Insulin Pen Needle

K230043 · Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · FMI · Sep 20, 2023 · General Hospital

Device Facts

• Record ID: K230043
• Device Name: Insulin Pen Needle
• Applicant: Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
• Product Code: FMI · General Hospital
• Decision Date: Sep 20, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Insulin Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin. The intended user population of insulin pen needle is for "Adult Use Only" (ages 21yrs old and above).

Device Story

Insulin Pen Needle is a single-use, sterile, hypodermic needle designed for attachment to insulin pen injectors via a threaded connection. It consists of a needle tube (304 stainless steel), needle hub, needle container, and needle shield (all polypropylene). The device is used by adult patients to deliver insulin subcutaneously. It is available in various gauges (28G-34G) and lengths (4mm-12mm). The device is manually operated by the patient. It facilitates insulin delivery, which is essential for diabetes management. The device is EO sterilized.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via ISO 11608-2, ISO 9626, and ISO 7864. Biocompatibility testing (cytotoxicity, sensitization, irritation, systemic toxicity, hemolysis, pyrogen, subacute toxicity) performed per ISO 10993-1. Particulate matter testing per USP <788>. Packaging integrity verified via ASTM D3078-02, ASTM F1929-15, DIN 58953-6, and ASTM F88/F88M-21. Sterilization validated per ISO 11135 with EO residuals per ISO 10993-7. Shelf-life validated per ASTM F1980-16.

Technological Characteristics

Materials: 304 stainless steel needle tube, polypropylene hub/container/shield. Energy: Manual. Connectivity: None. Sterilization: EO (SAL 10^-6). Dimensions: 28G-34G; 4mm-12mm lengths. Standards: ISO 11608-2, ISO 7864, ISO 9626, ISO 10993, ISO 11135, ASTM F1980-16, USP <788>.

Indications for Use

Indicated for subcutaneous insulin injection using pen injector devices in adults (ages 21 and older).

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

• Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) (K202319)

Submission Summary (Full Text)

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September 20, 2023

Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. % Alice Huang RA Manager Shanghai Mind-link Business Consulting Co., Ltd. Room 8208, Second Floor, No 1399, Jiangyue Road, Minhang District Shanghai, 201114 China

Re: K230043

Trade/Device Name: Insulin Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: August 20, 2023 Received: August 23, 2023

Dear Alice Huang:

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

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

Sincerely,

Image /page/1/Picture/7 description: The image shows the text "Courtney Evans -S" in a large, sans-serif font. The text is arranged vertically, with "Courtney" on the top line, "Evans" on the second line, and "-S" on the third line. The background of the image is white, with a faint, light blue watermark pattern.

Digitally signed by Courtney Evans -S Date: 2023.09.20 11:28:53 -04'00'

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

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# Indications for Use

510(k) Number (if known) K230043

Device Name Insulin Pen Needle

Indications for Use (Describe)

The Insulin Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin. The intended user population of insulin pen needle is for "Adult Use Only" (ages 21yrs old and above).

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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# K230043- 510(K) Summary

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#### I. SUBMITTER:

Manufacture Name: Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. Address : No.2 Guanyin Road, Taihu Economic Development Zone, Anqing City, Anhui Province, China. Tel: [phone] Fax: [phone] Contact Person: Bingyi Xiang Title:General Manager Phone: [phone] Email:[e-mail]

Submission Correspondent: Alice Huang Email: [e-mail] Tel:[phone] Shanghai Mind-link Business Consulting Co., Ltd. Room A08, Floor 14th, No 699, Jiaozhou Road, Jingan District, Shanghai

Summary prepared: September 15, 2023

#### II. DEVICE

Name of Device:Insulin Pen Needle Regulation Number: 21 CFR 880.5570 Common Name: Insulin Pen Needle for single use Classification Panel: General Hospital Regulatory Class: II Product Code: FMI

#### III. PREDICATE DEVICE

Primary predicate device: Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) (K202319)

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#### DEVICE DESCRIPTION IV.

