(93 days)
The Antineedle Stick Protector is an integral, active safety device intended to minimize accidental needle stick injuries when used to shield needles for Kawasumi products manufactured with a wing and needle assembly for solution infusion and blood sampling.
The Small Vein Infusion Set with Antineedle Stick Protector is a single use, sterile device used for peripheral venous access for solution administration or blood collection. The Antineedle Stick Protector is an integral, active safety device intended to minimize accidental needle stick injuries when used to shield needles.
The Winged Collection Set with Multi-Sample Luer Adapter and Antineedle Stick Protector is a single use, sterile, blood collection device used for peripheral venous access for blood sampling. The Antineedle Stick Protector is an integral, active safety device intended to minimize accidental needle stick injuries when used to shield needles.
The Antineedle Stick Protector is a polymeric device designed to be used integral with winged needle sets and shields the needle when the needle with hub and wing assembly is removed from the patient
Here's an analysis of the provided text regarding the acceptance criteria and study for the device:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided K023917 510(k) Summary, the acceptance criteria are implicitly tied to the performance of the predicate device and the prevention of needlestick injuries. The document does not explicitly state quantitative acceptance criteria with specific thresholds (e.g., "99% activation rate"). Instead, it focuses on achieving the same results as the predicate device regarding needle tip protection.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Minimize accidental needlestick injuries | Successful simulated use study |
| Shield the needle effectively after use | Needle tip is protected inside the device after use |
| Substantially equivalent to predicate devices in function | Achieves the same results as predicate device (Becton Dickinson Vacutainer Brand Safety-Lok Blood Collection Set) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified. The document mentions "a successful simulated use study" but does not provide details on the number of units or uses tested.
- Data Provenance: The study was conducted by Kawasumi Laboratories, Inc., located in Tokyo, Japan. The study is described as a "simulated use study," implying it was conducted in a controlled environment, likely within their facility. It is a prospective study as it was conducted specifically to demonstrate the device's performance for this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the given text. The study is described as a "simulated use study" but does not mention the involvement of experts in establishing ground truth or evaluating the results. The determination of "success" likely relied on internal assessment criteria by Kawasumi Laboratories.
4. Adjudication Method for the Test Set
This information is not provided in the given text. There is no mention of independent reviewers or an adjudication process for the "simulated use study."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging devices or algorithms where human readers interpret medical images with or without AI assistance. The device in question is a medical device designed to prevent needlestick injuries, and such a study would not be applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable to the device described. The device is a physical product (winged needle set with an antineedle stick protector), not an algorithm or software. Its performance inherently involves human interaction during its use to activate the protector.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance would likely be a direct observation of whether the needle tip was successfully shielded or retracted after simulated use, thereby preventing accidental needlestick. The text states: "In both devices, the needle tip is protected inside the device after use." This implies the ground truth for success was the successful physical enclosure of the needle tip.
8. The Sample Size for the Training Set
This question is not applicable as there is no "training set" for this type of physical medical device. Training sets are relevant for machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no "training set."
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.