(174 days)
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:
| Test Category | Test Name | Standard / Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Bench Testing | Cleanliness | ISO 7864:2016 Section 4.3 | Met predetermined acceptance criteria. |
| Limits for acidity or alkalinity | ISO 7864:2016 Section 4.4 | Met predetermined acceptance criteria. | |
| Limits for extractable metals | ISO 7864:2016 Section 4.5 | Met predetermined acceptance criteria. | |
| Positive pressure liquid leakage | ISO 7864:2016 Section 4.8.1; ISO 80369-7:2016 Section 6.1 | Met predetermined acceptance criteria. | |
| Sub-atmospheric pressure air leakage | ISO 7864:2016 Section 4.8.1; ISO 80369-7:2016 Section 6.2 | Met predetermined acceptance criteria. | |
| Stress cracking | ISO 7864:2016 Section 4.8.1; ISO 80369-7:2016 Section 6.3 | Met predetermined acceptance criteria. | |
| Resistance to separation from axial load | ISO 7864:2016 Section 4.8.1; ISO 80369-7:2016 Section 6.4 | Met predetermined acceptance criteria. | |
| Resistance to separation from unscrewing | ISO 7864:2016 Section 4.8.1; ISO 80369-7:2016 Section 6.5 | Met predetermined acceptance criteria. | |
| Resistance to overriding | ISO 7864:2016 Section 4.8.1; ISO 80369-7:2016 Section 6.6 | Met predetermined acceptance criteria. | |
| Surface finish and visual appearance (Needle tube) | ISO 7864:2016 Section 4.10.1; ISO 9626:2016 Section 5.2 | Met predetermined acceptance criteria. | |
| Cleanliness (Needle tube) | ISO 7864:2016 Section 4.10.1; ISO 9626:2016 Section 5.3 | Met predetermined acceptance criteria. | |
| Limits for acidity and alkalinity (Needle tube) | ISO 7864:2016 Section 4.10.1; ISO 9626:2016 Section 5.4 | Met predetermined acceptance criteria. | |
| Dimensions (Needle tube) | ISO 7864:2016 Section 4.10.1; ISO 9626:2016 Section 5.6 | Met predetermined acceptance criteria. | |
| Stiffness (Needle tube) | ISO 7864:2016 Section 4.10.1; ISO 9626:2016 Section 5.8 | Met predetermined acceptance criteria. | |
| Resistance to breakage (Needle tube) | ISO 7864:2016 Section 4.10.1; ISO 9626:2016 Section 5.9 | Met predetermined acceptance criteria. | |
| Resistance to corrosion (Needle tube) | ISO 7864:2016 Section 4.10.1; ISO 9626:2016 Section 5.10 | Met predetermined acceptance criteria. | |
| Freedom from defects | ISO 7864:2016 Section 4.10.3 | Met predetermined acceptance criteria. | |
| Lubricant | ISO 7864:2016 Section 4.10.4 | Met predetermined acceptance criteria. | |
| Needle point | ISO 7864:2016 Section 4.11 | Met predetermined acceptance criteria. | |
| Bond between hub and needle tube | ISO 7864:2016 Section 4.12 | Met predetermined acceptance criteria. | |
| Patency of lumen | ISO 7864:2016 Section 4.13 | Met predetermined acceptance criteria. | |
| Needle length | In-house Standard | Met predetermined acceptance criteria. | |
| Bevel length | In-house Standard | Met predetermined acceptance criteria. | |
| Needle hub strength | In-house Standard | Met predetermined acceptance criteria. | |
| Dead volume | In-house Standard | Met predetermined acceptance criteria. | |
| General (Syringe) | ISO 7886-1:2017 Section 6.1 | Met predetermined acceptance criteria. | |
| Limits for acidity or alkalinity (Syringe) | ISO 7886-1:2017 Section 6.2 | Met predetermined acceptance criteria. | |
| Limits for extractable metals (Syringe) | ISO 7886-1:2017 Section 6.3 | Met predetermined acceptance criteria. | |
| Lubricant (visual inspection - Syringe) | ISO 7886-1:2017 Section 7 | Met predetermined acceptance criteria. | |
| Lubricant (quantity - Syringe) | ISO 7886-1:2017 Section 7 | Met predetermined acceptance criteria. | |
| Tolerance on graduated capacity | ISO 7886-1:2017 Section 8 | Met predetermined acceptance criteria. | |
| Barrel (rotation of flange) | ISO 7886-1:2017 Section 10 | Met predetermined acceptance criteria. | |
| Barrel (visual inspection of flange) | ISO 7886-1:2017 Section 10 | Met predetermined acceptance criteria. | |
