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 document describes the acceptance criteria and the study that proves the EZ-Inject Single Use Needle device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Requirement – Test (Standard)	Acceptance Criteria (Implicitly "Pass" based on Results)	Reported Device Performance
Visual check	Pass	Pass
Dimension	Pass	Pass
Elasticity	Pass	Pass
Flexural strength	Pass	Pass
Pullout	Pass	Pass
Cleanliness (ISO 7864)	Pass	Pass
Limits for acidity or alkalinity (ISO 7864)	Pass	Pass
Limits for extractable metals	Pass	Pass
Needle hub (Conical fitting, Colour of hub)	Pass	Pass
Needle tube (Tolerances on length, Lubricant)	Pass	Pass
Needle point	Pass	Pass
Bond between hub and needle tube	Pass	Pass
Patency of lumen	Pass	Pass
Tolerances on length (ISO 7864)	Pass	Pass
Stiffness (ISO 9626)	Pass	Pass
Resistance to breakage (ISO 9626)	Pass	Pass
Resistance to corrosion (ISO 9626)	Pass	Pass
Cleanliness (ISO 9626)	Pass	Pass
Limits for acidity or alkalinity (ISO 9626)	Pass	Pass
LAL test (Bacterial Endotoxin) (USP 41, <85>)	Pass	Pass
Luer connector performance (ISO 80369)	Pass	Pass
Dimension (ISO 80369)	Pass	Pass
Biocompatibility Tests:
Cytotoxicity	Pass	Pass
Skin Sensitization Test	Pass	Pass
Intracutaneous Reactivity Test	Pass	Pass
Acute Systemic Toxicity Test	Pass	Pass
Pyrogen Test	Pass	Pass
Hemolysis Test	Pass	Pass
Particulate matter in injections	Pass	Pass
Sterility & LAL Tests:
LAL test	Pass	Pass
E.O sterilization validation	Pass	Pass
Sterility test	Pass	Pass
E.O Residual test	Pass	Pass
Hub/needle bond strength	N/A (Compared to predicate, met ISO 7864)	18 G-40 mm : 137.7 N, 19 G-40 mm: 177.8 N, etc. (All listed values resulted in "Pass")

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes for each specific test or the provenance (country of origin, retrospective/prospective) of the data, as these are typically bench tests performed on manufactured devices. The studies are described as "Bench test" and "The performance tests," suggesting these were conducted 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 Their Qualifications

The document describes bench testing, biocompatibility testing, and sterility testing according to international standards (ISO, USP). For these types of tests, ground truth is established by objective measurements and adherence to specified standard limits rather than expert human interpretation in the way, for example, a radiologist would interpret an image. Therefore, there is no mention of "experts" in the context of establishing ground truth for individual test cases as it would apply to a clinical study. The tests are conducted by qualified laboratory personnel following established protocols.

4. Adjudication Method for the Test Set

Given that the performance evaluation relies on bench tests against objective, quantitative standards (e.g., ISO and USP standards), an adjudication method like "2+1" or "3+1" (common in clinical trials with subjective endpoints) is not applicable. The results are binary (Pass/Fail) based on whether the device meets the specified criteria in the relevant standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a single-use hypodermic needle, and its performance evaluation focuses on physical, chemical, and biological safety and efficacy aspects through bench testing, not on comparative effectiveness with human readers or AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. The EZ-Inject Single Use Needle is a physical medical device, not a software algorithm or an AI system. Therefore, the concept of a "standalone algorithm" performance study is irrelevant to this submission.

7. Type of Ground Truth Used

The ground truth for evaluating the device's performance is based on International Standards and Pharmacopeial Monographs. Specifically, the document references:

ISO 7864: Sterile hypodermic needles for single use.
ISO 9626: Stainless steel needle tubing for the manufacture of medical devices.
ISO 80369-7: Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications.
ISO 6009: Hypodermic needles for single use - Colour coding for identification.
USP 41, <85>: United States Pharmacopeia for Bacterial Endotoxin Test.
ISO 10993-5, -10, -11, -4, -7: Biological evaluation of medical devices (for Cytotoxicity, Irritation/Sensitization, Systemic Toxicity, Interaction with blood, Ethylene oxide residuals).
ISO 11135:2014: Sterilization of health-care products - Ethylene oxide.
ISO 11737-2: Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process.

These standards define the acceptable physical properties, material safety, sterility, and functional performance limits, which serve as the "ground truth" for each test.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical device. It does not involve a training set as would be used for machine learning or AI models. There is no algorithm being "trained."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set involved for this physical medical device, the concept of establishing ground truth for a training set is not relevant.

