(33 days)
An intravascular catheter is a device that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.
Insyte™, Insyte-N™, and Insyte-W™ are available in 14-24 gauge and are made of BD Vialon™ Material. Angiocath™ is available in 14-24 gauge and is made of FFP Polymer material
This is an IV catheter from Becton Dickinson, which is a class II device under 21 CFR 880.5200. This device, named BD Angiocath™ and Insyte™ IV Catheters, did not have any AI/ML components in 2015. So, the request for acceptance criteria for such components cannot be fulfilled.
However, I can provide the acceptance criteria and performance data for the mechanical and physical tests performed on the device.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic / Test Performed | Test Method | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Per ISO 10993-1 | Meet biocompatibility standards | Pass |
| Liquid leakage | Per ISO 594-1, -2 | No liquid leakage | Pass |
| Air leakage | Per ISO 594-1, -2 | No air leakage | Pass |
| Separation force | Per ISO 594-1, -2 | Withstand specified separation force | Pass |
| Stress cracking | Per ISO 594-1, -2 | No stress cracking | Pass |
| Unscrewing torque | Per ISO 594-2 | Withstand specified unscrewing torque | Pass |
| Ease of assembly | Per ISO 594-2 | Easy assembly | Pass |
| Resistance to overriding | Per ISO 594-2 | Resistant to overriding | Pass |
| General | Per ISO 10555-1 | Meet general requirements | Pass |
| Radio-detectability | Per ISO 10555-1 | Radio-detectable | Pass |
| Biocompatibility (repeated) | Per ISO 10555-1 | Meet biocompatibility standards | Pass |
| Surface | Per ISO 10555-1 | Acceptable surface finish | Pass |
| Corrosion resistance | Per ISO 10555-1 | Corrosion-resistant | Pass |
| Peak tensile force | Per ISO 10555-1 | Withstand specified peak tensile force | Pass |
| Freedom from leakage | Per ISO 10555-1 | Freedom from leakage | Pass |
| Hubs | Per ISO 10555-1 | Meet hub requirements | Pass |
| Flowrate | Per ISO 10555-1 | Meet specified flowrate | Pass |
| Power injection | Per ISO 10555-1 | Suitable for power injection | Pass |
| Side holes | Per ISO 10555-1 | N/A (Not applicable / no side holes) | NA |
| Distal tip | Per ISO 10555-1 | Meet distal tip requirements | Pass |
| Color code | Per ISO 10555-5 | Correct color coding | Pass |
| Catheter unit | Per ISO 10555-5 | Meet catheter unit requirements | Pass |
| Needle point | Per ISO 10555-5 | Meet needle point requirements | Pass |
| Needle hub | Per ISO 10555-5 | Meet needle hub requirements | Pass |
| Strength of union between needle hub and needle tube | Per ISO 10555-5 | Withstand specified union strength | Pass |
| Vent fitting | Per ISO 10555-5 | Meet vent fitting requirements | Pass |
| Needle (Cannula) penetration force | Internal design input, identical to predicate | Penetration force specified by internal design input | Pass |
| Catheter penetration force | Internal design input, identical to predicate | Penetration force specified by internal design input | Pass |
| Catheter average drag force | Internal design input, identical to predicate | Average drag force specified by internal design input | Pass |
| Minimal catheter and cannula tip adhesion | Internal design input, identical to predicate | Minimal adhesion specified by internal design input | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each individual test. It states that "design verification tests were performed based on the risk analysis." The data provenance is internal, as these were tests conducted by the manufacturer, Becton Dickinson Infusion Therapy Systems Inc., as part of their design control process for regulatory submission. The document defines these as "design verification tests."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a physical medical device, and its performance criteria are established through standardized international and internal engineering test methods, not through expert consensus on medical images or clinical outcomes.
4. Adjudication Method for the Test Set
Not applicable. Performance testing is based on objective measurements against defined standards and specifications, not on subjective interpretations requiring an adjudication method.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML diagnostic tools that humans interact with, which is not the case for this physical medical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical medical product, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests presented are established international standards (ISO standards like ISO 10993-1, ISO 594-1, ISO 594-2, ISO 10555-1, ISO 10555-5) and internal design inputs that set specific thresholds for physical and mechanical properties.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device, so there is no training set in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).