(87 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and sterilization of a hypodermic needle, with no mention of AI or ML.
No
Explanation: This device is a needle for injecting or aspirating fluids, not for treating a disease or condition. While it is used with therapeutic substances, the device itself does not provide therapy.
No
Explanation: The device is a sterile hypodermic needle intended for general purpose fluid injection/aspiration, not for diagnosing medical conditions.
No
The device description clearly states it is composed of physical components like a needle hub, protective cover, needle tube, and jointing, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "general purpose fluid injection/aspiration" using a syringe. This involves introducing or withdrawing substances directly from the body, not analyzing samples in vitro (outside the body).
- Device Description: The description details a needle designed for physical injection/aspiration, not for collecting, preparing, or analyzing biological samples for diagnostic purposes.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a condition or disease.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a tool for delivering or removing fluids from the body, which is a different function entirely.
N/A
Intended Use / Indications for Use
The Sterile Hypodermic Needles for Single Use are intended to be used with a luer slip syringe and injection devices for general purpose fluid injection/aspiration.
Product codes
FMI
Device Description
The Sterile Hypodermic Needles for Single Use is composed of a needle hub, protective cover, needle tube and jointing, connected with a luer lock or luer slip syringe and injection devices for general purpose fluid injection. The Sterile Hypodermic Needles for Single Use is for single use only. After opening the inner packaging and taking out the product, tighten the needle to the syringe and remove the protective cover, extract the drug liquid, exhaust the air and then inject. It is provided sterile. The sterilization method is EO sterilization and the sterilization assurance level is 10-6.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Medical professionals and trained care givers / Hospitals and clinics
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
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing: Biocompatibility of the Sterile Hypodermic Needles for Single Use were evaluated in accordance with ISO 10993-1:2018 for the body contact category of "External communication device - Blood path indirect" with a contact duration of "Limited ( Particulate Matter in Injections and met the USP acceptance criteria.
Sterilization and shelf life testing: The sterilization method has been validated to ISO11135, which has thereby determined the routine control and monitoring parameters. The shelf life of the Sterile Hypodermic Needles for Single Use is determined based on stability study which includes ageing test. The shelf-life of the Sterile Hypodermic Needles for Single Use is five (5) years. Tests conducted: Sterilization Evaluation (ISO11135: 2014), EO residue (ISO 10993-7:2008), ECH residue (ISO 10993-7:2008), Bacterial Endotoxin testing (USP42-NF37), Sterile barrier packaging testing & Shelf Life Evaluation (Seal Strength ASTM F88/F88M-15, Dye Penetration ASTM F1929-15, Creep/Burst Testing ASTM F1140/F1140M-13, Gross Leakage ASTM F2096-11), Antibacterial Testing (DIN 58953-6:2010).
Performance testing: Performed according to ISO 7864: 2016 (Cleanliness, Limits for acidity or alkalinity, Limits for extractable metals, Tubular needle designation, Colour coding, Needle hub, Needle cap, Needle tube (Tolerance on length), Needle Point, Bond between Tube and Hub, Patency of Lumen), ISO 9626:2016 (Surface finish and visual appearance, Cleanliness, Limits for acidity and alkalinity, Size designation, Dimensions, Stiffness, Resistance to breakage, Resistance to corrosion), and ISO 80369-7:2016 (Dimensional requirements for luer connectors, Fluid leakage (Positive pressure liquid leakage), Sub-atmospheric pressure air leakage, Stress cracking, Resistance to separation from axial load, Resistance to separation from unscrewing, Resistance to overriding).
Key Metrics
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.
September 8, 2023
Wepon Medical Technology Co., Ltd. % Esther Zhang Official Correspondent Shanghai Ling Fu Technology Co., Ltd. 4F No. 585-2, Wanyuan Rd. Minhang District Shanghai, Shanghai 201102 China
Re: K231720
Trade/Device Name: Sterile Hypodermic Needles for Single Use Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: June 8, 2023 Received: June 13, 2023
Dear Esther Zhang:
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 medical devices and radiation-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,
Alan Sthe
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
Indications for Use
510(k) Number (if known) K231720
Device Name Sterile Hypodermic Needles for Single Use
Indications for Use (Describe)
The Sterile Hypodermic Needles for Single Use are intended to be used with a luer slip syringe and injection devices for general purpose fluid injection/aspiration.
