(403 days)
No
The summary explicitly states that the device does not monitor or diagnose the patient and does not issue any alarms. It focuses on data recording and display for interpretation by a healthcare professional. There are no mentions of AI, ML, or related concepts in the description of the device's functionality or the performance studies.
No.
The device is described as a "digital recording device" that assists in the "identification of sleep apnea" by displaying physiological parameters, not by treating or preventing any condition.
No
The device description explicitly states: "The device does not monitor or diagnose the patient and does not issue any alarms." It collects data for display to assist trained personnel in identifying sleep apnea, but it does not perform the diagnosis itself.
No
The device description explicitly states that the system consists of an abdominal patch, a thoracic patch, and a mobile application. The patches are described as single-use wearable hardware components that record physiological parameters. Therefore, the device is not software-only.
Based on the provided information, the Wesper Lab device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The Wesper Lab device records physiological parameters directly from the patient's body (sleep position, respiratory effort, flow/pressure, pulse rate, blood oxygen saturation). It does not analyze blood, urine, tissue, or other bodily fluids or substances.
- The intended use is for recording physiological parameters to assist in the identification of sleep apnea. This is a diagnostic aid based on physiological measurements, not an in vitro analysis of a specimen.
- The device description focuses on wearable sensors and data transmission. This aligns with a physiological monitoring device, not an IVD.
Therefore, the Wesper Lab device falls under the category of a physiological monitoring and recording device, not 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 body-worn component of the system is single-use, to be discarded nightly application. The device does not monitor or diagnose the patient and does not issue any alarms.
Product codes
MNR
Device Description
Wesper Lab ("the device") is indicated as 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 device consists of an abdominal patch, a thoracic patch and a mobile application. The patches are single-use wearable, flexible, thin, and wireless, and are designed to record sleep data in adult patients. Both patches are identical and differ only in their anatomical designation at test setup time. The flexible fabric allows the patch to retract 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 patches collect multiple physiological parameters related to sleep to be used by a healthcare professional. Specifically, the patches measure sleep position, respiratory effort, and Wesper-Sum- Flow / Wesper-Sum-Pressure.
Data from the patches is transmitted via Bluetooth low energy (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 pulse 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
Thorax, Abdomen, Finger
Indicated Patient Age Range
Adults
Intended User / Care Setting
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)
Clinical Testing: Wesper has conducted a prospective, multi-center clinical study for Wesper Lab to demonstrate equivalence to the gold standard - in-lab, polysomnographic (PSG) tests. Wesper Lab was applied to 45 patients undergoing an attended PSG study, with both systems recording their respective signals simultaneously from the patient. Study results showed a correlation between Wesper Lab and PSG AHI of 95.1%, with a onesided lower confidence interval of 91%. The slope and intercept were not statistically different from 1 and 0, respectively. No Adverse Events or Serious Adverse Events were reported. The study had a wide, well-distributed range of age (22-76 years), race (white, black and others), BMI (19.6-56.1) and skin tone (Fitzpatrick skin tone type II-VI), as well as a balanced mix of gender (60% male).
Transit Testing: To show the packaging solution's safety in transit, Wesper tested it against ISTA 3A -Packaged- Products for Parcel Delivery System Shipments 70kg (150 lb) or Less (standard, small, flat or elongated). This procedure simulates the physical process of shipping the product through normal small parcel distribution channels, by running it through a series of steps, such as atmospheric conditioning, vibration, etc. Wesper Lab met all acceptance criteria.
Biocompatibility Testing: The biocompatibility evaluation for the Wesper Lab was conducted in accordance with the FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process," September 4, 2020, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The Wesper Lab is considered tissue contacting for less than 24 hours. The patient contacting materials of the Wesper Lab are biocompatible.
Software: Software development and testing has been performed for Wesper Lab in accordance with IEC 62304:2006+AMD1:2015 CSV, Medical Device Software - Software Life-Cycle Processes, and 'General Principles of Software Validation - Final Guidance for Industry and FDA Staff'. Additionally, cyber security risks have been assessed in accordance with the FDA Guidance 'Content of Premarket Submissions for Management of Cybersecurity in Medical Devices'. The software for this device is considered as a "moderate" level of concern, a malfunction or a latent design flaw in the software device could lead to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to minor injury.
Electrical Safety / EMC: The Wesper Lab was tested in accordance with IEC 60601 - Medical Electrical Equipment and IEC 60529 ED. 2.2 B:2013 - Degrees of protection provided by enclosures (IP Code). Wesper Lab met all acceptance criteria.
Bench Testing: Wesper's bench testing demonstrated substantial equivalence to the predicate for body position measurement. Acceptance criteria required that the devices agree to within a 45° interval for the entire range of degrees tested. The Wesper Lab met the acceptance criteria. Wesper conducted a bench test with a simulated breathing apparatus, comparing its respiratory effort sensors with the predicate's RIP technology over a range of breath frequencies amplitudes, and perturbations (ex. BMI, body hair). The test showed Wesper Lab met or exceeded the predicate's performance in detecting clinically significant breathing events. Wesper conducted integration tests, to show the integrity of its interface with the Nonin WristOx.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Study results showed a correlation between Wesper Lab and PSG AHI of 95.1%, with a onesided lower confidence interval of 91%.
