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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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The Unifine Pentips range of pen needles are intended for use with pen injector devices for the subcutaneous injection of drugs, including insulin.

Unifine® Pentips® and Unifine® Pentips® Plus are sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of drugs from pen injectors. The pen needles are used by consumers, caregivers, and healthcare professionals. They are available in a variety of lengths (4mm, 5mm, 6mm, 8mm and12mm) and gauges (29G, 31G and 32G).

The pen needle assembly consists of a double-ended cannula, a needle hub, a needle shield, primary container and sterility seal that covers the assembly inside the primary container.

The hub has internal threads, which allows the pen needle to be screwed onto a pen injector device. The Non Patient (NP) end of the cannula (inside the hub) penetrates the rubber septum of the cartridge in the pen injector device. The Patient end and NP end of the cannula are lubricated using a silicone based lubricant to aid in injection and penetration into the rubber septum. The inner needle shield is injection molded and assembled over the Patient end of the needle to protect the needle from damage and accidental needle-sticks. The pen needle assembly is then inserted into an iniection molded outer container and sealed with a protective peel-away label to ensure a sterility barrier and tamper evidence. The outer container can be used to remove the hub with cannula from the pen injector device after the injection is completed. The peel-away label is pre-printed with information, which includes the lot number, expiry date, and size (length) and gauge of the needle. The individual needle assemblies are then packaged in bags and/or cartons, and placed into shippers with appropriate labeling. The shipper cases are then placed on pallets for sterilization.

Unifine Pentips Plus pen needles differ from Unifine Pentips pen needles because the primary container consists of two 'chamber contains a new, unused pen needle and the second chamber is empty. The empty chamber serves as a built-in pen needle remover, and may prevent accidental needlesticks. Users can insert their used needle into the chamber, then unscrew from the injection pen. The primary container is designed to hold the used pen needle until it can be disposed of in a suitable sharps container. The actual pen needle is identical between Unifine Pentips and Unifine Pentips Plus in both the physical appearance and functionality.

This document is a 510(k) Premarket Notification for medical devices, specifically pen needles. It is not a study proving an AI/ML medical device meets acceptance criteria. Therefore, most of the requested information regarding AI/ML device performance, ground truth establishment, sample sizes for training/test sets, expert adjudication, and MRMC studies, cannot be extracted from this document.

This document focuses on demonstrating substantial equivalence of the Unifine® Pentips® and Unifine® Pentips® Plus pen needles to legally marketed predicate devices, primarily K973899 (Unifine® Pentips®). This is a regulatory pathway for Class II medical devices in the US, where the manufacturer needs to show that their new device is as safe and effective as an already cleared device.

Here's what can be extracted based on the provided text, and where the requested information is not applicable or not present:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for these pen needles are primarily defined by adherence to ISO standards and internal performance tests. The document states that the devices meet these standards/criteria.

Note: The document states "The devices comply with the acceptance criteria established based on the specifications of the devices" for internal tests, but does not provide the specific numerical criteria for these tests.

Regarding the study that proves the device meets acceptance criteria (for an AI/ML context):

This document describes a regulatory submission for a physical medical device (pen needles), not an AI/ML software device. Therefore, the concepts of "test set," "training set," "ground truth," "experts for ground truth," "adjudication," and "MRMC studies" as they apply to AI/ML performance evaluation are not relevant here. The "study" described is a series of non-clinical performance (bench) tests and biocompatibility tests to demonstrate substantial equivalence to existing devices.

Here's why the specific questions are not applicable or cannot be answered from this document:

2. Sample sized used for the test set and the data provenance:

• Not Applicable in AI/ML context: This is a physical device. "Test set" refers to samples tested during bench testing.
• Sample Size: The document does not specify the number of pen needles tested for each performance test. It only states that the tests were performed and results "meet standard" or "meet acceptance criteria."
• Data Provenance: Not applicable in the AI/ML sense. Data is from laboratory bench testing of manufactured pen needles. The manufacturing locations mentioned are the UK (Owen Mumford) and Italy (Artsana S.p.A.).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable: There is no "ground truth" in the AI/ML sense (e.g., expert-annotated images) for a physical device like a pen needle. The "ground truth" is defined by the objective physical and mechanical properties measured against established ISO standards and internal specifications. Bench testing is typically performed by trained technicians.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Applicable: No expert adjudication process as would be used for clinical image interpretation or AI model validation. Bench tests have objective, measurable outcomes.

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 type of study (MRMC, human readers, AI assistance) is for clinical decision support or diagnostic AI devices. This document is for a mechanical device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not Applicable: This is not an algorithm or software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not Applicable in AI/ML context: The "ground truth" for these pen needles is defined by objective physical and mechanical measurements against established ISO standards (e.g., dimensions, flow rate, bond strength) and internal engineering specifications. Biocompatibility is assessed through standardized biological tests.

