Who is the manufacturer of Wesper Lab?

Wesper, Inc. filed the 510(k) submission for Wesper Lab (K221816).

What is the FDA product code for Wesper Lab?

MNR. It is classified under 21 CFR 868.2375 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for Wesper Lab?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Wesper Lab?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Wesper Lab

K221816 · Wesper, Inc. · MNR · Mar 9, 2023 · Anesthesiology

Device Facts

Record ID	K221816
Device Name	Wesper Lab
Applicant	Wesper, Inc.
Product Code	MNR · Anesthesiology
Decision Date	Mar 9, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.2375
Device Class	Class 2

Intended Use

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 Story

Wesper Lab is a wearable digital recording system for adult sleep studies. It consists of two flexible, thin, wireless patches (thoracic and abdominal) and a mobile application. Patches use accelerometry and optical sensing to measure sleep position, respiratory effort, and airflow/pressure. The mobile app receives data via Bluetooth Low-Energy (BLE) from the patches and an external FDA-cleared pulse oximeter (for heart rate and SpO2). Data is uploaded to a secure cloud, then downloaded to a local PC where Wesper staff use a Study Output Module (SOM) to save data for physician interpretation. The device is applied by laypeople under physician/technician direction. It does not provide real-time monitoring, diagnosis, or alarms. The system benefits patients by enabling sleep data collection in home environments.

Clinical Evidence

Bench testing only. Performance testing included electrical safety (IEC 60601 series), electromagnetic compatibility, wireless coexistence (IEEE/ANSI C63.27), enclosure protection (IEC 60529), and battery safety (IEC 62133). Usability was validated per IEC 62366 and FDA human factors guidance, confirming no critical tasks.

Technological Characteristics

Wearable sensor system; thoracic/abdominal patches with optical sensors and accelerometers. Materials: biocompatible silicone-based adhesive (ISO 10993). Power: internal Li-ion battery, rechargeable via charging pad. Connectivity: BLE to mobile app, cloud-based storage. Dimensions: 3.8" L x 2.1" W x 0.23" D. Non-sterile. Software: Study Output Module (SOM) for data processing.

Indications for Use

Indicated for adult patients undergoing sleep studies in home or clinical environments to record physiological parameters for sleep apnea identification. Not for active monitoring or diagnosis; no alarms.

Regulatory Classification

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.

Predicate Devices

Wesper Lab (K203343)

Related Devices

K203343 — Wesper Lab · Wesper, Inc. · Dec 21, 2021
K220095 — ANNE Sleep · Sibel, Inc. · Jul 11, 2022
K230148 — Vlab · Dormotech Medical, Ltd. · Oct 11, 2023
K244027 — SANSA HSAT · Huxley Medical · Jan 28, 2025
K210593 — Onera Sleep Test System (Onera STS) · Onera B.V. · Apr 6, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the word "WESPER" in bold, black letters. To the left of the word is a gray circle that is partially filled in, resembling a crescent moon. The font is simple and sans-serif, giving the logo a clean and modern look. The overall composition is straightforward and emphasizes the text. #### 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) 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. | 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) | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.qov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF {3}------------------------------------------------ ## WESPER # 510(k) Summary ### 1. SUBMITTER | Company & Address: | 234 5th Avenue New York, NY 10001 516-654-4166 | |--------------------|------------------------------------------------------| | 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 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 - 2. Thoracic patch - 3. Pulse oximeter {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "WESPER" in black font. To the left of the word is a gray circle that is partially shaded. The shading gives the circle a crescent moon appearance. The font is sans-serif and appears to be a bold typeface. 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. ### 5. INDICATIONS FOR USE 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. ### 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. {5}------------------------------------------------ | | Wesper Lab (Subject) - K221816 | Wesper Lab (Predicate) - K203343 | Similarities and Differences | |------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Classification regulation | 21 CFR 868.2375 | | Same | | Product code | MNR | MNR | Same | | Intended Use | For the recording of physiological parameters from a sleeping patient. | | Same | | Indications for Use | 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. | 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 body- worn component of the system is single-use, to be discarded after its dedicated nightly application. The device does not monitor or diagnose the patient and does not issue any alarms. | Similar The indications for use for the subject device have been modified from the predicate to remove references to single use limitations. This change does not raise any different questions of safety or effectiveness. | | Intended environment(s) | Home or clinical environment | | Same | | Patient population | Adults | Same | | | Rx or OTC | Rx | Same | | | Device Type | Wearable Sensor | Same | | | Main anatomical Site | Torso | Same | | | Airflow | Indirect measurement using respiratory effort signals. | Same | | | Respiratory Efforts | Thoracic and abdominal effort based on optical sensor. | Same | | | Body Position | Solid State Accelerometer | Same | | | Body adherence method | Biocompatible double- sided silicone-based adhesive, separable | Biocompatible double- sided silicone-based adhesive, non- separable | Similar | | Display type | Visual display including LEDs and device specific visual indicators. | Same | | | Power source | Internally powered using li-ion battery | Same | | | Charging | Multiple times in patient's home or clinical environment | Once at manufacturing | Similar The difference in the charging mechanism has been tested using IEC 60601 and IEC 62133 to show that there is no change in the safety, EMC or usability risk profile of the device. | | Data storage | Internal memory and secured cloud storage | Same | | | Communication interface | Bluetooth low energy (BLE) | Same | | | Access to recorded data | Output file available to healthcare provider for review | 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 Recorded Channels | 1. Thoracic effort 2. Abdominal effort 3. Body position 4. Airflow 5. Pressure | | Same | | Internal memory | Flash memory card. Recording time 40 hours. | | Same | | Pulse oximeter | Coupled with an authorized FDA-cleared pulse oximeter to measure pulse-rate and SpO2. | | Same | | Sterility | Non-sterile | | Same | | Electrical safety | IEC 60601, IEC 62133 | IEC 60601 | Similar | | | | | The predicate device's test standards are included in the subject device's safety test profile. | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "WESPER" in a bold, sans-serif font. To the left of the word is a gray circle that is partially filled in, resembling a crescent moon. The text and the circle are the only elements in the image. The overall impression is clean and modern. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the word "WESPER" in all caps. To the left of the word is a gray circle that is partially filled in, resembling a moon. The font is sans-serif and the letters are bold. ### 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. {8}------------------------------------------------ ## 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.