(264 days)
Droplet® Pen Needles are intended for use with pen injector devices for the subcutaneous injection of drugs.
The Droplet® Pen Needles are sterile, single use needles intended for use with pen injector devices for the subcutaneous injection of drugs. Pen needles are used by consumers, caregivers and healthcare professionals.
The pen needle assembly consists of a double-ended cannula that is assembled into an injection molded hub using adhesive. The hub has internal threads, which allow it to be screwed onto the pen injector device. This allows the cartridge end of the cannula to penetrate through the rubber septum of the cartridge. The patient end and the cartridge end of the cannula are lubricated using a silicone based lubricant for ease of injection and rubber septum penetration.
There is an inner needle shield assembled over the patient end of the cannula to protect the needle point from damage and accidental needle sticks. There is also an outer cover. Each pen needle assembly is protected with a peel away seal to provide a sterility barrier.
This is a 510(k) summary for a medical device (pen needles), not an AI/ML device. Therefore, the requested information about acceptance criteria, study sizes, expert involvement, and ground truth establishment is not applicable in the context of AI/ML device evaluation.
The document describes non-clinical performance data for the pen needles as part of the substantial equivalence determination process for a Class II medical device.
Here's a breakdown of the relevant sections from the document that align with your request (non AI/ML related):
-
Table of Acceptance Criteria and Reported Device Performance: This information is available in the "Non-Clinical Performance Data" section on pages 7-9. It outlines the requirements from ISO 11608-2:2012 for various test parameters and states that the device met these requirements.
Test Parameter Requirement - ISO 11608-2:2012 Reported Device Performance Materials The needle shall be made of tubing materials specified in ISO 9626. Requirement met Dimensions The needles shall fit the test apparatus specified in item 7.3 of ISO 11608-2. Requirement met Determination of flow rate through the needle (not required by the standard) The needle was tested in accordance with Annex A to ISO 11608-2 to determine flow rate through the needle. Requirement met Bond between hub and needle tube The union of the hub and needle tube shall not break when tested in accordance with Clause 9 of ISO 11608-2. Requirement met Freedom from defects The needle tube shall fulfill the requirements of ISO 7864, clause11.3. Requirement met Lubrication The needle tube should be lubricated at both the patient end and the cartridge end. The lubricant shall not, under normal or corrected-to-normal vision, be visible as droplets of fluid on the outside surface of the needle tube. Requirement met Dislocation of measuring point at patient end Dislocation of the cannula point at the patient end shall be in accordance with Table 2 when tested in accordance with Clause 8 (of ISO 11608-2). Requirement met Determination of functional compatibility with needle-based injection systems Compatibility with any NIS (Needle-based Injection System) shall be claimed only after testing in accordance with Clause 11. Requirement met Ease of assembly and disassembly Attachment of the needle shall be possible without removing the needle from its opened unit packaging. Compliance is checked according to the requirements of Clause 11. Requirement met Pre-conditioning of needles All requirements of the standard related to preconditioning of needles were met. Requirement met Biocompatibility Test Summary:
Test method Compliance with Result Cytotoxicity Study Using the ISO Elution Method ISO 10993-5 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity The test article showed no evidence of causing cell lysis or toxicity. ISO Guinea Pig Maximization Sensitization Test ISO 10993-10 - Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization The test article extracts showed no evidence of causing delayed dermal contact sensitization in the guinea pig. The test article was not considered a sensitizer in the guinea pig maximization test. ISO Intracutaneous Study in Rabbits ISO 10993-10 - Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization The test article met the requirements of the test. ASTM Hemolysis Study ASTM F756, Standard Practice for Assessment of Hemolytic Properties of Materials and ISO 10993-4 - Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood Both the test article in direct contact with blood and the test article extract were non-hemolytic. ISO Two Week Toxicity Study in the Rat, Repeated Parenteral Administration of Two Extracts ISO 10993-11 - Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity There were no microscopic changes considered to be a test article related response. Parenteral administration of the test article extract did not produce systemic toxicity in rats. ISO Systemic Toxicity Study in Mice ISO 10993-11 - Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity There was no mortality or evidence of systemic toxicity from the extracts injected into mice. Each test article met the requirements of the study. USP Rabbit Pyrogen Study, Material-mediated ISO 10993-11 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity The total rise of rabbit temperatures during the 3 hour observation period was within acceptable USP limits. The test article was judged as non-pyrogenic. USP Pyrogen Study - Material Mediated USP, General Chapter , Pyrogen Test as recommended by ISO 10993-11 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity The test article was judged as nonpyrogenic. -
Sample size used for the test set and the data provenance: This information is not specified in the document beyond the tests being performed in accordance with the listed ISO standards. The document doesn't provide details on the number of pen needles used for each specific test or the country of origin of the testing data. It only states the device "successfully passed all the required non-clinical testing." The nature of these tests (mechanical and biological safety testing) often does not involve human subjects, thus "retrospective or prospective" is not applicable in the typical sense.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable to the non-clinical performance and biocompatibility testing described for a physical medical device like a pen needle. The "ground truth" for these tests is defined by the objective performance criteria outlined in the ISO and ASTM standards.
-
Adjudication method for the test set: Not applicable. The tests involve objective measurements against established technical standards.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document is not about AI/ML or diagnostic imaging that involves human readers.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
-
The type of ground truth used: For the non-clinical performance data, the ground truth is the objective technical specifications and safety requirements defined by international standards (ISO 11608-2:2012, ISO 9626, ISO 7864) and biocompatibility standards (ISO 10993 parts 5, 10, 11; ASTM F756; USP General Chapter ).
-
The sample size for the training set: Not applicable, as this is not an AI/ML device that undergoes training.
-
How the ground truth for the training set was established: Not applicable.
§ 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).