SENSICARDIAC

K121617

DIACOUSTIC MEDICAL (PTY) · cleared 2012-07-27 · product code DQD · Cardiovascular

Premarket evidence — what FDA accepted

Device typesimd
source quote (p.1)
“The Sensi Diagnostic Heart Murmur Software is a decision support device intended to acquire, record, and anlyze heart sounds. It is used to distinguish between normal/ physiological and pathological heart murmurs by recording the acoustic signal of the heart by means of an electronic stethoscope.”
Algorithmsignal processing algorithms, classifier and feature extraction algorithm
source quote (p.3)
“Both Sensi and Cardioscan uses equivalent signal processing algorithms by analyzing only the recorded acoustic heart signal at the four main recording locations. The new Sensi software's classifier and feature extraction algorithm are identical to the previous FDA cleared Sensi software.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (6)

Bench

sample size not stated

endpoints: Usability validation was performed within real life clinical settings by intended users.; On average all users scored the usability of the Sensi Software more than 4 out of 5.

Retrospective clinical

n=43 patients

endpoints: Sensi V1 achieves overall accuracy of 70.8%; Cardioscan achieves an accuracy of 67.9%; Sensi V2 achieves overall accuracy 69.7%

Bench

sample size not stated

endpoints: Specificity of 95% and sensitivity of 84%

Bench

sample size not stated

endpoints: The Sensi V1 and Sensi V2 software packages uses the same tested and trialed graphical user interface. Functional and graphical differences are compared.

Retrospective clinical

n=1,568 other

Bench

sample size not stated

endpoints: A study was conducted to verify the technical equivalence between the stethoscopes specified.

Reported performance (5 observations)

sensitivity0.84
source quote (p.3)
“Specificity of 95% and sensitivity of 84%”
specificity0.95
source quote (p.3)
“Specificity of 95% and sensitivity of 84%”
accuracyas written: “overall accuracy (Sensi V1)”0.708
source quote (p.3)
“Sensi V1 achieves overall accuracy of 70.8%.”
accuracyas written: “overall accuracy (Cardioscan)”0.679
source quote (p.3)
“Cardioscan achieves an accuracy of 67.9%”
accuracyas written: “overall accuracy (Sensi V2)”0.697
source quote (p.3)
“Sensi V2 achieves overall accuracy 69.7%”

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
1
MAUDE reports in code, 12mo
+200%
vs code's own 3-yr baseline
1
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K131044 (decision 2013-09-04) from DIACOUSTIC MEDICAL DEVICES (PTY) LTD. for a matching device line ("SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K131044

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/K121617