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.

Device Description

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:

1. Abdominal patch
1. Thoracic patch
1. 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.

AI/ML Overview

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:

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."
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.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not provided.
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.
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."
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.
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.
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.

Summary

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March 9, 2023

Wesper Inc. Amir Reuveny CEO 234 5th Ave New York, New York 10001

Re: K221816

Trade/Device Name: Wesper Lab Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: MNR Dated: February 8, 2023 Received: February 8, 2023

Dear Amir Reuveny:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Rachana Visaria -S

Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K221816

Device Name Wesper Lab

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
> Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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WESPER

510(k) Summary

1. SUBMITTER

Company & Address:	234 5th AvenueNew York, NY 10001516-654-4166
Contact Person:	Amir Reuveny
Date Prepared:	11/18/2022

2. DEVICE

Name of Device:	Wesper Lab
Common or Usual Name:	Breathing frequency monitor.
Classification Name:	Breathing frequency monitor.
Regulation:	21 CFR 868.2375
Regulatory Class:	II
Product Code:	MNR

3. PREDICATE DEVICE

Wesper Lab (K203343)

4. DEVICE DESCRIPTION

The device's BLE ports connect to the following:

1. Abdominal patch
1. Thoracic patch
1. Pulse oximeter

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5. INDICATIONS FOR USE

6. COMPARISON OF INTENDED USE

Both the Wesper Lab and the predicate device have the same intended use, specifically, for the recording of physiological parameters from a sleeping patient.

7. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The subject device is substantially equivalent to the predicate device (Wesper Lab, K203343). Both devices have the same intended use and similar indications, technological characteristics and principles of operation, with two design changes introduced in the subject device:

. A charging element was added to the patch's electronic assembly, which will receive energy from a corresponding charging pad ("Wesper Charger").
. The biocompatible adhesive layer at the bottom of the patch has been made replaceable, intended to be discarded after each nightly application. The adhesive material is identical to the one used in the predicate.

A substantial equivalence chart comparing the similarities and differences between the subject and the predicate device is provided in Table 1. Any minor differences in the technological characteristics do not raise different questions of safety or effectiveness.

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	Wesper Lab(Subject) - K221816	Wesper Lab(Predicate) - K203343	Similarities andDifferences
Classificationregulation	21 CFR 868.2375		Same
Product code	MNR	MNR	Same
Intended Use	For the recording of physiological parametersfrom a sleeping patient.		Same
Indications for Use	The Wesper Lab is adigital recording devicedesigned to be usedunder the direction of aphysician or trainedtechnician but may beapplied by a layperson.Wesper Lab recordsmultiple physiologicalparameters from asleeping patient for thepurpose ofsimultaneous orsubsequent display ofthe parameters. Thedisplayed data assistsin the identification ofsleep apnea by trainedpersonnel. WesperLab is intended to beused for adult sleepstudies at home orclinical environment.The device does notactively monitor ordiagnose the patientand does not issueany alarms.	The Wesper Lab is adigital recording devicedesigned to be usedunder the direction of aphysician or trainedtechnician but may beapplied by a layperson.Wesper Lab recordsmultiple physiologicalparameters from asleeping patient for thepurpose ofsimultaneous orsubsequent display ofthe parameters. Thedisplayed data assistsin the identification ofsleep apnea by trainedpersonnel. Wesper Labis intended to be usedfor adult sleep studiesat home or clinicalenvironment. The body-worn component of thesystem is single-use, tobe discarded after itsdedicated nightlyapplication. The devicedoes not monitor ordiagnose the patientand does not issue anyalarms.	SimilarThe indications foruse for the subjectdevice have beenmodified from thepredicate toremove referencesto single uselimitations. Thischange does notraise any differentquestions of safetyor effectiveness.
Intendedenvironment(s)	Home or clinical environment		Same
Patient population	Adults	Same
Rx or OTC	Rx	Same
Device Type	Wearable Sensor	Same
Main anatomicalSite	Torso	Same
Airflow	Indirect measurement using respiratory effortsignals.	Same
Respiratory Efforts	Thoracic and abdominal effort based on opticalsensor.	Same
Body Position	Solid State Accelerometer	Same
Body adherencemethod	Biocompatible double-sided silicone-basedadhesive, separable	Biocompatible double-sided silicone-basedadhesive, non-separable	Similar
Display type	Visual display including LEDs and devicespecific visual indicators.	Same
Power source	Internally powered using li-ionbattery	Same
Charging	Multiple times inpatient's home orclinical environment	Once at manufacturing	SimilarThe difference inthe chargingmechanism hasbeen tested usingIEC 60601 andIEC 62133 toshow that there isno change in thesafety, EMC orusability riskprofile of thedevice.
Data storage	Internal memory and secured cloud storage	Same
Communicationinterface	Bluetooth low energy (BLE)	Same
Access to recordeddata	Output file available to healthcare provider forreview	Same
Device dimensions	3.8 L x 2.1 W x 0.23 D (inches, max)		Same
Biocompatibility	Biocompatible in accordance with ISO 10993		Same
Signal RecordedChannels	1. Thoracic effort2. Abdominal effort3. Body position4. Airflow5. Pressure		Same
Internal memory	Flash memory card.Recording time 40 hours.		Same
Pulse oximeter	Coupled with an authorized FDA-cleared pulseoximeter to measure pulse-rate and SpO2.		Same
Sterility	Non-sterile		Same
Electrical safety	IEC 60601, IEC 62133	IEC 60601	Similar
			The predicatedevice's teststandards areincluded in thesubject device'ssafety test profile.

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8. PERFORMANCE DATA

Wesper has performed bench testing on its device battery to establish its reusability lifetime and has provided cleaning instructions to the operator to apply between uses.

In addition, Wesper conducted comprehensive performance testing according to the following standards and guidelines:

8.1. Electrical Safety / EMC

. IEC 60601 – Medical Electrical Equipment, Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances requirements and tests
. IEC 60601 - Medical electrical equipment - Part 1-1: General requirements for safety -Collateral standard: Safety requirements for medical electrical systems
IEEE/ANSI C63.27 - Evaluation of wireless coexistence
. IEC 60529 ED. 2.2 B:2013 - Degrees of protection provided by enclosures (IP Code).
. IEC 62133 - Secondary cells containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications – Part 2: Lithium systems (2017)

Wesper Lab met all acceptance criteria.

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OWESPER

8.2. Usability / Human Factors

Wesper Lab has been assessed to have no critical tasks as established by a Use-Related Risk Analysis, confirmed by a usability study. This assessment was conducted in accordance with IEC 62366 - Medical devices - Part 1: Application of usability engineering to medical devices and FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices", issued February 2016.

CONCLUSION

The Wesper Lab (subject) and Wesper Lab (predicate, K203343) have the same intended use and similar indications, technological characteristics, and principles of operation. The technological differences between the subject and the predicate device, as described above, do not present different questions of safety or effectiveness. The data provided demonstrates that Wesper Lab is substantially equivalent to its predicate.

Regulation Number and Section

§ 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).