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510(k) Data Aggregation
(99 days)
MODIFICATION TO MODIFIED HD GUIDE CATHETER
The Modified HD Guide Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary or neuro vascular systems. It may also be used as a diagnostic angiographic catheter.
The Modified HD Guide Catheter consists of a single lumen, braided, variable stiffness shaft with a radiopaque marker on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. A rotating hemostatic valve with side-arm adapter is provided with each catheter.
This submission K092298 for the Modified HD Guide Catheter is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study with detailed performance metrics. For devices like this catheter, the acceptance criteria are generally related to demonstrating that the new device is as safe and effective as a legally marketed predicate device.
Here's a breakdown based on the provided text, addressing the points where information is available or inferable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Suitable for intended use | "performs as designed, is suitable for its intended use" |
| Substantially equivalent to predicate device | "is substantially equivalent to the predicate device with regard to device design, intended use, patient population and anatomical site." |
| Does not raise new safety or effectiveness issues | "Any differences in technological characteristics between the Modified HD Guide Catheter and the predicate device do not raise any new issues of safety or effectiveness." |
| Materials are suitable for intended use | "All materials used...are suitable for the intended use of the device and have been used in numerous previously cleared products." |
2. Sample sized used for the test set and the data provenance
The document states "The results of verification and validation conducted on the Modified HD Guide Catheter..." However, it does not provide details on specific sample sizes, the nature of the test set (e.g., patient data), or data provenance (e.g., country of origin, retrospective or prospective). Given that this is a catheter and the mention of "verification and validation," it's highly probable that the "testing" refers to bench testing and possibly animal studies, not human clinical trials with a test set of patient data in the context of AI/diagnostic device evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable or provided in the context of this 510(k) submission. Establishing ground truth by medical experts is typically relevant for diagnostic devices (especially those using AI) where expert consensus, pathology, or outcomes data are needed to evaluate diagnostic accuracy. This submission is for a medical catheter, a therapeutic/interventional device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable or provided. Adjudication methods are typically used in clinical trials for diagnostic accuracy or efficacy, which is not the type of study described for this device.
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
An MRMC comparative effectiveness study is not applicable and was not done for this device. This type of study is relevant for diagnostic devices that either incorporate AI or are intended to assist human readers in interpretation. The Modified HD Guide Catheter is an interventional/delivery device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the device is a physical medical catheter, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this type of device, ground truth would typically be established through engineering specifications, material science standards, and performance benchmarks as demonstrated through bench testing (e.g., tensile strength, burst pressure, lubricity, device dimensions) and potentially animal studies for biological compatibility and in-vivo performance. The document explicitly mentions "All materials used... are suitable for the intended use of the device and have been used in numerous previously cleared products," implying that material safety and suitability are established. "Verification and validation" results demonstrate performance as designed.
8. The sample size for the training set
This information is not applicable or provided. Training sets are relevant for machine learning models.
9. How the ground truth for the training set was established
This information is not applicable or provided.
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