(171 days)
Not Found
No
The description focuses on the device's function as a constant current stimulator with user-selectable settings and connections to other equipment. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No.
The intended use states the device is "used as a nerve stimulator for surgical procedures and brain mapping" and "for the intraoperative diagnosis of acute dysfunction." Both uses are diagnostic or for mapping, not for delivering therapy.
Yes
The "Intended Use / Indications for Use" section states: "When High output is selected the MS-120BK is used for the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency." This explicitly indicates a diagnostic function.
No
The device description explicitly states it is a "dual (high & low) output constant current stimulator" and details its connection to other hardware components (MEE 1000A, JB-116BK, JB-132BK, JS-102B, BM-121B) and use with electrodes. The summary of performance studies also mentions both "Software and hardware verification and validation." This indicates it is a hardware device with associated software, not a software-only medical device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The description of the MS-120BK clearly states it is a nerve stimulator that applies electrical stimulation directly to the brain (cortical) during surgical procedures. It does not analyze biological samples like blood, urine, or tissue.
- The intended use involves direct interaction with the patient's nervous system. The device is used for nerve stimulation for surgical procedures, brain mapping, and diagnosing acute dysfunction in corticospinal axonal conduction. These are all in-vivo applications, not in-vitro (outside the body) diagnostics.
Therefore, the Nihon Kohden MS-120BK is a therapeutic and diagnostic device used in vivo, not an IVD.
N/A
Intended Use / Indications for Use
When the Low output is selected the MS-120BK is used as a nerve stimulator for surgical procedures and brain mapping during treatment of patients with seizure disorders.
When High output is selected the MS-120BK is used for the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.
The system is intended for use by qualified medical personnel within a hospital or clinical environment. The stimulator is available for use on any patients as determined by the qualified medical personnel.
Product codes (comma separated list FDA assigned to the subject device)
GWF, GYC
Device Description
The Nihon Kohden MS-120BK is a dual (high & low) output constant current stimulator. The high and low setting, stimulation current and frequency of stimulation is selected by the user. The Nihon Kohden MS-120BK is connected to the MEE 1000A through the JB-116BK or JB-132BK amplifier.
In the Low output setting the Nihon Kohden MS-120BK applies cortical stimulation energy through the Nihon Kohden stimulation pod (JS-102B) which is connected to commercially available cortical electrodes (strip and grid electrodes).
In the High output setting, the MS-120BK outputs electrostimulation pulse through the Nihon Kohden extension cord (BM-121B) which is connected to commercially available stimulation electrode(s).
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
Not Found
Intended User / Care Setting
qualified medical personnel within a hospital or clinical environment.
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)
Testing of the Nihon Kohden System with the MS-120BK was performed in compliance with the Nihon Kohden Corporation design control process. Testing included:
Software and hardware verification and validation, and the device is in compliance with the following voluntary industrial standards:
Medical Electrical Equipment Par1: General requirements for safety IEC 60601-J 1988 IEC 60601-1, Amendment 1 Part 1: General Requirements for safety, Amendment 1, 1991 IEC 60601-1, Amendment 2 Part 1: General Requirements for safety, Amendment 2, 1995 IEC 60601-1-2-40 * Part 2-40: Particular Requirements for the safety of electromyographs and evoked response equipment, 1998 IEC 60601-1-1 200 edition: Part 1-1: General requirements for safety -Collateral standard Safety requirements for medical electrical systems, 2000 IEC 60601-1-2 2" edition: Medical electrical equipment- Part 1: General requirements for safety - 2. Collateral standard: Electromagnetic compatibility, 2001 EN 60601-1: 1990 Equivalent to IEC 60601-1: 1998* EN 60601-1 Amendment 1 Medical equipment general requirements for safety, 1993 EN 60601-1 Amendment 2 Medical equipment general requirements for safety, 1995 EN 60601-1-1: 2001 Equivalent to IEC 60601-1:2001 Electromagnetic compatibility requirement test EN 60601-1-2:2001 CAN/CSA-C22.2 No. 601.1-M90 Medical electrical equipment, Part 1: General requirements for safety. CAN/CSA-C22.2 No. 601.1S1-94 Supplement No. 1-94 to CAN/CSA-C22.2 No. 601-1-M90 Medical Equipment- Part 1:General requirements for safety. CAN/CSA-C22.2 No. 60601-1-1-02 Medical electrical equipment, Part 1-1: General requirements for safety- Collateral: Safety requirements for medical electrical systems, 2006 CAN/CSA-C22.2 No. 60601-2-40-01 Medical electrical equipment, Part 2-40: Particular requirements for safety of electromyographs and evoked response equipment (adopted 60601-2-40: 1998 CAN/CSA-C22.2 No. 601.1B-90 Amendment 2 to CAN/CSA-C22.2 No. 601.1-M90 Medical equipment Part 1: General requirements for safety: 2002
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.
