(28 days)
Not Found
No
The summary describes a device for acquiring, storing, and transferring biophysical parameters for EEG and sleep studies. It mentions processing CO2 data but does not include any language related to AI, ML, or advanced data interpretation beyond basic parameter processing and transfer. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is described as assisting in diagnosis and as a diagnostic aid, performing functions such as acquiring, storing, transferring biophysical parameters, and monitoring physiological data. It does not perform any therapeutic intervention or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device assists "the diagnosis of neurological and sleep disorders" and that "These data, may be used by the clinician in Sleep Disorders, Epilepsies and other related disorders as a diagnostic tool." The "Device Description" also mentions that the data "may be used by clinicians in Sleep Disorders, Epilepsies and other disorders as a diagnostic aid."
No
The device description explicitly mentions hardware components like a CO2 Sensor, accessory, adapter, processing unit, and electrode junction box, indicating it is not software-only.
Based on the provided text, this device 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. They are used to examine these samples outside of the body.
- Device Function: The description clearly states the device is intended to "acquire, store, and transfer biophysical parameters to EEG machines" and "record, measure and display the physiological data required for EEG and sleep studies". It also mentions a CO2 sensor that monitors non-intubated patients' CO2 pressure.
- Nature of Data: The data being acquired (biophysical parameters, physiological data for EEG/sleep studies, CO2 pressure) are measured directly from the patient's body (in vivo), not from samples taken from the body and tested in a lab (in vitro).
The device is a medical device used for physiological monitoring and data acquisition for diagnostic purposes related to neurological and sleep disorders, but it does not perform in vitro testing.
N/A
Intended Use / Indications for Use
The device is intended to acquire, store, and transfer biophysical parameters to EEG machines for the purpose of assisting the diagnosis of neurological and sleep disorders, measurement and display of 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 a diagnostic tool. As with the predicate, the information transferred to EEG will be stored, interpreted and printed with commercially software programs available with Nihon Kohden marketed products. The device is intended for use by medical personnel in any location within a medical facility, physician's office, laboratory, clinic or nursing home or outside of a medical facility under supervision of a medical professional. The device will be available on all patient populations, including pediatrics.
Product codes (comma separated list FDA assigned to the subject device)
GWQ
Device Description
The device is intended to record, measure and display the physiological data required for EEG and sleep studies (Polysmonography or PSG). These data, may be used by clinicians in Sleep Disorders, Epilepsies and other disorders as a diagnostic aid. 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 on all patient populations. The availability of new option, CO2 Sensor and accessory provides the physician the ease of connecting the CO2 adapter directly to the amplifier instead of separately connecting to a monitor. The product design and function is equivalent to the predicate in acquisition and data development. The same sensor design is utilized in both devices. The processing unit housed within the CO2 adapter, processes data, to continously monitor non-intubated patcint’s CO2. The status of real time CO2 pressure, ETCO2, expiration, and the suction point, can be transferred by the electrode junction box to a Nihon Kohden's EEG monitor.
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
all patient populations, including pediatrics.
Intended User / Care Setting
medical personnel in any location within a medical facility, physician's office, laboratory, clinic or nursing home or outside of a medical facility under 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 device complies with IEC 60601-1 sub-clause 56.3(c) implemented by 21 CFR Part 898 Performance Standard for Electrode Lead Wires and Patient Cables. The device is designed to comply with the following voluntary industrial standards, such as: IEC 60601-1 (1988-12), Amendment 1 (1991-11), Amendment 2 (1995-03), IEC 60601-1-1 (1992-06), Amendment 1 (1995-10), IEC 60601-1-2 (1993), IEC 60601-1-2 (second edition: 2001-09), IEC 60601-2-26 (1994), IEC 60601-2-26 (second edition: 2002-11). The device was developed in accordance with design controls and operation of the device was appropriately verified and validated using test methods as with all other existing devices. The device was subjected to environmental testing including temperature/humidity stress testing, electromagnetic interference / electromagnetic compatibility testing and safety standards testing and performance testing procedures. Test criteria are established prior to testing based upon product specifications and applicable standards. The completed testing showed that the device met its product specifications and verified conformance to safety, reliability, and applicable standards. Software verification and validation tested the operation of the software 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.
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
Image /page/0/Picture/0 description: The image shows the text 'SECTION 2 - 510(K) SUMMARY' along with a box containing the text 'K050833'. The text is in black and appears to be part of a document. The box is drawn around the alphanumeric text to highlight it.
Page 1 of 2
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
APR 2 9 2005
Device Name and Classification: Electrode Junction Box and accessories. The device is classified by the Neurology Panel under 21 CFR Part 882.1400 "Electroencephalograph" per GWQ. Common names for the device include Electroencephalograph (EEG) and Polysomnograph (PSG). The internal CO2 input addition will enable the junction box to transfer the CO2 data to the EEG monitor. The CO2 module has been classified as Class II by the Division of Anesthesiology Devices and the Anesthesiology Classification Panel under 21 CFR Part 868.1400 "Analyzer, gas, carbon dioxide, gaseous-phase" as per part 73 CCK.
Legally Marketed Predicate: Nihon Kohden JE-912AK, cleared per 510(k): K022121, is in commercial distribution certification dated 7/29/2002. The CO2 module, in commercial distribution, has been previously cleared under 510K submission, K040875, dated 10/15/2004.
There are no significant changes in function, biocompatibility, performance or manufacturability compared to the predicate devices that would affect the safety and effectiveness of the device as intended for use. Therefore, Nihon Kohden believes that the new amplifier is substantially equivalent to the predicate device. The device has the same intended use and indications for use as the existing marketed devices and uses the same fundamental scientific technology.
