(133 days)
Sterile, single-use plastic cannula used to penetrate pre-slit septums covering injection sites as well as, vials designed for penetration with needleless IV access cannula. The cannula is pre-lubricated to reduce septum insertion forces.
The B-D® Blunt Plastic Cannula replaces hypodermic needles currently used to access injection sites, as well as, vials designed for penetration with needleless IV access cannula. The B-D Blunt Plastic Cannula provides access to the fluid path and prevents accidental needlesticks in this application.
Sterile, single-use plastic cannula used to penetrate pre-slit septums covering injection sites as well as, vials designed for penetration with needleless IV access cannula. The cannula is pre-lubricated to reduce septum insertion forces.
B-D® Blunt Plastic Cannula is a molded plastic blunt tipped cannula for use in preslit IV safety systems, (i.e. Baxter InterLink® , Abbott LifeShield®, and McGaw SafeLine™). The B-D Blunt Plastic Cannula is intended for penetration of pre-slit IV port septums or vials designed for penetration with needleless IV access cannula (i.e. Abbott LifeShield® Single Dose Vials). B-D® Blunt Plastic Cannula, InterLink® Syringe Cannula, and McGaw SafeLine™ Blunt Cannula are all plastic devices. LifeShield® Blunt Cannulas is a two (2) piece design which has a plastic hub with a blunt steel cannula attached.
B-D® Blunt Plastic Cannula is molded from copolyester resin.
Here's a breakdown of the acceptance criteria and supporting studies for the B-D® Blunt Plastic Cannula, based on the provided document:
Acceptance Criteria and Device Performance for B-D® Blunt Plastic Cannula
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance (B-D® Blunt Plastic Cannula) |
|---|---|---|
| General Equivalence Tests (Section 6.1): | ||
| Injection Site Peak Penetration Force (6.1.1) | Performed at an acceptable level in all sites; forces within the range of predicate devices (InterLink® Syringe Cannula, McGaw SafeLine™) and Abbott LifeShield®). Consistency between old and new device performance. | Performance was acceptable in all sites. Differences (lower or higher than predicates) were attributed to dimensional differences in stem ODs, but overall forces were within the range of predicate devices. |
| Lipid Flow Rate Testing (6.1.2) | Equivalent flow rates to all predicate devices. No significant particle generation during infusion. | Flow rates were equivalent to all predicate devices. Filter examination showed no concerning particle generation. |
| Lipid Compatibility (6.1.3) | No leakage due to physical changes/material degradation after 24-hour lipid infusion. No damage observed on luer slip magnification. | No leakage due to physical changes or material degradation. Magnification (20X) revealed no damage to luer slips, indicating no impact on cannula function. |
| Microbial Ingress Testing (6.1.4) | Did not compromise microbial barrier efficacy of pre-slit needleless septums after 200 penetrations. No microbial ingress. | Did not compromise microbial barrier efficacy. No microbial ingress was found in any of the six challenged cannula and injection site combinations, even with added stress of wiping septums and changing cannulas after every fourth penetration. |
| Leakage Testing (6.1.5) | No drops of water forming and falling off within 30 seconds at 45 psi pressure after 200 penetrations. | No leakage observed due to the B-D® Blunt Plastic Cannula. |
| Gravity Flow Rate (6.1.6) | Acceptance criteria were not explicitly stated but implied comparison to predicate devices and acceptable clinical performance. | Flow rate was greater than the Abbott LifeShield® 18G Blunt Steel Cannula. While lower than McGaw SafeLine™ and InterLink® Syringe Cannula due to a smaller ID, the reduced ID/OD allowed access to all systems. |
| Particulate Matter Generation (6.1.7) | Produced equivalent or reduced particulate matter compared to predicate devices after 200 penetrations. | Produced equivalent or reduced particulate matter compared to the predicate devices. |
| Specific Claims Tests (Section 6.2): | ||
| Peak Penetration Forces in Abbott LifeShield® Single Dose Vials (6.2.1) | Maintained stopper integrity despite potential higher forces due to larger OD. | Slightly higher penetration forces were observed due to larger cannula OD, but subsequent tests confirmed this did not affect stopper integrity. |
| Full Dose Draw / Vial Integrity (6.2.2) | Maintained vial integrity (no leakage) and allowed aspiration of full fluid volume after pressurization with 10cc air. | Vial integrity was maintained through pressurization (10cc air = 10 ml fluid +/- 10%). The cannula successfully allowed for vial penetration and aspiration of fluid without leakage. |
| Vial Particulate Matter Generation (6.2.3) | No particulates of vial stopper material observed on filters. | No particulates of vial stopper material were observed on filters for either the B-D® Blunt Plastic Cannula or the predicate device during fluid aspiration from vials. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the total number of individual devices or injection sites/vials included in each test. However, it mentions specific quantities for certain test procedures:
- Microbial Ingress Testing (6.1.4): Injection sites were penetrated two hundred (200) times with various cannulas. Six combinations of cannula and injection sites were challenged.
- Leakage Testing (6.1.5): Injection sites were penetrated two hundred (200) times with various cannulas.
- Particulate Matter Generation (6.1.7): Injection sites were penetrated two hundred (200) times with cannula.
Data Provenance: The studies appear to be retrospective in the sense that they are laboratory tests conducted on existing materials and designs, comparing a new device to already marketed predicate devices. The country of origin of the data is not specified but is implicitly from the manufacturer's testing facilities (Becton Dickinson).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not mention the use of human experts or their qualifications to establish ground truth for the test set. These are largely engineering and performance tests based on measurable physical and biological parameters, rather than human interpretation.
4. Adjudication Method for the Test Set:
No adjudication method is mentioned, as the tests are objective laboratory measurements (e.g., force, flow rate, presence of microbes/particles, leakage).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC study was not done. This type of study is typically used for diagnostic devices that involve human interpretation of images or other data, where the AI assists the human reader. The current device is a sterile medical accessory, and its performance is evaluated through physical, mechanical, and biological compatibility tests.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This question is not applicable to the B-D® Blunt Plastic Cannula. The device itself is a physical medical accessory, not an AI algorithm. Its performance is inherent to its design and material properties.
7. The type of ground truth used:
The "ground truth" for these tests is established by:
- Physical measurements: E.g., peak penetration force, flow rate (ml/min), pressure (psi), volume (cc/ml), particle size (>10 µm, >100 µm).
- Absence/Presence criteria: E.g., absence of microbial ingress, absence of leakage, absence of visible particulates.
- Comparisons to predicate devices: Performance is deemed acceptable if it is equivalent, superior, or within an acceptable range compared to established, legally marketed predicate devices.
- Material analysis: Fourier Transform Infrared (FTIR) analysis for particle characterization.
8. The sample size for the training set:
This concept is not applicable. The device is a physical product, not a machine learning model, so there is no "training set" in the context of AI. The development process would have involved design, prototyping, and iterative testing, but not machine learning training.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for an AI model.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).