(78 days)
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Not Found
No
The summary explicitly states "This device does not provide automated diagnostic analysis of EEG data" and there are no mentions of AI, DNN, or ML.
No
While the system is used for relaxation training, which can have therapeutic benefits, its intended use, as stated, is for providing signals that correlate with EEG changes for achieving relaxation, not directly treating a specific disease or condition.
No
The "Intended Use / Indications for Use" section explicitly states, "This device does not provide alarms and does not provide automated diagnostic analysis of EEG data." Instead, it is intended for relaxation training.
Unknown
The summary describes a "system" that provides signals correlating with EEG activity. While it doesn't explicitly mention hardware, the term "system" and the need to acquire EEG data strongly suggest the involvement of hardware (like EEG sensors or a headset) to capture the physiological signals. The summary focuses on the function of the system in providing feedback, but doesn't clarify if the submission covers only the software component or the entire system including hardware.
Based on the provided information, the AlphaOne EEG biofeedback system is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- AlphaOne's Function: The AlphaOne system uses EEG (electroencephalography) to measure electrical activity in the brain. It provides biofeedback based on this activity for relaxation training. It does not analyze samples taken from the body.
- Intended Use: The intended use is explicitly stated as "relaxation training," not for diagnosing any disease or condition based on analysis of bodily samples.
Therefore, the AlphaOne EEG biofeedback system falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AlphaOne EEG biofeedback system is intended for use in relaxation training. In applications for relaxation training, the AlphaOne system provides visual and/or auditory signals that correlate with changes in EEG activity useful for achieving a state of relaxation.
This device does not provide alarms and does not provide automated diagnostic analysis of EEG data.
Product codes
HCC, GWQ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three stylized wing segments.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 5 2007
TeleDiagnostic Systems, Inc % Mr. Larry Woodward 2483 Old Middlefield Way Suite 202 Mountain View, California 94043
K071661 Re:
Trade/Device Name: AlphaOne EEG Biofeedback System Regulation Number: 21 CFR 882.5050 Regulation Name: Biofeedback Device Regulatory Class: Class II Product Code: HCC, GWQ Dated: August 7, 2007 Received: August 9, 2007
Dear Mr. Woodward:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -- Mr. Larry Woodward
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Neil R.P. Ogden
Mark Melkerson
Director Division of General Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications For Use
AlphaOne EEG Biofeedback System
Device Name:
Indications For Use:
The AlphaOne EEG biofeedback system is intended for use in relaxation training. In applications for relaxation
training, the AlphaOne system provides visual and/or auditory signals that correlate with changes in EEG activity useful for achieving a state of relaxation.
This device does not provide alarms and does not provide automated diagnostic analysis of EEG data.
US Federal Law restricts this device to sale by, or on the order of, a licensed healthcare provider.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
Concurrence of CDRA Office of Device Evaluation (ODE)
for mxm
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | K071661 |
|---|---|
| --------------- | --------- |
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