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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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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 <X%"). The reported data (Table 2) implicitly serves as the performance demonstration against an unstated or assumed acceptance level for viral viability.

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

• Test Set Description: The test set comprised commercial strains of three viruses: Influenza A virus A/PR/8/34 H1N1, Rhinovirus Type 16, and Respiratory syncytial virus Type A.
• Sample Size for each virus: For each virus, three different lots of the preservation solution (080921ES1, 040121PS, 101020E01) were tested. For each lot, an initial virus titer was established at 0 hours. Then, at two different temperatures (23-25 ℃ and 2-8 ℃) and two different time points (24 and 48 hours), the viral recovery was assessed. Each time point was assessed in triplicate.
  • Calculation: 3 viruses * 3 lots * (1 initial + 2 temperatures * 2 timepoints) * 3 replicates = 3 * 3 * (1 + 4) * 3 = 135 samples (or measurements) per lot, for a total of 405 samples/measurements across all lots and viruses.
• Data Provenance: The data appears to be prospective, generated specifically for this premarket notification. The clinical matrix (negative clinical nasopharyngeal matrix) was collected from healthy subjects. The country of origin of the data is not explicitly stated, but the company is Wuxi NEST Biotechnology Co., Ltd., which is based in Wuxi, China.

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

This study does not involve human readers or experts establishing ground truth in the traditional sense for diagnostic performance. Ground truth for viral recovery is based on laboratory measurements of viral activity (plaque-forming units) after exposure to the transport media.

4. Adjudication Method for the Test Set

Not applicable. This is a non-clinical, laboratory-based viral recovery study, not a study involving human interpretation or adjudication of diagnostic images/results.

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

No. This is a non-clinical laboratory study of a viral transport medium, not a study evaluating human reader performance with or without AI assistance.

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

No. This device is a viral transport medium, not an algorithm or AI device. The study evaluates the standalone performance of the transport medium in preserving viral viability.

7. The Type of Ground Truth Used

The ground truth used is laboratory culture results, specifically the measurement of Mean Virus Titer (x10^4 PFU/mL - Plaque-Forming Units per Milliliter). This directly quantifies the viable viral particles recovered.

8. The Sample Size for the Training Set

No training set is mentioned or applicable. This is a non-clinical performance evaluation of a medical device, not an AI/machine learning model that requires training data.

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

Not applicable, as there is no training set for this type of device and study.

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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:

Study Details:

1. Sample Size Used for Test Set and Data Provenance:

   • LoD Test Set:
     • Preliminary LoD: 5 replicates per concentration for each of the 3 viruses (Adenovirus, Influenza A, Parainfluenza 2 virus) at multiple concentrations (1.0x10^4, 1.0x10^3, 5.0x10^2, 1.0x10^2 copies/mL).
     • Confirmatory LoD: 20 replicates per virus (Adenovirus, Influenza A, Parainfluenza 2 virus) at 5.0x10^2 copies/mL.
   • Viral Stability Test Set: At least 20 replicates for each virus (Adenovirus, Influenza A, Parainfluenza 2 virus) per time point (Day 0, 9, 15) and storage condition (4°C, 25°C). This means a total of 20 x 3 x 2 = 120 samples per virus for stability, across 3 lots.
   • Inactivation Test Set: Not explicitly stated as a number of replicates, but the method suggests controlled laboratory experiments comparing virus only, virus + NEST ITM, and NEST ITM only.
   • Data Provenance: The studies were conducted by Wuxi Nest Biotechnology Co., Ltd. The data is based on laboratory testing of synthetic viral material (spiked into contrived matrix) rather than patient samples. No mention of country of origin of data beyond the manufacturer's location (China). These are non-clinical, prospective studies designed to evaluate product performance.

2. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications of those Experts:

   • Not applicable. This is a non-clinical, in-vitro diagnostic device component. The "ground truth" for these tests is the known concentration of spiked virus or the measured reduction in viral titer / preservation of nucleic acids using validated laboratory assays (e.g., PCR, TCID50). There's no human expert adjudication of images or clinical outcomes in these studies.

3. Adjudication Method for the Test Set:

   • Not applicable. As described above, these are lab-based quantitative measurements using predefined assay thresholds and controls.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

   • No. This type of study is typically performed for AI/ML diagnostic aids for image interpretation or similar tasks that directly assist human readers. This device is a sample transport media.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is not an algorithm. The "performance" is the physical and chemical properties of the transport media.

6. Type of Ground Truth Used:

   • For LoD and Viral Stability: The "ground truth" is the known concentration of spiked virus (e.g., 5.0x10^2 copies/mL) and subsequent detection/quantification using validated molecular methods (PCR, measured in Ct values).
   • For Inactivation: The "ground truth" is the initial viral titer (TCID50) and the measured reduction in viable virus after exposure to the transport media, assessed by absence of cytopathic effect (CPE) in cell culture.

7. Sample Size for the Training Set:

   • Not applicable. This is not an AI/ML device that requires a training set. The device formulation and manufacturing processes are developed through R&D and quality control, not machine learning.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable.

In summary, the document details the rigorous non-clinical laboratory testing performed to demonstrate that the NEST ITM meets its functional performance requirements for viral inactivation, nucleic acid stabilization, and detection limit, thereby supporting its substantial equivalence to the predicate device. The acceptance criteria and the proof align with the nature of a microbial nucleic acid storage and stabilization device.

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