ELECTRODE JUNCTION BOX, MODEL JE-921A
Device Facts
| Record ID | K050833 |
|---|---|
| Device Name | ELECTRODE JUNCTION BOX, MODEL JE-921A |
| Applicant | Nihon Kohden America, Inc. |
| Product Code | OLV · Neurology |
| Decision Date | Apr 29, 2005 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 882.1400 |
| Device Class | Class 2 |
| Attributes | Pediatric |
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.
Device Story
Electrode junction box (JE-921A Series) acquires, stores, and transfers biophysical parameters to EEG monitors; includes integrated CO2 module for non-intubated patient monitoring. Input signals include physiological data for EEG and polysomnography (PSG); CO2 adapter processes real-time CO2 pressure, ETCO2, expiration, and suction point data. Operated by medical personnel in clinical, hospital, or supervised home settings. Output transferred to Nihon Kohden EEG monitors for storage, interpretation, and printing via commercial software. Facilitates diagnostic aid for clinicians in managing epilepsy and sleep disorders; allows direct connection of CO2 adapter to amplifier, streamlining workflow.
Clinical Evidence
Bench testing only. Device verified and validated through environmental testing (temperature/humidity stress), electromagnetic interference/compatibility (EMC) testing, and safety standards testing (IEC 60601 series). Software verification and validation confirmed operation within specifications. No clinical data required as patient-contacting accessories are identical to legally marketed components.
Technological Characteristics
Electrode junction box with integrated CO2 monitoring module. Complies with IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, and IEC 60601-2-26. Non-sterile. Patient-contacting accessories (electrodes, CO2 adapters, SPO2 probes) utilize established materials. Connectivity via integration with Nihon Kohden EEG monitors. Software-based data processing for physiological signal acquisition.
Indications for Use
Indicated for all patient populations, including pediatrics, for the acquisition, storage, and transfer of biophysical parameters to EEG machines to assist in the diagnosis of neurological and sleep disorders, including epilepsy and sleep disorders.
Regulatory Classification
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.
Predicate Devices
Submission Summary (Full Text)
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## 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
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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.
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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.
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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
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G. Indications for Use
510(k) Number (if known):
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
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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
