wheezo is intended to detect and record abnormal breath sounds (continuous adventitious breath sounds/CABS) at the windpipe (trachea), reported as WheezeRate in adults and children (2 years and older). A licensed health care professional's advice is required to understand the meaning and importance of the wheezo readings.

Device Description

The Respiri wheezo WheezeRate Detector contains the following components (1) wheezo Sensing Device (2) wheezo App and (3) Secure cloud server. The wheezo transfers a user's breath sound data to the App using a Smart Device. The sound data is analysed in the alqorithm, which is integrated inside the App and runs on the Smart Device.

It is a hand-held, battery-operated, computer-based, pulmonary sound detector that utilises microphones to acquire, amplify, filter, record and quantify the presence of wheezing. The breath sound is transferred using Bluetooth® technology to smartphone for detection and quantification of wheeze presence, expressed as wheeze rate.

The wheezo samples breathing and ambient sounds, and streams the audio data wirelessly via Bluetooth SPP profile to a connected Smart Device Mobile App. It does not store any recorded data into persistent memory. The Mobile App, through user interaction, must perform the standard Bluetooth pairing process to the wheezo prior to use. Wheeze rate is calculated by the Mobile App using the audio data received from the sensing device. A remote device can connect to the wheezo Sensing Device via Standard Bluetooth. The device supports Bluetooth Serial Port Protocol (SPP) mode, where asynchronous serial packets are transported using Bluetooth RFCOMM protocol. When not paired, the sensing device will be in discoverable mode.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the wheezo WheezeRate Detector, based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance:

The document doesn't explicitly state quantitative acceptance criteria for "wheeze rate accuracy" for the wheezo device to be considered substantially equivalent. Instead, it relies on a comparison to a predicate device (SonoSentry) and a clinical validation study demonstrating agreement with expert assessment. The key "performance" is the detection and quantification of wheezing.

Given the information, the primary "acceptance criteria" appear to be:

Accuracy in Wheeze Rate Calculation: The wheezo's calculated wheeze rate must align with expert manual calculations.
Safety and Effectiveness: The device must not raise new questions of safety or effectiveness compared to the predicate device, despite technological differences.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Accuracy in Wheeze Rate Calculation	Validation of the wheezo device output (calculated wheeze rate) was performed by comparing it to a panel of three respiratory experts' manual calculation of the wheeze rate. The study found sufficient agreement to support substantial equivalence. (Specific quantitative metrics like sensitivity, specificity, or error rates for the wheeze rate are NOT provided in this summary.)
Safety and Effectiveness	"Performance testing, including but not limited to side comparative testing demonstrated that the new device is substantially equivalent to the predicate device with respect to safety and effectiveness." "Technological characteristics of the wheezo do not raise new or different questions in relation to safety or effectiveness."
Compliance with International Standards	Passed all testing in accordance with internal company protocols and various international standards (listed in Section 9), covering biocompatibility, risk analysis, mechanical testing, electrical safety, EMC, transport, software, and cybersecurity.

Here's the breakdown of the study details:

2. Sample size used for the test set and the data provenance:

Sample Size: 189 recordings from 56 patients and 20 healthy individuals.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the study describes "patients and healthy individuals," suggesting it was prospective data collection specifically for validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: A panel of three respiratory experts.
Qualifications of Experts: Only stated as "respiratory experts." Specific qualifications like years of experience or board certification are not provided in this summary.

4. Adjudication method for the test set:

The document states that the wheezo's calculated wheeze rate was "compared to a panel of three respiratory experts' manual calculation of the wheeze rate." It does not specify an explicit adjudication method like "2+1" or "3+1" for reaching a consensus among experts on each recording. It implies that the experts' manual calculations individually formed the ground truth against which the device was validated, rather than a single adjudicated ground truth per case.

5. 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, an MRMC comparative effectiveness study was not explicitly described. The clinical testing section refers to "Validation of the wheezo device output... compared to a panel of three respiratory experts' manual calculation of the wheeze rate." This suggests a standalone performance evaluation against expert opinion, not an evaluation of human readers using the AI device compared to human readers without it.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Yes, a standalone performance study was done. The clinical testing section explicitly describes "Validation of the wheezo device output (calculated wheeze rate)... compared to a panel of three respiratory experts' manual calculation of the wheeze rate." This is a direct measure of the algorithm's performance in calculating the WheezeRate independently.

7. The type of ground truth used:

Expert Consensus / Expert Opinion: The ground truth for the clinical validation was established by the "manual calculation of the wheeze rate" by a "panel of three respiratory experts."

