(146 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 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.
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Bench Test Performance | Device meets predetermined acceptance criteria for non-aged and aged samples as established for the primary predicate (K181369). (Specific criteria not detailed in this document but implied as met by K181369). | Bench testing for Immucise Intradermal Injection System was performed in K181369 using non-aged and aged samples and met the predetermined acceptance criteria. No additional bench tests were deemed necessary for the expanded indication as the subject device is identical to K181369. |
| Animal Study (Functionality) | Successful wheal formation post-injection for the Immucise Intradermal Injection System, comparable to the reference device (West Intradermal Adapter), for the expanded patient population (infants to adults). (Specific success rate not quantified but implied as met). | The study "evaluated the efficacy of Immucise Intradermal Injection System for the indication for use. The test compared the post-injection wheal formation success rate between the Immucise Intradermal Injection System and the reference device of West Intradermal Adapter." The conclusion states, "Terumo concludes that the Immucise Intradermal Injection System has been found to be substantially equivalent for the intended use and for the target patient population without raising different questions of safety and effectiveness." This implies successful wheal formation in the target population. |
| Animal Study (Histopathological) | Validation of the required injection depth for intradermal injections in the expanded patient population (infants to adults). (Specific depth criteria not detailed but implied as met). | The study was "conducted to validate the injection depth required for the indications for use." The conclusion states, "Terumo concludes that the Immucise Intradermal Injection System has been found to be substantially equivalent for the intended use and for the target patient population without raising different questions of safety and effectiveness." This implies successful validation of injection depth for the target population. |
| Material Biocompatibility | Patient contacting parts assessed in accordance with ISO-10993-1. | The finished device's patient contacting parts were assessed in accordance with tests recommended in the FDA Guidance - Use of International Standard ISO-10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." It is stated as "Biocompatible." |
| Sterilization Method (Electron Beam) | Device able to be sterilized effectively by Electron Beam radiation. | Electron Beam radiation. |
| Shelf Life | Needle: 36 months, Syringe: 12 months. | Needle: 36 months, Syringe: 12 months. |
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.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).