(90 days)
ProTector™ Needle Sheath Prop is a disposable, non-sterile device that can be used to safely uncap and recap needles using a one-handed technique. ProTector™ Needle Sheath Prop facilitates OSHA requirements by reducing the possibility of accidental needle sticks and discourages leaving the needle unsheathed on the tray. The Prop is autoclavable for one-time sterile tray set-up. It holds the cap securely in the ready position.
The ProTector™ Needle Sheath Prop is a disposable, non-sterile, one-time use device that can be used to safely uncap and recap needles using a one-handed technique. The ProTector™ facilitates and meets OSHA's Bloodborne Pathogens requirement to promote reduction in accidental needle sticks. Use of the ProTector™ discourages leaving the needle unsheathed on an instrument trav. The device is specifically designed to capture the needle cover/cap and hold it in the ready position. The ProTector™ is manufactured using a premium grade rectangular paper board card. The sheathed needle cap is inserted into the targeted hole up to the cover hub, securing the needle cover firmly in the ProTector™. The targeted hole is designed as a flexible press-fit to accommodate all sizes of needle protector cover up to 3/8" OD which accommodates most needle covers on the market. After the needle and cover is inserted into the ProTector™, it is now in the ready position to be able to safely withdraw the needle. The rectangular shape of the ProTector™ allows the loaded needle cover to be propped on the dental or medical tray.
The provided text is a 510(k) summary for the ProTector™ Needle Sheath Prop, a disposable one-handed recapper for needles. It describes the device's function and its substantial equivalence to a predicate device. However, the document does not contain information about acceptance criteria, detailed study designs, or actual device performance data in the context of specific metrics.
Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader studies.
Here's why and what information is available:
- Type of Submission: This is a 510(k) premarket notification. For many Class I and Class II devices, 510(k)s often rely on demonstrating "substantial equivalence" to a predicate device already on the market, rather than requiring extensive de novo clinical studies with detailed performance metrics and acceptance criteria as might be seen for novel or higher-risk devices.
- Focus of the Document: The content primarily focuses on:
- Device description and intended use.
- Comparison to a predicate device (Bull's Eye Disposable Needle Recapping Aid).
- Declaration of substantial equivalence.
- Regulatory information (classification, product code, FDA contact).
What the document does state regarding equivalence and implied performance:
- Technological Characteristics & Material Construction: "The ProTector™ has the same technological characteristics and material construction as the Hunter Research Bull's Eye Recapping Aid. Both products are constructed of paper board material with a variable press-fit target hole in the card." This implies that because the materials and design are similar to a legally marketed device, its performance related to those characteristics should also be similar.
- Functionality: "The targeted hole is designed as a flexible press-fit to accommodate all sizes of needle protector cover up to 3/8" OD which accommodates most needle covers on the market." And "It holds the cap securely in the ready position." This describes the intended function but doesn't quantify performance with acceptance criteria (e.g., what percentage of caps are held securely, or what forces are resisted).
- OSHA Compliance: "ProTector™ Needle Sheath Prop facilitates OSHA requirements by reducing the possibility of accidental needle sticks and discourages leaving the needle unsheathed on the tray." This is a key benefit derived from its function, but again, no quantitative reduction in needle sticks is presented as a study outcome or target.
Conclusion:
Based on the provided text, there are no explicit acceptance criteria or a dedicated study described that proves the device meets such criteria in terms of quantitative performance metrics. The submission relies on demonstrating substantial equivalence to a predicate device that is already legally marketed and presumed to be safe and effective for its indicated use. Therefore, a table of acceptance criteria and reported device performance, as requested, cannot be generated from this document. All other questions related to sample size, ground truth, expert opinions, and specific study types are also unanswerable from the provided text.
§ 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).