(65 days)
No
The document describes a device for acquiring and transferring biophysical parameters for EEG and Sleep Studies. There is no mention of AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML algorithms. The focus is on data acquisition and transfer.
No.
The device is intended for diagnostic purposes (acquiring, storing, recording, measuring, and displaying biophysical parameters) for conditions such as Sleep Disorders and Epilepsies, not for treating or rehabilitating those conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the data acquired by the device "may be used by the clinician in Sleep Disorders, Epilepsies and other related disorders as a diagnostic tool."
No
The device description explicitly states it is comprised of a telemetry unit, electrode junction box, and access point, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the body (in vitro).
- Device Function: The description clearly states the device is intended to "acquire, store, and transfer biophysical parameters" and "acquire, store, record, measure and display cerebral and extracerebral activity." This involves directly measuring physiological signals from the patient's body (in vivo).
- Parameters Measured: The listed parameters (EEG, EOG, ECG, EMG, respiration, PLM, snore, SpO2, sleep position) are all physiological measurements taken from the patient's body, not from a specimen.
Therefore, the device's function and the type of data it collects align with a physiological monitoring device rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The device is intended to record, measure and display the physiological data required for EEG and sleep studies as an aid in diagnosis.
The device, a multi-functional ambulatory recording device, is intended for medical purposes to store, record, measure and display cerebral and extracerebral activity for EEG and Sleep Studies. These data, may be used by the clinician in Sleep Disorders, Epilepsies and other related disorders as an aid in diagnosis.
The device is intended to acquire, store, and transfer biophysical parameters to EEG machines. The device is intended to acquire, store, and display of cerebral and extracerebral activity for EEG and Sleep Studies. These data, may be and used for the neurological and sleep disorders, measurement for the purpose of assisting the cases on Epilepsies and other related disorders as a diagnostic tool.
Product codes
GWQ, OLV
Device Description
The product is comprised of telemetry unit, Electrode junction box and access point to operate with our current commercially available EEG devices. The basic measurement data includes: EEG, EOG, ECG, EMG, respiration, periodic limb movement (PLM), snore, SpO2 and sleep position.
Electrodes and sensors from the patient are connected to telemetry unit through the electrode junction box. The telemetry unit communicates with Nihon Kohden Access point, ZR-101AA. The Access point is connected to other cleared Nihon Kohden EEG machines for all previously cleared indications of monitoring patients' physiological data.
The device does not directly contact patients. New accessories that contact patients such as the EEG electrodes are made from the same component materials as similar legally marketed accessories.
The device is not sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
The use of the device will be available on all patient populations, including pediatrics.
Intended User / Care Setting
This device is intended for use by medical personnel and will be available for use within a medical facility or outside of a medical facility under direct supervision of a medical professional.
The device is intended for use by medical personnel in any location within a medical facility, such as a physicians' office, laboratory, clinic, nursing home or outside of a medical facility under physician supervision.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The device was developed in accordance with design controls and operation of the device was appropriately verified and validated using the same test methods as with the existing device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
JAN - 7 2004
SECTION 2 - 510(K) SUMMARY
November 2, 2003
Name and Address of Applicant Nihon Kohden America, Inc. Attn: Regulatory Affairs 90 Icon Street Foothill Ranch, California 92610 Phone: (949) 580-1555 Fax: (949) 580-1550
Trade name: Wireless Input Unit Common Name: Electroencephalograph Classification: II The Predicate: Siesta system by Compumedix, 510K No: K003175
The device is classified by the Neurology Panel under 21 CFR Part 882.1400 "Electroencephalograph" per GWQ, OLV
The device is intended to record, measure and display the physiological data required for EEG and sleep studies as an aid in diagnosis. The product is comprised of telemetry unit, Electrode junction box and access point to operate with our current commercially available EEG devices. The basic measurement data includes: EEG, EOG, ECG, EMG, respiration, periodic limb movement (PLM), snore, SpO2 and sleep position.
This device is intended for use by medical personnel and will be available for use within a medical facility or outside of a medical facility under direct supervision of a medical professional.
The device does not directly contact patients. New accessories that contact patients such as the EEG electrodes are made from the same component materials as similar legally marketed accessories. Therefore, good laboratory practice studies were not required per 21 CFR part 58. Electrodes and sensors from the patient are connected to telemetry unit through the electrode junction box. The telemetry unit communicates with Nihon Kohden Access point, ZR-101AA. The Access point is connected to other cleared Nihon Kohden EEG machines for all previously cleared indications of monitoring patients' physiological data.
The device is not sterile.
The device was developed in accordance with design controls and operation of the device was appropriately verified and validated using the same test methods as with the existing device.
The device technological characteristics are the same as predicate. The device Risk analysis and summary of Validation/Verification are attached.
1
KO33475
SECTION 3 - PROPOSED LABELING
A. Intended Use
The device, a multi-functional ambulatory recording device, is intended for medical purposes to store, record, measure and display cerebral and extracerebral activity for EEG and Sleep Studies. These data, may be used by the clinician in Sleep Disorders, Epilepsies and other related disorders as an aid in diagnosis. This is the same intended use as previously cleared for the EEG-1100A, and EEG-9100A ( per K992742 and K 011204) as well as Siesta system (predicate).
B. Device/Package Labels
The proposed labels for the device are located in Attachment # 4.
C. Proposed Packaging
Packaging is similar to the packaging for the existing marketed device and is included in Attachment # 4.
D. Instructions for Use
The proposed instructions for use, including warnings and cautions, are provided with each packaged device and a draft is presented in Attachment # 2.
E. Advertisement/Promotional Literature
To date, no advertisement or promotional literature for the new device options has been created for distribution in the United States.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing and body. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Nihon Kohden America, Inc. c/o Ms. Serrah Namini Regulatory Affairs Associate Director 90 Icon Street Foothill Ranch, California 92610
APR - 9 2012
Re: K033475
Trade/Device Name: Wireless Input Unit; WEE-1000A Series Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLV, GWQ Dated (Date on orig SE Itr): November 1, 2003 Received (Date on orig SE ltr): November 3, 2003
Dear Ms. Namini:
This letter corrects our substantially equivalent letter of January 7, 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.
3
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 (OS) 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 vours.
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
4
Indications for Use
Ko33415 510(k) Number (if known):
Wireless Input Unit; WEE-1000A series Device Name:_
Indications For Use:
The device is intended to acquire, store, and transfer biophysical parameters to BBG machines I he device is mended to acquire, secreting the neurological and sleep disorders, measurement for the purpose of assisting the cases on activity for EBG and Sleep Studies. These data, may be and usplay of catolial and cannous volu. Epilepsies and other related disorders as a diagnostic tool.
The device is intended for use by medical personnel in any location within a medical facility, I he device is intention for as by inser nursing home or outside of a medical facility under physicial s office, aboratory, came of the device will be available on all patient populations, including pediatrics.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
Sivision Sign-Off) Division of General, Restorative and Neurological Devices
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510(k) Number K033475