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.

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 battery-powered 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 snug, 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.

AI/ML Overview

Here's a detailed breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
SpO2 ARMS ≤ 3.5% (70-100% SaO2 Range)	SpO2 ARMS = 2.56% (N=223) – Pass
Pulse Rate ARMS ≤ 3 BPM	Pulse Rate ARMS = 2.2 BPM (N=235) – Pass
HR Measurement Range: 30-230 BPM across its target range	Validated via bench testing, passed for every dataset. (Note: Clinical testing only observed 59-122 BPM).
SpO2 Display Range: 70-100%	SpO2 Display Range: 70-100%
SpO2 Resolution: 1%	SpO2 Resolution: 1%
Pulse Rate Measurement Range: 30-230 BPM	Pulse Rate Measurement Range: 30-230 BPM
Pulse Rate Resolution: 2 BPM	Pulse Rate Resolution: 2 BPM

Study Details

Based on the provided text, the primary study for the WesperO2 focused on standalone performance and did not involve a multi-reader, multi-case comparative effectiveness study with human readers.

Sample size used for the test set and the data provenance:
- Test Set Sample Size (for SpO2): N=223 (for ARMS calculation). This refers to the number of data points or observations, not necessarily the number of unique subjects.
- Test Set Sample Size (for Pulse Rate): N=235 (for ARMS calculation).
- Data Provenance: The text states the study was a clinical study. While the specific country of origin is not explicitly mentioned, it's generally understood that FDA submissions for clinical studies conducted for US market clearance are often performed in North America or under international standards recognized by the FDA. The study was conducted in accordance with ISO 80601-2-61:2019 and FDA-2007-D-0205 guidance, which outlines requirements for clinical performance in adult subjects. The study appears to be prospective as it was conducted for the validation of the WesperO2 pulse oximeter.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The ground truth for SpO2 accuracy was established by arterial blood sample CO-Oximetry. This is a direct, objective measurement from a laboratory device, not reliant on human expert interpretation.
- The ground truth for Pulse Rate accuracy was compared to a "Reference Oximeter Pulse Rate." The text does not specify how this reference oximeter's pulse rate ground truth was established, but it would typically be from a validated reference device or ECG.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Since the ground truth for SpO2 was established by CO-Oximetry and for Pulse Rate by a reference oximeter (or equivalent objective method), human adjudication was not applicable for establishing the primary ground truth.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not described. The study focused on the accuracy of the device itself (standalone performance) against objective physiological measurements. The device is a measurement tool, not an AI-assisted diagnostic aid for human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance study was conducted. The clinical study evaluated the WesperO2 pulse oximeter's accuracy in measuring SpO2 and Pulse Rate against established physiological reference methods.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- SpO2: Arterial blood sample CO-Oximetry (a direct physiological measurement).
- Pulse Rate: Reference Oximeter Pulse Rate (a measurement from a validated reference device or potentially ECG).
The sample size for the training set:
- The document does not provide information regarding the sample size of a training set. This is typical for medical device submissions that focus on the validation of a commercial product (especially hardware) rather than AI/ML models that would explicitly require a separate training dataset. The WesperO2's core technology is based on photoplethysmography (PPG) waveforms, a well-established principle in pulse oximetry. While there is software, its validation is described in terms of adherence to standards and risk analysis rather than a statistical training-testing split as seen in AI/ML performance studies.
How the ground truth for the training set was established:
- As no training set is explicitly mentioned or detailed, the method for establishing its ground truth is not provided.

Summary

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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)

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

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.

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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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Table 1: Summary of SpO2 Accuracy Results

Comparison to Reference CO-Oximetry(functional SaO2)	SpO2Range	SpO2 ARMS	ARMS Spec <3.5%
WesperO2	70-100%	2.56 (N=223)	Pass

Table 2: Summary of Pulse Rate Accuracy Data

Comparison to Reference OximeterPulse Rate	Pulse RateRange	Pulse RateARMS	ARMS Spec <3BPM
WesperO2	59-122 BPM	2.2 (N=235)	Pass

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.

Substantial Equivalence

Both devices use light absorption in the finger to measure SpO2 and Pulse Rate, and both use Red and Infra-Red as their working wavelength bands. The subject device uses reflected energy to measure absorption, while the predicate device uses transmitted energy to accomplish that. Both methods are well understood and accepted methodologies to accurately measure Sp02 and Pulse Rate.

Both devices have identical SpO2 and Pulse Rate ranges (70% - 100%, and 30BPM – 250BPM, respectively), with the subject device having a maximum resolution of 2BPM against the predicate's 1BPM resolution. This difference in resolutions is not clinically significant. The subject device has an overall Arms of 2.56%, while the predicate has an Arms of 1.88%. Both results are within the necessary acceptance criteria, making them clinically equivalent.

