Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single Use- Disposable Needles; Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles
Device Facts
| Record ID | K232165 |
|---|---|
| Device Name | Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single Use- Disposable Needles; Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles |
| Applicant | Berpu Medical Technology Co., Ltd. |
| Product Code | FMI · General Hospital |
| Decision Date | Feb 1, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5570 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The Sterile Safety Hypodermic Needles for Single Use are intended to be used with a luer slip or luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick. The Sterile Hypodermic Needles for Single Use- Disposable Needles are intended to be used with a luer slip or luer lock syringes and injection devices for general purpose fluid injection/aspiration. The Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles are intended to be used with a luer slip or luer lock syringes and injection devices for general purpose fluid injection/aspiration.
Device Story
Device consists of sterile, single-use hypodermic needles, including safety needles with manual shields and self-sealing needles with end caps. Used with luer slip or luer lock syringes for fluid aspiration/injection. Safety needles feature a manual sheath activated post-withdrawal to prevent needlestick injuries. Operated by clinicians or healthcare providers in clinical settings. Output is the delivery or aspiration of fluids. Benefits include reduced risk of accidental needlestick (for safety models) and maintenance of sterility via protective caps. Device is manual; no electronic or software components.
Clinical Evidence
No clinical study included. Evidence consists of bench testing (physical, mechanical, chemical) and a simulated clinical study evaluating the safety mechanism per ISO 23908:2011 and FDA guidance. Biocompatibility testing (cytotoxicity, sensitization, irritation, systemic toxicity, hemolysis, pyrogen) confirmed safety.
Technological Characteristics
Materials: Polypropylene (PP) hub/cap/sheath, stainless steel needle. Dimensions: 18G-34G, 2mm-40mm lengths. Sterilization: Ethylene Oxide (SAL 10-6). Connectivity: None. Energy: Manual. Standards: ISO 7864, ISO 9626, ISO 80369-7, ISO 6009 (color coding), USP <788> (particulates).
Indications for Use
Indicated for use with luer slip or luer lock syringes for aspiration and injection of fluids for medical purposes. Applicable to patients requiring hypodermic injection or aspiration. No specific age or gender contraindications stated.
Regulatory Classification
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.
Predicate Devices
- Sterile Hypodermic Needles for Single Use / Sterile Safety Hypodermic Needles for Single Use (K180417)
Related Devices
- K170651 — Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle · Yangzhou Medline Industry, Co., Ltd. · Aug 2, 2017
- K211329 — Sterile Disposable Syringe with Saftey Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle · Jiangsu Kangbao Medical Equipment Co., Ltd. · Nov 15, 2021
- K213535 — Sterile Safety Hypodermic Needles for Single Use · Zhejiang Kangkang Medical-Devices Co., Ltd. · May 13, 2022
- K051865 — TERUMO SURGUARD 2 SAFETY NEEDLE OR SIMILAR · Terumo Medical Corp. · Sep 27, 2005
- K221308 — Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle · Jiangxi Maidikang Medical Devices Co., Ltd. · Oct 17, 2022
Submission Summary (Full Text)
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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.
February 1, 2024
Berpu Medical Technology Co., Ltd. % Diana Hong, General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, Shanghai 200120, China
# Re: K232165
Trade/Device Name: Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single Use- Disposable Needles: Sterile Hypodermic Needles for Single Use-Self-sealing Hypodermic Needles
Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: January 2, 2024 Received: January 2, 2024
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
# Shruti N. Mistry -S
Shruti Mistry, MS 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
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Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
# Indications for Use
510(k) Number (if known) K232165
#### Device Name
Sterile Safety Hypodermic Needles for Single Use Sterile Hypodermic Needles for Single Use- Disposable Needles Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles
### Indications for Use (Describe)
The Sterile Safety Hypodermic Needles for Single Use are intended to be used with a luer slip or luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.
The Sterile Hypodermic Needles for Single Use- Disposable Needles are intended to be used with a luer slip or luer lock syringes and injection devices for general purpose fluid injection/aspiration.
The Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles are intended to be used with a luer slip or luer lock syringes and injection devices for general purpose fluid injection/aspiration.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| <div> <span> <span style="text-decoration: underline;">Prescription Use</span> (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |
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# K232165 510(k) Summary
- 1. Date of Preparation: 2/1/2024
- 2. Sponsor Identification
# Berpu Medical Technology Co., Ltd.
NO.14 Xingji Road, Yongxing Street, Longwan District, Wenzhou, Zhejiang, China 325000
Establishment Registration Number: 3004496829
Contact Person: Buxin Yu Position: Management Representative Tel: +86-577-86651999 Fax: +86-577-86630389 Email: ybx@berpu.com
- 3. Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Mr. Tingting Su (Alternative Contact Person)
# Mid-Link Consulting Co., Ltd
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net
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#### 4. Identification of Proposed Device
Trade Name: Sterile Safety Hypodermic Needles for Single Use Sterile Hypodermic Needles for Single Use- Disposable Needles Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles
Regulation Name: Hypodermic, Single Lumen Needle Classification: II Regulation Number: 21 CFR 880.5570 Product Code: FMI
Predicate Device: 510(k) Number: K180417 Product Name: Sterile Hypodermic Needles for Single Use Sterile Safety Hypodermic Needles for Single Use
Indications for use:
The Sterile Safety Hypodermic Needles for Single Use are intended to be used with a luer slip or luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.
The Sterile Hypodermic Needles for Single Use- Disposable Needles are intended to be used with a luer slip or luer lock syringes and injection devices for general purpose fluid injection/aspiration.
The Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles are intended to be used with a luer slip or luer lock syringes and injection devices for general purpose fluid injection.
# Device Description
The proposed devices are provided in two types of configurations; one type is a Sterile Safety Hypodermic Needles for Single Use, the other is Sterile Hypodermic Needles for Single Use. The Sterile Hypodermic Needles also divided into two types, one type is an ordinary disposable needle contained in a sterility maintenance package, the other is self-sealing hypodermic needle with an end cap, the protective cap and end cap form a sterility maintenance package.
The Sterile Safety Hypodermic Needles for Single Use are intended for single use only, which consists of a hypodermic needle with a safety sheath attached to the needle hub. The proposed device is available in 28-34 gauge and 4-32 mm lengths. The safety sheath will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.
The Sterile Hypodermic Needles for Single Use are intended for single use only. The proposed device is
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available in 18-34 gauge and 2-40 mm lengths.
The proposed devices are sterilized by Ethylene Oxide Gas to achieve a SAL of 106 and are supplied in a sterility maintenance package which could maintain the sterility of the device during the shelf life of five years.
| Needle Type | Needle gauge | Needle Length |
|---------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Sterile Safety Hypodermic<br>Needles for Single Use | 28G, 29G, 30G, 31G, 32G,<br>33G, 34G | 4mm, 5mm, 6mm, 8mm, 9mm, 10mm,<br>12mm, 13mm, 16mm, 20mm, 22mm,<br>25mm, 30mm, 32mm |
| Sterile Hypodermic Needles<br>for Single Use- Disposable<br>Needle | 27G, 30G, 31G, 32G, 33G,<br>34G | 2mm, 2.5mm, 4mm, 5mm, 6mm, 8mm,<br>9mm, 10mm, 12mm, 13mm, 16mm,<br>20mm, 22mm, 25mm, 30mm, 32mm |
| Sterile Hypodermic Needles<br>for Single Use- Self-sealing<br>Hypodermic Needle | 18G, 19G, 20G, 21G, 22G,<br>23G, 24G, 25G, 26G, 27G,<br>28G, 29G, 30G, 31G, 32G,<br>33G, 34G | 2mm, 2.5mm, 4mm, 5mm, 6mm, 8mm,<br>9mm, 10mm, 12mm, 13mm, 16mm,<br>20mm, 22mm, 25mm, 30mm, 32mm,<br>35mm, 38mm, 40mm |
Table 1 Specifications for Proposed Devices
