(266 days)
Unknown
The summary describes an "Algorithm Server" that analyzes audio files and returns a binary result, but it does not explicitly state that this algorithm uses AI or ML. While the function is consistent with what an AI/ML model might do, the document does not provide details about the algorithm's nature, training, or architecture that would confirm the use of AI/ML.
No.
The device is a decision support software system that analyzes lung sounds to identify "Wheeze"; it is not intended to provide therapy or treatment.
Yes
Explanation: The device is referred to as a "decision support software system" used in the "evaluation of lung sounds" and "identifies recordings where a specific abnormal lung sound suggestive of 'Wheeze' is suspected." This indicates its role in providing information for diagnosis, even though it states a healthcare professional's advice is required to understand the result. The performance studies evaluate its accuracy in detecting wheeze.
Yes
The device is described as a "web-based software system" and its components are listed as software subsystems hosted in the cloud. While it processes data from a separate hardware device (Tyto Stethoscope), the device itself is solely software.
Based on the provided information, the TytoCare Lung Sounds Analyzer is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- TytoCare Lung Sounds Analyzer Function: This device analyzes acoustic signals (lung sounds) recorded by a stethoscope. It does not analyze biological specimens taken from the body.
- Intended Use: The intended use is to analyze lung sounds to identify recordings where a specific abnormal lung sound ("Wheeze") is suspected. This is an analysis of a physical signal, not a biological sample.
Therefore, the TytoCare Lung Sounds Analyzer falls under the category of a medical device that analyzes physiological signals, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The TytoCare Lung Sounds Analyzer is an over-the-counter decision support software system used in the evaluation of lung sounds in adults and children (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 TytoCare Lung Sounds Analyzer result. Healthcare provider should consider the device result in conjunction with recording and other relevant patient data.
Product codes
PHZ, DQD
Device Description
The TytoCare Lung Sounds Analyzer is a web-based 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 TytoCare Lung Sounds Analyzer 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:
-
- The TytoCare Lung Sounds Analyzer Application Server (APS) communicates with the TytoCare Lung Sounds Analyzer Algorithm Server (ALS) and implements an application programming interface (API) for communication with the telehealth server.
-
- The TytoCare Lung Sounds Analyzer 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 TytoCare Lung Sounds Analyzer Web Server (WBS) provides a graphic 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lung
Indicated Patient Age Range
adults and children (2 years and older)
Intended User / Care Setting
licensed health care professional, professional users, lay users / Non-clinical (home) and clinical
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
The performance of the TytoCare Lung Sounds Analyzer device in detecting wheeze in recordings acquired by the compatible Tyto Stethoscope has been evaluated on a retrospective validation dataset of Tyto Stethoscope recordings sourced from real world use of the Tyto Care FDA cleared Tyto Stethoscope. 371 recordings (86 recordings were Wheeze positive and 285 negative, from a total of 359 patients) corresponded to the intended patient population of the TytoCare Lung Sounds Analyzer Software (Age >2 years). The validation data-set included recordings with known pre-existing conditions (COPD or Asthma) (7.28%).
To establish the ground truth, all of the recordings were read by three blinded experienced Pulmonologists at random, the binary ground truth was determined by majority vote of these three Pulmonologists.
Summary of Performance Studies
The TytoCare Lung Sounds Analyzer was subject to performance evaluation following methodology similar to the ones used to test the predicate device. A testing plan was developed and performed to verify that the TytoCare Lung Sounds Analyzer meets its specifications. The main aspects of the testing plan included:
- SW verification and validation: The software including both custom developed software and OTS software, have been verified and validated. The software is a Moderate Level of Concern (LOC) per FDA guidance.
- Cybersecurity: The cybersecurity assessment including cybersecurity risk analysis was performed per FDA guidance for Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.
- Human factors validation testing: Human factors data supports that individuals are able to successfully self-select themselves for the device and the risk of self-diagnosis is effectively mitigated similar to the predicate device.
- Performance evaluation: The Technical (Analytical) accuracy has been characterized and the Clinical preference has been validated including reproducibility.
The performance of the TytoCare Lung Sounds Analyzer device in detecting wheeze in recordings acquired by the compatible Tyto Stethoscope has been evaluated on a retrospective validation dataset of 371 recordings (86 Wheeze positive, 285 negative) from 359 patients. The dataset included recordings with known pre-existing conditions (COPD or Asthma) (7.28%). Ground truth was established by majority vote of three blinded experienced Pulmonologists.
