(21 days)
Philips Lumify Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), Color Doppler, Combined (B+Color), and M modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications:
Fetal/Obstetric, Abdominal, Pediatric, Cephalic, Urology, Gynecological, Cardiac Fetal Echo, Small Organ, Musculoskeletal, Peripheral Vessel, Carotid, Cardiac.
Lumify is a transportable ultrasound system intended for use in environments where healthcare professionals.
The Lumify Diagnostic Ultrasound System is a mobile, general purpose, softwarecontrolled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data in various modes of operation. Lumify is a portable system facilitating point of care ultrasound applications.
The Lumify Diagnostic Ultrasound System includes:
- A commercial off-the-shelf (COTS) Android or iOS mobile device ●
- Philips Ultrasound software running as an app (Android or iOS) on the COTS device ●
- The C5-2 Curved array USB transducer
- The L12-4 Linear array USB transducer
- The S4-1 Sector array USB transducer
- The Lumify Power Module (LPM) to convert the USB interface used on the family of Lumify transducers to Apple's iAP2 Lightning interface standard used on iPhones and iPads, and to provide battery power to the transducers when using an iOS mobile device
This Philips Healthcare K192226 submission is for a Diagnostic Ultrasound System. The information provided does not detail specific acceptance criteria and performance data for an AI/ML component or a standalone algorithm. Instead, it focuses on the substantial equivalence of the Lumify Diagnostic Ultrasound System to a predicate device, primarily addressing hardware and software expansion to support iOS mobile devices.
Therefore, many of the requested data points (such as sample sizes for test and training sets, number of experts for ground truth, adjudication methods, MRMC studies, and standalone algorithm performance) are not applicable or not provided in the given document. The document explicitly states: "The Lumify Diagnostic Ultrasound System did not require clinical studies because substantial equivalence to the currently marketed predicate Lumify Ultrasound System (K162549) has been established."
However, I can extract the information related to the overall system's safety and nonclinical performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Standard/Guidance | Reported Device Performance |
|---|---|---|
| Acoustic Output | IEC 60601-2-37 Ed 2.1 (Particular requirements for the basic safety and essential performance of ultrasonic medical and monitoring equipment) | Complies with the referenced standard and FDA ultrasound guidance document, "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" (June 27, 2019). System acoustic output limits are identical to the predicate device (K162549): Ispta.3 ≤ 720 MW/cm2, MI |
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.