(138 days)
Yes
The document explicitly states the device is "artificial intelligence (Al) enabled" and uses an "AI Algorithm" for analysis.
No.
This device is a diagnostic aid, providing decision support by analyzing lung sounds to detect wheezing, but it does not treat or directly alleviate any medical condition.
Yes
The device analyzes acoustic signals to identify abnormal lung sounds suggestive of "Wheeze," providing a result (positive or negative for wheeze detection) that can be used in the evaluation of lung sounds, which is a diagnostic function.
Yes
The device description explicitly states that the system is composed of software subsystems (servers and storage) hosted in the cloud and communicating through an IP network. While it processes data from a compatible hardware device (Tyto Stethoscope), the device being cleared is the software system itself.
Based on the provided information, the Tyto Insights for Wheeze Detection is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. This typically includes things like blood, urine, tissue, or other bodily fluids.
- The Tyto Insights for Wheeze Detection analyzes acoustic signals of the lung. This is sound data recorded externally from the body using a stethoscope, not a biological sample taken from within the body.
The device falls under the category of a medical device software that uses AI to analyze physiological signals (lung sounds) to provide decision support. It is not performing a test on a biological specimen.
No
The provided text does not contain any explicit statement that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
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.
Product codes
PHZ
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:
-
- 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.
-
- 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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.
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 AI enabled 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 clinician side and the patient side.
Both the subject device and the reference device include AI enabled algorithm designed for the analysis of stethoscope recordings.
The new algorithm's AI enabled modality for analysis of stethoscope recordings doesn't raise different questions of safety and effectiveness.
Reference device was added to support that AI enabled algorithm designed for the analysis of stethoscope recordings, was cleared previously by the FDA (K220766) Similar method of performance evaluation was employed for both devices.
Similarly to the reference device, the output is based on the AI algorithm's analysis.
The Algorithm of the proposed device is Artificial Intelligence enabled while the Algorithm of the predicate device is rule based. The AI Algorithm was trained with recordings acquired by the real-world use of the compatible Tyto Stethoscope.
Input Imaging Modality
Lung sounds recorded by compatible Tyto Stethoscope
Anatomical Site
lung
Indicated Patient Age Range
adults and pediatrics (2 years and older).
Intended User / Care Setting
Intended to be used by professional users and lay users (18-65 years old).
Non-clinical (home) and clinical
Description of the training set, sample size, data source, and annotation protocol
The AI Algorithm was trained with recordings acquired by the real-world use of the compatible Tyto Stethoscope.
Description of the test set, sample size, data source, and annotation protocol
The performance of the Tyto Insights for Wheeze Detection 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 FDA cleared compatible Tyto Stethoscope. 371 recordings (359 patients) corresponded to the intended patient population of the Tyto Insights for Wheeze Detection Software recorded (86 recordings were Wheeze positive and 285 negative). The sample 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Type: retrospective stand-alone performance evaluation
Sample size: 371 recordings (359 patients)
AUC:
TytoCare Lung Sounds Analyzer (K221614): 0.9085 [0.8678 - 0.9372]
Tyto Insights for Wheeze Detection: 0.9654 [0.9459 - 0.9790]
Insights - Analyzer: 0.0570 [0.0289 - 0.0917]
Key results:
The primary study endpoints and hypotheses were met for the intended patient population, the difference in AUCs was in favor of Tyto Insights for Wheeze Detection compared to the predicate device and in favor of the non-inferiority claim.
Non-inferiority of Tyto Insights for Wheeze Detection compared to TytoCare Lung Sounds Analyzer (K221614) for 2 years and above was established. Similar effect trend was also shown within the subgroup analysis, as evidence that the device accuracy is consistent with age groups and relevant pre-existing conditions.