K072964, K924226, K020400, K050798, K071969
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
§ 882.1310 Cortical electrode.
(a)
Identification. A cortical electrode is an electrode which is temporarily placed on the surface of the brain for stimulating the brain or recording the brain's electrical activity.(b)
Classification. Class II (performance standards).
0
Nihon Kohden America, Inc. July 25, 2011
Traditional 510(k) Notification MS-120 Electric Stimulator
K110410
510(k) Summary
ﺒﻪ .
| Company Name: | Nihon Kohden Corporation
90 Icon Street
Foothill Ranch, CA 92610 | AUG - 4 2011 |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------|--------------|
| Device Name: | Nihon Kohden MS-120BK Electric Stimulator (Extension Unit) | |
| 510(k) Sponsor,
Contact: | Nihon Kohden America, Inc.
90 Icon Street
Foothill Ranch, CA 92610 | |
| | Steve Geerdes
Director Quality Assurance and Regulatory Affairs
Phone: (949) 580-1555 Ext. 3325
Fax: (949) 580-1550 | |
| Summary Date: | 7/25/2011 | |
| Common Name: | MS-120BK Electric Stimulator (Extension Unit) | |
Classification Names:
| Evoked Response Electrical Stimulator | 882.1870 | GWF |
|---|---|---|
| Cortical Electrode | 882.1310 | GYC |
| Class II |
Predicate Device(s):
| Nicolet Cortical Stimulator | K072964 |
|---|---|
| Ojemann Cortical Stimulator | K924226 |
| Digitimer D185 Multipulse Cortical Stimulator | K020400 |
| Axon Eclipse Neurological workstation | K050798 |
| Nihon Kohden SEN-4100 Electric Stimulator | K071969 |
1
, l
. 1.0 Description of Device
The Nihon Kohden MS-120BK is a dual (high & low) output constant current stimulator. The high and low setting, stimulation current and frequency of stimulation is selected by the user. The Nihon Kohden MS-120BK is connected to the MEE 1000A through the JB-116BK or JB-132BK amplifier.
In the Low output setting the Nihon Kohden MS-120BK applies cortical stimulation energy through the Nihon Kohden stimulation pod (JS-102B) which is connected to commercially available cortical electrodes (strip and grid electrodes).
In the High output setting, the MS-120BK outputs electrostimulation pulse through the Nihon Kohden extension cord (BM-121B) which is connected to commercially available stimulation electrode(s).
2.0 Intended Use of Device
When the Low output is selected the MS-120BK is used as a nerve stimulator for surgical procedures and brain mapping during treatment of patients with seizure disorders.
When High output is selected the MS-120BK is used for the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.
The system is intended for use by qualified medical personnel within a hospital or clinical environment. The stimulator is available for use on any patients as determined by the qualified medical personnel.
