Disposable Insulin Pen Needle

K221178 · Ningbo Medsun Medical Co., Ltd. · FMI · Nov 17, 2022 · General Hospital

Device Facts

• Record ID: K221178
• Device Name: Disposable Insulin Pen Needle
• Applicant: Ningbo Medsun Medical Co., Ltd.
• Product Code: FMI · General Hospital
• Decision Date: Nov 17, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Disposable Insulin Pen Needle(Model CT) : Disposable Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin. Disposable Insulin Pen Needle(Model ST) : Disposable Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin. Additionally, it has sharps injury protection feature that it can reduce the occurrence of accidental needlesticks from the patient end of the needle due to the effect of safe-lock guard.

Device Story

Disposable Insulin Pen Needle (Models CT and ST) attaches to pen injectors for subcutaneous insulin delivery. Model CT is a standard needle; Model ST includes a spring-loaded safe-lock guard for sharps injury protection. Device components include needle hub, container, tube, shield/jacket, and seal. Needle tube is fixed with UV glue; lubricated with silicone oil. In use, the needle is screwed onto a pen injector; the protective jacket is pressed to expose the needle for injection. For Model ST, the guard automatically locks after use, indicated by a red slider. Used in home or clinical settings by patients or caregivers. Benefits include ease of injection and reduced risk of accidental needlesticks for the safety model.

Clinical Evidence

Bench testing only. Performance verified per ISO 11608-2, ISO 7864, ISO 9626, and ISO 23908. Biocompatibility confirmed per ISO 10993. Clinical simulated use testing performed for Model ST sharps injury prevention feature per FDA guidance and ISO 23908. Compatibility verified with specific insulin pen injectors (NovoPen Echo, Humapen Luxura, Humapen Luxura HD, HumanPen Ergo II).

Technological Characteristics

Materials: Stainless steel (SUS304/SUS304H), Polypropylene (PP), silicone oil, UV glue, medical dialyzing paper. Dimensions: 0.20mm-0.33mm outer diameter. Energy: Manual. Connectivity: None. Sterilization: EO gas (SAL 10^-6). Standards: ISO 11608-2, ISO 7864, ISO 9626, ISO 23908, ISO 10993, ASTM F88/F88M-2015, ASTM D4169-16.

Indications for Use

Indicated for use with pen injector devices for subcutaneous insulin injection. Model ST includes a sharps injury protection feature to reduce accidental needlesticks. Intended for self-administration or by a caregiver in home or health center settings.

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

• Disposable Insulin Pen Needle (K170846)
• Safety Pen Needle (K192677)

Submission Summary (Full Text)

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November 17, 2022

Ningbo Medsun Medical Co., Ltd. % Marvin Li Consultant Shanghai Mihe Enterprise Management Consulting Co., Ltd. Room 313. No. 620 Zhennan Road (Building 9, Tongji University Science Park), Putuo District Shanghai, 200331 China

Re: K221178

Trade/Device Name: Disposable Insulin Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: October 18, 2022 Received: October 21, 2022

Dear Marvin Li:

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

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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).

> CAPT. Alan M. 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

Sincerely,

Alan M.
Stevens -
S3
Alan Str

Image /page/1/Picture/8 description: The image shows the word "Sincerely," followed by a signature and the name "Alan M. Stevens - S3". The signature is in black ink and is difficult to read. The name is in a simple, sans-serif font. The image is likely a scan of a document.

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# Indications for Use

510(k) Number (if known) K221178

Device Name Disposable Insulin Pen Needle

#### Indications for Use (Describe)

Disposable Insulin Pen Needle(Model CT) : Disposable Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin.

Disposable Insulin Pen Needle(Model ST) : Disposable Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin. Additionally, it has sharps injury protection feature that it can reduce the occurrence of accidental needlesticks from the patient end of the needle due to the effect of safe-lock guard.

| Type of Use (Select one or both, as applicable) | <div> <span> <input type="checkbox"/> </span> <span> <input type="checkbox"/> </span> </div> |
|-------------------------------------------------|----------------------------------------------------------------------------------------------|
|-------------------------------------------------|----------------------------------------------------------------------------------------------|

| | Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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# K221178

# 510(k) Summary

## 1.Date Prepared: November 17th, 2022

### 2.Submitter

Ningbo Medsun Medical Co., Ltd.

