K Number
K173881
Device Name
Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30G
Manufacturer
Date Cleared
2018-07-11

(202 days)

Product Code
Regulation Number
880.5570
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
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 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.
More Information

No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML.

No.
The device facilitates the delivery of drugs, but it does not directly treat or diagnose a disease itself.

No
The device is a pen needle intended for drug delivery (subcutaneous injection), not for diagnosing a condition.

No

The device description clearly outlines a physical, disposable pen needle assembly with various hardware components (cannula, hub, safety guard, etc.) and describes bench testing related to physical properties and performance. There is no mention of software as a component or function of the device.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
  • Device Function: The Unifine SafeControl™ pen needle is a device used for the delivery of drugs (like insulin) into the body via subcutaneous injection. It is a delivery mechanism, not a tool for analyzing biological samples.
  • Intended Use: The intended use clearly states it's for "subcutaneous injection of FDA approved drugs." This is a therapeutic or drug delivery function, not a diagnostic one.

The device description and performance studies further support this. They focus on the physical properties, safety features, and compatibility of the needle for injection, not on any analytical or diagnostic capabilities.

N/A

Intended Use / 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.

Product codes

FMI

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 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 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 given treatment regime.

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

self-administering patients, care-givers and healthcare professionals.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical performance data was obtained through design verification testing to demonstrate that the device operates safely and effectively. Bench testing included: Visual Inspection, Torque to attach to pen, Torque to remove from pen, Dose accuracy, Flow Rate, Force to over-ride safety feature, Needle Retention, Needle Dislocation, Sterility - Seal integrity, Internal pressure test (Burst Testing), NIS Compatibility, and Simulated Clinical use testing (sharps safety testing). All tests met the specified standards (e.g., ISO 11608-2:2012, ISO 11608-5:2012, ISO 11607-1:2007, ASTM-F-1140-07, ASTM 4169 2016, ISO 23908:2011).

Biocompatibility evaluation was conducted in accordance with ISO 10993-1 and FDA guidance, classifying the device as 'Externally Communicating Device, Blood Path Indirect, Limited (≤24 hour) use'. Tests included Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Hemocompatibility, and Pyrogenicity. Results demonstrated the materials are biocompatible.

Sterilization validation (Dose mapping) was performed according to ISO 11137 for gamma radiation (20-40kGy dose range). Shelf life studies were conducted per ISO 11608-2, ISO 23908, and ASTM F1980-16, supporting an initial 2-year shelf life with protocols for a 5-year shelf life.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K152339

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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).

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.

July 11, 2018

Owen Mumford Ltd % Patty Cronan Quality Manager Owen Mumford USA Inc 1755 West Oak Commons CT Marietta, Georgia 30062

Re: K173881

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: May 24, 2018 Received: May 25, 2018

Dear Patty Cronan:

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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

1

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely. Digitally signed by Alan M. Alan M Stevens -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, Stevens 0.9.2342.19200300.100.1.1=1300 189211, cn=Alan M. Stevens -S Date: 2018.07.11 07:16:33 -04'00' for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation 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: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K173881

Device Name Unifine SafeControl™M

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)
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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H

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SECTION 5.0

510(k) SUMMARY

1.Submitter

| Prepared by: | Watheq Al-Hakam
Regulatory Affairs Officer - Projects
Owen Mumford Ltd.
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 |
| Contact Person: | Paul Smith
Head of Quality
Owen Mumford Ltd,
Tel: +44(0)1993 812021
Fax: +44(0)1993 813466
Email: paul.smith@owenmumford.com |
| Contact Person: | Watheq Al-Hakam
Regulatory Affairs Officer - Projects
Owen Mumford Ltd,
Tel: +44(0)1993 812021
Fax: +44(0)1993 813466
Email: watheq.al-hakam@owenmumford.com |
| Date Prepared: | 15 DECEMBER 2017 |

4

2.Device

Name of Device: Unifine SafeControl™ Common Name: Pen Needles Classification Name: Needle, Hypodermic, Single Lumen (21 CFR 880.5570) Regulatory Class: II Product Code: FMI

3.Predicate Devices

Predicate Device Name: Unifine Pentips and Unifine Pentips Plus, 510k number K152339

4.Description of The Device

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 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 given treatment regime.

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.