Stand-alone accuracy (compared to ground truth):
- Sensitivity (Se): 0.69 (95% CI: 0.57–0.78)
- Specificity (Sp): 0.92 (95% CI: 0.88–0.95)
Clinical performance (compared to clinical readers - Physicians non-Pulmonologists):
- Primary Endpoint: Establish non-inferiority of the device's clinical accuracy to clinical readers with a 5% non-inferiority margin.
- Secondary Endpoint: Reproducibility of the software compared to readers.
Results:
- AUC TytoCare Lung Sound Analyzer: 0.91 (95% CI: 0.86-0.94)
- AUC Clinical readers: 0.83 (95% CI: 0.78-0.86)
- Difference in AUC: 0.09 (95% CI: 0.04-0.13)
Noninferiority was established (0.04 > margin of -0.05), even when accounting for confounders like age groups (6 yo) and pre-existing conditions (Asthma or COPD) in subgroup analysis.
Reproducibility (Kappa scores):
- Clinical Readers: 0.6134 (LCI 0.5183, UCI 0.7016)
- TytoCare Lung sounds analyzer: 1.0000 (LCI 1.0000, UCI 1.0000)
- TytoCare Lung sounds analyzer – Clinical Readers: 0.3866 (LCI 0.2984, UCI 0.4817)
Key Metrics
Sensitivity (Se): 0.69 (0.57–0.78)
Specificity (Sp): 0.92 (0.88–0.95)
AUC TytoCare Lung Sound Analyzer: 0.91 (0.86-0.94)
AUC Clinical readers: 0.83 (0.78-0.86)
Kappa (Clinical Readers): 0.6134
Kappa (TytoCare Lung sounds analyzer): 1.0000
Kappa (TytoCare Lung sounds analyzer – Clinical Readers): 0.3866
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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February 24, 2023
Tyto Care Ltd. Stella Perry RA&QA Director 14 Beni Gaon Street Netanya, 4250803 Israel
Re: K221614
Trade/Device Name: TytoCare Lung Sounds Analyzer Regulation Number: 21 CFR 868.1900 Regulation Name: Diagnostic Pulmonary-Function Interpretation Calculator Regulatory Class: Class II Product Code: PHZ Dated: January 26, 2023 Received: January 26, 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 (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 -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 Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221614
Device Name
TytoCare Lung Sounds Analyzer
Indications for Use (Describe)
The TytoCare Lung Sounds Analyzer is an over-the-counter decision support software system used in the evaluation of lung sounds in adults and children (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 TytoCare Lung Sounds Analyzer result. Healthcare provider 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)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
| Submitter Name
and Address: | Tyto Care Ltd.
14 Beni Gaon Street
Netanya, Israel, 4250803 |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Stella Raizelman Perry
RA & QA Director
Email: stellar@tytocare.com
Phone Number: +972 72-2210750
Fax Number: +972 72-2210752 |
| Establishment
Registration
Number: | 3012678246 |
| Date Prepared: | February 24, 2023 |
| Device Trade
Name(s): | TytoCare Lung Sounds Analyzer |
| Device Common
Name: | TytoCare Lung Sounds Analyzer |
| Classification: | Name: Diagnostic pulmonary-function interpretation
calculator
Product code: PHZ
Secondary product code: DQD
Regulation No: 21 CFR 868.1900
Class: II
Panel: Anesthesiology |
Predicate Device(s):
Device name wheezo WheezeRate Detector (by Respiri Limited) 510(k) No. K202062
Date of Clearance March 11, 2021
Reference Device(s):
| Device name | 510(k) No. | Date of Clearance |
|---|---|---|
| Tyto Stethoscope | K181612 | December 17, 2018 |
4
Intended use / indication for use statement
The TytoCare Lung Sounds Analyzer is an over-the-counter decision support software system used in the evaluation of lung sounds in adults and children (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 TytoCare Lung Sounds Analyzer result. Healthcare provider should consider the device result in conjunction with recording and other relevant patient data.
