(30 days)
The Clarius Ultrasound Scanner is a software-based ultrasound imaging system and accessories, intended for diagnostic imaging. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: ophthalmic, fetal, abdominal, intra-operative (non-neurological), pediatric, small organ, cephalic (adult), trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), urology, cardiac (adult, pediatric), peripheral vessel, carotid, and procedural guidance of needles into the body.
The system is a transportable ultrasound system intended for use in environments where is provided by trained healthcare professionals.
The Clarius Ultrasound Scanner is a portable, general-purpose, software-controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through an off-the-shelf (OTS) iOS or Android device. The Clarius Ultrasound Scanner comprises a series of wireless transducers employing Bluetooth and Wi-Fi-based technology to communicate with traditional tablet/smartphone devices via direct Wi-Fi. This allows the user to export ultrasound images and display them across a range of portable personal devices.
The Clarius Ultrasound Scanner system is a transportable ultrasound system intended for use in environments where healthcare is provided by trained healthcare professionals, including the emergency medical services (EMS) environment. The Clarius Ultrasound Scanner is intended for use by qualified healthcare practitioners (e.g., doctors, nurses, sonographers) who are trained in the use of ultrasound imaging technology.
The Clarius Scanner PAL HD3 ("PAL HD3") (subject device of this 510(k) premarket notification) is a multipurpose dual-array transducer that incorporates high-frequency linear array (equivalent to the L15 HD3 transducer cleared under K213436)) and low-frequency phased array (equivalent to the PA HD3 transducer cleared under K213436) ultrasound functionalities where the two separate transducer ceramics are arranged side-by-side within the same transducer model (PAL HD3). The Clarius Scanner PAL HD3 is a new Clarius HD3 transducer variant introduced into the HD3 product line of the Clarius Ultrasound Scanner device family and represents a design modification to the existing PA HD3 transducer of the Clarius Ultrasound Scanner system, which was most recently 510(k)-cleared under K213436.
The Clarius Scanner PAL HD3 has two separate transducer ceramics positioned side-by-side which consist of the linear array and the phased array. The Clarius Scanner PAL HD3 offers a wide frequency range of 1 – 15 MHz within a single transducer. The body and electronics of the PAL HD3 scanner are identical to the currently released HD3 scanner models (the PA HD3 and the L15 HD3) of the Clarius Ultrasound Scanner device family (cleared under K213436); the main difference is in the scanner head. The Clarius Scanner PAL HD3 will allow clinicians to switch between the phased array and the linear array without having to use two separate scanners during exams and procedures.
The Clarius Ultrasound Scanner, subject of this 510(k) premarket notification, comprises the following:
Transducer/ Scanner: PAL HD3
Software: Clarius Ultrasound App (Clarius App) for iOS; Clarius Ultrasound App (Clarius App) for Android
Accessories: Clarius Charger HD3; Clarius Power Fan HD3
The provided document, a 510(k) Premarket Notification from the FDA to Clarius Mobile Health Corp., does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.
Instead, it is a clearance letter from the FDA stating that the new device, the Clarius Ultrasound Scanner with the PAL HD3 transducer, has been found "substantially equivalent" to a previously marketed predicate device (K213436). The document explicitly states:
"The Clarius Ultrasound Scanner (PAL HD3 transducer model) did not require clinical studies to support the determination of substantial equivalence."
This means that a detailed clinical performance study with defined acceptance criteria, test sets, expert adjudication, or MRMC studies, as requested in your prompt, was not performed or submitted for this specific 510(k) clearance due to the nature of the "substantial equivalence" determination for this device modification.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance: No such data is present.
- Sample size used for the test set and data provenance: No test set described.
- Number of experts and qualifications for ground truthing: No ground truthing process described.
- Adjudication method for the test set: No adjudication described.
- MRMC comparative effectiveness study results: No such study was done.
- Standalone (algorithm only) performance: This device is an ultrasound scanner, not an AI algorithm.
- Type of ground truth used: No ground truth used as no clinical study was performed.
- Sample size for the training set: Not applicable as this is not an AI/ML device requiring a training set in the context of clinical performance.
- How ground truth for the training set was established: Not applicable.
The document focuses on demonstrating substantial equivalence through:
- Comparison of Indications for Use: The new device has the same indications for use as the predicate.
- Comparison of Technological Characteristics: The new device (PAL HD3) combines two transducer types (phased array and linear array) that were already present in separate models of the predicate device (PA HD3 and L15 HD3). The body and electronics are identical.
- Compliance with Recognized Standards: The device underwent non-clinical performance testing to demonstrate compliance with relevant safety and performance standards (e.g., IEC 60601 series, ISO 14971) indicating electrical safety, EMC, usability, and acoustic output.
In summary, the provided text explains why a detailed clinical performance study with acceptance criteria was not required for this 510(k) clearance, rather than describing such a study.
§ 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.