(112 days)
The ConfiDose™ IM auto-injector is a semi-automatic injection system intended to be used for the manual transfer, containment and intramuscular injection of liquid drugs and biologics under the direction of a physician. The ConfiDose™ IM auto-injector system includes an automatic needle retraction mechanism that is intended to aid in the prevention of accidental needle sticks. The ConfiDose™ IM auto-injector system is intended to mask needle insertion, injection and needle withdrawal from patient view.
The ConfiDose™ IM auto-injector consists of a syringe cartridge with prefixed needle, power pack housing with spring loaded mechanism to insert a hypodermic needle into a patient to predetermined depth below the skin surface and a window tube with springloaded retraction mechanism. It is pressure actuated. Once activated, the device automatically performs all three steps of the injection process, needle insertion, drug injection and needle withdrawal. The ConfiDose™ IM auto-injector is individually packaged and ETO sterilized for single use.
The provided text describes a 510(k) submission for the ConfiDose™ IM Auto-injector. The nature of this submission focuses on demonstrating substantial equivalence to existing devices through performance testing against established standards, rather than a clinical study involving human subjects or AI-driven diagnostics. Therefore, many of the requested categories (like MRMC studies, expert ground truth, sample sizes for training/test sets in AI/ML context) are not applicable to this type of device clearance.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria were "requirements and specifications" defined by ISO 11608-1: Pen-Injectors for Medical Use-Part 1: Requirements and Test Method. The reported performance was that "The device met all the requirements and specifications."
| Performance Metric (from ISO 11608-1) | Acceptance Criteria (Implicitly from ISO 11608-1) | Reported Device Performance |
|---|---|---|
| Dose accuracy | Met requirements & specifications | Met all requirements |
| Dead space | Met requirements & specifications | Met all requirements |
| Flow rate | Met requirements & specifications | Met all requirements |
| Injection time / dwell time | Met requirements & specifications | Met all requirements |
| Reliability (number of activations without failure) | Met requirements & specifications | Met all requirements |
| Accuracy of penetration depth | Met requirements & specifications | Met all requirements |
| Needle bond strength | Met requirements & specifications | Met all requirements |
| Absence of leakage | Met requirements & specifications | Met all requirements |
| Verification of non-coring needle properties | Met requirements & specifications | Met all requirements |
| Needle penetration force | Met requirements & specifications | Met all requirements |
| Device actuation force | Met requirements & specifications | Met all requirements |
| Torque necessary to defeat the safety of the device | Met requirements & specifications | Met all requirements |
| Verification of syringe markings accuracy | Met requirements & specifications | Met all requirements |
| Chemical resistance | Met requirements & specifications | Met all requirements |
| Free fall resistance | Met requirements & specifications | Met all requirements |
| Environmental stability | Met requirements & specifications | Met all requirements |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for each specific test or the overall test set. It mentions "extensive testing performed by the company." The testing was conducted according to ISO 11608-1, which would dictate the appropriate sample sizes for each test. The data provenance is internal to the company (Pharma-Pen, Inc.) and is prospective testing of the device prototypes/production samples. There is no indication of country of origin of data beyond the company being based in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is a mechanical auto-injector, and its performance is evaluated against engineering and functional specifications, not against expert interpretation of medical images or symptoms. The "ground truth" is typically defined by the objective measurement of physical properties and functions as per the ISO standard.
4. Adjudication Method for the Test Set
Not applicable. As described above, the testing involves objective measurements against engineering standards, not subjective expert judgment that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of outputs (e.g., radiologists reading images) and AI assistance. The ConfiDose™ IM Auto-injector is a mechanical device, and its evaluation focuses on its physical and functional performance, not on aiding human interpretation for diagnosis.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
No, a standalone study in the context of an AI/ML algorithm was not done. This device does not feature an AI/ML algorithm. The performance evaluation was of the physical device functioning independently.
7. The Type of Ground Truth Used
The ground truth used was based on the objective performance specifications and requirements outlined in ISO 11608-1. This involves precise measurements of physical parameters such as dose accuracy, penetration depth, flow rate, and reliability against the defined tolerances of the standard. It is not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
Not applicable. This device does not use machine learning or AI, and therefore, there is no "training set" in the context of algorithm development.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no AI/ML training set for this device.
§ 880.6920 Syringe needle introducer.
(a)
Identification. A syringe needle introducer is a device that uses a spring-loaded mechanism to drive a hypodermic needle into a patient to a predetermined depth below the skin surface.(b)
Classification. Class II (performance standards).