Tyto Insights for Wheeze Detection

K232237 · Tyto Care , Ltd. · PHZ · Dec 13, 2023 · Anesthesiology

Device Facts

• Record ID: K232237
• Device Name: Tyto Insights for Wheeze Detection
• Applicant: Tyto Care , Ltd.
• Product Code: PHZ · Anesthesiology
• Decision Date: Dec 13, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1900
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device, Pediatric

Intended Use

The Tyto Insights for Wheeze Detection is an over-the-counter artificial intelligence (AI) enabled decision support software system used in the evaluation of lung sounds in adults and pediatrics (2 years and older). It automatically analyzes the acoustic signal of the lung as recorded by the FDA cleared compatible Tyto Stethoscope and identifies recordings where a specific abnormal lung sound suggestive of "Wheeze" is suspected. It is not intended to detect other abnormal or normal lung sounds. A licensed health care professional's advice is required to understand the meaning of the Tyto Insights for Wheeze Detection result. Healthcare providers should consider the device result in conjunction with recording and other relevant patient data.

Device Story

Web-based AI software system; analyzes lung sound recordings from FDA-cleared Tyto Stethoscope. Input: audio files (6-12 seconds). Processing: cloud-hosted algorithm server identifies presence/absence of wheeze. Output: positive/negative wheeze detection displayed via web interface. Used in clinical or home settings by patients or clinicians. Healthcare providers use output alongside patient data for clinical decision-making. Benefits: provides automated decision support for lung sound assessment.

Clinical Evidence

Retrospective stand-alone performance evaluation using 371 recordings (359 patients, ages 2+). Ground truth established by majority vote of three blinded pulmonologists. Primary endpoint: AUC non-inferiority vs. predicate. Results: Subject device AUC 0.9654 vs. predicate AUC 0.9085 (difference 0.0570, 95% CI 0.0289-0.0917). Sensitivity: 0.54 (95% CI 0.43-0.65); Specificity: 0.98 (95% CI 0.97-0.99).

Technological Characteristics

Cloud-hosted, web-based software system. Composed of Application Server (APS), Algorithm Server (ALS), and Web Server (WBS). Communicates via IP network/REST/JSON API. AI-enabled algorithm for acoustic signal analysis. Standards: ISO 14971:2019, IEC 62304:2006/A1:2016, ISO 15223-1:2021, IEC 62366-1:2015+AMD1:2020.

Indications for Use

Indicated for evaluation of lung sounds in adults and pediatrics (2 years and older) to identify suspected wheeze. Not intended to detect other abnormal or normal lung sounds. Requires licensed healthcare professional interpretation.

Regulatory Classification

Identification

A diagnostic pulmonary-function interpretation calculator is a device that interprets pulmonary study data to determine clinical significance of pulmonary-function values.

Predicate Devices

• TytoCare Lung Sounds Analyzer (K221614)

Reference Devices

• eMurmur Heart AI (K220766)

Submission Summary (Full Text)

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December 13, 2023

Tyto Care Ltd. Stella Perry RA&QA Director 14 Beni Gaon Street Natanya, 4250803 Israel

Re: K232237

Trade/Device Name: Tyto Insights for Wheeze Detection Regulation Number: 21 CFR 868.1900 Regulation Name: Diagnostic Pulmonary-Function Interpretation Calculator Regulatory Class: Class II Product Code: PHZ Dated: November 13, 2023 Received: November 14, 2023

Dear Stella Perry:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

## Rachana Visaria -S

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

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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) K232237

Device Name Tyto Insights for Wheeze Detection

### Indications for Use (Describe)

The Tyto Insights for Wheeze Detection is an over the-counter artificial intelligence (Al) enabled decision support software system used in the evaluation of lung sounds in adults and pediatrics (2 years and older). It automatically analyzes the acoustic signal of the lung as recorded by the FDA cleared compatible Tyto Stethoscope and identifies recordings where a specific abnormal lung sound suggestive of "Wheeze" is suspected. It is not intended to detect other abnormal or normal lung sounds. A licensed health care professional's advice is required to understand the meaning of the Tyto Insights for Wheeze Detection result. Healthcare providers should consider the device result in conjunction with recording and other relevant patient data.

