(144 days)
The DAI-R™ Autoinjector is a hand-held mechanical device intended for the automated, selfadministration of FDA-approved drugs and biologics. The DAI-R™ Autoinjector is designed to be used with a standard Glass Barrel 1mL Long Syringe with Luer Lock Tip that has been prefilled prior to an injection. The DAI-R™ Autoinjector is for use in the home environment to aid and support prescribed treatment and therapy.
The DAI-R is an automatic drug delivery device that is used for the injection of drugs and biologics from standard Glass Barrel 1mL Long syringes with Luer Lock Tip that have been prefilled prior to use in the DAI-R. The DAI-R is a single-use, disposable, syringe needle introducer device. It is spring-powered and designed to administer the entire contents of the prefilled syringe in one dose. The DAI-R injection has three operational steps: 1) the automatic insertion of the syringe needle to a predetermined depth into the body, 2) the automatic delivery of the syringe contents, and 3) the withdrawal of the needle from the body.
The DAI-R consists of a main body and a syringe carrier assembly. The syringe carrier is used to load the prefilled syringe into the main body to make a complete DAI-R delivery system. The complete DAI-R is a plastic tube with the loaded prefilled syringe, a front needle shield and a rear power assembly. The components of DAI-R are made of plastic and steel. The DAI-R does not have any fluid path and does not have any contact with the drug or biologic contained within the syringe.
The provided text describes the acceptance criteria and a study for the DAI-R™ Autoinjector.
1. Table of Acceptance Criteria and Reported Device Performance
The device was assessed using sections and methods specified in ISO 11608:2000 "Pen injectors for medical use-Part 1: Pen injectors - Requirements and test methods."
| Acceptance Criteria (from ISO 11608:2000) | Reported Device Performance |
|---|---|
| Activation force | Met requirements |
| Needle extension | Met requirements |
| Injection time | Met requirements |
| Completeness of injection | Met requirements |
| Functionality | Met requirements |
| Robustness | Met requirements |
2. Sample Size and Data Provenance
The provided document does not specify the exact sample sizes used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only states that the DAI-R met the requirements of ISO 11608:2000.
3. Number of Experts and Qualifications for Ground Truth
This information is not applicable and not provided in the document. The device is a mechanical autoinjector, and its performance evaluation against ISO standards typically involves engineering and functional testing rather than expert-established ground truth in a clinical or diagnostic sense.
4. Adjudication Method
This information is not applicable and not provided. Performance against an ISO standard for a mechanical device does not typically involve an adjudication method in the way medical imaging or clinical studies do.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC comparative effectiveness study is not applicable and was not done for this type of mechanical device.
6. Standalone (Algorithm Only) Performance
No. This concept is not applicable to a mechanical autoinjector. The performance described is inherently "standalone" in a functional sense, as it refers to the device's ability to meet its operational specifications.
7. Type of Ground Truth Used
The "ground truth" for evaluating the DAI-R's performance was the requirements and specifications identified in ISO 11608:2000. This standard sets objective, measurable criteria for pen injectors.
8. Sample Size for the Training Set
This information is not applicable and not provided in the document. Mechanical devices are typically developed and validated through engineering design, testing, and adherence to standards, not through "training sets" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set was Established
This information is not applicable and not provided. The development and validation process for this mechanical device would not involve establishing ground truth for a training set in the way AI models are trained.
§ 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).