Sterile Hypodermic Needles for Single Use

K211214 · Azur Medical Company, Inc. · FMI · Oct 14, 2021 · General Hospital

Device Facts

• Record ID: K211214
• Device Name: Sterile Hypodermic Needles for Single Use
• Applicant: Azur Medical Company, Inc.
• Product Code: FMI · General Hospital
• Decision Date: Oct 14, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Sterile Hypodermic Needles for Single Use consist of a needle hub, needle tube, and protective cover. Used in hospitals and clinics by medical professionals and trained caregivers for manual fluid injection or aspiration. The device attaches to luer lock or luer slip syringes. The needle hub is color-coded per ISO 6009. The device is provided sterile via EO sterilization (SAL 10^-6) for single use only. It facilitates the delivery of medications or the withdrawal of fluids, benefiting patients by providing a sterile, single-use interface for hypodermic procedures.

Clinical Evidence

Bench testing only. No clinical data. Performance testing included biocompatibility (ISO 10993-1, -4, -5, -10, -11), particulate matter (USP <788>), sterilization validation (ISO 11135), and mechanical/functional testing per ISO 7864, ISO 9626, and ISO 80369-7. All acceptance criteria were met.

Technological Characteristics

Materials: Polypropylene (hub/cap), stainless steel (tube). Dimensions: 18G-30G gauges; 1/2"-1 1/2" lengths. Standards: ISO 7864:2016, ISO 9626:2016, ISO 80369-7:2021, ISO 80369-20:2015, ISO 6009 (color coding). Sterilization: EO (SAL 10^-6). Packaging tests: ASTM F88/F88M-15, ASTM F1929-15, ASTM F1140/F1140M-13, ASTM F2096-11, DIN 58953-6:2010.

Indications for Use

Indicated for general purpose fluid injection or aspiration in patients requiring hypodermic needle use, intended for use by medical professionals and trained caregivers.

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 (K180417)

Submission Summary (Full Text)

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October 14, 2021

Azur Medical Company Inc. Di Zhao General Manager 6710 Everglades Dr. Richmond, Virginia 23838

Re: K211214

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: August 9, 2021 Received: August 20, 2021

Dear Di Zhao:

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

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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) 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 (OS) 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For 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

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## Indications for Use

510(k) Number (if known) K211214

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)

| <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: overline;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|

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# K211214 510(k) summary

Preparation Date: October 14, 2021

#### l Submitter

Device submitter: Azur Medical Company Inc. 6710 Everglades Dr., Richmond, Virginia, VA 23838, USA

Contract manufacturer: Zhejiang Kangkang Medical-Devices CO., Ltd. Longwang Industrial District, Chumen Town, Yuhuan, Zhejiang, 317605, China Registration number: 3015042030

### Contact person: Di Zhao

General Manager Phone: [phone] Email: [e-mail]

#### II 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

#### III Predicate Device

| Trade name: | Self-destruction Safety Syringes for Single Use;<br>Sterile Hypodermic Syringes for Single Use;<br>Sterile Hypodermic Needles for Single Use (used as the predicate device);<br>Sterile Safety Hypodermic Needles for Single Use |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common name: | Hypodermic single lumen needle |
| Classification: | Class II, 21 CFR 880.5570 |
| Product Code: | FMI |
| 510(K) Number: | K180417 |
| Manufacturer: | Berpu Medical Technology Co., Ltd |

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### IV Device description

The Sterile Hypodermic Needles for Single Use is composed of a needle hub, protective cover, needle tube and jointing. The Sterile Hypodermic Needles for Single Use is for single It is provided sterile. The sterilization method is EO sterilization and the use only, sterilization assurance level is 10-6.

| Gauge<br>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

### V 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.

### VI Comparison of technological characteristics with the predicate devices

The Sterile Hypodermic Needles for Single Use have intended use, technology, and 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 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. |
| Product code | FMI | FMI |
| Regulation number | 21 CFR 880.5570 | 21 CFR 880.5570 |
| Class | II | II |
| Principle of operation | For manual use only | For manual use only |
| Intended user | Medical professionals and trained care givers | Medical professionals and trained care givers |