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
Section 5 510(k) summary
l Submitter
Device submitter: Wepon Medical Technology CO., LTD. Floor 4, Building A, No. 58, Jinhu Road, Chengdong Street, Wenling Zhejiang, CN 317500
Contract manufacturer: Zhejiang Kangkang Medical-Devices CO., Ltd. Longwang Industrial District, Chumen Town, Yuhuan, Zhejiang, 317605, China Registration number: 3015042030
Contact person: Di Zhao Deputy General Manager Phone: 928-5922380 Email: dizhao@wepon-ppe.com
II Correspondent
Shanghai Ling Fu Technology Co., Ltd. 4F No. 585-2, Wanyuan Rd. Minhang District, Shanghai, P.R.China Contact: Esther ZHANG Email: Esther.zhang@llins-tech.com
III Device
Trade Name of Device: Sterile Hypodermic Needles for Single Use Common Name: Hypodermic Single Lumen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product code: FMI Review Panel: General Hospital
IV Predicate Devices
| Trade name: | Sterile Hypodermic Needles for Single Use (used as the predicate device); |
|---|---|
| Common name: | Hypodermic single lumen needle |
| Classification: | Class II, 21 CFR 880.5570 |
| Product Code: | FMI |
| Premarket Notification: | K180417 |
4
Manufacturer:
V Device description
The Sterile Hypodermic Needles for Single Use is composed of a needle hub, protective cover, needle tube and jointing, connected with a luer lock or luer slip syringe and injection devices for general purpose fluid injection. The Sterile Hypodermic Needles for Single Use is for single use only. After opening the inner packaging and taking out the product, tighten the needle to the syringe and remove the protective cover, extract the drug liquid, exhaust the air and then inject. It is provided sterile. The sterilization method is EO sterilization and the sterilization assurance level is 10-6.
| Gauge
| Length | 30G | 27G | 26G | 25G | 24G | 23G | 22G | 21G | 20G | 19G | 18G |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1/2" | ● | ● | ● | ||||||||
| 5/8" | ● | ● | ● | ||||||||
| 1" | ● | ● | ● | ● | ● | ● | ● | ● | |||
| 1 1/4" | ● | ● | ● | ● | ● | ● | |||||
| 1 1/2" | ● | ● | ● | ● | ● | ● |
Table 1 specification of proposed device
VI Indications for use
The Sterile Hypodermic Needles for Single Use are intended to be used with a luer lock or luer slip syringe and injection devices for general purpose fluid injection/aspiration.
VII Comparison of technological characteristics with the predicate devices
The Sterile Hypodermic Needles for Single Use have intended use, technology, design and performance specifications are either identical or substantially equivalent to existing legally marketed predicate devices. The differences between the Sterile Hypodermic Needles for Single Use and predicate devices do not alter suitability of the proposed device for its intended use.
| Device
feature | Subject Device | Predicate Device
K180417 | Comments |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| Indications for
use | The Sterile Hypodermic
Needles for Single Use
are intended to be used
with a luer lock or luer slip
syringe and injection
devices for general
purpose fluid
injection/aspiration. | The Sterile Hypodermic
Needles for
Single Use are intended to
be used with a luer slip or
luer slip syringe and
injection devices for
general purpose fluid
injection/aspiration. | Same |
| Product code | FMI | FMI | Same |
| Regulation | 21 CFR 880.5570 | 21 CFR 880.5570 | Same |
| Device
feature | Subject Device | Predicate Device
K180417 | Comments |
| number | | | |
| Class | II | II | Same |
| Principle of
operation | For manual use only | For manual use only | Same |
| Intended user | Medical professionals and
trained care givers | Medical professionals and
trained care givers | Same |
| Environment
of use | Hospitals and clinics | Hospitals and clinics | Same |
| Needle gauge | 30G, 27G, 26G, 25G,
24G, 23G, 22G, 21G,
20G, 19G, 18G | 14G, 15G, 16G, 17G,
18G, 19G, 20G, 21G,
22G, 23G, 24G, 25G,
26G, 27G, 29G, 30G | Difference |
| Length | 1/2", 5/8", 1", 1¼", 1½" | 6-60mm | |
| Type of wall | normal wall or thin wall | not provide | |
| blade angle | short bevel or long bevel | not provide | |
| Needle hub | Needle hub
Polypropylene | Needle hub
Polypropyle ne | Same |
| main structure
and materials | Needle tube
Stainless steel | Needle
Stainless steel | |
| | protective
cover
Polypropylene | protective
cap
Polypropyle ne | |
| Needle hub | Color-coded per ISO 6009 | Color-coded per ISO 6009 | Same |
| Single use | Yes | Yes | Same |
| Performance
specifications | Complies with ISO 7864;
ISO 9626; ISO 80369-7 | Complies with ISO 7864;
ISO 9626; ISO 80369-7 | Same |
| Sterilization | EO | EO | Same |
| SAL | 10-6 | 10-6 | Same |
| Pyrogen | Non-pyrogenic | Non-pyrogenic | Same |
| Biocompatibility | The
biocompatibility
evaluation for the subject
device was conducted in
accordance with the
International Standard ISO
10993-1 "Biological
Evaluation of Medical
Devices - Part 1:
Evaluation and Testing
Within a Risk | Comply with ISO 10993.
