SignalHF (IM008)

K230842

Implicity Inc. · cleared 2023-10-25 · product code QNL · Cardiovascular

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.6)
“SignalHF is a software as medical device (SaMD) that uses a proprietary and validated algorithm, the SignalHF HF Score, to calculate the risk of a future worsening condition related to Heart Failure (HF).”
Algorithmproprietary and validated algorithm that computes an HF score using physiologic measures from cardiac implants and personal health records, performing physiologic data analysis using machine learning.
source quote (p.6)
“SignalHF is a software as medical device (SaMD) that uses a proprietary and validated algorithm, the SignalHF HF Score, to calculate the risk of a future worsening condition related to Heart Failure (HF). The algorithm computes this HF score using data obtained from (i) a diverse set of physiologic measures generated in the patient's remotely accessible pre-existing cardiac implant (activity, atrial burden, heart rate variability, heart rate, heart rate at rest, thoracic impedance (for fluid retention), and premature ventricular contractions per hour), and (ii) his/her available Personal Health Records (demographics).”
Adaptive (vs locked)No
source quote (p.6)
“Based on an alert and a recovery threshold on the SignalHF score established during the learning phase of the algorithm and fixed for all patients, our monitoring system is expected to raise an alert 30 days (on median) before a predicted HF hospitalization event (see Figure 1).”
PCCPNo
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

n=3,678 patients

endpoints: Sensitivity for detecting hospitalizations with HF as primary diagnosis; Unexplained alert rate per patient-year; Time before HF hospitalization event for true positive alerts

Reported performance (18 observations)

sensitivity59.8CI [54.0%; 65.4%]
source quote (p.10)
“59.8% [54.0%; 65.4%]”
sensitivityas written: “Sensitivity (Pacemaker/CRT-P)”45.9CI [38.1%; 53.8%]
source quote (p.10)
“45.9% [38.1%; 53.8%]”
sensitivityas written: “Medtronic ICD/CRT-D Sensitivity”52CI [43.6%; 60.2%]
source quote (p.11)
“52.0% [43.6%; 60.2%]”
sensitivityas written: “Medtronic Pacemaker/CRT-P Sensitivity”50.4CI [30.6%; 70.2%]
source quote (p.11)
“50.4% [30.6%; 70.2%]”
sensitivityas written: “Boston Scientific ICD/CRT-D Sensitivity”62.5CI [46.9%; 75.8%]
source quote (p.11)
“62.5% [46.9%; 75.8%]”
sensitivityas written: “Biotronik ICD/CRT-D Sensitivity”70CI [60.6%; 77.9%]
source quote (p.12)
“70.0% [60.6%; 77.9%]”
sensitivityas written: “Biotronik Pacemaker/CRT-P Sensitivity”45.3CI [36.9%; 53.9%]
source quote (p.12)
“45.3% [36.9%; 53.9%]”
sensitivityas written: “Medtronic ICD/CRT-D One lead Sensitivity”43.5CI [29.6%; 58.5%]
source quote (p.13)
“43.5% [29.6%; 58.5%]”
sensitivityas written: “Medtronic ICD/CRT-D Two leads Sensitivity”49.3CI [35.8%; 63.0%]
source quote (p.13)
“49.3% [35.8%; 63.0%]”
sensitivityas written: “Medtronic ICD/CRT-D Three leads Sensitivity”62.7CI [48.0%; 75.4%]
source quote (p.13)
“62.7% [48.0%; 75.4%]”
sensitivityas written: “Medtronic PM/CRT-P One lead Sensitivity”16.7CI [2.3%; 63.1%]
source quote (p.13)
“16.7% [2.3%; 63.1%]”
sensitivityas written: “Medtronic PM/CRT-P Two leads Sensitivity”64.6CI [34.5%; 86.3%]
source quote (p.13)
“64.6% [34.5%; 86.3%]”
sensitivityas written: “Biotronik ICD/CRT-D One lead Sensitivity”71.2CI [40.3%; 90.0%]
source quote (p.14)
“71.2% [40.3%; 90.0%]”
sensitivityas written: “Biotronik ICD/CRT-D Two leads Sensitivity”67.5CI [50.3%; 81.1%]
source quote (p.14)
“67.5% [50.3%; 81.1%]”
sensitivityas written: “Biotronik ICD/CRT-D Three leads Sensitivity”63.1CI [48.4%; 75.8%]
source quote (p.14)
“63.1% [48.4%; 75.8%]”
sensitivityas written: “Biotronik PM/CRT-P One lead Sensitivity”29.4CI [11.2%; 58.0%]
source quote (p.15)
“29.4% [11.2%; 58.0%]”
sensitivityas written: “Biotronik PM/CRT-P Two leads Sensitivity”40.2CI [30.9%; 50.2%]
source quote (p.15)
“40.2% [30.9%; 50.2%]”
sensitivityas written: “Biotronik PM/CRT-P Three leads Sensitivity”48CI [26.3%; 70.4%]
source quote (p.15)
“48.0% [26.3%; 70.4%]”

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 Cardiovascular 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/K230842