(85 days)
The VACUETTE® Safety Infusion Set is a single-use, sterile, winged blood collection needle bonded to a flexible tubing with a luer connector. The VACUETTE® Safety Infusion Set is used for blood collection and/or the shortterm infusion of intravenous fluids. The winged needle is designed with a safety shield, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury.
The VACUETTE® Safety Infusion Set is a single-use, sterile, winged blood collection needle bonded to a flexible tubing with a luer connector. The VACUETTE® Safety Infusion Set is used for blood collection and/or the short-term infusion of intravenous fluids. The winged needle is designed with a safety shield, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury. The safety feature is easily operated through the release of a latch mechanism whereby the user slides a winged cover over the needle, as it is removed from the patient. Once the needle is covered, the safety cover locks in place. The VACUETTE® Safety Infusion Set will be available in 2 configurations of needle gauge (21G and 23G) and one tubing length (7.5 inches). The devices are packaged as sterile and are labeled for single use only. There is no ability to clean and reuse these devices. The devices were tested for sterility, pyrogenicity and systemic injection testing and were found to be biocompatible.
The provided text describes a 510(k) submission for the VACUETTE® Safety Infusion Set. This is a medical device application that demonstrates substantial equivalence to a predicate device, rather than a study proving performance against acceptance criteria in the same way one would for a novel AI algorithm or diagnostic test.
Therefore, many of the requested categories in your prompt (e.g., sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, types of ground truth) are not applicable to this type of regulatory submission. The submission focuses on demonstrating that the new device is as safe and effective as a previously cleared device.
Here's an analysis based on the available information:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Nipro® SafeTouch Safety Scalp Vein Set (for intended use) | The VACUETTE® Safety Infusion Set is deemed substantially equivalent in intended use to the Nipro® SafeTouch Safety Scalp Vein Set. |
| Design, safety feature, raw materials, biocompatibility, and performance identical to Greiner VACUETTE® Safety Blood Collection Set (K011786) | The device's design, safety feature (latch mechanism, winged cover, locking), raw materials, biocompatibility, and performance are identical to K011786. |
| Sterility | Devices were tested for sterility and found to be sterile. |
| Pyrogenicity | Devices were tested for pyrogenicity. (Result implies compliance). |
| Systemic Injection (Biocompatibility) | Devices underwent systemic injection testing and were found to be biocompatible. |
Explanation: The "acceptance criteria" for a 510(k) are primarily demonstrating substantial equivalence to a predicate device. This means showing that the new device has the same intended use and similar technological characteristics, or if there are differences, that those differences do not raise new questions of safety or effectiveness. The performance is assessed against the predicate and established standards for medical devices (like sterility and biocompatibility).
Study Details (as applicable)
- Sample size used for the test set and the data provenance: Not applicable. This is not a study assessing performance on a "test set" in the context of an AI algorithm or diagnostic test. The evaluation is based on comparison to a predicate device and standard device testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the sense of expert consensus for a diagnostic outcome, is not relevant here.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: 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. This is a physical medical device, not an AI or diagnostic tool involving human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this type of device is regulatory compliance, established manufacturing standards, and the safety and effectiveness profile of the predicate device. For specific tests like sterility and biocompatibility, the ground truth is defined by validated testing methodologies and acceptable limits for those tests.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary based on the document:
The VACUETTE® Safety Infusion Set gained 510(k) clearance by demonstrating substantial equivalence to a predicate device, the Nipro® SafeTouch Safety Scalp Vein Set (K011297). Furthermore, its design, safety feature mechanism, raw materials, biocompatibility, and overall performance were declared identical to the previously FDA-cleared Greiner VACUETTE® Safety Blood Collection Set (K011786), which serves as a "new intended use" predicate for those specific aspects.
The submission confirms that the device underwent standard testing for sterility, pyrogenicity, and systemic injection, and was found to be biocompatible. These tests are presumably performed on a representative sample of manufactured devices, according to established medical device standards, to ensure they meet predefined safety thresholds. The document does not specify the sample sizes for these tests, which is typical for 510(k) summaries where detailed test protocols are not typically disclosed. The data provenance for these tests would almost certainly be internal company testing.
§ 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).