(49 days)
The UltraFlow™ HPC Flow Directed Micro Catheter is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuro anatomy. It is not intended for use in the coronary vasculature.
The UltraFlow™ HPC Flow Directed Micro Catheters are single-lumen, endhole catheters designed for the subselective infusion of physician-specified pharmacologic agents or contrast media in tortuous, distal vessels. The catheters have a semi-rigid proximal shaft and a highly flexible distal shaft to facilitate the advancement of the catheter in the anatomy. The proximal end of the catheter incorporates a standard luer adapter to facilitate the attachment of accessories. The catheter has a radiopaque marker at the distal end to facilitate fluoroscopic visualization. The outer surfaces of the catheter are coated to increase lubricity. The stylet accompanying the catheter is used to increase the rigidity of the distal section during introduction into the guiding catheter.
This submission (K024118) is a special 510(k) for a name change and minor design enhancements to an already cleared device, the Modified FlowRider™ Flow Directed Micro Catheter (K010004). Therefore, the provided text does not contain detailed acceptance criteria and a study proving those criteria for a novel device. Instead, the focus is on demonstrating substantial equivalence to the predicate device.
However, I can extract the information related to the performance testing that was conducted to verify the minor product changes.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Although specific numerical acceptance criteria are not detailed in this summary, the testing performed was to verify minor product changes and demonstrate substantial equivalence to the predicate device. The general acceptance criterion for these tests would be that the UltraFlow™ HPC Micro Catheter performs comparably to the predicate device (Modified FlowRider™) in these specific aspects.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility (comparable to predicate) | Biocompatibility testing performed to verify minor changes. |
| Angiographic Visualization (comparable to predicate) | Angiographic visualization testing performed to verify minor changes. |
| Dimensional Verification (within specified tolerance) | Dimensional verification testing performed to verify minor changes. |
| Functional Performance (comparable to predicate) | Functional performance testing performed to verify minor changes. |
| Changes are minor and do not affect safety or effectiveness | Minor enhancements to the design (verified by the above tests). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each of the performance tests (Biocompatibility, Angiographic Visualization, Dimensional Verification, Functional Performance). It simply states that "Selected in-vitro performance testing...were performed."
The data provenance is in-vitro testing. The country of origin for the data is not explicitly stated, but Micro Therapeutics, Inc. is located in Irvine, CA, USA, so it's reasonable to infer the testing was conducted in the USA or managed by a US-based company. The study is prospective in the sense that the tests were specifically designed and executed for this 510(k) submission to evaluate the modified device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For in-vitro performance testing, "ground truth" is typically established by engineering standards, specifications, and validated test methods, rather than clinical experts.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of in-vitro performance testing, an adjudication method like 2+1 or 3+1 (common in image analysis or clinical trials) is generally not applicable. Test results would be compared against pre-defined engineering specifications.
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
No, an MRMC comparative effectiveness study was not done. This device is a micro catheter, not an AI-powered diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This device is a physical medical device, not a software algorithm.
7. The Type of Ground Truth Used
For the in-vitro performance tests, the "ground truth" would be the engineering specifications and performance characteristics of the predicate device (Modified FlowRider™ Flow Directed Micro Catheter (K010004)) and established industry standards for similar devices. For biocompatibility, it would be compliance with relevant ISO standards.
8. The Sample Size for the Training Set
This concept is not applicable. This is a physical medical device, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This concept is not applicable as there is no training set for this type of device.
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).