(172 days)
This is a diagnostic device for use upon the order of a physician and under the supervision of qualified health care professional. The device is used in the assessment of sleep related disorders by recording a range of physiologic parameters during sleep. These parameters are presented graphically on a computer screen for diagnostic review, similar in application to the use of a traditional paper based polygraph recorder. This device does not provide alarms, is not intended for use as an automated apnea monitor, and does not provide automated diagnostic analysis.
Nightron Polysomnography System
I need more information to provide a comprehensive answer. The provided text is a 510(k) clearance letter for the "Nightron Polysomnography System," which indicates the device is substantially equivalent to a predicate device. However, this letter does not contain details about specific acceptance criteria or a study proving that the device meets those criteria.
Typically, such information would be found within the original 510(k) submission document itself, or in supporting studies referenced in that submission, which are not provided in the input.
The document primarily focuses on:
- Device Name & Regulatory Information: Nightron Polysomnography System, 21 CFR 882.1400 (Electroencephalograph), Class II, Product Code OLV.
- Indications for Use: Diagnostic device for assessing sleep-related disorders by recording physiologic parameters for diagnostic review, similar to a traditional polygraph.
- Limitations: Does not provide alarms, not for automated apnea monitoring, no automated diagnostic analysis.
- Substantial Equivalence: A statement that FDA has determined the device is substantially equivalent to legally marketed predicate devices.
Without the actual study report or the details from the 510(k) submission describing performance testing, I cannot fill out the requested table and answer questions 2-9.
To answer your request, I would need additional documents, specifically the performance testing section of the 510(k) submission or any referenced clinical/non-clinical studies that demonstrate the device's performance.
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).