(154 days)
The Minnie support catheters are intended to be used in conjunction with steerable guidewires in order to access discreet regions of the arterial and or coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices. The Minnie support catheters also may be used to subselectively infuse/deliver therapeutic agents.
The Minnic Support Catheter is available in nine models. Each Minnie catheter is a single lumen polycthylenc tube that comprises the catheter shaft. To create a lower crossing profile, the shaft tapers at the distal end. A polyethylene hub is overmolded onto the shaft and each catheter has a printed strain relief component that is just distal of the hub. To confirm position and aid in estimating geometries in the vasculature, each device has three evenly-spaced, radiopaque marker bands at the distal end-the distal-most marker band is approximately 2.5mm from the distal tip. The 5700 and 5701 models have printed-positioning markers at 95cm and 105cm from the distal tip. A hydrophilic coating is applied to the distal-most 40cm of the shaft to provide a lubricious outer surface. Each Minnie catheter is compatible with ≥5F introducer sheaths and ≥6F guide catheters. The Minnie catheter is provided sterile and intended for a single-patient use.
The provided 510(k) summary is for the Minnie™ Support Catheter, a medical device. This type of device is not an AI/ML-driven product, but rather a physical catheter used in interventional procedures. Therefore, many of the requested criteria related to AI/ML device studies (such as sample sizes for test/training sets, ground truth establishment methods, expert panel details, MRMC studies, and standalone performance) are not applicable to this submission.
However, I can extract and present the information related to the acceptance criteria and the study that proves the device meets them, based on the provided document.
Minnie™ Support Catheter Acceptance Criteria and Performance Study
1. A table of acceptance criteria and the reported device performance
The document lists various bench tests conducted to assess the physical properties and intended use suitability of the Minnie™ Support Catheter. For each of these tests, the "reported device performance" is implicitly stated as having "confirmed the suitability of the device for its intended use" and "Bench tests confirmed the suitability of the device for its intended use." Specific quantitative acceptance criteria or detailed performance results for each test are not provided in this summary.
| Acceptance Criteria (Bench Test Category) | Reported Device Performance (Implicit) |
|---|---|
| Visual inspection for sharp edges | Suitability for intended use confirmed |
| Radiopacity | Suitability for intended use confirmed |
| Hydrophilic coating (lubricity) | Suitability for intended use confirmed |
| Visual inspection for excessive hydrophilic coating | Suitability for intended use confirmed |
| Hydrophilic coating integrity | Suitability for intended use confirmed |
| Hydrophilic coating integrity—Congo Red Dye | Suitability for intended use confirmed |
| Tortuosity | Suitability for intended use confirmed |
| Kink resistance | Suitability for intended use confirmed |
| Flow rate | Suitability for intended use confirmed |
| Hub-to-shaft bond strength | Suitability for intended use confirmed |
| Distal shaft strength | Suitability for intended use confirmed |
| Liquid leak under pressure | Suitability for intended use confirmed |
| Air leak during aspiration | Suitability for intended use confirmed |
| Corrosion resistance | Suitability for intended use confirmed |
| Positioning marker integrity | Suitability for intended use confirmed |
| Torque strength | Suitability for intended use confirmed |
| Dynamic pressure | Suitability for intended use confirmed |
| Static pressure | Suitability for intended use confirmed |
| Distal outer diameter measurement | Suitability for intended use confirmed |
| Marker band spacing | Suitability for intended use confirmed |
| Hub luer compliance | Suitability for intended use confirmed |
| Guidewire compatibility | Suitability for intended use confirmed (explicitly states compatibility) |
| Guide catheter compatibility | Suitability for intended use confirmed (explicitly states compatibility) |
| Introducer sheath compatibility | Suitability for intended use confirmed (explicitly states compatibility) |
| Temperature and humidity conditioning | Suitability for intended use confirmed |
2. Sample size 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: This information is not provided in the document. The tests conducted are "bench tests," implying laboratory testing of device samples. The exact number of samples tested for each criterion is not specified.
- Data Provenance: The tests are "bench testing," meaning in-vitro laboratory evaluations, not tests on human data. No country of origin for data is relevant in this context, nor is retrospective or prospective classification.
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)
This is not applicable. The "ground truth" for a physical medical device in bench testing is determined by established engineering and material science standards and measurement techniques, not by expert medical opinion in the same way an AI model's output might be adjudicated.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods involving multiple expert readers are relevant for subjective interpretations of data (e.g., medical images) or algorithm outputs, not for objective physical bench tests of a 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
This is not applicable. The Minnie™ Support Catheter is a physical medical device, not an AI/ML-driven system that would assist human readers in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The Minnie™ Support Catheter is a physical medical device and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the bench tests would have been established by objective measurements against predefined engineering specifications and industry standards. For example, "Distal outer diameter measurement" would have a specified tolerance, and the ground truth is whether the measured diameter falls within that tolerance. Similarly for "Flow rate" or "Kink resistance," there would be measurable standards.
8. The sample size for the training set
This is not applicable. There is no "training set" for a physical medical device in the context of this 510(k) submission.
9. How the ground truth for the training set was established
This is not applicable for the reasons stated above.
Summary of Study for the Minnie™ Support Catheter:
The study proving the Minnie™ Support Catheter meets its acceptance criteria was comprised solely of bench testing. These tests assessed the physical properties and functionality of the device against internal specifications, engineering standards, and performance expectations for its intended use. Clinical evaluations were explicitly stated as "not required" for this device. The conclusion of the submission is based on the findings from these bench tests, affirming the device's suitability for its intended use, and its substantial equivalence to predicate devices (Quick-Cross® Support2 Catheters and Skyway™ Support Catheter) based on classifications, indications, technological characteristics, and sterilization methods.
§ 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).