(270 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML or related concepts like image processing, data sets, or performance metrics typically associated with AI/ML algorithms.
No
The device is described as a needle for injecting or withdrawing fluids, which is a diagnostic or procedural tool, not a device that provides therapy for a condition. Its function is to facilitate the delivery or removal of substances, not to directly treat a disease or condition.
No
The "Intended Use" states it is for injecting or withdrawing fluids, which are procedural actions, not diagnostic. There are no mentions of analyzing data or providing a diagnosis based on the device's function.
No
The device description explicitly states it consists of a "metal tube" and a "female connector (hub)," which are physical hardware components. The performance studies also focus on bench testing of physical properties like biocompatibility and mechanical testing.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "inject fluids into or withdraw fluids from parts of the surface of the skin." This describes a procedure performed directly on a patient's body, not a test performed on a sample taken from a patient.
- Device Description: The description of a "metal tube that is beveled at one end and at the other end join to a female connector (hub)" is consistent with a hypodermic needle, which is used for direct patient contact.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely for the physical act of fluid transfer into or out of the body.
N/A
Intended Use / Indications for Use
This device is intended for use to inject fluids into or withdraw fluids from parts of the surface of the skin
Product codes (comma separated list FDA assigned to the subject device)
FMI
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
parts of the surface of the skin, parts of the body below the surface of the skin.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench tests were performed, including biocompatibility and mechanical testing (e.g., visual check, dimension, elasticity, flexural strength, pullout, cleanliness, limits for acidity or alkalinity, limits for extractable metals, needle hub properties, needle tube properties, needle point, bond between hub and needle tube, patency of lumen, tolerances on length, stiffness, resistance to breakage, resistance to corrosion). Biological tests included cytotoxicity, skin sensitization test, intracutaneous reactivity test, acute systemic toxicity test, pyrogen test, hemolysis test, and particulate matter injections. Sterility tests included LAL test, E.O sterilization validation, sterility test, and E.O Residual test. The tests demonstrated that the device performs in a substantially equivalent manner to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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
2
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."
3
510(k) Summary
[as required by 807.92(c)]
1. Applicant
- Company: POONGLIM Pharmatech Inc. 1)
-
- Address: 21, Jayumuyeok 1-gil, Gunsan-si, Jeollabuk-do, Korea
- Tel : 82-63-451-8141 3)
-
- Fax : 82-63-451-8145
-
- Prepared date : July 11, 2019
- Contact person : Peter Chung, 412-512-8802 6)
- Contact person address : 300 Atwood Street, Pittsburgh, PA, 15213, USA 7)
-
- Submission date: August 11, 2017
- ರು) Prior related submission : K172483
Device Information 2.
-
- Trade name : EZ-Inject Single use Needle
- Common name : Single-use needle, hypodermic needle 2)
-
- Classification name : Needle, Hypodermic, Single Lumen
-
- Product code : FMI
-
- Regulation number : 880.5570
- ୧) Class of device : Class II
-
- Panel : General hospital
-
- Model/type Name : 159 model codes including Y18-13
-
- 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 |
4
K192222
-
- 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) | |
| -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 |
5
K192222
| Limits for acidity or alkalinity | Pass | |
|---|---|---|
| Stiffness | -PQC-200302-02 | Pass |
| Resistance to breakage | Pass | |
| Resistance to corrosion | Pass | |
| Requirement – Test (USP 41, ) | 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 | ||
| Test | ISO 10993-10 irritation and skin sensitization | Pass | |
| 3 | Intracutaneous | ||
| Reactivity Test | ISO 10993-10 Test for irritation and skin sensitization, maximization | ||
| test for delayed hypersensitivity | Pass | ||
| 4 | Acute Systemic | ||
| 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 | |
| material-mediated pyrogens. | Pass | ||
| 6 | Hemolysis Test | ISO 10993-4 Selection of tests for interactions with blood | Pass |
| 7 | Particulate matter | ||
| injections | USP Particulate Matter in Injection | Pass |
3) Sterility and LAL test
| # | Test item | Test standard | Test result |
|---|---|---|---|
| 1 | LAL test | USP39 , Bacterial Endotoxins Test (Unit : EU/Device) | Pass |
| 2 | E.O sterilization | ||
| validation | According to ISO 11135:2014 | ||
| E.O 30%, CO2 70% | |||
| Temperature : 55°C | |||
| 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 | |
| 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.
6
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 | ||
| inject fluids into or withdraw from | |||
| parts of the body below the surface | |||
| of the skin | This device is intended for use to | ||
| inject fluids into or withdraw from | |||
| parts of the body below the | |||
| surface of the skin | Same | ||
| Hub of | |||
| 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, | ||
| 31, 32, 33, 34G | 30G | See discussion below | |
| Tip | |||
| configuration | Bevel | Bevel | Per 7864:2016 |
| Section 4.11 | |||
| Cover | |||
| dimension | Y type : 49 mm, 63 mm | ||
| I type : 51 mm, 65 mm | |||
| L type : 61 mm, 75 mm | Y type : 49 mm, 63 mm | ||
| I type : 51 mm, 65 mm | Similar | ||
| Cover | |||
| strength | Y type (63 mm) : 2.0 N | ||
| I type (65 mm) : 3.5 N | |||
| L type (65 mm) : 2.5 N | Y type (63 mm) : 2.0 N | ||
| I type (65 mm) : 3.5 N | Similar | ||
| Hub/needle | |||
| bond | |||
| strength | 18 G-40 mm : 137.7 N | ||
| 19 G-40 mm : 177.8 N | |||
| 21 G-25 mm : 82.0 N | |||
| 22 G-25 mm : 114.0 N | |||
| 23 G-25 mm : 144.3 N | |||
| 25 G-13 mm : 91.1 N | |||
| 26 G-13mm : 74.0 N | |||
| 27 G-13 mm : 82.0 N | |||
| 29 G-13 mm : 71.3 N | |||
| 30 G-13 mm : 67.6 N | |||
| 31 G-4 mm : 45.0 N | |||
| 32 G-4 mm : 43.5 N | |||
| 33 G-8 mm : 22.6 N | |||
| 34 G-8 mm : 29.0 N | 30 G-13 mm : 67.5 N | Similar | |
| Although we | |||
| compared only 30 G, | |||
| the rest of the gauges | |||
| meet the | |||
| requirements of the | |||
| 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.