(220 days)
Not Found
No
The summary describes a standard pulse oximeter that uses PPG waveforms to calculate SpO2 and pulse rate. There is no mention of AI, ML, or any advanced algorithms beyond standard signal processing for these measurements. The performance studies focus on standard accuracy metrics for pulse oximetry.
No.
The device is a diagnostic tool that measures and displays physiological parameters (SpO2 and pulse rate), but it does not treat or alleviate any medical condition.
Yes
Explanation: The device measures and displays functional oxygen saturation (SpO2) and pulse rate, which are physiological parameters used to assess a patient's health status. The performance studies compare the device's accuracy against recognized standards and arterial blood sample CO-Oximetry, validating its ability to provide reliable measurements that are critical for diagnosis and patient management.
No
The device description clearly states that the WesperO2 is a pulse oximeter that includes a physical probe with an electronics assembly, battery, PCB, LEDs, and a photodiode. While it has a companion mobile application, the core measurement technology is hardware-based.
Based on the provided information, the WesperO2 device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The WesperO2 device measures physiological parameters (SpO2 and pulse rate) directly from the patient's finger using optical sensing. It does not analyze blood, urine, tissue, or any other bodily fluid or substance.
- The intended use and device description clearly state it's a pulse oximeter for measuring SpO2 and pulse rate. This is a non-invasive measurement of physiological function, not an analysis of a biological specimen.
- The input imaging modality is Photoplethysmography (PPG) waveforms. This is a method of measuring changes in blood volume in the tissue, not an analysis of a specimen.
Therefore, the WesperO2 device falls under the category of a medical device that performs physiological measurements, but it is not an IVD.
N/A
Intended Use / Indications for Use
WesperO2 is a finger-worn pulse oximeter in measuring, displaying, storing and transmitting functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult patients. It is intended for spot-check and/or continuous data collection, and not continuous monitoring. It can be used in sleep labs and home use.
Product codes (comma separated list FDA assigned to the subject device)
DQA
Device Description
WesperO2 ("the device") is a pulse oximeter, meant to be worn on the finger of an adult patient over the age of 21. The device is intended for spot checking or continuous collection of functional oxygen saturation of arterial hemoglobin by way of sensing peripheral capillary perfusion ("SpO2") and Pulse Rate. It is intended to be used in the patient's home or in a sleep lab.
The device's core technology is based on collecting reflected light from the intact skin of the patient's finger to form Photoplethysmography ("PPG") waveforms. These waveforms can then be used to extract a measurement of SpO2 and Pulse Rate.
The sensing component is carried by an electronics assembly, which is comprised of a batterypowered Printed Circuit Board ("PCB"). The electronics assembly is housed inside of a soft, flexible casing, which encapsulates the entirety of the assembly, except for the actual optical front-end of the sensing component, which exposes an array, consisting of two LEDs and a photodiode. The entire assembly is referred to as "the WesperO2 probe."
The silicone housing has a "thimble-style" form factor, such that the patient can wear it on their fingertip, with the optical sensor pointed at the pad of their finger. The probe is then meant to create a snuq, yet comfortable fit to ensure consistent positioning of the optical sensor throughout the usage period.
The probe has a Bluetooth interface through which it sends SpO2 and Pulse Rate measurements to a companion mobile application ("WesperO2 app"), which resides on the patient's mobile device. The application can both record the data and display it in real-time to the patient. Recordings are saved on the mobile device and can be shared later through the application with a healthcare provider over the internet.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Reflected light from the intact skin of the patient's finger to form Photoplethysmography ("PPG") waveforms.
Anatomical Site
Finger
Indicated Patient Age Range
Adult patients. (over the age of 21)
Intended User / Care Setting
Sleep labs and home use.
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
An SpO2 accuracy comparison was conducted as part of the final validation of the WesperO2 pulse oximeter.
The study was conducted in accordance with the following standards:
- ISO 80601-2-61:2019, Medical electrical equipment Particular requirements for basic . safety and essential performance of pulse oximeter equipment
- FDA-2007-D-0205, Pulse Oximeters Premarket Notification Submissions [510(k)s] Guidance for Industry and Food and Drug Administration Staff
The objective of the study was to validate the SpO2 accuracy of the WesperO2 pulse oximeter over the range of 70-100% SaQ2 as compared to arterial blood sample CO-Oximetry. It was expected that the Accuracy Root Mean Square (ARMS) performance of the oximeter would meet the required specification of ARMS of 3.5% or less.
