(196 days)
The B-D® Blunt Plastic Cannula replaces hypodermic needles currently used to access injection sites, as well as, vials designed for penefration with needleless IV access cannula. The B-D@ Blunt Plastic Cannula provides access to fluid path for Injection/aspiration of fluids. Use of this device prevents accidental hypodermic needlesticks in this application. These devices can also be used to flush pre-slit injection sites.
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 with medical grade silicone to reduce septum insertion forces.
The provided text is related to a 510(k) submission for a medical device, the Becton Dickinson Blunt Plastic Cannula. The primary claim supported by data is the effective flushing of pre-slit injection sites.
However, the document does not contain information about:
- Specific acceptance criteria in the form of numerical targets for performance metrics. Instead, the acceptance criterion seems to be "superior flushing effectiveness" compared to competitive cannulas, which is a comparative claim.
- A "device performance" table with quantitative results directly linked to acceptance criteria.
- Sample sizes for the test set in terms of the number of injection sites or repetitions for each cannula type.
- Data provenance (country of origin, retrospective/prospective).
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- MRMC comparative effectiveness study or related effect sizes.
- Standalone performance (algorithm only without human-in-the-loop) because this is a physical medical device, not an AI/software device.
- Ground truth type for the flushing effectiveness (while red blood cell count is mentioned, it's the outcome of the test, not an externally established ground truth for a diagnostic claim).
- Sample size for the training set (not applicable for this type of device and study).
- How ground truth for the training set was established (not applicable).
Therefore, based only on the provided text, a comprehensive answer for all requested points cannot be generated. I will provide the information that is present and indicate where information is missing.
Acceptance Criteria and Study Details for B-D® Blunt Plastic Cannula
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Claim | Performance Description |
|---|---|
| Superior Flushing Effectiveness compared to competitive cannulas for compatible pre-slit injection sites. | The B-D® Blunt Plastic Cannula demonstrated superior flushing effectiveness as compared to the competitive cannulas tested (Baxter InterLink® Syringe Cannula, Abbott LifeShield® Blunt Steel Cannula, McGaw SafeLine® Blunt Cannula, Abbott LifeShield® BlunTip™ Cannula). |
Flushing effectiveness was assessed by counting the remaining red blood cells in the injection site after flushing under controlled test conditions. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size (e.g., number of injection sites, number of trials) for the test set. It mentions four experiments were developed.
- Test Set Sample Size: Not explicitly stated (e.g., number of replicates for each condition).
- Data Provenance: The study was conducted internally by Becton Dickinson ("Becton Dickinson Test Protocol"). The country of origin and whether it was retrospective or prospective data are not specified, but typically, such testing is prospective and conducted in a lab environment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided. The "ground truth" here is the physical outcome of flushing (number of remaining red blood cells), which is a measurable quantity, not an expert opinion or diagnosis.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication typically applies to expert review of diagnostic information, not to the direct measurement of a physical phenomenon in a laboratory test.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study applies to diagnostic imaging or AI devices involving human interpretation, not to the functional performance of a physical medical device like a cannula.
6. If a Standalone Performance Study Was Done
Yes, a standalone study of the device's flushing performance was done. The "Injection Site Flushing Evaluation" was a controlled laboratory test assessing the B-D® Blunt Plastic Cannula's flushing effectiveness independently and compared to competitor devices. This is a standalone study of the device itself. (Note: "Standalone" in the context of AI often refers to algorithm-only performance, which is not relevant here).
7. The Type of Ground Truth Used
The ground truth for flushing effectiveness was established by direct measurement of the outcome: the "number of red blood cells remaining in the injection site measured flushing effectiveness." This is a quantifiable, objective outcome data, not expert consensus or pathology in the traditional sense.
8. The Sample Size for the Training Set
This information is not applicable and not provided. This device is not an AI/machine learning model, so there is no concept of a "training set" for an algorithm. The data presented is for validation testing of the physical device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided, as there is no training set for this type of device.
§ 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).