Disposable Pen Injector Assembly

K240961 · Wuxi Nest Biotechnology Co., Ltd. · FMF · Aug 15, 2024 · General Hospital

Device Facts

• Record ID: K240961
• Device Name: Disposable Pen Injector Assembly
• Applicant: Wuxi Nest Biotechnology Co., Ltd.
• Product Code: FMF · General Hospital
• Decision Date: Aug 15, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Disposable Pen Injector Assembly is a disposable pen injector designed for single patient use by diabetics for the subcutaneous self-injection of a desired dose insulin. The disposable pen injector assembly uses 3 mL cartridge of HUMALOGTM (U-100, insulin lispro for injection), and a single use detachable and disposable insulin pen needle (supplied separately). The pen injector allows the user to dial the desired dose up to 80 units in 1 unit increments. It is intended for general population.

Device Story

Disposable pen injector for subcutaneous insulin delivery; manual operation by patient. Input: 3 mL insulin cartridge (HUMALOG U-100) and detachable insulin pen needle. Mechanism: user dials dose (1-80 units, 1-unit increments) via mechanical interface; internal piston mechanism delivers insulin. Used in home healthcare environment. Output: precise insulin dose delivery. Benefits: enables self-administration of insulin for diabetes management. Device is single-patient use and disposable.

Clinical Evidence

No clinical data. Bench testing only. Verification tests confirm compliance with ISO 11608-1:2022 for dose accuracy and needle-based injection system requirements. Biocompatibility testing performed per ISO 10993-1, -5, -10, and -23. Shelf life validated per ASTM F1980-16; transportation testing per ASTM D4169:2022.

Technological Characteristics

Mechanical pen injector; 3 mL cartridge capacity; 1-80 unit dose range; 1-unit increments. Materials evaluated for biocompatibility (cytotoxicity, sensitization, irritation). Standards: ISO 11608-1:2022 (dose accuracy), ISO 10993 series (biocompatibility), ASTM F1980-16 (shelf life), ASTM D4169:2022 (transportation). Non-sterile, single-patient use, disposable. No software or electronic components.

Indications for Use

Indicated for diabetics in the general population requiring subcutaneous self-injection of insulin using 3 mL HUMALOG (U-100) cartridges.

Regulatory Classification

Identification

A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

Predicate Devices

• NovoPen Echo® (K182387)

Submission Summary (Full Text)

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August 15, 2024

Wuxi NEST Biotechnology Co., Ltd. % Ryan Li, Consultant ICAS Group No.155 Pingbei Road, Minhang District Shanghai, 201109, China

Re: K240961

Trade/Device Name: Disposable Pen Injector Assembly Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: July 16, 2024 Received: July 16, 2024

Dear Ryan 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 (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" (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).

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

Sincerely,

# Shruti N. Mistry -S

Shruti Mistry Assistant Director Division of Drug Delivery and General Hospital Devices, and Human Factors 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) K240961

Device Name Disposable Pen Injector Assembly

#### Indications for Use (Describe)

The Disposable Pen Injector Assembly is a disposable pen injector designed for single patient use by diabetics for the subcutaneous self-injection of a desired dose insulin. The disposable pen injector assembly uses 3 mL cartridge of HUMALOGTM (U-100, insulin lispro for injection), and a single use detachable and disposable insulin pen needle (supplied separately). The pen injector allows the user to dial the desired dose up to 80 units in 1 unit increments. It is intended for general population.

Type of Use (Select one or both, as applicable)

| <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |
|--------------------------------------------------------------------------------------|----------------------------------------------------------------------|
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#### 510(k) Summary - K240961

#### I. Submitter Information

Submitter Name: Wuxi NEST Biotechnology Co., Ltd. Submitter Address: No. 530, Xida Road, Meicun Industrial Park, Xinwu District, Wuxi, Jiangsu, China Contact Person: Cheng Zhiwei Position: Registration Director Tel.: [phone]-5021 Email: [e-mail]

Date of Preparation: August 12, 2024

#### II. Proposed Device

Device Trade Name: Disposable Pen Injector Assembly Common Name: Pen-injector Classification Name: Piston Syringe Regulation Number: 21 CFR 880.5860 Regulatory Class: Class II Product Code: FMF Review Panel: General Hospital

# III. Predicate Device

#### Primary predicate device

510(k) Number: K182387 Trade Name: NovoPen Echo®

### IV. Device Description

The Disposable Pen Injector Assembly is a disposable single-patient use pen injector capable of injecting a dose of up to 80 units of insulin in 1 unit increments. The pen injector is intended for use with 3mL insulin cartridges and single-use, disposable insulin pen needles (supplied separately). After the intended insulin cartridge is used up, the Disposable Pen Injector Assembly should be disposed. The Disposable Pen Injector Assembly is intended for single user only and provided non-sterile.

### V. Indication for use

The Disposable Pen Injector Assembly is a disposable pen injector designed for single patient use by diabetics for the subcutaneous self-injection of a desired dose insulin. The disposable pen injector assembly uses 3 mL cartridge of HUMALOGTM (U-100, insulin lispro for injection), and a single use detachable and disposable insulin pen needle (supplied separately). The pen injector allows the user to dial the desired dose from 1 to up to 80 units in 1 unit increments. It is intended for general population.

