Top Fine® 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 various gauge sizes (29G, 30G, 31G, 32G, 33G and 34G) and lengths (4mm, 5mm, 6mm, 8mm, 12mm). Top Fine® Pen Needles are sterile (EO gas sterilization), non-toxic and non-pyrogenic.

Top Fine® Pen Needle assembly consists of hub, needle cap, sterile cap and sterile paper.

AI/ML Overview

The document provided describes the Top Fine® Pen Needle and its equivalence to a predicate device (Feel Fine Insulin Pen Needle). The acceptance criteria are based on bench testing to demonstrate equivalent performance to the predicate device.

Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria Study	Standard/Method	Reported Device Performance (Top Fine® Pen Needle)
Inside and outside dimensions of needles	Not specified	Compliant (implied by overall conclusion of equivalence)
Size designation	Not specified	Compliant (implied by overall conclusion of equivalence)
Elasticity of the needle tube	ISO 11608-2:2012	Conforms to standard
The flexural rigidity	ISO 11608-2:2012	Conforms to standard
Pull (referring to needle pull-out force)	ISO 11608-2:2012	Conforms to standard
Lubricant (presence/effectiveness)	ISO 7864:1993	Conforms to standard
Compatibility test (with pen injectors)	Not specified (Specific compatible pens listed)	Compatible with listed pens (BD Pen, FlexPen, HumalogPen, etc.)
Needle dose accuracy	Not specified	Compliant (implied by overall conclusion of equivalence)
Needle hub torque removal	Not specified	Compliant (implied by overall conclusion of equivalence)
Endotoxin Test	USP 39: <85> Bacterial Endotoxin test and KP 11: <32> Endotoxin Test Method	Compliant (implied by overall conclusion of equivalence)
Sterilization	ISO 11135: 2007 (EO Gas sterilization)	Conforms to standard

Notes:

The document explicitly states that the "principal device demonstrated equivalent performance to the predicate devices during bench testing" and that "The bench tests of Needles with 32G, 33G, 34G demonstrated conformances to ISO 11608-2 and ISO 7864." The general conclusion statement also implies compliance for other aspects.
For several criteria, specific numerical acceptance limits are not provided in the document, but compliance with the standards (ISO 11608-2, ISO 7864, ISO 11135, USP 39, KP 11) serves as the acceptance criteria.

2. Sample size used for the test set and the data provenance

Sample size for the test set: The document does not specify the exact sample sizes for each bench test conducted. It generally refers to "bench tests" being conducted.
Data provenance: The tests were conducted by MedExel Co., Ltd. in Korea (company address listed as "252, Geumgwangosan-ro, Geumgwang-myeon, Anseong-si, Gyeonggi-do, Korea"). The nature of bench testing implies the data would be prospective for the device being tested.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The "ground truth" for a medical device like a pen needle typically refers to its physical and functional performance against established engineering and medical standards, not expert opinions or diagnoses. The "bench tests" are designed to objectively measure these parameters.

4. Adjudication method for the test set

Not applicable. As described above, the evaluation relies on objective measurements against engineering and medical standards, not subjective expert judgment requiring adjudication.

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 device is a hypodermic single lumen needle, not an AI-powered diagnostic tool. Therefore, MRMC effectiveness studies with human readers and AI assistance are not relevant to its evaluation.

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

Not applicable. This device is a physical medical instrument, not an algorithm. Its performance is evaluated through physical and functional bench tests.

7. The type of ground truth used

The ground truth used is based on established engineering and medical device standards and objective physical and functional performance measurements. Specifically, the document mentions:

ISO 11608-2:2012 (Needle systems for medical use - Part 2: Needles for pen injectors)
ISO 7864:1993 (Sterile hypodermic needles for single use)
ISO 11135: 2007 (Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices)
USP 39: <85> Bacterial Endotoxin test
KP 11: <32> Endotoxin Test Method

8. The sample size for the training set

Not applicable. This device is a physical medical instrument, not an AI model requiring a training set.

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

Not applicable. There is no training set for this type of device.

Summary

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

February 2, 2016

MedExel Co., Ltd. c/o Mr. Peter Chung President Plus Global 300 Atwood Street Pittsburgh, Pennsylvania 15213

Re: K152410

Trade/Device Name: Top Fine® Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: December 16, 2015 Received: December 31, 2015

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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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina Kiang
-s

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K152410

Device Name

Top Fine® Pen Needle

Indications for Use (Describe)

Top Fine® Pen Needle is intended for use with pen injector device for the subcutaneous injection of insulin.

