SureFine Pen Needle

K250658 · Shina Med Corporation · FMI · Apr 3, 2025 · General Hospital

Device Facts

• Record ID: K250658
• Device Name: SureFine Pen Needle
• Applicant: Shina Med Corporation
• Product Code: FMI · General Hospital
• Decision Date: Apr 3, 2025
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

SureFine Pen Needle is intended for use with a pen injector for the subcutaneous injection of insulin.

Device Story

SureFine Pen Needle is a sterile, single-use, disposable hypodermic needle designed for subcutaneous insulin delivery. The device consists of a needle, hub, and shield assembly, with a blister paper-sealed primary container to maintain sterility. It is compatible with standard pen injectors. The user attaches the needle to the pen injector, removes the shield, and performs the injection. The device is intended for both prescription and over-the-counter use. It provides a physical interface for insulin administration, facilitating patient self-administration of medication. Available in various gauges (29G-32G) and lengths (4mm-12.7mm) to accommodate different injection requirements.

Clinical Evidence

No clinical data. Bench testing only. Performance evaluated per ISO 9626 (materials, dimensions, stiffness, corrosion resistance) and ISO 11608-2 (flow rate, hub bond, needle point defects, injector compatibility). Biocompatibility testing conducted per ISO 10993-1, including cytotoxicity, skin sensitization, hemocompatibility, intracutaneous reactivity, acute systemic toxicity, and pyrogenicity. All tests passed.

Technological Characteristics

Hypodermic single lumen needle. Materials conform to ISO 9626. Sterilization via EO gas (ISO 11135). Shelf-life 5 years. Available in 29G, 30G, 31G, 32G gauges and 4mm, 6mm, 8mm, 12.7mm lengths. Components: needle, hub, shield, blister paper. Complies with ISO 11608-2 for needle-based injection systems.

Indications for Use

Indicated for use with a pen injector for the subcutaneous injection of insulin in patients requiring insulin therapy.

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

• SureFine Pen Needle (K152877)

Reference Devices

• Unifine SafeControl (K210399)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

April 3, 2025

Shina Med Corporation
% Peter Chung
President
Plus Global
300 Atwood Street
Pittsburgh, Pennsylvania 15213

Re: K250658
Trade/Device Name: SureFine Pen Needle
Regulation Number: 21 CFR 880.5570
Regulation Name: Hypodermic Single Lumen Needle
Regulatory Class: Class II
Product Code: FMI
Dated: March 5, 2025
Received: March 5, 2025

Dear Peter Chung:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K250658 - Peter Chung
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).

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K250658 - Peter Chung
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Sincerely,

Shruti N. Mistry -S

Shruti Mistry
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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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K250658 | |
| Device Name SureFine Pen Needle | |
| Indications for Use (Describe) SureFine Pen Needle is intended for use with a pen injector for the subcutaneous injection of 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." | |

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510(k) Summary

1. Date of Preparation: March 27, 2025

2. Applicant
1) Company: SHINA MED CORPORATION
2) Address: 455-30, Bogaewonsam-ro Bogae-myun, Anseong-si, Gyeonggi-do, 17509, Republic of Korea
3) Tel: [phone]
4) Fax: [phone]
5) Contact person: Peter Chung, 412-512-8802
6) Contact person address: 300 Atwood Street, Pittsburgh, PA, 15213, USA
7) Submission date: March 5, 2025
8) Prior related submission: K152877

3. Subject Device Information
1) Trade name: SureFine Pen Needle
2) Common name: Insulin Pen Needle
3) Classification name: Hypodermic single lumen needle
4) Product code: FMI
5) Regulation number: 880.5570
6) Class of device: Class II
7) Panel: General Hospital

4. Predicate Device
1) Trade name (K152877): SureFine Pen Needle
2) Manufacturer: SHINA MED CORPORATION

5. Reference Device
1) Trade name (K210399): Unifine SafeControl
2) Manufacturer: Owen Mumford Ltd

6. Device description
SureFine Pen Needle is designed for use with a pen injector for the subcutaneous injection of insulin. The pen needle consists of a needle, hub, and shield assembly. Blister paper covers primary container. The primary container maintains sterility of the needle because primary container covers the hub and needle cap with blister paper sealed on the opening hole of primary container.
The needle hub can be connected screwed onto the pen. The needle shield is intended to provide physical protection to the needle tube.
SureFine Pen Needle is offered in various gauges sizes (29G, 30G, 31G, 32G) and Lengths (4mm, 6mm, 8mm, 12.7mm). These are sterile (EO gas sterilization), non-toxic, and non-pyrogenic. The pen needles are disposable, single use devices.

7. Indications for Use
SureFine Pen Needle is intended for use with a pen injector for the subcutaneous injection of insulin.