8. The sample size for the training set:

Not provided. The document describes the clinical validation study but does not provide information about the training set used for the wheezo's algorithm.

9. How the ground truth for the training set was established:

Not provided. As the training set details are not included, how its ground truth was established is also not available in this summary.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 11, 2021

Respiri Limited Samaneh Sarraf Chief Research Officer Level 10/446 Collins Street Melbourne, Victoria 3000 Australia

Re: K202062

Trade/Device Name: wheezo WheezeRate Detector Regulation Number: 21 CFR 868.1900 Regulation Name: Diagnostic pulmonary-function interpretation calculator Regulatory Class: Class II Product Code: PHZ Dated: January 29, 2021 Received: February 4, 2021

Dear Samaneh Sarraf:

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 (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 ENT, 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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Indications for Use

510(k) Number (if known) K202062

Device Name wheezo WheezeRate Detector

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

|X Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

1. DATE PREPARED

Date Summary Prepared March 10, 2021

2. 510(K) OWNER AND SUBMISSION CORRESPONDENT

Submission Sponsor	Respiri Limited
Company Address	Level 10/446 Collins Street, Melbourne, Victoria, 3000 Australia
Contact Details	Samaneh Sarraf – Chief Research OfficerPhone: +61 491 208 783Email: samaneh@respiri.co

3. DEVICE IDENTIFICATION

Type of 510(k) Submission	Traditional
Trade or Proprietary Name	wheezo WheezeRate Detector
Common or Usual Name	wheezo
Regulation Number	21 CFR 868.1900
Regulation Description	Diagnostic pulmonary-function interpretation calculator
Product Code	PHZ
Classification of Device	II
Review Panel	Anesthesiology
Predicate Device	SonoSentry (K131285)

4. INDICATIONS FOR USE STATEMENT

5. DEVICE DESCRIPION

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6. SUBSTANTIAL EQUIVALENCE DISCUSSION

The wheezo is an updated version of the SonoSentry (K131285)- which is the predicate device. These devices have the same indications for use, the same intended use and utilize similar technology. The specific change to the device pertains to its ability to be used with a Smartphone.

A substantial equivalence comparison of the wheezo with the SonoSentry predicate device is shown below.

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Characteristics	SonoSentry(K131285)	wheezo(K202062)	Substantial Equivalence
General Device Information
Device Name	SonoSentry	wheezo	N/A
Device Manufacturer	iSonea, Ltd.	Respiri Limited (previously called iSonea, Ltd)	N/A
Device Image	Image: SonoSentry device	Image: wheezo device	N/A
Single Use	No	No	Equivalent
Single Patient Use	Yes	Yes	Equivalent
Sterile	No	No	Equivalent
FDA regulatory Information
Product Code	PHZ	PHZ	Equivalent
Device Class	II	II	Equivalent
Regulation No.	21 CFR 868.1900	21 CFR 868.1900	Equivalent
Clinical Equivalence
Indications for Use	SonoSentry is intended to detect and record	wheezo is intended to detect and record abnormal breath	Equivalent
Characteristics	SonoSentry(K131285)	wheezo(K202062)	Substantial Equivalence
	abnormal breath sounds(continues adventitiousbreath sounds /CABS) atthe windpipe (trachea),reported as WheezeRatein adults and children (2years and older).WheezeRate™ representsthe percentage ofabnormal breath sounddetected during themeasurement time. Alicensed health careprofessional's advice isrequired to understandthe meaning andimportance of theSonoSentry™ readings.	sound (continues adventitiousbreath sounds /CABS) at thewindpipe (trachea), reported asWheezeRate in adults andchildren (2 years and older). Alicensed health careprofessional's advice is requiredto understand the meaning andimportance of the wheezoreadings.
Target Population	Home users:Adults, Children (2 yearsand older)	Home users:Adults, Children (2 years andolder)	Equivalent
Anatomical Site	Trachea	Trachea	Equivalent
IntendedEnvironment	Non-clinical (home)	Non-clinical (home)	Equivalent
Characteristics	SonoSentry(K131285)	wheezo(K202062)	Substantial Equivalence
Technological Equivalence
Description	The SonoSentry consists of:	The wheezo consists of:
	Acoustic (piezoelectric) contact sensor	Acoustic (microphone) contact sensor	DifferentDifferences do not affect safety or performance.
	User interface LCD screen	Measurement displayed	Different
	to display measurementresults	through the smartphone	Difference does not affect safety or performance. Patient receiveswheeze rate via different method.
	User Interface proprietaryapplication which allowsuser to record, manage anddisplay WheezeRATE™	User Interface proprietaryapplication which allows user torecord, manage and displayWheezeRATE™	Equivalent
Device Operation	User places sensor on theirneck for 30 seconds toperform a passivemanoeuvre. The devicerecords, analyses the lungsounds and quantifies thepresence of wheezing.	User places sensor on their neckfor 30 seconds to perform apassive manoeuvre. The devicerecords, analyses the lungsounds and quantifies thepresence of wheezing.	Equivalent
Set Up	Detector is self-containedwith on-board processor,recording memory andambient microphone	Requires a smartphone. Thewheezo connects via Bluetoothto the user's smartphone whereprocessing and storage are	DifferentDifference does not affect safety or performance.
Characteristics	SonoSentry(K131285)	wheezo(K202062)	Substantial Equivalence
Data Transfer andStorage	From device via USB	done. Ambient microphone is onthe wheezo.	DifferentThe user may lose historical data if they are not connected to internetafter more than 20 recordings. However, the performance and safety ofthe wheeze measurement is not affected.
Sensor Material	Silicone	Silicone	Equivalent
Size	130mm x 56mm x 33mm	86mm x 56mm x 50mm	DifferentVariation in size does not affect safety or performance.
Weight	200g (with battery)103g (without battery)	104g (with battery)	DifferentVariation in weight does not affect safety or performance.
Battery	Battery powered - 2AAbatteries (1.5v)	Built in rechargeable Lithium-ionpolymer battery 300mAh 3.7V,1.11Wh	DifferentLithium battery complies with relevant international standards. Differencein battery does not affect safety or performance.
Graphical InterfaceUnit Display	On unit	On smartphone	DifferentThe WheezeRate is available to the user. This difference does not affectthe safety or performance.

