(84 days)
The Medi-tech® 4 and 5 French Nighthawk™ Flush Angiographic Catheters are designed to provide a pathway to be used for delivering contrast media to selected sites in the vascular system during an angiographic procedure.
The Medi-tech 4 and 5 French Nighthawk Flush Angiographic Catheters are available in the following dimensions and tip taper configurations. The 4 F Nighthawk catheters are tapered at the tip to be compatible with 0.035" guidewires. The 5 F Nighthawk catheters have two tapered tip configurations to be compatible with 0.038" and 0.035" guide wires. The Nighthawk Flush catheters utilize common biocompatible materials. The Nighthawk catheter shaft is coextruded using Pebax combined with a radiopaque filler for the inner layer and Pebax with a radiopaque filler and colorant as the outer surface layer. The shaft provides a smooth surface to allow for dye flow and easy guide wire movement as well as stiffness and curve retention. The radiopaque materials are utilized in the shaft and tip to allow visualization of the catheter during the procedure. The catheter will be provided with sideholes and optional silicone coating applied to the exterior surface of the outer layer. The catheters utilize a polycarbonate hub and Pebax strain relief. The hub is molded to the proximal end of the catheter shaft. A tip straightener is included as an accessory to the Flush line of catheters. The devices will be provided sterile and are intended for one procedure use only.
The provided 510(k) document (K9716007) describes the Medi-tech® 4 and 5 F Flush Angiographic Catheters. This submission is for a medical device (angiographic catheter) and not for an AI/ML-based diagnostic device. Therefore, many of the requested criteria related to AI/ML device studies (such as sample size for test set and training set, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable to this traditional medical device submission.
The document primarily focuses on demonstrating substantial equivalence to a predicate device through functional (non-clinical) testing.
Here's an analysis based on the information provided, with an emphasis on what is applicable for this type of device:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative table format suitable for performance metrics like sensitivity or specificity, as it's a physical device rather than a diagnostic algorithm. Instead, it refers to various functional tests. The reported performance is a qualitative statement of adequacy.
| Acceptance Criteria (Functional Test Type) | Reported Device Performance (as stated in document) |
|---|---|
| Pressure burst | Verified adequate for intended use |
| Tip bond tensile | Verified adequate for intended use |
| Dye flow | Verified adequate for intended use |
| Tip coefficient of friction | Verified adequate for intended use |
| Force transmitted by the catheter tip | Verified adequate for intended use |
| Radiopacity | Verified adequate for intended use |
| Torque | Verified adequate for intended use |
| Tip straightener peel-away force | Verified adequate for intended use |
| Particulate | Verified adequate for intended use |
| Silicone coating integrity | Verified adequate for intended use |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified quantitatively. The document states "Functional testing consisted of..." but does not provide the number of units tested for each functional test.
- Data Provenance: Not specified, but generally for physical device testing, the tests are conducted in a laboratory setting by the manufacturer (SCIMED Life Systems, Inc. in Maple Grove, Minnesota). These are generally prospective tests conducted specifically for the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This pertains to AI/ML diagnostic devices where expert consensus is used to label data. For physical device functional testing, a "ground truth" in this sense isn't established by experts, but rather by standardized test methods or engineering specifications.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. This is relevant for clinical studies or AI algorithm ground truth establishment, not for physical device functional testing.
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 refers to studies involving human interpretation of diagnostic results, often with and without AI assistance. This device is a catheter used to deliver contrast media, not a diagnostic imaging AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This refers to the performance of an AI algorithm; this is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the AI/ML context. For physical device testing, the "ground truth" or reference standard for acceptable performance is typically defined by engineering specifications, international standards (e.g., ISO), or established test methods designed to simulate intended use conditions. The document states "Test results verified that the 4 and 5 French Nighthawk Flush Angiographic Catheters are adequate for their intended use," implying compliance with such internal or external standards.
8. The sample size for the training set
- Not applicable. This is for AI/ML models.
9. How the ground truth for the training set was established
- Not applicable. This is for AI/ML models.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).