JSM insulin pen needle consists of a cap, needle, hub and paper. The cap and paper function to maintain the sterility of the needle. This device is single use and sterilized by EO gas. The hub can be connected with pen injector. After removing the paper, the needle can be screwed on to the pen. The needle cap protects the needle. This device has various gauge sizes (29G, 30G, 31G, 32G) and length (4mm, 5mm, 6mm, 10mm, 12mm) The color of needle cap per needle gauge is distinguished according to the standard given by our company.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the JSM Insulin Pen Needle. It details the device's characteristics, comparison to a predicate device, and performance testing results against various ISO standards.

However, the questions posed (regarding acceptance criteria and a study proving a device meets these criteria, especially concerning AI/human reader performance, ground truth, and training data) are not applicable to this document.

This document describes the regulatory approval process for a physical medical device (an insulin pen needle) and focuses on engineering and biocompatibility performance data, not artificial intelligence or diagnostic algorithms. There is no mention of "AI" or "human readers" or "ground truth" in the context of an algorithmic assessment.

Therefore, I cannot provide a table of acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment based on the provided text. These concepts are relevant to the evaluation of AI/ML-driven diagnostic devices, which is not what this document describes.

Summary

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

July 11, 2016

Jeesung Medical Co Ltd % Mr. Peter Chung President Plus Global 300 Atwood Street Pittsburgh, Pennsylvania 15213

Re: K152166

Trade/Device Name: JSM Insulin Pen Needle Regulation Number: 21 CFR 880.5770 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: May 27, 2016 Received: June 7, 2016

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 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 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" (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 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,

Tina Kiang -

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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K152166

Device Name JSM Insulin Pen Needle

Indications for Use (Describe)

JSM insulin pen needle is intended for use with pen injector devices for the subcutaneous injection of insulin in the treatment of diabetes.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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 PRAStaff(@fda.hhs.gov

"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."

FORM FDA 3881 (1/14)

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510(k) Summary

[as required by 807.92]

1. Applicant

1. Company : JeeSung Medical Co.,Ltd.
1. Address : 54, Mujini 1-gil, Daedeok-gu, Daejeon, Korea
1. Tel : 82-42-932-6061
1. Fax : 82-42-932-6063
1. Contact person : Peter Chung, 412-687-3976
1. Contact person address : 300 Atwood Street, Pittsburgh, PA, 15213, USA
1. Date of preparation : July 8, 2016
1. 510(k) number : K152166

2. Device Information

1. Trade Name : JSM Insulin Pen Needle
1. Common Name : Insulin Pen Needle
1. Classification Name : Needle, Hypodermic, Single Lumen
1. Product Code : FMI
1. Regulation Number : 880.5570
1. Class of device : Class II
1. Panel : General Hospital

3. The legally marketed device to which we are claiming equivalence

K080904 Feel Fine Insulin Pen Needle

4. Device description

JSM insulin pen needle consists of a cap, needle, hub and paper. The cap and paper function to maintain the sterility of the needle. This device is single use and sterilized by EO gas.

The hub can be connected with pen injector. After removing the paper, the needle can be screwed on to the pen. The needle cap protects the needle.

This device has various gauge sizes (29G, 30G, 31G, 32G) and length (4mm, 5mm, 6mm, 10mm, 12mm) The color of needle cap per needle gauge is distinguished according to the standard given by our company.

5. Indication for Use

JSM insulin pen needle is intended for use with pen injector devices for the subcutaneous injection of insulin in the treatment of diabetes.

Manufacturer	JeeSung Medical Co.,Ltd.	Feel Tech Co.,Ltd.
Element of Comparison	Submission Device	Predicate DeviceK080904
Indication for use	JSM insulin pen needle is intended foruse with pen injector devices for thesubcutaneous injection of insulin in thetreatment of diabetes.	These disposable sterile insulin penneedles are intended forsubcutaneous injection of insulin inthe treatment of diabetes.
Trade name	JSM Insulin Pen Needle	Feel Fine Insulin Pen Needle
Model/type	JSPN-29, JSPN-30,	Feel Fine Insulin Pen Needle-29

