(89 days)
The MEB-2200A Neuropack Evoked Potential and EMG Measuring System is intended to monitor, record and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor, record and display the electrical activity produced by nerves to aid the clinician in the diagnosis and prognosis of neuromuscular disease (EMG). The device is also intended to measure and display nerve conduction time by applying a stimulus to a patient's nerve (NCV). The device may use electrical stimulus, visual stimulus, or sound stimulus for use in evoked response measurements (EP). The device may be used to determine autonomic responses as psychological indicators by measuring the electrical resistance of the skin and the tissue path between two electrodes applied to the skin. The device may also measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head (EEG).
The MEB-2200A device is intended for medical purposes to monitor, record and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor, record and display the electrical activity produced by nerves to aid the clinician in the diagnosis and prognosis of neuromuscular disease (EMG). The device is also intended to measure and display nerve conduction time by applying a stimulus to a patient's nerve (NCV). The device may use electrical stimulus, visual stimulus, or sound stimulus for use in evoked response measurements (EP). The device may be used to determine autonomic responses as psychological indicators by measuring the electrical resistance of the skin and the tissue path between two electrodes applied to the skin. The device may also measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head (EEG).
The provided text describes a 510(k) summary for the Nihon Kohden MEB-2200A Neuropack Evoked Potential and EMG Measuring System. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria as typically sought for AI/ML devices.
The document focuses on:
- Device Classification: Identifies the device as Class II with multiple classifications (Diagnostic Electromyograph, Electroencephalograph, Nerve Conduction Velocity Measurement Device, etc.).
- Predicate Device: States the predicate device is the Nihon Kohden MEB-5500A Neuropack Sigma (K950208).
- Intended Use: Details the device's intended uses for EMG, NCV, EP, autonomic responses (GSR), and EEG, and the intended users/settings.
- Compliance: Lists compliance with various IEC and CAN/CSA standards, and mentions compliance with 21 CFR Part 898 for electrode lead wires and patient cables.
- Testing: Briefly mentions that the MEB-2200A underwent "electromagnetic, environmental, safety and performance testing procedures" and "Software validation tested the operation of the device." It concludes that "The results confirmed that the device performed within specifications."
- Substantial Equivalence: The primary conclusion is that the device is substantially equivalent to the predicate device.
Missing Information:
The document lacks the specific details requested regarding acceptance criteria and performance studies. Specifically, it does not provide:
- A table of acceptance criteria and reported device performance: While it states "performed within specifications," it doesn't quantify what those specifications are (e.g., accuracy, sensitivity, specificity, or specific error rates for any diagnostic task).
- Sample size used for the test set and data provenance: No test set is described, nor is the origin of any data.
- Number of experts used to establish ground truth and their qualifications: No ground truth establishment process is mentioned.
- Adjudication method for the test set: Not applicable as no test set is described.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: No such study is mentioned. The device is a measurement system, not typically an AI-driven diagnostic aid that would assist human readers in this context.
- Standalone (algorithm-only) performance: The device is a measuring system, not an AI algorithm in the typical sense of generating a diagnostic output without human interpretation of the bioelectric signals.
- Type of ground truth used: Not mentioned.
- Sample size for the training set: Not applicable, as it's not described as an AI/ML device that requires training.
- How the ground truth for the training set was established: Not applicable.
Conclusion:
Based on the provided text, the Nihon Kohden MEB-2200A is a traditional medical device (neurological testing equipment) and not an AI/ML diagnostic system. Therefore, the detailed performance metrics, ground truth establishment, reader studies, and sample sizes typically associated with AI/ML device evaluations are not present in this 510(k) summary. The "study" mentioned is general safety, electromagnetic, environmental, and performance testing to ensure the device operates as intended and meets relevant safety standards and specifications, rather than a diagnostic performance study against a specific clinical outcome.
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SEP - 1 1990
SECTION 2 - 510(K) SUMMARY
Name and Address of Applicant
Nihon Kohden America, Inc. 2601 Campus Drive Irvine. California 92612-1601 (949) 250-3959
The device has been classified as Class II under 21 CFR Part 890.1375 "Diagnostic Electromyograph" per IKN; 21 CFR Part 882.1400 "Electroencephalograph" per GWQ; 21 CFR Part 882.1550 "Nerve Conduction Velocity Measurement Device" per JXE; 21 CFR 882.1540 "Galvanic Skin Response Measurement Device" PER GZO: 21 CFR 882.1870 "Evoked Response Electrical Stimulator" per GWF: 21 CFR 882.1890 "Evoked Response Photic Stimulator" per GWE; and 21 CFR 882.1990 "Evoked Response Auditory Stimulator" per GWJ.