Predicate Device(s)
Natus Medical Embletta MPR PG (K122516)
Reference Device(s)
Compumedics Summit IP (K040194), Dymedix Reusable Respiratory Effort Belt Model 6015 (K040605)
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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December 21, 2021
Wesper Inc. Amir Reuveny CEO 234 5th Avenue New York, New York 10001
Re: K203343
Trade/Device Name: Wesper Lab Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: MNR Dated: November 19, 2021 Received: November 23, 2021
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, 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
Indications for Use
510(k) Number (if known)
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 body-worn component of the system is single-use, to be discarded nightly application. The device does not 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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510(k) Summary
1. SUBMITTER
| Company & Address: | Wesper Inc.
234 5th Avenue
New York, NY 10001
516-654-4166 |
|--------------------|---------------------------------------------------------------------|
| Contact Person: | Amir Reuveny |
| Date Prepared: | November 11, 2020 |
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
- Natus Medical Embletta MPR PG (K122516) (Predicate Device) ●
- Compumedics Summit IP (K040194) (Reference Device)
- Dymedix Reusable Respiratory Effort Belt Model 6015 (K040605) (Reference Device) .
Neither the predicate nor reference devices have been subject to a design-related recall.
4. DEVICE DESCRIPTION
Wesper Lab ("the device") is indicated as 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 device consists of an abdominal patch, a thoracic patch and a mobile application. The patches are single-use wearable, flexible, thin, and wireless, and are designed to record sleep data in adult patients. Both patches are identical and differ only in their anatomical designation at test setup time. The flexible fabric allows the patch to retract 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 patches collect multiple physiological parameters related to sleep to be used by a healthcare professional. Specifically, the patches measure sleep position, respiratory effort, and Wesper-Sum- Flow / Wesper-Sum-Pressure.
4
Data from the patches is transmitted via Bluetooth low energy (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 pulse 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 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.
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
Recording of multiple physiological parameters from a sleeping patient for the purpose of simultaneous or subsequent display of the parameters is the technical principle for both the subject and predicate devices. The displayed data assists in the identification of sleep apnea by trained personnel. The subject and the predicate device (K122516) are based on the following similar technological elements:
- Input from respiratory effort sensors
- . Coupled with an FDA- cleared pulse oximeter
- o Currently compatible with the Nonin WristOx Model 3150 BLE
- . Body position output
- Data storage
- . Study access via file
The following technological differences exist between the subject and predicate devices:
- Both devices are placed around or on the torso area and measure respiratory effort. The predicate device records respiratory effort measurements from compatible flexible belts using Respiratory Inductance Plethysmography (RIP) or Polyvinylidene Fluoride (PVDF) sensors, while Wesper Lab records respiratory effort measurements from flexible adhesive patches.
5
- . The Wesper Lab and predicate Embletta MPR PG are similar as they measure the flow of air and its pressure. However, they differ in that the Wesper Lab does not produce a direct measurement of airflow using a nasal cannula to sense physiological flow of air as the Embletta MPR PG does.
- . The reference devices demonstrate that there are other legally marketed Class II devices that utilize an indirect assessment of airflow (K040194) and a localized measurement of respiratory effort (K040605) and that these differences between the subject and the predicate device do not raise new questions of safety and effectiveness.
- . Both the subject and predicate devices record data on the device and then transmit the data to another location. The subject device transmits the data wirelessly to a mobile phone and cloud storage, whereas the predicate device uses wireless transmission to a proprietary relay.
| Device & Predicate Device(s): | Wesper Lab
(K203343) | Embletta MPR
PG (K122516) | Similarities
and
Differences | |
|-------------------------------|--------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|------|
| Classification regulation | 21 CFR
868.2375 | 21 CFR
868.2375 | Same | |
| Product code | MNR | MNR | Same | |
| Intended Use | For the
recording of
physiological
parameters from
a sleeping
patient. | For the
recording of
physiological
parameters
from a sleeping
patient. | Same | |
| Intended environment | Home or clinical
environment | Home or
clinical
environment | Same | |
| Patient population | Adults | Adults and
pediatric | Similar;
substantially
equivalent | |
| Device Type | Wearable
Sensor | Wearable
Sensor | Same | |
| Main anatomical Site | Thorax,
Abdomen,
Finger | Head, Thorax,
Abdomen,
Finger | Similar;
substantially
equivalent | |
| Airflow | Indirect
measurement
using
respiratory
effort signals. | Direct
measurement
using
pressure
transducers and
thermistors. | Similar;
substantially
equivalent | |
| Respiratory Efforts | Thoracic and
abdominal
effort based on | Thoracic and
abdominal
effort based on | Similar;
substantially
equivalent | |
| | optical
