(84 days)
This product is intended to be used to administer intraligamental injections of anaesthetic product, through a two-ended needle.
The Miniiect Syringe is a cartridge syringe with a metal syringe barrel to which the metal or plastic hub of the injection needle is threaded. The barrel accommodates a 1.8cc anesthetic cartridge. The syringe has a plunger on one end, which engages the rubber piston of the anesthetic cartridge. These characteristics are the same or similar for the "Intralig", by Miltex, (K823536) and Ligmaject, (K802483).
The provided text is related to a 510(k) submission for a medical device called the "Miniject Syringe." However, it is a regulatory document focused on establishing substantial equivalence to predicate devices and does not contain information about acceptance criteria or a study that proves the device meets those criteria.
Therefore, I cannot fulfill your request for the tables and details regarding acceptance criteria and device performance based on the input provided. The document primarily identifies the device, its intended use, and its substantial equivalence to previously marketed devices (K823536 Intralig and K802483 Ligmaject). There is no mention of a clinical or performance study with acceptance criteria, sample sizes, expert involvement, or ground truth establishment.
§ 872.6770 Cartridge syringe.
(a)
Identification. A cartridge syringe is a device intended to inject anesthetic agents subcutaneously or intramuscularly. The device consists of a metal syringe body into which a disposable, previously filled, glass carpule (a cylindrical cartridge) containing anesthetic is placed. After attaching a needle to the syringe body and activating the carpule by partially inserting the plunger on the syringe, the device is used to administer an injection to the patient.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.