(14 days)
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No
The summary describes a device for signal amplification and connection for display, storage, and analysis, but does not mention any AI/ML capabilities for the analysis itself.
No
The device is used for diagnosing sleep disorders by assisting physicians through signal amplification and display, not for treating any condition.
Yes
The device is designed "to assist the physician in diagnosing sleep disorders."
No
The device description explicitly states it is a "three channel ambulatory device providing signal amplification of two channels of EEG and one of EMG and connections to external devices". This indicates the presence of hardware components for signal acquisition and amplification, not just software.
Based on the provided information, the Oxford BioSignals BioSomnia V3 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. The description of the BioSomnia V3 clearly states it's an ambulatory device that amplifies EEG and EMG signals from the patient directly. It does not involve the analysis of biological samples like blood, urine, or tissue.
- The intended use is to assist in diagnosing sleep disorders by monitoring physiological signals. This is a direct measurement of the body's electrical activity, not an analysis of a sample taken from the body.
Therefore, the BioSomnia V3 falls under the category of a medical device used for physiological monitoring and diagnosis, but not an IVD.
N/A
Intended Use / Indications for Use
Oxford BioSignals BioSomnia V3 is a three channel ambulatory device providing signal amplification of two channels of EEG and one of EMG and connections to external devices for subsequent EEG / EMG signal display, storage and analysis.
The device is designed to be used overnight in the patient's home environment to assist the physician in diagnosing sleep disorders.
Product codes
OMC, OLV
Device Description
a three channel ambulatory device providing signal amplification of two channels of EEG and one of EMG and connections to external devices for subsequent EEG / EMG signal display, storage and analysis.
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
Physician / patient's home environment
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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§ 882.1400 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).
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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized image of a bird or abstract human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Oxford Biosignals Limited c/o Mr. Simon J. Griffin Lifelines Neurodiagnostic Systems Inc. 611 Riggin Road Troy, Illinois 62294
Re: K042309
Trade/Device Name: BioSomnia V3 Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OMC, OLV Dated (Date on orig SE ltr): August 23, 2004 Received (Date on orig SE ltr): August 25, 2004 APR - 9 2012
Dear Mr. Griffin:
This letter corrects our substantially equivalent letter of September 8, 2004.
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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
1
Page 2 - Mr. Simon J. Griffin
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kesia Alexander
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
Oxford BioSignals Limited Applicant:
510(k) Number (if known): KC42309
Device Name: BioSomnia V3
Indications For Use:
Oxford BioSignals BioSomnia V3 is a three channel ambulatory device providing signal amplification of two channels of EEG and one of EMG and connections to external devices for subsequent EEG / EMG signal display, storage and analysis.
The device is designed to be used overnight in the patient's home environment to assist the physician in diagnosing sleep disorders.
Warning: Federal (U.S.A) law restricts this device for use by or on the order of a physician.
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Prescription Use (Per 21CFR801.109) | ✓ |
| OR | Over-The-Counter-Use ______ |
(Division Sign Off)
| 510(k) Number | K042309 |
|---|---|
| --------------- | --------- |
| Miriam C. Provost | |
|---|---|
| (Division Sign-Off) |
Division of General, Restorative, and Neurological Devices
510(k) Number K042309