(266 days)
The above referenced Broadsound transducer assemblies are intended for use, with standard ultrasound systems, in diagnostic ultrasound imaging or fluid flow analysis of the human body and to be operated by or under the direction of a physician.
Their specific indications for use are listed as following:
| Model Name | Specific Indications of Use* | |
|---|---|---|
| 1 | AL3C34A | Abdominal, Fetal |
| 2 | AL7L50A | Small organ, Peripheral vascular |
| 3 | AL3C79B | Abdominal, Fetal, Pediatric |
| 4 | AL7L24B | Small organ, Peripheral vascular |
| 5 | AT3C42B | Abdominal, Fetal, Pediatric |
| 6 | AT3C52B | Abdominal, Fetal, Pediatric |
| 7 | AT5L40B | Abdominal, Pediatric, Peripheral vascular, Musculo-skeletal |
| 8 | AT3P32A | Abdominal, Adult cephalic, Cardiac |
| 9 | AT3P42A | Abdominal, Adult cephalic, Cardiac |
The above referenced devices are replacement ultrasound transducers used with standard ultrasound systems. Each of them consists of piezoelectric crystals covered with an acoustic lens, a scan head that fits around the lens, a cable with strain relief devices on both ends, and a connector to attach the transducer to the ultrasound console.
This document describes the 510(k) summary for Broadsound Corporation's diagnostic ultrasound transducer assemblies. The submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing de novo performance criteria. Therefore, the information provided relates to equivalence criteria and comparative testing against predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here is "substantial equivalence" to predicate devices. The reported device performance is that the Broadsound transducers are "statistically comparable" to their corresponding predicate devices in terms of acoustic output and general performance.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | Similar in features and use parameters to predicate devices. Used on the same diagnostic ultrasound systems. No new technology employed. Compliance with electrical, mechanical, thermal, and biocompatible safety standards. Acoustic output statistically comparable to predicate. | Broadsound transducers are "very similar to [their corresponding predicate device] in terms of features and use parameters." |
| "used on the same diagnostic ultrasound systems." | ||
| "No new technology is employed on these devices." | ||
| Electrical, Mechanical, thermal, and biocompatible safety testing conducted. | "the results are included in the submission." (Implying compliance) | |
| Acoustic output and general performance comparable to predicate devices. | "acoustic output and found statistically comparable to each other." "Performance testing was also conducted and included in the submission." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size for the test set used for performance testing. It states that "Each of above referenced ultrasound transducer assemblies and its corresponding predicate device were tested," which implies a comparison of individual units of each Broadsound model against individual units of its corresponding predicate model.
The data provenance is not explicitly stated as retrospective or prospective, nor does it specify the country of origin of the data. However, the manufacturer is in Taiwan, so it is likely the testing was conducted there or arranged by the manufacturer.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This submission is for an ultrasound transducer assembly, not a diagnostic algorithm that requires expert interpretation of images for ground truth. Therefore, the concept of "experts" to establish ground truth in the context of image interpretation is not applicable here. The evaluation focuses on the physical and functional performance of the device against established predicate devices and safety standards.
4. Adjudication Method for the Test Set
Not applicable, as this is not a study involving human interpretation with adjudication. The performance testing is based on objective measurements of device characteristics and comparison to predicate devices and safety standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is a premarket notification for a medical device (ultrasound transducer) demonstrating substantial equivalence to existing devices, not a comparative effectiveness study involving human readers and AI for diagnostic improvement.
6. Standalone (Algorithm Only) Performance Study
No, this is about hardware (ultrasound transducers) and their performance characteristics. It does not involve any algorithms in a standalone performance study as described in AI/ML performance evaluations.
7. Type of Ground Truth Used
The "ground truth" in this context refers to established technical specifications, safety standards, and the performance characteristics of the predicate ultrasound transducers. The Broadsound devices are compared against these benchmarks, rather than against expert consensus, pathology, or outcomes data which are typically used for diagnostic accuracy studies. The ground truth for this submission would involve:
- Predicate Device Specifications: The technical and performance characteristics of the legally marketed predicate ultrasound transducers.
- Safety Standards: Established electrical, mechanical, thermal, and biocompatibility safety standards for medical devices.
- Acoustic Output Measurements: Standardized measurements of acoustic power and intensity.
8. Sample Size for the Training Set
Not applicable. This submission is for hardware (ultrasound transducers) and does not involve a "training set" in the context of machine learning or AI models.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as 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.