(309 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML terms or functionalities.
No
The device is described as a needle intended for injecting or withdrawing fluids, which is a diagnostic or procedural tool, not a device that provides therapy itself.
No
The device is described as being used to "inject fluids into or withdraw fluids from parts of the surface of the skin," which are actions related to administering or collecting substances, not diagnosing a condition. There is no mention of analysis, interpretation of data to identify a disease, or providing diagnostic information.
No
The device description clearly states it consists of a metal tube, a female connector, and a needle cap, indicating it is a physical hardware device.
Based on the provided information, 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 device used for direct interaction with the body for therapeutic or diagnostic purposes in vivo (within a living organism), not for testing samples in vitro (outside of a living organism).
- 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 injections or aspirations directly on or into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (like blood, urine, tissue), or any components typically associated with IVD tests (reagents, test strips, analyzers).
- Predicate Device: The predicate device is a "hypodermic Needle," which further confirms the device's nature as a tool for direct interaction with the body.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function falls outside of that definition.
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.
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
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 test were performed. Bench testing included biocompatibility, mechanical testing, sterility testing including EO residues. 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.
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);
1
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
2
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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3
510(k) Summary
[as required by 807.92(c)]
1. Applicant
- Company: POONGLIM Pharmatech Inc. 1)
-
- Address: 21, Jayumuyeok 1-gil, Gunsan-si, Jeollabukdo-do, Korea
- Tel : 82-63-451-8141 3)
-
- Fax : 82-63-451-8145
- Prepared date : July 11, 2017 5)
- Contact person : Peter Chung, 412-512-8802 6)
-
- Contact person address : 300 Atwood Street, Pittsburgh, PA, 15213, USA
-
- Submission date: August 11, 2017
2. Device Information
-
- Trade name : Kopac Sterile Needle
-
- Common name : Single-use needle, hypodermic needle
-
- Classification name : Hypodermic Single Lumen Needle
-
- Product code : FMI
-
- Regulation number : 880.5570
-
- Class of device : Class II
-
- Panel : General hospital
3. The legally marketed device to which we are claiming equivalence
K102584, IMC hypodermic 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.
| Model | Gauge | Inch (") | mm | Length of Cannula (A) | Cover dimension (mm) | |
|---|---|---|---|---|---|---|
| Type | ||||||
| Y | ||||||
| and | ||||||
| I | 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 Surface | |
| There 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 |
4
| 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 have | |
| uniform cross section and thickness. | Pass |
| When injecting glycerin into the needle tuve or needle hub, coloring of glycerin should not | |
| take place. | 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. | 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 | Pass |
| Requirement - Test (ISO 9626) | Result |
|---|---|
| Stiffness | |
| 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. | Pass |
| Resistance to breakage | |
| The cannula edg When tested in accordanc with Annex C, the tubing shall not show visible | |
| breakage 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 corrosion | |
| When tested in accordance with the method given in ISO 9626 Annex D, the tubing is partially immersed | |
| in sodium chloride solution( $c(NaCl) = 0.5mol/L$ ) at (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 |
2) Biocompatibility
| # | 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 |
5
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.
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 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 | | |
| 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 | | |
| Cover
dimension | 1/2" size: 60mm
5/8" size : 60mm
1" size: 60mm
1⁄2" size: 60mm | 1/2" size: 40mm
5/8" size: 40mm
3/4" size: 40mm
7/8" size: 40mm
1" size: 40mm
1⁄4" size: 56mm
1⁄2" size: 56mm | Similar | | |
| | Tip
configuration | 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.