The overall diagnostic performance show overall good diagnostic accuracy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity (Se): 0.54 (0.43-0.65)
Specificity (Sp): 0.98 (0.97-0.99)
Positive Predictive Value (PPV): 0.72 (0.48-0.89)
Negative Predictive Value (NPV): 0.97 (0.97-0.98)
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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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"
1
(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 (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
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
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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Image /page/4/Picture/0 description: The image shows the logo for "tytocare" in blue font. Below the logo, the text "510(k) Summary" is written in a bold, serif font. The logo features a stylized image of a ninja-like character with a round head and two eyes, followed by the company name.
| 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: | December 13, 2023 |
| Device Trade
Name(s): | Tyto Insights for Wheeze Detection |
| Device Common
Name: | Tyto Insights for Wheeze Detection |
| Classification: | Name: Diagnostic pulmonary-function interpretation
calculator
Product code: PHZ
Regulation No: 21 CFR 868.1900
Class: II
Panel: Anesthesiology |
Predicate Device(s):
| Device name
TytoCare Lung Sounds
Analyzer | 510(k) No.
K221614 | Date of Clearance
January 26, 2023 |
|-------------------------------------------------|-----------------------|---------------------------------------|
| Reference Device(s): | | |
| Device name | 510(k) No. | Date of Clearance |
| eMurmur Heart AI | K220766 | May 31, 2022 |
5
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:
-
- 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.
-
- 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 | |||
| Detection | TytoCare Lungs Sounds | |||
| Analyzer | eMurmur Heart AI | NA | ||
| Device | ||||
| 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- | |||
| function interpretation | ||||
| calculator, | ||||
| Stethoscope | Diagnostic pulmonary- | |||
| function interpretation | ||||
| calculator, | ||||
| Stethoscope | Electronic Stethoscope; | |||
| Phonocardiograph; | Same as the predicate device. | |||
| Intended use and | ||||
| indication for use | The “Tyto Insights for | |||
| Wheeze Detection” is an | The TytoCare Lung | |||
| Sounds Analyzer is an | The 'eMurmur Heart AI' | |||
| software is a decision | Same as the predicate device. | |||
| 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 | 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 providers | ||||
| should consider the | support system in the | |||
| evaluation of recorded | ||||
| patient heart sounds. The | ||||
| automated analysis by | ||||
| eMurmur Heart AI | ||||
| identifies specific heart | ||||
| sounds that may be present, | ||||
| including S1, S2, | ||||
| physiological heart | ||||
| murmurs, pathological | ||||
| heart murmurs and the | ||||
| absence of a heart murmur. | ||||
| eMurmur Heart AI is | ||||
| indicated for use in a | ||||
| setting where auscultation | ||||
| would typically be | ||||
| performed by a healthcare | ||||
| provider. It is not intended | ||||
| as a sole means of | ||||
| diagnosis. The heart sound | ||||
| interpretations offered by | ||||
| eMurmur Heart AI are only | ||||
| significant when | ||||
| considered in conjunction | ||||
| with healthcare provider | ||||
| over-read and including all | ||||
| other relevant patient data. | ||||
| Device | Predicate device | |||
| conjunction with | ||||
| recording and other | ||||
| 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 | |||
| professional users and lay | ||||
| users (18-65 years old). | Intended to be used by | |||
| professional users and lay | ||||
| users (18-65 years old). | Professional users | Same as the predicate device. | ||
| 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 as the predicate device. | |||
| Intended | ||||
| environment | Non-clinical (home) and | |||
| clinical | Non-clinical (home) and | |||
| clinical | Clinical setting | Same as the predicate device | ||
| Form | Stand-alone software | |||
| system | Stand-alone software | |||
| system | Stand-alone software | |||
| system | Same | |||
| Device composition | The following modules | |||
| compose the Tyto Insights | ||||
| for Wheeze Detection: | ||||
| The Tyto Insights for | ||||
| Wheeze Detection | ||||
| Application Server | ||||
| (APS)The Tyto Insights for | ||||
| Wheeze Detection | ||||
| Algorithm Server | ||||
| (ALS)The Tyto Insights for | ||||
| Wheeze Detection Web | 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 | 'eMurmur' is a non- | |||
| medical device software | ||||
| platform which includes | ||||
| the eMurmur apps and | ||||
| eMurmur web portal. |
eMurmur Heart AI
interacts with the
'eMurmur' software
platform. | Same as the predicate device
Both the subject device and the
reference device include AI
enabled algorithm designed for
the analysis of stethoscope
recordings. |
| | Device | Predicate device | Reference device | Summary |
| | Server (WBS) provides a
graphic indication
whether a wheeze is
detected in the recording
It can be utilized both in
patient and clinician side. | Server (WBS) provides
a graphic indication
whether a wheeze is
detected in the
recording It can be
utilized both in patient
and clinician side. | | |
| Input | Lung sounds recorded by
compatible Tyto
Stethoscope | Lung sounds recorded by
compatible Tyto
Stethoscope | Acquires acoustic signals
by means of compatible
electronic stethoscope | Same |
| 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
Tyto Insights for Wheeze
Detection web server
using its dedicated API.
