(19 days)
The Disetronic PenFine® Injection Pen Needles are intended for the hypodermic injection of fluids into the body when attached to an automatic injector pen.
The Disetronic PenFine® Injection Pen Needles are sterile, non-pyrogenic, single use needles designed to be used with commercially available Injection Pens. They will be offered with a 29 and 30 gauge needle in an 8, 10 and 12 mm length.
The PenFine® Pen Needle is comprised of a siliconized stainless steel cannula welded into in a polyethyleneterapthalate (PETP) hub. A polyethylene protective cap snaps onto the hub over the needle. This assembly fits into a K-Resin outer protective container which provides the sterile barrier along with the peel tab.
The PenFine® has a patented design feature that differs from currently available pen needles. Existing pen needles must be screwed onto the threaded male extension of the injection pen. The PenFine® uses a single motion "snap on" mechanism.
The needles are used by peeling back the peel tab and snapping the hub onto the threaded end of the Injection Pen. The back end of the cannula punctures the rubber injection port on the drug reservoir in the Injection Pen. The outer protective cap is then removed. The inner protective cap will remain over the needle until the drug is ready to be injected.
When the injection is needed, the inner protective cap is removed and the needle is inserted into the chosen site. The Injector Pen automatically delivers the drug through the needle. The protective cap is replaced and the needle is then removed, safely discarded and replaced with a new needle.
This document is a 510(k) summary for the Disetronic PenFine® Injection Pen Needle. It establishes substantial equivalence to existing predicate devices but does not provide a study to prove acceptance criteria. Instead, it relies on "Performance data has been generated in compliance with existing international standards and protocols and found equivalent to the predicate devices." Therefore, many of the requested fields cannot be filled.
Here's an analysis of the provided text based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
Not provided in the document. The document states: "Performance data has been generated in compliance with existing international standards and protocols and found equivalent to the predicate devices." This implies that the acceptance criteria are met by virtue of being equivalent to existing, approved devices and conforming to standards, but the specific criteria and their measured performance are not detailed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not provided. The document only vaguely mentions "Performance data has been generated".
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This type of device (injection pen needle) does not typically involve expert review for "ground truth" in the way a diagnostic imaging device would. Performance is typically assessed through engineering tests and adherence to standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. See point 3.
5. 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 device is a pen needle, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a pen needle, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not explicitly stated or applicable in the traditional sense for this device. Performance would likely be measured against engineering specifications, biocompatibility standards, and sterility testing, rather than a clinical "ground truth." The "ground truth" in this context is adherence to established standards for mechanical performance, sterility, and material safety.
8. The sample size for the training set
Not applicable. This device is a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established
Not applicable. This device is a physical medical device, not a machine learning model.
Summary of what is provided in the document regarding validation:
The document relies on "design equivalency and the functional and safety testing" to establish substantial equivalence to predicate devices (Novo Nordisk NovoFine 30 Injection Pen Needles and Becton Dickinson B-D Micro-Fine, Ultra-Fine and Ultra-Fine II Injection Pen Needles).
The core of the "proof" for this device's acceptance seems to be:
- Comparison to Currently Marketed Devices: The Disetronic PenFine® Injection Pen Needles are stated to be substantially equivalent to established products on the market.
- Technological Characteristics: The document claims "The technological characteristics are the same as the predicate devices."
- Performance Data: It broadly states that "Performance data has been generated in compliance with existing international standards and protocols and found equivalent to the predicate devices." This implies that the device was tested against relevant industry standards (e.g., for needle sharpness, sterility, flow rates, compatibility with pens, material safety) and met the requirements, thus demonstrating equivalency to already approved devices.
In essence, this 510(k) summary indicates that the device meets acceptance criteria by demonstrating conformance to established standards and substantial equivalence to existing, approved devices, rather than through a novel clinical study with explicit acceptance metrics and performance results. Specific numerical performance metrics or detailed study methodologies are not included in this summary.
§ 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).