(24 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, gynecology, 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 system is a transportable ultrasound system intended for use in environments where is provided by trained healthcare professionals, including the emergency medical services (EMS) environment.
The Clarius Ultrasound Scanner is a software-based ultrasound imaging system with various transducers. The acceptance criteria and the study proving the device meets these criteria are described below.
1. Table of Acceptance Criteria and Reported Device Performance:
| Criteria for Comparison | Predicate Device (K180799) Performance | Subject Device (Clarius Ultrasound Scanner) Performance |
|---|---|---|
| Portability | Portable ultrasound system | Portable ultrasound system |
| Power Source | Removable battery (Li-ion) | Removable battery (Li-ion) |
| Display | iOS or Android mobile device | iOS or Android mobile device |
| Wireless Capability | Communicates wirelessly via Wi-Fi and Bluetooth | Communicates wirelessly via Wi-Fi and Bluetooth |
| 510(k) Track | Track 3 | Track 3 |
| Transducer Types | Convex Array, Linear Array, Phased Array, Intracavity | Convex Array, Linear Array, Phased Array, Intracavity |
| Intended Use | Diagnostic ultrasound imaging and fluid flow analysis | Diagnostic ultrasound imaging and fluid flow analysis |
| Indications for Use | Ophthalmic, Fetal, Abdominal, Intraoperative (Ab/Vasc), Pediatric, Small organ, Adult cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conv.), Musculo-skeletal (Superfic.), Urology, Gynecology, Cardiac adult, Cardiac pediatric, Peripheral vessel, Carotid, Needle guidance | Ophthalmic, Fetal, Abdominal, Intraoperative (Ab/Vasc), Pediatric, Small organ, Adult cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conv.), Musculo-skel. (Superfic.), Urology, Gynecology, Cardiac adult, Cardiac pediatric, Peripheral vessel, Carotid, Needle guidance |
| Modes of Operation | B-mode, M-mode, Color Doppler, Power Doppler, PWD, Combined (B+M; B+CD; B+PD; B+PWD) | B-mode, M-mode, Color Doppler, Power Doppler, PWD, Combined (B+M; B+CD; B+PD; B+PWD) |
The reported performance of the subject device (Clarius Ultrasound Scanner) is identical to the predicate device (Clarius Ultrasound Scanner, K180799) across all listed criteria, indicating substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance:
The provided document does not mention a specific "test set" or its sample size for evaluating the performance of the new transducer models. The study primarily relies on demonstrating substantial equivalence to a previously cleared predicate device.
- Data Provenance: Not explicitly stated for a dedicated test set. The submission focuses on nonclinical performance data related to compliance with various international standards, rather than direct human subject testing for the new transducer models.
3. Number of Experts and Qualifications for Ground Truth:
Not applicable. The document states that "The Clarius Ultrasound Scanner did not require clinical testing to establish substantial equivalence." Therefore, no experts were used to establish ground truth for a clinical test set. The substantial equivalence argument is based on technical specifications and adherence to recognized standards.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test set requiring expert adjudication was conducted or described in the provided information.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was mentioned or performed as per the provided document. The submission focuses on comparing the new device models to a predicate device based on technical and functional equivalence.
6. Standalone Performance Study (Algorithm Only):
The document does not describe a standalone algorithm-only performance study. The "Clarius Ultrasound Scanner" is described as a comprehensive ultrasound imaging system, not a device primarily driven by an AI algorithm requiring standalone performance evaluation in the context of this submission. The device is software-based but its performance evaluation within this 510(k) submission is related to hardware compliance and functional equivalence, not AI-driven diagnostic performance that would necessitate standalone algorithm studies.
7. Type of Ground Truth Used:
Not applicable. As clinical testing was not required for substantial equivalence, no clinical ground truth (e.g., expert consensus, pathology, outcomes data) was established or used for the evaluation of the subject device in this submission. The "ground truth" for the device's capabilities is implicitly established by its adherence to recognized industry standards for medical electrical equipment and its equivalence to the predicate device’s established performance.
8. Sample Size for the Training Set:
Not applicable. The provided information relates to a 510(k) submission for new transducer models, demonstrating substantial equivalence to a predicate device. It does not mention machine learning or AI models requiring a training set for diagnostic or analytical performance.
9. How Ground Truth for the Training Set Was Established:
Not applicable, as no training set for a machine learning or AI model was mentioned in the provided text.
§ 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.