(13 days)
The Sonicath Ultra™ 3.2F 20MHz Imaging Catheter is intended for ultrasound examination of peripheral intravascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.
The Sonicath Ultra™ 3.2F 20MHz Imaging Catheter is a sterile, single-use, short rail (SR), 20 MHz imaging catheter with a 3.2F distal crossing profile. The catheter is intended to operate with the BSC ClearView Ultra™, Galaxy®, Galaxy2™, or iLab® intravascular ultrasound imaging instruments. The catheter and instrument form an imaging system that is intended for the ultrasonic examination of peripheral intravascular pathology only. The catheter consists of two (2) main assemblies: a sheath assembly and an imaging core assembly. The sheath assembly is the outer part of the catheter that comprises much of the working length of the device. The imaging core is internal to the sheath assembly and rotates independently of the sheath. The imaging core contains the piezoelectric transducer that converts electrical energy from the instrument to ultrasonic energy that is in turn transmitted. The transducer converts the returned ultrasonic energy into electrical energy for display on the instrument. The rotating imaging core drive shaft directs the path of the ultrasonic energy (beam) from the transducer. A proximal telescoping section allows the imaging core to be retracted and advanced, across an anatomical region of interest, without requiring movement of the sheath within the anatomy. The modified Sonicath Ultra™ 3.2F 20MHz Imaging Catheter is identical in all aspects to the current Sonicath Ultra™ 3.2F 20MHz Imaging Catheter except for the following change: Changed catheter sheath support material from one Low Density Polyethylene (LDPE) resin formulation to another.
The provided document K060947 is a 510(k) summary for the Boston Scientific Sonicath Ultra™ 3.2F 20MHz Imaging Catheter. This summary describes a device modification (change in catheter sheath support material) and demonstrates its substantial equivalence to a predicate device.
It's important to note that this document does not describe a study involving an AI device or a comparative effectiveness study with human readers. The device is an intravascular ultrasound imaging catheter, and the "study" referred to in the document is design verification testing and bench testing of the catheter itself, not a clinical study involving AI or human interpretation of images.
Therefore, many of the requested criteria related to AI performance, sample size for test/training sets, expert ground truth, adjudication methods, and MRMC studies are not applicable to this submission.
Here's an analysis of the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (What they tested for) | Reported Device Performance |
|---|---|
| Physical integrity and functionality (e.g., tensile, pressure) of catheter sheath support and full, sterile device. | "The results demonstrated that the device satisfies all performance, physical and functional requirements." (Bench Testing section) |
| Biocompatibility | "The results of the biocompatibility testing demonstrate that the modified Sonicath Ultra™ 3.2F 20MHz Imaging Catheter is acceptable for it intended use." (Biological Safety Testing section) |
| Acoustic output | "Acoustic Output testing was not required... has no effect on acoustic output." (Acoustic Output Testing section) |
| Predetermined acceptance criteria for design verification testing | "Design verification testing confirms that predetermined acceptance criteria were met and no new issues of safety or efficacy have been raised with the use of this new catheter sheath support material." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in terms of number of catheters or specific test units. The testing described is bench and biological safety testing of the device itself, not image data.
- Data Provenance: Not applicable as it's not a data-driven study. The testing was conducted internally by Boston Scientific Corporation.
- Retrospective/Prospective: Not applicable.
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)
- Number of experts: Not applicable. The ground truth for device performance (tensile strength, biocompatibility, etc.) is established through engineering standards and laboratory testing, not expert interpretation of clinical data.
- Qualifications of experts: Not applicable in the context of clinical experts. The testing would have been conducted by engineers and laboratory personnel qualified in their respective fields.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. This is not a study involving human interpretation of clinical data that would require an adjudication process for ground truth establishment.
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
- MRMC Study: No. This document describes a modification to a medical device (an imaging catheter), not an AI device, and therefore no MRMC study was performed or is relevant.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
- Standalone Performance: No. This document does not pertain to an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: The "ground truth" here refers to established engineering specifications, material properties, and biological safety standards. For instance, tensile strength must meet a certain Newton threshold, and biocompatibility tests must show no cytotoxic or irritant effects.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is not an AI device, so there is no training set. The "training" here would refer to the development and testing process of the physical catheter.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable. As there is no AI training set, there is no ground truth for it.
§ 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.