The purpose of this 510(k) Premarket Notification is to obtain a Prescription Use and Over-The-Counter Use clearance for the Unifine SafeControl™ safety pen needle device. The intended use for the Unifine SafeControl™ remains the same as the predicate device.

Figure 5.1: Exploded view of the Unifine SafeControl™ safety pen needle assembly

Image /page/4/Figure/10 description: The image shows an exploded view of a medical device, likely a needle or syringe, and its packaging. The components are arranged in a line, starting with the primary container or packaging on the left, followed by a safety guard, a needle carrier with cannula, a hub, and finally, a sterility seal or packaging on the right. The labels indicate the function of each component, emphasizing the packaging and safety features of the device.

5

ComponentBase MaterialPatient ContactDuration
HubPolypropyleneSurface (Intact Skin)A - Limited (≤24 hour)
Safety GuardPolystyrolSurface (Intact Skin)A - Limited (≤24 hour)
Needle CarrierPolypropyleneSurface (Intact Skin)A - Limited (≤24 hour)
Cannula 30GSTAINLESS STEEL -
AISI 304 coated with
siliconeExternally
Communicating
(Bloodpath Indirect)A - Limited (≤24 hour)
Adhesive (Glue)DYMAX 1180-M-SV04Surface (Intact Skin)A - Limited (≤24 hour)
Primary Packaging
Primary Container
(Packaging)PolypropyleneSurface (Intact Skin)A - Limited (≤24 hour)
Foil seal (Packaging)Paper LaminateSurface (Intact Skin)A - Limited (≤24 hour)

Table 5.1: Biocompatibility Device Categorization for Submission Device Components

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 an additional safety feature allowing the exposed needle to be covered after use.

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

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Table 5.2: Comparison of Device Characteristics between Submission Devices and Predicate Device

| Device Characteristic | Predicate Device: Unifine Pentips &
Unifine Pentips Plus - K152339 | Submission Device - Unifine
SafeControl™ |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Unifine Pentips range of pen
needles are intended for use with
multi-dose injection devices for the
subcutaneous injection of FDA
approved drugs, including insulin | Unchanged from the predicate
device |
| Operating principle | Manual | Manual with an additional safety
feature allowing the exposed
needle to be covered after use. |
| Design/ construction | Needle assembly (cannula, needle
hub packaged in a needle shield and
primary container) | Device unchanged from the
predicate device with the
exception of an addition of a
safety feature (safety guard)
integrated in the device. The
needle carrier was integrated in
the needle hub in the predicate
device. |
| Components and Materials | Unifine Pentips by Owen Mumford:
Device:
• Cannula - Stainless Steel
• Lubricant - Silicone
• Adhesive – Medical Grade Adhesive
• Needle Hub – Polypropylene
Packaging:
• Needle Shield - High Density
Polyethylene
• Outer Container - High Density
Polyethylene
• Sterility Seal - Paper Laminate
Unifine Pentips Plus by Owen
Mumford:
Device:
• Cannula - Stainless Steel
• Lubricant - Silicone
• Adhesive – Medical Grade Adhesive
• Needle Hub – Polypropylene
Packaging:
• Needle Shield - High Density
Polyethylene
• Primary Container - Polypropylene
• Sterility Seal - Paper Laminate | Unchanged from the predicate
device with the exception of a
safety feature (safety guard)
component:
• Safety guard -
Polystyrol
The needle carrier was
integrated in the needle hub in
the predicate device, the colour
additive is changed. |
| Package | • Plastic outer container
• Sterility Seal
• Shelf box | Unchanged from the predicate
device |

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| Needle
Specification | | Needle Length | Unifine Pentips by Owen Mumford:
4mm for 32G; 5mm, 6mm and 8mm
for 31G; 12mm for 29G
Unifine Pentips Plus by Owen
Mumford: 4mm for 32G; 5mm, 6mm
and 8mm for 31G; 12mm for 29G | 5mm for 30G
8mm for 30G |
|-------------------------|--|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| | | Effective Gauge | 29G, 31G and 32G | 30G |
| | | Tip
Configuration | Patient-side: Tri-bevel (3) | Unchanged from the predicate
device |
| Sterilization | | | Unifine Pentips by Owen Mumford:
Gamma Radiation (validated to
achieve SAL 10-6) | Unchanged from the predicate
device, Gamma Radiation
(validated to achieve SAL 10-6). |
| | | | Unifine Pentips Plus by Owen
Mumford: Gamma Radiation (validated
to achieve SAL 10-6) | |