No.55 Jinxi Road, Zhenhai, 315221, Ningbo, P.R.China

Contact Person: Liu Ping, Regulation Affairs Manager

Tel: [phone] Fax:[phone]

Primary correspondent: Marvin Li, Consultant Tel:[phone] E-mail: [e-mail] Shanghai Mihe Enterprise Management Consulting Co., Ltd. Room 313, No. 620 Zhennan Road(Building 9, Tonqii University Science Park), Putuo District, 200331, Shanghai, P.R.China Date Prepared: November 17th, 2022

## 3.Device

Trade Name: Disposable Insulin Pen Needle Common Name: Hypodermic single lumen needle Classification Name: Needle, Hypodermic, Single Lumen Regulation Number:21 CFR 880.5570 Regulatory Class: II Product Code: FMI Review Panel: General Hospital 4. Predicate device 4.1 Primary Predicate device A Manufacturer: Jiangsu Caina Technology Co., Ltd. Device name: Disposable Insulin Pen Needle 510(k) number: K170846 Secondary Predicate device B Manufacturer: Jiangsu Caina Technology Co., Ltd. Device name: Safety Pen Needle 510(k) number: K192677

## 5.Device description

Disposable Insulin Pen Needle, could be divided into Model CT (normal type) and model ST(safety type) according to whether there is sharps protection features. Model CT consists of needle hub, needle container, needle tube, needle shield and seal (dialyzing paper). Model ST consists of needle hub, needle container, protective cap, needle tube, spring, slider,

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#### 510(k) Notification document-Disposable Insulin Pen Needle

protective jacket and seal (dialyzing paper). The device is sterilized by EO gas and for single use. The shelf life is 5 years.

Needle tube is fixed in the center of the needle hub with UV glue, the needle tip is protected with needle shield or protective jacket before use, medical dialyzing paper is covered and sealed needle container to maintain sterile of the cartridge end of needle can be inserted into the rubber of insulin pen, meanwhile the needle hub is connected to insulin pen with screw thread to provide sterile fluid path for injection of insulin during use. When Disposable Insulin Pen Needle is connected to insulin pen operates on the principles of common piston syringes. The patient end and the cartridge end of the needle tube are lubricated with silicone oil for ease of injection and rubber penetration.

Model ST has sharps injury protection feature that it can reduce the occurrence of accidental needlesticks from the patient end of the needle due to the effect of safe-lock guard.

#### 6.Indications for use

Disposable Insulin Pen Needle (Model CT): Disposable Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin.

Disposable Insulin Pen Needle (Model ST): Disposable Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin. Additionally, it has sharps injury protection feature that it can reduce the occurrence of accidental needlesticks from the patient end of the needle due to the effect of safe-lock guard.

### 7.Comparison of technological characteristics with the predicate device

7.1Comparison between Model CT Disposable Insulin Pen Needle and Predicate Device A

