(30 days)
992742
Not Found
No
The description focuses on the hardware components (switch boxes, junction boxes) and their function in routing electrical signals for EEG and sleep studies. There is no mention of AI/ML algorithms for data analysis, interpretation, or diagnosis. The performance studies focus on hardware and basic software functionality.
No
The device is described as aiding in diagnosis by recording, measuring, and displaying activity, not by providing treatment.
Yes
The "Intended Use / Indications for Use" states that the data from the device "may be used by the clinician... as an aid in diagnosis."
No
The device description explicitly mentions "Switch Boxes" and describes their physical connections and functionality related to switching electrical signals from electrodes. This indicates the presence of hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis.
- The EEG-1100A is described as recording, measuring, and displaying cerebral and extracerebral activity in vivo (within the body) using electrodes placed on the patient.
- The device description focuses on the hardware for connecting and switching electrode signals, not on analyzing biological samples.
- The intended use is to aid in the diagnosis of neurological and sleep disorders based on electrical activity measured directly from the patient.
Therefore, the EEG-1100A is a medical device used for physiological measurement in vivo, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The EEG-1100A Switch Boxes product is connected between the multi-channel electrode junction boxes. JE-207A/209A/212A and a mini electrode junction box and switches the signal line of electrodes to EEG or stimulation unit. It corresponds to 65 to 128 channels and 129 to 192 channels.
The EEG-1100A is intended to record, measure and display cerebral and extracerebral activity for EEG and Sleep Studies. These data may be used by the clinician in Sleep Disorder, Epilepsies and other related disorders as an aid in diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
GWQ, OLV
Device Description
The EEG-1100A Switch Boxes device has two switch boxes, the AAA-15919 switch box which is designed for the JE-207A, JE-209A, JE-212A electrode Junction Boxes and JE-208A, JE-210A, JE-214A, JE-214A, JE-2156A, JE-216A, JE-216A, JE-217A Mini Junction Boxes and the AAA-16060 192 channel Switch Box which is designed for the JE-212A Electrode Junction Box and JE-213A, JE-214A, JE-217A Mini Junction Boxes. The electrical stimulation signals from an electrical stimulation unit can be applied to each electrode through the switch box. The AAA-6060 192 channel switching is available by connecting to the AAA-15919 128 channel Switch Box.
The device is not sterile.
The device does not directly contact patients. Accessories that contact patients, such as electrodes, are the same accessories as used with the predicate or are comprised of the same component material with the same design and manufacturing processes as the prodicate accessories. The device may also use commercially available electrode and sensor products.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cerebral and extracerebral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The device is intended for use by medical personnel in any location within a medical facility, laboratory, clinic or nursing home or outside or a medical facility under direct supervision of a medical professional.
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 EEG-1100A Switch Boxes was subjected to electromagnetic, environmental, safety and performance testing procedures. These tests verified the operation of the device. Software validation tested the operation of the software functions or acquiring, processing, displaying and recording of all functions of the device. The results confirmed that the device performed within specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
992742
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.
Not Found
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).
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
SPECIAL 510(k) NOTIFICATION EEG-1100A Switch Boxes
NIHON KOHDEN AMERICA, INC.
SECTION 2- 510(K) SUMMARY
Name and Address of Applicant
Nihon Kohden America, Inc. 90 Icon Street Foothill Ranch, CA 92610
Contact: Jack Coggan Director, Regulatory Affairs (949) 580-1555 ex. 3325 Fax: (949) 580-1550
Trade/Device Name: EEG-1100A Switch Boxes
Common or Usual Name: Electroencephalograph (EEG)
JAN 1 1 2018
Classification Name:
The device has been classified as Class 2 by the Neurology Device Classification Panel under 21 CFR Part 882.1400 Electroencephalograph per GWQ , OLV
Legally Marketed Predicate Device:
Nihon Kohden EEG-1100A and Accessories per 510(k) 992742 commercial distribution certification dated October 14, 1999.
Intended Use:
The EEG-1100A Switch Boxes product is connected between the multi-channel electrode junction boxes. JE-207A/209A/212A and a mini electrode junction box and switches the signal line of electrodes to EEG or stimulation unit. It corresponds to 65 to 128 channels and 129 to 192 channels.
A summary of the technological characteristics of the device compared to the
predicate device: The new EEG-1100A Switch Boxes device has two switch boxes, the AAA-15919 switch box which is designed for the JE-207A, JE-209A, JE-212A electrode Junction Boxes and JE-208A, JE-210A, JE-214A, JE-214A, JE-2156A, JE-216A, JE-216A, JE-217A Mini Junction Boxes and the AAA-16060 192 channel Switch Box which is designed for the JE-212A Electrode Junction Box and JE-213A, JE-214A, JE-217A Mini Junction Boxes. The EEG-1100 predicate device did not previously control the electrical stimulation signals through a switch box. The electrical stimulation signals from an electrical stimulation unit can be applied to each electrode through the switch box. The AAA-6060 192 channel switching is available by connecting to the AAA-15919 128 channel Switch Box.
1
510(k) Summary:
- . The device is not sterile.
- The device does not directly contact patients. Accessories that contact patients, . such as electrodes, are the same accessories as used with the predicate or are comprised of the same component material with the same design and manufacturing processes as the prodicate accessories. The device may also use commercially available electrode and sensor products. Therefore, good laboratory practice studies were not required per 21 CFR Part 58.
- The EEG-1100A Switch Boxes was subjected to electromagnetic, environmental, . safety and performance testing procedures. These tests verified the operation of the device. Software validation tested the operation of the software functions or acquiring, processing, displaying and recording of all functions of the device. The results confirmed that the device performed within specifications.
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 or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Nihon Kohden America Inc. c/o Mr. Jack Coggan Director, Regulatory Affairs 90 Icon Street Foothill Ranch, CA 92610
Re: K073491 Trade/Device Name: EEG-1100A Switch Boxes Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLV, GWQ Dated (Date on orig SE ltr): December 12, 2007 Received (Date on orig SE ltr): December 12, 2007
APR - 9 2012
Dear Mr. Coggan:
This letter corrects our substantially equivalent letter of January 11, 2008.
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 (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.
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.
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Page 2 - Mr. Jack Coggan
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/CDRH/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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NIHON KOHDEN AMERICA, INC.
G. Indications for Use Statement:
510(k) Number (if known):
Device Name: EEG-1100A Switch Boxes
Indication of Use:
The EEG-1100A is intended to record, measure and display cerebral and extracerebral activity for EEG and Sleep Studies. These data may be used by the clinician in Sleep Disorder, Epilepsies and other related disorders as an aid in diagnosis.
The device is intended for use by medical personnel in any location within a medical facility, laboratory, clinic or nursing home or outside or a medical facility under direct supervision of a medical professional.
Mark A. Melhusen
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K073491
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