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510(k) Data Aggregation
(66 days)
iHealth BP3L Wireless Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.
iHealth BP3L Wireless Blood Pressure Monitors are designed and manufactured according to IEC 80601-2-30.
The operational principle is based on oscillometric and silicon integrates pressure sensor technology. it can calculate the systolic and diastolic blood pressure, the measurements results can also be classified by the function of blood pressure classification indicator. If any irregular heartbeat is detected, it can be shown to the user. The new devices achieves its function by an iOS or Andriod devices.
The provided document describes the iHealth BP3L Wireless Blood Pressure Monitor and its premarket notification to the FDA. The relevant information for acceptance criteria and the study proving the device meets them is scattered across several sections.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard Reference: ISO 80601-2-30) | Reported Device Performance (iHealth BP3L) |
|---|---|
| Accuracy (Pressure): Mean difference between device measurement and reference measurement should be $\leq \pm 5$ mmHg with a standard deviation $\leq 8$ mmHg. | Pressure: $\pm 3$ mmHg (Stated "Accuracy" in paragraph 7.0 and "Range of measurement" in paragraph 7.0) |
| Accuracy (Pulse): Mean difference between device measurement and reference measurement should be $\leq\pm 5%$ | Pulse: $\pm 5%$ (Stated "Accuracy" in paragraph 7.0) |
| Cuff Pressure Range: 0 ~ 295 mmHg (Predicate device) | Cuff Pressure Range: 0 ~ 300 mmHg (Subject device) |
| Determination Range: 30 ~ 280 mmHg (Predicate device) | Determination Range: 40 ~ 260 mmHg (Subject device) |
| Operating Environment: 0~35°C, <90%RH (Predicate device) | Operating Environment: 10℃~40℃, ≤85%RH (Subject device) |
| Storage Environment: -20~55°C, <95%RH (Predicate device) | Storage Environment: -20~55°C, ≤85%RH (Subject device) |
| Software Platform: iOS (Predicate device) | Software Platform: iOS and Android (Subject device) |
Note: The document primarily references the predicate device's (BP3, K102939) specifications as benchmarks for the subject device (BP3L). The key acceptance criteria for blood pressure monitors generally stem from standards like ISO 80601-2-30, which the device conforms to according to section 9.0.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the clinical test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "Non-clinical and clinical test performed" and "The test in this submission provides demonstrates that these small differences do not raise any new questions of safety and effectiveness." (Paragraph 8.0, 10.0).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document.
4. Adjudication Method
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not done based on the document. The document describes a substantial equivalence submission to the FDA, focusing on comparing the new device (BP3L) to its predicate device (BP3) and adherence to safety standards. It does not mention any studies involving human readers or AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone performance study focused on the algorithm only, without human-in-the-loop performance, was implicitly done as part of the "Safety and performance characteristics of the test according to IEC 80601-2-30" (Paragraph 8.0). This standard would assess the device's accuracy in measuring blood pressure values independently. The accuracy figures provided ($\pm 3$ mmHg for pressure, $\pm 5%$ for pulse) are measures of the device's standalone performance.
7. Type of Ground Truth Used
The ground truth for blood pressure monitors typically involves reference measurements from a calibrated clinical device (e.g., a mercury sphygmomanometer or another validated oscillometric device) taken concurrently by trained clinical professionals. While not explicitly stated as "ground truth," the testing against standards like ISO 80601-2-30 implies comparison to such reference methods.
8. Sample Size for the Training Set
The document does not provide information on a training set sample size. This type of device (blood pressure monitor) is typically calibrated and validated through engineering tests and clinical studies (test sets) rather than deep learning-style training sets.
9. How the Ground Truth for the Training Set Was Established
As no training set is described for this type of device, the method for establishing its ground truth is not applicable and therefore not provided in the document.
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