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.

May 12, 2020

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

Re: K192222

Trade/Device Name: EZ-Inject Single Use Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: March 27, 2020 Received: April 13, 2020

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. 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 located 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.

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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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).

Sincerely,

For CAPT Alan Stevens 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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K192222

Device Name EZ-Inject Single use 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) 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: 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."

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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, Jeollabuk-do, Korea
Tel : 82-63-451-8141 3)
1. Fax : 82-63-451-8145
1. Prepared date : July 11, 2019
Contact person : Peter Chung, 412-512-8802 6)
Contact person address : 300 Atwood Street, Pittsburgh, PA, 15213, USA 7)
1. Submission date: August 11, 2017
ರು) Prior related submission : K172483

Device Information 2.

1. Trade name : EZ-Inject Single use Needle
Common name : Single-use needle, hypodermic needle 2)
1. Classification name : Needle, Hypodermic, Single Lumen
1. Product code : FMI
1. Regulation number : 880.5570
୧) Class of device : Class II
1. Panel : General hospital
1. Model/type Name : 159 model codes including Y18-13
1. List of models : Y (53 models), I (53 models), L (53 models)

	18-13	18-25	18-30	18-40	19-13	19-25	19-30	19-40
Y	21-13	21-25	21-30	21-40	22-13	22-25	22-30	22-40
	23-13	23-16	23-25	23-30	25-13	25-16	25-25	25-30
	26-13	26-16	26-25	27-13	27-16	27-25	29-08	29-13
	29-16	30-04	30-08	30-13	30-16	31-04	31-06	31-08
	31-13	32-04	32-06	32-08	32-13	33-04	33-06	33-08
	33-13	34-04	34-06	34-08	34-13

	18-13	18-25	18-30	18-40	19-13	19-25	19-30	19-40
I	21-13	21-25	21-30	21-40	22-13	22-25	22-30	22-40
	23-13	23-16	23-25	23-30	25-13	25-16	25-25	25-30
	26-13	26-16	26-25	27-13	27-16	27-25	29-08	29-13
	29-16	30-04	30-08	30-13	30-16	31-04	31-06	31-08
	31-13	32-04	32-06	32-08	32-13	33-04	33-06	33-08
	33-13	34-04	34-06	34-08	34-13

	18-13	18-25	18-30	18-40	19-13	19-25	19-30	19-40
L	21-13	21-25	21-30	21-40	22-13	22-25	22-30	22-40
	23-13	23-16	23-25	23-30	25-13	25-16	25-25	25-30
	26-13	26-16	26-25	27-13	27-16	27-25	29-08	29-13
	29-16	30-04	30-08	30-13	30-16	31-04	31-06	31-08
	31-13	32-04	32-06	32-08	32-13	33-04	33-06	33-08
	33-13	34-04	34-06	34-08	34-13

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K192222

1. The legally marketed device to which we are claiming equivalence K172483, KOPAC Sterile Needle

4. Device description

Needle gauge : 18, 19, 21, 22, 23, 25, 26, 27, 29, 30, 31, 32, 33, 34G Needle length : 4, 6, 8, 13, 16, 25, 30, 40 mm Wall thickness RW (Regular-Wall) : 18G, 19G, 21G, 22G, 23G, 25G, 26G, 27G, 29G, 30G, 31G, 32G, 33G, 34G TW (Thin Wall) : 18G, 19G, 21G, 22G, 23G, 25G, 26G, 27G, 29G, 30G, 31G, 32G, 33G, 34G

