(73 days)
To provide sleep assessment. For instance, the device can assess current sleep habits by measuring sleep latency and total sleep time.
The Sleep Management System consists of a slender plastic case with front and back faces and a plastic strap. The user wears the strap around his wrist so that the device will not drop to the floor when the user falls asleep. On the front face, the device has a display, three function buttons, and two electrodes. On the back face, the device has a thumb-activated switch. The display shows either minutes and hours awake or asleep. Two of the three function buttons cause either time awake or time asleep to be displayed and the third function button is the stop/reset button.
The two electrodes are located in a recessed section of the front face. The two electrodes form two ends of a circuit. The circuit is completed by placing fingers across the electrodes. The current in the circuit flows through the user's fingers to pass from one electrode to the other electrode. The switch on the back face of the case and the circuit formed between the two electrodes operate the timing function of the device.
The circuitry of the device includes a 1.5 volt watch battery, power supply, clock, alarm, light, memory, delay and a control and routing circuit. The power supply powers the device using the battery's stored energy. The clock times the user's time awake and time asleep. By pressing the various function buttons, the device will display the time awake or asleep. The memory stores the user's time awake and time asleep. The timing functions have a three second delay for switching between functions so that the user can briefly adjust finger positioning without changing modes.
The provided text, K981844 for the RMP, Inc. Sleep Management System, does not contain any information regarding specific acceptance criteria or a study proving the device meets said criteria.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies with acceptance criteria.
Therefore, I cannot populate the table or answer the specific questions as the required information is not present in the provided text.
Here's what the document does include, relevant to understanding why the detailed performance study information is missing:
- Intended Use Statement: "RMP. Inc.'s Sleep Management System is intended to provide sleep assessment." It further specifies it can "assess current sleep habits by measuring sleep latency and total sleep time."
- Substantial Equivalence Claim: The majority of the document explains how the RMP Sleep Management System is substantially equivalent to two predicate devices: Thought Technology, Ltd.'s GSR2 Relaxation/Biofeedback Monitor and Ambulatory Monitoring, Inc.'s Actigraph. Substantial equivalence is argued based on similar intended use and technological characteristics (e.g., using galvanic skin resistance vs. an accelerometer, similar current levels).
- FDA Clearance Letter: This confirms the device was cleared based on substantial equivalence to pre-existing legally marketed devices.
Conclusion: The provided K981844 document describes the device, its intended use, and argues for its substantial equivalence to predicate devices for 510(k) clearance. It does not include the details of a study with acceptance criteria and device performance as requested. Such detailed performance studies are typically required for different regulatory pathways or for devices where substantial equivalence is not sufficient.
§ 882.5050 Biofeedback device.
(a)
Identification. A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.