(261 days)
Not Found
No
The summary describes a standard hypodermic needle and does not mention any AI or ML components or functionalities.
No.
A therapeutic device is one that treats a disease or condition. This device is a needle used for fluid injection/aspiration, which is a delivery mechanism, not a treatment in itself.
No
The intended use statement explicitly states the device is for "fluid injection/ aspiration," which is a treatment or collection purpose, not for diagnosis.
No
The device description clearly outlines physical components (needle hub, needle cap) and mentions manufacturing processes and testing related to physical properties and sterility, indicating it is a 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 "for general purpose fluid injection/ aspiration." This describes a device used to introduce or withdraw substances from the body, which is a clinical procedure, not an in vitro diagnostic test.
- Device Description: The description focuses on the physical components of a needle used for injection/aspiration (needle hub, cap, gauge, length, etc.). It does not mention any components or functions related to analyzing samples outside of the body.
- Lack of IVD Indicators: There is no mention of:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances within those samples
- Providing information for diagnosis, monitoring, or treatment based on sample analysis
- Reagents, calibrators, or controls typically associated with IVD tests
The device is clearly intended for direct interaction with the patient's body for the purpose of administering or withdrawing fluids. This falls under the category of a general medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Disposable Sterile Needle is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.
Product codes (comma separated list FDA assigned to the subject device)
FMI
Device Description
The Disposable Sterile Needle consists of three components: needle hub, and the needle cap. The Disposable Sterile Needle is supplied sterile for single use and has a shelf life of 5 years. The proposed device is available in various combinations of needle gauge, length, wall type and Edges. The hub color of the needle complies with ISO 6009: 2016 - Hypodermic needles for single use — Colour coding for identification.
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
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)
Non-clinical tests were conducted to verify that the proposed devices met all design specifications and are substantially equivalent (SE) to the hypodermic needle component of the predicate device. The test results demonstrated that the proposed devices comply with the following standards:
- ISO 7864:2016, Sterile Hypodermic Needles for Single Use
- ISO 6009: 2016 Hypodermic needles for single use Colour coding for identification
- ISO 9626:2016, Stainless Steel Needle Tubing for the Manufacture of Medical Devices
- ISO 594-1:1986 Conical Fittings with A 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment - Part 1: General Requirements.
- ISO 594-2:1998 Conical Fittings with A 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment - Part 2: Lock Fittings.
- ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration
- ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials.
- USP Bacterial Endotoxins Test
- ISO 11135-1:2007 Sterilization of Health Care Products- Ethylene Oxide- Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices
The Disposable Sterile Needle is supplied sterile for single use and are sterilized by Ethylene Oxide to achieve a SAL of 10-6 and supplied in sterility maintenance package which could maintain the sterility of the device during the shelf life of 5 years. Sterility was validated in accordance with ISO 11135-1:2007. Packaging tests were performed per ASTM F88/F88M-15 and ASTM F1929-15.
The Disposable Sterile Needle has been tested for biocompatibility and meets the biocompatibility requirements of the applicable standards in the ISO 10993 series. The device was tested to the following biocompatibility endpoints: cytotoxicity, sensitization, irritation sensitivity, acute systemic toxicity, and material mediated pyrogenicity, hemocompatibility.
A risk analysis was conducted in accordance with ISO 14971: 2007 - Medical devices -Application of risk management to medical devices.
In all testing, the pre-determined acceptance criteria were met.
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 logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 14, 2018
Jiangsu Caina Medical Co., Ltd. % Diana Hong General Manager Mid-link Consulting Co., Ltd P.O.Box 120-119 Shanghai, 200120, China
Re: K172938
Trade/Device Name: Disposable Sterile Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: May 4, 2018 Received: May 8, 2018
Dear Diana Hong:
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.
Alan M. Stevens -
Digitally signed by Alan M. Stevens -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=130 0189211, cn=Alan M. Stevens -S Date: 2018.06.14 13:35:06 -04'00'
Tina Kiang, Ph.D. for 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) K172938
Device Name Disposable Sterile Needle
Indications for Use (Describe)
The Disposable Sterile Needle is intended for use with syringes and injection devices for general purpose fluid injection/ aspiration.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K172938 510(k) SUMMARY
| Submitter: | Jiangsu Caina Medical Co., Ltd.
