(880 days)
The Easy-Ject device is an automatic injection device with a cooling mechanism, for insulin injection and needle withdrawal.
automatic injection device with a cooling mechanism
Information about acceptance criteria and a study proving a device meets them is not available in the provided document.
The document is a 510(k) clearance letter from the FDA for the "Easy-Ject Device," an automatic injector with a cooling mechanism for insulin injection and needle withdrawal. It confirms the device's substantial equivalence to a predicate device and allows it to be marketed.
The FDA letter and the "Indications for Use Statement" do not contain:
- A table of acceptance criteria or reported device performance.
- Details about a study, sample sizes, data provenance, expert qualifications, or adjudication methods for establishing ground truth.
- Information regarding MRMC comparative effectiveness studies or standalone algorithm performance.
- Details on training set size or how ground truth was established for a training set.
The document focuses on the regulatory clearance process based on substantial equivalence, not on a detailed performance study against specific acceptance criteria.
§ 874.3850 Endolymphatic shunt tube with valve.
(a)
Identification. An endolymphatic shunt tube with valve is a device that consists of a pressure-limiting valve associated with a tube intended to be implanted in the inner ear to relieve symptoms of vertigo and hearing loss due to endolymphatic hydrops (increase in endolymphatic fluid) of Meniere's disease.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document “Class II Special Controls Guidance Document: Endolymphatic Shunt Tube With Valve; Guidance for Industry and FDA.”