(202 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 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.
| Test | Standard/Requirement | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Visual Inspection | ISO 11608-2:2012 Section 12.2.2 | Meets standard | Meets standard |
| Torque to attach to pen | ISO 11608-2:2012 Section 11.4.1.5 | Meets standard | Meets standard |
| Torque to remove from pen | ISO 11608-2:2012 Section 11.4.3 | Meets standard | Meets standard |
| Dose accuracy | ISO 11608-2:2012 Section 11.4.2 | Meets standard | Meets standard |
| Flow Rate | ISO 11608-2:2012 Section 4.3 | Meets standard | Meets standard |
| Force to over-ride safety feature | ISO 11608-5:2012 Section 5.1.11.2 | Meets standard | Meets standard |
| Needle Retention | ISO 11608-2:2012 Section 9 | Meets standard | Meets standard |
| Needle Dislocation | ISO 11608-2:2012 Section 4.8 | Meets standard | Meets standard |
| Sterility - Seal integrity | ISO 11607-1:2007 Section 6.3 | Meets standard | Meets standard |
| Internal pressure test (Burst Testing) | ASTM-F-1140-07:2007, ASTM 4169 2016 Section 16.2 | Meets standard | Meets standard |
| NIS Compatibility | ISO 11608-2:2012 Section 4.9 | Meets standard | Meets standard |
| Simulated Clinical use testing (sharps safety testing) | ISO 23908:2011 & Guidance for Industry and FDA Staff-Medical Devices with Sharps Injury Prevention Features | Meets standard | Meets standard |
| Biocompatibility (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Hemocompatibility, Pyrogenicity) | ISO 10993-1, ISO 10993-11 Annex F | Materials are biocompatible | Materials are biocompatible |
| Sterilization (Dose mapping) | ISO 11137: "Sterilization of Healthcare Products - Radiation - Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices." | Achieves SAL 10-6 | Achieves SAL 10-6 |
| Shelf life | ISO 11608-2, ISO 23908, and ASTM F1980-16 | 2-year initial, 5-year upon studies completed | 2-year initial, studies for 5-year ongoing |
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.
{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
{2}------------------------------------------------
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:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
PRAStaff(@fda.hhs.gov
H
{3}------------------------------------------------
SECTION 5.0
510(k) SUMMARY
1.Submitter
| Prepared by: | Watheq Al-HakamRegulatory Affairs Officer - ProjectsOwen Mumford Ltd.Tel: +44(0)1993 812021Fax: +44(0)1993 813466 |
|---|---|
| Prepared for: | Owner/ OperatorOwen Mumford LtdBrook HillWoodstockOxfordshireOX20 1TUUnited KingdomEstablishment Registration Number: 3003348846 |
| Contact Person: | Darren MansellRegulatory Affairs ManagerOwen Mumford Ltd,Tel: +44(0)1993 812021Fax: +44(0)1993 813466Email: darren.mansell@owenmumford.com |
| Contact Person: | Paul SmithHead of QualityOwen Mumford Ltd,Tel: +44(0)1993 812021Fax: +44(0)1993 813466Email: paul.smith@owenmumford.com |
| Contact Person: | Watheq Al-HakamRegulatory Affairs Officer - ProjectsOwen Mumford Ltd,Tel: +44(0)1993 812021Fax: +44(0)1993 813466Email: 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}------------------------------------------------
| Component | Base Material | Patient Contact | Duration |
|---|---|---|---|
| Hub | Polypropylene | Surface (Intact Skin) | A - Limited (≤24 hour) |
| Safety Guard | Polystyrol | Surface (Intact Skin) | A - Limited (≤24 hour) |
| Needle Carrier | Polypropylene | Surface (Intact Skin) | A - Limited (≤24 hour) |
| Cannula 30G | STAINLESS STEEL -AISI 304 coated withsilicone | ExternallyCommunicating(Bloodpath Indirect) | A - Limited (≤24 hour) |
| Adhesive (Glue) | DYMAX 1180-M-SV04 | Surface (Intact Skin) | A - Limited (≤24 hour) |
| Primary Packaging | |||
| Primary Container(Packaging) | Polypropylene | Surface (Intact Skin) | A - Limited (≤24 hour) |
| Foil seal (Packaging) | Paper Laminate | Surface (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.
