(179 days)
- Administration of intraosseous anesthesia for dental indications.
The Cyberjet™ is a dental device intended for intraosseous injection of local anesthetics. Intraosseous injection requires the dentist to drill a small hole in the bone adjacent to the problem tooth. The dentist then uses a standard anesthesia needle and svringe to inject the local anesthetic solution into the previously drilled hole to numb the nerve of the tooth. The Cyberjet™ combines the dental drill and the injection needle into one device and performs both the drilling and injection functions with the same device. After an appropriate injection site has been identified, a topical anesthetic is applied to the gum, followed by a few minutes wait to allow the topical anesthetic to take effect. The previously selected injection site is located and the injection motor and the injection motor are turned on. The tip of the drill/needle is placed on the overlying gum and pressure is applied. The drill/needle passes through the soft tissue and starts to perforate the cortical plate. After the penetration of the cortical plate, the drill motor is turned off by releasing the momentary-switch on the foot-pedal. Local anesthetic is continuously dispensed into the tissue during and after the drilling process through the Infuser. Use of the Cyberjet™ will result in a simple one-step intraosseous injection for dental anesthesia. The system includes 5 components: 1. A Hollow Tubing Needle referred to as a drill/needle or Infuser that serves as a drill as well as a hypodermic iniection needle.
The provided document is a 510(k) Premarket Notification Summary of Safety and Effectiveness Information for the Cyberjet™ Local Anesthesia System. It focuses on regulatory classifications and substantial equivalence to a predicate device, rather than providing detailed acceptance criteria or a study proving device performance against such criteria.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them based on the text provided. The document primarily addresses regulatory approval based on demonstrating substantial equivalence to a legally marketed predicate device.
Specifically, the document does not contain:
- A table of acceptance criteria and reported device performance.
- Information on sample sizes for test sets, data provenance, or details about the experts establishing ground truth.
- Adjudication methods.
- Results from multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- The type of ground truth used.
- Sample size for the training set or how ground truth for the training set was established.
The document's purpose is to outline the device's classification, intended use, and its substantial equivalence to the predicate device Stabident System Intraosseous Local Anesthesia K910446.
§ 872.4475 Spring-powered jet injector.
(a)
Identification. A spring-powered jet injector is a syringe device intended to administer a local anesthetic. The syringe is powered by a spring mechanism which provides the pressure to force the anesthetic out of the syringe.(b)
Classification. Class II.