6. Predicate device comparison table

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Manufacturer	JeeSung Medical Co.,Ltd.JSPN-31, JSPN-32			Feel Tech Co.,Ltd.Feel Fine Insulin Pen Needle-30Feel Fine Insulin Pen Needle-31
Principle of operation	To inject insulin into body, Pen needle is connected and used with pen injector. By pen injector, the dosage of insulin is regulated. After injection, pen needle is connected with the sterile cap and unscrewed from pen injector and discarded.			To inject insulin into body, Pen needle is connected and used with pen injector. By pen injector, the dosage of insulin is regulated. After injection, pen needle is connected with the sterile cap and unscrewed from pen injector and discarded.
Appearance	Image: [purple pen needle]			Image: [orange pen needle]
Product configuration	HubNeedle capSterile capNeedleSterile paper			HubNeedle capSterile capNeedleSterile paper
Material	Sterile cap	Polypropylene		Hub	Polypropylene
	Needle cap	Polyethylene		Needle cap	Polyethylene
	Needle	Stainless steel 304		Needle	Stainless steel 304
	Hub	Polypropylene		Hub	Polypropylene
Gauge	29G	30G	31G	32G	29G,	30G,	31G
Length of needle tube(specified length ±1.25mm)	5 mm8 mm10 mm12 mm	5 mm8 mm10 mm12 mm	4 mm5 mm6 mm8 mm	4 mm5 mm6 mm8 mm	5 mm8 mm12.7 mm	5 mm8 mm12.7 mm	5 mm8 mm12.7 mm
Performances	Conforms to ISO7864, ISO 11608-2, ISO9626			Conforms to ISO7864, ISO 11608-2, ISO9626
Biocompatibility	Conforms to ISO10993			Conforms to ISO10993
Shelf life	3years			3years
Sterilization	EO Gas sterilization			EO Gas sterilization
Labeling	Meet the requirements of 21 CFR 801			Meet the requirements of 21 CFR 801
Packaging	Sterile cap(PP)+sterile paper			Sterile cap(PP)+sterile paper
Intended population	All ages			All Ages

The proposed and predicate devices have the similar indications for use, principle of operation, product configuration, material, performance, biocompatibility, shelf life, sterilization. Although the indications for use are not identical, the intended uses are as both are for the subcutaneuous injection of insulin and does not raise new questions of safety or effectiveness.

The testing in conformance with ISO 11608-2, ISO 7864 and ISO 9626 provides additional evidence that the proposed device is substantially equivalent to the predicate device

The pen injectors to be used with our pen needles are FlexPen

7. Performance data:

The JSM Pen Needle has been designed and tested to meet applicable requirements of the standards listed below.

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Biocompatibility Testing

No	Testidentification	Test method	Test criteria	Test result
1	Cytotoxicity test	ISO10993-5Tests for in vitro cytotoxicity,Test on extracts method	Cytotoxicity reactivity is 0	Non- cytotoxicity (Pass)
2	Hemolysis test	ISO10993-4Tests for interactions withblood, Evaluation of hemolyticproperties of medical and theircomponents	Hemolytic index :0-2%	Hemolytic index was0.158%. As a result, therewas non-hemolytic to theextraction solution(Pass)
3	Acute systemictoxicitytest	ISO10993-11Tests for systemic toxicity, Acutesystemic toxicity	No adverse clinical signs inanimals and no animals lostin excess of 10% of bodyweight.	Non-acute systemictoxicity (Pass)
4	Skin sensitizationtest	ISO10993-10Test for Irritation andsensitization, Guinea pigMaximization test (GPMT)	Non-skin hypersensitivityreaction to negative controland test substance material.	Non-skin hypersensitivityreaction (Pass)
5	Pyrogen Test	ISO 10993Test for systemic, Annex(F)Information on material-mediated pyrogens	No animal show an individualtemperature rise of 0.5°C orabove its respective controltemperature.	Non-pyrogenicity (Pass)
6	Intracutaneousreactivity test	ISO 10993-10Test for irritation and skinsensitization, AnimalIntracutaneous(intradermal)reactivity Test	The calculated final testsample scores of polar andnon-polar extract is 0.0	Non-intracutaneous(Pass)

Testing Performance to ISO 7864 (1993)

