The device consists of a metal tube that is beveled at one end and at the other end join to a female connector (hub). The needle cap covers intended to provide physical protection to the needle tube. This product is packed by blister paper and sterilized by E.O. gas.

AI/ML Overview

The provided text describes the acceptance criteria and performance data for the Kopac Sterile Needle as part of its 510(k) submission (K172483) to the FDA.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Requirement – Test (ISO 7864)	Acceptance Criteria (Implied)	Reported Device Performance
Inner and Outer Surface	No bumps and flaws on the outer surface. Smooth, electrolytically polished or equivalent. No hazardous oxides, dusts, and powders on the inner surface. Sharply polished blade without visible bending, uniform cross-section and thickness.	Pass
When injecting glycerin into the needle tube or needle hub, coloring of glycerin should not take place.	Glycerin should not cause coloring.	Pass
When a lubricant is applied on the needle tube, the lubricant must be non-toxic and satisfy ISO 7864. When observed by unaided eyes, no lubricant drops should be found on the inner and outer surfaces of the needle tube.	Lubricant must be non-toxic, satisfy ISO 7864, and no lubricant drops visible on inner/outer surfaces.	Pass
Dimensions (Measured using digital vernier calipers and digital thickness gauge)	Outer diameter of the needle tube must be satisfied. Length of the needle tube must be satisfied.	Pass
The needle hub and hub hole	When the test gauge indicated on the figure below is inserted into the hub hole at low pressure, the taper must fit with the taper gauge of the hub hole. Also, the nozzle of the needle hub must be within the gauge limit.	Pass
Elasticity	Return to original position when bent to 12° using a protractor.	Pass
Flexural strength	No snapping when bent to 90° using a protractor.	Pass
Pullout	Measurement of maximum value using a tension and compression tester (specific criteria not detailed, but implied to meet an acceptable threshold).	Pass
Stiffness (ISO 9626 Annex B)	When tested in accordance with the method given in ISO 9626 Annex B, apply a downward force given in table at a speed 1 mm/min. Measure the deflection of the tubing at the point of application of the force (specific deflection limits not detailed, but implied to meet an acceptable threshold within the standard).	Pass
Resistance to breakage (ISO 9626 Annex C)	The cannula edge shall be sharply ground to a regular cross-section and thickness, with no visible bending. No visible breakage when examined by normal or corrected vision.	Pass
Resistance to corrosion (ISO 9626 Annex D)	The tubing is partially immersed in sodium chloride solution ($\text{c(NaCl)} = 0.5mol/L$) at ($\text{23±2}$)°C, for 7h±5min. The immersed half of the tubing shall show no evidence of corrosion resulting from the test compared visually with the unimmersed portion.	Pass
Biocompatibility (ISO 10993 Series)	Cytotoxicity: Pass (ISO 10993-5 criteria). Skin Sensitization: Pass (ISO 10993-10 criteria). Intracutaneous Reactivity: Pass (ISO 10993-10, maximization test for delayed hypersensitivity criteria). Acute Systemic Toxicity: Pass (ISO 10993-11 criteria). Pyrogen Test: Pass (ISO 10993-11, Annex F criteria). Hemolysis Test: Pass (ISO 10993-4 criteria).	Pass
Sterility and LAL test	LAL test: Pass (USP39 <85>, Bacterial Endotoxins Test, Unit: EU/Device - specific limit not provided but implied to be below the threshold). E.O sterilization validation: Pass (ISO 11135:2014, EO 30%, CO2 70%, Temp: 55°C, Exposure time: 5 hours - implying successful sterilization). Sterility test: Pass (ISO 11737-2 criteria - implying no microbial growth). E.O Residual test: Pass (ISO 10993-7:2008 criteria).	Pass

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

The document does not specify the exact sample sizes for each of the bench tests. It broadly states “Bench test were performed.” and lists various types of tests. Data provenance is not explicitly mentioned (e.g., country of origin, retrospective/prospective), but these are standard bench tests typically performed in a laboratory setting by the manufacturer (Poonglim Pharmatech Inc., Korea).

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

This information is not applicable to this submission. The "ground truth" for a device like a hypodermic needle is established through objective physical, chemical, and biological measurements against international standards (ISO, USP) and predefined specifications, not through expert consensus on interpretation.