A secondary goal was to evaluate the Pulse Rate (PR) performance simultaneously collected over the SpO2 range covered. The PR ARMs performance of the WesperO2 pulse oximeter was expected to meet a specification of 3 Beats per Minute (BPM).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing - Bench. Validation of the Range of Heart Rate Measurement: Testing was performed to ensure that the WesperO2 pulse oximeter measures heart rate accurately over its targeted range. One heart rate measurement accuracy test was applied to three independently generated datasets. The test passed for every dataset. Based on these three successful tests. WesperO2 is validated for measuring heart rate across its target range of 30 to 230 BPM. This full range was not observed in clinical testing of the device. Therefore, bench testing was performed to supplement clinical testing in demonstrating the accuracy across the full tarqet range.
Performance Testing - Clinical. An SpO2 accuracy comparison was conducted (N=223) with ARMS of 2.56 for SpO2 range 70-100%. Pulse Rate performance (N=235) with ARMS of 2.2 for Pulse Rate range 59-122 BPM. The results of the study show that the WesperO2 pulse oximeter outperforms the ARMS specification of 3.5% for the range 70-100%. WesperO2 provides accurate PR values over the range 59-122 BPM, meeting a specification of 3 BPM. The validated pulse rate range was extended beyond the limits of clinical observation to 30-230 BPM using bench testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2 ARMS = 2.56 (N=223) for 70-100% SpO2 Range. (Passes ARMS Spec
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).
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June 10, 2022
Wesper Inc. Amir Reuveny CEO 234 5th Ave New York, New York 10001
Re: K213515
Trade/Device Name: WesperO2 Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: May 11, 2022 Received: May 12, 2022
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 (QS) 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,
Todd Courtney Assistant Director DHT1C: Division of Sleep Disordered Breathing. Respiratory and Anesthsia 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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Indications for Use
510(k) Number (if known) K213515
Device Name WesperO2
Indications for Use (Describe)
WesperO2 is a finger-worn pulse oximeter in measuring, displaying, storing and transmitting functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult patients. It is intended for spot-check and/or continuous data collection, and not continuous monitoring. It can be used in sleep labs and home use.
| 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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Image /page/3/Picture/2 description: The image shows the word "WESPER" in black font. 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 design is minimalist and professional.
Section 5. 510(k) Summary
WesperO2 Pulse Oximeter Date Prepared: October 29, 2021
Name of Device and Sponsor Information
Device Name: WesperO2 Sponsor Name: Wesper Inc. (formerly Tatch Inc.) Sponsor Address: 234 5th Ave., New York, USA, 10001 Phone: 917-841-4830 Contact Person: Amir Reuveny
Classification Name
Classification Name: Oximeter Product Code: DQA Regulation: 21 CFR 870.2700 Device Class: Class II
Predicate Device
Name: Oxiband (Checkme) O2 Pulse Oximeter K-Number: K191088 Classification Name: Oximeter Product Code: DQA Regulation: 21 CFR 870.2700 Device Class: Class II Sponsor Name: Shenzhen Viatom Technology Co., Ltd.
Indications for Use
WesperO2 is a finger-worn pulse oximeter indicated for use in measuring, displaying, storing and transmitting functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult patients. It is intended for spot-check and/or continuous data collection, and not continuous monitoring. It can be used in sleep labs and home use.
Device Description
WesperO2 ("the device") is a pulse oximeter, meant to be worn on the finger of an adult patient over the age of 21. The device is intended for spot checking or continuous collection of functional oxygen saturation of arterial hemoglobin by way of sensing peripheral capillary perfusion ("SpO2") and Pulse Rate. It is intended to be used in the patient's home or in a sleep lab.
The device's core technology is based on collecting reflected light from the intact skin of the patient's finger to form Photoplethysmography ("PPG") waveforms. These waveforms can then be used to extract a measurement of SpO2 and Pulse Rate.
4
Image /page/4/Picture/2 description: The image shows the word "WESPER" in a sans-serif font. To the left of the word is a gray circle that is partially filled in, resembling a crescent moon. The text is black and the background is white. The image is simple and clean, with a focus on the text and the circular graphic.
The sensing component is carried by an electronics assembly, which is comprised of a batterypowered Printed Circuit Board ("PCB"). The electronics assembly is housed inside of a soft, flexible casing, which encapsulates the entirety of the assembly, except for the actual optical front-end of the sensing component, which exposes an array, consisting of two LEDs and a photodiode. The entire assembly is referred to as "the WesperO2 probe."