The proposed device, Insulin pen needle and insulin injection pen are use cooperatively to inject insulin into the human body. The Insulin Pen Needle is composed of a needle container, a needle shield, a needle hub, a needle tube.

The insulin pen needle for single use is offered in various gauge sized and length.

The proposed device is available in EO sterilized to achieve a Sterility Assurance Level (SAL) of 106.

| Designated<br>metric size<br>(mm) | Gauge | Bevel<br>angle | | Outer<br>diameter of<br>stylet (mm) | | Nominal length of needle tube<br>(mm) | | | | | | ID<br>(mm) | | OD<br>(mm) | | Color |
|-----------------------------------|-------|----------------|----|-------------------------------------|------|---------------------------------------|---|---|---|----|----|------------|-------|------------|-------|------------|
| | | LB | SB | RW | TW | 4 | 5 | 6 | 8 | 10 | 12 | RW | TW | MIN | MAX | |
| 0.18 | 34G | √ | √ | / | / | √ | √ | √ | – | – | – | 0.064 | 0.091 | 0.178 | 0.191 | Orange |
| 0.20 | 33G | √ | √ | / | / | √ | √ | √ | √ | – | – | 0.089 | 0.105 | 0.203 | 0.216 | Black |
| 0.23 | 32G | √ | √ | / | / | √ | √ | √ | √ | √ | – | 0.089 | 0.105 | 0.229 | 0.241 | Deep green |
| 0.25 | 31G | √ | √ | / | / | √ | √ | √ | √ | √ | – | 0.114 | 0.125 | 0.254 | 0.267 | White |
| 0.30 | 30G | √ | √ | 0.11 | 0.13 | √ | √ | √ | √ | √ | √ | 0.133 | 0.165 | 0.298 | 0.320 | Yellow |
| 0.33 | 29G | √ | √ | 0.11 | 0.15 | √ | √ | √ | √ | √ | √ | 0.133 | – | 0.324 | 0.351 | Red |
| 0.36 | 28G | √ | √ | 0.11 | 0.15 | √ | √ | √ | √ | √ | √ | 0.133 | – | 0.349 | 0.370 | Blue-green |

Table 1 Specification of Insulin Pen Needle

#### V. INDICATIONS FOR USE

The Insulin Pen Needle is intended for use with pen iniector devices for subcutaneous injection of insulin. The intended user population of insulin pen needle is for "Adult Use Only" (ages 21yrs old and above).

#### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE

Insulin pen needle and insulin injection pen are use cooperatively to inject insulin into the human body. Additionally, the Insulin Pen Needle is similar to the Insulin Pen Needle (Ordinary Type) (K202319) in regard to insertion, design, size ranges, and material.