Device description
The TytoCare Lung Sounds Analyzer is a web-based 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 TytoCare Lung Sounds Analyzer 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:
-
- The TytoCare Lung Sounds Analyzer Application Server (APS) communicates with the TytoCare Lung Sounds Analyzer Algorithm Server (ALS) and implements an application programming interface (API) for communication with the telehealth server.
-
- The TytoCare Lung Sounds Analyzer 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 TytoCare Lung Sounds Analyzer Web Server (WBS) provides a graphic 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.
Substantial Equivalence to Predicate Devices
The following table compares the TytoCare Lung Sounds Analyzer to the predicate
and reference device devices:
5
| Device | Predicate | Reference device | Summary | |
|---|---|---|---|---|
| Device Name | TytoCare Lungs Sounds | |||
| Analyzer | wheezo WheezeRate | |||
| Detector | Tyto Stethoscope (OTC) | NA | ||
| Device | ||||
| Manufacturer | Tyto Care Ltd. | Respiri Limited | Tyto Care Ltd. | NA |
| 510(k) Number | K221614 | K202062 | K181612 | NA |
| Device Class | Class II | Class II | Class II | Same |
| Review Panel | Anesthesiology | Anesthesiology | Cardiovascular | Same |
| Product code | PHZ | |||
| DQD | PHZ | DQD | Same | |
| Regulation number | 21 CFR 868.1900 | 21 CFR 868.1900 | 21 CFR 870.1875 | Same |
| Classification Name | Diagnostic pulmonary- | |||
| function interpretation | ||||
| calculator | Diagnostic pulmonary- | |||
| function interpretation | ||||
| calculator | Stethoscope | Same | ||
| Intended use and | ||||
| indication for use | The TytoCare Lung Sounds | |||
| Analyzer is an over-the- | ||||
| counter decision support | ||||
| software system used in the | ||||
| evaluation of lung sounds in | ||||
| adults and children (2 years | ||||
| and older). It automatically | ||||
| analyzes the acoustic signal | 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 | The Tyto Stethoscope is an | |||
| electronic stethoscope that | ||||
| enables transmission of | ||||
| auscultation sound data, | ||||
| whereby a clinician at one | ||||
| location on an IP network | ||||
| can listen to the auscultation | ||||
| sounds of a patient on site or | Same | |||
| Both the predicate device and the | ||||
| subject device have the same | ||||
| intended use and indication for | ||||
| use in that both are intended to | ||||
| detect specific and abnormal | ||||
| breath sounds in the same | ||||
| Device | Predicate | Reference device | Summary | |
| 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 TytoCare Lung Sounds | ||||
| Analyzer result. Healthcare | ||||
| provider should consider | ||||
| the device result in | ||||
| conjunction with recording | ||||
| and other relevant patient | ||||
| data. | years and older). A | |||
| licensed health care | ||||
| professional's advice is | ||||
| required to understand the | ||||
| meaning and importance | ||||
| of the wheezo readings. | at a different location on the | |||
| IP network with the signal | ||||
| carried on an IP connection | ||||
| between the two locations. | ||||
| The Tyto Stethoscope is | ||||
| intended to be used by | ||||
| professional users in a | ||||
| clinical environment or by | ||||
| lay users in a nonclinical | ||||
| environment. The device is | ||||
| for medical diagnostics | ||||
| purposes only. The device is | ||||
| not intended for self- | ||||
| diagnosis. | intended patient population (adult | |||
| and pediatric) by the same user | ||||
| [Health Care Professional (HCP)] | ||||
| when self-administered by patient | ||||
| and/or the HCPs. | ||||
| Both devices are only intended to | ||||
| be interpreted by HCP and HCP | ||||
| advice is required for the patient | ||||
| to understand their result. Both | ||||
| are labeled OTC. | ||||
| Type of use | Over-The-Counter Use | Over-The-Counter Use | Over-The-Counter Use | Same |
| Intended users | Intended to be used by | |||
| professional users and lay | ||||
| users. | Intended to be used by lay | |||
| users | Intended to be used by | |||
| professional users and lay | ||||
| users | Similar, the TytoCare Lung | |||
| Sounds Analyzer is intended for | ||||
| clinicians and lay users. |
6
7
| Device | Predicate | Reference device | Summary | |
|---|---|---|---|---|
| Intended patient population | Intended for patients of 2 years and older | Intended for patients of 2 years and older | Intended for patients of all ages | Same |
| Intended environment | Non-clinical (home) and clinical | Non-clinical (home) | Non-clinical (home) and clinical | Similar. |
