(45 days)
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 and 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 designed for use in facilitating the insertion and guidance of an occlusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary or neurovascular system. A radiopaque marker is included on the distal end for angiographic visualization. The catheter shaft has a hydrophilic coating to reduce friction during use. A luer hub on the proximal end allows attachments for flushing, insertion of catheters and aspiration. A rotating hemostatic valve with side-arm adapter is provided with each catheter for flushing, catheter insertion and aspiration. Modified HD Guide Catheter dimensions are indicated on product label. The Modified HD Guide catheter family is being extended to include a 6.3 F size.
The provided document is a 510(k) summary for a medical device called the "Modified HD Guide Catheter." It describes the device, its intended use, a summary of testing, and the FDA's substantial equivalence determination.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Test Performed) | Reported Device Performance |
|---|---|
| Kink resistance | Performs as designed |
| Flow rate | Performs as designed |
| Coating lubricity | Performs as designed |
| Leak resistance | Performs as designed |
| Tensile strength | Performs as designed |
| Flexibility | Performs as designed |
Explanation: The document states that "The same performance standards, test methods and specifications were applied as those previously submitted in the predicate HD Guide Catheter 510(k) submissions." It then lists the specific tests. The general finding for all these tests is that the device "demonstrate[s] that it performs as designed, is suitable for its intended use and is substantially equivalent to the predicate device." While specific numerical performance values for acceptance criteria are not provided in this summary, the statement implies that the Modified HD Guide Catheter met the established performance standards of its predicate device for each of these tests.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document mentions "verification and validation conducted on the Modified HD Guide Catheter" and that "The same performance standards, test methods and specifications were applied as those previously submitted in the predicate HD Guide Catheter 510(k) submissions." Without more detail on those predicate submissions, the exact sample sizes for each test listed (kink resistance, flow rate, etc.) are unknown.
- Data Provenance: Not explicitly stated. This is a medical device submission, so it's likely internal company testing data. There is no mention of country of origin of data, nor whether it was retrospective or prospective in this 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is a physical medical device (catheter), not an AI or diagnostic imaging device. Therefore, the concept of "ground truth" established by human experts in the context of diagnostic interpretation or classification does not apply. The "ground truth" for this device would be established by engineering specifications and physical test methods.
4. Adjudication method for the test set:
Not applicable, as this is a physical medical device and not related to interpretive diagnostic tasks requiring adjudication.
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:
Not applicable. This document is for a physical medical catheter, not an AI or diagnostic imaging device that involves human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI algorithm. The performance described relates to the physical characteristics of the catheter itself.
7. The type of ground truth used:
The "ground truth" for this device is based on engineering specifications and established test methods for medical catheters. For example, "kink resistance" would have a defined standard or threshold that the catheter must meet, which is determined by physical testing rather than human expert opinion on an image or medical case.
8. The sample size for the training set:
Not applicable. This is not an AI device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for a physical medical device like this catheter.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).