(29 days)
No.
The device description and performance studies do not mention any components or functionalities related to AI, deep neural networks, or machine learning. It is a physical, disposable medical device for insulin injection.
No.
A therapeutic device is intended to treat a condition. This device is a pen needle used for drug delivery (insulin injection), which is an accessory to a therapeutic regimen, not a therapeutic device itself.
No
A diagnostic device is used to identify a disease or condition. The SureFine Pen Needle is primarily used for the delivery of insulin, which is a treatment, not a diagnostic procedure.
No
The device description clearly defines a physical medical device (pen needle) with components like a needle, hub, and shield assembly, designed for subcutaneous insulin injection. The performance studies also focus on material properties, physical dimensions, biocompatibility, and sterilization, all characteristic of a hardware medical device, not software.
No
The device is a pen needle used for subcutaneous injection, not for in vitro diagnostic testing of samples from the human body.
N/A
Intended Use / Indications for Use
SureFine Pen Needle is intended for use with a pen injector for the subcutaneous injection of insulin.
Product codes
FMI
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.
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
Not Found
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)
Bench tests for the device's performance were conducted.
ISO 9626: Materials (Pass), Cleanliness (Pass), Limits for acidity and alkalinity (Pass), Size designation (Pass), Dimension (Pass), Stiffness (Pass), Resistance to breakage (Pass), Resistance to corrosion (Pass).
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).
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.
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 of 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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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).
FDA 510(k) Clearance Letter - SureFine Pen Needle
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
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).
Page 2
K250658 - Peter Chung Page 2
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Page 3
K250658 - Peter Chung Page 3
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
Page 4
FORM FDA 3881 (8/23) Page 1 of 1
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:
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Page 5
510(k) Summary
Page 1 / 3
1. Date of Preparation
March 27, 2025
2. Applicant
- Company: SHINA MED CORPORATION
- Address: 455-30, Bogaewonsam-ro Bogae-myun, Anseong-si, Gyeonggi-do, 17509, Republic of Korea
- Tel: +82-31-8057-2125
- Fax: +82-31-8057-2150
- Contact person: Peter Chung, 412-512-8802
- Contact person address: 300 Atwood Street, Pittsburgh, PA, 15213, USA
- Submission date: March 5, 2025
- Prior related submission: K152877
3. Subject Device Information
- Trade name: SureFine Pen Needle
- Common name: Insulin Pen Needle
- Classification name: Hypodermic single lumen needle
- Product code: FMI
- Regulation number: 880.5570
- Class of device: Class II
- Panel: General Hospital
4. Predicate Device
- Trade name (K152877): SureFine Pen Needle
- Manufacturer: SHINA MED CORPORATION
5. Reference Device
- Trade name (K210399): Unifine SafeControl
- 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
- 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 |
| Stiffness | Pass |
| Resistance to breakage | Pass |
| Resistance to corrosion | Pass |
Page 6
Page 2 / 3
| 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 |
- 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 of 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 | Same |
Page 7
Page 3 / 3
| Proposed device | Predicate device | Remark | |
|---|---|---|---|
| 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).