Indications For Use:
The device is intended to acquire, store, and transfer biophysical parameters to EEG machines for the purpose of assisting the diagnosis of neurological and sleep disorders, measurement and display of 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 a diagnostic tool. As with the predicate, the information transferred to EEG will be stored, interpreted and printed with commercially software programs available with Nihon Kohden marketed products.
The device is intended for use by medical personnel in any location within a medical facility, physician's office, laboratory, clinic or nursing home or outside of a medical facility under supervision of a medical professional. The device will be available on all patient populations, including pediatrics.
Description: The device is intended to record, measure and display the physiological data required for EEG and sleep studies (Polysmonography or PSG). These data, may be used by clinicians in Sleep Disorders, Epilepsies and other disorders as a diagnostic aid. This device is intended for use by medical personnel and will be available for use within a medical
1
Page 2 of 2
facility or outside of a medical facility under direct supervision of a medical professional on all patient populations.
The availability of new option, CO2 Sensor and accessory provides the physician the ease of connecting the CO2 adapter directly to the amplifier instead of separately connecting to a monitor. The product design and function is equivalent to the predicate in acquisition and data development. The same sensor design is utilized in both devices. The processing unit housed within the CO2 adapter, processes data, to continously monitor non-intubated patcint's CO2. The status of real time CO2 pressure, ETCO2, expiration, and the suction point, can be transferred by the elcctrode junction box to a Nihon Kohden's EEG monitor.
Performance Testing
-
The device complies with IEC 60601-1 sub-clause 56.3(c) implemented by 21 CFR Part 898 Performance Standard for Electrode Lead Wires and Patient Cables. To date, no other special controls or performance standards are known or established for this device. The device is designed to comply with the following voluntary industrial standards, such as: IEC 60601-1 (1988-12), Amendment 1 (1991-11), Amendment 2 (1995-03), IEC 60601-1-1 (1992-06), Amendment 1 (1995-10), IEC 60601-1-2 (1993), IEC 60601-1-2 (second edition: 2001-09), IEC 60601-2-26 (1994), IEC 60601-2-26 (second edition: 2002-11)
-
The device is not sterile.
-
The device does not directly contact patients. Accessories that contact patients, such as the EEG electrodes, CO2 adapters and SPO2 probes are the same as current available component materials and accessories legally cleared and marketed in the USA (see accessories list). Therefore, good laboratory practice studies were not required per 21 CFR, part 58.
- A The device was developed in accordance with design controls and operation of the device was appropriately verified and validated using test methods as with all other existing devices. The device was subjected to environmental testing including temperature/humidity stress testing, electromagnetic interference / electromagnetic compatibility testing and safety standards testing and performance testing procedures. Test criteria are established prior to testing based upon product specifications and applicable standards. The completed testing showed that the device met its product specifications and verified conformance to safety, reliability, and applicable standards. Software verification and validation tested the operation of the software functions of the device. The results confirmed that the device performed within specifications.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an abstract eagle design with three stylized wing segments. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 9 2005
Ms. Serrah Namini Regulatory Affairs Associate Director Nihon Kohden America, Inc. 90 Icon Street Foothill Ranch, California 92610
Re: K050833
Trade/Device Name: Electrode Junction Box, JE-921A Series Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: GWQ Dated: March 31, 2005 Received: April 1, 2005
Dear Ms. Namini:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to conninered pror to may 20, 110, in accordance with the provisions of the Federal Food, Drug, de nees mat have been room do not require approval of a premarket approval application (PMA). and Cosmetter Free (110. I 100) has the device, subject to the general controls provisions of the Act. The 1 ou may, mercere, mance the as 1203, and include requirements for annual registration, listing of general controls proficions of 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 your device is classified (o's aaa controls. Existing major regulations affecting your device it may of subject to back at Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA ean or found firther announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Teast of advised that I DTT 3 ibseance or our device complies with other requirements of the Act that I DA has made a actorinmancial an administered by other Federal agencies. You must or any I ederal statutes and registanents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI IT ratt 0077, lubeling (21 CFR Part 820); and if applicable, the electronic forth in the quarty bycellio (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 – Ms. Serrah Namini
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin manceing your avoiralence of your device to a legally premarket notification. "The PDT Inturing sification 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 If you desire specific advice for your don't . Also, please note the regulation entitled, colliati the Office of Compliance at (21 tristication" (21CFR Part 807.97). You may obtain "Misoranding by reference to premarket novilies ander the Act from the Division of Small other general Information on your responsion.cass ance at its toll-free number (800) 638-204) or Manufacturers, Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely yours,
Miriam C. Provost
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
G. Indications for Use
510(k) Number (if known):
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The device is intended to acquire, store, and transfer biophysical parameters to BEG machines a I he device is intended to acquire, secret and neurological and sleep disorders, measurement for the purpose of assisting the diagnosis of hourerse. Cand Sleep Studies. These data, may be
and display of cerebral and extracerebral activity for EEG and Sleep by and ex and display of celebral and extracted as and other related disorders as a diagnostic used by the citificiall in Siccp Disorders, Ephopers and to EEG will be stored, interpresd and tool. As with the predicate, the mornation available with Nihon Kohden marketed products.
Printed with commercially software programs available with Nihon Kohden marketed pro
The device is intended for use by medical personnel in any location within a medical facility, I he device is intended for ase of model personome or outside of a medical facility under physician's office, laboratory, cimie of nating nome of a wailable on all patient populations, including pediatrics.
X -Prescription Use __ (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 Provoet
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_K 050 833