(36 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 innsideration 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 luerlocking adapters to which an IV line or accessories may be attached.
The provided text is a 510(k) Premarket Notification summary for IV catheters. It focuses on demonstrating "substantial equivalence" of modified devices to previously marketed devices, primarily due to a change in the lubrication system to make the manufacturing process "ozone friendly." This document does not describe an AI device or a study involving AI. Therefore, I cannot fulfill your request for information related to AI device acceptance criteria or studies proving its effectiveness.
However, I can extract the information regarding the nonclinical tests conducted to support the substantial equivalence claim for these IV catheters, as this is the closest equivalent to "acceptance criteria and study" in the provided text.
Acceptance Criteria and Study for BD Medical Systems IV Catheters (K013800)
This document describes a premarket notification for updated IV catheters, primarily focused on a manufacturing process change (lubrication system). The "acceptance criteria" here refer to demonstrating that the modified devices perform equivalently to the predicate devices. The study's purpose was to support "substantial equivalence" to market the modified devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Attribute Compared) | Reported Device Performance (Conclusion) |
|---|---|
| Penetration | Data provided demonstrates substantial equivalence between modified and unmodified devices. |
| Tip Adhesion | Data provided demonstrates substantial equivalence between modified and unmodified devices. |
| Catheter / Adapter Separation Force | Data provided demonstrates substantial equivalence between modified and unmodified devices. |
| Biocompatibility | Data provided demonstrates substantial equivalence between modified and unmodified devices. (Implied from the "Nonclinical Tests Support Substantial Equivalence" section) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes used for "side-by-side testing." It only states that "side-by-side testing of modified and unmodified devices was conducted."
- Data Provenance: The data provenance is internal to Becton Dickinson Infusion Therapy Systems Inc. The study is retrospective in the sense that it compares new manufacturing process devices to existing, already marketed devices. The origin of the data (e.g., country) is not explicitly stated but is implicitly from BD's testing facilities.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the study described is a nonclinical, side-by-side performance comparison of device attributes, not a study requiring expert clinical judgment or ground truth establishment in the context of diagnoses or interpretations.
4. Adjudication Method (for the test set)
This information is not applicable. Adjudication methods are typically used in studies involving human interpretation or clinical endpoints. This study involves objective physical attribute testing.
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, as the device is an IV catheter and not an AI-powered diagnostic or assistive technology.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable, as the device is an IV catheter and not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context is the performance of the predicate devices (unmodified devices). The testing aimed to show that the performance of the modified devices aligned with, or was substantially equivalent to, the established performance of the unmodified (predicate) devices for the specified attributes.
8. The Sample Size for the Training Set
This information is not applicable, as this is not an AI device nor a study involving a "training set" in that context.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as explained 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).