VI. Comparison of technological characteristics with the predicate devices The following table summarizes the proposed device technological characteristics

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| Item | Proposed Device | Primary Predicate Device<br>(K182387) | Discussion |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Product Name | Disposable Pen Injector Assembly | NovoPen Echo® | N/A |
| Product Code | FMF | FMF | Same |
| Regulation No. | 21 CFR 880.5860 | 21 CFR 880.5860 | Same |
| Class | Class II | Class II | Same |
| Indications for Use | The Disposable Pen Injector Assembly is a disposable pen injector designed for single patient use by diabetics for the subcutaneous self-injection of a desired dose insulin. The disposable pen injector assembly uses 3 mL cartridge of HUMALOGTM (U-100, insulin lispro for injection), and a single use detachable and disposable insulin pen needle (supplied separately). The pen injector allows the user to dial the desired dose up to 80 units in 1 unit increments. It is intended for general population. | The NovoPen Echo® is a re-useable pen injector designed for single patient use by diabetics for the self-injection of a desired dose of insulin. The pen injector uses PenFill® 3 mL cartridge of NovoLog®, 100 units/mL (U-100) [insulin aspart injection], Fiasp® 100 units/mL (U-100) [insulin aspart injection], and a single use detachable and disposable pen needle (supplied separately). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in 0.5 unit increments | Different<br>Note 1 |
| User Environment | Home healthcare environment | Home healthcare environment | Same |
| Reusable Device | No | Yes | Different<br>Note 2 |
| Compatible Cartridge Volume | 3 mL (300 units of U-100 insulin) | 3 mL (300 units of U-100 insulin) | Same |
| Dose Accuracy | Meets ISO 11608-1:2022 requirements | Meets ISO 11608-1:2014 requirements | Same |
| Dial Increments | 0.01 mL per increment providing one unit (1U) dose increments | 0.005 mL per increment providing half unit (0.5U) dose increments | Different<br>Note 3 |
| Maximum Delivered Dose | 80 Units | 30 Units | Different<br>Note 4 |
| Shelf Life | 5 years | 5 years | Same |
| Biocompatibility | Cytotoxicity<br>Skin Sensitization<br>Irritation | Unknown | Different<br>Note 5 |
| Sterility | Not a sterile device | Not a sterile device | Same |

with compared to the predicate device under K182387.

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## Discussion

# Note 1

The first difference in indications for use is that the proposed device is a disposable device while the predicate device is a reusable device. This difference does not affect the substantial equivalence because the risk of single use is lower compared to the multiple use risk of the predicate device. Another is the difference in maximum delivered dose and dial increments: The subject pen injector allows the user to dial the desired dose from 1 to up to 80 units in 1 unit increments, where the predicate pen injector allows the user to dial the desired dose from 0.5 to 30 units in 0.5 unit increments. The third difference is the intended insulin brand: The subject pen injector uses 3 mL cartridge of HUMALOG (U-100, insulin lispro for injection), where the predicate pen injector uses PenFill® 3 mL cartridge of NovoLog®, 100 units/mL (U-100) [insulin aspart injection] and Fiasp® 100 units/mL (U-100) [insulin aspart injection]. These differences do not affect the substantial equivalence because adequate performance of the subject device has been demonstrated by testing per ISO 11608-1: 2022.

# Note 2

The proposed device is disposable while the predicate device is reusable. However, this difference does not affect the substantial equivalence because the risk of single use is lower compared to the multiple use risk of the predicate device.

# Note 3

Although the dial increments between the proposed device and the predicate device are different, corresponding performance tests were conducted on the proposed device to demonstrate its compliance with the ISO 11608-1: 2022 standard. Therefore, this difference would not affect the substantial equivalence.

# Note 4

Although the maximum delivered dose between the proposed device and the predicate device is different, corresponding performance tests were conducted on the proposed device to demonstrate that its dose accuracy performance complies with the ISO 11608-1: 2022 standard. Therefore, this difference would not affect the substantial equivalence.

# Note 5

The biocompatibility tests were conducted to demonstrate the proposed device's biological safety for its intended use. Therefore, this difference would not affect the substantial equivalence.

# VII. Performance Data

## Non-Clinical Performance Test Conclusion

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## Biocompatibility

The proposed device, Disposable Pen Injector Assembly is categorized as skin contact with a duration of category A-limited (<24hrs) according to FDA guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part1: Evaluation and testing within a risk management process". The Biocompatibility tests were conducted to verify that the proposed devices are safe for contacting human skinbased on the following standards:

- ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation and ● testing within a risk management process
- . ISO 10993-5:2009 Biological evaluation of medical devices- Part 5: Test for in vitro cytotoxicity
- ISO 10993-10:2021 Biological evaluation of medical devices - Part 10: Tests for skin sensitization
- . ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation

## Performance Testing

Device Verification Tests confirm that Disposable Pen Injector Assembly meets the requirements of ISO 11608-1:2022 Needle-based injection systems for medical use -Requirement and test methods - Part 1: Needle-based injection systems.

The Disposable Pen Injector Assembly is intended to be used with 3mL insulin cartridges. Therefore, the dose accuracy performance test of FDA clear insulin cartridges with Disposable Pen Injector Assembly was performed which meets the requirements of ISO 11608-1:2022.

## Shelf Life

The Disposable Pen Injector Assembly has a five-year shelf life. For shelf life, in accordance with ASTM F1980-16, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices, aging studies have been conducted to verify a fiveyear shelf life of the proposed device and ensure that its functionality is successfully maintained throughout the duration of this shelf life.

## Simulated Transportation

A test is conducted according to ASTM D4169:2022 to demonstrate the proposed device could function as intended after transportation.

## Clinical Test Conclusion

No clinical study is included in this submission.

## VIII. Conclusion

The conclusion drawn from the non-clinical tests demonstrates that the proposed device, Disposable Pen Injector Assembly is as safe, as effective, and performs as well as the legally marketed predicate device NovoPen Echo® (K182387).