(260 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the data being analyzed by "trained personnel" and "healthcare provider" after being downloaded to a local PC. There is no mention of automated analysis or algorithms that would suggest AI/ML.
No.
The device is described as a "digital recording device designed to be used under the direction of a physician or trained technician" that "records multiple physiological parameters from a sleeping patient for the purpose of simultaneous or subsequent display of the parameters." It "assists in the identification of sleep apnea" but "does not actively monitor or diagnose the patient and does not issue any alarms", indicating it is for diagnostic support rather than therapy.
Yes
The device assists in the identification of sleep apnea by trained personnel, which is a diagnostic purpose. It records multiple physiological parameters for the purpose of display and analysis to help identify a medical condition.
No
The device description explicitly states that the device consists of an abdominal patch, a thoracic patch, and a mobile application. The patches are described as multi-use wearable, flexible, thin, and wireless, and they leverage accelerometry and optical sensing to provide measurements. This indicates the presence of hardware components beyond just software.
Based on the provided information, the Wesper Lab device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens from the human body. The Wesper Lab device records physiological parameters directly from the patient's body (sleep position, respiratory effort, airflow/air pressure, heart rate, blood oxygen saturation). It does not analyze samples like blood, urine, or tissue.
- The intended use is for recording and displaying physiological data. The device's purpose is to collect and present data to assist trained personnel in identifying sleep apnea. It does not perform a diagnostic test on a biological sample.
- The device description focuses on sensors and data transmission. The components described are patches that measure physical parameters and a mobile application for data relay. There is no mention of reagents, assays, or laboratory procedures typically associated with IVDs.
Therefore, the Wesper Lab device falls under the category of a medical device that records physiological signals, rather than an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes
MNR
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:
-
- Abdominal patch
-
- Thoracic patch
-
- 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Torso
Indicated Patient Age Range
Adults
Intended User / Care Setting
Used under the direction of a physician or trained technician but may be applied by a layperson.
Home or clinical environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
8.2. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Wesper Lab (K203343)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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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
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
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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) |
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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:
-
- Abdominal patch
-
- Thoracic patch
-
- 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. |
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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.
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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.