EnsoSleep

K210034

EnsoData, Inc. · cleared 2021-06-16 · product code OLZ · Neurology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“EnsoSleep is a software-only medical device to be used under the supervision of a clinician to analyze physiological signals and automatically score sleep study results, including the staging of sleep, detection of arousals, leg movements, and sleep disordered breathing events including obstructive apneas (OSA), central sleep apneas (CSA), and hypopneas.”
AlgorithmAutomated algorithms are applied to the raw signals in order to derive additional signals and interpret the raw and derived signal information. The software automates recognition of the following: respiratory events, sleep staging events, arousal events, movement events, cardiac events, derived signals, and calculated indices.
source quote (p.5)
“Automated algorithms are applied to the raw signals in order to derive additional signals and interpret the raw and derived signal information. The software automates recognition of the following: respiratory events, sleep staging events, arousal events, movement events, cardiac events, derived signals, and calculated indices.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.11)
“Authentication controls, authorization controls, cryptographic controls, access controls, checksum controls, software distribution controls, intrusion detection system controls, network and systems controls, and database controls.”

Validation studies (1)

Retrospective clinical

n=147 patients · 3 site(s)

endpoints: EnsoSleep is intended to assist clinicians with the assessment of sleep quality, therefore performance of device sleep scoring must be validated.; EnsoSleep is intended to assist clinicians with the scoring sleep disordered breathing events used in diagnostic evaluation, therefore device performance for diagnosing sleep apnea must be validated.; EnsoSleep is intended to analyze physiological signals and automatically score sleep study results, including detection of SDB events, Hypopnea events, Apnea events, including OSA events, CSA events, Arousal events, Limb Movement events, RERA events, CS events, and PB events, therefore device performance for detecting each event type must be validated.; EnsoSleep is intended to analyze physiological signals and automatically score sleep study results, including detection of Respiratory Rate events, Sleep-Wake events, and Total Sleep Time, therefore device performance for detecting each event type must be validated.

Reported performance (3 observations)

sensitivity0.944CI 89.0%, 98.7%
source quote (p.19)
“Positive Percent Agreement (%) with two-sided 95% bootstrap median percentile CI's (R=2000) 94.4% (89.0%, 98.7%)”
specificity0.897CI 75.8%, 100.0%
source quote (p.19)
“Negative Percent Agreement (%) with two-sided 95% bootstrap median percentile CI's (R=2000) 89.7% (75.8%, 100.0%)”
agreement_kappaas written: “Overall Percent Agreement”0.93CI 88.0%, 97.0%
source quote (p.19)
“Overall Percent Agreement (%) with two-sided 95% bootstrap median percentile CI's (R=2000) 93.0% (88.0%, 97.0%)”

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
2
MAUDE reports in code, 12mo
+20%
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 Neurology 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/K210034