PeriCALM Patterns 3.0

K241009

PeriGen, Inc. · cleared 2025-01-10 · product code HGM · Obstetrics and Gynecology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“PeriCALM Patterns 3.0 is a software device to be used with fetal/maternal monitoring systems. The subject device is a software algorithm to detect, label and measure features (accelerations, decelerations, baseline, and contractions) in electronic fetal monitoring (EFM) records.”
AlgorithmLong and Short-Term Memory (LSTM) neural networks
source quote (p.5)
“The subject device includes present-day Long and Short-Term Memory (LSTM) neural networks to identify segments of a fetal heart rate tracing corresponding to accelerations, decelerations, baseline as well as uninterpretable segments where there is missing tracing.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedYes
source quote (p.7)
“Cybersecurity was evaluated as recommended in the 2023 FDA guidance document “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.””

Validation studies (2)

Bench

sample size not stated

Reader study (MRMC)

n=70 patients

endpoints: non-inferiority for accelerations and decelerations (Sensitivity, Specificity, PPV); FHR baseline measurements (bias, mean difference, Limits of Agreement)

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

5
recalls in product code, 24mo
108
MAUDE reports in code, 12mo
-1%
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 Obstetrics and Gynecology 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/K241009