(27 days)
The HI VISION Avius is intended for use by trained personnel (doctor, songrapher, etc.) for the diagnostic ultrasound evaluation of Abdominal, Cardiac, Intra-operative, Fetal, Pediatric, Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Trans-vaginal, Musculoskeletal, Neonatal Cephalic, Adult Cephalic, Endoscopy, Intra-luminal, Gynecology, Urology and Laparoscopic clinical applications.
An ultrasound system consists of the following:
- Ultrasound transducer(s) to generate the transmitted ultrasound energy and detect the reflected echoes
- A computer system to control the transducer and analyze the signals resulting from the reflected echoes
- A video monitor with optional image recorder to display the computed image or derived Doppler data
The Hitachi HI VISION Avius Diagnostic Ultrasound Scanner (K102901) is intended for diagnostic ultrasound evaluation across various clinical applications. The submission primarily relies on substantial equivalence to a predicate device (HITACHI HI VISION Preirus Diagnostic Ultrasound Scanner K093466) rather than presenting new clinical study data with specific acceptance criteria and performance metrics for the Avidus. Therefore, the information typically found in acceptance criteria tables and detailed study reports for efficacy and performance (e.g., sensitivity, specificity, reader performance) is not available here.
However, the document does list the intended uses for each transducer with the modes of operation as a form of "acceptance criteria" through successful comparison to the predicate device. The "study" proving the device meets these criteria is the submission for substantial equivalence.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly met by demonstrating substantial equivalence to the predicate device, K093466, for each clinical application and mode of operation listed. The "reported device performance" is the assertion that the new device (HI VISION Avius) performs equivalently to the predicate for these applications.
The tables for each transducer (e.g., EUP-B512, EUP-B514, EUP-C511, etc.) indicate the approved clinical applications and the modes of operation. A "P" signifies that the clinical application and mode were previously cleared in the predicate device (K093466), implying the new device meets the same performance standards.
| Clinical Application (Example: Fetal) | Mode of Operation (B, M, PWD, CWD, Color Doppler, Combined*, Other**) | Reported Device Performance (Implicitly: Substantial Equivalence to K093466) |
|---|---|---|
| Fetal | P (B, M, PWD, CWD, Color Doppler, Combined, Other) | Functions equivalently to the predicate device for Fetal imaging. |
| Abdominal | Pa (B, M, PWD, CWD, Color Doppler, Combined, Other) | Functions equivalently to the predicate device for Abdominal imaging. |
| Intra-operative (Spec.) | Pb (B, M, PWD, Color Doppler, Combined, Other) | Functions equivalently to the predicate device for Intra-operative imaging. |
| Pediatric | P (B, M, PWD, CWD, Color Doppler, Combined, Other) | Functions equivalently to the predicate device for Pediatric imaging. |
| Small Organ (Spec.) | Pc/Pd (B, M, PWD, CWD, Color Doppler, Combined, Other) | Functions equivalently to the predicate device for Small Organ imaging. |
| Neonatal Cephalic | P (B, M, PWD, Color Doppler, Combined, Other) | Functions equivalently to the predicate device for Neonatal Cephalic imaging. |
| Adult Cephalic | P (B, M, PWD, CWD, Color Doppler, Combined, Other) | Functions equivalently to the predicate device for Adult Cephalic imaging. |
| Trans-rectal | Pe/Ph (B, M, PWD, Color Doppler, Combined, Other) | Functions equivalently to the predicate device for Trans-rectal imaging. |
| Trans-vaginal | Pf (B, M, PWD, Color Doppler, Combined, Other) | Functions equivalently to the predicate device for Trans-vaginal imaging. |
| Musculo-skeletal (Convent.) | P (B, M, PWD, Color Doppler, Combined, Other) | Functions equivalently to the predicate device for Musculoskeletal imaging. |
| Musculo-skeletal (Superfic.) | P (B, M, PWD, Color Doppler, Combined, Other) | Functions equivalently to the predicate device for Musculoskeletal imaging. |
| Cardiac Adult | P (B, M, PWD, CWD, Color Doppler, Combined, Other) | Functions equivalently to the predicate device for Cardiac Adult imaging. |
| Cardiac Pediatric | P/Pg (B, M, PWD, CWD, Color Doppler, Combined, Other) | Functions equivalently to the predicate device for Cardiac Pediatric imaging. |
| Trans-esophageal (card.) | P (B, M, PWD, CWD, Color Doppler, Combined, Other) (for EUP-ES52E, EUP-ES52M) | Functions equivalently to the predicate device for Trans-esophageal Cardiac imaging. |
| Peripheral vessel | P (B, M, PWD, CWD, Color Doppler, Combined, Other) | Functions equivalently to the predicate device for Peripheral vessel imaging. |
Combined: Combination of each operating mode (B, M, PWD, CWD, Color Doppler).
Other: Amplitude Doppler, Harmonic Imaging, 3D Imaging, 4D Imaging (for Preirus, Avidus lists up to 3D), Real Time Tissue Elastography, Trapezoid, Contrast, Oblique, High Compound Imaging, Omni Directional M-mode, Wide View, Tissue Doppler Imaging. Specific "Other" modes vary slightly by transducer.
Subscripts (a, b, c, d, e, f, g, h) denote specific types of imaging within broader categories (e.g., biopsy guidance).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily relies on engineering and design comparison to establish substantial equivalence, stating that "The technological characteristics of this device are identical to the primary predicate device. The control and image processing hardware and the base elements of the system software are identical to the predicate device."
For the new transmitter, mentioned as an exception, the validation is included in "Section 6 - Clinical Safety & Effectiveness." However, this summary document does not provide details about the sample size, data provenance, or whether this validation involved a clinical test set. Given the date of the submission (2010), extensive clinical trial data with specific sample sizes for each clinical application would typically not be required for a substantial equivalence claim for an ultrasound device unless new fundamental technology or clinical indications were introduced.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the supplied document. Such details are usually part of a specific clinical study report, which is not present here. The submission focuses on technical equivalence to an already cleared device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the supplied document.
5. 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 is mentioned, nor is there any mention of AI assistance in this submission. The device is a diagnostic ultrasound scanner, and at the time of this filing (2010), AI in medical imaging was not as prevalent as it is today.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable to a diagnostic ultrasound scanner that is operated by trained personnel (doctor, sonographer).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided for this specific submission, as it relies on substantial equivalence. For the predicate device, K093466, it would have been established through methods appropriate for diagnostic ultrasound, likely involving expert interpretation, correlation with other imaging modalities, or, where applicable, pathology or clinical outcomes.
8. The sample size for the training set
This is not applicable as the submission describes a hardware and software system for an ultrasound scanner and not a new algorithm or AI application. The "training" for such a device would refer to the engineering and development process, rather than an algorithmic training set derived from patient data.
9. How the ground truth for the training set was established
Not applicable for the reasons stated above.
§ 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.