Tyto Insights for Wheeze Detection

K232237

Tyto Care Ltd. · cleared 2023-12-13 · product code PHZ · Anesthesiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“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).”
AlgorithmArtificial Intelligence enabled
source quote (p.14)
“The Algorithm of the proposed device is Artificial Intelligence enabled while the Algorithm of the predicate device is rule based.”
Adaptive (vs locked)No
PCCPNo
Cybersecurity addressedYes
source quote (p.15)
“Cybersecurity- all the applicable information to reflect effective cybersecurity 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.”

Validation studies (1)

Retrospective clinical

n=371 images

endpoints: Sensitivity; Specificity; Positive Predictive Value; Negative Predictive Value; Area under the Curve

standards: ANSI AAMI ISO 14971:2019, ANSI AAMI IEC 62304:2006/A1:2016, ISO 15223-1 Fourth edition 2021-07, ANSI AAMI IEC 62366-1:2015+AMD1:2020

Reported performance (5 observations)

sensitivity0.54CI 0.43-0.65
source quote (p.16)
“Sensitivity (Se) 0.54 (0.43-0.65)”
specificity0.98CI 0.97-0.99
source quote (p.16)
“Specificity (Sp) 0.98 (0.97-0.99)”
aurocas written: “auc”0.9654CI 0.9459-0.9790
source quote (p.17)
“Tyto Insights for Wheeze Detection [Insights] 0.9654 0.9459 0.9790”
ppvas written: “Positive Predictive Value”0.72CI 0.48-0.89
source quote (p.16)
“Positive Predictive Value (PPV) 0.72 (0.48-0.89)”
npvas written: “Negative Predictive Value”0.97CI 0.97-0.98
source quote (p.16)
“Negative Predictive Value (NPV) 0.97 (0.97-0.98)”

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Anesthesiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K232237