| Plunger stopper /plunger assembly (Detachment of plunger stopper from plunger) | ISO 7886-1:2017 Section 11 | Met predetermined acceptance criteria. | |
| Piston /plunger assembly (Distance between plunger and flange) | ISO 7886-1:2017 Section 11 | Met predetermined acceptance criteria. | |
| Nozzle | ISO 7886-1:2017 Section 12.1; ISO 80369-7:2016 Section 5 | Met predetermined acceptance criteria. | |
| Positive pressure liquid leakage (Syringe) | ISO 7886-1:2017 Section 12.1; ISO 80369-7:2016 Section 6.1 | Met predetermined acceptance criteria. | |
| Sub-atmospheric pressure air leakage (Syringe) | ISO 7886-1:2017 Section 12.1; ISO 80369-7:2016 Section 6.2 | Met predetermined acceptance criteria. | |
| Stress cracking (Syringe) | ISO 7886-1:2017 Section 12.1; ISO 80369-7:2016 Section 6.3 | Met predetermined acceptance criteria. | |
| Resistance to separation from axial load (Syringe) | ISO 7886-1:2017 Section 12.1; ISO 80369-7:2016 Section 6.4 | Met predetermined acceptance criteria. | |
| Resistance to separation from unscrewing (Syringe) | ISO 7886-1:2017 Section 12.1; ISO 80369-7:2016 Section 6.5 | Met predetermined acceptance criteria. | |
| Resistance to overriding (Syringe) | ISO 7886-1:2017 Section 12.1; ISO 80369-7:2016 Section 6.6 | Met predetermined acceptance criteria. | |
| Dead Space | ISO 7886-1:2017 Section 13.1 | Met predetermined acceptance criteria. | |
| Freedom from air leakage past piston | ISO 7886-1:2017 Section 13.2 | Met predetermined acceptance criteria. | |
| Freedom from liquid leakage past piston | ISO 7886-1:2017 Section 13.2 | Met predetermined acceptance criteria. | |
| Force to operate the piston | ISO 7886-1:2017 Section 13.3 | Met predetermined acceptance criteria. | |
| Fit of plunger stopper/plunger in barrel | ISO 7886-1:2017 Section 13.4 | Met predetermined acceptance criteria. | |
| Sliding resistance | In-house Standard (verified requirements of ISO 7886-1:2017 Section 11) | Met predetermined acceptance criteria. | |
| Stopper force | In-house Standard (verified requirements of ISO 7886-1:2017 Section 11) | Met predetermined acceptance criteria. | |
| Drug flowability | In-house Standard | Met predetermined acceptance criteria. | |
| Pressure resistance | In-house Standard | Met predetermined acceptance criteria. | |
| Particulate matter | USP 788 | Met USP acceptance criteria. | |
| Animal Study | Intradermal injection functionality | Successful wheal formation and histopathological evaluation validating injection depth for intended use, showing substantial equivalency to predicate device. | Met predetermined acceptance criteria; demonstrated substantial equivalency and validated injection depth. |
| Human Factors and Usability Engineering Study | User interface evaluation | No use-errors determined to cause serious harm, in accordance with FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices," issued on February 3, 2016. | No use errors causing serious harm were found. |
| Biocompatibility | Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogenicity, Hemolysis (Indirect Contact), Physicochemical Profile (Non-aged, Sterile, Finished Device) | ISO 10993-1 and FDA Guidance for Industry and Food and Drug Administration Staff - Use of International Standard ISO-10993-1 | Demonstrated an acceptable biocompatibility profile. |
| Cytotoxicity, Hemolysis (Indirect Contact), Physicochemical Profile (Accelerated Aged, Sterile, Finished Device) | ISO 10993-1 and FDA Guidance for Industry and Food and Drug Administration Staff - Use of International Standard ISO-10993-1 | Demonstrated an acceptable biocompatibility profile throughout shelf life. | |
| Sterilization | Sterility Assurance Level (SAL) | ISO 11137-1/ISO 11137-2 to provide SAL of 10-6 | Achieved SAL of 10-6. |
| Packaging | Package integrity | ISTA 3A (after environmental conditioning and simulated transportation) | All packaging was deemed acceptable for product protection and sterility maintenance. |
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.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).