| Description | Subject Device (Model CT)<br>(K221178) | Predicate Device A<br>(K170846) | Remark |
|------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary/<br>trade name | Disposable Insulin<br>Pen Needle | Disposable Insulin<br>Pen Needle | / |
| Product Code | FMI | FMI | Same |
| Regulation<br>Number | 21 CFR 880.5570 | 21 CFR 880.5570 | Same |
| Indications<br>for use | Disposable Insulin Pen<br>Needle is intended for use<br>with pen injector device for<br>subcutaneous injection of<br>insulin. | The Disposable Insulin<br>Pen Needle is intended for<br>use with pen injector<br>devices for the<br>subcutaneous injection of<br>insulin. | Same |
| Prescription/over<br>-the counter use | Over-the counter use | Over-the counter use | Same |
| Operation Mode | Manual | Manual | Same |
| Environment<br>of use | Home, Health center | Home, Health center | Same |
| 510(k) Notification document-Disposable Insulin Pen Needle | | | K221178 |
| Intended users | For self-administration<br>or by a caregiver | | Same |
| Hub/needle<br>bond strength | Conform with ISO 11608-2 | | Same |
| Method of<br>attachment to<br>pen injector | Screw structure, conform with ISO 11608-2 | | Same |
| Needle tip<br>configuration | Tri-bevel edge needle | | Same |
| Shelf life | 5 years | | 3 years<br>(Note 1) |
| Size(s) | Outer<br>diameter | Length | Similar<br>(Note 2) |
| | 0.33mm | 10mm,<br>12mm | |
| | 0.30mm | 5mm | |
| | 0.25mm | 5mm,6mm,8<br>mm | |
| | 0.23mm<br>0.20mm | 4mm,5mm,<br>6mm,8mm<br>4mm | |
| Configuration<br>and Material | Needle tube | Stainless<br>steel<br>SUS304 | Cannula<br>304 Stainless Steel |
| | Needle hub | PP | Hub<br>Polypropylene |
| | Needle<br>container | PP | Needle<br>Cap<br>Polyethylene |
| | Needle<br>shield | PP | Needle Hub<br>Protector<br>Polypropylene<br>(Note 3) |
| | Lubricant | Silicon oil | Lubricant<br>Polydimethyls iloxane |
| | Adhesive | UV glue | / |
| | Seal | Medical<br>dialyzing<br>paper | Sealed<br>Paper<br>Paper |
| | | | Needle Gauge:29G, 30G,<br>31G, 32G<br>Needle Dimension (mm):<br>0.23×4, 0.25×4, 0.25×5,<br>0.25×6, 0.25×8, 0.30×8,<br>0.30×10, 0.33×12 |
| 510(k) Notification document-Disposable Insulin Pen Needle | | | K221178 |
| Performance | Meet the requirements of<br>ISO 7864, ISO 9626, ISO<br>11608-2 | Comply with ISO 7864,<br>ISO 9626, and ISO<br>11608-2 | Same |
| Sterilization | EO Sterilization | EO sterilized, SAL: 10-6 | Same |
| | SAL:10-6 | | |
| Labeling | Conform with 21 CFR 801 | Conform with 21 CFR 801 | Same |
| Biocompatibility | Meet the requirements of<br>ISO10993 series<br>standards, and the<br>following tests are<br>performed: In vitro<br>cytotoxicity, skin<br>sensitization,<br>intracutaneous reactivity,<br>acute systemic toxicity,<br>hemocompatibility,<br>subchronic toxicity,<br>particulate matter for<br>injections and pyrogen. | Conform with ISO 10993<br>standards | Similar<br>(Note 4) |
| Reuse or<br>single use | Single use | Single use | Same |

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Note 1: The shelf life of the predicate device A is 3 years. The shelf life of the subject device is 5 years according to the result of accelerated aging test by ASTM F88/F88M-2015, which will not affect the safety and effectiveness of the subject device.

Note 2: The outer diameter (gauge) of the predicate device A is covered by the subject device. The subject device has a 0.20mm(33G) type, while the predicate device A doesn't have. The lengths of the subject device for each outer diameter(gauge) have some differences that are physical, the performance bench testing of needle tube with lengths for subject device are demonstrated to meet the requirements of ISO 11608-2.

Note 3: The configuration and material of the predicate device A are mostly the same as the subject device. For the subject device, the adhesive is UV glue, where the predicate device's adhesive is unknown. UV glue is widely used for Insulin Pen Needle hub and needle tube. The safety of UV glue is demonstrated with the biocompatibility of final product.

