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 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.

AI/ML Overview

This document describes the FDA's decision regarding the 510(k) premarket notification for the "Disposable Pen Injector Assembly" from Wuxi NEST Biotechnology Co., Ltd. It outlines the device's characteristics, comparison to a predicate device, and performance data used to establish substantial equivalence.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Disposable Pen Injector Assembly are primarily based on meeting the requirements of ISO 11608-1:2022 Needle-based injection systems for medical use - Requirement and test methods - Part 1: Needle-based injection systems.

Acceptance Criteria / Performance Aspect	Standard / Requirement	Reported Device Performance
Dose Accuracy	ISO 11608-1:2022 requirements	Meets ISO 11608-1:2022 requirements. Performance test with FDA-cleared insulin cartridges (3mL) demonstrated compliance.
Biocompatibility	ISO 10993-1: Evaluation and testing within a risk management process ISO 10993-5:2009: Test for in vitro cytotoxicity ISO 10993-10:2021: Tests for skin sensitization ISO 10993-23:2021: Tests for irritation	Biocompatibility tests were conducted and verified that the proposed devices are safe for contacting human skin. The device is categorized for skin contact, duration A-limited (<24hrs). Specific results for each test are not detailed but the conclusion is positive.
Shelf Life	ASTM F1980-16: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices	A five-year shelf life is claimed. Aging studies conducted in accordance with ASTM F1980-16 verified this shelf life and maintained functionality.
Simulated Transportation	ASTM D4169:2022	A test was conducted according to ASTM D4169:2022 and demonstrated that the device could function as intended after transportation.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify sample sizes for any of the performance tests (Dose Accuracy, Biocompatibility, Shelf Life, Simulated Transportation).

The data provenance is from non-clinical performance tests conducted by the manufacturer, Wuxi NEST Biotechnology Co., Ltd., in China. The data is retrospective, as it was submitted as part of the 510(k) premarket notification.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document. The tests performed are primarily engineering and technical performance tests based on established ISO and ASTM standards, rather than clinical studies requiring expert ground truth for interpretation of medical images or patient outcomes.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. The studies are non-clinical performance tests against defined international standards, not studies involving human perception or interpretation where adjudication would be necessary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "No clinical study is included in this submission."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done

This question is not applicable as the device is a physical medical device (pen injector) and not an AI/algorithm-based software device. The performance tests are for the physical device's mechanics and material properties.

7. The Type of Ground Truth Used

The ground truth used for these studies is based on:

Compliance with international standards: ISO 11608-1:2022 for dose accuracy, ISO 10993 series for biocompatibility, and ASTM standards for shelf life and simulated transportation. These standards define the acceptable performance parameters and test methods.
Material properties and physical functionality: The device's ability to precisely deliver insulin, its biological safety with human contact, and its durability under various conditions.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical product, not an AI/machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set for a physical medical device like this.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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

Prescription Use (Part 21 CFR 801 Subpart D)	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.: +86-0510-68006788-5021 Email: project01@nest-wuxi.com

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

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(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	DifferentNote 1
User Environment	Home healthcare environment	Home healthcare environment	Same
Reusable Device	No	Yes	DifferentNote 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	DifferentNote 3
Maximum Delivered Dose	80 Units	30 Units	DifferentNote 4
Shelf Life	5 years	5 years	Same
Biocompatibility	CytotoxicitySkin SensitizationIrritation	Unknown	DifferentNote 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).

Regulation Number and Section

§ 880.5860 Piston syringe.

(a)
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.(b)
Classification. Class II (performance standards).