Laminar P1 (LDH-HW-001)
Laminar Digital Health, Inc.Laminar P1 is a wearable and disposable ultrasound patch sensor designed to detect blood flow in peripheral vessels to help identify peripheral vascular disease. It is intended for use by healthcare professionals in various settings and offers a compact alternative to traditional Doppler ultrasound probes, providing audio output and selectable sensitivity settings to aid clinical assessments.
Intended Use
The Laminar P1 device is a wearable and disposable, ultrasound-based (4.5 MHz, continuous-wave) patch sensor designed to detect blood flow in peripheral vessels and assist in the detection of peripheral vascular disease. It is intended to be used by medical professionals, such as physicians and nurses, in hospitals, clinics and private offices and healthcare facilities, on adults 18 years and older.
Technology
The device consists of a single-use sensor patch with piezoelectric transducers operating at 4.5 MHz in continuous-wave Doppler mode, a single-use sticky patch frame for positioning, and a reusable battery-operated processing unit that controls the sensor, provides audio output with volume control, and three ultrasound receiver settings (shallow, medium, deep) to optimize signal quality.
Performance
The device was tested non-clinically for biocompatibility, software reliability, electrical and EMC safety, acoustic output, and bench performance including audio and mechanical function, adhering to recognized standards. No clinical testing was provided but the results demonstrated substantial equivalence to the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/21/2024
3 months - 2
FDA Approval
12/13/2024
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