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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 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.

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.

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.

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