(120 days)
Introcan Safety® 3 Closed Intravascular Catheter is inserted into a patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure or administer fluids and blood intravascularly.
The 18-22 gauge catheters may be used with power injectors at a maximum pressure of 300 psi with a luer lock connection only.
The Introcan Safety® 3 Closed IV Catheter consists of an over-the-needle, peripheral intravascular catheter made of radiopaque polyurethane, an integrated bidirectional septum, a stabilization platform, and a passive safety needle-shielding mechanism.
The Introcan Safety® 3 will be offered in the following gauge sizes and lengths:
18ga x 1-3/4" (45mm)
18ga x 1-1/4" (32 mm)
20ga x 1-1/4" (32mm)
20ga x 1" (25mm)
22ga x 1" (25mm)
24ga x ¾" (19mm)
Introcan Safety® 3 design is described as a closed IV catheter since it protects clinicians and patients from blood exposure. Since the needle is withdrawn through a septum that seals after the needle has been removed, blood is thus contained within the Introcan Safety® 3 device. The pressure exerted on the needle as it passes through the septum wipes blood from the needle further reducing potential blood exposure.
The Introcan Safety® 3 catheter has an integrated stabilization platform is designed to improve catheter stability while minimizing catheter movement within the vessel.
The passive safety needle-shielding mechanism of the Introcan Safety® 3 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.
The provided document [K111236](https://510k.innolitics.com/search/K111236) is a 510(k) premarket notification for a medical device (Introcan Safety® 3 Closed IV Catheter) and includes a summary of the device, its intended use, and a conclusion about its substantial equivalence to predicate devices. However, the document does not contain detailed information regarding acceptance criteria, the specific study design, sample sizes for test or training sets, ground truth establishment, or expert involvement as requested in your prompt.
The document states:
"Testing was conducted to demonstrate the performance of the Introcan Safety® 3 Closed IV Catheter and substantial equivalence with the predicate devices: B. Braun Medical Inc.'s Introcan Safety® and BD's Nexiva™ Closed IV Catheter System Closed IV Catheter System. The functional performance testing conducted with the proposed device demonstrates that the Introcan Safety® 3 Closed IV Catheter is as safe and effective as the predicate devices."
This indicates that functional performance testing was performed to show substantial equivalence, but the specifics of that testing (e.g., acceptance criteria, study methodologies, statistical analyses, or specific performance metrics) are not provided within the given text.
Therefore, I cannot fulfill your request for the following information based on the provided document:
- A table of acceptance criteria and the reported device performance: This information is not explicitly stated. The document only mentions "functional performance testing" demonstrating the device is "as safe and effective as the predicate devices."
- Sample sizes used for the test set and the data provenance: Not provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this device is not an AI/diagnostic imaging device and "ground truth" in this context would refer to objective physical or mechanical performance standards rather than expert interpretation.
- Adjudication method: Not applicable.
- 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, as this is a physical medical device (catheter), not an AI-assisted diagnostic tool.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not explicitly stated, though it would likely be based on engineering specifications and objective measurements of the catheter's physical and mechanical properties.
- The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable.
§ 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).