| 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)

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| Submitter Name and<br>Address: | Tyto Care Ltd.<br>14 Beni Gaon Street Netanya, Israel,<br>4250803 |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Stella Raizelman Perry RA & QA<br>Director<br>Email: [e-mail]<br>Phone Number: [phone]<br>Fax Number: [phone] |
| Establishment<br>Registration<br>Number: | 3012678246 |
| Date Prepared: | December 13, 2023 |
| Device Trade<br>Name(s): | Tyto Insights for Wheeze Detection |
| Device Common<br>Name: | Tyto Insights for Wheeze Detection |
| Classification: | Name: Diagnostic pulmonary-function interpretation<br>calculator<br>Product code: PHZ<br>Regulation No: 21 CFR 868.1900<br>Class: II<br>Panel: Anesthesiology |

## Predicate Device(s):

| Device name<br>TytoCare Lung Sounds<br>Analyzer | 510(k) No.<br>K221614 | Date of Clearance<br>January 26, 2023 |
|-------------------------------------------------|-----------------------|---------------------------------------|
| Reference Device(s): | | |
| Device name | 510(k) No. | Date of Clearance |
| eMurmur Heart AI | K220766 | May 31, 2022 |

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### Intended use / indication for use statement

The Tyto Insights for Wheeze Detection is an over-the-counter artificial intelligence (AI) enabled decision support software system used in the evaluation of lung sounds in adults and pediatrics (2 years and older). It automatically analyzes the acoustic signal of the lung as recorded by the FDA cleared compatible Tyto Stethoscope and identifies recordings where a specific abnormal lung sound suggestive of "Wheeze" is suspected. It is not intended to detect other abnormal or normal lung sounds. A licensed health care professional's advice is required to understand the meaning of the Tyto Insights for Wheeze Detection result. Healthcare providers should consider the device result in conjunction with recording and other relevant patient data.

### Device description

The Tyto Insights for Wheeze Detection is a web-based (AI) enabled software system designed to aid in the clinical assessment of lungs auscultation sound data by analyzing recorded lung sounds to determine whether a Wheeze is detected within the recorded sound data.

The Tyto Insights for Wheeze Detection Software is intended to process recordings from the FDA-cleared compatible Tyto Stethoscope (Tyto Stethoscope, K181612). The acquisition of the acoustic data (recordings) is carried out by a professional user in a clinical environment or by a lay- user in a non-medical environment, in compliance with the labeling of the Tyto Stethoscope. The system is composed of the following sub-systems:

- 1. The Tyto Insights for Wheeze Detection Application Server (APS) communicates with the Tyto Insights for Wheeze Detection Algorithm Server (ALS) and implements an application programming interface (API) for communication with the telehealth server.
- 2. The Tyto Insights for Wheeze Detection Algorithm Server (ALS) receives an audio file as input and returns an analysis result of positive or negative regarding whether a wheeze was detected as output.
- The Tyto Insights for Wheeze Detection Web Server (WBS) provides a graphic 3. indication whether a wheeze is detected in the recording. It can be utilized both in patient and clinician side.

All the software subsystems (servers and storage) are hosted in the cloud and communicate through IP network.

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## Substantial Equivalence to Predicate Devices

The following table compares the Tyto Insights for Wheeze Detection to the predicate device.