4. Adjudication method for the test set

Not applicable. The tests are quantitative or qualitative assessments against defined standards, not subjective interpretations 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 is a submission for a medical device (hypodermic needle), not an AI/software as a medical device (SaMD) that involves human readers or AI assistance.

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

Not applicable. This is a physical medical device.

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

The "ground truth" for the performance tests relies on:

International Standards: Primarily ISO 7864 (Hypodermic needles for single use), ISO 9626 (Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods), ISO 10993 series (Biological evaluation of medical devices), ISO 11135 (Sterilization of health-care products — Ethylene oxide), ISO 11737-2 (Sterilization of medical devices — Microbiological methods), and USP39 <85> (Bacterial Endotoxins Test).
Defined Specifications: Manufacturer's internal specifications for dimensions, material properties, and visual characteristics.
Objective Measurements: Using instruments like digital vernier calipers, digital thickness gauges, protractors, tension and compression testers, and laboratory analyses for chemical and biological properties.

8. The sample size for the training set

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

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

Not applicable. No training set for an AI model was used.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 21, 2018

Poonglim Pharmatech Inc. % Peter Chung President Plus Global 300 Atwood Pittsburgh, Pennsylvania 15213

Re: K172483

Trade/Device Name: Kopac Sterile needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: June 20, 2018 Received: June 20, 2018

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 (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.

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 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);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely. Carolyn Dorgan -

Digitally signed by Carolyn C. Dorgan -S
DN: c=US, o=U.S. Government,
ou=HHS, ou=FDA, ou=People,
0.9.2342.19200300.100.1.1=200180081
4, cn=Carolyn C. Dorgan -S
Date: 2018.06.21 16:21:51 -04'00'

For Tina Kiang, Ph.D. Acting 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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Indications for Use

510(k) Number (if known) K172483

Device Name Kopac Sterile Needle

Indications for Use (Describe)

This device is intended for use to inject fluids into or withdraw fluids from parts of the surface of the skin

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

[as required by 807.92(c)]

1. Applicant

Company: POONGLIM Pharmatech Inc. 1)
1. Address: 21, Jayumuyeok 1-gil, Gunsan-si, Jeollabukdo-do, Korea
Tel : 82-63-451-8141 3)
1. Fax : 82-63-451-8145
Prepared date : July 11, 2017 5)
Contact person : Peter Chung, 412-512-8802 6)
1. Contact person address : 300 Atwood Street, Pittsburgh, PA, 15213, USA
1. Submission date: August 11, 2017

2. Device Information

1. Trade name : Kopac Sterile Needle
1. Common name : Single-use needle, hypodermic needle
1. Classification name : Hypodermic Single Lumen Needle
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

K102584, IMC hypodermic Needle

4. Device description

Model	Gauge	Inch (")	mm	Length of Cannula (A)	Cover dimension (mm)
TypeYandI	30-4	30G	1 1/2	40	40(+1.5/-2.5)	60
	30-3		1	25	25(+1.5/-2.5)	60
	30-2		5/8	16	16(+1/-2)	60
	30-1		1/2	13	13(+1/-2)	60

Lengh of cannula by type

5. Intended Use:

This device is intended for use to inject fluids into or withdraw fluids from parts of the body below the surface of the skin.

6. Performance data:

Bench test were performed. Bench testing included biocompatibility, mechanical testing, sterility 1) testing including EO residues. The tests demonstrated that the device performs in a substantially equivalent manner to the predicate device. The following bench testing is performed to demonstrate the functionality is substantially equivalent.

Requirement – Test (ISO 7864)	Result
Inner and Outer SurfaceThere must be bumps and flaws on the outer surface. The finished surface must be smooth,and the entire needle tuve must have undergone elecrolytic polishing or equivalent	Pass

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polishing treatment.There must be no hazardous oxides, dusts and powders on the inner surface	Pass
The blade of the needle tuve must be sharply polished without visible bending and haveuniform cross section and thickness.	Pass
When injecting glycerin into the needle tuve or needle hub, coloring of glycerin should nottake place.	Pass
When a lubricant is applied on the needle tube, the lubricant must be non-toxic and satisfyISO 7864. When observed by unaided eyes, no lubricant drops should be found on the innerand outer surfaces of the needle tube.	Pass
DimensionsMeasured using digital vernier calipers and digital thickness gaugeOuter diameter of the needle tube must be satisfied.Length of the needle tube must be satisfied.	Pass
The needle hub and hub holeWhen the test gauge indicated on the figure below is inserted into the hub hole at lowpressure, the taper must fit with the taper gauge of the hub hole. Also, the nozzle of theneedle hub must be within the gauge limit.	Pass
ElasticityReturn to original position when bent to 12° using a protractor	Pass
Flexural strengthNo snapping when bent to 90° using a protractor	Pass
PulloutMeasurement of maximum value using a tension and compression tester	Pass