| the TytoCare Lung Sounds Analyzer is intended for both home and clinical environment | ||||
| Form | Stand-alone software system | Hardware and Software, hand-held stand-alone device used with smartphone | Hardware and Software, hand-held stand-alone device used with smartphone | Different. |
| The acquisition of lung sounds of both devices is conducted by FDA cleared device, therefore there is no new question of effectiveness. | ||||
| Device | Predicate | Reference device | Summary | |
| Device composition | The following modules | |||
| compose the TytoCare | ||||
| Lung Sounds Analyzer: | ||||
| • The TytoCare Lung | ||||
| Sounds Analyzer | ||||
| Application Server (APS) | ||||
| • The TytoCare Lung | ||||
| Sounds Analyzer | ||||
| Algorithm Server (ALS) | ||||
| • The TytoCare Lung | ||||
| Sounds Analyzer Web | ||||
| Server (WBS) provides a | ||||
| graphic indication | ||||
| whether a wheeze is | ||||
| detected in the recording | ||||
| It can be utilized both in | ||||
| patient and clinician side. | The wheezo WheezeRate | |||
| Detector consists of: | ||||
| • Wheezo Sensing | ||||
| Device | ||||
| • Wheezo App | ||||
| • Cloud server | Hardware: | |||
| • A stethoscope Chest | ||||
| Piece: | ||||
| o Stethoscope Adaptor | ||||
| o TytoCare Device | ||||
| Software: | ||||
| • TytoCare Device | ||||
| Application | ||||
| [runs on TytoCare Device] | ||||
| • TytoCare | ||||
| Application | ||||
| [runs on the mobile | ||||
| device] | ||||
| • Clinician | ||||
| Application | ||||
| [runs on the clinician | ||||
| platform] | ||||
| • Server software | ||||
| [runs on the Tyto Server] | Different | |||
| The TytoCare Lung Sounds | ||||
| Analyzer is a Stand-alone | ||||
| software system used with | ||||
| compatible Tyto Stethoscope to | ||||
| record lung sounds. The Wheezo | ||||
| is Hardware and Software, hand- | ||||
| held device used with smartphone. | ||||
| Both devices acquire lung sounds | ||||
| and provide indication on the | ||||
| presence of wheeze to the user. | ||||
| The difference doesn't raise new | ||||
| questions of safety or | ||||
| effectiveness. | ||||
| Input | Lung sounds recorded by | |||
| compatible Tyto | ||||
| Stethoscope | Lung sounds recorded by | |||
| the wheezo device | Lung sounds recorded by | |||
| the Tyto Stethoscope | Different | |||
| Both devices acquire lung sounds | ||||
| with device cleared by the FDA | ||||
| for that purpose | ||||
| Device | Predicate | Reference device | Summary | |
| The difference doesn't raise new | ||||
| questions of safety or | ||||
| effectiveness | ||||
| Device technology | ||||
| and operating | ||||
| principle | The recordings are created | |||
| by the compatible Tyto | ||||
| Stethoscope (K181612) and | ||||
| are sent by the third-party | ||||
| point of care app to the | ||||
| clinician app through the | ||||
| telehealth server. | ||||
| The telehealth server sends | ||||
| the set of the lung sound | ||||
| recordings to the TytoCare | ||||
| Lung Sounds Analyzer web | ||||
| server using its dedicated | ||||
| API. | ||||
| The telehealth server | ||||
| subsequently sends the link | ||||
| to results and the relevant | ||||
| UI web view to the point of | ||||
| care app and clinician app. | ||||
| The algorithm runs | ||||
| automatically and returns a | ||||
| response for each audio file | ||||
| with the indication of | ||||
| wheezes to the telehealth | ||||
| server, which sends a | ||||
| response to both the | User places sensor on | |||
| their neck for 30 seconds | ||||
| to perform a passive | ||||
| manoeuvre. The device | ||||
| records, analyses the lung | ||||
| sounds and quantifies the | ||||
| presence of wheezing. | ||||
| The wheezo transfers a | ||||
| user's breath sound data to | ||||
| the App using a Smart | ||||
| Device. The sound data is | ||||
| analyzed in the algorithm, | ||||
| which is integrated inside | ||||
| the App and runs on the | ||||
| Smart Device. | User place the Tyto | |||
| Stethoscope's adaptor in full | ||||
| contact with the patient's | ||||
| body, data is recorded and | ||||
| transmitted from the chest | ||||
| piece (i.e., the The TytoCare | ||||
| device mounted with | ||||
| adaptor) to the user end unit | ||||
| (i.e., a mobile device such | ||||
| as smartphone), via Wi-Fi, | ||||
| and then over the internet to | ||||
| the clinician end unit (i.e., a | ||||
| clinician platform such as | ||||
| PC or laptop. | Same. | |||
| Both devices acquire lung | ||||
| sounds with device cleared by the | ||||
| FDA for that purpose, analyze the | ||||
| lung sounds and provide | ||||
| indication on the presence of | ||||
| wheeze. | ||||
| Device | Predicate | Reference device | Summary | |
