(55 days)
As provided in 21 CFR 880.5200, 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.
The products identified in this 510(k) notification include both standard catheters and catheters with a needle-shielding feature. The catheters listed have either a FEP polymer or Vialon material catheter. All have a luerlocking adapters to which an IV line or accessories may be attached.
The provided text describes a 510(k) premarket notification for various IV catheters (Insyte™, Angiocath™, Insyte™ Autoguard™, Angiocath™ Autoguard™, Autoguard™ Pro, Intima™, and Saf-T-Intima™). The notification focuses on a modification to the lubrication system used in the manufacturing process, making it "ozone friendly," while the catheter design and technological characteristics remain unchanged.
Here's an analysis of the acceptance criteria and study information based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Attribute Tested) | Reported Device Performance (Conclusion) |
|---|---|
| Penetration | Substantially equivalent |
| Tip Adhesion | Substantially equivalent |
| Catheter / Adapter Separation Force | Substantially equivalent |
| Biocompatibility | Substantially equivalent |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: Not specified. The document states "Side-by-side testing of modified and unmodified devices was conducted" but does not give a numerical sample size.
- Data Provenance: The tests were conducted internally by the manufacturer, Becton Dickinson Infusion Therapy Systems Inc., based in Sandy, UT, USA. The study design implies a comparison between modified and unmodified devices manufactured by this entity. The data is retrospective in the sense that the modified devices were tested against existing unmodified devices to demonstrate equivalence for an existing product line.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable to this type of submission. This 510(k) is for a manufacturing process change to an existing device and relies on nonclinical (i.e., benchtop) testing rather than clinical data requiring expert human assessment or ground truth establishment in a diagnostic context.
4. Adjudication Method for the Test Set
This information is not applicable. Since the testing involved nonclinical, side-by-side comparison of device attributes, there was no need for expert adjudication of results in the way one might evaluate diagnostic image interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The current submission is for a manufacturing process change to an intravascular catheter, which is a therapeutic device, and the evaluation relies on benchtop performance characteristics.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is not applicable. This is not an AI/algorithm-based device. The "device" here refers to physical IV catheters.
7. Type of Ground Truth Used
The "ground truth" for this study was established by objective, measurable performance characteristics of the devices themselves (e.g., force required for penetration, adhesion strength, separation force). These are physical properties measured directly from the devices, not expert consensus, pathology, or outcomes data in the traditional medical sense. The "ground truth" is that the modified device should perform as well as the unmodified device on these physical metrics.
8. Sample Size for the Training Set
This information is not applicable. There is no "training set" in the context of this 510(k). This is not an AI/machine learning model that requires training data. The "study" here is a set of nonclinical bench tests.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as in point 8.
§ 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).