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The Immucise Intradermal Injection System is indicated for intradermal injections of FDA approved drugs. The system is to be used in the deltoid region for infants aged two months (excluding low birth weight and/or preterm birth) to adults.

The Immucise Intradermal Injection System is a single use, electron beam radiation sterilized device that is designed to be used for intradermal injections of FDA approved drugs. This system consists of an Intradermal Injection Needle and an Immucise Syringe. The system is made of common materials used in needles and syringes. The Immucise Intradermal Injection Needle is comprised of a needle base. The Immucise Syringe is comprised of a barrel, a gasket and a plunger. The sterile Immucise Intradermal Injection Needle and Immucise Syringe are packed separately and assembled prior to use. The Immucise Intradermal Injection System is operated by a manual process.

Here's a breakdown of the acceptance criteria and study information for the Immucise Intradermal Injection System, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K181369) for an expanded indication (including infants). Therefore, the "acceptance criteria" are largely implied by meeting the same performance standards as the predicate, or by achieving successful outcomes in functionality tests.

2. Sample Size and Data Provenance for Test Set:

• Bench Test: No specific sample sizes for "non-aged and aged samples" are provided in this document, but it refers to the prior submission K181369. Data provenance is not explicitly stated beyond "performed in K181369."
• Animal Test: No specific sample sizes for the animal study are provided in this document. The data provenance is Terumo (Japan). The study was conducted specifically to support the expanded indication, suggesting it was prospective for this submission, though the methodology was based on a previous study.

3. Number of Experts and Qualifications for Ground Truth (Test Set):

• Neither the bench tests nor the animal studies described in this document involved human experts establishing ground truth in the way a clinical study with image interpretation might.
• For the animal study, the "ground truth" (e.g., successful wheal formation, validated injection depth) would have been assessed by trained personnel through observation and potentially histological analysis. No specific number or qualifications of experts are mentioned.

4. Adjudication Method for Test Set:

• This type of information (e.g., 2+1, 3+1) is typically relevant for studies involving subjective human interpretation, such as radiology reads.
• For bench and animal studies (focused on objective measurements and physiological responses), such adjudication methods are not applicable. The assessment would be based on predefined protocols and measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done.
• This device is a physical medical device (intradermal injection system), not an AI-powered diagnostic tool that human readers would use in conjunction with. The comparative effectiveness focused on technical performance against a reference device, not human reader improvement with AI.

6. Standalone (Algorithm Only) Performance:

• No, standalone performance was not done.
• Again, this is a physical medical device. The concept of "algorithm only" performance is not applicable here as there is no AI algorithm involved in its direct function. The device's performance is its physical function.

7. Type of Ground Truth Used:

• Bench Test: Physical and functional measurements against predefined specifications (e.g., durability, material properties, dimensional accuracy).
• Animal Test: Direct physiological observations (wheal formation) and histological evaluation for injection depth, based on in-house standards designed to confirm intended physiological effects of intradermal injection.

8. Sample Size for Training Set:

• This concept is not applicable for this device. This is a physical medical device, not a machine learning model that requires a training set. The "training" in the context of device development would refer to design iterations and engineering testing, not data used to train an algorithm.

9. How Ground Truth for Training Set Was Established:

• Not applicable, as there is no training set in the context of machine learning. The "ground truth" for the device's design and engineering would be established through established engineering principles, material science, and regulatory standards.

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The Immucise Intradermal Injection System is indicated for intradermal injections of FDA approved drugs. The system is to be used in the deltoid region for adults.

The Immucise Intradermal Injection System is a single use, electron beam radiation sterilized device that is designed to be used for intradermal injections of FDA approved drugs. The system consists of a needle and syringe that are packed separately and assembled prior to use. The Immucise Intradermal Injection Needle consists of a needle tube and needle base, and the Immucise Syringe consists of a barrel, gasket and plunger.

The Immucise Intradermal Injection System, intended for intradermal injections of FDA approved drugs in the deltoid region for adults, did not undergo a comparative effectiveness study with human readers assisted by AI, nor a standalone AI algorithm performance study, as it is a medical device (needle and syringe system) rather than an AI-powered diagnostic or therapeutic tool. Therefore, sections pertaining to MRMC effect size, standalone AI performance, sample sizes for test/training sets, data provenance, number and qualifications of experts, and adjudication methods for AI performance are not applicable.

The device's performance was evaluated through a series of non-clinical tests (bench, animal, human factors, biocompatibility, sterilization, and packaging) to demonstrate substantial equivalence to predicate devices and ensure it met predetermined acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance: Not applicable. The "test set" in this context refers to the samples of the device used for the various non-clinical performance evaluations. The provenance of these samples would be the manufacturer's production line in Japan (Kofu Factory of Terumo Corporation). All testing was conducted prospectively as part of the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This refers to the evaluation of the medical device's physical and functional properties against established engineering and biological standards, not diagnostic or interpretive tasks requiring expert ground truth in the context of AI studies.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This refers to consensus methods for establishing ground truth, typically in image interpretation or diagnostic performance studies. The performance of this device was assessed against objective, measurable criteria defined by international standards (ISO, USP) and in-house 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. The Immucise Intradermal Injection System is a medical device (needle and syringe system), not an AI-powered diagnostic or therapeutic tool for which such studies would be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The Immucise Intradermal Injection System is a medical device, not an AI algorithm. Its performance is inherent to its physical design and manufacturing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for the device's performance was established by:
* Bench Testing: Adherence to international standards (ISO, USP) and in-house established specifications.
* Animal Study: Direct observation of wheal formation and histopathological evaluation of injection depth.
* Human Factors and Usability Engineering Study: Observation of user interaction to identify potential use-errors that could cause serious harm, as per FDA guidance.
* Biocompatibility: Results of standardized biological tests (e.g., cytotoxicity, sensitization) evaluated against ISO 10993-1 criteria.
* Sterilization: Demonstrated Sterility Assurance Level (SAL) of 10-6 per ISO 11137 standards.
* Packaging: Verification of package integrity against ISTA 3A standards.

8. The sample size for the training set: Not applicable. This device is not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established: Not applicable. As the device is not an AI algorithm, there is no training set or associated ground truth.

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