Personalized Therapy Comfort Settings (PTCS)

K251657

ResMed Corp · cleared 2025-12-05 · product code BZD · Anesthesiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.6)
“The subject device, Personalized Therapy Comfort Settings (PTCS), is an AI-enabled software accessory intended for use with compatible ResMed positive airway pressure (PAP) therapy devices.”
AlgorithmAI-enabled, machine learning (ML)-based algorithm
source quote (p.6)
“The subject device, Personalized Therapy Comfort Settings (PTCS), is an AI-enabled software accessory intended for use with compatible ResMed positive airway pressure (PAP) therapy devices. PTCS functions as a stand-alone, machine learning (ML)-based algorithm that generates individualized comfort setting recommendations based on patient-specific input data.”
Adaptive (vs locked)No
source quote (p.11)
“The PCCP does not include provision for implementation of adaptive algorithms that continuously learn a production environment. All algorithm modifications will be trained, tuned, and locked prior to release of the software to the field.”
PCCPYes
source quote (p.1)
“FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP).”
Cybersecurity addressedYes
source quote (p.6)
“Cybersecurity – ResMed's approach to cybersecurity aligns with the FDA guidance "Cybersecurity in Medical Devices" (issued March 2024) and Section 524B of the FD&C Act.”

Validation studies (1)

Retrospective clinical

sample size not stated

endpoints: patient therapy engagement; increased nightly usage; additional usage days; comparable residual AHI; mask leak

standards: FDA guidance “Content of Premarket Submissions for Device Software Functions” (issued June 2023), FDA's draft guidance, “AI-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations" (issued January 2025), FDA guidance "Cybersecurity in Medical Devices" (issued March 2024), Section 524B of the FD&C Act

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

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

3
recalls in product code, 24mo
35817
MAUDE reports in code, 12mo
-43%
vs code's own 3-yr baseline
0
drift signals on this device

Recalls attributed to this device

  • Recalling firm matches this device's applicant (Resmed Corporation) — same firm and product code, not necessarily this device · initiated 2016-07-12

    Masks in this lot, labelled and sold as 62702 vented Quattro Air FFM size Medium actually contain a non-vented (NV) Quattro Air FFM Large mask.

    recall event 74736 (openFDA)

  • Recalling firm matches this device's applicant (Resmed Corporation) — same firm and product code, not necessarily this device · initiated 2007-04-23

    S8 devices manufactured between July 2004 and May 15, 2006 are susceptible to fatigue in the connection of the AC appliance inlet connector and the power supply (power cord) leading to possible failure (short circuit, electrical failure, sparks, smoke).

    recall event 37832 (openFDA)

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/K251657