Note 4: Subject Device has been tested for all required biocompatibility endpoints per ISO 10993.

| Description | Subject Device (Model<br>ST) (K221178) | Predicate Devices B<br>(K192677) | Remark |
|----------------------------|----------------------------------------|----------------------------------|--------|
| Proprietary/<br>trade name | Disposable Insulin<br>Pen Needle | Safety Insulin Pen Needle | / |
| Product Code | FMI | FMI | Same |
| Regulation No. | 21 CFR 880.5570 | 21 CFR 880.5570 | Same |
| Class | II | II | Same |

## 7.2Comparison between Model ST Disposable Insulin Pen Needle and Predicate Device B

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| 510(k) Notification document-Disposable Insulin Pen Needle | | | K221178 |
|------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Indications<br>for use | Disposable Insulin Pen<br>Needle is intended for use<br>with pen injector device for<br>subcutaneous injection of<br>insulin. Additionally, it has<br>sharps injury protection<br>feature that it can reduce the<br>occurrence of accidental<br>needlesticks from the patient<br>end of the needle due to the<br>effect of safe-lock guard. | The Safety Insulin Pen<br>Needle is intended for use<br>with pen injector devices<br>for the subcutaneous<br>injection of insulin. The<br>attached safety shield<br>automatically locks after<br>injection and reduces the<br>occurrence of accidental<br>needle sticks from the<br>patient end of the needle. | Same |
| Prescription/over<br>-the counter use | Over-the counter use | Over-the counter use | Same |
| Environment<br>of use | Home, Health center | Home, Health center | Same |
| Intended users | For self-administration<br>or by a caregiver | For self-administration<br>or by a caregiver | Same |

| Hub/needle bond<br>strength | Conform with ISO 11608-2 | Conform with ISO 11608-2 | Same |
|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| Method of<br>attachment to<br>pen injector | Screw structure, conform with<br>ISO 11608-2 | Screw structure,<br>conform with ISO 11608-2 | Same |
| Needle tip<br>configuration | Tri-bevel edge needle | Tri-bevel edge needle | Same |
| Shelf life | 5 years | 3 years | Different<br>(Note 5) |
| Method of<br>activation for<br>the safety<br>mechanism | Before use, red slider is<br>hidden in the protective cap,<br>needle tip is in protective<br>jacket and seen. In use,<br>protective jacket is pressed<br>down and the needle tip is<br>exposed for injection.<br>After use, protective jacket<br>will rebound and red slider is<br>exposed in the transparent<br>protective jacket. The red<br>slider will be seen by user<br>and indicate that safe-lock<br>guard have be activated.<br>The needle cannot be used<br>again. | Before use, red slider is<br>exposed in the protective<br>cap, needle tip is in<br>protective jacket and seen.<br>In use, protective jacket is<br>pressed down and the<br>needle tip is exposed for<br>injection. After use,<br>protective jacket will<br>rebound and red slider is<br>hidden in the transparent<br>protective jacket. The red<br>slider will be not seen by<br>user and indicate that<br>safe-lock guard have be<br>activated. The needle<br>cannot be used again. | Similar<br>(Note 6) |
| Design<br>specifications<br>of the safety<br>mechanism | Dimensions | Slider:3.4mm<br>Protective<br>jacket:<br>10.3mm | Similar<br>(Note 7) |
| | Dimensions | unknown | |
| | Color | Slider:red<br>Protective<br>jacket:<br>colorless | |
| | Color | Slider:red<br>Protective<br>jacket:<br>colorless | |
| | Strength | $\leq$ 6N | |
| | Strength | unknown | |

