EZ-Inject Single use Needle

K192222 · Poonglim Pharmatech, Inc. · FMI · May 12, 2020 · General Hospital

Device Facts

• Record ID: K192222
• Device Name: EZ-Inject Single use Needle
• Applicant: Poonglim Pharmatech, Inc.
• Product Code: FMI · General Hospital
• Decision Date: May 12, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

The EZ-Inject Single Use Needle is a sterile, single-use hypodermic needle consisting of a beveled metal (SUS304) tube joined to a polypropylene (PP) female connector (hub) and protected by a PP needle cap. It is available in various gauges (18G-34G) and lengths (4mm-40mm). The device is used by healthcare professionals to inject or withdraw fluids from below the skin surface. It is supplied sterile via E.O. gas sterilization. The device functions as a standard hypodermic needle; the clinician attaches the needle to a compatible syringe via the hub, inserts the needle into the patient, and performs the fluid transfer. The device provides a physical conduit for fluid delivery or aspiration, facilitating medication administration or sample collection.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including biocompatibility (cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, pyrogenicity, hemolysis), mechanical testing (elasticity, flexural strength, pullout, stiffness, resistance to breakage/corrosion), and sterility/LAL testing per ISO and USP standards.

Technological Characteristics

Materials: SUS304 stainless steel cannula, polypropylene (PP) hub and protector, epoxy adhesive. Design: Single lumen, beveled tip. Dimensions: 18G-34G, 4mm-40mm lengths. Connectivity: Standard Luer connector (ISO 80369). Sterilization: E.O. gas. Standards: ISO 7864, ISO 9626, ISO 80369-7, ISO 6009, ISO 10993, USP <85>, USP <788>.

Indications for Use

Indicated for the injection of fluids into or withdrawal of fluids from parts of the body below the surface of the skin.

Regulatory Classification

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.

Predicate Devices

• KOPAC Sterile Needle (K172483)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)
- 2) Address: 21, Jayumuyeok 1-gil, Gunsan-si, Jeollabuk-do, Korea
- Tel : [phone])
- 4) Fax : [phone]
- 5) Prepared date : July 11, 2019
- Contact person : Peter Chung, 412-512-8802 6)
- Contact person address : 300 Atwood Street, Pittsburgh, PA, 15213, USA 7)
- 8) 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)
- 3) Classification name : Needle, Hypodermic, Single Lumen
- 4) Product code : FMI
- 5) Regulation number : 880.5570
- ୧) Class of device : Class II
- 7) Panel : General hospital
- 8) Model/type Name : 159 model codes including Y18-13
- 9) 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

- 3. The legally marketed device to which we are claiming equivalence K172483, KOPAC Sterile Needle
### 4. Device description

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.

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)<br>-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)<br>-PQC-200217-01 (Cover) | Pass |
| Elasticity | -PQC-90527-01 (1) (Needle) | Pass |
| Flexural strength | -PQC-90527-01 (1) (Needle)<br>- PQC-200217-01 (Cover strength) | Pass |
| Pullout | -PQC-90527-01 (1) (Needle)<br>-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))<br>-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 Sensitization<br>Test | ISO 10993-10 irritation and skin sensitization | Pass |
| 3 | Intracutaneous<br>Reactivity Test | ISO 10993-10 Test for irritation and skin sensitization, maximization<br>test for delayed hypersensitivity | Pass |
| 4 | Acute Systemic<br>Toxicity 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 on<br>material-mediated pyrogens. | Pass |
| 6 | Hemolysis Test | ISO 10993-4 Selection of tests for interactions with blood | Pass |
| 7 | Particulate matter<br>injections | 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 sterilization<br>validation | According to ISO 11135:2014<br>E.O 30%, CO2 70%<br>Temperature : 55°C<br>Exposure 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<br>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.

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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 to<br>inject fluids into or withdraw from<br>parts of the body below the surface<br>of the skin | This device is intended for use to<br>inject fluids into or withdraw from<br>parts of the body below the<br>surface of the skin | Same |
| Hub of<br>needle | 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,<br>31, 32, 33, 34G | 30G | See discussion below |
| Tip<br>configuration | Bevel | Bevel | Per 7864:2016<br>Section 4.11 |
| Cover<br>dimension | Y type : 49 mm, 63 mm<br>I type : 51 mm, 65 mm<br>L type : 61 mm, 75 mm | Y type : 49 mm, 63 mm<br>I type : 51 mm, 65 mm | Similar |
| Cover<br>strength | Y type (63 mm) : 2.0 N<br>I type (65 mm) : 3.5 N<br>L type (65 mm) : 2.5 N | Y type (63 mm) : 2.0 N<br>I type (65 mm) : 3.5 N | Similar |
| Hub/needle<br>bond<br>strength | 18 G-40 mm : 137.7 N<br>19 G-40 mm : 177.8 N<br>21 G-25 mm : 82.0 N<br>22 G-25 mm : 114.0 N<br>23 G-25 mm : 144.3 N<br>25 G-13 mm : 91.1 N<br>26 G-13mm : 74.0 N<br>27 G-13 mm : 82.0 N<br>29 G-13 mm : 71.3 N<br>30 G-13 mm : 67.6 N<br>31 G-4 mm : 45.0 N<br>32 G-4 mm : 43.5 N<br>33 G-8 mm : 22.6 N<br>34 G-8 mm : 29.0 N | 30 G-13 mm : 67.5 N | Similar<br>Although we<br>compared only 30 G,<br>the rest of the gauges<br>meet the<br>requirements of the<br>ISO 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.