(31 days)
Introcan Safety® 3 Closed Intravascular 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 with power injectors at a maximum pressure of 325 psi with 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. Introcan Safety® 3 design is 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 Since the needle is withdrawn through a septum that seals after the needle has been removed, blood is thus contained within the Introcan Safety® 3 device.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 is designed to improve catheter stability while minimizing catheter movement within the vessel. The device controls the flow of blood, aiding in the prevention of blood exposure. 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 document is a 510(k) summary for the Introcan Safety® 3 Closed IV Catheter, indicating that the device has been found substantially equivalent to a previously cleared predicate device (K182870). The primary difference for the new submission is an extension of the power injection capabilities to higher pressure rates for all gauge sizes.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly laid out in a table format with specific pass/fail thresholds for each test in the provided document. However, the document lists "Nonclinical Testing" that was performed and states that the "Results of the testing conducted on the proposed devices demonstrate that the Introcan Safety® 3 Closed IV Catheters are substantially equivalent to the predicate device and are as safe and effective as the predicate devices."
Based on the information provided, we can infer the tested parameters and their implied "acceptance" through comparison to the predicate. The "Comparison" column in the Technological Characteristics table effectively serves as the reported device performance relative to the predicate, with the implied acceptance criteria being "Same" or that the difference does not raise additional safety and effectiveness questions.
| Acceptance Criteria (Implied by Predicate & Standards) | Reported Device Performance (Proposed Device) |
|---|---|
| Indications for Use: Short term use to sample blood, monitor blood pressure, administer fluids/blood intravascularly. Power injectors at max pressure 300 psi for 18-24 gauge. | Indications for Use: Short term use to sample blood, monitor blood pressure, administer fluids/blood intravascularly. Power injectors at max pressure 325 psi for 14-24 gauge. |
| Configuration: Single Lumen, Tapered Tip | Single Lumen, Tapered Tip |
| Material Composition: (Catheter Tube, Hub, Needle, Safety Clip, Septum, Septum Opener, Septum Housing) | Identical to predicate (Polyurethane, Polypropylene, Stainless steel, MABS, Stainless steel, Silicone or Polyisoprene Rubber, Polyoximethylene, Polypropylene) |
| Catheter Gauge Sizes: 14ga-24ga | 14ga-24ga |
| Catheter Length: 3/4" (19mm) - 2" (50mm) | 3/4" (19mm) - 2" (50mm) |
| Gravity Flow Rate: (Specific values for each gauge x length) | Identical to predicate for all listed gauge x length combinations (e.g., 14ga x 32mm: 325 mL/min; 24ga x 19mm: 22 mL/min) |
| Sterilization: Ethylene Oxide | Ethylene Oxide |
| Shelf-Life: 5 year | 5 year |
| Power Injection (Performance at specified pressure/flow): Max 300 psi for 18-24g | Bench testing performed to demonstrate acceptable performance at 325 psi for 14-24ga, concluding that differences do not raise additional questions of safety and effectiveness. (Specifically, "Power Injection test for flowrate and device pressure per ISO 10555-1 Section 4.10 Annex G" and "Test for burst pressure under static conditions per ISO 10555-1 Section 4.10 Annex F" were conducted.) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (number of devices) used for each nonclinical test (Power Injection and Burst Pressure). It only states that "Bench testing performed on Introcan Safety® 3 Closed IV Catheters supports substantial equivalence of the proposed device."
- Sample Size: Not explicitly stated for each test.
- Data Provenance: The data is from "bench testing" performed by the manufacturer, B. Braun Medical Inc., located in Allentown, PA, USA. This is retrospective data collected for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not applicable as the study described is nonclinical bench testing of a physical medical device, not a diagnostic AI system requiring expert consensus for ground truth.
4. Adjudication Method for the Test Set
- This information is not applicable as it refers to clinical studies or studies using human interpretation, which is not the case here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
- No, an MRMC comparative effectiveness study was not done. The study was nonclinical bench testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This is not applicable as the device is a physical medical catheter, not an algorithm or AI system. The "standalone" performance here refers to the device's physical and mechanical properties. The bench tests conducted (Power Injection test, Burst Pressure test) represent the standalone performance of the device under simulated conditions.
7. Type of Ground Truth Used
The "ground truth" for the nonclinical tests is established by:
- Engineering specifications and recognized international standards: The tests were performed "per ISO 10555-1 Section 4.10 Annex G" (Power Injection) and "per ISO 10555-1 Section 4.10 Annex F" (Burst Pressure). These standards define the methodology and expected performance characteristics for intravascular catheters.
- Comparison to the predicate device: The new device's performance is gauged against the established and cleared performance of its predicate counterpart. The objective is to demonstrate that the proposed changes (higher pressure for power injection) do not compromise safety or effectiveness compared to the predicate, and meet the new specified performance.
8. Sample Size for the Training Set
- This is not applicable as there is no mention of a training set. This is a nonclinical bench test of a physical device, not an AI/ML algorithm that requires training.
9. How the Ground Truth for the Training Set Was Established
- This is 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).