Fine Ject insulin pen needle consists of a Sterile Cap, needle hub, which can be fixed with needle and blister paper. The sterile cap has function to sustain sterilization of needle because sterile cap covers the needle hub and needle cap with blister paper sealed on the opening hole of sterile cap. The needle hub can be connected with pen. The needle cap covers intended to provide physical protection to the needle tube.

Fine Ject insulin pen needles are single use, sterile, medical devices designed to be used in conjunction with pen injectors and pen cartridges. Pen needles are used by consumers, caregivers and health care professionals. They are offered in variougauge sizes (29G, 30 G, 31G and 32G) and lengths (4mm, 5mm, 8mm and 12.7mm). Fine Ject insulin pen needles are sterile (gamma irradiation sterilization), non-toxic and non-pyrogenic.

The hub has internal threads, which allows it to be screwed onto the pen-injector device. This allows the Non Patient (NP) end of the cannula to penetrate through the rubber septum of the cartridge.

AI/ML Overview

This document describes the premarket notification (510(k)) for the Fine Ject Insulin Pen Needle. It details the device's characteristics, comparison to predicate devices, and non-clinical testing performed to establish substantial equivalence.

Here's an analysis of the provided information, focusing on the requested categories. It's important to note that this 510(k) summary is for a medical device (insulin pen needle), not an AI/ML powered device, so many of the requested categories related to AI performance, ground truth, and expert evaluation are not directly applicable. I will address each point as best as the provided text allows.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Standard)	Reported Device Performance
ISO 7864 (Sterile hypodermic needles for single use)	Successfully tested to meet applicable requirements.
ISO 9626 (Stainless steel needle tubing for the manufacture of medical devices)	Successfully tested to meet applicable requirements.
ISO 11608-2 (Pen-injectors for medical use - Part 2: Needles)	Successfully tested to meet applicable requirements.
ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process) - for External Communicating Devices, Circulating Blood	Materials successfully passed testing.
Sterilization (Gamma Irradiation)	Fine Ject insulin pen needles are sterile.
Non-toxicity	Fine Ject insulin pen needles are non-toxic.
Non-pyrogenicity	Fine Ject insulin pen needles are non-pyrogenic.
Shelf-life	Supports a shelf-life of 3-years after sterilization.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the exact sample sizes used for each non-clinical performance test (e.g., for ISO standards compliance, biocompatibility, sterilization, shelf-life). These are typically determined by the testing protocols for each standard.

The data provenance is from non-clinical testing conducted by Twobiens Co., Ltd. in Korea. The document doesn't explicitly state "retrospective" or "prospective" for these tests, but non-clinical laboratory testing is typically conducted prospectively to meet specific requirements.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to this type of medical device submission. Ground truth established by medical experts (like radiologists) is relevant for diagnostic AI/ML products, not for physical medical devices like insulin pen needles. The "ground truth" here is compliance with established international standards for device design, materials, and performance, which is verified through laboratory testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods like "2+1" or "3+1" are used in studies involving human readers or evaluators for diagnostic agreement, which is not relevant for the non-clinical testing of a physical device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-powered device, and no MRMC comparative effectiveness study was conducted or is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context is the compliance with recognized international standards (ISO 7864, ISO 9626, ISO 11608-2, ISO 10993-1). This is established through specific laboratory tests and measurements designed to verify that the device meets the defined performance and safety criteria outlined in these standards.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device that requires a training set with established ground truth.

Summary

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K112332 page 1 of 2

JAN 1 0 2012

5. 510(k) Summary

[as required by 807.92(c)]

A. Applicant:

Company: Twobiens Co., Ltd. #602, Ace High-end Tower 8, Gasan-dong, Geumcheon-gu, Seoul, 153-802, Korea TEL. 82-2 6123 3070 Mobile. 82 10 5355 8124 http://www.twobiens.com -Contact person: Peter Chung 412-687-3976 -Date: Aug 16, 2011

B. Proprietary and Established Names:

Trade Name: Fine Ject Insulin Pen Needle Common Name: Insulin Pen Needle. Classification Name: Needle, Hypodermic, Single Lumen Product Code: FMI Regulation: 880.5570 Class of device : Class II.

Device Description: ﺯ

The hub has internal threads, which allows it to be screwed onto the pen-injector device. This allows the Non Patient (NP) end of the cannula to penetrate through the rubber septum of the cartridge.

D Summary of the comparison of technological characteristics

Fine Ject insulin pen needles are substantially equivalent to the intended use, function, principle of operation, and basic composition of the predicate devices.

The non-clinical testing to voluntary standards and applicable FDA guidance provide evidence Fine Ject insulin pen needle are substantially equivalent to the predicate devices in terms of safety, efficacy, and performance.

The minor differences between the Fine Ject insulin pen needle and the predicate devices, including needle gauge, needle length, and primary container material, raise no new issues of safety or effectiveness.

E. Brief discussion of non-clinical data

The Fine Ject insulin pen needles have been designed and tested to meet the requirements of voluntary standards and FDA guidance documents applicable to the subject and predicate devices.

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K112332 page 2 of 2

Results of the non-clinical testing supports the conclusion of substantial equivalence of the Fine Ject insulin pen needles to the predicate devices.

Performance-Testing:

The Fine Ject insulin pen needles have been designed and successfully tested to meet the applicable requirements outlined in ISO7864, ISO 9626 and ISO 11608-2.

Biocompatibility testing

The materials of the Fine Ject insulin pen needles have successfully passed testing as outlined in ISO 10993-1 for devices categorized as External Communicating Devices, Circulating Blood,

Sterilization and Shelf-lifeTesting.

Fine Ject insulin pen needles are sterile (gamma irradiation), non-toxic and nonpyrogenic.

Shelf-life testing supports a shelf-life of 3-years after sterilization.

F. Conclusion that data demonstrates substantial equivalence

The results of above tests demonstrate that The Fine Ject insulin pen needles performs equivalent to the predicate device and is safe and effective when used as intended.

G. The legally marketed devices to which we are claiming equivalence:

Feel Fine Insulin Pen Needle. K080904 BD 32G x 4mim Pen Needle :K100005

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The caduceus is black, and the text is also black. The logo is simple and recognizable, representing the department's mission to protect the health of all Americans.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Peter Chung President Twobiens Company, Limited 300 Atwood Street Pittsburgh, Pennsylvania 15213

JAN 1 0 2012

Re: K112332

Trade/Device Name: Fine Ject Insulin Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: November 26, 2011 Received: December 14, 2011

Dear Mr. 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 (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.

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Page 2 - Mr. Chung

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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Th for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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KI12332

Indications for Use Statement 4.

Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:Fine Ject Insulin Pen Needle

Indications For Use:

These disposable sterile Insulin pen needles are intended for subcutaneous injection of insulin in the treatment of diabetes.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rill C. Chapman 1/3/12
(Division Sign Off)

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Page 1 of 1

510(k) Number: K112332

Regulation Number and Section

§ 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).