The test is as follows:
The devices meet
biocompatibility endpoints
for cytotoxicity, irritation,
sensitization, systemic
toxicity, and
hemolysis material-mediated
pyrogens | Same |
| Device
feature | Subject Device | Predicate Device
K180417 | Comments |
| | Management Process," as
recognized by FDA and
the "Use of International
Standard ISO 10993-1
"Biological evaluation of
medical devices- Part 1:
Evaluation and testing
within a risk management
process", June 16, 2016.
The syringe of testing
included the following
tests:
Cytotoxicity;
Skin sensitization;
Hemolysis;
Intracutaneous reactivity;
Acute systemic toxicity;
Pyrogenicity.
The evaluation of the
above testing items meets
the requirements | | |
| | Labeling | Meet the requirements of
21 CFR Part 801 | Meet the requirements of
21 CFR Part 801 |
5
6
Different 1
The needle gauge and length of subject devices are different from the predicate device, and the type of wall and needle bevel are unknown. The subject device specifications are within the range of the predicate device. This difference does not affect intended use and does not raise different questions of safety and effectiveness.
VIII Performance data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
Biocompatibility of the Sterile Hypodermic Needles for Single Use were evaluated in accordance with ISO 10993-1:2018 for the body contact category of "External
7
communication device - Blood path indirect" with a contact duration of "Limited ( Particulate Matter in Injections and met the USP acceptance criteria.
Sterilization and shelf life testing
The sterilization method has been validated to ISO11135, which has thereby determined the routine control and monitoring parameters. The shelf life of the Sterile Hypodermic Needles for Single Use is determined based on stability study which includes ageing test. The shelf-life of the Sterile Hypodermic Needles for Single Use is five (5) years.
| Sterilization Evaluation | ISO11135: 2014 |
|---|---|
| EO residue | ISO 10993-7:2008 |
| ECH residue | ISO 10993-7:2008 |
| Bacterial Endotoxin testing | USP42-NF37 |
| Sterile barrier packaging testing & | |
| Shelf Life Evaluation | Seal Strength ASTM F88/F88M-15 |
| Dye Penetration ASTM F1929-15 | |
| Creep/Burst Testing | |
| ASTMF1140/F1140M-13 | |
| Gross Leakage ASTM F2096-11 |
Antibacterial Testing DIN 58953-6:2010
Performance testing
Freedom from defects, Lubricant)
Performance testing is performed according to the following standards:
| ➤ | ISO 7864: 2016 | |
|---|---|---|
| Cleanliness | Clause 4.3 of ISO 7864: 2016 | |
| Limits for acidity or alkalinity | Clause 4.4 of ISO 7864: 2016 | |
| Limits for extractable metals | Clause 4.5 of ISO 7864: 2016 | |
| Tubular needle designation | Clause 4.6 of ISO 7864: 2016 | |
| Colour coding | Clause 4.7 of ISO 7864: 2016 | |
| Needle hub | Clause 4.8 of ISO 7864: 2016, ISO | |
| 80369-7 and ISO 6009 | ||
| Needle cap | Clause 4.9 of ISO 7864: 2016 | |
| Needle tube (Tolerance on length, | Clause 4.10 of ISO 7864: 2016 |
8
| Needle Point | Clause 4.11 of ISO 7864: 2016 | |
|---|---|---|
| Bond between Tube and Hub | Clause 4.12 of ISO 7864: 2016 | |
| Patency of Lumen | Clause 4.13 of ISO 7864: 2016 | |
| > | ISO 9626:2016 | |
| Surface finish and visual appearance | Clause 5.2 of ISO 9626:2016 | |
| Cleanliness | Clause 5.3 of ISO 9626:2016 | |
| Limits for acidity and alkalinity | Clause 5.4 of ISO 9626:2016 | |
| Size designation | Clause 5.5 of ISO 9626:2016 | |
| Dimensions | Clause 5.6 of ISO 9626:2016 | |
| Stiffness | Clause 5.8 of ISO 9626:2016 | |
| Resistance to breakage | Clause 5.9 of ISO 9626:2016 | |
| Resistance to corrosion | Clause 5.10 of ISO 9626:2016 | |
| > | ISO 80369-7:2016 | |
| Dimensional requirements for luer | ||
| connectors. | Clause 5 of ISO 80369-7: 2021 | |
| Fluid leakage (Positive pressure liquid | ||
| leakage) | Clause 6.1.3 of ISO 80369-7: 2021 | |
| Sub-atmospheric pressure air leakage | Clause 6.2 of ISO 80369-7: 2021 | |
| Stress cracking | Clause 6.3 of ISO 80369-7: 2021 | |
| Resistance to separation from axial load | Clause 6.4 of ISO 80369-7: 2021 | |
| Resistance to separation from | Clause 6.5 of ISO 80369-7: 2021 | |
| unscrewing | ||
| Resistance to overriding | Clause 6.6 of ISO 80369-7: 2021 |
IX Conclusion
The Sterile Hypodermic Needles for Single Use are substantially equivalent to its predicate device. The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed device.