	Test items	Criteria and Result summary
1	Inner/outside and structure	No scratch, no crack, smooth, no foreign materials, sharped needle edge, glycerin untinged, no lubricant on the surfacePassed
	Measurement	Outside diameter of needle : 0.267mm for criterial 0.254-0.267Length of needle : 7.6mm for criteria 8(+1/-2)Passed
	Elasticity test	Fix A point randomly and bend 12° with weight and 1 minutes at B pointNeedle returned after remove weightPassed
	Draw test	Pulled in the direction of the needle axis by minimum force (22N)The union of the hub and needle tube was not brokenPassed

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Testing Performance to ISO 11608-2 (2012) and ISO 9626 (1991)_

The pen injectors tested under 11608-2 : FlexPen

	Test items	Criteria and Result summary
		Model code	29Gx8mm	29Gx10mm	29Gx12mm
		Average	8.2414mL/min	8.1687mL/min	7.8848mL/min
		Model code	30Gx5mm	30Gx8mm	30Gx10mm	30Gx12mm
		Average	6.1566mL/min	6.1154mL/min	5.8387mL/min	5.738mL/min
Flow rate testing		Model code	31Gx4mm	31Gx5mm	31Gx6mm	31Gx8mm
		Average	4.298mL/min	4.250mL/min	4.162mL/min	4.149mL/min
		Model code	32Gx4mm	32Gx5mm	32Gx6mm	32Gx8mm
		Average	4.189 mL/min	4.216 mL/min	4.135 mL/min	4.094 mL/min
		The calculation for flow rate is as above.
1	Bond between huband needle tubetesting	PassedThe force min. (N) for nominal outside diameter of needle (29G, 30G, 31G, 32G) is22 N.The union of the hub and needle tube was not broken per each gauge by theminimum force (22N)
	Needle pointtesting	PassedWhen examined under a magnification of x2.5, needle points shall appear sharpand free from feather edges, burrs and hooks.The needle points per each gauge appeared sharp and free from feather edges,burrs and hooks.
	Freedom fromdefects	PassedWhen examined by normal or corrected vision, the needle tube shall appearstraight and of regular cross-section and wall thickness.The needle tube per each gauge appeared straight and regular cross-section andwall thickness.
	Lubrication testing	PassedIf the hypodermic needle tube is lubricated, the lubricant shall not be visible,under or corrected vision, as droplets of fluid on the outside or inside surfaces ofthe needle tube.The lubricant was not visible, under or corrected vision, as droplets of fluid on theoutside or inside surfaces of the needle tube.
Dislocation ofmeasuring point atpatient end		Patient-end needle length, /1, mm	Maximum allowable dislocationDmax , mm
		8	0,9
		12	1,1
		16	1,4
		Others	$0.07 x/1 + 0.3$
	Needle hub-assembly testing	For 12mm, 10mm, 8mm, 6mm, 5mm, 4mm, the test is performed and the testresult was passed.The needle assembly torque values shall all be within the range of 0.06Nm to0.080Nm. The needle assembly torque values is 0.070NmPassed
	Needle doseaccuracy testing	The following two conditions shall be met:$S+(k \times S_{sd}) \leq UL$ and $S-(k \times S_{sd}) \geq LL$The two conditions were metPassed

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	Needle hub torqueremoval testing	The needle hub removal torque shall be less than 0.1000Nm.The needle hub removal torque is 0.071NmPassed
	Inner/outside andstructure	No scratch, no crack, smooth, no foreign materials, sharped needle edge, glycerinuntinged, no lubricant on the surfacePassed
	Dimension	Needle outside diameter, Needle length, Needle cap Inner diameter29G, 30G, 31G, 32GPassed
2	Flexural strength	When the needle is bended to 90° the center of the cannula according to theradius of curvature of 5mm radius, it should not be brokenPassed
	Elasticity test	Fix A point randomly and bend 12° with weight and 1 minutes at B pointNeedle returned after remove weightPassed
	Draw test	Pulled in the direction of the needle axis by minimum force (22N)The union of the hub and needle tube was not brokenPassed

8. Conclusion

Based on the comparison and analysis above, the JSM Pen Needle has the same intended use, technological characteristics, materials of construction and performance specifications as the predicate device. The subject device is determined to be Substantially Equivalent (SE) to the predicate device

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).