(111 days)
The BD Intima II Closed IV Catheter System is inserted into a patient's vascular system for short-term use to monitor blood pressure or administer fluids intravascularly. These devices may be used for any patient with consideration given to adequacy of vascular anatomy, procedure being performed, and duration of therapy.
The BD Intima IITM Closed IV Catheter System is a closed system IV Catheter. The closed system is designed to keep blood contained within the device throughout the insertion process. The system consists of a radiopaque VialonTM material catheter, a notched needle for flashback visualization, a septum to remove visible blood from the needle tubing, a clamp (slide clamp/pinch clamp), extension tubing and Luer connector. It incorporates an integrated extension set which is available in two configurations: Y Connection (dual port) and Straight Connection (single port). The Luer connector is color-coded to indicate catheter gauge. It is provided EO sterilized to achieve a Sterility Assurance Level (SAL) of 10-6. The package system is able to maintain the sterility during its specified shelf life of 3 years.
This document describes the BD Intima II™ Closed IV Catheter System and compares it to a predicate device, also named BD Intima II™ Closed IV Catheter System (K100775). The key takeaway is that the new device is a modified version of the predicate device, specifically regarding some adhesives, lubricants, and the addition of a new pinch clamp option. Because this document focuses on establishing substantial equivalence to another device and the described modifications are minor, the "study" referred to is a series of design verification tests, not a clinical study involving human patients or complex AI algorithms.
Here's a breakdown of the requested information based on the provided text:
1. Table of acceptance criteria and the reported device performance
| Characteristic / Test Performed | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Meets ISO 10993 | Pass |
| Needle/Paddle Hub Pull Force | Meets predicate's performance | Pass |
| Catheter/Catheter Adaptor Pull Force | Meets predicate's performance | Pass |
| Extension Tubing/Catheter Adapter Pull Force | Meets predicate's performance | Pass |
| Septum Burst Test | Meets predicate's performance | Pass |
| Catheter Burst Test | Meets predicate's performance | Pass |
Note: The document states "Same Methodology as Predicate" for most tests, implying the acceptance criteria would be to perform equivalently to the predicate device, or meet established internal specifications derived from the predicate's performance.
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each test. It refers to "design verification tests" without providing details on the number of units tested. The data provenance is internal design verification data from Becton Dickinson Infusion Therapy Systems Inc. (USA), for modifications made to an existing device. It is retrospective in the sense that it's comparing a new version to an existing design.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable. The "ground truth" for a medical device such as an IV catheter is typically established through established engineering principles, international standards (like ISO 10993 for biocompatibility), and internal quality control specifications. These are objective measures, not subjective interpretations by experts in the same way clinical diagnoses would be.
4. Adjudication method for the test set
Not applicable. The tests are objective and quantitative (e.g., Pass for biocompatibility, pull force tests). There's no subjective interpretation requiring adjudication.
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
Not applicable. This device is an IV catheter, a physical medical device, not an AI-powered diagnostic or decision support system that would involve human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device.
7. The type of ground truth used
The ground truth used for these tests is based on:
- Engineering specifications and performance characteristics of the predicate device.
- International standards (e.g., ISO 10993 for biocompatibility).
- Internal quality control and design requirements for medical devices.
- Objective physical and chemical properties.
8. The sample size for the training set
Not applicable. This device does not use an AI model or machine learning, therefore there is no "training set."
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).