(219 days)
The Unifine SafeControl™ range of pen needles are intended for use with multi-dose injection devices for the subcutaneous injection of FDA approved drugs, including insulin.
The Unifine SafeControl™ safety pen needle is a sterile, single-use, disposable device intended for use with multi-dose Injector devices for the subcutaneous injection of FDA approved drugs, including insulin. The device is designed for prescription and overthe-counter use and to be used by self-administering patients, caregivers and healthcare professionals. The safety pen needle is currently available in 30-gauge size with 5mm and 8mm lengths.
The pen needle assembly consists of a cannula attached to a needle carrier assembled into a plastic moulded needle hub and safety guard, a primary container that houses the entire assembly and a sterility seal that covers the assembly inside the primary container. The entire device is packaged and labelled as a sterile singleuse device.
The purpose of this Special 510(k) Premarket Notification is to increase the range of Unifine SafeControl™ safety pen needle devices to include qauge sizes of 31G and 32G in 4, 5, 6, and 8mm lengths.
This document is a 510(k) premarket notification for a medical device (Unifine SafeControl™ pen needles) and primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria for an AI/ML-based medical device.
Therefore, many of the requested criteria (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies, standalone AI performance, ground truth establishment) are not applicable or not present in this type of submission. This document describes a traditional medical device (hypodermic needle) where performance is assessed through bench testing against established industry standards.
Here's an analysis based on the provided text, highlighting what is present and what is not:
Device Name: Unifine SafeControl™ (Pen Needle)
Regulation Number: 21 CFR 880.5570 (Hypodermic Single Lumen Needle)
Regulatory Class: Class II
Product Code: FMI
Purpose of the 510(k): To introduce additional needle lengths and gauge sizes (31G and 32G in 4, 5, 6, and 8mm lengths) to an already cleared predicate device (Unifine SafeControl™) approved under K173881. The submission aims to demonstrate that these new variations do not impact safety and effectiveness.
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the "Meets standard" result for each test listed, indicating compliance with the specified ISO standards or protocols from the predicate device.
| Test | Standard/Requirement | Reported Device Performance (Acceptance) |
|---|---|---|
| Visual Inspection | ISO 11608-2:2012 Section 12.2.2 and as per K173881 protocols | Meets standard |
| Needle Retention | ISO 11608-2:2012 Section 9 and as per K173881 protocols | Meets standard |
| Glide Force | As per K173881 protocols | Meets standard |
| Penetration Force | As per K173881 protocols | Meets standard |
| Flow Rate | ISO 11608-2:2012 Section 4.3 and as per K173881 protocols | Meets standard |
| Needle Dislocation | ISO 11608-2:2012 Section 4.8 and as per K173881 protocols | Meets standard |
| Accelerated Aging | ISO 11608-2:2012 and as per K173881 protocols | Meets standard |
| Real Time Aging | ISO 11608-2:2012 and as per K173881 protocols | Ongoing |
Study Details (Focusing on the Provided Document)
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Sample sizes used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the provided text. The document refers to "bench testing" but does not detail the number of units tested for each criterion.
- Data Provenance: The manufacturer, Owen Mumford Ltd, is located in Woodstock, Oxfordshire, United Kingdom. The testing would presumably have been conducted there or by a contracted lab. The data is retrospective, as it's part of a premarket submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a hardware medical device; ground truth is established through physical measurements and adherence to engineering standards, not through expert consensus on diagnostic interpretations.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. This is not a study requiring human adjudication of results in the traditional sense, as it involves physical bench testing.
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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-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a physical product, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Engineering/Performance Standards: The "ground truth" for the device's performance is compliance with established international standards (e.g., ISO 11608-2:2012) and internal protocols validated with the predicate device (K173881). These standards define acceptable physical properties and functionalities for hypodermic needles.
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The sample size for the training set:
- Not Applicable. This is not an AI/ML device that requires a training set.
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How the ground truth for the training set was established:
- Not Applicable. This is not an AI/ML device.
Summary of what is covered by the document:
- Device Description: Detailed description of the pen needle, its components, and the new larger range of gauge sizes and lengths being introduced.
- Predicate Comparison: Explicit table comparing the new device characteristics to the predicate device, highlighting that the essential characteristics are unchanged except for needle dimensions.
- Performance Bench Testing: A table outlining specific non-clinical bench tests performed (e.g., Visual Inspection, Needle Retention, Flow Rate, Aging).
- Standard Compliance: Indication that the tests were conducted according to ISO standards or established protocols, and that the device "Meets standard."
- Biocompatibility: Stated that existing biocompatibility reports from the predicate device are still valid as materials have not changed.
- Sterilization: Confirmed that sterilization methods comply with ISO 11137 and achieve a SAL of 10-6.
In conclusion, this 510(k) submission successfully demonstrates substantial equivalence for the modified pen needle by showing that the new needle lengths and gauges still meet the same performance standards as the predicate device through bench testing. The requested elements related to AI/ML or complex clinical study design are not relevant to this type of medical device submission.
§ 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).