sensor. | RIP / PVDF
sensors. | | |
| Body Position | Solid State
Accelerometer | Solid State
Accelerometer | Same | |
| Display type | Visual display
including LEDs
and device
specific visual
indicators. | Visual display
including
LEDs and
device specific
visual
indicators. | Similar;
substantially
equivalent | |
| Power source | Internally
powered using
li-ion
battery | 2 x AA
batteries,
standard
alkaline or
rechargeable | Similar;
substantially
equivalent | |
| Data storage | Internal memory
and secured
cloud storage | Internal
memory and
secured cloud
storage | Same | |
| Communication interface | Bluetooth low
energy (BLE) | Bluetooth low
energy (BLE)
and USB | Similar;
substantially
equivalent | |
| Access to recorded data | Output file
downloaded to a
dedicated PC. | Output file
downloaded to
a dedicated PC. | Same | |
| Device dimensions | 3.8 L x 2.1 W x
0.23 D | 3.9 L x 2.8 W
x 0.4 D | Similar;
substantially
equivalent | |
| Biocompatibility | Biocompatible
in accordance
with ISO 10993 | Biocompatible
in accordance
with ISO
10993 | Same | |
| Signal Recorded Channels | 1. Thoracic
effort
2. Abdominal
effort
3. Body position
4. Airflow
5. Pressure | 1. Gravity
2. Thoracic
effort
3. Abdominal
effort
4. Body
position
5. Airflow
6. Pressure
7. Sound
8. Bipolar ExG | Similar;
substantially
equivalent | |
| Pulse oximeter | Coupled with an
authorized
FDA-cleared
pulse oximeter | Coupled with
an authorized
FDA-cleared
pulse oximeter | Same | |
| | | to
measure pulse-
rate and SpO2. | to
measure pulse-
rate and SpO2. | |
| | Sterility | Non-sterile | Non-sterile | Same |
| | Electrical safety | IEC 60601 | IEC 60601 | Same |
Below is a table containing a comprehensive comparison of the subject and predicate devices:
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7
8. PERFORMANCE DATA
8.1 Transit Testing
To show the packaging solution's safety in transit, Wesper tested it against ISTA 3A -Packaged- Products for Parcel Delivery System Shipments 70kg (150 lb) or Less (standard, small, flat or elongated). This procedure simulates the physical process of shipping the product through normal small parcel distribution channels, by running it through a series of steps, such as atmospheric conditioning, vibration, etc. Wesper Lab met all acceptance criteria.
8.2. Biocompatibility Testinq
The biocompatibility evaluation for the Wesper Lab was conducted in accordance with the FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process," September 4, 2020, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The Wesper Lab is considered tissue contacting for less than 24 hours. The patient contacting materials of the Wesper Lab are biocompatible.
8.3 Software
Software development and testing has been performed for Wesper Lab in accordance with IEC 62304:2006+AMD1:2015 CSV, Medical Device Software - Software Life-Cycle Processes, and 'General Principles of Software Validation - Final Guidance for Industry and FDA Staff'. Additionally, cyber security risks have been assessed in accordance with the FDA Guidance 'Content of Premarket Submissions for Management of Cybersecurity in Medical Devices'. The software for this device is considered as a "moderate" level of concern, a malfunction or a latent design flaw in the software device could lead to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to minor injury.
8.4. Electrical Safety / EMC
The Wesper Lab was tested in accordance with IEC 60601 - Medical Electrical Equipment and IEC 60529 ED. 2.2 B:2013 - Degrees of protection provided by enclosures (IP Code). Wesper Lab met all acceptance criteria.
8.5. Bench Testing
Wesper's bench testing demonstrated substantial equivalence to the predicate for body position measurement. Acceptance criteria required that the devices agree to within a 45° interval for the entire range of degrees tested. The Wesper Lab met the acceptance criteria. Wesper conducted a bench test with a simulated breathing apparatus, comparing its respiratory effort sensors with the predicate's RIP technology over a range of breath frequencies amplitudes, and
8
perturbations (ex. BMI, body hair). The test showed Wesper Lab met or exceeded the predicate's performance in detecting clinically significant breathing events. Wesper conducted integration tests, to show the integrity of its interface with the Nonin WristOx.
8.4. Clinical Testing
Wesper has conducted a prospective, multi-center clinical study for Wesper Lab to demonstrate equivalence to the gold standard - in-lab, polysomnographic (PSG) tests. Wesper Lab was applied to 45 patients undergoing an attended PSG study, with both systems recording their respective signals simultaneously from the patient. Study results showed a correlation between Wesper Lab and PSG AHI of 95.1%, with a onesided lower confidence interval of 91%. The slope and intercept were not statistically different from 1 and 0, respectively. No Adverse Events or Serious Adverse Events were reported. The study had a wide, well-distributed range of age (22-76 years), race (white, black and others), BMI (19.6-56.1) and skin tone (Fitzpatrick skin tone type II-VI), as well as a balanced mix of gender (60% male).
9. CONCLUSION
The Wesper Lab and Embletta MPR PG have the same intended use and similar indications, technological characteristics and principles of operation. The technological differences between the Wesper Lab and the predicate device, as described above, do not present different questions of safety or effectiveness. Where differences exist, reference devices have been utilized that further demonstrate that there are no different questions of safety and effectiveness for the Wesper Lab.
The data provided in this 510(k) Premarket Notification support substantial equivalence of the Wesper Lab and Embletta MPR PG.