Common names for the MEB-2200A device include Evoked Response. Evoked Potential (EP) and Electromyograph (EMG).
The predicate marketed device is the Nihon Kohden MEB-5500A Neuropack Sigma per 510(k) #K950208, commercial distribution certification dated May 10, 1995.
Nihon Kohden's, model number MEB-2200A is intended for medical purposes to monitor, record and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor, record and display the electrical activity produced by nerves to aid the clinician in the diagnosis and prognosis of neuromuscular disease (EMG). The device is also intended to measure and display nerve conduction time by applying a stimulus to a patient's nerve (NCV). The device may use electrical stimulus, visual stimulus, or sound stimulus for use in evoked response measurements (EP). The device may be used to determine autonomic responses as psychological indicators by measuring the electrical resistance of the skin and the tissue path between two electrodes applied to the skin. The device may also measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head (EEG).
The device is intended for use by medical personnel within a hospital, laboratory, clinic or nursing home setting or outside of a medical facility under direct supervision of a medical professional. The device may also be placed in the intensive care unit or operating room for continuous recording. The device is available for use on any patient as determined by the medical professional including adults and children.
The device complies with IEC 601-1 subclause 56.3(c) as implemented by 21 CFR Part 898 Performance Standard for Electrode Lead Wires and Patient Cables. No other special controls or performance standards are known or established for this device is in compliance with the following voluntary industrial standards; IEC 60601-1 (1988-12), Amendment 2 (1995-03); IEC 60601-1-1 (1992-06); Amendment 1 (1995-10); IEC 60601-2-10 (1987-12); EN 60601-1-2 (1993-05); CAN/CSA-C22.2 No. 601.1-M90 (1999-11) and CAN/CSA-C22.2 No. 601.2.10-92 (1992-08)
The device is not intended to be sterile. No GLP studies were required for this device.
The MEB-2200A was subjected to electromagnetic, environmental, safety and performance testing procedures. Software validation tested the operation of the device. The results confirmed that the device performed within specifications.
Therefore based on the above, Nihon Kohden believes that the MEB-2200A Neuropack Evoked Potential and EMG Measuring System is substantially equivalent to the predicate MEB-5500A Neuropack Sigma.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 1 1999
Ms. Bonnie Bishop Regulatory Affairs Manager Nihon Kohden America, Inc. 2601 Campus Drive Irvine. California 92612
Re: K991899 Trade Name: MEB-2200A Neuropack Evoked Potential and EMG Measuring System Regulatory Class: II Product Code: GWF, IKN, GWQ, and GZO Dated: June 3, 1999 Received: June 4, 1999
Dear Ms. Bishop:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the deyice, 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Bonnie Bishop
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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G. Indications for Use Statement
510{k) Number (if known):
Device Name: MEB-2200A Neuropack Evoked Potiential and EMG Measuring System
Indications for Use:
The MEB-2200A Neuropack Evoked Potential and EMG Measuring System is intended to monitor, record and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor, record and display the electrical activity produced by nerves to aid the clinician in the diagnosis and prognosis of neuromuscular disease (EMG). The device is also intended to measure and display nerve conduction time by applying a stimulus to a patient's nerve (NCV). The device may use electrical stimulus, visual stimulus, or sound stimulus for use in evoked response measurements (EP). The device may be used to determine autonomic responses as psychological indicators by measuring the electrical resistance of the skin and the tissue path between two electrodes applied to the skin. The device may also measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head (EEG).
The device is intended for use by medical personnel within a hospital, laboratory, clinic or nursing home setting or outside of a medical facility under direct supervision of a medical professional. The device may also be placed in the intensive care unit or operating room for continuous recording.
The device is available for use on any patient as determined by the medical professional including adults and children.
Prescription Use
(Per 21 CFR 801.109)
Division Sign Off
(Division St idn-Off) Division of General Restorative Devices 510(k) Number
§ 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).