(219 days)
No
The device description and performance studies focus on the mechanical and physical properties of a pen needle, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is a safety pen needle intended for the subcutaneous injection of FDA approved drugs. It is used to deliver medication, not to provide therapy itself.
No
The device is described as an "injection device" and a "pen needle" for the "subcutaneous injection" of drugs, indicating its therapeutic rather than diagnostic function.
No
The device description clearly outlines a physical, sterile, single-use, disposable pen needle assembly with various hardware components (cannula, needle carrier, hub, safety guard, container, seal). The submission is for expanding the range of physical sizes for this hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "subcutaneous injection of FDA approved drugs, including insulin." This describes a device used to administer substances into the body, not to test samples taken from the body.
- Device Description: The description details a "pen needle assembly" designed for injection. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances in samples
- Providing information for diagnosis, monitoring, or screening
The device is clearly intended for drug delivery, which falls under a different category of medical devices than IVDs.
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 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 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.
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.
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, caregivers 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
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.
Bench Testing:
Visual Inspection, Needle Retention, Glide Force, Penetration Force, Flow Rate, Needle Dislocation, Accelerated Aging. All met the stated standards/requirements.
Real Time Aging is Ongoing.
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.
Key Metrics
Not Found
Predicate Device(s)
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 contains 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 is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
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
1
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
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
4
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 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 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.
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.
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
5
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
| Device
| Characteristic | Predicate Device | Submission Device | Comment |
|---|---|---|---|
| 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 | Unchanged from the | ||
| predicate device | The characteristic is | ||
| identical | |||
| Operating | |||
| principle | Manual with an additional | ||
| safety feature allowing | |||
| the exposed needle to be | |||
| covered after use. | Unchanged from the | ||
| predicate device | The characteristic is | ||
| identical | |||
| Design/ | |||
| Construction | Needle assembly | ||
| (cannula, needle hub | |||
| packaged in a needle | |||
| shield and primary | |||
| container). The safety | |||
| guard is integrated into | |||
| the device. | Unchanged from the | ||
| predicate device | The characteristic is | ||
| identical | |||
| Components and | |||
| Materials | • Cannula - Stainless | ||
| Steel | |||
| • Lubricant - Silicone | |||
| • Adhesive – Medical | |||
| Grade Adhesive | |||
| • Needle Hub - | |||
| Polypropylene | |||
| • Needle Shield - High | |||
| Density Polyethylene | |||
| • Safety guard- | |||
| Polystryol | |||
| • Outer Container - High | |||
| Density Polyethylene | |||
| • Sterility Seal - Paper | |||
| Laminate | Unchanged from the | ||
| predicate device | The characteristic is | ||
| identical | |||
| Package | • Plastic outer container: | ||
| • Sterility Seal | |||
| • Shelf box | Unchanged from the | ||
| predicate device | The characteristic is | ||
| identical | |||
| Shelf life | 5 years | 5 years | The characteristic is |
| identical | |||
| Needle Sizes and | |||
| Gauges | 5mm x 30G | ||
| 8mm x 30G | 8mm x 31G | ||
| 6mm x 31G | |||
| 5mm x 31G | |||
| 4mm x 32G | The characteristic is | ||
| different - the | |||
| submission device | |||
| presents different | |||
| needle lengths and | |||
| gauges. The different | |||
| needle lengths and | |||
| gauges were | |||
| addressed through | |||
| the bench testing | |||
| summarised in Table | |||
| 9 of this document. |
6
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.
7
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.