{6}------------------------------------------------
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 - UnifineSafeControl™ |
|---|---|---|
| Intended Use | The Unifine Pentips range of penneedles are intended for use withmulti-dose injection devices for thesubcutaneous injection of FDAapproved drugs, including insulin | Unchanged from the predicatedevice |
| Operating principle | Manual | Manual with an additional safetyfeature allowing the exposedneedle to be covered after use. |
| Design/ construction | Needle assembly (cannula, needlehub packaged in a needle shield andprimary container) | Device unchanged from thepredicate device with theexception of an addition of asafety feature (safety guard)integrated in the device. Theneedle carrier was integrated inthe needle hub in the predicatedevice. |
| Components and Materials | Unifine Pentips by Owen Mumford:Device:• Cannula - Stainless Steel• Lubricant - Silicone• Adhesive – Medical Grade Adhesive• Needle Hub – PolypropylenePackaging:• Needle Shield - High DensityPolyethylene• Outer Container - High DensityPolyethylene• Sterility Seal - Paper LaminateUnifine Pentips Plus by OwenMumford:Device:• Cannula - Stainless Steel• Lubricant - Silicone• Adhesive – Medical Grade Adhesive• Needle Hub – PolypropylenePackaging:• Needle Shield - High DensityPolyethylene• Primary Container - Polypropylene• Sterility Seal - Paper Laminate | Unchanged from the predicatedevice with the exception of asafety feature (safety guard)component:• Safety guard -PolystyrolThe needle carrier wasintegrated in the needle hub inthe predicate device, the colouradditive is changed. |
| Package | • Plastic outer container• Sterility Seal• Shelf box | Unchanged from the predicatedevice |
{7}------------------------------------------------
| NeedleSpecification | Needle Length | Unifine Pentips by Owen Mumford:4mm for 32G; 5mm, 6mm and 8mmfor 31G; 12mm for 29GUnifine Pentips Plus by OwenMumford: 4mm for 32G; 5mm, 6mmand 8mm for 31G; 12mm for 29G | 5mm for 30G8mm for 30G | |
|---|---|---|---|---|
| Effective Gauge | 29G, 31G and 32G | 30G | ||
| TipConfiguration | Patient-side: Tri-bevel (3) | Unchanged from the predicatedevice | ||
| Sterilization | Unifine Pentips by Owen Mumford:Gamma Radiation (validated toachieve SAL 10-6) | Unchanged from the predicatedevice, Gamma Radiation(validated to achieve SAL 10-6). | ||
| Unifine Pentips Plus by OwenMumford: Gamma Radiation (validatedto 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:
| Test | Standard/ Requirement | Results |
|---|---|---|
| Visual Inspection | ISO 11608-2:2012 Section 12.2.2 | Meets standard |
| Torque to attach to pen | ISO 11608-2:2012 Section 11.4.1.5 | Meets standard |
| Torque to remove from pen | ISO 11608-2:2012 Section 11.4.3 | Meets standard |
| Dose accuracy | ISO 11608-2:2012 Section 11.4.2 | Meets standard |
| Flow Rate | ISO 11608-2:2012 Section 4.3 | Meets standard |
| Force to over-ride safety feature | ISO 11608-5:2012 Section 5.1.11.2 | Meets standard |
| Needle Retention | ISO 11608-2:2012 Section 9 | Meets standard |
| Needle Dislocation | ISO 11608-2:2012 Section 4.8 | Meets standard |
| Sterility - Seal integrity | ISO 11607-1:2007 Section 6.3 | Meets standard |
| Internal pressure test (BurstTesting) | ASTM-F-1140-07:2007ASTM 4169 2016 Section 16.2 | Meets standard |
| NIS Compatibility | ISO 11608-2:2012 Section 4.9 | Meets standard |
| Simulated Clinical usetesting (sharps safetytesting) | ISO 23908:2011 &Guidance for Industry and FDA Staff-Medical Devices with SharpsInjury Prevention Features | Meets 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.
{9}------------------------------------------------
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.
§ 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).