The telehealth server
subsequently sends the
link to results and the
relevant UI web view to | 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 | To analyze heart sounds
via the eMurmur Heart AI,
a digital recording of a
patient's heart sounds is
required. Recordings are
made using a supported
digital stethoscope,
connected to a front-end
client like, e.g., the
eMurmur app or the
eMurmur web portal. The
recorded auscultation data
are transmitted from the
front-end client to the
eMurmur backend, which
hosts the eMurmur Heart
AI. After analysis by the
eMurmur Heart AI, the
results of the analysis on | Similar
The proposed device, the
predicate and reference device
acquire lung sounds with device
cleared by the FDA for that
purpose, analyze the lung
sounds and provide indication
on the presence of wheeze.
The new algorithm's AI enabled
modality for analysis of
stethoscope recordings doesn't
raise different questions of
safety and effectiveness.
Reference device was added to
support that AI enabled
algorithm designed for the |
| | Device | Predicate device | Reference device | Summary |
| | the point of care app and
clinician app.
The AI enabled 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 clinician side and
the patient side.
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. | the point of care app and
clinician app.
The rule-based 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 clinician side and
the patient side.
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. | returned to the front-end
client where they are
displayed to the user.
Was not specified. | analysis of stethoscope
recordings, was cleared
previously by the FDA
(K220766) Similar method of
performance evaluation was
employed for both devices.
Same as the predicate device |
| Data transfer and
storage | The telehealth server
sends the list of the
recordings (identified by a
unique identifier and time
stamp) to the Tyto
Insights for Wheeze | The telehealth server
sends the list of the
recordings (identified by
a unique identifier and
time stamp) to the
TytoCare Lung Sounds | Server analyzes (algorithm)
and stores (database)
patient-related data and
communicates with the
other components of
eMurmur. The interface to | Same as the predicate device,
similar to the reference device. |
| | Device | Predicate device | Reference device | Summary |
| | Detection web server
using its dedicated API.
The server executes the
Tyto Insights for Wheeze
Detection which runs the
algorithm and provides
the results. Then the Tyto
Insights for Wheeze
Detection web server
initiates the web user
interface.
All the software
subsystems (server and
storage) are hosted in the
cloud and communicate
through IP network. | 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 Sounds
Analyzer web server
initiates the web user
interface.
All the software
subsystems (server and
storage) are hosted in the
cloud and communicate
through IP network. | the other components is a
REST/JSON web API.
The backend is not a part
of eMurmur Heart AI
(medical device); the
backend is part of
'eMurmur', a non-medical
device. | |
| Output | • Positive (wheeze
suspected),
• Negative (Wheeze not
suspected),
• The Tyto Insights for
Wheeze Detection was
not able to analyze the
recording | • Positive (wheeze
suspected),
• Negative (Wheeze not
suspected),
The TytoCare lungs
sounds analyzer was not
able to analyze the
recording | Identifies specific heart
sounds that may be present,
including S1, S2,
physiological heart
murmurs, pathological
heart murmurs and the
absence of a heart murmur. | Same as the predicate device
Similarly to the reference
device, the output is based on
the AI algorithm's analysis. |
| Performance | The primary study
endpoints and hypotheses
were met for the intended
patient population, the
difference in AUCs was | The primary study
endpoints and hypotheses
were met for the intended
patient population, the
difference in AUC was in | Sensitivity: 85.0% (72.9%-
92.5%)
Specificity: 86.7% (74.9%-
93.7%) | The study endpoints and
hypotheses were met for the
intended patient population.
The performance of the Tyto
Insights for Wheeze Detection |
| | Device | Predicate device | Reference device | Summary |
| | in favor of Tyto Insights
for Wheeze Detection
compared to the predicate
device and in favor of the
non-inferiority claim.
Sensitivity and specificity
were evaluated as the
secondary endpoints.