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7. PERFORMANCE DATA - BENCH (NON-CLINICAL)

The wheezo WheezeRate Detector passed all testing in accordance with internal company protocols, as well as international standards shown to support substantial equivalence of the subject device. This includes:

. Accuracy Testing
Biocompatibility Testing .
- . Contact Type: Surface device
- Contact Duration: Permanent (>30 days) .
Risk Analysis including usability
Mechanical Testing ●
. Electrical Safety Testing
. Electromagnetic Compatibility Testing
Transport/Packaging Testing o
o Software and Cybersecurity
- o Moderate Level of Concern

8. CLINICAL TESTING

Validation of the wheezo device output (calculated wheeze rate, 189 recordings from 56 patients and 20 healthy individuals) compared to a panel of three respiratory experts' manual calculation of the wheeze rate.

9. STANDARDS APPLIED

. ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 60601-1 2005 and A1:2012 Medical electrical equipment Part 1: General requirements for . basic safety and essential performance
ISO 60601-1-2:2015 Medical electrical equipment Part 1-2: General requirements for basic safety . and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-1-6:2010 Medical electrical equipment Part 1-6: General requirements for basic safety . and essential performance - Collateral standard: Usability
. IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices
IEC 60601-1-11:2015 Medical electrical equipment Part 1-11: 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
IEC 62304:2004 Medical device software Software life cycle processes .

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IEC 62133-2:2017 Secondary cells and batteries 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
. ISO 14971:2012 Medical devices - Applications of risk management to medical devices
. ISO 15223-1 Medical devices - Symbols to be used with medical devices labels, labeling, and information to be supplied - Part 1: General requirements

10. SUBSTANTIAL EQUIVALENCE DISCUSSION AND CONCLUSION

Both the SonoSentry and the wheezo are 1) intended to detect and record abnormal breath sounds and report it as a WheezeRate 2) used in the same environment 3) used by the same patient population and 4) used on the same site in the body, therefore there are no substantial differences between the wheezo and the predicate device.

The performance testing, including but not limited to side comparative testing demonstrated that the new device is substantially equivalent to the predicate device with respect to safety and effectiveness.

Although the two devices have different technological characteristics, evidence demonstrates that the technological characteristics of the wheezo do not raise new or different questions in relation to safety or effectiveness.

Therefore, based on the substantial equivalence analysis described above, the wheeze ate Detector, is determined to be substantially equivalent to the iSonea SonoSentry.

Regulation Number and Section

§ 868.1900 Diagnostic pulmonary-function interpretation calculator.

(a)
Identification. A diagnostic pulmonary-function interpretation calculator is a device that interprets pulmonary study data to determine clinical significance of pulmonary-function values.(b)
Classification. Class II (performance standards).