(48 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 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.
Piezoelectric material in the systems transmits high frequency, non-ionizing sound waves to the designated region of the body and converts the subsequent echoes detected into electronic signals in order to construct an image of the internal structures of an anatomical field. This image is sent wirelessly to an external iOS or Android viewing device on which the image can be displayed. The transducer houses a battery and power generator, multichannel beam former, pre-scan converter, and Wi-Fi components. The battery is removable and comes with a separate charger. Communication between the transducer and the compatible viewing device is performed via Wi-Fi Direct® (Ad-Hoc mode with security) for easy pairing.
The Clarius Ultrasound System product/package components include:
- Software:
. The Clarius Ultrasound App (Clarius App) for iOS; OR
The Clarius Ultrasound App (Clarius App) for Android. ● - Transducers/Scanners:
Clarius Scanner C3 (C3 Convex Transducer);
. Clarius Scanner EC7 (EC7 Convex Endocavitary Transducer);
Clarius Scanner C7 (C7 Convex Transducer); OR ●
Clarius Scanner L7 (L7 Linear Transducer). - Accessories:
a. Clarius-Built:
o Battery Pack (Li-ion);
Battery Charger; O
Clarius Dock (Optional; charging station); and O
Clarius Fan (Optional). O
b. OEM/Off-the-Shelf Product(s):
Medical Power Supply (Off-the-shelf power adaptor from SL Power Electronics; O Model Number ME20A1203B02; approved in the US); and
Medical Power Supply (Optional for use with Clarius Dock; off-the-shelf power o adaptor from MEAN WELL Enterprises Co., Ltd.; Model Number GSM160B12-R7B; approved in the US).
The concept of the Clarius Ultrasound System transducers and software is to provide an easy to use, highperformance, low-cost, ultrasound platform for teaching and clinical applications. The Clarius Ultrasound Scanner is intended for use in professional healthcare facilities where healthcare is provided by trained medical professionals. The device is also intended for use in Emergency Medical Service, ambulance, or rotary aircraft environments.
The Clarius Ultrasound Scanner is a diagnostic ultrasound system. The provided text, a 510(k) summary, outlines its substantial equivalence to predicate devices, thus demonstrating it meets acceptance criteria through a comparison study rather than independent performance testing against predefined metrics.
Here's a breakdown of the requested information based on the provided document:
Acceptance Criteria and Device Performance
The acceptance criteria are not directly stated as quantitative performance metrics (e.g., sensitivity, specificity for a specific diagnostic task). Instead, the device's acceptance is based on demonstrating "substantial equivalence" to legally marketed predicate devices. This means the device performs at a level comparable to, or as safely and effectively as, the predicate devices for its intended use, without raising new questions of safety or effectiveness.
The "reported device performance" is implicitly demonstrated through its substantial equivalence to the predicate devices and compliance with relevant nonclinical performance standards.
The table below outlines the comparison criteria used to establish substantial equivalence, which serves as the framework for acceptance.
| Criteria for Comparison | Clarius Ultrasound Scanner Performance (Subject Device) | Predicate Device Performance (Clarius Ultrasound System K172385) | Predicate Device Performance (ACCUSON S3000, S2000, S1000 K172162) |
|---|---|---|---|
| Portability | Portable ultrasound system | Portable ultrasound system | Mobile ultrasound system |
| Power Source | Removable battery (Li-ion) | Removable battery (Li-ion) | Battery or AC power |
| Display | iOS or Android mobile device | iOS or Android mobile device | Inbuilt digital display |
| Wireless Capability | Communicates wirelessly via Wi-Fi and Bluetooth | Communicates wirelessly via Wi-Fi and Bluetooth | Communicates via cable |
| 510(k) Track | Track 3 | Track 3 | Track 3 |
| Transducer Types | – Convex Array | ||
| – Linear Array | |||
| – Phased Array | |||
| – Intracavity | – Convex Array | ||
| – Linear Array | |||
| – Phased Array | – Convex Array | ||
| – Linear Array | |||
| – Phased Array | |||
| – Intracavity Array | |||
| – Trans-esophageal | |||
| Intended Use | Diagnostic ultrasound imaging and fluid flow analysis | 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-skel. (Conv.) | |||
| – Musculo-skel. (Superfic.) | |||
| – Urology | |||