Table 2 General Comparison for Insulin Pen Needle

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| Item | Proposed Device<br>Insulin Pen Needle | Predicate Device<br>Insulin Pen Needle<br>(Ordinary Type) | Remark |
|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| K number | TBD | K202319 | |
| Classification | Class II | Class II | Same |
| Product Code | FMI | FMI | Same |
| Regulation No. | 880.5570 | 880.5570 | Same |
| Intended use | Insulin pen needle and insulin<br>injection pen are use<br>cooperatively to inject insulin<br>into the human body. | The Insulin Pen Needle<br>(Ordinary Type) is intended<br>for use with pen injector<br>devices for the<br>subcutaneous injection<br>of insulin. | Similar<br>Note 1 |
| Indications for use | The Insulin Pen Needle is<br>intended for use with pen<br>injector devices for<br>subcutaneous injection of<br>insulin. The intended user<br>population of insulin pen<br>needle is for “Adult Use Only”<br>(ages 21yrs old and above). | The Insulin Pen Needle<br>(Ordinary Type) is intended<br>for use with pen injector<br>devices for the<br>subcutaneous injection<br>of insulin. | Similar<br>Note 1 |
| User population | “Adult Use Only” (ages 21yrs<br>old and above) | Adult and Pediatric | Different<br>Note 2 |
| Type-of-use | Prescription only | Over the counter | Different<br>Note 3 |
| Configuration and<br>materials of<br>construction for all<br>components | Needle tube 304 stainless<br>steel | Needle tube 304 stainless<br>steel | |
| | Needle hub Polypropylene | Needle hub Polypropylene | |
| | Needle container Polypropylene | Outer Sheath Polypropylene | Same |
| | Needle shield Polypropylene | Inner Sheath Polypropylene | |
| | Sealed Paper Paper | Sealed Paper Paper | |
| Operation Mode | For Manual Use Only | For Manual Use Only | Same |
| Method of<br>attachment to pen<br>injector | Through threaded connection | Through threaded<br>connection | Same |
| Item | Proposed Device<br>Insulin Pen Needle | Predicate Device<br>Insulin Pen Needle (Ordinary<br>Type) | Remark |
| Needle Gauge | 28G, 29G, 30G, 31G, 32G, 33G,<br>34G | 29G, 30G, 31G, 32G, 33G | Different<br>Note 4 |
| Needle Length | 4mm, 5mm, 6mm, 8mm, 10mm,<br>12mm | 4mm, 5mm, 6mm, 8mm, 10mm,<br>12mm | Same |
| Patient-contact materials | | | |
| Needle Tube | 304 stainless steel | 304 stainless steel | Different<br>Note 5 |
| Needle Hub | PP | Polypropylene | Note 5 |
| Lubricant | Silicone oil | MDX4-4159 | |
| adhesive | Uv-curable adhesive | UV glue | |
| Design<br>specification of<br>the inner sheath<br>(dimensions,<br>color, materials<br>and strength) | 14.5*5.8*5.8mm;<br>Transparent color; Polypropylene;<br>Tensile stress at yield>24MPa;<br>Flexural Modulus:>1000MPa;<br>Charpy Notched Impact<br>Strength (23°C) >7kJ/m2 | 14.3*5.8*5.8mm;<br>Transparent color; Polypropylene;<br>Tensile stress at yield>20MPa;<br>Flexural Modulus:>800MPa;<br>Charpy Notched Impact<br>Strength (23°C) >2.8kJ/m2 | Similar |
| Design<br>specification of<br>the outer sheath<br>(dimensions,<br>color, materials<br>and strength) | 30*16*16mm;<br>Transparent color; Polypropylene;<br>Tensile stress at yield>24MPa;<br>Flexural Modulus:>1000MPa;<br>Charpy Notched Impact<br>Strength (23°C) >7kJ/m2 | 30.3*13.4*13.4mm;<br>Transparent color; Polypropylene;<br>Tensile stress at yield>20MPa;<br>Flexural Modulus:>800MPa;<br>Charpy Notched Impact<br>Strength (23°C) >2.8kJ/m2 | Similar |
| Bond between<br>hub and needle<br>tube | Clause 4.4 of ISO 11608-2:2012;<br>Clause 4.12 of ISO 7864:2016 | Clause 4.4 of ISO 11608-2:2012;<br>Clause 4.12 of ISO 7864:2016 | Same |
| Needle tip<br>configuration | Conform with ISO 7864 standards | Conform with ISO 7864 standards | Same |
| Cytotoxicity | No Cytotoxicity | No Cytotoxicity | Same |
| Intracutaneous<br>reactivity | No Irritation to Skin | No Irritation to Skin | |
| Skin<br>Sensitization | No Skin Sensitization | No Skin Sensitization | |
| Acute Systemic<br>Toxicity | No Systemic Toxicity | No Systemic Toxicity | |
| Pyrogen | No pyrogen | No pyrogen | |
| Hemolysis | No Hemolysis | No Hemolysis | |
| | | | |
| Subacute<br>Systemic Toxicity | No Subacute Systemic Toxicity | No Subacute Systemic Toxicity | |
| | | | |
| Method | EO Sterilized | Irradiation Sterilized | Different<br>Note 6 |
| SAL | 10-6 | 10-6 | Same |
| Endotoxin Limit | 20 EU per device | 20 EU per device | Same |
| Shelf life | 5 years | 5 years | Same |
| Label/ Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same |

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# Table 3 Safety and Performance Comparison for Insulin Pen Needle

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### Discussion in details:

### Note 1: Intended Use and Indications for use

Insulin pen needle and insulin pen needle (Ordinary Type) have similar intended use and indications for use, which are intended to be used with Insulin Pen for injection of insulin.

