(292 days)
Diagnostic Ultrasound Imaging of the human body in the applications detailed below.
Clinical Applications:
- Intra-Operative: Cardiovascular
- Pediatric
- Cardiac Adult
- Cardiac Pediatric
- Peripheral Vessel
The new intra-operative transducer has equivalent functionality to the existing transducer now being used. The new intra-operative transducer has new patient contact materials.
This 510(k) submission (K971116) is for a new intra-operative imaging transducer (Model 21380A) for the Sonos 5500 Imaging System. The submission states that the only significant change from the predicate device (21275A, K944048) is the new patient contact materials. Therefore, the studies and acceptance criteria are focused on ensuring the safety and equivalence of these new materials and the continued functionality of the transducer.
Since the device is a transducer for an ultrasound imaging system and the core functionality is claimed to be the same as the predicate device, with changes only to patient contact materials, the acceptance criteria and supporting studies are centered on material biocompatibility and continued equivalent imaging performance, rather than a clinical efficacy study with human readers or complex diagnostic accuracy metrics.
Here's an attempt to structure the information based on the provided text, acknowledging that detailed study methodologies are not fully present in this summary document:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Equivalent functionality to predicate device (21275A) | "The new transducer has equivalent functionality to the existing transducer now being used." (Claimed) |
| Same scientific concepts as predicate device | "Scientific Concepts: same as existing intra-operative transducer" (Claimed) |
| No significant differences in safety between 21380A and 21275A | "There are no significant differences in safety and efficacy between the 21275A and 21380A transducers." (Claimed) |
| No significant differences in efficacy between 21380A and 21275A | "There are no significant differences in safety and efficacy between the 21275A and 21380A transducers." (Claimed) |
| Biocompatibility of new patient contact materials | Implied: The need to file a 510(k) is specifically due to "new patient contact materials," which necessitates demonstrating their safety, typically through biocompatibility testing. The document states a "detailed comparison of the transducers can be found in the 510(k) report," which would contain these details, but they are not in the provided summary. |
| Continued intended use for diagnostic ultrasound imaging of the human body in specified applications (Intra-Operative: Cardiovascular, Pediatric, Cardiac Adult, Cardiac Pediatric, Peripheral Vessel) | The "Ultrasound Device Indications Statement" confirms these applications for the 21380A transducer, implying functionality for these uses. |
Study Information
The provided 510(k) summary is high-level and does not offer explicit details on sample sizes, data provenance, expert qualifications, or adjudication methods for specific studies. Instead, it relies on the concept of "substantial equivalence" to a predicate device.
1. Sample sizes used for the test set and the data provenance:
- Not explicitly stated for a clinical test set. The submission refers to a "detailed comparison of the transducers" in the full 510(k) report, which would likely include technical performance data. For the new patient contact materials, biocompatibility testing would have been performed on material samples, not patient data.
- Data Provenance: Not specified, but given the nature of a 510(k) for a transducer, the "data" would likely originate from internal engineering and safety testing, rather than a large-scale clinical trial with patient data.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this 510(k) summary. This submission is not based on a diagnostic accuracy study requiring expert adjudication of images or clinical outcomes. The "ground truth" for the material change would be laboratory testing results for biocompatibility and engineering specifications for performance.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. As this is not a diagnostic accuracy study, there is no need for expert adjudication of medical cases.
4. 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. This is an ultrasound transducer, not an AI-powered diagnostic algorithm. Therefore, an MRMC study related to AI assistance for human readers is not relevant to this submission.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is a transducer, a hardware component of an imaging system, not a standalone algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For functionality and efficacy: The ground truth is implied to be the established performance characteristics and clinical utility of the predicate device (21275A). The new device asserts "equivalent functionality" and "no significant differences in safety and efficacy." Supporting data would typically involve technical performance metrics (e.g., image resolution, penetration, Doppler accuracy) compared against specifications and potentially the predicate device.
- For safety (new patient contact materials): The ground truth would be established through biocompatibility testing (e.g., cytotoxicity, sensitization, irritation tests as per ISO 10993 standards) against established safety limits for medical devices.
7. The sample size for the training set:
- Not applicable. This device is a hardware component. There is no "training set" in the context of machine learning.
8. How the ground truth for the training set was established:
- Not applicable. There is no "training set" for this type of device submission.
§ 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.