No.23, Huanxi Road, Zhutang Town, Jiangyin, Jiangsu, 214425,
China |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Application Correspondent: | Ms. Diana Hong
General Manager
Mid-Link Consulting Co., Ltd
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850,
Fax: 240-238-7587
Email: info@mid-link.net |
| Preparation Date: | June 13, 2018 |
| Trade Name: | Disposable Sterile Needle |
| Common or Usual Name: | Needle, Hypodermic, Single Lumen |
| Regulation Name: | Hypodermic Single Lumen Needle. |
| Regulation Number: | 21 CFR 880.5570 |
| Product Code: | FMI |
| Device Class: | Class II |
| Primary Predicate Device: | K072739; Jierui Syringes and Needles |
| | Note – K072739 is a bundled 510(k) submission containing a sterile
hypodermic needle. K172938 is substantially equivalent to the
sterile hypodermic needle component of K072739. |
Indications for Use:
The Disposable Sterile Needle is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.
4
Device Description:
The Disposable Sterile Needle consists of three components: needle hub, and the needle cap. The Disposable Sterile Needle is supplied sterile for single use and has a shelf life of 5 years. The proposed device is available in various combinations of needle gauge, length, wall type and Edges. The hub color of the needle complies with ISO 6009: 2016 - Hypodermic needles for single use — Colour coding for identification. The product specifications are listed in following table.
| Gauge | Hub Color | Product specification | Gauge | Hub Color | Product specification |
|---|---|---|---|---|---|
| 33G | Black | 33Gx6mm RWxLB | 22G | Black | 22Gx25mm RWxLB |
| 33Gx6mm RWxSB | 22Gx25mm RWxSB | ||||
| 33Gx6mm TWxLB | 22Gx25mm TWxLB | ||||
| 33Gx6mm TWxSB | 22Gx25mm TWxSB | ||||
| 32G | Deep | ||||
| Green | 32Gx13mm RWxLB | 22Gx25mm ETWxLB | |||
| 32Gx13mm RWxSB | 22Gx25mm ETWxSB | ||||
| 32Gx13mm TWxLB | 22Gx38mm RWxLB | ||||
| 32Gx13mm TWxSB | 22Gx38mm RWxSB | ||||
| 32Gx13mm ETWxLB | 22Gx38mm TWxLB | ||||
| 32Gx13mm ETWxSB | 22Gx38mm TWxSB | ||||
| 30G | Yellow | 30Gx25mm RWxLB | 22Gx38mm ETWxLB | ||
| 30Gx25mm RWxSB | 22Gx38mm ETWxSB | ||||
| 30Gx25mm TWxLB | 21G | Deep | |||
| Green | 21Gx38mm RWxLB | ||||
| 30Gx25mm TWxSB | 21Gx38mm RWxSB | ||||
| 30Gx25mm ETWxLB | 21Gx38mm TWxLB | ||||
| 30Gx25mm ETWxSB | 21Gx38mm TWxSB | ||||
| 25G | Orange | 25Gx25mm RWxLB | 21Gx38mm ETWxLB | ||
| 25Gx25mm RWxSB | 21Gx38mm ETWxSB | ||||
| 25Gx25mm TWxLB | 20G | Yellow | 20Gx38mm RWxLB | ||
| 25Gx25mm TWxSB | 20Gx38mm RWxSB | ||||
| 25Gx38mm RWxLB | 20Gx38mm TWxLB | ||||
| 25Gx38mm RWxSB | 20Gx38mm TWxSB | ||||
| 25Gx38mm TWxLB | 20Gx38mm ETWxLB | ||||
| 25Gx38mm TWxSB | 20Gx38mm ETWxSB | ||||
| Note: | 18G | Pink | 18Gx50mm RWxLB | ||
| RW = Regular Wall; TW = Thin Wall; | |||||
| ETW= Extra Thin Wall | |||||
| LB=Long Bevel; SB=Short Bevel | 18Gx50mm RWxSB | ||||
| 18Gx50mm TWxLB | |||||
| 18Gx50mm TWxSB |
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Device Comparison of Technology
A technological comparison table is provided below that compares the subject device and predicate device:
| Item | Proposed Device -K172938 | Predicate Device - K072739 | Comparison | |
|---|---|---|---|---|
| Disposable Sterile Needle | Jierui Syringes and Needles: | |||
| Sterile Hypodermic Needle | ||||
| Component Only | ||||
| Product Code | FMI | FMI | Same | |
| Intended Use | The Disposable Sterile Needle | |||
| is intended for use | ||||
| with syringes and injection | ||||
| devices for general purpose | ||||
| fluid injection/aspiration. | The Sterile Hypodermic Needle for | |||
| single use is intended for use with | ||||
| syringes and injection devices for | ||||
| general purpose fluid | ||||
| injection/aspiration | Same | |||
| Single Use | Yes | Yes | Same | |
| Sterility Condition | EO Sterilization | EO Sterilization | Same | |
| Material | Needle | |||
| Tube | 304 Stainless Steel | Stainless Steel | Different | |
| Cap | Polypropylene | Unknown | Different | |
| Hub | Polypropylene | Unknown | Different | |
| Needle Gauge | 18G,20G,21G,22G,25G,30G,32 | |||
| G,33G | 16G,18G,19G,20G,21G,22G,23G,2 | |||
| 4G,25G,26G,27G,29G | Different |
6
| Needle Length | 6mm, 13mm, 20mm, 25mm,
38mm, 45mm, 50mm | 13 mm, 16 mm, 19 mm, 25 mm, 32 mm, 38 mm | Different |
|----------------------------|---------------------------------------------------|---------------------------------------------------|-----------|
| Needle Edge/Bevel Angle | Long Bevel: angle 11 °
Short Bevel: angle 17 ° | Long bevel
Short Bevel | Different |
| Needle Performance | Complies with
ISO 7864: 2016
ISO 9626: 2016 | Complies with
ISO 7864: 1993
ISO 9626: 1991 | Same |
| Luer Connector Performance | Complies with
ISO 594-1:1986
ISO 594-2:1998 | Complies with
ISO 594-1:1986
ISO 594-2:1998 | Same |
| Needle Hub Color | Complies with ISO 6009: 2016 | Complies with ISO 6009: 2016 | Same |
Substantial Equivalence Discussion
The indications for use and intended use of the hypodermic needle component in the predicate bundled 510(k) K072739, are equivalent to the subject 510(k) device.