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#### 5. Technological Characteristic Table
| ITEM | Proposed Device<br>K232165 | Predicate Device<br>K180417 | Remark |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Product | Sterile Safety Hypodermic Needles<br>for Single Use | Sterile Safety Hypodermic Needles<br>for Single Use | / |
| Product Code | FMI | FMI | Same |
| Regulation No. | 21 CFR 880.5570 | 21 CFR 880.5570 | Same |
| Class | Class II | Class II | Same |
| Indication for Use | The Sterile Safety Hypodermic Needles for Single Use are intended to<br>be used with a luer slip or luer lock<br>syringe for aspiration and injection of<br>fluids for medical purpose. After<br>withdrawal of the needle from the<br>body, the attached needle safety shield<br>can be manually activated to cover the<br>needle immediately after use to<br>minimize risk of accidental<br>needlestick. | The Sterile Safety Hypodermic Needles for Single Use are intended to<br>be used with a luer slip or luer lock<br>syringe for aspiration and injection of<br>fluids for medical purpose. After<br>withdrawal of the needle from the<br>body, the attached needle safety shield<br>can be manually activated to cover the<br>needle immediately after use to<br>minimize risk of accidental<br>needlestick. | Same |
| Configuration and<br>material | Needle hub Polypropylene (PP)<br>Protective cap Polypropylene (PP)<br>Needle Stainless Steel<br>Safety sheath Polypropylene (PP) | Needle hub Polypropylene (PP)<br>Protective cap Polypropylene (PP)<br>Needle Stainless Steel<br>Safety sheath Polypropylene (PP) | Same |
| Safety sheath | Image: Safety sheath | | Same |
| Operation Mode | For manual use only | For manual use only | Same |
| Single Use | Single Use | Single Use | Same |
| Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same |
| Needle Gauge | Available in 28G, 29G, 30G, 31G,<br>32G, 33G, 34G | Available in 18G, 19G, 20G, 21G,<br>22G, 23G, 24G, 25G, 26G, 27G | Different |
| Needle Length | Available in 4mm, 5mm, 6mm, 8mm,<br>9mm, 10mm, 12mm, 13mm, 16mm,<br>20mm, 22mm, 25mm, 30mm, 32mm | Available in 6-50mm | |
| Needle tube colors | Comply with ISO 6009 | Comply with ISO 6009 | Similar |
| | 34G: Orange | 27G: Medium Grey | |
| | 33G: Black | 26G: Brown | |
| | 32G: Deep green | 25G: Orange | |
| | 31G: White | 24G: Medium Purple | |
| | 30G: Yellow | 23G: Dark Blue | |
| | 29G: Red | 22G: Black | |
| | 28G: Blue-green | 21G: Dark Green | |
| | | 20G: Yellow | |
| | | 19G: Cream | |
| | | 18G: Pink | |
| Needle Performance | Complied with<br>ISO 7864,<br>ISO 9626 | Complied with<br>ISO 7864,<br>ISO 9626 | Same |
| Luer Connector<br>Performance | Complied with<br>ISO 80369-7 | Complied with<br>ISO 594-2 | Different |
| Biocompatibility | | | |
| Cytotoxicity | No cytotoxicity | No cytotoxicity | Same |
| Irritation | No intracutaneous reactivity | No intracutaneous reactivity | |
| Sensitization | No sensitization | No sensitization | |
| Systemic Toxicity | No systemic toxicity | No systemic toxicity | |
| Hemolysis | No Hemolysis | No Hemolysis | |
| Pyrogen | No Pyrogen | No Pyrogen | |
| Particulate | Comply with USP<788><br>no more than 6000 /device≥10µm, and<br>no more than 600 /device≥25µm. | Comply with USP<788> | |
| Sterilization | | | |
| Method | EO Sterilized | EO Sterilized | Same |
| SAL | 10-6 | 10-6 | Same |
| Endotoxin Limit | 20 EU per device | 20 EU per device | Same |
| Shelf life | 5 years | 5 years | Same |
Table 2 Comparison of Sterile Safety Hypodermic Needles
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Different Analysis 1-Needle Size and Length
The needle size and length for the proposed device is different from the predicate devices. This difference is just in dimension. Different size and length devices will be selected by the physician per the patient's condition. Moreover, the needle length of the proposed device with safety needle is included in the range of the needle length of the predicate device. The performance of the needle was tested, and the test results showed that it was in accordance with ISO 7864 and ISO 9626 standards. Therefore, this difference does not raise new questions of safety and effectiveness.
