(100 days)
Introcan Salety® 2 IV Catheter is inserted into a patient's vascular system for short term use to sample blood, monitor blood pressure or administer fluids and blood intravascularly. The catheters may be used intravascularly with power injectors at a maximum pressure of 325 psi with a luer lock connection only.
The Introcan Safety® 2 IV Catheter consists of an over-the-needle, peripheral catheter made of radiopaque polyurethane, an integrated septum, and a passive safety needleshielding mechanism. Introcan Safety® 2 is designed to protect clinicians and patients from blood exposure. During needle withdrawal through a septum that seals after the needle has been removed, blood is thus contained within the Introcan Safety® 2 device. The pressure exerted on the needle as it passes through the septum wipes blood from the needle further reducing potential blood exposure. The passive safety needle-shielding mechanism of the Introcan Safety® 2 is located inside the catheter hub. Upon withdrawal of the needle, the safety shield engages as the needle passes through the catheter hub and deploys automatically to shield the needle tip. The safety shield protects during disposal, aiding in the prevention of needlestick injuries. Once the safety shield engages and shields the needle tip, the user is unable to re-insert the needle which aids in the prevention of catheter shearing. This device may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy. The catheters may be used intravascularly with power injectors for which the maximum pressure setting is 325 psi with a luer lock connection only.
This document is a 510(k) Pre-market Notification for the Introcan Safety® 2 IV Catheter. As such, it focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets novel acceptance criteria through a standalone study structured like a diagnostic AI performance evaluation. Therefore, many of the requested elements (like MRMC studies, number of experts, training set details) are not applicable or provided in the context of this regulatory submission for a physical medical device.
However, based on the provided text, I can extract information related to the device's performance and the non-clinical testing conducted to support its substantial equivalence.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally established based on international standards (e.g., ISO 10555-1, ISO 10555-5) and internal specifications. The reported performance is presented as the device successfully passing or meeting these criteria, particularly highlighting the changes from the predicate device.
| Performance Metric (Acceptance Criteria Implicit in Standards/Internal Specs) | Reported Device Performance (Proposed Introcan Safety® 2 IV Catheter) | Comparison/Notes |
|---|---|---|
| Maximum Pressure for Power Injection | 325 psi | Meets the new proposed maximum pressure. (Predicate was 300 psi). Confirmed through bench testing. |
| Blood Control Capabilities | Multi blood control (design changes to septum and septum opener) | Meets the enhanced multi-access blood control capabilities. (Predicate had one-time blood control). Confirmed through bench testing. |
| Gravity Flow Rate | ||
| 18ga x 32 mm | 105 mL/min | Same as Predicate (105 mL/min) |
| 18ga x 45 mm | 90 mL/min | Meets this flow rate. (Predicate was 100 mL/min). This specific flow rate for 18ga x 45mm changed and was confirmed through bench testing. |
| 20ga x 25 mm | 65 mL/min | Same as Predicate (65 mL/min) |
| 20ga x 32 mm | 60 mL/min | Same as Predicate (60 mL/min) |
| 20ga X 50 mm | 55 ml/min | Same as Predicate (55 ml/min) |
| 22ga x 25 mm | 35 mL/min | Same as Predicate (35 mL/min) |
| 24ga x 14 mm | 26 mL/min | Same as Predicate (26 mL/min) |
| 24ga x 19 mm | 22 mL/min | Same as Predicate (22 mL/min) |
| Air tightness (ISO 10555-1) | Testing successfully completed. | Meets standard as demonstrated by successful completion of testing. |
| High pressure (Burst Test) (ISO 10555-1) | Testing successfully completed. | Meets standard as demonstrated by successful completion of testing. |
| Flow rate through capillary (ISO 10555-1) | Testing successfully completed. | Meets standard as demonstrated by successful completion of testing. |
| Projecting length capillary tip (ISO 10555-1) | Testing successfully completed. | Meets standard as demonstrated by successful completion of testing. |
| Catheter hub air aspiration (ISO 10555-1) | Testing successfully completed. | Meets standard as demonstrated by successful completion of testing. |
| Power injection (ISO 10555-1) | Testing successfully completed. | Meets standard as demonstrated by successful completion of testing, confirming 325psi capability. |
| Dynamic tensile load (ISO 10555-5) | Testing successfully completed. | Meets standard as demonstrated by successful completion of testing. |
| Siliconization (Internal Requirement) | Testing successfully completed. | Meets internal specification. |
| Flow rate through metal cannula (Internal Requirement) | Testing successfully completed. | Meets internal specification. |
| Liquid tightness (Internal Requirement) | Testing successfully completed. | Meets internal specification. |
| Force Testing (Internal Requirement) | Testing successfully completed. | Meets internal specification. |
| Blood flashback (Internal Requirement) | Testing successfully completed. | Meets internal specification. |
| Septum opener retention force (Internal Requirement) | Testing successfully completed. | Meets internal specification. |
| Blood exposure (Internal Requirement) | Testing successfully completed. | Meets internal specification, demonstrating effective blood control. |
| Flushing (Internal Requirement) | Testing successfully completed. | Meets internal specification. |
| Cannula withdrawal angle test (Internal Requirement) | Testing successfully completed. | Meets internal specification. |
| Biocompatibility Classification | Externally communicating blood path, indirect prolonged contact (Same as predicate) | Same as predicate, implying continued compliance with biocompatibility requirements. |
| MRI labeling | MRI Conditional (Same as predicate) | Same as predicate, implying continued compliance with MRI safety requirements. |
| Sterilization | Ethylene Oxide (Same as predicate) | Same as predicate, implying continued compliance with sterilization requirements. |
| Shelf life | 1 year (Same as predicate) | Same as predicate, implying continued compliance with shelf-life requirements. |
2. Sample size used for the test set and the data provenance
The document describes non-clinical bench testing rather than clinical studies with human data. Therefore, the concept of "test set" in the context of diagnostic AI is not directly applicable.
- Sample Size: Not explicitly stated as a single number across all tests. The testing section lists various tests performed (e.g., ISO standards, internal specifications). For each test, an appropriate number of device samples would have been used to demonstrate compliance, but specific counts are not provided in this summary.
- Data Provenance: N/A, as this is bench testing of physical devices, not clinical data provenance (country of origin, retrospective/prospective). The tests were conducted internally by B. Braun Medical Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. This is a physical device, and the "ground truth" for its performance is established through adherence to engineering standards and protocols, not through expert human interpretation of clinical data as would be done for a diagnostic AI.
4. Adjudication method for the test set
N/A. Adjudication methods (like 2+1, 3+1) are for resolving discrepancies in expert interpretations of data, typically in diagnostic studies. This is not relevant for bench testing of a physical 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
N/A. This is a physical medical device, not an AI diagnostic tool. No MRMC study was performed, nor would it be relevant for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This is a physical medical device. It does not involve an algorithm, so "standalone performance" in the AI sense is not applicable.
7. The type of ground truth used
The "ground truth" for this device's performance is compliance with established international consensus standards (ISO 10555-1, ISO 10555-5) and internal engineering specifications and test protocols. These standards define measurable performance characteristics (e.g., flow rate, burst pressure, air tightness) that the device must meet.
8. The sample size for the training set
N/A. This device is not an AI algorithm and therefore does not have a "training set."
9. How the ground truth for the training set was established
N/A. Not applicable, as there is no training set for a physical medical device.
§ 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).