Type of Use (Select one or both, as applicable)

الص Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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FOR FDA USE ONLY

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510(k) Summary (K152410)

[as required by 807.92(c)]

Applicant

Company : MedExel Co.,Ltd. Address : 252, Geumgwangosan-ro, Geumgwang-myeon, Anseong-si, Gyeonggi-do, Korea Tel : 82-31-677-8004 Fax : 82-31-677-8087 Prepared date : Dec. 15, 2015 Contact person : Peter Chung, 412-687-3976 Contact person address : 300, Atwood Street, Pittsburgh, PA, 15213, USA Current date : Jan. 15, 2016 510(k) Number : K152410

Device Information

Trade name : Top Fine® Pen Needle Common name : Hypodermic single lumen needle Classification name : Needle, Hypodermic, Single Lumen Product code : FMI Regulation number : 880.5570 Class of device : Class II Panel : General Hospital Model codes : 13 model codes including Top Fine® Pen Needle 29GX12mm

Top Fine® Pen Needle 29G X 12mm, 12.7mm
Top Fine® Pen Needle 30G X 8mm
Top Fine® Pen Needle 31G X 5mm, 6mm, 8mm
Top Fine® Pen Needle 32G X 4mm, 5mm, 6mm
Top Fine® Pen Needle 33G X 4mm, 5mm
Top Fine® Pen Needle 34G X 4mm, 5mm

The legally marketed device to which we are claiming equivalence

K080904 Feel Fine Insulin Pen Needle

Device description

Top Fine® Pen Needle assembly consists of hub, needle cap, sterile cap and sterile paper.

Indications for Use :

Top Fine® Pen Needle is intended for use with insulin pens for the subcutaneous injection of insulin.

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Performance data:

Bench tests relating to the performance of the Top Fine® Pen Needles were conducted.

The principal device demonstrated equivalent performance to the predicate devices during bench testing.

Bench testing consisted of:

Inside and outside dimensions of needles
Size designation
Elasticity of the needle tube
The flexural rigidity	Test standard
Pull	ISO 11608-2:2012
Lubricant	ISO 7864:1993
Compatibility test
Needle dose accuracy
Needle hub torque removal

COMPATIBLE Pens

PEN NAME
BD Pen	InDuo	Novopen 3ml	Novopen Junior
FlexPen	InnoLet	Sanofi SoloStar	Sanofi Optiset
HumalogPen	Humulin Pen	Sanofi OptiPen	Owen Autopen

Predicate device comparison table

Manufacturer	MedExel Co.,Ltd.	Feel Tech	Remark
510(k) No.	K152410	K080904	N/A
Indication for use	Top Fine® Pen Needle is intended for use with insulin pens for the subcutaneous injection of insulin.	These disposable sterile insulin pen needles are intended for subcutaneous injection of insulin in the treatment of diabetes.	Similar
Product name	Hypodermic single lumen needle	Hypodermic single lumen needle	Same
Trade name	Top Fine® Pen Needle	Feel Fine Insulin Pen Needle	N/A
Model/type	13 model codes including Top Fine® Pen Needle 29GX12mm	Feel Fine Insulin Pen Needle-29Feel Fine Insulin Pen Needle-30Feel Fine Insulin Pen Needle-31	N/A
Appearance	Image: MedExel Co.,Ltd. needle	Image: Feel Tech needle	Similar
Product configuration	HubNeedle capSterile capNeedleSterile paper	HubNeedle capSterile capNeedleSterile paper	Similar
Material	Part Material Sterile cap Polypropylene Needle cap Polyethylene Needle Stainless steel 304 Hub Polypropylene			Part Material Sterile cap Polypropylene Needle cap Polypropylene Needle Stainless steel 304 Hub Polypropylene	Same orSimilar
Length of parts (mm)
Total length of assembly	29.8	28.8	Similar
Side length of	15.2	15.5

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Manufacturer	MedExel Co.,Ltd.	Feel Tech	Remark
assembly(max)
Inner diameter ofsterile cap	11.2	12.95	Similar
Gauge	29G, 30G, 31G, 32G, 33G, 34G	29, 30, 31G	Similar
Length of needle	4 mm, 5 mm, 6 mm, 8 mm, 12 mm, 12.7 mm	5 mm, 8 mm, 12.7 mm	Similar
Sterilization	EO Gas sterilizationAccording to ISO 11135: 2007	EO Gas sterilization	Same
Packaging	Sterile cap(PP or PE)+sterile paper	Sterile cap(PP)+sterile paper	Similar

The bench tests of Needles with 32G, 33G, 34G demonstrated conformances to ISO 11608-2 and ISO 7864. Therefore the differences do not raise new concerns to establish substantial equivalence to the predicate.

Endotoxin Test was based on USP 39: <85> Bacterial Endotoxin test and KP 11: <32> Endotonix Test Method.

Conclusion:

The vast similarities of the Top Fine® Pen Needle to the predicate devices support the substantial equivalence in indications for use, function and basic composition.

The differences between the Top Fine® Pen Needle and the predicate device do not raise new issues.

The testing that conformance with ISO 11608-2 and ISO 7864 provides additional evidence that the Top Fine® Pen Needle is substantially equivalent to the predicate device in terms of efficacy and performance.

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).