Sense System with IBT Electrodes

K182112

Infinite Biomedical Technologies, LLC · cleared 2018-10-05 · product code GXY · Neurology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.4)
“The Sense System is a surface electromyography (EMG) electrode system designed to enhance control of upper limb prosthetic devices. The Sense System detects EMG signals using the IBT Electrodes (previously approved by the FDA under 510k, K173571). The electrode signals are then processed using a pattern recognition algorithm and translated to output signals that are standardized to be compatible with an array of connected prosthetic devices, such as hands, wrists or elbows.”
Algorithmpattern recognition algorithm
source quote (p.4)
“The electrode signals are then processed using a pattern recognition algorithm and translated to output signals that are standardized to be compatible with an array of connected prosthetic devices”
Adaptive (vs locked)No
PCCPNo
Cybersecurity addressedNo

Validation studies (1)

Bench

sample size not stated

standards: IEC/EN 60601-1, IEC 60601-1-11, IEC 60601-1-2, IEC 62133, UN38.3

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

0
recalls in product code, 24mo
57
MAUDE reports in code, 12mo
+38%
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/K182112