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.

Device Description

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.

AI/ML Overview

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)

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.
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.
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.
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.
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.
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.
The sample size for the training set:
- Not Applicable. This is not an AI/ML device that requires a training set.
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.

Summary

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September 17, 2021

Owen Mumford Ltd Darren Mansell Regulatory Affairs Manager Brook Hill Woodstock, Oxfordshire OX20 1TU United Kingdom

Re: K210399

Trade/Device Name: Unifine SafeControl Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: August 20, 2021 Received: August 23, 2021

Dear Darren Mansell:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For CAPT Alan Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known) K210399

Device Name Unifine SafeControl™

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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SECTION 6.0 SPECIAL 510(k) SUMMARY: 510k Number: K210399

1. Submitter

Prepared by: Darren Mansell Regulatory Affairs Manager Tel: +44(0)1993 812021 Fax: +44(0)1993 813466

Prepared for: Owner/ Operator Owen Mumford Ltd Brook Hill Woodstock Oxfordshire OX20 1TU United Kingdom Establishment Registration Number: 3003348846

Contact Person: Darren Mansell Regulatory Affairs Manager Owen Mumford Ltd, Tel: +44(0)1993 812021 Fax: +44(0)1993 813466 Email: darren.mansell@owenmumford.com

Paul Smith Quality & Regulatory Affairs Director Owen Mumford Ltd, Tel: +44(0)1993 812021 Fax: +44(0)1993 813466 Email: paul.smith@owenmumford.com

Date Prepared: 17 September 2021

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2. Device

Name of Device: Unifine SafeControl™ Common Name: Pen Needle Classification Name: Needle, Hypodermic, Single Lumen Classification Regulation: 21 CFR 880.5570 Requlatory Class: II Product Code: FMI

3. Predicate Devices

The predicate device, Unifine SafeControl™ by Owen Mumford Ltd, was approved under K173881.

The new needle lengths and gauge sizes presented in this submission have not been previously submitted.

4. Description of The Device

The target population includes male and female right or left-handed self-administering patients, care givers and healthcare professionals. The frequency of use and intended patient population is dependent on qiven treatment regime.

5. Indications for Use

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.

6. Technological Characteristics

The Unifine SafeControl™ safety pen needles are substantially equivalent to the predicate device, with the exception of the gauge sizes and needle lengths as

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described above. A comparison of the intended use and technological characteristics is summarized in the table below.

Table 8: Comparison of Device Characteristics between Submission Devices and Predicate Device

DeviceCharacteristic	Predicate Device	Submission Device	Comment
Intended Use	The Unifine SafeControlrange of pen needles areintended for use withmulti-dose injectiondevices for thesubcutaneous injection ofFDA approved drugs,including insulin	Unchanged from thepredicate device	The characteristic isidentical
Operatingprinciple	Manual with an additionalsafety feature allowingthe exposed needle to becovered after use.	Unchanged from thepredicate device	The characteristic isidentical
Design/Construction	Needle assembly(cannula, needle hubpackaged in a needleshield and primarycontainer). The safetyguard is integrated intothe device.	Unchanged from thepredicate device	The characteristic isidentical
Components andMaterials	• Cannula - StainlessSteel• Lubricant - Silicone• Adhesive – MedicalGrade Adhesive• Needle Hub -Polypropylene• Needle Shield - HighDensity Polyethylene• Safety guard-Polystryol• Outer Container - HighDensity Polyethylene• Sterility Seal - PaperLaminate	Unchanged from thepredicate device	The characteristic isidentical
Package	• Plastic outer container:• Sterility Seal• Shelf box	Unchanged from thepredicate device	The characteristic isidentical
Shelf life	5 years	5 years	The characteristic isidentical
Needle Sizes andGauges	5mm x 30G8mm x 30G	8mm x 31G6mm x 31G5mm x 31G4mm x 32G	The characteristic isdifferent - thesubmission devicepresents differentneedle lengths andgauges. The differentneedle lengths andgauges wereaddressed throughthe bench testingsummarised in Table9 of this document.

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7. Performance Data

Non-clinical performance data:

Risk management was performed to identify required verification/validation testing needed to support the introduction of the new needle lengths and gauges. To support this submission, design verification testing was performed to demonstrate that the device operates safely and effectively. The following table shows a summary of the performance tests to standards.

Bench Testing:

Test	Standard/ Requirement	Results
Visual Inspection	ISO 11608-2:2012 Section 12.2.2 and as per protocols used in K173881	Meets standard
Needle Retention	ISO 11608-2:2012 Section 9 and as per protocols used in K173881	Meets standard
Glide Force	As per protocols used in K173881	Meets standard
Penetration Force	As per protocols used in K173881	Meets standard
Flow Rate	ISO 11608-2:2012 Section 4.3 and as per protocols used in K173881	Meets standard
Needle Dislocation	ISO 11608-2:2012 Section 4.8 and as per protocols used in K173881	Meets standard
Accelerated Aging	ISO 11608-2:2012 and as per protocols used in K173881	Meets standard
Real Time Aging	ISO 11608-2:2012 and as per protocols used in K173881	Ongoing

Table 9: Summary of the performance tests to standards:

Biocompatibility:

The biocompatibility of the device is governed by the materials used, which have not been changed as a result of the additional needle gauge sizes and lengths. Therefore, the biocompatibility reports presented in K173881 are still valid and no additional testing is required.

Sterilization:

The sterility of the devices is assured using a sterilization method validated in accordance with ISO 11137 "Medical Devices – Validation and Routine Control of Radiation Sterilization" for Unifine SafeControl™ manufactured by Owen Mumford UK. Through the sterilization methods used, all Unifine SafeControl™ devices are sterilized to provide a Sterility Assurance Level (SAL) of 10-6.

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8. Conclusion

In summary, Table 8 in this document indicates that the characteristics between the submission device and the predicate device are identical, with the exception of the additional needle lengths and gauges presented in the submission device.

The results of the bench testing, summarised in Table 9 of this document, demonstrate that the differences between the submission Unifine SafeControl™ and the predicate (additional needle lengths and gauges) have no impact on safety and effectiveness and the product is therefore substantially equivalent to the predicate device.

Regulation Number and Section

§ 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).