Nihon Kohden Sen-4100 Electric Stimulator is used for the intraoperative diagnosis of acute dysfunction in corticospinal tract axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.

Device Description

The SEN-4100A is the stimulator to output electrostimulation pulses. It conducts the constant voltage stimulation that is necessary for MEP (Motor Evoked Potential) measurement, from an electrophysiological viewpoint, diagnosing and analyzing the neuromuscular action potential for a patient provided with anesthesia care in an operating room.

AI/ML Overview

The provided text describes the Nihon Kohden SEN-4100 Electric Stimulator, a device used for intraoperative diagnosis of acute dysfunction in corticospinal tract axonal conduction. However, the document does not contain specific acceptance criteria or details of a study that quantifies device performance in terms of metrics like sensitivity, specificity, accuracy, or other performance characteristics.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Digitimer D185 Multipulse Cortical Stimulator) based on technological characteristics and compliance with electrical safety and performance standards.

Here's an attempt to answer the questions based on the available information, noting where data is absent:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not explicitly defined in terms of specific performance metrics (e.g., accuracy, sensitivity, specificity, or quantitative output precision).	The device's operation, software, and hardware were confirmed to be in accordance with design specifications through design validation.
Compliance with electrical safety and performance standards (e.g., IEC 60601-1, IEC 60601-1-2).	The device was subjected to electromagnetic, environmental, safety, and performance testing procedures, which "verified the proper operation of the device." Specific results of these tests (e.g., measured electromagnetic emissions/immunity levels, environmental withstand limits, actual safety parameter readings) are not detailed within this summary.
Substantial Equivalence to predicate device (Digitimer D185 Multipulse Cortical Stimulator, K020400).	Nihon Kohden believes the SEN-4100 is "substantially equivalent" to the predicate, stating it performs the same function (outputting electrostimulation pulses for MEP measurements and neuromuscular action potential analysis) for the same intended use.

2. Sample size used for the test set and the data provenance

The document does not mention any clinical "test set" in the context of device performance evaluation (e.g., for diagnostic accuracy). The testing described appears to be engineering validation and verification.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The submission focuses on substantial equivalence and engineering testing, not a clinical study involving ground truth establishment by experts for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical test set or adjudication process is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The device is an electrical stimulator, not an AI or imaging diagnostic aid, and therefore, an MRMC study is not relevant to its stated function or the information provided.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is an electrical stimulator designed to be used in conjunction with other clinical devices for neurological function (EMG/Stimulator for evoked reaction) and would always involve human operation/interpretation. There is no "algorithm only" performance reported as it's a hardware device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the engineering validation, the "ground truth" was likely the design specifications and established engineering standards (e.g., IEC standards). For the claim of "proper operation," it implies that the device's output and characteristics (e.g., voltage, pulse shape) met predefined engineering targets. No medical or biological ground truth (like pathology or clinical outcomes) was used for performance assessment in this submission.

8. The sample size for the training set

Not applicable. The device is not a machine learning or AI algorithm, so there is no concept of a "training set" in the context of its development or submission.

9. How the ground truth for the training set was established

Not applicable. As there is no training set mentioned, this question is not relevant.

In summary, the K071969 submission for the Nihon Kohden SEN-4100 Electric Stimulator primarily relies on demonstrating compliance with recognized electrical safety and performance standards, and substantial equivalence to a legally marketed predicate device based on technological characteristics and intended use. It does not present a study with specific clinical performance metrics (like accuracy or sensitivity) derived from a test set with established ground truth. The "study" referenced is the design validation and engineering testing (electromagnetic, environmental, safety, and performance testing) which "verified the proper operation of the device" according to design specifications and relevant voluntary industrial standards.

Summary

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K071969

OCT 0 6 2008

Name and Address of Applicant .

Nihon Kohden America, Inc. 90 Icon Street Foothill Ranch, Ca 92610

Telephone: (949) 580-1555 Ext. 3325 Fax: (949) 580-1550 Attn: Jack Coggan, Director of Regulatory Affairs

Date: June 29, 2007

SECTION 2 - 510(K) SUMMARY

Name of the Device: Evoked Response Electrical Stimulator .
. Trade or proprietary name: SEN-4100 Electric Stimulator
The common or usual Name: Evoked Response Electrical Stimulator .
The Classification: The device has been classified as 21 CFR Part 882.1870 "Evoked . Response Electrical Stimulator" per GWF.
The legally marketed equivalence: The predicate-marketed device is the Digitimer . D185 Multipulse Cortical Stimulator, K020400, commercial distribution certification dated August 23, 2002.
A description of the device: The SEN-4100A is the stimulator to output . electrostimulation pulses. It conducts the constant voltage stimulation that is necessary for MEP (Motor Evoked Potential) measurement, from an electrophysiological viewpoint, diagnosing and analyzing the neuromuscular action potential for a patient provided with anesthesia care in an operating room.
A summary of the technological characteristics of the device compared to the . predicate device: The new device is equivalent to the Digitimer D185 Multipulse Cortical Stimulator in that the stimulator will output electrostimulation pulses. It conducts the constant voltage stimulation that is necessary for MEP (Motor Evoked Potential) measurements from an electrophysiological viewpoint while diagnosing and analyzing the neuromuscular action potential for a patient provided anesthesia care in an operating room.

The device performs as an electrostimulation part under IEC 60601-1-2-40 for ME system when it is used with the clinical device for neurological function (or EMG/Stimulator for evoked reaction). The device is in compliance with the following voluntary industrial standards: IEC 60601-1: 1988; IEC 60601-1 Amendment 1:1991; IEC 60601-1 Amendment 2: 1995; IEC 60601-1-1 2nd edition: 2000; IEC 60601-1-2 2nd edition: 2001; EN 60601-1:1990; EN 60601-1 Amendment 1: 1993; EN 60601-1 Amendment 2:1995; EN 60601-1-1:2001; EN 60601-1-2:2001; CAN/CSA-C22.0 No. 601.1-M90; CAN/CSA-C22.2 No. 601.1S1-94; CAN/CSA-C22.2 No. 601.1B-90 (R2002); CAN/CSA-C22.2 No. 60601-1-1-02; CAN/CSA-C22.2 No. 60601-1-1-02.

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The device is not sterile. Design validation confirmed the operation of the software and hardware of the device is in accordance to the design specifications.

The device was subjected to electromagnetic, environmental, safety and performance testing procedures. These test verified the proper operation of the device.

Therefore base on the above, Nihon Kohden believes that the SEN-4100 Electric Stimulator measuring system is substantially equivalent to the predicate device, Digitimer D185 Multipulse Cortical Stimulator.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA", which is arranged in a circular fashion around the left side of the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 0 6 2008

Nihon Kohden America, Inc. Mr. Jack Coggan Director Regulatory Affairs and Ouality Assurance 90 Icon Street Foothill Ranch, California 92610

Rc: K071969

Trade/Device Name: SEN-4100 Electric Stimulator Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked Response Electrical Stimulator Regulatory Class: Class II Product Code: GWF Dated: July 7, 2008 Received: July 08, 2008

Dear Mr. Coggan:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Mr. Jack Coggan

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N Mcllhenny

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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். Indications for Use Statement

510(k) Number (if known)

Device Name: SEN-4100 Electric Stimulator

Indications for Use:

Prescription use: X (21 CFR Part 801 Subpart D) AND/OR

Over - the - Counter Use (21 CFR Part 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R.P. Ogle form xmp

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K071969

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Regulation Number and Section

§ 882.1870 Evoked response electrical stimulator.

(a)
Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.(b)
Classification. Class II (performance standards).