/AAMI/ISO 81060-2." This standard outlines specific requirements for clinical validation of non-invasive sphygmomanometers, which typically involves prospective data collection under controlled clinical conditions. The text does not specify the country of origin, but given it's a 510(k) submission to the FDA, it could be conducted anywhere that meets these international standards. It can be inferred as prospective due to the nature of clinical accuracy studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not explicitly stated. The method used for reference blood pressure (BP) measurement was the "Standard auscultation method." This method in clinical studies typically involves trained observers (often physicians or nurses) with certified sphygmomanometers.
- Qualifications of Experts: Not explicitly stated, but they would be expected to be qualified for the "Standard auscultation method," usually involving medical or clinical professionals trained in accurate blood pressure measurement.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly detailed. The text states that "BP measurements were repeated alternatively with the device and auscultation in the same arm according to the sequence in AAMI." This typically implies comparison against the auscultation measurements. There's no mention of a specific expert adjudication process for discrepancies beyond the direct comparison to the reference method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No. A MRMC comparative effectiveness study was not done. The study focused on the device's accuracy against a standard reference method (auscultation), not on how human readers' performance improved with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Yes. The clinical accuracy study evaluated the device's (and its embedded algorithm's) performance in measuring blood pressure and pulse rate compared to the standard auscultation method. This is a standalone performance evaluation of the device as it outputs the measurements directly.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the clinical accuracy study was established using the Standard auscultation method (reference blood pressure). This is considered a gold standard for non-invasive blood pressure measurement in clinical validation studies.
8. The Sample Size for the Training Set
- The document states that "The algorithm used to determine pulse rate, systolic and diastolic pressure is identical to the predicate." This implies that the algorithm itself was not newly trained for the HEM-6221 device but rather reused from a previously validated predicate device.
- Therefore, a training set for this specific device's algorithm development is not applicable or provided in this submission, as the algorithm was pre-existing.
9. How the Ground Truth for the Training Set was Established
- As mentioned above, the algorithm was identical to the predicate device. The document does not detail how the ground truth for the predicate's algorithm training (if any) was established. It's common for such algorithms to be developed and validated against extensive clinical datasets using reference methods like auscultation.
§ 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).