| clinician side and the | ||||
| patient side. | ||||
| Sensor type and | ||||
| technology | NA, software only | Microphone sensor (made | ||
| of silicon) acquires, filters | ||||
| and digitizes the breath | ||||
| sounds. | Embedded acoustic | |||
| piezoelectric contact sensor | ||||
| captures analog auscultation | ||||
| sound data, amplifies it, | ||||
| filters, digitizes and store it. | Different but the difference | |||
| doesn't raise new questions of | ||||
| safety or effectiveness. The | ||||
| subject device is intended to be | ||||
| used with compatible Tyto | ||||
| Stethoscope (reference device) to | ||||
| record lung sounds. | ||||
| The predicate and the reference | ||||
| devices both use a handheld piece | ||||
| with embedded sensor in the chest | ||||
| piece to acquire lung sounds. The | ||||
| safety and performance of the | ||||
| reference device sensor's type and | ||||
| technology has been established | ||||
| previously for acquiring lung | ||||
| sounds by means of FDA | ||||
| clearance. | ||||
| Sensor location | NA, software only | Trachea | Top part of the chest and the | |
| top part of patient's back | ||||
| (Left Upper Lobe, Left | ||||
| Lower Lobe, Right Upper | ||||
| Lobe, Right Lower Lobe). | Different but the difference | |||
| doesn't raise new questions of | ||||
| safety or effectiveness. The | ||||
| subject device is intended to be | ||||
| used with compatible Tyto | ||||
| Stethoscope (reference device) to | ||||
| record lung sounds. | ||||
| The safety and performance of the | ||||
| reference device sensor's location | ||||
| for acquiring lung sounds has | ||||
| been established before by means | ||||
| of FDA clearance. | ||||
| Signal length | The length of the signal is dictated by the recording process of the compatible Stethoscope. The subject device processes the recordings in segments of up to 12 seconds while signals shorter than 6 seconds will not be processed. | 30 seconds | Variable | Different but the difference doesn't raise new questions of safety or effectiveness. The safety and performance of the different signal length that is used in the process of lung sound acquisition by numerous FDA cleared electronic stethoscopes including the reference device as well as Diagnostic Pulmonary-Function Interpretation Calculators including the predicate device was established. Thus, the impact of different signal length on performance does not raise a new question of safety or performance. |
| Data transfer and storage | The telehealth server sends the list of the recordings (identified by a unique identifier and time stamp) to the TytoCare Lung Sound Analyzer web server using its dedicated API. The server executes the TytoCare Lung Sounds Analyzer which runs the algorithm and provides the results. Then the TytoCare Lung Sound Analyzer web | Every recording is automatically uploaded to the cloud. However, if an Internet connection is not available, up to 20 most recent recordings will be stored locally on the smartphone. | The stethoscope recordings are transferred to the server using the software of the Tyto Stethoscope. However, if an Internet connection is not available, most recent recordings will be stored locally on the Tyto Stethoscope. | Different medical device data system but the difference doesn't raise new questions of safety or effectiveness. |
| Device | Predicate | Reference device | Summary | |
| server initiates the web user | ||||
| interface. | ||||
| All the software subsystems | ||||
| (server and storage) are | ||||
| hosted in the cloud and | ||||
| communicate through IP | ||||
| network. | ||||
| Output | • Positive (wheeze | |||
| suspected), | ||||
| • Negative (Wheeze not | ||||
| suspected), | ||||
| • The TytoCare lungs | ||||
| sounds analyzer was not | ||||
| able to analyze the | ||||
| recording | Detection and | |||
| quantification of wheeze | ||||
| presence, expressed as | ||||
| "wheeze rate". | NA | Different but no new questions of | ||
| safety and effectiveness as both | ||||
| the device and the predicate use | ||||
| software algorithm to detect | ||||
| abnormal breath sound (wheeze) | ||||
| in lung recordings. | ||||
| Accuracy | Non-inferior to clinical | |||
| readers | Non-inferior to clinical | |||
| readers | NA | Same | ||
| User interface for | ||||
| point of care and | ||||
| clinician apps | Web view | Mobile App | • TytoCare Device LCD | |
| screen | ||||
| • TytoCare mobile App | Same | |||
| Both predicate and reference | ||||
| device use a proprietary mobile | ||||
| App for recordings acquisition | ||||
| and management. | ||||
| Different UI of the device using | ||||
| web-view doesn't raise new | ||||
| questions of safety or | ||||
