(50 days)
HL158TA automatically measures human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method during inflation. All values can be read out in one LCD panel. Measurement position is at human being's wrist. The intended use of this over-the-counter device is for adults aged 18 years and older with wrist circumference ranging from 5.3 inches to 7.7 inches (approx.135 mm to 195 mm) and for home use.
HL158TA detects the appearance of irregular heartbeats during measurement; an indicated symbol will appear with measuring reading. And the Risk Category Indicator will show the information with the readings on the screen for the user tracking their blood pressure level.
HL158TA automatically measures human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method during inflation. All values can be read out in one LCD panel. Measurement position is at human being's wrist. The intended use of this over-the-counter device is for adults aged 18 years and older with wrist circumference ranging from 5.3 inches to 7.7 inches (approx.135 mm to 195 mm) and for home use.
The device will display a symbol ( heartbeat rhythm as defined as a rhythm is more than or less than 25% from the average heartbeat intervals during the measurement. Additionally, after measurement, the Risk Category Indicator function will show the information with the readings on the screen for the user tracking their blood pressure level.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: Full Automatic (NIBP) Blood Pressure Monitor, Model HL158TA
Predicate Device: Full Automatic (NIBP) Blood Pressure Monitor, Model HL158BT (K093824)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy (Pressure) | ± 3mmHg |
| Accuracy (Pulse) | ± 5% |
| Clinical Validation | Met required limits for mean difference and standard deviation in accordance with ISO 81060-2:2013 |
| EMC Compliance | Compliant with IEC 60601-1-2 Edition 3:2007-03 |
| Safety Compliance | Compliant with IEC 60601-1:2005, IEC 60601-1-11:2010 |
| FCC Compliance | Compliant with FCC 47 CFR Part 15, Subpart B |
| Biocompatibility | Compliant with ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2010 |
| Reliability | Compliant with IEC 80601-2-30 Edition 1.1 2013-07 |
| Risk Assessment | Compliant with ISO 14971:2007 |
| Software V&V | Compliant with IEC 62304 Ed.1.0 (2006), IEC 60601-1-4 |
| Usability Validation | Compliant with IEC 62366-1:2015, IEC 60601-1-6 |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 85 subjects for the clinical investigation (ISO 81060-2).
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It only states that the clinical investigation was performed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide information about the number of experts or their qualifications for establishing the ground truth in the clinical study. However, the ISO 81060-2 standard for non-invasive sphygmomanometers typically requires measurements by trained observers or reference devices to establish ground truth.
4. Adjudication Method for the Test Set
The document does not explicitly state the adjudication method used for the test set in the clinical study. ISO 81060-2 standards involve comparison against auscultatory blood pressure measurements, often performed by multiple trained observers to mitigate error.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The study described is a clinical validation study against a recognized standard (ISO 81060-2) for objective performance, not a study comparing human reader performance with and without AI assistance. The device is an automated blood pressure monitor, not an AI diagnostic tool that assists human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the primary clinical study described for the HL158TA is a standalone performance study of the device's accuracy in measuring blood pressure, as required by ISO 81060-2. This standard evaluates the algorithm and hardware's ability to accurately measure blood pressure independently of human interpretation of readings, although human subjects are part of the measurement process. The device provides "Full Automatic" measurements.
7. The Type of Ground Truth Used
For the clinical study (ISO 81060-2), the ground truth for blood pressure measurements is typically established through auscultatory measurements performed by trained observers using a reference sphygmomanometer. This is the standard reference method against which automated devices are validated.
8. The Sample Size for the Training Set
The document does not provide information on the sample size used for the training set. It focuses on the clinical validation (test set) for regulatory submission.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for the training set was established, as a training set is not explicitly mentioned or detailed in the regulatory submission information provided. This information is typically proprietary to the device manufacturer and not always included in 510(k) summaries, which focus on safety and effectiveness demonstration rather than development details.
§ 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).