(256 days)
The ND Infusion Catheter is a multi-channel balloon catheter designed to isolate a specific vascular treatment region from biood flow while allowing infusion of physician-specified fluids into the target region.
The ND Infusion Catheter is a multilumen (3) and multichannel (6) balloon catheter designed to isolate a specific treatment region from blood flow while directing infusion of fluids into the specified region. The catheter has a length of 135cm and diameter of 3F, and is intended to be used with a 6F or larger guide catheter along with a 0.014" rapid exchange guide wire for positioning the catheter in the desired region. The bifurcated proximal hub provides for the following functionality: 1) Balloon Port · Inflation of a compliant balloon to requlate blood flow during therapy infusion; target vessel diameter = 2.0 - 4.5 mm. · Balloon is prepared via a 3-way stopcock connection using a 10cc syringe and inflated using a 50:50 contrast/saline solution delivered via a 1cc syringe for precise inflation under fluoroscopic guidance. 2) Infusion Port · Infusion of a therapeutic agent into the vasculature through multiple fluid channels (each with diameter = 0.006"). · Physician-specified fluid is administered through the infusion port via a 1-way stopcock connection using a 1cc syringe. The catheter is designed with 3 shaft transitions. As a result, the catheter has 4 contiguous segments: PROXIMAL, MID, EXPANSION, and DISTAL. Radiopaque marker bands at each end of the balloon and at the distal tip allow for catheter positioning under fluoroscopic guidance.
This document is a 510(k) summary for the ND Infusion Catheter, a medical device. It does not describe an AI/ML device or its performance in diagnostic tasks. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering and biocompatibility tests, not clinical performance studies involving human readers or AI.
Therefore, most of the requested information (sample sizes for test and training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone AI performance, type of ground truth for training) is not applicable to this document as it pertains to a traditional medical device submission, not specifically an AI/ML diagnostic or assistive device.
However, I can extract the closest analogous information regarding the device's functional and safety testing as presented in the document:
1. A table of acceptance criteria and the reported device performance:
The document doesn't provide explicit "acceptance criteria" values in a table for each test. Instead, it describes general conclusions, indicating that the device "meets requirements" or that results were "not considered significant."
Here's a summary of the technical and biocompatibility testing results, which serve as the reported performance, implying they met internal acceptance criteria for substantial equivalence:
| Test Category | Specific Test | Reported Device Performance |
|---|---|---|
| Technical Testing | Balloon Fatigue | Results imply conformance to requirements. |
| Balloon Burst Testing | Results imply conformance to requirements. | |
| Balloon Inflation/Deflation | Results imply conformance to requirements. | |
| Balloon Radial Force Testing | Results imply conformance to requirements. | |
| Track Force Testing | Results imply conformance to requirements. | |
| Torque Strength Test | Results imply conformance to requirements. | |
| Tensile Testing | Results imply conformance to requirements. | |
| Separation Force at Break | Results imply conformance to requirements. | |
| Flexibility-Kink Resistance Test | Results imply conformance to requirements. | |
| Liquid Leakage Under Pressure | Results imply conformance to requirements. | |
| Biocompatibility | Cytotoxicity -- L929 MEM Elution Test | Non-Cytotoxic (meets requirements, not considered cytotoxic) |
| Cytotoxicity -- L929 Neutral Red Uptake | Non-Cytotoxic (meets requirements, not considered cytotoxic) | |
| Sensitization -- Kligman Maximization | Non-Sensitizing (Grade I not significant, meets ISO guidelines) | |
| Irritation -- Intracutaneous Injection | Non-Irritating (no significantly greater biological reaction) | |
| Systemic Toxicity -- Systemic Injection | Nontoxic (no significantly greater biological reaction) | |
| Genotoxicity -- S Typhimurium & E Coli Reverse Mutation | Non-Genotoxic (no statistically significant increase in revertants) | |
| Hemolysis -- Rabbit Blood | Non-Hemolytic (meets requirements, not considered hemolytic) | |
| Thrombogenicity - Study in Dogs | Non-Thrombogenic (minimal thrombosis, not significant) | |
| Complement Activation Assay | Non-Complement Activating (meets requirements, no complement activation) | |
| Coagulation - Unactivated PTT Assay | Non-Coagulating (meets requirements, no effect on coagulation) | |
| Hemocompatibility -- In Vitro Assay | Hemocompatible (meets requirements, no effect on hematological parameters) | |
| Animal Studies | Acute animal study (swine arterial vasculature) | Excellent trackability, pushability, balloon inflation, deflation, removal, fluid infusion, marker band visibility, no hub/catheter leak, and no vascular injury. |
2. Sample size used for the test set and the data provenance:
- Technical Testing: Sample sizes are not specified for individual bench tests (e.g., how many catheters for balloon burst, how many cycles for fatigue). The provenance is "bench testing," meaning laboratory-based tests.
- Biocompatibility Testing: Sample sizes are generally small for these types of tests (e.g., refers to mice for systemic toxicity, rabbits for hemolysis, dogs for thrombogenicity). The provenance is laboratory testing using biological materials/animals.
- Animal Studies: "2/2 test sites and 2/2 control sites" for the thrombogenicity study in dogs. The acute animal study was performed in "swine arterial vasculature." These are prospective animal studies.
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. The evaluations are based on direct measurement, observation of physical properties, and biological reactions in laboratory or animal settings, not on expert interpretation of data like images for ground truth.
4. Adjudication method for the test set:
- This information is not applicable. Adjudication typically refers to resolving discrepancies between human readers or between human readers and AI. These are direct measurements and observations from engineered and biological tests.
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 as the device is an infusion catheter, not an AI/ML diagnostic device requiring human reader or AI performance evaluation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is not applicable. The device is a physical catheter, not an algorithm.
7. The type of ground truth used:
- Technical Testing: Physical measurements, engineering specifications, and established test methods define the "ground truth" or acceptance criteria.
- Biocompatibility Testing: Accepted standards for biological reaction, cellular response, and material interaction with biological systems (e.g., ISO 10993 guidelines) define the "ground truth."
- Animal Studies: Angiography, gross examination for vascular injury, and direct observation of catheter performance and thrombosis define the "ground truth."
8. The sample size for the training set:
- This is not applicable. The device is not an AI/ML model, so there is no "training set."
9. How the ground truth for the training set was established:
- This is not applicable for the reasons stated above.
§ 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).