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| Device feature | Subject Device | Predicate Device K180417 | | |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|---------------------------------------------------|
| Environment of<br>use | Hospitals and clinics | Hospitals and clinics | | |
| Needle gauge | 30G, 27G, 26G, 25G, 24G, 23G,<br>22G, 21G, 20G, 19G, 18G | 14G, 15G, 16G, 17G, 18G, 19G,<br>20G, 21G, 22G, 23G, 24G, 25G,<br>26G, 27G, 29G, 30G | | |
| Length | 1/2", 5/8", 1", 1 1/4", 1 1/2" | 1/4", 5/16", 1/2", 5/8", 3/4", 1", 1 1/2", 2", 2<br>1/2" | | |
| Type of wall | Normal wall or thin wall | Not provided | | |
| blade angle | Short bevel or long bevel | Not provided | | |
| Main structure and<br>materials | Needle hub<br>Needle tube<br>Protective<br>cover | Polypropylene<br>Stainless steel<br>Polypropylene | Needle hub<br>Needle<br>Protective cap | Polypropylene<br>Stainless steel<br>Polypropylene |
| Needle hub Color | Color-coded per ISO 6009 | Color-coded per ISO 6009 | | |
| Single use | Yes | Yes | | |
| Performance<br>specifications | Complies with ISO 7864:2016<br><i>Sterile hypodermic needles for<br/>single use - Requirements and test<br/>methods, ISO 9626:2016 Stainless<br/>steel needle tubing for the<br/>manufacture of medical devices -<br/>Requirements and test methods,<br/>ISO 80369-7:2021 Small-bore<br/>connectors for liquids and gases in<br/>healthcare applications — Part 7:<br/>Connectors for intravascular or<br/>hypodermic applications, ISO<br/>80369-20:2015 Small-bore<br/>connectors for liquids and gases in<br/>healthcare applications - Part 20:<br/>Common test methods</i> | Complies with ISO 7864:2016 <i>Sterile<br/>hypodermic needles for single use -<br/>Requirements and test methods, ISO<br/>9626:2016 Stainless steel needle<br/>tubing for the manufacture of medical<br/>devices - Requirements and test<br/>methods</i> | | |
| Sterilization | EO | EO | | |
| SAL | 10-6 | 10-6 | | |
| Pyrogen | Non-pyrogenic | Non-pyrogenic | | |
| Biocompatibility | The biocompatibility evaluation for<br>the subject device was conducted<br>in accordance with the<br>International Standard ISO 10993-<br>1 "Biological Evaluation of Medical | Complies with ISO 10993.<br>The testing is as follows:<br>The devices meet biocompatibility<br>endpoints for cytotoxicity, irritation,<br>sensitization systemic toxicity | | |

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| Device feature | Subject Device | Predicate Device K180417 |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| | Devices - Part 1: Evaluation and<br>Testing Within a Risk Management<br>Process," as recognized by FDA<br>and the “Use of International<br>Standard ISO 10993-1 “Biological<br>evaluation of medical devices- Part<br>1: Evaluation and testing within a<br>risk management process", June<br>16, 2016. The syringe of testing<br>included the following tests:<br>Cytotoxicity;<br>Skin sensitization;<br>Hemolysis;<br>Intracutaneous reactivity;<br>Acute systemic toxicity;<br>Pyrogenicity.<br>The evaluation of the above testing<br>items meets the requirements | hemolysis and material-mediated<br>pyrogens. |
| Labeling | Meets the requirements of 21 CFR<br>Part 801 | Meets the requirements of 21 CFR<br>Part 801 |

### VII 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, Sterile Safety 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 (< 24 hours)" and USP <788>. The following tests were performed, as recommended:

| Cytotoxicity | ISO 10993-5: 2009 |
|---------------------------|--------------------|
| Skin sensitization | ISO 10993-10: 2010 |
| Hemolysis | ISO 10993-4: 2017 |
| Intracutaneous reactivity | ISO 10993-10: 2010 |
| Acute systemic toxicity | ISO 10993-11: 2017 |
| Pyrogenicity | ISO 10993-11: 2017 |

All evaluation acceptance criteria were met.

Particulate matter testing was conducted in accordance with USP <788> Particulate Matter in Injections and met the USP acceptance criteria.

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#### 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, Sterile Safety 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, Sterile Safety 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<85> |
| Sterile Barrier Packaging Testing &<br>Shelf-Life Evaluation | Seal Strength ASTM F88/F88M-15<br>Dye Penetration ASTM F1929-15<br>Creep/Burst Testing ASTM<br>F1140/F1140M-13<br>Gross Leakage ASTM F2096-11<br>Antibacterial Testing DIN 58953-6:2010 |

#### Performance testing

Performance testing is performed according to the following standards:

- ISO 7864: 2016 A
>

| 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,<br>Freedom from defects, Lubricant) | Clause 4.10 of ISO 7864: 2016 |
| 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 |

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| 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 unscrewing | Clause 6.5 of ISO 80369-7: 2021 |
| Resistance to overriding | Clause 6.6 of ISO 80369-7: 2021 |

### VIII 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.