Similar Analysis 2-Needle hub color
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The color of needle hub for proposed devices is different from the predicate devices. The color is indicating the nominal outer diameter of the needle. The proposed device and the predicate device have different needle gauges, so the color of the needle hub is different, but the needle hub complies with the ISO 6009 standard. Therefore, this difference does not raise new questions of safety and effectiveness.
# Different Analysis 3-Luer Connector Performance
Although the proposed device and the predicate device follow different luer connector standards, this is because ISO 594-2 is replaced by ISO 80369-7 according to current recognitions. The test results of the proposed device show that the connector performance meets the requirements of ISO 80369-7. Therefore, this difference does not raise new questions of safety and effectiveness.
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| ITEM | Proposed Device<br>K232165 | Predicate Device<br>K180417 | Remark |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Product | Sterile Hypodermic Needles for Single Use- Disposable Needles | Sterile Hypodermic Needles for Single Use | / |
| Product Code | FMI | FMI | Same |
| Regulation No. | 21 CFR 880.5570 | 21 CFR 880.5570 | Same |
| Class | Class II | Class II | Same |
| Indication for Use | The Sterile Hypodermic Needles for Single Use-Disposable Needles are intended to be used with a luer slip or luer lock syringes 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 lock syringe and injection devices for general purpose fluid injection/aspiration. | Same |
| Configuration and material | Needle Hub Polypropylene (PP)<br>Protective cap Polypropylene (PP)<br>Needle Stainless Steel | Needle hub Polypropylene (PP)<br>Protective cap Polypropylene (PP)<br>Needle Stainless Steel | Same |
| Operation Mode | For manual use only | For manual use only | Same |
| Single Use | Single Use | Single Use | Same |
| Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same |
| Needle Gauge | Available in 27G, 30G, 31G, 32G, 33G, 34G | Available in 14G, 15G, 16G, 17G, 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 29G, 30G | Different |
| Needle Length | Available in 2mm, 2.5mm, 4mm, 5mm, 6mm, 8mm, 9mm, 10mm, 12mm, 13mm, 16mm, 20mm, 22mm, 25mm, 30mm, 32mm | Available in 6-60mm | |
| Needle hub color | Complied with ISO 6009<br>34G: Orange<br>33G: Black<br>32G: Deep green<br>31G: White<br>30G: Yellow<br>27G: Medium Grey | Complied with ISO 6009<br>30G: Yellow<br>29G: Red<br>27G: Medium Grey<br>26G: Brown<br>25G: Orange<br>24G: Medium Purple<br>23G: Dark Blue<br>22G: Black<br>21G: Dark Green<br>20G: Yellow<br>19G: Cream | Similar |
| | | 17G: Red Purple | |
| | | 16G: White | |
| | | 15G: Blue Grey | |
| | | 14G: Light Green | |
| Needle Performance | Complied with<br>ISO 7864,<br>ISO 9626 | Complied with<br>ISO 7864,<br>ISO 9626 | Same |
| Luer Connector<br>Performance | Complied with<br>ISO 80369-7 | Complied with<br>ISO 594-2 | Different |
| Biocompatibility | | | |
| Cytotoxicity | No cytotoxicity | No cytotoxicity | Same |
| Irritation | No intracutaneous reactivity | No intracutaneous reactivity | |
| Sensitization | No sensitization | No sensitization | |
| Systemic Toxicity | No systemic toxicity | No systemic toxicity | |
| Hemolysis | No Hemolysis | No Hemolysis | |
| Pyrogen | No Pyrogen | No Pyrogen | |
| Particulate | Comply with USP<788><br>no more than 6000 /device≥10µm, and<br>no more than 600 /device≥25µm. | Comply with USP<788> | |
| Sterilization | | | |
| Method | EO Sterilized | EO Sterilized | Same |
| SAL | 10-6 | 10-6 | Same |
| Endotoxin Limit | 20 EU per device | 20 EU per device | Same |
| Shelf life | 5 years | 5 years | Same |
Table 3 Comparison of Sterile Hypodermic Needles for Single Use- Disposable Needles
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Different Analysis 4-Needle Size and Length
The needle size and length for the proposed device is different from the predicate devices. This difference is just in dimension. Different size and length devices will be selected by the physician per the patient's condition. Moreover, the needle length of the proposed device with disposable needle is similar to the needle length of the predicate device. The performance of the needle was tested, and the test results showed that it was in accordance with the ISO 7864 and ISO 9626 standards. Therefore, this difference does not raise new questions of safety and effectiveness.