| effectiveness. |
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Table 1. Substantial Equivalence Summary
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The TytoCare Lung Sounds Analyzer and the predicate device have the same intended use and indication for use in that both are intended to detect specific and abnormal breath sounds in the same intended patient population (adult and children's) by the same user [Health Care Professional (HCP)] when administered by patient and/or the HCPs. Both devices are only intended to be interpreted by HCP advice is required for the patient to understand their result. Both are labeled OTC.
The TytoCare Lung Sounds Analyzer is a stand-alone software system that has the same intended use as the predicate (automatically detect wheezes) but at the absence of the sensor technology that is built into the predicate device. The Tyto Stethoscope (K181612) that is source of the lung recordings for the TytoCare Lung Sounds Analyzer was added as reference device to this premarket notification to account for these technological differences. The compatible Tyto Stethoscope is FDA cleared thus the technical differences as far as the different input to the device and its predicate do not raise new or different questions of safety and effectiveness.
Both devices are intended to detect wheezes and the output conveys this information to the user. The question concerning the ability of a software (in both cases the recording is analyzed by proprietary software) to accurately detect abnormal breath sound is not new. The predicate utilizes software for the analysis thus it raised similar questions before. The different software algorithm does require that its accuracy will be substantiated with valid performance data (accuracy testing).
Both devices display the result to the user interface is different but the difference does not raise new questions of safety and effectiveness as the predicate already introduced the questions concerning the impact of displaying the results to the same lay user. The different user interface does require that the substantial equivalence be based on performance evaluation (human factor testing).
Performance evaluation:
The TytoCare Lung Sounds Analyzer was subject to performance evaluation following methodology similar to the ones used to test the predicate device. A testing plan was developed and performed to verify that the TytoCare Lung Sounds Analyzer meets its specifications. The main aspects of the testing plan included:
- · SW verification and validation The software including both custom developed software and OTS software, have been verified and validated. The software is a Moderate Level of Concern (LOC) per FDA guidance.
- · Cybersecurity- The cybersecurity assessment including cybersecurity risk analysis was performed per FDA guidance for Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.
- · Human factors validation testing was conducted, human factors data supports that individuals are able to successfully self-select themselves for the device and the risk of self-diagnosis is effectively mitigated similar to the predicate device.
- · Performance evaluation the Technical (Analytical) accuracy has been characterized and the Clinical preference has been validated including reproducibility:
The performance of the TytoCare Lung Sounds Analyzer device in detecting wheeze in recordings acquired by the compatible Tyto Stethoscope has been evaluated on a retrospective validation dataset of Tyto Stethoscope recordings sourced from real world use of the Tyto Care FDA cleared Tyto Stethoscope. 371 recordings (86 recordings
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were Wheeze positive and 285 negative, from a total of 359 patients) corresponded to the intended patient population of the TytoCare Lung Sounds Analyzer Software (Age >2 years). The validation data-set included recordings with known pre-existing conditions (COPD or Asthma) (7.28%). The demographics of the validation dataset are presented hereunder:
Table 2: Validation data-set demographics
| | | | N=359
patients |
|-------------------|-----------------|-----------------|-------------------|
| Age Group (Years) | Wheeze Positive | Wheeze Negative | Total |
| 2-18 | 63 (24.3%) | 196 (75.7%) | 259 (72.1%) |
| >=18 | 17 (17%) | 83 (83%) | 100 (27.9%) |
| Gender | Positive | Negative | Total |
| Male | 49 (25.9%) | 140 (74.1%) | 189 (52.6%) |
| Female | 31(18.2%) | 139 (81.8%) | 170 (47.3%) |
To establish the ground truth, all of the recordings were read by three blinded experienced Pulmonologists at random, the binary ground truth was determined by majority vote of these three Pulmonologists.