Table 1. Substantial Equivalence Summary

| | Device | Predicate device | Reference device | Summary |
|-----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Tyto Insights for Wheeze<br>Detection | TytoCare Lungs Sounds<br>Analyzer | eMurmur Heart AI | NA |
| Device<br>Manufacturer | Tyto Care Ltd. | Tyto Care Ltd. | CSD Labs GmbH | NA |
| 510(k) Number | K232237 | K221614 | K220766 | NA |
| Device Class | Class II | Class II | Class II | Same as the predicate device. |
| Review Panel | Anesthesiology | Anesthesiology | Cardiology | Same as the predicate device. |
| Product code | PHZ | PHZ | DQD, DQC | Same as the predicate device. |
| Regulation number | 21 CFR 868.1900 | 21 CFR 868.1900 | 21 CFR 870.1875 | Same as the predicate device. |
| Classification Name | Diagnostic pulmonary-<br>function interpretation<br>calculator,<br>Stethoscope | Diagnostic pulmonary-<br>function interpretation<br>calculator,<br>Stethoscope | Electronic Stethoscope;<br>Phonocardiograph; | Same as the predicate device. |
| Intended use and<br>indication for use | The “Tyto Insights for<br>Wheeze Detection” is an | The TytoCare Lung<br>Sounds Analyzer is an | The 'eMurmur Heart AI'<br>software is a decision | Same as the predicate device. |
| | over-the-counter artificial<br>intelligence (AI) enabled<br>decision support software<br>system used in the<br>evaluation of lung sounds<br>in adults and pediatrics (2<br>years and older). It<br>automatically analyzes the<br>acoustic signal of the lung<br>as recorded by the FDA<br>cleared compatible Tyto<br>Stethoscope and identifies<br>recordings where a<br>specific abnormal lung<br>sound suggestive of<br>"Wheeze" is suspected. It<br>is not intended to detect<br>other abnormal or normal<br>lung sounds. A licensed<br>health care professional's<br>advice is required to<br>understand the meaning<br>of the Tyto Insights for<br>Wheeze Detection result.<br>Healthcare providers<br>should consider the<br>device result in<br>conjunction with<br>recording and other | over-the-counter decision<br>support software system<br>used in the evaluation of<br>lung sounds in adults and<br>children (2 years and<br>older). It automatically<br>analyzes the acoustic<br>signal of the lung as<br>recorded by the FDA<br>cleared compatible Tyto<br>Stethoscope and identifies<br>recordings where a<br>specific abnormal lung<br>sound suggestive of<br>"Wheeze", is suspected.<br>It is not intended to detect<br>other abnormal or normal<br>lung sounds. A licensed<br>health care professional's<br>advice is required to<br>understand the meaning<br>of the TytoCare Lung<br>Sounds Analyzer result.<br>Healthcare providers<br>should consider the | support system in the<br>evaluation of recorded<br>patient heart sounds. The<br>automated analysis by<br>eMurmur Heart AI<br>identifies specific heart<br>sounds that may be present,<br>including S1, S2,<br>physiological heart<br>murmurs, pathological<br>heart murmurs and the<br>absence of a heart murmur.<br>eMurmur Heart AI is<br>indicated for use in a<br>setting where auscultation<br>would typically be<br>performed by a healthcare<br>provider. It is not intended<br>as a sole means of<br>diagnosis. The heart sound<br>interpretations offered by<br>eMurmur Heart AI are only<br>significant when<br>considered in conjunction<br>with healthcare provider<br>over-read and including all<br>other relevant patient data. | |
| | Device | Predicate device<br>conjunction with<br>recording and other<br>relevant patient data. | Reference device | Summary |
| Type of use | Over-The-Counter Use | Over-The-Counter Use | Prescription use | Same as the predicate device. |
| Intended users | Intended to be used by<br>professional users and lay<br>users (18-65 years old). | Intended to be used by<br>professional users and lay<br>users (18-65 years old). | Professional users | Same as the predicate device. |
| Intended patient<br>population | Intended for patients of 2<br>years and older | Intended for patients of 2<br>years and older | Intended for patients of all<br>ages | Same as the predicate device. |
| Intended<br>environment | Non-clinical (home) and<br>clinical | Non-clinical (home) and<br>clinical | Clinical setting | Same as the predicate device |
| Form | Stand-alone software<br>system | Stand-alone software<br>system | Stand-alone software<br>system | Same |
