(69 days)
The Intravascular Infusion Device is indicated for the infusion of diagnostic agents into the general vasculature including the peripheral, coronary and neurovasculature.
The Intravascular Infusion Device is a single lumen device constructed with progressively softer characteristics from proximal to distal end to aid in selective placement in the vasculature.
This 510(k) premarket notification describes an Intravascular Infusion Device. It's important to note that this document is for a medical device that predates the widespread use of AI/ML in medical diagnostics, and thus, many of the questions related to AI/ML specific aspects (like multi-reader multi-case studies, standalone algorithm performance, training data sets, and ground truth establishment for AI) are not directly applicable.
Here's an analysis based on the provided text, focusing on the device's functional and biocompatibility testing:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists various tests performed but does not explicitly state specific acceptance criteria (e.g., "Infusion rate must be X mL/min with Y% accuracy") or quantitative reported performance values (e.g., "Infusion rate achieved Z mL/min"). It only lists the types of tests conducted to demonstrate safety and performance.
| Acceptance Criteria (Not explicitly stated in the document) | Reported Device Performance (Implied by successful testing) |
|---|---|
| Adequate Infusion Rate | Device passed Infusion Rate Testing |
| Adequate Dynamic Infusion | Device passed Dynamic Infusion Testing |
| Resistance to Static Burst Pressure | Device passed Static Burst Testing |
| Appropriate Tip Flexibility | Device passed Tip Flexibility Testing |
| Responsive Torque | Device passed Torque Response Testing |
| Sufficient Torsion Strength | Device passed Torsion Strength Testing |
| Sufficient Tensile Strength | Device passed Tensile Strength Testing |
| Adequate Coating Integrity | Device passed Coatings Testing |
| Biocompatibility in vivo | Device passed In vivo Testing |
| Non-cytotoxic | Device passed Cytotoxicity testing |
| Non-hemolytic | Device passed Hemolysis testing |
| Non-acutely toxic systemically | Device passed Acute Systemic Toxicity testing |
| Non-intracutaneous toxic | Device passed Intracutaneous Toxicity testing |
| Non-sensitizing | Device passed Sensitization testing |
| Non-pyrogenic | Device passed Pyrogenicity testing |
| Compliant with USP Physiochemical standards | Device passed USP Physiochemical Testing |
The conclusion states: "Based on the Indications for Use, technological characteristics and safety and performance testing, the Intravascular Infusion Device has been shown to be sate and effective for its intended use." This implies that the device met all unstated acceptance criteria for these tests.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample size for any of the functional or biocompatibility tests.
- Data Provenance: The tests are described as "Functional Testing" and "Biocompatibility Testing," implying lab-based, pre-clinical testing conducted by the manufacturer (Boston Scientific Corporation / SciMed Life Systems). The data is therefore prospective in nature, generated specifically for this premarket notification. The country of origin for the data generation would be where the manufacturer is located, which is USA (Maple Grove, MN).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable to this type of device and testing. Functional and biocompatibility tests for an intravascular catheter do not typically involve human experts establishing "ground truth" in the same way an AI diagnostic algorithm for image analysis would. The "ground truth" for these tests would be the measured physical properties or biological responses against predefined engineering specifications or recognized biological safety standards.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods like "2+1" or "3+1" are relevant for expert review in clinical studies or AI algorithm validation, not for functional engineering or biocompatibility testing of a physical medical 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 question is not applicable. MRMC studies are specific to evaluating human reader performance, particularly in diagnostic imaging, often in the context of AI tools. This 510(k) is for a physical intravascular infusion device manufactured in 1996 and does not involve AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. This 510(k) describes a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
For the functional tests (e.g., Infusion Rate, Burst Testing, Tensile Strength), the "ground truth" would be established by engineering specifications and established test methodologies. For biocompatibility tests (e.g., Cytotoxicity, Hemolysis, Pyrogenicity), the "ground truth" is based on recognized biological safety standards and validated laboratory assays (e.g., ISO 10993 series and USP standards), where specific thresholds for toxicity, hemolytic activity, or pyrogenicity define "safe" or "acceptable" outcomes.
8. The Sample Size for the Training Set
This question is not applicable. This 510(k) is for a physical medical device and does not involve an AI algorithm with a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no AI algorithm training set for this 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).