Both devices use silicone-based housings and are applied to the finger. The subject device is entirely contained in the fingertip unit and the predicate device attaches to a wrist-worn unit. Since both devices have biocompatible patient-contacting materials and similar form factors, they are functionally equivalent.

Both devices have capabilities to record, and display in real time, SpO2 and Pulse Rate. The subject device uses the companion mobile application via Bluetooth to achieve this, while the predicate has an on-board LCD display. The displayed measurements are the same both units perform the same function, and the subject device's software has been fully validated to meet the necessary functional requirements.

A substantial equivalence chart comparing the similarities and differences between WesperO2, and its predicate device is provided in Table 1. Differences in technology as described above do not raise new type questions of safety and effectiveness. Furthermore, clinical performance testing per ISO 80601-2-61:2019 and Pulse Oximeters - Premarket Notification Submissions [510(k)s] - Guidance for Industry and Food and Drug Administration

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O WESPER

Staff, March 4, 2013 has shown that WesperO2 successfully meets the accuracy criteria for Pulse Oximeters intended for marketing in the US.

Characteristic	Subject DeviceWesperO2	Predicate DeviceOxiband (Checkme)O2 Pulse Oximeter(K191088)	Comparison
Product Code	DQA	DQA	Same.
Class	II	II	Same.
Indications For Use	WesperO2 is a finger-worn pulse oximeterindicated for use inmeasuring, displaying,storing and transmittingfunctional oxygensaturation of arterialhemoglobin (SpO2) andpulse rate for adultpatients. It is intendedfor spot-check and/orcontinuous datacollection, and notcontinuous monitoring.It can be used in sleeplabs and home use.	The Oxiband PulseOximeter is a wristpulse oximeterindicated for use inmeasuring, displaying,storing, andtransmitting functionaloxygen saturation ofarterial hemoglobin(SpO2) and pulse ratefor adult patients. It isintended for spot-checkand/or continuous datacollection, and notcontinuous monitoring.It can be used in sleeplabs, long-term care,hospitals and homeuse.	Indications for use aresimilar between thetwo devices. Thesubject device is onlyindicated for sleeplabs and home usewhich is a subset ofthe predicate'sindications.
Intended application site	Finger	Finger	Same.
Continuous collection	Yes	Yes	Same.
Sensor formfactor	Self-contained, wirelessfinger unit	Detachable, wiredfinger unit	Both devices targetthe finger, where thedetachable design ofthe predicate does notaffect the accuracy ofthe measurement.

Table 3: Substantial Equivalence Table
Sp02measurementaccuracy	70 - 100%: Arms = 2.5670 - 80%: Arms = 3.680 - 90%: Arms = 2.0590 - 100%: Arms = 1.84	70 - 100%: Arms = 1.8870- 80%: ±3%80- 90%: ±2%90- 100%: ±2%	Both devices meet thenecessary accuracyrequirements for 70-100% and have similarerror profiles decade-by-decade, thereforethey have equivalentSpO2 measurementaccuracies.
SpO2 displayrange	70 - 100%	0 - 100%	The predicate'sextended displayrange has no practicalsignificance, as bothdevices claim thesame SpO2 range,which is the same asthe subject's displayrange. The subjectdevice's display rangeis within the range ofthe predicate device.
SpO2 resolution	1%	1%	Same.
Pulse Ratemeasurementrange	30 - 230 BPM	30 - 250 BPM	Similar.
Pulse Rateaccuracy	±3 BPM RMSE	±2 BPM or ± 2%(whichever is greater)	In the worst-casescenario, the twodevices differ in 1BPM on average,which is not clinicallysignificant.
Pulse Rateresolution	2 BPM	1 BPM	1 BPM does notconstitute a clinicallysignificant difference.
Display method	In-app via Bluetooth	On-unit OLED screen	Both devices willdisplay the same typeof live data. Bothdisplays rely onsoftware componentsto render themeasurements, andWesper performedsoftware validation ofthe integrity and real-time response of theapp display todemonstrateequivalence.
Wirelessconnectivity	Bluetooth	Bluetooth	Same.
Storage	Yes, on-probe and in-app	Yes, on-probe	Similar.
Contact duration	Up to 24h	Up to 24h	Same.

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Image /page/8/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 shaded, 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.

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Image /page/9/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. The image is clean and minimalist.

Conclusion

The information provided in this submission, in accordance with the requirements of 21 CFR 807 Subpart E, supports the conclusion that WesperO2 is substantially equivalent to the predicate device, the Oxiband (Checkme) O2 Pulse Oximeter.

Regulation Number and Section

§ 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).