Estimate two-sided 95%
CI):
Sensitivity: 0.5465
[0.4304 - 0.6549]
Specificity: 0.9895
[0.9684 – 0.9966] | favor of TytoCare Lungs
Sounds Analyzer
compared to the clinical
readers.
Sensitivity and specificity
were evaluated as the
secondary endpoints.
Estimate two-sided 95%
CI):
Sensitivity: 0.69 [0.57-
0.78]
Specificity:0.92 [0.88-
0.95] | | is non inferior to the predicate
device.
The overall diagnostic
performance show overall good
diagnostic accuracy. |
| User interface for
point of care and
clinician apps | Web view | Web view | The user interface is not a
part of eMurmur Heart AI
(medical device); the user
interface is part of
'eMurmur', a non-medical
device. | Same as the predicate device |
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Image /page/8/Picture/0 description: The image shows the logo for TytoCare. The logo features a cartoon ninja character on the left, followed by the text "tytocare" in a stylized font. The ninja character is blue and white, and the text is blue. There is a trademark symbol after the word "tytocare".
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Image /page/12/Picture/0 description: The image shows the logo for TytoCare. The logo features a cartoon ninja character on the left, followed by the text "tytocare" in a stylized font. The ninja character is blue and white, and the text is blue. There is a trademark symbol after the word "tytocare".
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The Tyto Insights for Wheeze Detection like its predicate device the TytoCare Lung Sounds Analyzer (K221614) have the same intended use, in that both are intended to identify recordings where a specific abnormal lung sound suggestive of "Wheeze" is suspected in the same intended patient population (adult and pediatric 2 years and older) 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.
Both the Tyto Insights for Wheeze Detection and its predicate device are stand-alone software systems that deliver the same intended benefit (identify recordings where a specific abnormal lung sound suggestive of "Wheeze" is suspected). For both devices the source of the Lung sounds recordings is the compatible FDA cleared Tyto Stethoscope (K181612).
Similarly, to the predicate device, the Tyto Insights for Wheeze Detection system is composed of three sub-systems: Application Server (APS), Algorithm Server (ALS) and Web Server (WBS). The APS communicates with the ALS and implements an application programming interface API for communication with the telehealth server. The 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 ALS sub-system is composed of an Algorithm and logic wrapper and Interface components. The code of the logic wrapper and Interface component of the ALS component is the same as of the ALS component of the predicate device, the Algorithm's component is different. The Algorithm of the proposed device is Artificial Intelligence enabled while the Algorithm of the predicate device is rule based. The AI Algorithm was trained with recordings acquired by the real-world use of the compatible Tyto Stethoscope. The differences in the software algorithm modality do not raise new questions of safety and effectiveness. A reference device (K220766) was added to provide an example of FDA cleared device that uses as an input recordings recorded by means of compatible digital stethoscope and analyzed by AI enabled algorithm. The different algorithm modality between the proposed device and the predicate device does require that the accuracy of the device be substantiated with valid performance data using acceptable methods. Similar approach of performance evaluation was employed for the reference device as well. The WBS provides a graphic indication whether a wheeze is detected in the recording. It can be utilized both in the patient and clinician side. The minor wording differences in the user interface did not raise
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new questions of safety and effectiveness, the differences as compared to the predicate device did not introduce new critical tasks and didn't impact existing critical tasks.
Standards Conformance
- 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.
- ANSI AAMI IEC 62366-1:2015+AMD1:2020 (Consolidated Text) Medical devices Part 1: Application of usability engineering to medical device.
Performance evaluation:
The Tyto Insights for Wheeze Detection 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 Tyto Insights for Wheeze Detection 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 and have been demonstrated to be safe and effective for its intended use. The software documentation level is basic per Content of Premarket Submissions for Device Software Functions, Guidance for Industry and Food and Drug Administration Staff, dated June 14, 2023. All required items related to software as required by FDA guidance for Basic Documentation Level have been included in this submission.
- Cybersecurity- all the applicable information to reflect effective cybersecurity o management and to address the FDA's recommendations described in Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices and Related Systems Under Section 524B of the FD&C Act, issue date March 2023, Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, issue date September 2023 and in the other FDA's applicable policies have been included in this submission.
