(192 days)
The Needle Stick Block is a single needle holder to be used after the needle is removed from the patient and until it can be properly disposed, therefore, aiding in the prevention of needle stick injuries. The Needle Stick Block is a safety device designed to help the health care facilities to minimize the risk of needle sticks. Busse Hospital Disposable intent to sell this device individually and as part of safety trays in which needle is involved. The intended use will remain the same whether is sold individually or as part of a tray.
Sterile/ Latex Free/ Needle Stick Block. The proposed Needle Stick Block was created to help prevent needle sticks by providing a means of moving used sharps from procedure and hold it temporarily until procedure is completed to then be disposed off in a sharps container.
This document describes the regulatory submission for the "Needle Stick Block" device and the testing performed to demonstrate its substantial equivalence to a predicate device, the "SharpsAway Disposal Cup."
Here's an analysis of the provided information regarding acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Test Performed | Reported Device Performance |
|---|---|
| A) Determination of puncture resistance of the foam insert for both devices. | Implicitly, the Needle Stick Block's foam insert was found to have comparable puncture resistance to the predicate device's foam insert. (The document states "Summary of tests performed to prove the substantial equivalence... A) Determination of puncture resistance of the foam insert for both devices.") Specific quantitative results are not provided. |
| B) Determination of puncture resistance of vessel wall for Needle Stick Block and SharpsAway predicate device. | Implicitly, the Needle Stick Block's vessel wall was found to have comparable puncture resistance to the predicate device's vessel wall. (The document states "Summary of tests performed to prove the substantial equivalence... B) Determination of puncture resistance of vessel wall for Needle Stick Block and SharpsAway predicate device.") Specific quantitative results are not provided. |
| C) Test to show that once inserted, Needle Stick Block with foam insert exerts enough resistance to retain needle for at least one hour under normal circumstances. | Implicitly, the Needle Stick Block met this retention criterion. (The document states "Summary of tests performed to prove the substantial equivalence... C) Test to show that once inserted, Needle Stick Block with foam insert exerts enough resistance to retain needle for at least one hour under normal circumstances.") Specific quantitative results are not provided. |
| D) Simulate use study by experienced medical experts (at least 1 year experience with handling needles using the predicate instrument) to demonstrate: |
- Same intended use
- Same features | Implicitly, the simulated use study demonstrated that the Needle Stick Block has the same intended use and features as the predicate device when used by experienced medical experts. (The document states "D) Simulate use study by experienced medical experts (at least 1 year experience with handling needles using the predicate instrument)"). Specific qualitative or quantitative results are not provided beyond the general statement of substantial equivalence. |
Note: The document provided is a 510(k) summary, which often provides high-level statements about tests performed but often omits detailed quantitative results. The "reported device performance" is inferred from the statement that these tests were performed "to prove the substantial equivalence."
Study Details:
The overall goal of the study was to demonstrate substantial equivalence of the "Needle Stick Block" to the "SharpsAway Disposal Cup" predicate device.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size (Test Set): Not explicitly stated for any of the tests (A, B, C, D).
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the company, Busse Hospital Disposables, is located in Hauppauge, NY, United States, suggesting the tests would likely have been conducted in the US. The nature of the tests (material properties and simulated use) suggests they were conducted prospectively.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not explicitly stated for the "simulate use study" (Test D). It refers to "experienced medical experts."
- Qualifications of Experts: "at least 1 year experience with handling needles using the predicate instrument."
4. Adjudication Method for the Test Set:
- Not applicable as the tests described are primarily engineering/material property tests and a simulated use study, not diagnostic performance evaluations requiring adjudication of expert interpretations.
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 conducted. The study involves material property testing and a simulated use study, not a comparative effectiveness study of human readers' performance with and without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- This question is not applicable as the device is a physical medical device (a needle holder), not an algorithm or AI software. Therefore, there is no "standalone performance" of an algorithm. The device's performance is inherently physical and involves human interaction for its intended use.
7. The Type of Ground Truth Used:
- For tests A, B, and C (puncture resistance, needle retention), the "ground truth" would be established by the physical measurement and engineering standards used to quantify these properties.
- For test D (simulated use study), the "ground truth" was established by the observation and assessment of "experienced medical experts" confirming the device's equivalent intended use and features.
8. The Sample Size for the Training Set:
- This question is not applicable as the device is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- This question is not applicable as the device is a physical medical device, not an AI/ML algorithm that requires a training set.
§ 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).