The silicone housing has a "thimble-style" form factor, such that the patient can wear it on their fingertip, with the optical sensor pointed at the pad of their finger. The probe is then meant to create a snuq, yet comfortable fit to ensure consistent positioning of the optical sensor throughout the usage period.
The probe has a Bluetooth interface through which it sends SpO2 and Pulse Rate measurements to a companion mobile application ("WesperO2 app"), which resides on the patient's mobile device. The application can both record the data and display it in real-time to the patient. Recordings are saved on the mobile device and can be shared later through the application with a healthcare provider over the internet.
Performance Data
Software
Wesper's software development life cycle is in accordance with the following standards:
- FDA Guidance: General Principles of Software Validation, January 2002 ●
- FDA Guidance: Guidance for the Content of Premarket Submissions for Software ● Contained in Medical Devices, May 2005
- FDA Guidance: Off-The-Shelf Software Use in Medical Devices, September 2019 ●
- IEC 62304:2006+AMD1:2015 CSV, Medical Device Software Software Life-Cycle ● Processes
- ISO 14971:2019, Medical Devices Application of Risk Management to Medical Devices ●
Based on this process, Wesper has established it has a Moderate Level of Concern for its software used in the WesperO2 pulse oximeter. Therefore, Wesper has performed a detailed Risk Analysis and developed a Software Requirement Specification and Software Detailed Design which were verified and validated and shown to have full traceability back to all risk mitigations, which reduce the level of residual risk in the software to an acceptable level. Wesper has also performed Off-The-Shelf (OTS) Software validation.
In addition, Wesper has performed a full Cybersecurity Threat Analysis based on recommendations provided in FDA Guidance: "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices," October 2014.
Electromagnetic Compatibility (EMC) and Electrical Safety
The following standards were met for EMC and Electrical Safety:
- IEC 60601-1:2005+AMD 2012, 3rd Ed. Part 1: General Requirements for Basic Safety . and Essential Performance
- IEC 60601-1, Part 11:2015 General requirements for basic safety and essential ● performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
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OWESPER
- IEC 60601-1-2:2014 General requirements for basic safety and essential performance -● Collateral Standard: Electromagnetic disturbances - Requirements and tests
- ISO 80601-2-61:2017 - Particular requirements for basic safety and essential performance of pulse oximeter equipment [selected sections pertaining to safety]
- IEEE/ANSI C63.27-2017 American National Standard for Evaluation of Wireless . Coexistence
Biocompatibility
All skin-contacting materials in the WesperO2 probe have been tested to comply with ISO 10993-1 with conditions which meet Wesper's intended use of up to 24 hours at 37°C on intact skin.
Performance Testing - Bench
Validation of the Range of Heart Rate Measurement: Testing was performed to ensure that the WesperO2 pulse oximeter measures heart rate accurately over its targeted range. One heart rate measurement accuracy test was applied to three independently generated datasets. The test passed for every dataset. Based on these three successful tests. WesperO2 is validated for measuring heart rate across its target range of 30 to 230 BPM. This full range was not observed in clinical testing of the device. Therefore, bench testing was performed to supplement clinical testing in demonstrating the accuracy across the full tarqet range.
Performance Testing - Animal
No animal testing was conducted for this 510(k) submission.
Performance Testing - Clinical
An SpO2 accuracy comparison was conducted as part of the final validation of the WesperO2 pulse oximeter. The study was conducted in accordance with the following standards:
- ISO 80601-2-61:2019, Medical electrical equipment Particular requirements for basic . safety and essential performance of pulse oximeter equipment
- FDA-2007-D-0205, Pulse Oximeters Premarket Notification Submissions [510(k)s] ● Guidance for Industry and Food and Drug Administration Staff
The objective of the study was to validate the SpO2 accuracy of the WesperO2 pulse oximeter over the range of 70-100% SaQ2 as compared to arterial blood sample CO-Oximetry. It was expected that the Accuracy Root Mean Square (ARMS) performance of the oximeter would meet the required specification of ARMS of 3.5% or less.
A secondary goal was to evaluate the Pulse Rate (PR) performance simultaneously collected over the SpO2 range covered. The PR ARMs performance of the WesperO2 pulse oximeter was expected to meet a specification of 3 Beats per Minute (BPM).
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Image /page/6/Picture/2 description: The image shows the word "WESPER" in black, bold, sans-serif font. To the left of the word is a gray circle that is partially filled in, resembling a crescent moon. The word is horizontally aligned and centered.
Table 1: Summary of SpO2 Accuracy Results
| Comparison to Reference CO-Oximetry
(functional SaO2) | SpO2
Range | SpO2 ARMS | ARMS Spec