3.0 Technical Characteristics
The technical characteristics of the MS-120BK are equivalent to those of the predicate devices. The following tables summarizes equivalence.
| Stimulator Comparison | Predicate Device
Nihon Kohden
SEN-4100A (K#071969) | Digitimer D185 | New Device
Nihon Kohden
MS-120BK |
|------------------------|----------------------------------------------------------|------------------|----------------------------------------|
| Stimulator Output | | | |
| Voltage | 1000V | 1000V | 350V |
| Current | 1A (1k Ω load) | 1A (1k Ω load) | 200mA (1k Ω load) |
| Maximum Stimulation | | | |
| Energy | 50mJ | 50mJ | 40mJ |
| Output Impedance | less than 120 Ω | less than 120 Ω | 50 Ω |
| Stimulation Mode | Constant Voltage | Constant Voltage | Constant Current |
| Stimulation Parameters | | | |
2
స
| Pulse Duration | 50 μs | 50 μs | 50-1000 μs |
|---|---|---|---|
| Output Frequency Range | 1 Hz | 1 Hz | 0.1-1Hz |
| Number of Pulse Trains | 1-9 | 1-9 | 1-9 |
| Interpulse Interval | 1.0-9.9ms | 1.0-9.9ms | 1.0-1000ms |
| Limitation of Voltage / | |||
| Current and Pulses | 1000V: 3 Pulses | ||
| 510V: 6 Pulses | |||
| 350V: 9 Pulses | 1000V: 3 Pulses | ||
| 510V: 6 Pulses | |||
| 350V: 9 Pulses | 200mA: 3 Pulses*1 | ||
| 142mA: 6 Pulses*1 | |||
| 115mA: 9 Pulses*1 | |||
| Polarity Change | OK | OK | OK |
| Monophasic | OK | OK | OK |
| Biphasic | NO | NO | OK |
| Alternate | NO | NO | OK |
| Maximum Charge | 50 micro-Coulomb | 50 micro-Coulomb | 200 micro-Coulomb |
| Pulse Shape | Rectangular | Rectangular | Rectangular |
| Maximum Energy Per Pulse | 50mJ | 50mJ | 40mJ |
| Maximum Energy Per | |||
| Second | 150mJ | 150mJ | 40mJ |
| Electrode Minimum Size | 0.5cm2 | 0.5cm2 | 0.5cm2 |
| Maximum Charge Density | 100 Micro-C/cm2 | 100 Micro-C/cm2 | 400 Micro-C/cm2 |
| Interface | |||
| Control From EP/EMG | |||
| Machine | MEE-1000A | NO | Only MEE-1000A |
| Trigger Input | OK | OK | OK*2 |
| Trigger Output | OK | OK | OK*2 |
| Foot Switch Control | OK | OK | OK*2 |
*1: The pulse width in the case
. *2: Depends on interface of MEE-1000A
| Stimulator Comparison | Predicate Device Nicolet
Cortical Stimulator
(K#072964) | Ojemann
Cortical Stimulator
(K#924226) | New Device
Nihon Kohden
MS-120BK |
|------------------------------------------|---------------------------------------------------------------|----------------------------------------------|----------------------------------------|
| Constant Current Stimulator | Yes | Yes | Yes |
| Maximum Stimulation Charge | 15 micro-Coulomb | 20 micro-Coulomb | 4.5 micro-Coulomb |
| Current Stimulation Range | 0.1 to 15mA (peak) | 0 to 10mA (peak) | 0 to 15mA (peak) |
| Stimulation Frequency | 1 to 100Hz | 5, 10, 20, 50, 75,
100Hz | 0.1 to 50Hz |
| Stimulation Pulse Width Duration | 0.1 to 1.0 msec Per
Phase | 0.1 to 2.0 msec Per
Phase | 0.05 to 0.3 msec Per
Phase |
| Pulse Shape | Rectangular | Rectangular | Rectangular |
| Electrode Minimum Size | 0.04cm2 | 0.5cm2 | 0.04cm2 |
| Maximum Charge Density | 375 micro-C/cm2 | 40 micro-C/cm2 | 113 micro-C/cm2 |
| Maximum RMS Current Density
Per Pulse | 119 mA RMS/cm2 | 8.9 mA RMS/cm2 | 46 mA RMS/cm2 |
of 1ms
3
4.0 Data Summary
Testing of the Nihon Kohden System with the MS-120BK was performed in compliance with the Nihon Kohden Corporation design control process. Testing included:
Software and hardware verification and validation, and the device is in compliance with the following voluntary industrial standards:
Medical Electrical Equipment Par1: General requirements for safety IEC 60601-J 1988 IEC 60601-1, Amendment 1 Part 1: General Requirements for safety, Amendment 1, 1991 IEC 60601-1, Amendment 2 Part 1: General Requirements for safety, Amendment 2, 1995 IEC 60601-1-2-40 * Part 2-40: Particular Requirements for the safety of electromyographs and evoked response equipment, 1998 IEC 60601-1-1 200 edition: Part 1-1: General requirements for safety -Collateral standard Safety requirements for medical electrical systems, 2000 IEC 60601-1-2 2" edition: Medical electrical equipment- Part 1: General requirements for safety - 2. Collateral standard: Electromagnetic compatibility, 2001 EN 60601-1: 1990 Equivalent to IEC 60601-1: 1998* EN 60601-1 Amendment 1 Medical equipment general requirements for safety, 1993 EN 60601-1 Amendment 2 Medical equipment general requirements for safety, 1995 EN 60601-1-1: 2001 Equivalent to IEC 60601-1:2001 Electromagnetic compatibility requirement test EN 60601-1-2:2001 CAN/CSA-C22.2 No. 601.1-M90 Medical electrical equipment, Part 1: General requirements for safety. CAN/CSA-C22.2 No. 601.1S1-94 Supplement No. 1-94 to CAN/CSA-C22.2 No. 601-1-M90 Medical Equipment- Part 1:General requirements for safety. CAN/CSA-C22.2 No. 60601-1-1-02 Medical electrical equipment, Part 1-1: General requirements for safety- Collateral: Safety requirements for medical electrical systems, 2006 CAN/CSA-C22.2 No. 60601-2-40-01 Medical electrical equipment, Part 2-40: Particular requirements for safety of electromyographs and evoked response equipment (adopted 60601-2-40: 1998 CAN/CSA-C22.2 No. 601.1B-90 Amendment 2 to CAN/CSA-C22.2 No. 601.1-M90 Medical equipment Part 1: General requirements for safety: 2002
5.0 Conclusions
4
Substantial equivalence of the Nihon Kohden MS-120BK was demonstrated by testing in compliance with the Design Control process. The intended use and technology of the Nihon Kohden MS-120BK is equivalent to the predicate devices. No new questions of safety or effectiveness are raised.
5
Image /page/5/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & H." are arranged in a semi-circle around the caduceus. The image is in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Steve Geerdes Director Regulatory Affairs and Quality Assurance Nihon Kohden America, Inc. 90 Icon St. Foothill Ranch. CA 92610
AUG - 4 2011
Re: K110410
Trade/Device Name: Nihon Kohden MS-120BK Electric Stimulator (Extension Unit) Regulation Number: 21 CFR 882.1310 Regulation Name: Cortical Electrode Regulatory Class: Class II Product Code: GYC and GWF Dated: June 27, 2011 Received: June 28, 2011
Dear Mr. Geerdes:
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.
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
6
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/ucm11.5809.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,
Keoia 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
7
Indications for Use Form
510(k) Number (if known):
Device Name: _ _ MS-120BK Electric Stimulator (Extension Unit)
Indications for Use:
When the Low output is selected the MS-120BK is used as a nerve stimulator for surgical procedures and brain mapping during treatment of patients with seizure disorders.
When High output is selected the MS-120BK is used for the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.
The system is intended for use by qualified medical personnel within a hospital or clinical environment. The stimulator is available for use on any patients as determined by the qualified medical personnel.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kristen Bowsher
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
Page 1 of ।
510(k) Number_K 110410