### Note 2: User population

The subject device' s user population is covered by the range of user population in the predicate devices. This different will do not raise different questions of safety and effectiveness than the predicate device because all necessary information will be labeled on the packaging and the Instruction for Use.

## Note 3: Type-of-use

The subject device' s type-of use is more rigorous than predicate devices. This different will do not raise different questions of safety and effectiveness than the predicate device because all necessary information will be labeled on the packaging and Instruction for Use.

## Note 4: Needle gauge

The needle gauge of proposed device is more than that of predicate devices. The difference in needle gauges is made of the same raw materials and the same manufacturing process. Different gauge of needle tube will be selected by users. This difference does not affect intended use and not affect substantially equivalence on safety and effectiveness. In addition, all the needle size of proposed device has been tested. The test results comply with ISO 7864 and ISO 9626 standards requirements. Therefore, this difference will not affect the Substantially Equivalency (SE) between the proposed and predicate device.

## Note 5: Patient-contact Material

Although the material of proposed and the predicate device is different, the MSDS of Silicone oil and UV-curable adhesive is provided, and the patient-contact material of the proposed device material conforms to the ISO 10993 series of standards. Therefore, this difference will not affect the Substantial Equivalence (SE) between the proposed and predicate device.

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### Note 6: Sterilize Method

Although the Sterilize Method of proposed and the predicate device is different, the sterilize of the proposed device conforms to the ISO 11135:2014 of standards. And the EO residue result was comply with ISO 10993-7 standard requirement. Therefore, this difference will not affect the Substantial Equivalence (SE) between the proposed and predicate device.

#### VII. PERFORMANCE DATA

The non-clinical tests of the proposed device are tested in conformance with the following standards.

#### Bench Testing

The chemical performance and physical performance have been tested in compliance with the following standard:

- . ISO11608-2: 2012,
- ISO 9626: 2016 and ●
- ISO 7864: 2016. ●

The testing results are in conformance with the corresponding standard.

#### Sterility and Shelf-life

The sterilization process of the proposed device has been validated in compliance with ISO 11135. The EO residual doesn't exceed the limit according to ISO 10993-7. The shelf-life validation study was conducted under the accelerated ageing condition in compliance with ASTM F1980-16 to verify the claimed 5 years shelf-life.

#### Package Testing

The packaging testing has been performed in compliance with the following FDA recognized consensus standards.

- Vacuum Leak Test, ASTM D3078-02;
- Dye Penetration Test ASTM F1929-15.
- Microbial Barrier Properties Test DIN 58953-6: 2016;
- Seal Strength Test ASTM F88/F88M-21.

#### Biocompatibility Testing

The biocompatibility evaluation for the insulin pen needles were conducted in accordance with the guidance that is "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, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within Risk Management Process," as

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recognized by FDA. The battery of testing included the following tests:

- Cytotoxicity
- · Sensitization
- · Irritation
- Systemic Toxicity
- Hemolysis
- Pyrogen
- Subacute Toxicity
- Particulate Matter

Particulate testing was conducted in accordance with USP <788>. The testing results and met the USP acceptance criteria.

#### Simulated Clinical Use Testing

Simulated clinical use testing of the proposed device has been conducted in compliance with the FDA Guidance for industry and FDA Stuff, Medical Devices with Sharps Injury Prevention Features, August 9, 2005.

### Clinical testing

Not Applicable.

#### VIII. CONCLUSION

The differences between the predicate and the proposed device do not raise any new or different questions of safety or effectiveness. The proposed device is substantially equivalent to the predicate device with respect to indications for use, technological characteristics, and performance.