(260 days)
The Wesper Lab is a digital recording device designed to be used under the direction of a physician or trained technician but may be applied by a layperson. Wesper Lab records multiple physiological parameters from a sleeping patient for the purpose of simultaneous or subsequent display of the parameters. The displayed data assists in the identification of sleep apnea by trained personnel. Wesper Lab is intended to be used for adult sleep studies at home or clinical environment. The device does not actively monitor or diagnose the patient and does not issue any alarms.
Wesper Lab ("the device") is a digital recording device designed to be used under the direction of a physician or trained technician but may be applied by a layperson. Wesper Lab records multiple physiological parameters from a sleeping patient for the purpose of simultaneous or subsequent display of the parameters. The displayed data assists in the identification of sleep apnea by trained personnel.
The device consists of an abdominal patch, a thoracic patch and a mobile application. The patches are multi-use wearable, flexible, thin, and wireless, and are designed to record sleep data in adult patients. Both patches are the same and differ only in their anatomical designation, which is determined by the order in which the user applies them at test setup time. The flexible fabric allows the patch to contract and expand as the patient breathes and moves during sleep.
The mobile application ("the app") resides on the patient's personal mobile device, relaying sleep data wirelessly to a secure remote storage location ("the cloud") for subsequent analysis by a healthcare professional. The app has 3 Bluetooth Low-Energy (BLE) ports, each of which receives multiple physiological channels from the patient.
The device's BLE ports connect to the following:
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- Abdominal patch
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- Thoracic patch
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- Pulse oximeter
The patches collect multiple physiological parameters related to sleep to be used by a healthcare professional. Specifically, the patches measure sleep position, respiratory effort, and airflow / air pressure. The patches leverage accelerometry and optical sensing to provide these measurements.
Data from the patches is transmitted via BLE throughout the night to the app, which uploads the data to the cloud. A third BLE port on the app connects to an FDA cleared pulse oximeter, which provides heart rate and blood oxygen saturation measurements.
The data recorded by the patches is relayed to a remote secure storage, where it will be downloaded to a local PC. Then, Wesper staff will execute the Study Output Module (SOM) and save the data locally on the desktop computer. The data is then ready for interpretation by a healthcare provider.
The provided text describes the Wesper Lab (K221816) device and its substantial equivalence to a predicate device (Wesper Lab, K203343). The information mainly focuses on justifying the substantial equivalence for FDA premarket notification. While it outlines the performance testing done for electrical safety, EMC, and usability, it does not include a detailed study proving the device meets specific acceptance criteria related to its primary function: recording physiological parameters for sleep apnea identification.
The document states: "Wesper Lab met all acceptance criteria" for Electrical Safety / EMC tests, but it does not provide acceptance criteria or performance data for the physiological parameter recording itself, nor for its utility in assisting with sleep apnea identification.
Therefore, many of the requested details cannot be extracted from the provided text.
Here is a breakdown of what can and cannot be answered based on the provided document:
Acceptance Criteria and Device Performance (Based on available information for Electrical Safety / EMC):
| Acceptance Criteria (Stated broadly for Electrical Safety/EMC) | Reported Device Performance |
|---|---|
| Compliance with IEC 60601-1-2 (EMC) | Met all acceptance criteria |
| Compliance with IEC 60601-1-1 (Safety) | Met all acceptance criteria |
| Compliance with IEEE/ANSI C63.27 (Wireless coexistence) | Met all acceptance criteria |
| Compliance with IEC 60529 (IP Code) | Met all acceptance criteria |
| Compliance with IEC 62133 (Lithium battery safety) | Met all acceptance criteria |
Note: The document does not provide specific numerical acceptance criteria or performance metrics for the primary function of recording physiological parameters relevant to sleep apnea.
Detailed Study Information:
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Sample size used for the test set and the data provenance:
- Not provided for the physiological parameter recording or sleep apnea identification assistance.
- For Electrical Safety/EMC and Usability, information on study specifics (like sample size or data provenance) is not detailed beyond "Wesper Lab met all acceptance criteria" and "confirmed by a usability study."
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not provided. The document states "The displayed data assists in the identification of sleep apnea by trained personnel," but it does not describe any study that involved experts establishing ground truth for sleep apnea identification based on the device's data.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not provided.
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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 evidence of an MRMC study or AI assistance evaluation is mentioned for this device. The device is described as a "digital recording device" that provides data to "trained personnel" for assistance in identification, not as an AI-powered diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not provided. The device is presented as a data recording device aiding human interpretation, not as a standalone algorithm for diagnosis. The document states, "The device does not actively monitor or diagnose the patient and does not issue any alarms."
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not provided for the device's primary function of assisting in sleep apnea identification. The testing detailed relates to hardware safety and usability.
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The sample size for the training set:
- Not applicable/Not provided. This device is a data acquisition system, not an AI/ML device that would typically have a "training set" in the context of diagnostic algorithms.
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How the ground truth for the training set was established:
- Not applicable/Not provided. (See point 7)
Summary of Device Functionality from the Text:
The Wesper Lab (K221816) is a digital recording device that records multiple physiological parameters (sleep position, respiratory effort, airflow/air pressure, heart rate, blood oxygen saturation via external oximeter). This data is displayed for "trained personnel" to assist in the identification of sleep apnea. The device itself does not actively monitor, diagnose, or issue alarms. The key changes from the predicate device (K203343) are the addition of a charging element and a replaceable adhesive layer for the patches. The performance data provided only confirms compliance with electrical safety, EMC, and usability standards, not the clinical performance related to sleep apnea identification. The FDA clearance is based on substantial equivalence, implying that its performance regarding physiological parameter recording is considered equivalent to the predicate, and therefore, no separate clinical performance study for that specific aspect was required for this 510(k) submission.
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).