(72 days)
This product is intended to measure systolic and diastolic blood pressure and pulse on upper arm of population over 12 years old in household or medical facilities. (Not suitable for neonate, pregnancy or pre-eclampsia).
Electronic blood pressure monitor is a Noninvasive Blood Pressure Measurement System that is intended to measure blood pressure through oscillation mensuration. The proposed device will automatically start to take measurements after the inflation of the cuff is finished, the results will show the systolic pressure and diastolic pressure with pulse rate. The blood pressure monitor will store the measurements automatically; The record may be revisited. It measures blood pressure and pulse rate through inflating cuff which rounding the upper arm of patients. The electronic blood pressure monitor is small, portable and used in home or medical facilities environment. It consists of two parts: main unit and cuffs. The electronic blood pressure monitor is composed of PCBA, crystal oscillator, pump, valve, enclose, and LCD. Cuffs including cuff of size 22cm32cm and cuff of size 22cm42cm.
The provided text describes the acceptance criteria and the study that proves the device (Electronic Blood Pressure Monitor models D6606US, D6607US) meets these criteria, primarily by demonstrating substantial equivalence to a predicate device (HTD6602US, K223170).
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily derived from international standards and are met by the device. The reported device performance is that it meets these standards.
| Acceptance Criteria (Standard/Parameter) | Reported Device Performance |
|---|---|
| Blood Pressure Indication Range: | |
| DIA: 30 mmHg~195mmHg | Met (Same as predicate) |
| SYS: 60 mmHg~255mmHg | Met (Same as predicate) |
| Measurement Pressure Range: | Met (Same as predicate) |
| 0 | |
| Range Accuracy: | Met (Same as predicate) |
| ±3mmHg (±0.4kPa) | |
| Measurement Pulse Range: | Met (Same as predicate) |
| 40~180 beats/min | |
| Pulse Accuracy: | Met (Same as predicate) |
| ±5% of reading value | |
| Performance Standard: | |
| ISO 81060-2 | Met (Results demonstrated predetermined acceptance criteria were fully met by the predicate device, and these results were transferred to the subject device due to identical critical components and algorithm.) |
| IEC 80601-2-30 | Met (Same as predicate) |
| Biocompatibility: | |
| ISO 10993-1, FDA Guidance | Met (Tests included Cytotoxicity, Sensitization, and Intracutaneous Reactivity. All test results were positive, implying compliance.) |
| Electrical Safety: | Met (Same as predicate - IEC60601-1) |
| IEC60601-1 | |
| EMC: | Met (Same as predicate - IEC60601-1-2) |
| IEC60601-1-2 | |
| Usability: | Met (Same as predicate - IEC 60601-1-6) |
| IEC 60601-1-6 | |
| Home Use: | Met (Same as predicate - IEC 60601-1-11) |
| IEC 60601-1-11 | |
| Alarm Systems: | Met (IEC 60601-1-8) |
| IEC 60601-1-8 | |
| Software Life Cycle: | Met (IEC 62304) |
| IEC 62304 |
2. Sample size used for the test set and the data provenance
The document states that a clinical study was performed on the predicate device (HTD6602US, K223170). The results of this study were transferred to the subject device (D6606US, D6607US) because the subject device has the same specifications, intended use, method of measurement, measurement type, critical components (e.g., air pump, sensor, cuff), and algorithm as the predicate device.
- Sample Size for Clinical Accuracy Testing: The document does not explicitly state the sample size. It only refers to "all the relevant activities were performed by designate individual(s)" as per ISO 81060-2. ISO 81060-2 specifies requirements for clinical investigation of automated non-invasive sphygmomanometers, which includes specific sample size requirements (e.g., typically at least 85 subjects with a distribution across blood pressure ranges). However, the exact number is not provided in this submission summary.
- Data Provenance: The clinical study data originates from the testing done for the predicate device K223170. The country of origin and whether it was retrospective or prospective are not specified in this document, but "clinical investigation" usually implies a prospective study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document mentions that for the clinical accuracy testing (performed on the predicate device), "all the relevant activities were performed by designate individual(s)". It does not specify the number of experts or their qualifications for establishing ground truth, but implicitly, highly qualified medical professionals/technicians are required to perform and verify measurements according to ISO 81060-2.
4. Adjudication method for the test set
The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). For blood pressure measurement studies following ISO 81060-2, ground truth is typically established by trained observers (often two) using a reference sphygmomanometer, with specific protocols for resolving discrepancies, although these details are not provided 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 MRMC Study: This device is an Electronic Blood Pressure Monitor, which is a standalone measurement device, not an AI-assisted diagnostic tool that requires human interpretation. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done as it is irrelevant for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, a standalone performance assessment was done (implicitly). The primary study cited is the clinical accuracy testing of the predicate device against ISO 81060-2. This standard evaluates the accuracy of the automated device (algorithm only) compared to a reference measurement performed by trained observers, effectively assessing its standalone performance. The results of this standalone performance were deemed acceptable for the predicate and transferred to the subject device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the clinical accuracy testing (following ISO 81060-2) is established by simultaneous or sequential measurements using a standardized reference method (e.g., mercury sphygmomanometer with trained observers) against which the automated device's readings are compared. This is a form of expert measurement/consensus in a controlled clinical setting.
8. The sample size for the training set
This information is not applicable/provided. The device is an Electronic Blood Pressure Monitor based on oscillometric measurement, not a machine learning or AI device that typically requires a "training set" in the conventional sense. The development of its algorithm would involve engineering and calibration, not statistical training on a dataset of labeled cases in the AI context.
9. How the ground truth for the training set was established
This information is not applicable/provided for the same reasons as 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).