(163 days)
The MAGIC Infusion Catheter is intended for regional infusion of contrast materials into selected vessels in the neurovasculature. The MAGIC Infusion Catheter may be used for controlled, regional infusion into selected vessels and is not intended for use in the coronary vasculature.
The MAGIC Infusion Catheters are microcatheters designed with progressive suppleness and a rigid proximal shaft to allow control and navigability in the vascular system. By their diameter and progressive suppleness features, these catheters are specifically designed for catheterization of small diameter, sinuous distal vessels. The catheter body and its distal tip (ring) are radiopaque to provide visibility under fluoroscopy. The MAGIC Infusion Catheter has an external hydrophilic coating which provides a lubricious surface during use. A PTFE coated mandrel is included inside the MAGIC Infusion Catheter to provide support during product preparation and insertion through the guide catheter. The MAGIC Infusion Catheters and accompanying support mandrels are provided sterile, non-pyrogenic, and intended for single use only.
The provided document describes the MAGIC Infusion Catheter and its 510(k) summary. The study is a bench and biocompatibility testing designed to demonstrate substantial equivalence to a predicate device.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Bench Test | Acceptance Criteria | Results |
|---|---|---|
| Dimensional and Physical Attributes | Shall meet the required dimensional measurements and physical attributes per established specifications. | PASS |
| Visual Inspection | Shall meet the established acceptance criteria for surface defects and contamination. | PASS |
| Torque Strength Test | Catheters shall withstand the established acceptance criteria for torque strength without breaking. | PASS (Device integrity suitable for intended clinical use) |
| Catheter Tensile Test | Shall meet ISO 105551-1, Annex B | PASS |
| Corrosion Resistance | Shall meet ISO 105551-1, Annex A | PASS |
| Flow Rate | Reference Data | N/A (Note: Not an acceptance criterion for passing/failing) |
| Dynamic Pressure | Catheters shall withstand the maximum infusion pressure (as indicated on the product labeling) under dynamic conditions. (Adopted from ISO 105551-1) | PASS (Device met maximum labeled infusion pressure) |
| Static Burst Pressure | Catheters shall withstand the maximum infusion pressure (as indicated on the product labeling) under static conditions. (Adopted from ISO 105551-1) | PASS (Device integrity suitable for intended clinical use) |
| Pressure and Hub Test (Fluid Leakage) | Catheters shall not leak when injected with water at the maximum infusion pressure (as indicated on the product labeling) for a 30 second duration. | PASS (Device integrity suitable for intended clinical use) |
| Simulated Use / Coating Lubricity and Durability | Catheters shall be tracked using a benchtop model under simulated use conditions per product IFU, and meet established acceptance criteria for product performance, trackability, coating lubricity and durability. | PASS (Results comparable to predicate device) |
| Kink Resistance | Catheter body shall be wrapped around different pin gauges at various locations and meet the expected acceptance criteria for kink resistance. No kinks shall be noted during Simulated Use. | PASS (Results comparable to predicate device) |
| Radiopacity | Marker band shall be detectable under radiographic techniques. (Per ASTM F640-12) | PASS |
| Particulates | Shall meet USP criteria. No particulates shall be noted pre and post Simulated Use. | PASS (Results comparable to predicate device) |
| Biocompatibility: Cytotoxicity – MEM Elution Test | ISO 10993-5 (implicitly: PASSED) | PASSED |
| Biocompatibility: Cytotoxicity – Agar Overlay Assay | ISO 10993-5 (implicitly: PASSED) | PASSED |
| Biocompatibility: Sensitization – Guinea Pig Maximization Test | ISO 10993-10 (implicitly: PASSED) | PASSED |
| Biocompatibility: Irritation – Intracutaneous Reactivity | ISO 10993-10 (implicitly: PASSED) | PASSED |
| Biocompatibility: Acute Systemic Toxicity – Systemic Injection Test | ISO 10993-11 (implicitly: PASSED) | PASSED |
| Biocompatibility: Systemic Toxicity – Rabbit Pyrogen Test | ISO 10993-11 (implicitly: PASSED) | PASSED |
| Biocompatibility: Hemocompatibility – Hemolysis | ISO 10993-4 / ASTM F756 (implicitly: PASSED) | PASSED |
| Biocompatibility: Hemocompatibility – Complement Activation | ISO 10993-4 (implicitly: PASSED) | PASSED |
| Biocompatibility: Hemocompatibility – Thrombogenicity: Canine Model | ISO 10993-4 (implicitly: PASSED) | PASSED |
| Biocompatibility: Hemocompatibility – Thrombogenicity: Partial Thromboplastin Time Assay | ISO 10993-4 / ASTM F2382-18 (implicitly: PASSED) | PASSED |
| Biocompatibility: Hemocompatibility – Thrombogenicity: Platelet/Leukocyte Count Assay | ISO 10993-4 / ASTM F2888-19 (implicitly: PASSED) | PASSED |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample sizes for each specific bench test. It generally refers to "the 1.2F MAGIC Infusion Catheter (subject device)" as being tested. For biocompatibility, it states "The 1.2F MAGIC Infusion Catheter was assessed for biocompatibility."
The provenance of the data is retrospective, as it refers to testing conducted on the subject device to demonstrate substantial equivalence to a previously cleared predicate device. The document does not specify the country of origin of the data beyond the applicant "Balt USA, LLC" being located in Irvine, CA, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of device submission. The study describes physical and biological bench testing of a medical device, not a diagnostic or AI-powered device that requires expert-established ground truth from a test set of clinical images or data. The "ground truth" for these tests is defined by established engineering standards and biological testing protocols (e.g., ISO standards, ASTM standards, USP criteria).
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving expert readers for diagnostic accuracy. This submission relies on objective physical and biological measurements against predefined acceptance criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is not applicable. This submission is for a physical medical device (infusion catheter) and does not involve AI or human readers for diagnostic interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. This is not an AI-powered device.
7. The Type of Ground Truth Used
The ground truth for the bench tests is based on established engineering specifications, international standards (ISO 105551-1, ASTM F640-12, USP ), and biological testing protocols (ISO 10993-series, ASTM F756, ASTM F2382-18, ASTM F2888-19). These standards define the acceptable performance characteristics and biological response for such medical devices.
8. The Sample Size for the Training Set
This information is not applicable. This is not an AI/machine learning device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This information 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).