7.Performance Data

Non-clinical performance data:

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:

Table 5.3: Summary of the performance tests to standards:

TestStandard/ RequirementResults
Visual InspectionISO 11608-2:2012 Section 12.2.2Meets standard
Torque to attach to penISO 11608-2:2012 Section 11.4.1.5Meets standard
Torque to remove from penISO 11608-2:2012 Section 11.4.3Meets standard
Dose accuracyISO 11608-2:2012 Section 11.4.2Meets standard
Flow RateISO 11608-2:2012 Section 4.3Meets standard
Force to over-ride safety featureISO 11608-5:2012 Section 5.1.11.2Meets standard
Needle RetentionISO 11608-2:2012 Section 9Meets standard
Needle DislocationISO 11608-2:2012 Section 4.8Meets standard
Sterility - Seal integrityISO 11607-1:2007 Section 6.3Meets standard
Internal pressure test (Burst
Testing)ASTM-F-1140-07:2007
ASTM 4169 2016 Section 16.2Meets standard
NIS CompatibilityISO 11608-2:2012 Section 4.9Meets standard
Simulated Clinical use
testing (sharps safety
testing)ISO 23908:2011 &
Guidance for Industry and FDA Staff-
Medical Devices with Sharps
Injury Prevention FeaturesMeets standard

8

The objective of all the bench testing conducted was to verify that the submission device met the pre-determined specifications, in order to support the conclusion that it is fit for purpose and is substantially equivalent. Where applicable, the testing for the submission device was conducted in accordance with ISO 11608-2:2012 Needle-based injection systems for medical use – Requirements and test methods – Part 2: Needles. Written protocols specified the scope, objectives, specifications, test equipment, test methods and acceptance criteria. Additional design verification testing was performed that was not required by ISO 11608- 2:2012. The type of Bench testing are summarized below.

The following are the tests conducted:

  • Visual Inspection
  • Torque to attach to pen
  • Torque to remove from pen
  • Dose accuracy
  • Glide Force
  • Penetration Force
  • · Force to remove foil
  • · Flow Rate
  • · Force to activate safety feature
  • · Force to over-ride safety feature
  • Needle Retention
  • · Needle Dislocation
  • · Sterility Seal integrity
  • · Internal pressure test
  • · Force to remove from Primary Container
  • Torque to Break Thread Bond

Biocompatibility:

In accordance with ISO 10993-1, the Unifine SafeControl™ safety pen needle is classified as: Externally Communicating Device, Blood Path Indirect, Limited (≤24 hour) use. The biocompatibility evaluation for finished devices' blood/body contacting parts were conducted in accordance with the FDA quidance document "Use of International Standard ISO 10993-1. "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The tests used for the biocompatibility evaluation of the contact materials are as follows:

  • Cytotoxicity
  • . Sensitization
  • Irritation ●
  • Systemic Toxicity
  • Hemocompatibility ●
  • Pyrogenicity ●

In addition to the tests set out in ISO 10993-1; the submission included evaluation of Pyrogenicity (ISO 10993-11 Annex F) and the whole device evaluation (ISO 10993-1 section 7). Pyrogenicity testing shall be considered for any components which come into internal contact with the user, classed as externally communicating. Full device evaluation includes a review of all the materials, consumables, manufacturing processes and environments by an expert toxicologist to ensure the device in its final form is biocompatible.

Results of the testing demonstrate the materials are biocompatible.

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Sterilization:

Unifine SafeControl™ safety pen needles manufactured by Owen Mumford in the UK are sterilized by gamma radiation. A summary of sterilization and shelf life details for all variants of device are as follows:

Sterilization Method: Gamma radiation

Radiation dose range: 20-40kGy

Description of the method used to validate the sterilization cycle:

Sterilization validation (Dose mapping) was conducted in accordance with Section 9 of ISO 11137: "Sterilization of Healthcare Products - Radiation - Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices."

Shelf life

Shelf life studies were conducted per ISO 11608-2, ISO 23908, and ASTM F1980-16 to support an initial 2-year shelf life, and protocols were submitted to support an increase to a 5-year shelf life upon successful completion of studies.

8.Conclusion

In summary, the differences between the Unifine SafeControl™ and the predicates do not raise different questions of safety and effectiveness and the performance data shows that the device is substantially equivalent to the predicate device.