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| 510(k) Notification document-Disposable Insulin Pen Needle | | | | K221178 |
|------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|-----------------------------------------------------------------------------------------------------|----------------------|
| | Outer<br>diameter | Length | | |
| Size(s) | 0.30mm | 5mm,8mm | Needle gauge:29G, 30G,<br>31G, 32G<br>Needle length:4mm, 5mm,<br>6mm, 8mm, 10mm | Similar<br>(Note 8) |
| | 0.25mm | 6mm,8mm | | |
| | 0.23mm | 4mm,8mm | | |
| Wall type | Thin-walled | | Thin-walled,<br>Extra-thin-walled | Similar<br>(Note 9) |
| Configuration<br>and Material | Needle tube | Stainless<br>steel<br>SUS304 | | |
| | Needle hub | PP | | |
| | Protective<br>cap | PP | | |
| | Spring | Stainless<br>steel<br>SUS304H | | |
| | Slider | PP | Needle tube ,Hub ,Spring,<br>Safety seat, Seal paper,<br>Outer container, Safety<br>shield, Housing | Similar<br>(Note 10) |
| | Protective<br>jacket | PP | | |
| | Needle<br>container | PP | | |
| | Lubricant | Silicon oil | | |
| | Adhesive | UV glue | | |
| | Seal | Medical<br>dialyzing<br>paper | | |
| Performance | Meet the requirements of<br>ISO 7864, ISO 9626, ISO<br>11608-2, ISO 23908 | | Complied with<br>ISO 7864:2016<br>ISO 9626:2016<br>ISO 11608-1:2014<br>ISO 11608-2:2012 | Similar<br>(Note 11) |
| Sterilization | EO Sterilization<br>SAL:10-6 | | EO Sterilization<br>SAL: 10-6 | Same |
| Biocompatibility | Meet the requirements of<br>ISO10993 series standards,<br>and the following tests are<br>performed: In vitro<br>cytotoxicity, skin<br>sensitization, intracutaneous<br>reactivity, acute systemic<br>toxicity, hemocompatibility,<br>subchronic toxicity,<br>particulate matter for<br>injections and pyrogen. | | Conform with ISO 10993<br>standards | Similar<br>(Note 12) |
| Reuse or<br>single use | Single use | | Single use | Same |
| | 510(k) Notification documents-Disposable Insulin Pen Needle | | K221178 | |
| Sharps injury<br>protection feature | Meet the requirements of<br>safe-lock guard activation<br>and safety overriding/<br>unlocking force after<br>activation (triggering<br>performance) as per ISO<br>23908. | With safety feature | Same | |
| Label/Labeling | Complied with<br>21 CFR part 801 | Complied with<br>21 CFR part 801 | Same | |
| Endotoxin Limit | 20 EU per device | 20 EU per device | Same | |

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Note 5: The shelf life of the predicate device B is 3 years. The shelf life of the subject device is 5 years according to the result of accelerated aging test by ASTM F88/F88M-2015, which will not affect the safety and effectiveness of the subject device.

Note 6: The method of activation for the safety mechanism is similar between the subject device and predicate device B. In fact, the structure of the safety mechanism is same, but the design of red slider (show the status of the activation) is opposite. Functionality of the safety mechanism has been verified by performing testing per ISO 23908:2011 Sharps injury protection-Requirements and test methods-Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling.

Note 7: The design specifications of the safety mechanism is similar between the subject device and predicate device B. The color is the same. The dimensions and strength of the subject device is unknown. The design specifications of the safety mechanism of subject device can achieve the function of preventing needlesticks, which is proved by various performance testing.

Note 8: The outer diameter(gauge) and length of the subject device are covered by the predicate device B. The performance bench testing of the outer diameter(gauge) and length for subject device are demonstrated to meet the requirements of ISO 7864, ISO 9626 and ISO 11608-2.

Note 9: The wall type of the subject device are covered by the predicate device B. The predicate device B has extra-thin-walled type, which is a difference. The performance bench testing of the thin-walled for subject device are demonstrated to meet the requirements of ISO 9626. This difference does not impact safety and effectiveness.

Note 10: The configuration of the subject device is mostly the same as the predicate device B, just the name is different. The materials of subject device are common materials and widely used for Insulin Pen Needle in the market, such as stainless steel SUS304,

PP, silicon oil, UV glue and Medical dialyzing paper. The safety of materials is demonstrated with the biocompatibility of final product.

Note 11: There are some differences in standards cited for conformance. These differences do not raise new questions of safety and effectiveness.

