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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.

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The Pen Injector is a re-usable pen injector designed for single patient use by diabetics for the self-injection of a desired dose of insulin. The Pen Injector uses HUMALOG (insulin lispro) injection (U-100) available in 3 mL cartridges, and a single use detachable and disposable insulin pen needle (supplied separately, needle sizes including: 32G4mm, 31G4mm, 31G5mm, and 31G6mm).

The Pen Injector is a reusable mechanical pen-injector capable of injecting a dose of up to 80 units of insulin, in 1 unit increments. The Pen Injector consists of a pen injector body, a push block, a injection button, a dose display window, a dose adjustment knob, a reservoir and a pen injector cap. The intended dose is mechanically set by rotating a dose adjustment knob. The insulin is injected by depressing the knob which mechanical coupling causes the piston in the insulin cartridge to move forward thereby expelling the intended dose. The Pen Injector is intended for single user and provided for non-sterile.

The provided document describes the FDA 510(k) clearance for the Wuxi NEST Biotechnology Co., Ltd. Pen Injector (K240774). The acceptance criteria and supporting studies are primarily focused on performance testing to demonstrate substantial equivalence to the predicate device, NovoPen Echo® (K182387).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes (e.g., number of devices, cartridges, or test repetitions) used for each individual performance test (dose accuracy, injection force, injection time, biocompatibility, shelf life, service life, transportation). It generally states that "corresponding performance tests were conducted" or "aging studies have been conducted."

The provenance of the data is from Wuxi NEST Biotechnology Co., Ltd. in China, and the studies are prospective in nature, conducted specifically to demonstrate the performance of the Pen Injector for this submission.

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

This information is not applicable to the reported studies. The performance tests rely on objective measurements against established international standards (ISO, ASTM) and not on human expert interpretation or ground truth establishment in a medical context.

4. Adjudication Method for the Test Set

Not applicable. The tests are based on direct physical and chemical measurements against pre-defined thresholds from international standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a mechanical pen injector, not an AI-powered diagnostic or imaging device, so MRMC studies or human reader performance with AI assistance are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This refers to the core performance testing of the device (dose accuracy, injection force, etc.) which demonstrates the standalone capabilities of the Pen Injector mechanism without human-in-the-loop performance evaluation in a clinical setting. The tests confirm the device's inherent mechanical functionalities meet the specified standards.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests outlined is defined by:

• International Standards: ISO 11608-1:2022 (for injection system performance), ISO 10993 series (for biocompatibility), ASTM F1980-16 (for accelerated aging/shelf life), and ASTM D4169:2022 (for transportation).
• Device Specifications: The inherent design parameters and intended performance of the Pen Injector (e.g., maximum dose, dial increments, service life).

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical medical device, not an AI/machine learning model, so there is no concept of a "training set."

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

Not applicable, as no training set is involved for this type of device.

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The NEST Disposable Sampler (Viral Transport Medium) is intended for the collection and transport of upper respiratory clinical specimens to the laboratory for standard diagnostic or identification techniques. The Viral Transport Medium can be used in the laboratory to perform culture, isolation and detection of upper respiratory viruses including Influenza A, Rhinovirus, and Respiratory Syncytial Virus (RSV).

The Disposable Sampler Viral Transport Media is composed of preservation tubes filled with VTM (Viral Transport Media), kitted with or without swabs, depending on the product type. The Disposable Sampler Viral Transport Media is composed of Sodium chloride, Disodium hydrogen phosphate dodecahydrate, Potassium chloride, Potassium dihydrogen phosphate, Magnesium sulfate heptahydrate, Glucose, HEPES, Sodium bicarbonate, Fluconazole, Gentamicin sulfate, Griseofulvin, Polymyxin sulfate, Phenol red (optional), Sodium hydroxide, Calcium chloride, Bovine serum albumin and L-Cysteine. The preservation tube is made of medical-grade polypropylene materials. For both oropharyngeal and nasopharyngeal swabs, the swab head is made of flocked nylon fiber, and the rod is made of ABS (acrylonitrile butadiene styrene).

The document describes a 510(k) premarket notification for the "Disposable Sampler Viral Transport Media" by Wuxi NEST Biotechnology Co., Ltd. The study conducted is a non-clinical performance test focusing on culture-based viral recovery.

Here's an analysis of the provided information according to your requested components:

1. Table of Acceptance Criteria and Reported Device Performance

*Note: The document states the device "meets the performance specifications," but does not explicitly list what those specifications are in a quantitative manner (e.g., "attenuation rate must be

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NEST ITM is an enclosed system intended for the collection, inactivation stabilization and transportation of pharyngeal and nasal swabs suspected of containing adenovirus, influenza A virus or parainfluenza virus 2 from the collection site to the testing laboratory. The specimen transported in NEST ITM can be used for molecular detection in the laboratory.

The NEST ITM is a medical-grade Polypropylene preservation tube (5 mL and 10 mL) filled with 2.5 mL ITM Inactivated Transport Media for 5 mL tube or 3 mL Inactive Transport Media for 10 mL tube, with or without the sterile swabs. NEST ITM is composed of Guanidine isothiocyanate, TCEP, sodium acetate, PEG-6000, Tris, Hcl, purified water in order to inactivate infectious unprocessed oropharyngeal and nasopharyngeal samples which are suspected of containing adenovirus, influenza A virus or parainfluenza virus 2 from human samples. For both oropharyngeal and nasopharyngeal swabs, the swab head is made of flocked nylon fiber, and the rod is made of ABS (acrylonitrile butadiene styrene).

The provided text describes the non-clinical performance data for the "Disposable Sampler Inactivated Transport Media (NEST ITM)". This device is a microbial nucleic acid storage and stabilization device, not an AI/ML-based device. Therefore, many of the requested criteria related to AI/ML device performance (e.g., human-in-the-loop, MRMC studies, ground truth establishment for deep learning models) are not applicable.

However, I can extract information related to the device's functional performance, which serves as its "acceptance criteria" for demonstrating substantial equivalence to a predicate device.

Here's the relevant information:

Device: Disposable Sampler Inactivated Transport Media (NEST ITM)
Purpose: Collection, inactivation, stabilization, and transportation of pharyngeal and nasal swabs suspected of containing adenovirus, influenza A virus, or parainfluenza virus 2 for molecular detection.

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for this device are its ability to:

1. Inactivate target viruses rapidly.
2. Preserve the nucleic acids of the target viruses over a specified period and temperatures (stability).
3. Detect the target viruses at a low concentration (Limit of Detection - LoD).

Table of Acceptance Criteria and Reported Device Performance:

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