Unifine SafeControl

K210399 · Owen Mumford, Ltd. · FMI · Sep 17, 2021 · General Hospital

Device Facts

• Record ID: K210399
• Device Name: Unifine SafeControl
• Applicant: Owen Mumford, Ltd.
• Product Code: FMI · General Hospital
• Decision Date: Sep 17, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

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.

Device Story

Unifine SafeControl is a sterile, single-use, disposable safety pen needle; attaches to multi-dose injection devices for subcutaneous drug delivery. Device assembly includes cannula, needle carrier, plastic hub, and integrated safety guard. Used by patients, caregivers, or clinicians in home or clinical settings. Safety guard covers needle after use to prevent injury. New gauge/length variants (31G/32G; 4-8mm) added to existing product line. Bench testing confirms performance consistency with predicate. Benefits include safe, effective subcutaneous drug administration with reduced needle-stick risk.

Clinical Evidence

Bench testing only. No clinical data. Verification testing performed per ISO 11608-2:2012 standards, including visual inspection, needle retention, glide force, penetration force, flow rate, needle dislocation, and accelerated aging. All tests met established standards.

Technological Characteristics

Cannula: Stainless Steel; Lubricant: Silicone; Adhesive: Medical Grade; Hub: Polypropylene; Shield: High Density Polyethylene; Safety guard: Polystyrol; Container: High Density Polyethylene; Seal: Paper Laminate. Manual operation with integrated safety guard. Sterilization: Radiation (ISO 11137, SAL 10^-6). Shelf life: 5 years.

Indications for Use

Indicated for subcutaneous injection of FDA-approved drugs (including insulin) using multi-dose injection devices. Intended for use by self-administering patients (male/female, left/right-handed), caregivers, and healthcare professionals.

Regulatory Classification

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.

Predicate Devices

• Unifine SafeControl (K173881)

Submission Summary (Full Text)

{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 ([e-mail]) or phone [phone] 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.

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 [e-mail]

"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."

{3}------------------------------------------------

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

### 1. Submitter

Prepared by: Darren Mansell Regulatory Affairs Manager Tel: [phone] Fax: [phone]

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: [phone] Fax: [phone] Email: [e-mail]

Paul Smith Quality & Regulatory Affairs Director Owen Mumford Ltd, Tel: [phone] Fax: [phone] Email: [e-mail]

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<br>Characteristic | Predicate Device | Submission Device | Comment |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Unifine SafeControl<br>range of pen needles are<br>intended for use with<br>multi-dose injection<br>devices for the<br>subcutaneous injection of<br>FDA approved drugs,<br>including insulin | Unchanged from the<br>predicate device | The characteristic is<br>identical |
| Operating<br>principle | Manual with an additional<br>safety feature allowing<br>the exposed needle to be<br>covered after use. | Unchanged from the<br>predicate device | The characteristic is<br>identical |
| Design/<br>Construction | Needle assembly<br>(cannula, needle hub<br>packaged in a needle<br>shield and primary<br>container). The safety<br>guard is integrated into<br>the device. | Unchanged from the<br>predicate device | The characteristic is<br>identical |
| Components and<br>Materials | • Cannula - Stainless<br>Steel<br>• Lubricant - Silicone<br>• Adhesive – Medical<br>Grade Adhesive<br>• Needle Hub -<br>Polypropylene<br>• Needle Shield - High<br>Density Polyethylene<br>• Safety guard-<br>Polystryol<br>• Outer Container - High<br>Density Polyethylene<br>• Sterility Seal - Paper<br>Laminate | Unchanged from the<br>predicate device | The characteristic is<br>identical |
| Package | • Plastic outer container:<br>• Sterility Seal<br>• Shelf box | Unchanged from the<br>predicate device | The characteristic is<br>identical |
| Shelf life | 5 years | 5 years | The characteristic is<br>identical |
| Needle Sizes and<br>Gauges | 5mm x 30G<br>8mm x 30G | 8mm x 31G<br>6mm x 31G<br>5mm x 31G<br>4mm x 32G | The characteristic is<br>different - the<br>submission device<br>presents different<br>needle lengths and<br>gauges. The different<br>needle lengths and<br>gauges were<br>addressed through<br>the bench testing<br>summarised in Table<br>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.