← Product Code [PHZ](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/PHZ) · K240555 # Tyto Insights for Crackles Detection (K240555) _Tyto Care , Ltd. · PHZ · Jul 2, 2024 · Anesthesiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/PHZ/K240555 ## Device Facts - **Applicant:** Tyto Care , Ltd. - **Product Code:** [PHZ](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/PHZ.md) - **Decision Date:** Jul 2, 2024 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 868.1900 - **Device Class:** Class 2 - **Review Panel:** Anesthesiology - **Attributes:** AI/ML, Software as a Medical Device, PCCP, Pediatric ## Intended Use The Tyto Insights for Crackles 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 510k cleared compatible Tyto Stethoscope and identifies recordings where a specific abnormal lung sound suggestive of "Crackle" 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 Crackles Detection result. Healthcare providers should consider the device result in conjunction with recording and other relevant patient data. ## Device Story Web-based AI decision support software; analyzes lung sound recordings from compatible Tyto Stethoscope (K181612). Input: acoustic lung sound files; Output: positive/negative indication for crackles. Used in clinical or home environments by professional or lay users. System comprises Application Server (APS), Algorithm Server (ALS), and Web Server (WBS) hosted in the cloud. Healthcare providers use the graphic output in conjunction with patient data to inform clinical decision-making. Benefits include automated detection of abnormal lung sounds to assist in patient assessment. ## Clinical Evidence Retrospective validation study using 446 recordings (120 positive, 326 negative) from 445 patients. Primary endpoint: non-inferiority of device AUC vs. clinical readers (margin -0.05). Results: Device AUC 0.97 (95% CI 0.95-0.98) vs. Readers AUC 0.77 (0.73-0.8). Sensitivity 0.72 (0.63-0.79), Specificity 0.99 (0.97-1.00). Non-inferiority established. ## Technological Characteristics Cloud-hosted software system; utilizes CRNN (Convolutional Recurrent Neural Network) architecture. Communicates via IP network. Compatible with Tyto Stethoscope (K181612). Standards: ISO 14971, IEC 62304, ISO 15223-1, IEC 62366-1. ## Regulatory 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 - Tyto Insights for Wheeze Detection ([K232237](/device/K232237.md)) ## Reference Devices - VRIxp ([K091732](/device/K091732.md)) - TytoCare Lung Sounds Analyzer ([K221614](/device/K221614.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. July 2, 2024 Tyto Care Ltd. Stella Raizelman Perry RA&QA Director 14 Beni Gaon Street Netanya, 4250803 Israel Re: K240555 Trade/Device Name: Tyto Insights for Crackles Detection Regulation Number: 21 CFR 868.1900 Regulation Name: Diagnostic Pulmonary-Function Interpretation Calculator Regulatory Class: Class II Product Code: PHZ Dated: Mav 31, 2024 Received: May 31, 2024 Dear Stella Raizelman 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. FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP). Under section 515C(b)(1) of the Act, a new premarket notification is not required for a change to a device cleared under section 510(k) of the Act, if such change is consistent with an {1}------------------------------------------------ established PCCP granted pursuant to section 515C(b)(2) of the Act. Under 21 CFR 807.81(a)(3), a new premarket notification is required if there is a major change or modification in the intended use of a device, or if there is a change or modification in a device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process. Accordingly, if deviations from the established PCCP result in a major change or modification in the intended use of the device, or result in a change or modification in the device that could significantly affect the safety or effectiveness of the a new premarket notification would be required consistent with section 515C(b)(1) of the Act and 21 CFR 807.81(a)(3). Failure to submit such a premarket submission would constitute adulteration and misbranding under sections 501(f)(1)(B) and 502(o) of the Act, respectively. 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" (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 (OS) 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 QS 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 medical devices and radiation-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-regulatory {2}------------------------------------------------ assistance/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, Image /page/2/Figure/3 description: The image shows a digital signature. The signature is for Binoy J. Mathews -S. The date of the signature is 2024.07.02 14:14:26 -04'00'. For Rachana Visaria 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 {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K240555 #### Device Name Tyto Insights for Crackles Detection #### Indications for Use (Describe) The Tyto Insights for Crackles 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 510k cleared compatible Tyto Stethoscope and identifies recordings where a specific abnormal lung sound suggestive of "Crackle" 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 Crackles 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) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for TytoCare. The logo features a stylized owl icon to the left of the word "tytocare" in a lowercase, sans-serif font. A trademark symbol is located to the upper right of the word "tytocare". # 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: | July 02, 2024 | | Device Trade
Name(s): | Tyto Insights for Crackles Detection | | Device Common
Name: | Tyto Insights for Crackles Detection | | Classification: | Name: Diagnostic pulmonary-function interpretation
calculator
Product code: PHZ
Regulation No: 21 CFR 868.1900
Class: II
Panel: Anesthesiology | | Primary Predicate Device(s): | | | |---------------------------------------|------------|-------------------| | Device name | 510(k) No. | Date of Clearance | | Tyto Insights for Wheeze
Detection | K232237 | December 13, 2023 | | Reference Device(s): | | | | Device name | 510(k) No. | Date of Clearance | | VRIxp | K091732 | March 04, 2010 | {5}------------------------------------------------ ## Intended use / indication for use statement The Tyto Insights for Crackles 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 510k cleared compatible Tyto Stethoscope and identifies recordings where a specific abnormal lung sound suggestive of "Crackle" 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 Crackles Detection result. Healthcare providers should consider the device result in conjunction with recording and other relevant patient data. ## Device description The Tyto Insights for Crackles 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 Crackle is detected within the recorded sound data. The Tyto Insights for Crackles 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 Crackles Detection Application Server (APS) communicates with 1. the Tyto Insights for Crackles Detection Algorithm Server (ALS) and implements an application programming interface (API) for communication with the telehealth server. - The Tyto Insights for Crackles Detection Algorithm Server (ALS) receives an audio file 2. as input and returns an analysis result of positive or negative regarding whether a Crackles was detected as output. - The Tyto Insights for Crackles Detection Web Server (WBS) provides a graphic 3. indication whether a Crackles 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. {6}------------------------------------------------ # Substantial Equivalence to Predicate Devices The following table compares the Tyto Insights for Crackles Detection to the predicate and reference device. Table 1. Substantial Equivalence Summary | | Device | Primary Predicate device | Reference device | Summary | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | Tyto Insights for Crackles
Detection | Tyto Insights for Wheeze
Detection | VRIxp | NA | | Device
Manufacturer | Tyto Care Ltd. | Tyto Care Ltd. | Deep Breeze Ltd. | NA | | 510(k) Number | TBD | K232237 | K091732 | NA | | Device Class | Class II | Class II | Class II | Same as the predicate
device. | | Review Panel | Anesthesiology | Anesthesiology | Cardiovascular
Diagnostic Devices | Same as the primary
predicate device. | | Product code | PHZ | PHZ | OCR | Same as the primary
predicate device. | | Regulation number | 21 CFR 868.1900 | 21 CFR 868.1900 | 21 CFR 870.1875 | Same as the primary
predicate device. | | Device
Classification Name | Abnormal breath sound
device | Abnormal breath sound
device | Lung sound monitor | Same as the primary
predicate device. | | Intended use and
indication for use | Device | Primary Predicate device | Reference device | Summary | | The “Tyto Insights for
Crackles 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 analyses 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
“Crackle” 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
Crackles Detection result.
Healthcare providers
should consider the device
result in conjunction with
recording and other
relevant patient data. | | 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 analyses 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 | The VRIxp is intended
for monitoring and
recording lung sounds
and automatic detection
of crackles and wheezes.
When interpreted by
physicians with general
medical training and
experience, the VRIxp
aids in diagnosis and
patient management. The
VRIxp is intended to be
used in healthcare
facilities on adults,
adolescents, and/or
children over the height
of 2 feet 9 inches. | Same intended use as
the primary predicate
device and similar
indication for use as the
reference device.

