(108 days)
Not Found
No
The device description and performance studies focus on the physical properties, materials, and sterilization of a standard hypodermic needle. There is no mention of AI, ML, image processing, or any data-driven decision-making components.
No.
The device is described as a sterile hypodermic needle intended for injecting or withdrawing fluids, which is a delivery mechanism, not a therapeutic agent itself.
No
The device is a hypodermic needle used for injecting or withdrawing fluids; it does not analyze or interpret bodily information to diagnose a condition.
No
The device description clearly states it is a sterile hypodermic needle, which is a physical hardware device made of materials like stainless steel and polypropylene.
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 body below the surface of the skin." This describes a procedure performed on the body, not a test performed on a sample taken from the body.
- Device Description: The device is a hypodermic needle. Hypodermic needles are used for administering substances or collecting samples from the body, not for analyzing those samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (e.g., reagents, test strips, analytical instruments).
- Performance Studies: The performance studies focus on the physical properties of the needle (strength, sterility, biocompatibility) and its ability to function as an injection/withdrawal device, not on the accuracy or reliability of a diagnostic test.
IVD devices are used to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or compatibility purposes. This device is a tool used in a medical procedure, not a diagnostic test itself.
N/A
Intended Use / Indications for Use
This device is intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.
Product codes (comma separated list FDA assigned to the subject device)
FMI
Device Description
The submitted device is a sterile hypodermic needle for single use. The device is a single lumen hypodermic needle offered in a 22 gauge x 1 ½ " length. The device is constructed of the material noted in the table below:
| Name | Material | Material Specification |
|---|---|---|
| Needle tube | 304 stainless steel | SUS304 |
| Needle hub | Polypropylene (PP) | R307Y |
| Needle cap | Polypropylene (PP) | R307Y |
| Hub colorant | Black Masterbatch | Carbon Black |
| Lubricant | Medical Highly Activated Silicone | Highly Reactive Silicone Oil |
| Adhesive | Ultraviolet adhesive | AA 3311 |
The device is classified for patient contact as externally communicating circulating blood in a limited contact duration ( Pyrogen Test; |
Sterility Information
Summary of Sterilization Validation is provided in the table below:
| Sterilization Method: | Ethylene Oxide Sterilization |
|---|---|
| Standards: | ISO11135-1: Sterilization of health care products - ethylene oxide - part 1: requirements for the development, validation, and routine control of a sterilization process for medical devices. ISO11737-1: Sterilization of medical devices - Microbiological methods - Part 1: Determination of the population of microorganisms on product. ISO11737-2: Sterilization of medical devices - Microbiological methods -- Part 2: Tests of sterility performed in the validation of a sterilization process. ISO 10993-7: Biological evaluation of medical devices - Part 7: Test of Ethylene Oxide Residuals. AAMI / ANSI ST72: Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing. |
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 and 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 18, 2018
Jiangsu Shenli Medical Production Co., Ltd c/o Mr. Charles Mack IRC 2950 E Lindrick Drive Chandler, Arizona 85249
Re: K180259
Trade/Device Name: Sterile Hypodermic Needle for Single Use Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: April 6, 2018 Received: April 17, 2018
Dear Charles Mack:
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.
1
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 (OS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-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.
Tina Kiang
-s
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) K180259
Device Name
Sterile Hypodermic Needle for Single Use
Indications for Use (Describe)
This device is intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Preservation Use (Part 21 CFR 601 Subpart D) | Over-The-Counter Use (21 CFR 331 Subpart C) |
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
The assigned 510(k) number is: K180259 Date Prepared: 2018.05.15
I. Submitter:
Name: Jiangsu Shenli Medical Production Co., Ltd. Address: No 20, Changzheng Road, Zhenglu, Changzhou City, Jiangsu Province, China 213111 Tel: + 86-519-88731071 Fax: + 86-519-88737101 Contact: Ms. Tina Cai, General Manager
US Agent and Correspondent Mr. Charles Mack Principal Engineer IRC 2950 E Lindrick Drive, Chandler, Arizona 85249 USA Tel: 931-625-4938 Email: charliemack@irc-us.com
II. Device:
Trade/proprietary name: Sterile Hypodermic Needle for Single Use Common Name: needle, hypodermic, single lumen Classification Name: Hypodermic single lumen needle
Classification Information:
Product Code: FMI Device Class: II Regulation number: 21CFR880.5570
III. Predicate Device Information:
| Manufacturer | Predicate Device | 510(k) Number | Submitted Device |
|---|---|---|---|
| International Medsurg | |||
| Connection | IMC Hypodermic Needle | K102584 | Sterile Hypodermic Needle for |
| Single Use |
IV. Device Description:
The submitted device is a sterile hypodermic needle for single use. The device is a single lumen hypodermic needle offered in a 22 gauge x 1 ½ " length. The device is constructed of the material noted in the table below:
| Name | Material | Material Specification |
|---|---|---|
| Needle tube | 304 stainless steel | SUS304 |
| Needle hub | Polypropylene (PP) | R307Y |
| Needle cap | Polypropylene (PP) | R307Y |
| Hub colorant | Black Masterbatch | Carbon Black |
| Lubricant | Medical Highly Activated Silicone | Highly Reactive Silicone Oil |
| Adhesive | Ultraviolet adhesive | AA 3311 |
4
The device is classified for patient contact as externally communicating circulating blood in a limited contact duration ( Pyrogen Test; |
Sterility Information
Summary of Sterilization Validation is provided in the table below:
| Sterilization Method: | Ethylene Oxide Sterilization |
|---|---|
| ISO11135-1: Sterilization of health care products - ethylene oxide - part 1: | |
| requirements for the development, validation, and routine control of a sterilization | |
| process for medical devices. | |
| ISO11737-1: Sterilization of medical devices - Microbiological methods - Part 1: | |
| Determination of the population of microorganisms on product. | |
| Standards: | ISO11737-2: Sterilization of medical devices - Microbiological methods -- Part 2: |
| Tests of sterility performed in the validation of a sterilization process. | |
| ISO 10993-7: Biological evaluation of medical devices - Part 7: Test of Ethylene | |
| Oxide Residuals. | |
| AAMI / ANSI ST72: Bacterial endotoxins - Test methods, routine | |
| monitoring, and alternatives to batch testing. |
VIII. Conclusions:
The non-clinical data demonstrate that the sterile hypodermic needle for single use perform as intended in the specified use conditions. Based on the information provided in this submission, Jiangsu Shenli Medical Production Co., Ltd. believes that the sterile hypodermic needle for single use is substantially equivalent to the predicate (K102584) IMC Hypodermic Needle (International Medsurg Connection).