Anesthesiology · 510(k) · 2023
Tyto Insights for Wheeze Detection
Tyto Care Ltd.. Cleared by FDA on 13 December 2023 under submission K232237, product code PHZ (abnormal breath sound device). What FDA's record says, in FDA's words.
Device record · K232237
- Device. Tyto Insights for Wheeze DetectionDEVICE
- Company. Tyto Care Ltd. (IL)COMPANY
- Decision. 13 December 2023, 510(k), substantially equivalent (traditional review); received 28 July 2023DECISION
- Panel. AnesthesiologyPANEL
- Product code. PHZ, Abnormal Breath Sound DeviceCODE
- Regulation. 21 CFR 868.1900, Class IIREG
- Source. FDA database entry · decision document (17 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
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.
The product code's definition, from FDA's classification record. The device is intended to measure abnormal breath sound, such as wheeze, rhonchi, and whistling.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsdetection or identification of findings
- Mentionsadult patients
- Mentionspediatric patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code PHZ. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code PHZ, in Anesthesiology, from Tyto Care Ltd., or cleared in 2023. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.