(19 days)
The EC9-4 endocavity curved array ultrasound transducer is primarily indicated for transrectal and transvaginal, fetal and neonatal and small parts applications on the ACUSON Antares ultrasound imaging platform.
Presently cleared EC9-4 endocavity curved array ultrasound transducer is primarily indicated for transrectal and transvaginal, fetal and neonatal and small parts applications on the ACUSON Antares ultrasound imaging platform.
This 510(k) summary describes a device modification to an existing ultrasound transducer, the EC9-4. As such, it focuses on demonstrating substantial equivalence to the previously cleared device rather than presenting a de novo study with detailed acceptance criteria and performance data in the way a new device submission might. Therefore, many of the requested elements (e.g., acceptance criteria, test set details, expert ground truth, MRMC study, training set details) are not explicitly provided in the document for this specific modification.
Here's a breakdown of the available information and what can be inferred:
Acceptance Criteria and Device Performance
Since this is a modification to a previously cleared device (EC9-4 transducer cleared under K050034), the "acceptance criteria" are primarily implicit: demonstrating continued mechanical, electrical, and acoustical safety, and maintaining the same performance characteristics as the predicate device. The document states the modified device is "substantially equivalent in its technology and functionality to the EC9-4 transducer which is already cleared." There are no explicit quantitative acceptance criteria or reported performance metrics provided in this document.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Safety | Conforms to UL 60601-1, CSA C22.2 No. 601-1, EN 60601-1, EN 60601-1-1, EN 60601-1-2, EN 60601-2-37. |
| Electrical Safety | Conforms to UL 60601-1, CSA C22.2 No. 601-1, EN 60601-1, EN 60601-1-1, EN 60601-1-2, EN 60601-2-37. |
| Acoustic Output Safety | Conforms to AIUM/NEMA UD-2, 1998, AIUM/NEMA UD-3, 1998. Acoustic output in accordance with ALARA principle. |
| Biological Safety | Conforms to ISO 10993-1. |
| Functionality | Substantially equivalent to the previously cleared EC9-4 transducer (K050034). No specific performance metrics for image quality, resolution, etc., are provided as part of this modification summary. |
Study Details
Given that this is a "Special 510(k): Device Modification" focused on substantial equivalence, the "study" conducted is likely a series of verification and validation tests to ensure the modified device still meets all relevant safety, performance, and regulatory standards, and remains functionally equivalent to its predicate. The document refers to conformance to various product safety standards.
- Sample size used for the test set and the data provenance: Not explicitly stated. For a device modification of an ultrasound transducer, the "test set" would typically involve testing the physical device itself (electrical, mechanical, acoustic, biological safety testing), not a dataset of patient images.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or not specified. "Ground truth" in this context would relate to objective measurements of the transducer's physical and acoustic properties, or clinical performance if a clinical study were performed (which is not indicated in this summary for this modification).
- Adjudication method: Not applicable or not specified.
- 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: Not applicable. This document is for an ultrasound transducer, not an AI-powered diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.
- The type of ground truth used: For safety and performance tests, the "ground truth" would be the established engineering and medical device standards (e.g., UL, CSA, AIUM/NEMA, ISO). For example, acoustic output measurements would be compared against the limits defined in AIUM/NEMA standards.
- The sample size for the training set: Not applicable. This is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.