(24 days)
The Auto Safety Injector 2 (ASI-2) is indicated for assisting the self-administered subcutaneous injection of fixed doses of FDA-approved drug products with non-viscous (aqueous) liquid formulations, which are presented in standard 1 ml long BD Hypak® pre-filled syringes with staked needles.
The ASI-2 is primarily intended for home use by patients to aid and support their treatment regime or may be used by Health Care Professionals or caregivers.
The ASI-2 is a single-use, automatic, disposable and hidden-needle auto-injector for the self-administration of liquid drug products.
The provided text describes the 510(k) summary for the "Auto Safety Injector-2 (ASI-2)". It does not contain information about acceptance criteria, device performance, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, or how ground truth was established.
Instead, the document focuses on:
- Device Identification: Trade name, common name, classification name, predicate device.
- Device Description: Single-use, automatic, disposable, hidden-needle auto-injector for self-administration of liquid drug products.
- Intended Use/Indications For Use: Assisting self-administered subcutaneous injection of fixed doses of FDA-approved, non-viscous liquid drug products in standard 1 ml long BD Hypak® pre-filled syringes with staked needles. Primarily for home use by patients, or by HCPs/caregivers.
- Technological Characteristics: Similar to the predicate device, with the key difference being that ASI-2 is not specifically intended for viscous liquid formulations.
- Performance Tests: States that "Extensive design verification, functional and performance testing have been conducted" and that these demonstrate the device is "safe and effective for the intended use and is substantially equivalent to the legally marketed predicate device." However, no specific details about the acceptance criteria or results of these tests are provided in this summary.
- FDA Clearance: The document includes the FDA's 510(k) clearance letter (K082587).
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document only states that such testing was done and that the device was found substantially equivalent, without giving the specifics of those tests.
§ 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).