For the characterization of the stand-alone accuracy, the automated binary result of the software has been compared to ground truth and specificity and sensitivity were calculated. This stand-alone accuracy is presented hereunder in table 3:
Table 3: The stand-alone accuracy of the TytoCare Lung Sounds Analyzer
| Parameter | Estimate (two-sided 95% CI) |
|---|---|
| Sensitivity (Se) | 0.69 (0.57–0.78) |
| Specificity (Sp) | 0.92 (0.88–0.95) |
For the characterization of the clinical performance the Area under the Receiver Operating Curve (AUC) for Wheeze detection by the device was compared to the clinical readers (Physicians non-Pulmonologists). To calculate the AUC the probability score was extracted from the device and compared to a 5-point likelihood score that was recorded by the clinical readers independently for every recording.
The primary endpoint was to establish that the clinical accuracy of the TytoCare Lung Sounds Analyzer software's is non- inferior to the clinical readers provided with a 5% non-inferiority margin. The secondary endpoint was the reproducibility of the software as compared to the readers.
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Table 4: The clinical accuracy of the TytoCare Lung Sounds Analyzer as compared to Clinical readers.
| Parameter | Estimate 95% two sides CI |
|---|---|
| AUC TytoCare Lung Sound Analyzer | 0.91 (0.86-0.94) |
| AUC Clinical readers | 0.83 (0.78-0.86) |
The AUC of the device was 0.91 (0.86-0.94) compared to the reader's AUC of 0.83 (0.78-0.86). The difference in AUC was 0.09 (0.04-0.13) which supports the noninferiority (0.04 > margin of -0.05) of the device compared to the reader. Noninferiority was established also when confounders such as age groups (6 yo) and the relevant pre-existing conditions (Asthma or COPD) were accounted for in subgroup analysis.
Table 5: Reproducibility of device compared to the clinical readers in the detection of wheezes.
| Parameter | Kappa | LCI | UCI |
|---|---|---|---|
| Clinical Readers | 0.6134 | 0.5183 | 0.7016 |
| TytoCare Lung sounds analyzer | 1.0000 | 1.0000 | 1.0000 |
| TytoCare Lung sounds analyzer | |||
| – Clinical Readers | 0.3866 | 0.2984 | 0.4817 |
LCI – lower bound of two-sided 95% confidence interval; UCI – upper bound of two-sided 95% confidence interval
Standards applied
- . ANSI AAMI ISO 14971:2019, Medical devices - Application of risk management to medical devices
- ANSI AAMI IEC 62304:2006/A1:2016, Medical device software - Software life cycle processes
- . ISO 15223-1 Fourth edition 2021-07, Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
- IEC 62366-1 Edition 1.1 2020-06, Medical devices Part 1: Application of ● usability engineering to medical devices
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Conclusion
The TytoCare Lung Sounds Analyzer Software has the same intended use and similar indication for use as the predicate. The TytoCare Lung Sounds Analyzer is only compatible with the reference FDA cleared TytoCare Stethoscope that provides the input stethoscope recording. Therefore, the technological differences in sensor technology, anatomical recording site, signal length and user interface as compared to the predicate do not raise new/different questions of safety and effectiveness relative to the reference device. The differences in the user interface and software algorithm do not raise new/different questions of safety and effectiveness. These differences were evaluated for their effect on safety and performance using a performance evaluation for device accuracy that followed the same method used to substantiate the predicate device and the results demonstrated that similarly the TytoCare Lung Sounds Analyzer is as safe and as effective as the predicate in that its accuracy in detecting wheeze is non inferior to that of the physician. Human factors data supports that the TytoCare Lung Sounds Analyzer has been found to be as safe and as effective for the intended users, uses and use environments. Thus, we conclude that the TytoCare Lung Sounds Analyzer is substantially equivalent. i.e. as safe and as effective as the predicate device.