| Device composition | The following modules<br>compose the Tyto Insights<br>for Wheeze Detection:<br>The Tyto Insights for<br>Wheeze Detection<br>Application Server<br>(APS)The Tyto Insights for<br>Wheeze Detection<br>Algorithm Server<br>(ALS)The Tyto Insights for<br>Wheeze Detection Web | The following modules<br>compose the TytoCare<br>Lung Sounds Analyzer:<br>The TytoCare Lung<br>Sounds Analyzer<br>Application Server<br>(APS)The TytoCare Lung<br>Sounds Analyzer<br>Algorithm Server<br>(ALS)The TytoCare Lung<br>Sounds Analyzer Web | 'eMurmur' is a non-<br>medical device software<br>platform which includes<br>the eMurmur apps and<br>eMurmur web portal.<br><br>eMurmur Heart AI<br>interacts with the<br>'eMurmur' software<br>platform. | Same as the predicate device<br>Both the subject device and the<br>reference device include AI<br>enabled algorithm designed for<br>the analysis of stethoscope<br>recordings. |
| | Device | Predicate device | Reference device | Summary |
| | Server (WBS) provides a<br>graphic indication<br>whether a wheeze is<br>detected in the recording<br>It can be utilized both in<br>patient and clinician side. | Server (WBS) provides<br>a graphic indication<br>whether a wheeze is<br>detected in the<br>recording It can be<br>utilized both in patient<br>and clinician side. | | |
| Input | Lung sounds recorded by<br>compatible Tyto<br>Stethoscope | Lung sounds recorded by<br>compatible Tyto<br>Stethoscope | Acquires acoustic signals<br>by means of compatible<br>electronic stethoscope | Same |
| Device technology<br>and operating<br>principle | The recordings are<br>created by the compatible<br>Tyto Stethoscope<br>(K181612) and are sent<br>by the third-party point of<br>care app to the clinician<br>app through the telehealth<br>server.<br>The telehealth server<br>sends the set of the lung<br>sound recordings to the<br>Tyto Insights for Wheeze<br>Detection web server<br>using its dedicated API.<br>The telehealth server<br>subsequently sends the<br>link to results and the<br>relevant UI web view to | The recordings are<br>created by the compatible<br>Tyto Stethoscope<br>(K181612) and are sent<br>by the third-party point of<br>care app to the clinician<br>app through the telehealth<br>server.<br>The telehealth server<br>sends the set of the lung<br>sound recordings to the<br>TytoCare Lung Sounds<br>Analyzer web server<br>using its dedicated API.<br>The telehealth server<br>subsequently sends the<br>link to results and the<br>relevant UI web view to | To analyze heart sounds<br>via the eMurmur Heart AI,<br>a digital recording of a<br>patient's heart sounds is<br>required. Recordings are<br>made using a supported<br>digital stethoscope,<br>connected to a front-end<br>client like, e.g., the<br>eMurmur app or the<br>eMurmur web portal. The<br>recorded auscultation data<br>are transmitted from the<br>front-end client to the<br>eMurmur backend, which<br>hosts the eMurmur Heart<br>AI. After analysis by the<br>eMurmur Heart AI, the<br>results of the analysis on | Similar<br><br>The proposed device, the<br>predicate and reference device<br>acquire lung sounds with device<br>cleared by the FDA for that<br>purpose, analyze the lung<br>sounds and provide indication<br>on the presence of wheeze.<br><br>The new algorithm's AI enabled<br>modality for analysis of<br>stethoscope recordings doesn't<br>raise different questions of<br>safety and effectiveness.<br><br>Reference device was added to<br>support that AI enabled<br>algorithm designed for the |
| | Device | Predicate device | Reference device | Summary |
| | the point of care app and<br>clinician app.<br>The AI enabled algorithm<br>runs automatically and<br>returns a response for<br>each audio file with the<br>indication of wheezes to<br>the telehealth server,<br>which sends a response to<br>both the clinician side and<br>the patient side.<br><br>The length of the signal is<br>dictated by the recording<br>process of the compatible<br>Stethoscope. The subject<br>device processes the<br>recordings in segments of<br>up to 12 seconds while<br>signals shorter than 6<br>seconds will not be<br>processed. | the point of care app and<br>clinician app.<br>The rule-based algorithm<br>runs automatically and<br>returns a response for<br>each audio file with the<br>indication of wheezes to<br>the telehealth server,<br>which sends a response to<br>both the clinician side and<br>the patient side.<br><br>The length of the signal is<br>dictated by the recording<br>process of the compatible<br>Stethoscope. The subject<br>device processes the<br>recordings in segments of<br>up to 12 seconds while<br>signals shorter than 6<br>seconds will not be<br>processed. | returned to the front-end<br>client where they are<br>displayed to the user.<br><br>Was not specified.…