Laminar P1 (LDH-HW-001)

The Laminar P1 is a wearable, disposable ultrasound-based patch sensor operating at 4.5 MHz in continuous-wave Doppler mode. It detects blood flow in peripheral vessels to assist in identifying peripheral vascular disease and is intended for use by medical professionals on patients 18 years and older in healthcare settings.

Both the Laminar P1 and predicate FloPatch use the Doppler effect via piezoelectric transducers in continuous-wave mode. Key differences: the P1 is smaller (52×38×22 mm vs. 135×108×43.3 mm), lighter (44g vs. <450g), operates at 4.5 MHz versus 4 MHz, has higher acoustic outputs (ISPTA 204.89 vs. 21.47 mW/cm²), includes adjustable volume levels and three receiver options (shallow, medium, deep), and uses a rechargeable battery instead of alkaline batteries.

Biocompatibility per ISO 10993-1, software per IEC 62304, electrical and EMC safety per IEC 60601-1 and IEC 60601-1-2, acoustic output levels per IEC 60601-2-37 and IEC 62359, and bench performance testing for functional, audio, and mechanical characteristics.

Both devices share the same intended use (detecting peripheral blood flow for vascular disease assessment), patient population (18+), use environment (healthcare settings), and application (peripheral vascular). Both employ identical Doppler principle and continuous-wave operation. Although the P1 differs in form factor, frequency, and acoustic output, the manufacturer argues these differences do not raise new safety or effectiveness questions because each difference underwent testing demonstrating equivalence to the predicate.