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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.

Study Details (Focusing on the Provided Document)

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. The sample size for the training set:

   • Not Applicable. This is not an AI/ML device that requires a training set.

8. 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.

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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 over-the-counter use and to be used by self-administering patients, care-givers and healthcare professionals. The safety pen needle is a 30-gauge needle available in sizes between 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 labeled as a sterile single-use device.

This document is a 510(k) Premarket Notification for the Unifine SafeControl™ safety pen needle. It describes the device's characteristics, intended use, and performance data to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the provided text to extract the requested information regarding acceptance criteria and the study proving the device meets them:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally "Meets standard" for each test listed, implying compliance with the specified ISO or ASTM standards. The reported device performance uniformly states "Meets standard" for all listed tests.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes used for each of the bench tests. It mentions that "Written protocols specified the scope, objectives, specifications, test equipment, test methods and acceptance criteria," which would typically include sample sizes, but these details are not provided in the summary.

The data provenance is not explicitly stated as retrospective or prospective clinical data. Given that it's a 510(k) summary focusing on bench testing, the data is primarily from non-clinical performance testing conducted by the manufacturer, Owen Mumford Ltd., which is based in the United Kingdom.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable to this submission. The "ground truth" for these tests relates to meeting objective engineering and material standards (e.g., specific force measurements, flow rates, sterility assurance levels), not a clinical diagnosis or interpretation by human experts.

For biocompatibility, it states that "Full device evaluation includes a review of all the materials, consumables, manufacturing processes and environments by an expert toxicologist." The number of toxicologists and their specific qualifications are not provided, but the expert's role here is to review and ensure compliance with biocompatibility standards based on material properties and testing results, not to establish a "ground truth" in the diagnostic sense.

4. Adjudication Method for the Test Set

This is not applicable as the tests are objective bench tests based on measurable physical properties and adherence to established standards, not subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI/ML-driven diagnostic devices where human readers' performance is compared with and without AI assistance. The Unifine SafeControl™ is a physical medical device (pen needle) and its effectiveness is determined by its physical and material properties, not through AI-assisted human interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

No, a standalone algorithm-only performance study was not done. This concept is relevant for AI/ML-driven diagnostic software. The Unifine SafeControl™ is a physical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is established through compliance with recognized industry standards and specifications. This includes:

• Engineering specifications: For physical properties like torque, force, flow rate, needle retention, etc. (e.g., ISO 11608-2, ISO 11608-5).
• Material and safety standards: For sterility assurance and biocompatibility (e.g., ISO 11607-1, ASTM F1980-16, ISO 10993 series, ISO 11137).
• Sharps safety guidelines: For the safety feature (e.g., ISO 23908:2011 & FDA Guidance).

Essentially, the ground truth is that the device performs as expected and safely according to these predefined, objective standards.

8. The Sample Size for the Training Set

There is no training set as this is a physical medical device (a pen needle) and not an AI/ML algorithm that requires training data.

9. How the Ground Truth for the Training Set Was Established

Since there is no training set mentioned, this question is not applicable.

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