(148 days)
The BB-613 WP is a wrist-worn or skin attached device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO₂) and pulse rate.
The BB-613WP can also track changes in blood pressure based on Pulse Wave Transit Time (PWTT) which is obtained utilizing pulse measurements from the integrated SpO2 sensor, following a calibration process using oscillometric blood pressure monitor.
The BB-613WP is intended for spot-checking of adult patients in hospitals, clinics, long-term care, and home use.
The BB-613WP consists of a light source (LEDs) and sensor array on the backside of the device. The device is available in two versions, a watch version and an adhesive patch version. The LEDs transmit light into the subject's skin and part of this light is reflected from the tissue and detected by a photo-diode. The integrated display is used to display the blood saturation, pulse rate results and changes in blood pressure following calibration. These results are displayed on the LCD screen for the watch version and/or displayed on a mobile application installed on the user's phone. The display also shows symbols that show if there was no signal as well as well as battery status.
I am unable to provide a detailed table of acceptance criteria and reported device performance for blood pressure measurement, as the provided text doesn't contain a specific table or detailed numerical results for blood pressure accuracy from the clinical studies. The text only states that the device "achieved the requirements of the ISO 81060-2:2013 and accurately displayed blood pressure" and lists an accuracy of "±5 mmHg" in the comparison table, but doesn't specify if this is a mean absolute difference (MAD) or part of a defined acceptance criteria.
However, I can extract the available information from the provided text for other aspects of your request.
Analysis of Acceptance Criteria and Study Details for BioBeat Technologies Ltd.'s BB-613 WP (K190792)
Based on the provided 510(k) summary, the BB-613 WP is a wrist-worn or skin-attached device that measures and displays functional oxygen saturation of arterial hemoglobin (%SpO2), pulse rate, and tracks changes in blood pressure based on Pulse Wave Transit Time (PWTT).
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Stated or Implied) | Reported Device Performance | Notes |
|---|---|---|---|
| SpO2 Accuracy | ±2% (Implied by comparison to predicate K181006) | Not explicitly stated for BB-6613WP, but claimed to be derived from K181006 performance as the algorithm is the same. K181006 SpO2 accuracy: ±2%. | The text states: "The device contains the same sensor unit and uses the same algorithm to compute SpO2 and pulse rate. Therefore, the SpO2 and pulse rate testing submitted in K181006 remains applicable to both models of the subject device." |
| Heart Rate (HR) Accuracy | ±3% (Implied by comparison to predicate K181006) | Not explicitly stated for BB-6613WP, but claimed to be derived from K181006 performance as the algorithm is the same. K181006 HR accuracy: ±3%. | Same as SpO2, performance is based on the predicate device due to identical sensor and algorithm. |
| Blood Pressure (BP) Accuracy (tracking changes) | "achieved the requirements of the ISO 81060-2:2013" and "accurately displayed blood pressure." (Specific numerical criteria of this ISO standard are not provided in the document, but typically involve mean difference and standard deviation). A comparison table lists "±5 mmHg" for accuracy. | "achieved the requirements of the ISO 81060-2:2013 and accurately displayed blood pressure." The comparative table lists "±5 mmHg" for accuracy of blood pressure. Specific statistical results (e.g., mean difference, standard deviation per ISO 81060-2:2013) are not detailed in this summary. | The ±5 mmHg value in the comparison table is likely the criterion they aimed to meet as per the ISO standard, rather than a specific reported result from the study. The phrasing in the performance data section confirms compliance with the standard without providing exact numerical results. |
| Software Validation | Compliance with FDA guidance | Performed | |
| EMC Testing | Compliance with IEC 60601-1-2:2014 | Performed | EMC testing unique to activated Bluetooth feature was also performed. |
| Biocompatibility | Cytotoxicity, sensitization, and irritation per ISO 10993 | Performed | |
| Safety Events | Absence of safety events during studies (Implied) | "during the studies, there were no safety events, showing the BB-613WP to be a safe device for use." |
2. Sample Size Used for the Test Set and Data Provenance
- SpO2 and Pulse Rate: The summary states that the SpO2 and pulse rate testing submitted for the predicate device (BB-613, K181006) remains applicable. Therefore, the sample size and data provenance for these parameters would be from the K181006 submission, which is not detailed in the provided document.
- Blood Pressure (PWTT):
- Clinical Tests: Conducted per ISO 80601-2:2013. The sample size for this clinical validation is not explicitly stated in the provided document.
- Animal Tests: An animal model study was performed in a swine model to evaluate the efficacy of the BB-613WP to detect blood pressure. The specific number of animals is not stated.
- Data Provenance (Clinical): The document does not specify the country of origin of the clinical data nor whether it was retrospective or prospective. It just states "Clinical validations of blood pressure per ISO 80601-2:2013 were performed."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- SpO2 and Pulse Rate: Ground truth related to the predicate device, not detailed here.
- Blood Pressure (PWTT):
- Clinical Tests: Not explicitly stated how the ground truth was established beyond referencing "reference devices" and compliance with ISO 81060-2:2013. The ISO standard itself outlines requirements for comparing a non-invasive blood pressure monitor to a reference measurement (often invasive arterial pressure or another validated non-invasive device). It doesn't mention expert consensus for establishing ground truth directly but relies on established measurement methods.
- Animal Tests: Gold standard device was used for systolic and diastolic blood pressure measurements. No mention of human experts for ground truth establishment.
4. Adjudication Method (for the test set)
- SpO2, Pulse Rate, Blood Pressure: No adjudication method is described in the provided text for any of the performance studies.
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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described for this device. This device is a measurement device, not an AI-assisted diagnostic imaging tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, for the blood pressure measurement, the clinical validation and animal tests assess the standalone performance of the device's algorithm in measuring or tracking blood pressure changes against a reference standard. The device "accurately displayed blood pressure" and results were compared between "reference devices" and the BB-613WP.
7. The type of ground truth used
- SpO2 and Pulse Rate: Not explicitly stated for BB-613WP, relies on predicate. Typically, oximetry ground truth in clinical studies involves arterial blood gas analysis for SpO2.
- Blood Pressure (PWTT):
- Clinical Tests: Comparison to "reference devices" as per ISO 81060-2:2013. This typically involves validated oscillometric blood pressure monitors or, less commonly for this type of device, invasive arterial pressure. The method for establishing ground truth is not explicitly stated as expert consensus, pathology, or outcomes data, but rather a comparison to established measurement techniques outlined in the ISO standard.
- Animal Tests: Comparison to a "gold standard device" for systolic and diastolic blood pressure measurement.
8. The sample size for the training set
- The document does not provide any information regarding a training set size. This suggests that the blood pressure algorithm might have been developed and internally validated using data not specified in this public summary, or the algorithm development process was not detailed as part of this 510(k) submission. For SpO2 and HR, the algorithms are reused from a previous device.
9. How the ground truth for the training set was established
- As no information on a training set or its sample size is provided, there is no information on how ground truth for a training set was established.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).