8. The sample size for the training set:

• Not Applicable: This is not an AI/ML device, so there is no "training set."

9. How the ground truth for the training set was established:

• Not Applicable: As above, no training set or AI/ML ground truth. The "ground truth" for manufacturing and quality control of pen needles is based on engineering specifications and adherence to international standards for medical devices.

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The device is for the subcuraneous injection of insulin.
The Unifine range of Syringes is designed for the subcutaneous injection of insulin.

The Unifica range if syringes are ldentical to that of the Orientan range of syringss manufactured by B Braun. The syringes are manufactured, packed and mentised by B Braun and supplied to Owen Mumford for sale or distribution. No re-packaging roworking or modifications are made to the systems or packaging by Owen Mumford, The are supplied in three sizes (0.3ml, 0.5ml) in boxes of 100. The individual syringes are supplied in peel pouches and are sterilised using Ethylone Oxide.

This document is a 510(k) summary for the Unifine Insulin Syringe. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and device performance as typically seen in AI/ML device submissions. Therefore, many of the requested categories about acceptance criteria, study details, ground truth, and expert involvement are not applicable or cannot be extracted from this specific filing.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

The provided document does not contain a table of acceptance criteria or reported device performance in the context of a new study to demonstrate safety and effectiveness. Instead, it asserts substantial equivalence to a predicate device based on manufacturing identity.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No formal test set or corresponding study data is presented in this 510(k) summary to evaluate a new device's performance. The basis for clearance is substantial equivalence.

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. No ground truth establishment by experts for a test set is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

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 is a medical device clearance for an insulin syringe, not an AI/ML product.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable.

8. The sample size for the training set

Not applicable.

9. How the ground truth for the training set was established

Not applicable.

Summary of Device and 510(k) Basis:

• Device Name: Unifine (Insulin syringes)
• Intended Use: Subcutaneous injection of insulin.
• Substantial Equivalence Claim: The Unifine syringes are stated to be identical to the Omnican Insulin Syringe manufactured and distributed by B. Braun (K962084). Owen Mumford Inc. sells and distributes these syringes without re-packaging, re-working, or modifications.
• Regulatory Conclusion: The FDA reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. This determination is based on the claim of product identity with a previously cleared device, not on new performance study data.

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The Unifine Pentip are intended for the subcutaneous injection of drugs from prefilled cartridges used in conjunction with variable dose delivery systems such as Pen Injectors. Its intended use is substantially equivalent to that of the BD Microfine.

The Unifine Pentip is single use, disposable hypodermic single lumen needle designed for use with multidose injection devices that use prefilled cartridges.

The protective paper is removed from the Pentip which is then screwed onto the device cartridge housing and then used in the prescribed manner.

One of the main uses of the Pentip is for use with pen Injectors for the delivery of insulin which is supplied in the form of prefilled cartridges. The patient places a fresh Pentip needle onto the Pen Injector, dials a dose, inserts the Pentip into the skin and delivers the dose.

The Owen Mumford Unifine Pentip is visually and mechanically extremely similar to the BD Microfine Pentip to which substantial equivalence is claimed.

I am sorry, but the provided text does not contain the detailed study information required to fill out the table and answer all the questions about acceptance criteria and device performance.

The document is a 510(k) submission for the Unifine Pentip, claiming substantial equivalence to the Becton Dickinson Microfine Pentip. While it states that the performance is "substantially equivalent," it does not provide specific acceptance criteria, quantitative performance metrics, or details about a study conducted to demonstrate this equivalence.

Here's a breakdown of what cannot be extracted from the provided text:

• Acceptance Criteria Table: No specific criteria (e.g., success rate, accuracy, failure rate) are mentioned.
• Reported Device Performance: No quantitative performance data is provided for the Unifine Pentip.
• Sample size for the test set: Not mentioned.
• Data provenance (country, retrospective/prospective): Not mentioned.
• Number of experts used for ground truth: Not applicable, as no such study is described.
• Qualifications of experts: Not applicable.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: Not mentioned.
• Effect size of human reader improvement: Not applicable.
• Standalone (algorithm only) performance study: Not applicable, as this is a physical medical device, not an AI algorithm.
• Type of ground truth used: Not applicable, as no study establishing ground truth is described.
• Sample size for the training set: Not applicable, as this is a physical medical device, not an AI algorithm.
• How ground truth for training set was established: Not applicable.

The document focuses on regulatory approval based on substantial equivalence to an existing marketed device, citing similarity in design, intended use, and operational principles, and noting that the product has been marketed in Europe without adverse reports. It does not include a detailed clinical or performance study with quantified acceptance criteria as might be expected for an AI/algorithm-based device.

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