The differences between the subject device and the predicate device are the following:
-
Needle length
Although the needle length range of the subject device is larger than needle length range of the predicate device r, the needle length of the subject device meets 4.10.2 Tolerances requirements of ISO 7864. This difference does not raise different questions of safety and effectiveness -
Needle Gauge
The subject device has 30G, 32G and 33G needle gauges, which are not included in the predicate device. All needle gauges of proposed device meet 5.4 Dimensions requirements of ISO 9626. This difference does not raise different questions of safety and effectiveness -
Edge/Bevel angle ●
Although the /bevel angle of the predicate device is unknown, the edge/bevel angle of subject device are listed in the product labeling, and the end user can choose the needle per their preference. This difference does not raise different questions of safety and effectiveness
7
- Materials .
Although the materials of the subject device are different from those of the predicate device, the subject device has been tested for biocompatibility and meets the biocompatibility requirements of the applicable standards in the ISO 10993 series. This difference does not raise different questions of safety and effectiveness
Based on the aforementioned modifications to the subject device device does not raise different types of safety and effectiveness questions when compared to the predicate device.
Performance Testing Summary
Non-clinical tests were conducted to verify that the proposed devices met all design specifications and are substantially equivalent (SE) to the hypodermic needle component of the predicate device. The test results demonstrated that the proposed devices comply with the following standards:
- ISO 7864:2016, Sterile Hypodermic Needles for Single Use ●
- ISO 6009: 2016 Hypodermic needles for single use Colour coding for identification ●
- ISO 9626:2016, Stainless Steel Needle Tubing for the Manufacture of Medical Devices ●
- ISO 594-1:1986 Conical Fittings with A 6% (Luer) Taper for Syringes, Needles and ● Certain Other Medical Equipment - Part 1: General Requirements.
- ISO 594-2:1998 Conical Fittings with A 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment - Part 2: Lock Fittings.
- . ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration
- ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier ● Materials.
- USP Bacterial Endotoxins Test
- ISO 11135-1:2007 Sterilization of Health Care Products- Ethylene ● Oxide- Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices
The Disposable Sterile Needle is supplied sterile for single use and are sterilized by Ethylene Oxide to achieve a SAL of 10-6 and supplied in sterility maintenance package which could maintain the sterility of the device during the shelf life of 5 years. Sterility was validated in accordance with ISO 11135-1:2007. Packaging tests were performed per ASTM F88/F88M-15 and ASTM F1929-15.
The Disposable Sterile Needle has been tested for biocompatibility and meets the biocompatibility requirements of the applicable standards in the ISO 10993 series. The device
8
was tested to the following biocompatibility endpoints: cytotoxicity, sensitization, irritation sensitivity, acute systemic toxicity, and material mediated pyrogenicity, hemocompatibility.
A risk analysis was conducted in accordance with ISO 14971: 2007 - Medical devices -Application of risk management to medical devices.
In all testing, the pre-determined acceptance criteria were met.
Substantially Equivalence Conclusion
The subject device has the same intended use and technological characteristics as the predicate device. The performance of the device is supported by non-clinical testing and risk management activities. The Disposable Sterile Needle is Substantially Equivalent (SE) to the Sterile Hypodermic Needle component of the bundled 510(k), Jierui Syringes and Needles, cleared under K072739.