(245 days)
The BD Vacutainer® Eclipse™ UltraFill™ Blood Collection Needle is a sterile, single use, medical device specifically intended to be used by trained healthcare professionals in accordance with the instructions for use for the collection of multiple blood samples into evacuated blood collection tubes, for the purpose of in vitro diagnostic testing. The needle is designed with an attached safety shield, which can be activated to cover the needle immediately after venipuncture to provide protection from accidental needle sticks.
The BD Vacutainer® Eclipse™ Blood Collection Needle consists of a double-ended hollow stainless steel cannula, a threaded polystyrene hub, a sleeve that interrupts blood flow between filling multiple tubes, a polystyrene collar, and a safety shield which can be activated to cover the needle immediately after venipuncture to protect against accidental needle sticks. The device is available in two versions: non-integrated holder and Pre-Attached Holder. The Pre-Attached model features a pre-attached needle holder, whereas the non-integrated model requires the user to obtain a compatible holder.
The device is single-use and supplied sterile. The stainless steel cannula and silicone cannula lubricants are classified as externally communicating with limited (≤24 hours) duration contact; all other device components have limited (≤24 hours) duration surface contact with intact skin of the health care professional user and the patient. Once the vein has been accessed by puncturing with the intravenous end of the cannula, the healthcare professional will begin the blood collection process by placing evacuated blood collection tubes on the cannula's non-patient end, where the sleeve acts as a non-return valve and allows for more than one tube to collect blood from the vein puncture.
The provided FDA 510(k) summary describes the BD Vacutainer® Eclipse™ UltraFill™ Blood Collection Needle, but it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a specific study proving it meets those criteria, especially in the context of AI/ML devices.
This document is for a medical device (a hypodermic needle), not an AI/ML diagnostic or therapeutic device. Therefore, many of your questions, particularly those related to expert adjudication, MRMC studies, standalone algorithm performance, and training sets, are not applicable to the information provided.
However, I can extract and present the available information regarding performance data and acceptance relevant to this specific device:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" with quantitative "reported device performance" values for each criterion in a comparative format as one might find for an AI/ML device's metrics (e.g., sensitivity, specificity thresholds). Instead, it lists various tests performed and states that the device "meets preestablished functional design requirements" or "meets its performance specifications."
Therefore, I will present the types of performance assessments conducted and the general conclusion.
| Performance Aspect | Acceptance Criteria (Implied/Stated Goal) | Reported Device Performance |
|---|---|---|
| Hemolysis Assessment | Verify performance as measured by analytical indicators of hemolysis. (Implied: Acceptable levels of hemolysis in collected blood samples.) | Samples of venous blood obtained were assessed to verify performance regarding hemolysis. |
| Safety Shield Feature | Validate the performance of the safety shield feature. (Implied: Effective protection from accidental needle sticks.) | Simulated use assessment was conducted to validate the performance of the safety shield feature. |
| Mechanical Integrity | Meet preestablished functional design requirements. | Confirmed met preestablished functional design requirements. |
| Penetration Force | Meet preestablished functional design requirements. | Confirmed met preestablished functional design requirements. |
| Tube Fill Time | Meet preestablished functional design requirements. (Note: The new device is designed for faster fill time due to Ultra-Thin Wall.) | Confirmed met preestablished functional design requirements, and changes do not impact safe use/intended performance. |
| Cannula Pull Force | Meet preestablished functional design requirements. | Confirmed met preestablished functional design requirements. |
| Safety Shield Activation Force | Meet preestablished functional design requirements. | Confirmed met preestablished functional design requirements. |
| Safety Shield Override Force (Snag Resistance) | Meet preestablished functional design requirements. | Confirmed met preestablished functional design requirements. |
| Sleeve Function | Meet preestablished functional design requirements. | Confirmed met preestablished functional design requirements. |
| 3 Point Stiffness | Meet preestablished functional design requirements. | Confirmed met preestablished functional design requirements. |
| Resistance to Breakage | Meet preestablished functional design requirements. | Confirmed met preestablished functional design requirements. |
| External Blood Splatter | Meet preestablished functional design requirements. | Confirmed met preestablished functional design requirements. |
| Biocompatibility | Compliance with ISO 10993 series. | Device complies with relevant ISO 10993 standards. |
| Sterilization | Compliance with ISO 11137 series. | Device complies with relevant ISO 11137 standards. |
| Sharps Injury Protection | Compliance with ISO 23908. | Device complies with ISO 23908. |
Study Conclusion: "The testing performed demonstrates the BD Vacutainer® Eclipse™ UltraFill™ Blood Collection Needle is substantially equivalent to its predicate device."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states "Samples of venous blood obtained with the BD Vacutainer® Eclipse™ UltraFill™ Blood Collection Needle were assessed..." and "Simulated use assessment was conducted..." as well as "Mechanical verification testing was performed..."
However, specific sample sizes for each test are not provided. The provenance of the data (country of origin, retrospective/prospective) is also not explicitly stated. These are typically detailed in the full 510(k) submission, not the summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to this type of device (a hypodermic needle). The "ground truth" for a medical device like this is established through engineering and performance testing against predefined specifications and recognized standards, not expert consensus on medical images or patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable for the reasons stated in point 3.
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
This question is not applicable. An MRMC study is relevant for AI/ML diagnostic tools where human interpretation is involved. This device is a blood collection needle and does not involve "human readers" or "AI assistance" in the context of diagnosis or interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as this device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" or basis for evaluation for this device consists of:
- Established engineering specifications and design requirements.
- Compliance with recognized international consensus standards (e.g., ISO 23908 for sharps injury protection, ISO 9626 for stainless steel tubing, ISO 10993 series for biocompatibility, ISO 11137 series for sterilization).
- Measurements of objective physical and biological parameters (e.g., hemolysis indicators, penetration force, tube fill time, pull force, activation force).
8. The sample size for the training set
This question is not applicable as this is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
This question is not applicable for the reasons stated in point 8.
§ 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).