(30 days)
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
Intended use. Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
The Hitachi HI VISION 900 Diagnostic Ultrasound Scanner is a Track 3 Diagnostic Ultrasound Pulsed Doppler and Pulsed Echo Imaging System capable of the following operating functions:
- B Mode
- M Mode
- Pulsed Wave Doppler
- Continuous Wave Doppler
- Color Flow
- Amplitude Doppler
- Harmonic imaging
- 3D imaging
This document is an FDA 510(k) premarket notification letter for the Hitachi HI VISION 900 Diagnostic Ultrasound Scanner and several associated transducers. It primarily focuses on demonstrating substantial equivalence to previously marketed devices and establishing the intended uses for each transducer with different clinical applications and operating modes.
The document does NOT contain information about specific acceptance criteria or performance studies in the way typically found for a new medical device claiming novel clinical performance metrics. Instead, the acceptance criteria are implicitly tied to the regulatory requirements for substantial equivalence, specifically compliance with established standards for diagnostic ultrasound equipment and its acoustic output, and demonstration of equivalency in intended use to predicate devices.
Therefore, many of the requested elements for a performance study are not explicitly present in this type of regulatory document. I will extract the available information and explicitly state where information is not provided.
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria for Hitachi HI VISION 900 Diagnostic Ultrasound Scanner
This document primarily outlines the regulatory clearance for the Hitachi HI VISION 900 Diagnostic Ultrasound Scanner based on substantial equivalence to predicate devices, rather than detailing a specific clinical performance study with acceptance criteria and a detailed analysis of device performance against those criteria.
The "acceptance criteria" here are implicitly meeting the regulatory standards for diagnostic ultrasound systems and demonstrating that the device and its transducers are safe and effective for their intended uses, comparable to legally marketed predicate devices.
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implicit from Regulatory Context) | Reported Device Performance (as per 510(k) Clearance) |
|---|---|
| Safety: | Compliance Confirmed: |
| a) Compliance with Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment (1992) - NEMA UD-3. | The Hitachi HI VISION 900 Diagnostic Ultrasound Scanner complies with NEMA UD-3 regarding thermal and mechanical acoustic output indices. (Stated as a Track 3 device) |
| b) Compliance with guideline limits set in the 510(k) Diagnostic Ultrasound Guidance - Revision: April 14, 1994, for acoustic outputs. | The Hitachi HI VISION 900 Diagnostic Ultrasound Scanner complies with the guideline limits for acoustic outputs in the 510(k) Diagnostic Ultrasound Guidance (1994). |
| c) Compliance with IEC 60601-1 (1998) Medical Electrical Equipment, Part 1 - General Requirements for Safety. | The Hitachi HI VISION 900 Diagnostic Ultrasound Scanner complies with IEC 60601-1 (1998) for general safety requirements. |
| Effectiveness/Intended Use: | Substantial Equivalence Demonstrated for Listed Intended Uses: The FDA reviewed the 510(k) and determined the device is substantially equivalent for the stated indications for use (diagnostic ultrasound imaging or fluid flow analysis of the human body) to legally marketed predicate devices. Specific indications for use (Clinical Application and Mode of Operation) are listed per transducer model. |
| a) Device demonstrates intended functions: B Mode, M Mode, Pulsed Wave Doppler, Continuous Wave Doppler, Color Flow, Amplitude Doppler, Harmonic imaging, Superficial musculoskeletal imaging, 3D imaging. | The device is capable of these operating functions. The FDA's clearance implies that the performance of these modes is acceptable for diagnostic purposes, in line with predicate devices. |
| b) Each listed transducer (e.g., EUP-B514, EUP-F531, EUP-850, EUP-C514, EUP-L53S, EUP-TC3, EUP-C532, EUP-L65, EUP-U533, EUP-CC531, EUP-053T, EUP-V53W, EUP-CV524, EUP-OL334, EUP-ES52M, EUP-R54AW-19, -33) is cleared for its specified clinical applications and modes of operation. | A detailed table is provided for each transducer model, listing the specific clinical applications (e.g., Fetal, Abdominal, Pediatric, Small Organ, Cardiac Adult, Peripheral vessel) and the modes of operation (B, M, PWD, CWD, Color Doppler, Combined, Amplitude Doppler, Harmonic Imaging, 3D Imaging) for which it has been cleared (indicated by 'P' for previous indication or 'N' for new indication). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This document does not provide information on a specific test set sample size or data provenance (country of origin, retrospective/prospective) for a performance study. 510(k) submissions for ultrasound devices primarily rely on engineering performance testing (acoustic output, electrical safety, EMC) and comparison to predicate devices, rather than extensive clinical efficacy studies with patient data for primary clearance. The "performance" assessment here refers to the device's ability to operate according to its specifications and regulatory standards.
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 as this document does not detail a clinical study where expert ground truth was established for image interpretation. The "ground truth" for regulatory clearance pertains to adherence to established engineering standards and guidelines for ultrasound equipment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided as this document does not refer to a clinical test set requiring adjudication of findings.
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:
This document is from 2006, pre-dating widespread integration of AI in diagnostic ultrasound for which MRMC studies are commonly conducted. Therefore, no MRMC comparative effectiveness study involving AI assistance was performed or reported in this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This document describes a diagnostic ultrasound scanner, which is a human-operated imaging device. It does not describe an AI algorithm or a standalone algorithmic performance study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For this 510(k) clearance, the "ground truth" is based on engineering performance specifications, compliance with recognized national and international standards (NEMA UD-3, IEC 60601-1), and comparison to functional attributes of legally marketed predicate devices. It does not involve clinical "ground truth" from expert consensus, pathology, or outcomes data in the context of a clinical performance study.
8. The sample size for the training set:
As this document does not pertain to an AI algorithm, there is no training set and therefore no sample size provided.
9. How the ground truth for the training set was established:
As there is no training set for an AI algorithm, this information is not applicable and not provided.
§ 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.