Note 12: Subject Device has been tested for additional subchronic toxicity and particulate matter for injections compared to the predicate device A.

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## 8.Performance testing summary

| Items | Summary |
|--------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterilization | Disposable Insulin Pen Needle is sterilized by EO gas and<br>the sterility assurance level (SAL) is 10⁻⁶. The process has<br>been validated according to ISO 11135: 2014 Sterilization of<br>health-care products – Ethylene oxide - Requirements for the<br>development, validation and routine control of a sterilization<br>process for medical devices. The maximum EO residual that<br>remain on the device is less than 0.8mg, the maximum ECH<br>residual that remain on the device should be less than<br>1.8mg according to ISO 10993-7:2008 Biological evaluation<br>of medical devices - Part 7: Ethylene oxide sterilization<br>residuals. |
| Product performance | After sterilization, Disposable Insulin Pen Needle meets<br>criteria specified in ISO 11608-2: 2012 Needle-based<br>injection systems for medical use – Requirements and test<br>methods - Part 2: Needles; ISO 9626: 2016 Stainless steel<br>needle tubing for the manufacture of medical devices -<br>Requirements and test methods; ISO 7864: 2016 Sterile<br>hypodermic needles for single use - Requirements and test<br>methods and other applicable standards. |
| Functional compatibility with<br>needle-based injection<br>systems | Selected the insulin pens of commonly used in the U.S.<br>market for compatibility verification. The tests have been<br>completed, the insulin pens which are declared in the label<br>are compatible with the needle. |
| Transport | The simulated transportation test has been completed<br>according to the requirements of ASTM D4169-16<br>Standard Practice for Performance Testing of Shipping<br>Containers and Systems. Model CT and Model ST of the<br>products are implemented simulated transportation test.<br>The test result is passed. |
| Shelf life | The performance of ISO 11608-2, chemical properties,<br>bacterial endotoxin and leakage test (according to ASTM<br>F1929-2015) of Model CT and Model ST have been tested<br>individually before accelerated aging, after 4 years of<br>accelerated aging and 5 years of accelerated aging.<br>According to the accelerated aging test results, the shelf<br>life of the product is determined to be 5 years. |
| Biocompatibility | Disposable Insulin Pen Needle meets the requirements of<br>ISO 10993 series standards, and the following tests are<br>performed: Cytotoxicity, skin sensitization, intracutaneous<br>reactivity, acute systemic toxicity, hemocompatibility,<br>subchronic toxicity and material-mediated pyrogenicity.<br>With the requirement of USP <788>, particulate matter for<br>injections also is performed. |
| Sharps protection features | Model ST product meets the requirements of safe-lock<br>guard activation and safety overriding/unlocking force after<br>activation(triggering performance) as per ISO 23908:2011<br>Sharps injury protection-Requirements and test methods-<br>Sharps protection features for single-use hypodermic<br>needles, introducers for catheters and needles used for<br>blood sampling |
| Clinical simulated use testing | Model ST of Disposable Insulin Pen Needle is a sterile, single-use medical device with an integral sharps injury prevention feature, intended for use with pen injector device for subcutaneous injection of insulin. According to ISO 23908:2011 Sharps injury protection-Requirements and test methods-Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling and Guidance for Industry and FDA Staff-Medical Devices with Sharps Injury Prevention Features, we have completed the test of clinical simulated use testing for sharps injury protection. The test results show that Model ST of the product has well sharps injury prevention feature. |
| The compatible pen injectors | 1. NovoPen Echo, K162602, Novo Nordisk Inc.<br>2. Humapen Luxura, K142518, Eli Lilly and Company<br>3. Humapen Luxura HD, K100988, Eli Lilly and Company<br>4. HumanPen Ergo II, K151686, Eli Lilly and Company |

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## 510(k) Notification documents-Disposable Insulin Pen Needle

K221178

## Conclusions

Based on device comparison information and non-clinical bench testing, the subject device is substantially equivalent to the predicate device.