| – Gynecology | |||
| – Cardiac adult | |||
| – Cardiac pediatric | |||
| – Peripheral vessel | |||
| – Carotid | |||
| – Needle guidance | – Ophthalmic | ||
| – Fetal | |||
| – Abdominal | |||
| – Intraoperative (Ab/Vasc) | |||
| – Pediatric | |||
| – Small organ | |||
| – Adult cephalic | |||
| – Musculo-skel. (Conv.) | |||
| – Musculo-skel. (Superfic.) | |||
| – Urology | |||
| – Gynecology | |||
| – Cardiac adult | |||
| – Cardiac pediatric | |||
| – Fetal echo | |||
| – Peripheral vessel | |||
| – Carotid | |||
| – Needle guidance | – Fetal | ||
| – Abdominal | |||
| – Intraoperative (Ab/Vasc) | |||
| – Intraoperative (Neuro) | |||
| – Pediatric | |||
| – Small organ | |||
| – Neonatal cephalic | |||
| – Adult cephalic | |||
| – Trans-rectal | |||
| – Trans-vaginal | |||
| – Musculo-skel. (Conv.) | |||
| – Musculo-skel. (Superfic.) | |||
| – Gynecology | |||
| – Cardiac adult | |||
| – Cardiac pediatric | |||
| – Trans-esophageal (Card.) | |||
| – Peripheral vessel | |||
| – Needle guidance | |||
| Modes of Operation | – B-mode | ||
| – M-mode | |||
| – Color Doppler | |||
| – Power Doppler | |||
| – PWD | |||
| – CWD | |||
| – Combined (B+M; B+CD; B+PD; B+PWD) | – B-mode | ||
| – M-mode | |||
| – Color Doppler | |||
| – Power Doppler | |||
| – CWD | |||
| – Combined (B+M, B+CD, B+PD) | – B-Mode | ||
| – M-Mode | |||
| – Color Doppler | |||
| – Color M Doppler | |||
| – Power Doppler | |||
| – PWD | |||
| – CWD | |||
| – Harmonic Imaging | |||
| – Combined (B+M, B+PWD, B+CD, B+PD, B+CWD) |
Study Proving Acceptance Criteria
The study described is a comparison study for substantial equivalence under the FDA's 510(k) pathway. It demonstrates that the Clarius Ultrasound Scanner does not introduce any new technology or indications for use that differ significantly from legally marketed predicate devices, thus concluding that it is substantially equivalent in safety and effectiveness.
-
Sample size used for the test set and the data provenance:
- The document states: "The Clarius Ultrasound Scanner did not require clinical testing to establish substantial equivalence to the predicate devices indicated."
- Therefore, there was no separate "test set" of clinical data for the subject device to quantify its performance against specific acceptance criteria. The equivalence is established by comparing the design, technological characteristics, intended use, and indications for use of the subject device to the previously cleared predicate devices.
- The provenance of data for the predicate devices is not detailed in this document.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Since no clinical testing was performed for the subject device, no experts were used to establish ground truth for a test set in the context of this 510(k) summary. The "ground truth" for the predicate devices' clearance would have been established during their respective regulatory processes, not during this submission.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as no clinical test set requiring adjudication was used for this submission.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study was done, as this submission did not involve clinical performance testing of the device's diagnostic accuracy or the impact of AI assistance on human readers. The device is purely an imaging system; the provided document does not mention AI components for image analysis or interpretation.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is an ultrasound imaging system, and the document focuses on establishing substantial equivalence based on hardware, software, intended use, and modes of operation, not on an algorithm's standalone diagnostic performance. No AI algorithm in a standalone capacity is mentioned.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the purposes of this 510(k) submission, the "ground truth" for acceptance is the established safety and effectiveness of the predicate devices as determined by their prior FDA clearances. The subject device is deemed safe and effective because it is substantially equivalent to these already cleared devices, not through new clinical ground truth establishment for its own performance.
-
The sample size for the training set:
- Not applicable. The document does not describe any machine learning components that would require a "training set" of data for this device.
-
How the ground truth for the training set was established:
- Not applicable. As there is no described training set, there methods for establishing ground truth for it are absent.
§ 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.