(268 days)
Safe Block Pen Needle is intended for use with pen injector devices for the injection of fluids, including insulin. Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental sticks from the patient end of the needle. The shield also serves to conceal the needle before and after injection.
SAFETY PEN NEEDLE. Safe Block Pen Needle is designated for use with pen injector for subcutaneous injection of a desired dose of drugs approved for delivery using a pen needle. Safe Block Pen Needle are offered in one gauge size (31G) and in a various lengths (5mm and 8mm). The Safe Block Pen Needle is sterile (ETO sterilization), non toxic and non-pyrogenic. It's a disposable single use device. Additionally the Safe Block Pen Needle is designed to reduce occurrence of accidental needle sticks from patient end of the needle by providing a shield that covers and locks the needle after use. Prior to injection the user will attach the Safe Block Pen Needle to the pen. The shield of Safe Block Pen Needle will hide the needle from the user prior to use. As the user proceeds with inserting the needle into the shield will retract. After the injection is completed and needle is removed from the skin, the shield will automatically extend to cover the needle and lock in place. The Safe Block Pen Needle should be removed from the pen and discarded.
The provided document is a 510(k) premarket notification for the "Safe Block Pen Needle." It details the device's description, indications for use, comparison to predicate devices, and non-clinical testing performed. However, it does not contain a dedicated section outlining specific acceptance criteria or a detailed study report that proves the device meets those criteria.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices through a comparison of technological characteristics, materials, and a declaration that bench testing was performed.
Here's an analysis based on the information provided, specifically addressing your points:
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A table of acceptance criteria and the reported device performance
The document does not explicitly provide a table of acceptance criteria linked to specific performance results for the Safe Block Pen Needle in the format requested. Performance is generally stated as meeting relevant ISO standards or internal protocols.However, there is a "Table of specifications (including relevant tests)" on page 7 which lists characteristics for the applicant device and predicate devices. This table indicates the tests performed to ensure compliance with standards.
Feature / Characteristics Acceptance Criteria (Implied by standard and predicate comparison) Reported Device Performance (Applicant Device) Intended Use Consistent with predicate devices and safety features Intended for use with pen injector devices for injection of drugs, including insulin. Safety shield automatically locks in place, reduces accidental sticks, and conceals the needle. Length / Tolerance As per ISO 11608-2 5 mm, 8 mm (tolerance as per ISO 11608-2) Gauge As per ISO 9626 G31 (as per ISO 9626) Tip configuration As per ISO 11608-2, section 4.5 Per ISO 11608-2, section 4.5, visually sharp at 2.5X magnification, designed to minimize coring and fragmentation. Hub/needle bond strength As per ISO 11608-2 Per ISO 11608-2 Biocompatibility As per ISO 10993-1 As per ISO 10993-1 (successfully passed tests for Cytotoxicity, Hemocompatibility, Sensitization/Skin Reactivity, Acute Systemic Toxicity) Compatibility test (type A needles) As per ISO 11608-2 (torque test) ISO 11608-2 (torque test) Lubrication As per ISO 11608-2 As per ISO 11608-2 Safety mechanism Activation As per ISO 23908 and internal protocol As per ISO 23908, internal protocol and test results. Safety overriding/unlocking force after activation As per ISO 23908 and internal protocol As per ISO 23908, internal protocol and test results. Sterilization As per ISO 11135-1:2007 (for ETO) and ISO 11138-1:2006 (HSKP method) Sterilization process validated using current standard ISO 11135-1:2007 using HSKP method (ISO 11138-1:2006). Shelf life 5 years 5 years from production date. -
Sample sizes used for the test set and the data provenance
The document states "Testing demonstrated the safety feature performance through laboratory testing and simulated user studies." However, it does not specify sample sizes for these tests or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "internal protocol and test results" for the safety mechanism. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The tests mentioned are non-clinical, laboratory, and "simulated user studies," which typically wouldn't involve expert ground truth in the manner of diagnostic image interpretation. -
Adjudication method
This information is not provided as it's not relevant for the type of bench and simulated user testing described. -
If a multi reader multi case (MRMC) comparative effectiveness study was done
No, a MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical tests were conducted in support of this 510(k) submission." -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the device is a physical medical device (pen needle with safety feature), not an algorithm or AI system. -
The type of ground truth used
For the non-clinical tests, the "ground truth" would be established by physical measurements against engineering specifications and relevant ISO standards. For the "simulated user studies," the ground truth would be based on predefined criteria for successful activation and locking of the safety mechanism. Pathology or outcomes data are not applicable here as there were no clinical studies. -
The sample size for the training set
This is not applicable as the document describes a physical medical device, not an AI or algorithm that requires a training set. -
How the ground truth for the training set was established
This is not applicable as there is no training set for this type of device.
§ 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).