- Performance evaluation - retrospective stand-alone performance evaluation of the "Tyto Insights for Wheeze Detection" device in detecting wheeze in the compatible Tyto Stethoscope lung recordings respective to ground truth and the predicate device.
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- Human factors validation the minor user interface modifications did not introduce new . critical tasks and didn't impact existing critical tasks. Therefore, no additional human factors validation was required and the human factors testing for the predicate device was applicable.
The performance of the Tyto Insights for Wheeze Detection 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 FDA cleared compatible Tyto Stethoscope. 371 recordings (359 patients) corresponded to the intended patient population of the Tyto Insights for Wheeze Detection Software recorded (86 recordings were Wheeze positive and 285 negative). The sample included recordings with known pre-existing conditions (COPD or Asthma) (7.28%). The demographics of the validation dataset are presented here under in Table 2:
| N=371
patients
| Age Group (Years) | |||
|---|---|---|---|
| Wheeze Positive | Wheeze Negative | Total | |
| 2-18 | 63 (24.2%) | 197 (75.8%) | 260 (70.08%) |
| >=18 | 23 (20.7%) | 88 (79.5%) | 111 (29.92%) |
| Gender | |||
| Positive | Negative | Total | |
| Male | 53 (27.3%) | 141 (72.7%) | 194 (52.29%) |
| Female | 33(18.6%) | 144 (81.4%) | 177 (47.71%) |
Table 2: Validation data-set demographics
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 standalone accuracy is presented hereunder in Table 3:
| Parameter | Estimate (two-sided 95% CI) |
|---|---|
| Sensitivity (Se) | 0.54 (0.43-0.65) |
| Specificity (Sp) | 0.98 (0.97-0.99) |
| Positive Predictive Value (PPV) | 0.72 (0.48-0.89) |
| Negative Predictive Value (NPV) | 0.97 (0.97-0.98) |
Table 3: The stand-alone accuracy of the Tyto Insights for Wheeze Detection
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To establish standalone accuracy and demonstrate substantial equivalency with the predicate device, the primary end point was area under the Curve (AUC) for the detection of wheezes by the proposed device compared to the TytoCare Lung Sounds Analyzer (K221614) for patients aged 2 years and above. The independent algorithm result was compared to the result of the TytoCare Lung Sounds Analyzer (K221614) for the same recordings to establish the noninferiority of the automated algorithm respective to the predicate device. Success was defined as a lower bound of 95% two-sided CI for the difference in AUCs between the Tyto Insights for Wheeze Detection and the TytoCare Lung Sounds Analyzer (K221614) is higher than noninferiority margin of -0.05 for the recordings. Non-inferiority of Tyto Insights for Wheeze Detection compared to TytoCare Lung Sounds Analyzer (K221614) is demonstrated in Table 4:
| AUC | LCI | UCI | |
|---|---|---|---|
| TytoCare Lung Sounds Analyzer (K221614) | |||
| [Analyzer] | 0.9085 | 0.8678 | 0.9372 |
| Tyto Insights for Wheeze Detection [Insights] | 0.9654 | 0.9459 | 0.9790 |
| Insights - Analyzer | 0.0570 | 0.0289 | 0.0917 |
Table 4: Primary Endpoint stand-alone assessment: Tyto Insights for Wheeze Detection compared to TytoCare Lung Sounds Analyzer (K221614)
AUC – Area Under the receiver operating characteristic Curve; LCI/UCI – lower/upper bound of two-sided 95% bootstrap (BCa) Confidence Interval
Non-inferiority of Tyto Insights for Wheeze Detection compared to TytoCare Lung Sounds Analyzer (K221614) for 2 years and above was established. Similar effect trend was also shown within the subgroup analysis, as evidence that the device accuracy is consistent with age groups and relevant pre-existing conditions.
Conclusion
The Tyto Insights for Wheeze Detection Software has the same intended use and indication for use as the predicate. The Tyto Insights for Wheeze Detection is only compatible with the FDA cleared TytoCare Stethoscope that provides the input stethoscope recordings. The minor differences in the user interface wording and software algorithm modality do not raise new questions of safety and effectiveness. Non-inferiority of Tyto Insights for Wheeze Detection compared to the predicate device for intended patient population was established. Thus, we conclude that the Tyto Insights for Wheeze Detection is as safe and effective as the predicate device.