# Similar Analysis 5-Needle hub color
The color of needle hub for the proposed devices is different from the predicate devices. The color is indicating the nominal outer diameter of the tube of the needle. The proposed device and the predicate device have different needle gauges, so the color of the needle hub is different, but the needle hub complies with the ISO6009 standard. Therefore, this difference does not raise new questions of safety and effectiveness.
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Different-Analysis 6-Luer Connector Performance
Although the proposed device and the predicate device follow different luer connector standards, this is because ISO 594-2 is replaced by ISO 80369-7 according to current recognitions. The test results of the proposed device show that the connector performance meets the requirements of ISO 80369-7. Therefore, this difference does not raise new questions of safety and effectiveness.
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| | ITEM | Proposed Device<br>K232165 | Predicate Device<br>K180417 | Remark |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|-----------|
| Product | Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles | Sterile Hypodermic Needles for Single Use | / | |
| Product Code | FMI | FMI | Same | |
| Regulation No. | 21 CFR 880.5570 | 21 CFR 880.5570 | Same | |
| Class | Class II | Class II | Same | |
| Indication for Use | The Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles are intended to be used with a luer slip or luer lock syringes 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 lock syringe and injection devices for general purpose fluid injection/aspiration. | Same | |
| Configuration and material | Needle Hub | Polypropylene (PP) | Needle hub<br>Polypropylene (PP) | Different |
| | Protective cap | Polypropylene (PP) | Protective cap<br>Polypropylene (PP) | |
| | Needle | Stainless Steel | Needle<br>Stainless Steel | |
| | End cap | Polypropylene (PP) | / | |
| Operation Mode | For manual use only | For manual use only | Same | |
| Single Use | Single Use | Single Use | Same | |
| Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same | |
| Needle Gauge | Available in 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G, 31G, 32G, 33G, 34G | Available in 14G, 15G, 16G, 17G, 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 29G, 30G | Different | |
| Needle Length | Available in 2mm, 2.5mm, 4mm, 5mm, 6mm, 8mm, 9mm, 10mm, 12mm, 13mm, 16mm, 20mm, 22mm, 25mm, 30mm, 32mm, 35mm, 38mm, 40mm | Available in 6-60mm | | |
| Needle hub color | Complied with ISO 6009<br>34G: Orange<br>33G: Black<br>32G: Deep green<br>31G: White<br>30G: Yellow<br>29G: Red<br>28G: Blue-green<br>27G: Medium Grey<br>26G: Brown<br>25G: Orange | Complied with ISO 6009<br>30G: Yellow<br>29G: Red<br>27G: Medium Grey<br>26G: Brown<br>25G: Orange<br>24G: Medium Purple<br>23G: Dark Blue<br>22G: Black<br>21G: Dark Green<br>20G: Yellow | Similar | |
| | | | | |
| | 24G: Medium Purple | 19G: Cream | | |
| | 23G: Deep Blue | 18G: Pink | | |
| | 22G: Black | 17G: Red Purple | | |
| | 21G: Deep Green | 16G: White | | |
| | 20G: Yellow | 15G: Blue Grey | | |
| | 19G: Cream | 14G: Light Green | | |
| | 18G: Pink | | | |
| Needle Performance | Complied with<br>ISO 7864,<br>ISO 9626 | Complied with<br>ISO 7864,<br>ISO 9626 | Same | |
| Luer Connector<br>Performance | Complied with<br>ISO 80369-7 | Complied with<br>ISO 594-2 | Different | |
| Biocompatibility | | | | |
| Cytotoxicity | No cytotoxicity | No cytotoxicity | Same |…
