wheezo WheezeRate Detector

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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 {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 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K202062 Device Name wheezo WheezeRate Detector #### Indications for Use (Describe) 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. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| Prescription Use (Part 21 CFR 801 Subpart D) |X Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 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 Officer<br>Phone: +61 491 208 783<br>Email: 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 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. #### 5. DEVICE DESCRIPION 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. {4}------------------------------------------------ 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. ## 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. {5}------------------------------------------------ | Characteristics | SonoSentry<br>(K131285) | wheezo<br>(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<br>(K131285) | wheezo<br>(K202062) | Substantial Equivalence | | | abnormal breath sounds<br>(continues adventitious<br>breath sounds /CABS) at<br>the windpipe (trachea),<br>reported as WheezeRate<br>in adults and children (2<br>years and older).<br>WheezeRate™ represents<br>the percentage of<br>abnormal breath sound<br>detected during the<br>measurement time. A<br>licensed health care<br>professional's advice is<br>required to understand<br>the meaning and<br>importance of the<br>SonoSentry™ readings. | sound (continues adventitious<br>breath sounds /CABS) at the<br>windpipe (trachea), reported as<br>WheezeRate in adults and<br>children (2 years and older). A<br>licensed health care<br>professional's advice is required<br>to understand the meaning and<br>importance of the wheezo<br>readings. | | | Target Population | Home users:<br>Adults, Children (2 years<br>and older) | Home users:<br>Adults, Children (2 years and<br>older) | Equivalent | | Anatomical Site | Trachea | Trachea | Equivalent | | Intended<br>Environment | Non-clinical (home) | Non-clinical (home) | Equivalent | | Characteristics | SonoSentry<br>(K131285) | wheezo<br>(K202062) | Substantial Equivalence | | Technological Equivalence | | | | | Description | The SonoSentry consists of: | The wheezo consists of: | | | | Acoustic (piezoelectric) contact sensor | Acoustic (microphone) contact sensor | Different<br>Differences do not affect safety or performance. | | | User interface LCD screen | Measurement displayed | Different | | | to display measurement<br>results | through the smartphone | Difference does not affect safety or performance. Patient receives<br>wheeze rate via different method. | | | User Interface proprietary<br>application which allows<br>user to record, manage and<br>display WheezeRATE™ | User Interface proprietary<br>application which allows user to<br>record, manage and display<br>WheezeRATE™ | Equivalent | | Device Operation | User places sensor on their<br>neck for 30 seconds to<br>perform a passive<br>manoeuvre. The device<br>records, analyses the lung<br>sounds and quantifies the<br>presence of wheezing. | User places sensor on their neck<br>for 30 seconds to perform a<br>passive manoeuvre. The device<br>records, analyses the lung<br>sounds and quantifies the<br>presence of wheezing. | Equivalent | | Set Up | Detector is self-contained<br>with on-board processor,<br>recording memory and<br>ambient microphone | Requires a smartphone. The<br>wheezo connects via Bluetooth<br>to the user's smartphone where<br>processing and storage are | Different<br>Difference does not affect safety or performance. | | Characteristics | SonoSentry<br>(K131285) | wheezo<br>(K202062) | Substantial Equivalence | | Data Transfer and<br>Storage | From device via USB | done. Ambient microphone is on<br>the wheezo. | Different<br>The user may lose historical data if they are not connected to internet<br>after more than 20 recordings. However, the performance and safety of<br>the wheeze measurement is not affected. | | Sensor Material | Silicone | Silicone | Equivalent | | Size | 130mm x 56mm x 33mm | 86mm x 56mm x 50mm | Different<br>Variation in size does not affect safety or performance. | | Weight | 200g (with battery)<br>103g (without battery) | 104g (with battery) | Different<br>Variation in weight does not affect safety or performance. | | Battery | Battery powered - 2AA<br>batteries (1.5v) | Built in rechargeable Lithium-ion<br>polymer battery 300mAh 3.7V,<br>1.11Wh | Different<br>Lithium battery complies with relevant international standards. Difference<br>in battery does not affect safety or performance. | | Graphical Interface<br>Unit Display | On unit | On smartphone | Different<br>The WheezeRate is available to the user. This difference does not affect<br>the safety or performance. | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ # 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 . {10}------------------------------------------------ - 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.