(87 days)
The Quantec-E Irrigation System is a self-contained, fluid delivery unit consisting of a pump unit console, irrigation reservoirs and tubing intended to be used in dentistry to provide irrigation while using the dental handpieces attached to the Quantec-E Endo System.
The device is a self-contained, fluid delivery unit consisting of a pump console, two irrigation reservoirs and tubing intended to be used in dentistry to provide irrigation while using the dental handpieces attached to the Quantec-E Endo System. The unit attaches to the Quantec-E Endo System via the accessory port located on the rear panel of the unit. The Quantec-E Irrigation System cannot operate as a stand alone device. The unit has a positive displacement peristaltic design to prevent fluid retraction which could result in patient cross-contamination. To operate the Quantec-E Endo System without irrigation, the Power Switch on the Quantec-E Irrigation System console is turned to the "O" position. When irrigation is desired, the switch is turned to "I". The irrigation tip assemblies supplied with the Quantec-E Irrigation System is autoclavable.
The provided 510(k) summary for the Quantec-E Irrigation System (K991035) does not contain information regarding detailed acceptance criteria or a study proving the device meets specific performance criteria.
Instead, this submission is a premarket notification (510(k)) which aims to demonstrate substantial equivalence to a predicate device already legally marketed in the United States. The focus of the 510(k) process is not to establish new performance metrics through clinical trials or detailed validation studies, but rather to show that the new device is as safe and effective as a legally marketed predicate device.
Therefore, the requested information about acceptance criteria, detailed performance results, sample sizes, expert qualifications, ground truth establishment, and MRMC studies is not available in the provided document because the nature of a 510(k) submission for this type of device does not typically require such extensive performance testing to be detailed in the summary.
The document primarily focuses on:
- Device Description: What the device is and how it functions.
- Intended Use: The purpose for which the device is designed.
- Substantial Equivalence Claim: Identifying a predicate device (Micro Motors, Inc., Micro SWP Sterile Water Pump) and arguing that the new device is sufficiently similar in function and intended use.
In summary, the provided text does not contain the information requested in your prompt regarding acceptance criteria and performance study details.
§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.