Both the predicate
device and the subject
device have the same
intended use in that
both are intended to
detect specific and
abnormal breath sounds
in the same 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.

The subject device is
indicated to detect | | | Device | Primary Predicate device | Reference device | Summary | | | | result in conjunction with
recording and other
relevant patient data. | | crackles similar to the
reference device. | | Type of use | Over-The-Counter Use | Over-The-Counter Use | Prescription use | Same as the primary
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 primary
predicate device. | | Intended patient
population | Intended for patients of 2
years and older | Intended for patients of 2
years and older | Adults, adolescents,
and/or children over the
height of 2 feet 9 inches. | Same as the primary
predicate device. | | Intended
environment | Non-clinical (home) and
clinical | Non-clinical (home) and
clinical | Clinical setting | Same as the primary
predicate device | | Form | Stand-alone software
system | Stand-alone software
system | Hardware (sensors) and
software.

Use sound sensors to
collect lung sounds via
dermal contact, which is
then converted to a visual
display. | Same as the primary
predicate device. | | Device composition | The following modules
compose the Tyto Insights
for Crackles Detection:
• The Tyto Insights for
Crackles Detection
Application Server
(APS) | The following modules
compose the Tyto Insights
for Wheeze Detection:
• The Tyto Insights for
Wheeze Detection
Application Server
(APS) | The system is composed
of:
1. Sound sensors
designed to collect
lung sounds via
dermal contact with
human skin
2. Digital Collection | The subject device
shares the same
structural sub-systems
as the primary predicate
device: ALS, APS, and
WBS.
The analytical
component of the ALS | | | Device | Primary Predicate device | Reference device… --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/PHZ/K240555](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/PHZ/K240555) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com