ETW (Extra Thin Wall) : 18G, 19G, 21G, 23G, 29G, 30G, 31G, 32G, 33G, 34G

UTW (Ultra Thin Wall) : 19G, 21G, 29G, 30G, 31G, 32G

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 1) 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)	Testing report no.	Result
Visual check	-PQC-90527-01 (1) (Needle inner and outer surfaces)-PQC-200217-01 (Cover inner and outer surfaces)	Pass
Dimension	-PQC-90527-01 (1) (Outer diameter of needle tube, Length of the needle tube, needle hub and hub hole)-PQC-200217-01 (Cover)	Pass
Elasticity	-PQC-90527-01 (1) (Needle)	Pass
Flexural strength	-PQC-90527-01 (1) (Needle)- PQC-200217-01 (Cover strength)	Pass
Pullout	-PQC-90527-01 (1) (Needle)-PQC-200217-02 (Hub/needle bond strength)	Pass
Cleanliness	-PQC-200302-01	Pass
Limits for acidity or alkalinity	-PQC-200302-01	Pass
Limits for extractable metals	-PQC-200302-01	Pass
Needle hub (Conical fitting, Colour of hub)	-Refer to KTL test report for relevant test (20-008504-01-1 (Conical fitting))-PQC-200302-01	Pass
Needle tube (Tolerances on length, Lubricant)	-PQC-200302-01	Pass
Needle point	-PQC-200302-01	Pass
Bond between hub and needle tube	-Refer to Poonglim Pharmatech Inc. test report for relevant test (PQC-200217-02 (Hub/needle bond strength))	Pass
Patency of lumen	-PQC-200302-01	Pass
Tolerances on length	-PQC-200508-07	Pass
Requirement – Test (ISO 9626)	Testing report no.	Result
Stiffness		Pass
Resistance to breakage	-PQC-90821-01 (1)	Pass
Resistance to corrosion		Pass
Cleanliness		Pass

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K192222

Limits for acidity or alkalinity		Pass
Stiffness	-PQC-200302-02	Pass
Resistance to breakage		Pass
Resistance to corrosion		Pass
Requirement – Test (USP 41, <85>)	Testing report no.	Result
LAL test (Bacterial Endotoxin)	-T2018-14332	Pass
Requirement – Test (ISO 80369)	Testing report no.	Result
Luer connector performance	-20-008504-01-1	Pass
Dimension	-PQC-200225-01 (Luer)	Pass

Biocompatibility 2)

Category: External Communicating Device Contact: Blood path, indirect Contact duration: A-limited (≤24h)

#	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
7	Particulate matterinjections	USP <788> Particulate Matter in Injection	Pass

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 sterilizationvalidation	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 sterilizationresiduals, 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.

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7. Comparison Table

Manufacturer	POONGLIM Pharmatech Inc.	POONGLIM Pharmatech Inc.	Remark
510(K) No.	K192222	K172483
Intended use	This device is intended for use toinject fluids into or withdraw fromparts of the body below the surfaceof the skin	This device is intended for use toinject fluids into or withdraw fromparts of the body below thesurface of the skin	Same
Hub ofneedle	Polypropylene (PP)	Polypropylene (PP)	Same
Protector	Polypropylene (PP)	Polypropylene (PP)
Cannula	SUS304	SUS304
Adhesive	Epoxy	Epoxy
Length	4, 6, 8, 13, 16, 25, 30, 40mm	13, 16, 25, 40mm	See discussion below
Gauge	18, 19, 21, 22, 23, 25, 26, 27, 29, 30,31, 32, 33, 34G	30G	See discussion below
Tipconfiguration	Bevel	Bevel	Per 7864:2016Section 4.11
Coverdimension	Y type : 49 mm, 63 mmI type : 51 mm, 65 mmL type : 61 mm, 75 mm	Y type : 49 mm, 63 mmI type : 51 mm, 65 mm	Similar
Coverstrength	Y type (63 mm) : 2.0 NI type (65 mm) : 3.5 NL type (65 mm) : 2.5 N	Y type (63 mm) : 2.0 NI type (65 mm) : 3.5 N	Similar
Hub/needlebondstrength	18 G-40 mm : 137.7 N19 G-40 mm : 177.8 N21 G-25 mm : 82.0 N22 G-25 mm : 114.0 N23 G-25 mm : 144.3 N25 G-13 mm : 91.1 N26 G-13mm : 74.0 N27 G-13 mm : 82.0 N29 G-13 mm : 71.3 N30 G-13 mm : 67.6 N31 G-4 mm : 45.0 N32 G-4 mm : 43.5 N33 G-8 mm : 22.6 N34 G-8 mm : 29.0 N	30 G-13 mm : 67.5 N	SimilarAlthough wecompared only 30 G,the rest of the gaugesmeet therequirements of theISO 7864.

Length: The additional lengths meet the requirements of ISO 7864:2016, ISO 9626:2016, ISO 80369-7:2016 and ISO 6009:2016. The 4mm needle has a minimum specification of 3.5mm to successfully inject fluids or withdrawal fluids below the surface of the skin.

Gauge: The additional gauge sizes meet the requirements of ISO 7864:2016, ISO 80369-7:2016 and ISO 6009:2016.

8. Conclusion

The device has completed testing to show that the device meets its intended use and demonstrates substantial equivalence to the predicate device, K172483. Therefore, it is concluded that the subject device, EZ-Inject Single use Needle, is substantially equivalent to the legally marketed predicate device, K172483.

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).