Requirement - Test (ISO 9626)	Result
StiffnessWhen tested in accordance with the method given in ISO 9626 Annex B, apply a downward force givenin table at a speed 1 mm/min. Measure the deflection of the tubing at the point of application of theforce.	Pass
Resistance to breakageThe cannula edg When tested in accordanc with Annex C, the tubing shall not show visiblebreakage when examined by normal or corrected vision.e shall be sharply ground to a regular cross-section and thickness, with no visible bending	Pass
Resistance to corrosionWhen tested in accordance with the method given in ISO 9626 Annex D, the tubing is partially immersedin sodium chloride solution( $c(NaCl) = 0.5mol/L$ ) at (23±2)°C, for 7h±5min. The immersed half of thetubing shall show no evidence of corrosion resulting from the test compared visually with theunimmersed portion.	Pass

2) Biocompatibility

#	Test item	Test method / Test criteria	Test result
1	Cytotoxicity	ISO 10993-5 Tests for in vitro cytotoxicity	Pass
2	Skin SensitizationTest	ISO 10993-10 irritation and skin sensitization	Pass
3	IntracutaneousReactivity Test	ISO 10993-10 Test for irritation and skin sensitization, maximizationtest for delayed hypersensitivity	Pass
4	Acute SystemicToxicity Test	ISO 10993-11 Test for systemic toxicity - Acute Systemic Toxicity	Pass
5	Pyrogen Test	ISO 10993-11 Tests for systemic toxicity, Annex(F) Information onmaterial-mediated pyrogens.	Pass
6	Hemolysis Test	ISO 10993-4 Selection of tests for interactions with blood	Pass

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3) Sterility and LAL test

#	Test item	Test standard	Test result
1	LAL test	USP39 <85>, Bacterial Endotoxins Test (Unit : EU/Device)	Pass
2	E.O sterilization validation	According to ISO 11135:2014E.O 30%, CO2 70%Temperature : 55°CExposure time : 5 hours	Pass
3	Sterility test	According to ISO 11737-2	Pass
4	E.O Residual test	Under the conditions of ISO 10993-7:2008, Ethylene oxide sterilization residuals, the test articles should meet the test requirements.	Pass

The performance tests demonstrated that this device is performs in a substantially equivalent manner to the predicate device.

7. Comparison Table

Manufacturer	POONGLIM Pharmatech Inc.	International Medsurg Connection(IMC)	Remark
510(K) No.		K102584
Intended use	This device is intended for use to injectfluids into or withdraw from parts ofthe body below the surface of the skin	This device is intended for use to injectfluids into or withdraw from parts ofthe body below the surface of the skin	Same
Material
Hub of needle	Polypropylene (PP)	Polypropylene (PP)	Same
Protector	Polypropylene (PP)	Polypropylene (PP)
Cannula	SUS304	SUS 304
Adhesive	Epoxy	Epoxy Resin
Length	1/2", 5/8", 1" & 1⁄2"	1/2", 5/8", 3/4", 7/8", 1", 1⁄4" & 1⁄2"	Similar
			Including predicate device
Gauge	30G	16G, 17G, 18G, 19G, 20G, 21G, 22G,23G, 24G, 25G, 26G, 27G, 28G, 29G &30G	Similar
			Including predicate device
Coverdimension	1/2" size: 60mm5/8" size : 60mm1" size: 60mm1⁄2" size: 60mm	1/2" size: 40mm5/8" size: 40mm3/4" size: 40mm7/8" size: 40mm1" size: 40mm1⁄4" size: 56mm1⁄2" size: 56mm	Similar
	Tipconfiguration	Bevel		Bevel	Same

8. Conclusion

The device has completed testing to show that the device meets its intended use and demonstrates substantial equivalence to the predicate device, K102584. Therefore, it is concluded that the subject device, Kopac Sterile Needle, is substantially equivalent to the legally marketed predicate device, K102584.

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).