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Pen Needles are sterile, single use needles intended for using with pen injector devices for the injection of drug.

The Pen Needle is a sterile, single use device intended for use with pen injector devices for the subcutaneous injection of drug. The device is available in ordinary and safety configurations.

The following are the types of needles:

• Ordinary Type I, Ordinary Type IB, Ordinary Type VIA, Ordinary Type VIB, and Ordinary Type VIC needle consists of needle hub, double-ended needle tube, which is bonded with the needle hub with joining medium, needle container, needle shield, and seal paper.

• Safety Type IIA, Safety Type IIB, and Safety Type IIIA needle consists of needle hub, double-ended needle tube, which is bonded with the needle hub with joining medium, needle container, needle shield, needle cover, spring, and seal paper.

• Safety Type IIIB, Safety Type VII, Safety Type VIII, and Safety Type IX needle consists of needle hub, double-ended needle tube, which is bonded with the needle hub with joining medium, needle container, needle shield, needle cover, inner core, spring, and seal paper.

• Safety Type IV needle consists of needle hub, double-ended needle tube, which is bonded with the needle hub with joining medium, needle container, needle shield, needle cover, inner core, rear inner core, spring, and seal paper.

• Safety Type V and Safety Type X needle consists of needle hub, double-ended needle tube, which is bonded with the needle hub with joining medium, needle container, needle shield, needle cover, inner core, rear needle shield, spring, rear spring and seal paper.

• Ordinary Type XI needle consists of needle hub, double-ended needle tube, which is bonded with the needle hub with joining medium, needle container, needle shield, adjusting sleeve and seal paper.

• Safety Type XII needle consists of needle hub, double-ended needle tube, which is bonded with the needle hub with joining medium, needle container, needle shield, needle cover, inner core, rear needle shield, adjusting sleeve, spring, rear spring and seal paper.

The needle shield and rear needle shield provide physical protection to the needle tube before and after use. The needle container together with seal paper forms the primary sterile barrier system and protects the needle hub. The hub is designed to be securely screwed onto the needle-based injection system (e.g. pen injector) for the subcutaneous injection of drug.

The product is individually packaged and sterilized by irradiation to achieve a sterility assurance level (SAL) of 10⁻⁶. It is intended for single use only.

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Pen Needle is intended for use with pen injector devices for the subcutaneous injection of drugs.

The proposed device, Pen Needle, is designed for use with pen injectors for subcutaneous injection of a desired dose of drugs approved for delivery using a pen needle. It is provided sterile, single use. The proposed device consists of four components, which are 1) Needle Container 2) Needle Shield 3) Needle Tube and 4) Needle Hub. Needle Container, together with Sealed Paper can forming the unit packaging of Pen Needle, that maintains the sterility of Pen Needle Hub can be connected screwed onto the pen injectors.

The provided document is a 510(k) premarket notification for a medical device (Pen Needle) and focuses on demonstrating substantial equivalence to a predicate device. It is not an AI/ML medical device submission. Therefore, the document does not contain information typically found in an AI/ML medical device acceptance criteria and study section, such as:

• A table of acceptance criteria and reported device performance for an AI/ML algorithm.
• Sample sizes used for a test set or data provenance for an AI/ML algorithm.
• Number of experts or qualifications of experts used for AI ground truth.
• Adjudication methods for AI test sets.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Standalone AI performance.
• Type of ground truth used for AI/ML.
• Sample size or ground truth establishment for an AI/ML training set.

The document discusses non-clinical tests performed to verify the Pen Needle met design specifications and complied with ISO standards, focusing on manufacturing quality, sterility, and biocompatibility rather than an AI algorithm's performance.

Therefore, I cannot extract the requested information as it is not present in the provided text.

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