8. Performance data
1) Bench tests for the device’s performance were conducted.

| | Test items | Result |
| --- | --- | --- |
| ISO 9626 | Materials | Pass |
| | Cleanliness | Pass |
| | Limits for acidity and alkalinity | Pass |
| | Size designation | Pass |
| | Dimension | Pass |
| | Sitffness | Pass |
| | Resistance to breakage | Pass |
| | Resistance to corrosion | Pass |

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| ISO 11608-2 | Dimension | Pass |
| --- | --- | --- |
| | Flow rate | Pass |
| | Bond between hub and needle tube | Pass |
| | Needle point freedom from defects lubrication | Pass |
| | Dislocation of measuring point at patient | Pass |
| | Compatibility of needles and injector system | Pass |

2) Biocompatibility

Biocompatibility of the Surefine Pen Needle was evaluated in accordance with ISO 10993-1:2018. The following tests were performed: Cytotoxicity; Skin sensitization; Hemocompatibility; Intracutaneous reactivity; Acute systemic toxicity; Pyrogenicity. All evaluation acceptance criteria were met.

| Test item | Test method / Test criteria | Test result |
| --- | --- | --- |
| Cytotoxicity test | When it was tested according to ISO 10993-5, tests for in vitro cytotoxicity-Test on extracts method, it should satisfy the requirements. | Pass |
| Hemolysis test | When it was tested according to ISO 10993-4, Selection off tests for interactions with blood-evaluation of hemolytic properties of medical devices and medical device materials, it should satisfy the requirements. | Pass |
| Intracutaneous reactivity test | When it was tested according to ISO 10993-10, Tests for irritation and skin sensitization-Animal intracutaneous (Intradermal) reactivity test, it should satisfy the requirements. | Pass |
| Skin sensitization test | when it was tested according to ISO 10993-10, Tests for irritation and skin sensitization-Guinea pig maximization test (GPMT), it should satisfy the requirements. | Pass |
| Acute systemic toxicity test | When it was tested according to ISO 10993-11, Tests for systemic toxicity-Acute systemic toxicity, it should satisfy the requirements. | Pass |
| Pyrogen Test | When it was tested according to ISO 10993-11, Tests for systemic toxicity-Information on material-mediated pyrogens, it should satisfy the requirements. | Pass |

9. Sterilization and Shelf-life Testing

Sterilization of the SureFine Pen Needle has been validated using the half-cycle method as outlined in ISO 11135. Testing demonstrated maximum levels of residues of ethylene oxide and ethylene chlorohydrins do not exceed the limits presented in ISO 10993-7. LAL testing was performed to demonstrate that bacterial endotoxins are adequately mitigated. Shelf-life testing supports a shelf-life of 5-years after sterilization.

10. Substantially Equivalent (SE) Comparison

| | Proposed device | Predicate device | Remark |
| --- | --- | --- | --- |
| Manufacturer | SHINA MED CORPORATION | SHINA MED CORPORATION | Same |
| 510(K) No. | K250658 | K152877 | N/A |
| Trade Name | SureFine Pen Needle | SureFine Pen Needle | Same |
| Indications for use | SureFine Pen Needle is intended for use with a pen injector for the subcutaneous injection of insulin. | SureFine Pen Needle is intended for use with a pen injector for the subcutaneous injection of insulin. | Same |
| Type of use | Prescription use and Over-The-Counter use | Prescription use | Note #1 |
| Components | Primary container
Paper seal
Needle shield
Cannula
Needle hub | Primary container
Paper seal
Needle shield
Cannula
Needle hub | Same |
| Needle length | 4mm, 6mm, 8mm, 12.7mm | 4mm, 6mm, 8mm, 12.7mm | Same |
| Needle gauge | 29G, 30G, 31G, 32G | 29G, 30G, 31G, 32G | |

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| Biocompatibility | Conform ISO10993-1
Cytotoxicity
Sensitization
Irritation
Systemic Toxicity
Hemocompatibility
Pyrogenicity | Conform ISO10993-1
Cytotoxicity
Sensitization
Irritation
Systemic Toxicity
Hemocompatibility
Pyrogenicity | Same |
| --- | --- | --- | --- |
| Needle performance requirements | ISO 11608-2 : 2012 Needle-based injection systems for medical use — Requirements and test methods | ISO 11608-2 : 2012 Needle-based injection systems for medical use — Requirements and test methods | Same |
| Shelf life | 5 years | 3 years | Note #2 |

Note 1 – Type of use

Over-The-Counter use is added to the type of use of for the subject device; however, this change does not alter the indications for use, nor does it affect the safety and effectiveness of the subject device when compared to the predicate device. Thus, the change from Rx only to Rx and OTC does not raise any additional questions of safety or effectiveness when compared to the predicate device.

Note 2 – Shelf-life

The Shelf-life has changed to 5 years from 3 years in comparison with the predicate device. To validate this claim, shelf-life testing for the pen needle was conducted. Therefore, the different shelf-life does not raise new questions of safety or effectiveness compared to the predicate device.

11. Substantially Equivalent (SE) Conclusion

Based on the information provided, the SureFine Pen Needle is substantially equivalent to the predicate device (K152877).