(0 days)
No
The device description and performance studies focus on the physical characteristics, material standards, and safety features of a sterile hypodermic needle. There is no mention of AI or ML in the intended use, device description, or performance data.
No
A therapeutic device is used to treat or cure a disease or condition. This device, a sterile single-use needle, is used to inject or withdraw fluids, which are procedures, not therapies in themselves.
No
The device is described as a needle for injecting and withdrawing fluids, not for identifying the presence or nature of a disease or condition.
No
The device description clearly outlines a physical medical device consisting of a metal tube, hub, needle cap, and safety guard. The performance studies focus on physical characteristics, material properties, and sterilization, not software validation.
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 fluid into or withdraw fluids from parts of the surface of the skin." This describes a procedure performed directly on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is a sterile needle designed for injection and withdrawal of fluids. This is a medical device used for direct patient care.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is purely procedural.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This needle does not fit that description.
N/A
Intended Use / Indications for Use
This product is intended for use to inject fluid into or withdraw fluids from parts of the surface of the skin.
Product codes
QNS
Device Description
Sterile single use 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). The needle cap covers intended to provide physical protection to the needle tube. This product is packed by sterile paper and sterilized by EO gas.
The safety guard is placed around the needle after using the product for safety and to prevent reuse. EZ-Injec LDV Sterile Safety Needle helps to decrease fluid volume loss because of its smaller hub inner size.
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)
The sterile, single lumen hypodermic needles described in this summary were tested and demonstrated to be in conformance with the following FDA recognized standards:
- ISO 9626 Second edition: Stainless steel needle tubing for the manufacture of medical devices -● Requirements and test methods
- ISO 7864 Fourth edition: Sterile hypodermic needles for single use Requirements and test methods ●
- ISO 23908 First edition: Sharps injury protection Requirements and test methods Sharps protection ● features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
Additionally, bench testing demonstrating the low dead space capability of the needle was conducted.
Biocompatibility testing was conducted in accordance with ISO 10993-1, with the needle classified as: Externally Communicating Device, Blood Path Indirect, Limited Contact ( Particulate Matter in Injections and met the USP acceptance criteria.
Sterilization validation was performed in accordance with ISO11135:2014 to prove that the EO Gas sterilization process has been suitable for the continuous production. Through validation, sterilization process was deemed acceptable.
Shelf life of 5 years is validated using the FDA recognized standard ASTM F1980-16 Standard Guide ● for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows 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.
Poonglim Pharmatech Inc. % Peter Chung President Plus Global 300. Atwood Pittsburgh, Pennsylvania 15213
Re: K210444
Trade/Device Name: EZ-Injec LDV Sterile Safety Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: QNS Dated: February 11, 2021 Received: February 16, 2021
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (QS) 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,
Rumi Young Acting 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
Indications for Use
510(k) Number (if known) K210444
Device Name EZ-Injec LDV Sterile Safety Needle
Indications for Use (Describe)
This product is intended for use to inject fluid 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
| Preparation Date: | February 10, 2021 |
|---|---|
| Submitter Name: | POONGLIM Pharmatech Inc. |
| 21, Jayumuyeok 1-gil, Gunsan-si, Jeollabuk-do, Korea | |
| Contact Person: | Peter Chung |
| President, Plus Global | |
| Telephone Number: | 412-512-8802 |
| E-mail Address: | peterchung210@gmail.com |
| Preparation Date: | February 10, 2021 |
| Trade Name: | EZ-Injec LDV Sterile Safety Needle |
| Regulation Name: | Hypodermic Single Lumen Needle |
| Regulation Number: | 21 CFR 880.5570 |
| Product Code: | QNS |
| Device Class: | Class II |
| Predicate Device: | K192222, EZ-Injec Single Use Needle |
Device Description
Sterile single use 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). The needle cap covers intended to provide physical protection to the needle tube. This product is packed by sterile paper and sterilized by EO gas.
The safety guard is placed around the needle after using the product for safety and to prevent reuse. EZ-Injec LDV Sterile Safety Needle helps to decrease fluid volume loss because of its smaller hub inner size.
| Gauge | Length | Wall Type | |
|---|---|---|---|
| EZ-Injec LDV Sterile Safety Needle | 25G | 25 mm | TW |
Indications for Use
EZ-Injec LDV Sterile Safety Needle
This product is intended for use to inject fluids into or withdraw fluids from parts of the surface of the skin.
Discussions of differences in Indications for Use statement
The indications for use statement for the subject device (EZ-Injec LDV Sterile Safety Needle) is identical to the predicate device.
Technological Characteristics
The table below includes a comparison of the technological characteristics between the new device and those of the predicate device:
4
| Technological
Characteristic | Subject Device
EZ-Injec LDV Sterile Safety Needle
K210444 | Predicate Device
EZ-Injec Single Use Needle
K192222 | Comments |
|---------------------------------|-----------------------------------------------------------------|------------------------------------------------------------|----------------|
| Gauge | 25G | 18, 19, 21, 22, 23, 25, 26, 27, 29, 30,
31, 32, 33, 34G | Same |
| Length | 25mm | 4, 6, 8, 13, 16, 25, 30, 40mm | Same |
| Dead space
specification | ≤0.0054ml | ≤0.0544ml (25G-25mm) | See Comment #1 |
| Sharps prevention
function | Safety Guard | No Safety Guard | See Comment #2 |
| Hub of needle | Polypropylene (PP) | Polypropylene (PP) | Same |
| Protector | Polypropylene (PP) | Polypropylene (PP) | Same |
| Cannula | SUS304 | SUS304 | Same |
| Adhesive | Epoxy | Epoxy | Same |
| Sterilization
method | EO gas | EO gas | Same |
Discussions of differences in technological characteristics
- Comment #1
EZ-Inject LDV sterile safety needle is a modification to the EZ-Inject single use needle (premarket submission no.:K192222). The modification involves a design change to the inner hub to reduce dead space of the needle. Comparative bench testing and analysis of drug delivery capability was provided to verify and validate this change.
Comment #2
EZ-Injec LDV sterile safety needle is a modification to the EZ-Injec single use needle (premarket submission no.: K192222). The modifications involve an addition of the safety guard to protect the user from sharps injuries. This change was validated by bench testing and performed in accordance with ISO 23908.
Performance Testing
The sterile, single lumen hypodermic needles described in this summary were tested and demonstrated to be in conformance with the following FDA recognized standards:
- ISO 9626 Second edition: Stainless steel needle tubing for the manufacture of medical devices -● Requirements and test methods
- ISO 7864 Fourth edition: Sterile hypodermic needles for single use Requirements and test methods ●
- ISO 23908 First edition: Sharps injury protection Requirements and test methods Sharps protection ● features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
Additionally, bench testing demonstrating the low dead space capability of the needle was conducted.
Biocompatibility
5
In accordance with ISO 10993-1, the needle is classified as: Externally Communicating Device, Blood Path Indirect, Limited Contact ( Particulate Matter in Injections and met the USP acceptance criteria.
Sterility, Shipping and Shelf-Life
- . Sterilization validation was performed in accordance with ISO11135:2014 to prove that the EO Gas sterilization process has been suitable for the continuous production. Through validation, sterilization process was deemed acceptable.
- Shelf life of 5 years is validated using the FDA recognized standard ASTM F1980-16 Standard Guide ● for Accelerated Aging of Sterile Barrier Systems for Medical Devices
Conclusions
The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The EZ-Injec LDV Sterile Safety Needle (K210444) is substantially equivalent to the EZ-Injec Single Use Needle (K192222) with respect to the indications for use, target populations, treatment method, and technological characteristics.