(12 days)
The Neurosign 400 is intended to monitor and to stimulate cranial motor nerves. Cranial motor nerves are monitored by detecting EMG activity in the muscles they innervate.
To locate and identify cranial motor nerves during ENT and intra-cranial procedures.
The Neurosign 400 is an EMG machine and nerve stimulator. The machine consists of a central control unit to which a pre-amplifier pod and intramuscular, or surface, electrodes are attached for EMG recordings. Additionally, connected to the main unit is a stimulator pod to which a stimulating probe, which delivers current to nerve tissue, may be connected. The Neurosign 400 is intended to monitor and to stimulate cranial motor nerves. Cranial motor nerves are monitored by detecting EMG activity in the muscles they innervate.
Here's an analysis of the provided text regarding the Neurosign 400 Motor Nerve Monitor, focusing on acceptance criteria and the study proving its effectiveness:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document extensively describes the Neurosign 400 as being "similar" to previously cleared devices (Neurosign 800 and Neurosign 100), and relies heavily on the safety and effectiveness history of these predicate devices. The acceptance criteria aren't explicitly quantified with specific performance metrics (e.g., minimum accuracy percentages, sensitivity, specificity). Instead, the criteria are qualitative and based on equivalence and lack of adverse events from predicate devices.
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Safety: No complaints related to safety for similar products. | "The history of the similar products listed above lacks complaints related to safety and effectiveness, and as far as we are aware there have been no reports of adverse effects or reportable incidents connected with them, or in any published papers on nerve monitoring." The Neurosign 400 "has met all the specifications and expectations for its intended use." |
| Effectiveness: No complaints related to effectiveness for similar products. | "The history of the similar products listed above lacks complaints related to safety and effectiveness..." The Neurosign 400 "has met all the specifications and expectations for its intended use based on the evaluations conducted thus far." |
| Equivalence to Predicate Devices: Performance similar to existing cleared devices. | The Neurosign 400 is marketed as "similar to the following products which are currently in commercial distribution in the U.S.A.: Neurosign 800 Nerve Monitor, The Magstim Company, K964869; Neurosign 100 Nerve Monitor, The Magstim Company, K923056/A." The FDA's 510(k) clearance explicitly states the device is "substantially equivalent" to predicate devices. |
| Meeting Specifications for Intended Use: Ability to monitor and stimulate cranial motor nerves. | "The Neurosign 400 has met all the specifications and expectations for its intended use based on the evaluations conducted thus far." |
| Manufacturing Quality: Materials and methods are consistent with current Magstim Company practices. | "The materials and methods used to manufacture the Neurosign 400 do not vary from the current materials and methods used by the Magstim Company in the manufacture of the Neurosign 800." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a test set sample size or describe any specific clinical study involving a "test set" in the traditional sense of a new, independent dataset for evaluation.
Instead, the safety and effectiveness are established through:
- Historical data of predicate devices: Review of complaints and adverse events for the Neurosign 800 and Neurosign 100. The provenance is implied to be historical market data from the U.S. and potentially other regions where these devices were distributed. This is retrospective data.
- In-house and on-site clinical evaluation: Performed by The Magstim Company for "all its products, both prior to, and after product release for distribution." The data provenance for these internal evaluations is not detailed (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
No specific "test set" with ground truth established by external experts is described. The acceptance relies on:
- Market feedback on predicate devices: The absence of reported adverse events or complaints is implicitly the "ground truth" for proving safety and effectiveness of the existing technology.
- Internal "team participation" for evaluations: "Team members include, but are not limited to Marketing, Manufacturing, Engineering and Quality Assurance." While these individuals are experts in their respective fields, they are internal to the company and not independent clinical experts establishing ground truth for a defined test set. Their qualifications are not specified beyond their departmental roles.
4. Adjudication Method for the Test Set:
No specific test set or adjudication method (e.g., 2+1, 3+1) is mentioned or implied, as there was no formal independent clinical study with a predefined test set and expert review for this 510(k) submission. Acceptance is based on the lack of complaints for predicate devices and internal company evaluations.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study is presented or referenced. The submission does not involve comparing human reader performance with or without AI assistance, as the device is a nerve monitor/stimulator and not an AI-driven image analysis tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
This detail is not applicable in the context of the Neurosign 400. The device is an EMG machine and nerve stimulator designed for direct use by a clinician during surgical procedures. Its functionality is not based on a standalone algorithm or AI performance that would be evaluated without human interaction. The "performance" is its ability to accurately detect EMG activity and stimulate nerves, which is inherently part of a human-in-the-loop diagnostic/monitoring process.
7. The Type of Ground Truth Used:
The ground truth mainly relies on:
- Historical safety and effectiveness data of predicate devices: Absence of adverse events and complaints for Neurosign 800 and Neurosign 100. This is essentially "outcomes data" in a broad sense, demonstrating safe and effective use in real-world clinical practice over time.
- Internal company specifications and expectations: The device passed internal evaluations against established product specifications.
8. The Sample Size for the Training Set:
The document does not describe a "training set" in the context of machine learning or algorithm development. The device's functionality is based on established electrophysiological principles and hardware design, not on a data-driven learning model. Therefore, sample sizes for training sets are not applicable or mentioned.
9. How the Ground Truth for the Training Set Was Established:
As there is no described training set for an algorithm, the concept of establishing ground truth for a training set is not relevant to this 510(k) submission. The safety and effectiveness are established through substantial equivalence based on the history of predicate devices and internal validation processes.
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Neurosign 400 Motor Nerve Monitor Special 510(k)
Section 3: Summary of Safety and Effectiven
Neurosign 400 Motor Nerve Monitor
The Neurosign 400 is an EMG machine and nerve stimulator. The machine consists of a central control unit to which a pre-amplifier pod and intramuscular, or surface, electrodes are attached for EMG recordings. Additionally, connected to the main unit is a stimulator pod to which a stimulating probe, which delivers current to nerve tissue, may be connected.
The Neurosign 400 is intended to monitor and to stimulate cranial motor nerves. Cranial motor nerves are monitored by detecting EMG activity in the muscles they innervate.
The Neurosign 400 is similar to the following products which are currently in commercial distribution in the U.S.A.
Neurosign 800 Nerve Monitor, The Magstim Company, K964869 Neurosign 100 Nerve Monitor. The Magstim Company. K923056/A
The safety and effectiveness of the Neurosign 400 has been established through various techniques. The history of the similar products listed above lacks complaints related to safety and effectiveness, and as far as we are aware there have been no reports of adverse effects or reportable incidents connected with them, or in any published papers on nerve monitoring.
The Magstim Company performs extensive in-house an on-site clinical evaluation of all its products, both prior to, and after product release for distribution. Our methods and procedures for acceptance of products as well as our techniques for clinical evaluation are performed using team participation. Team members include, but are not limited to, Marketing, Manufacturing, Engineering and Quality Assurance. The Neurosign 400 has met all the specifications and expectations for its intended use based on the evaluations conducted thus far.
The materials and methods used to manufacture the Neurosign 400 do not vary from the current materials and methods used by the Magstim Company in the manufacture of the Neurosign 800. We will incorporate new, proven technologies as they become available; however, these improvements support product performance through greater reliability.
The Magstim Company concludes that the Neurosign 400 is safe and effective for its intended use. Clinical evidence in support of this statement is presented in Section 9 of this application.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three stripes representing the bird's wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 9 1999
Dr. Reza Jalinous The Magstim Co. Ltd. 730 Fifth Ave., 9th Floor New York, New York 10019
Re: K991583 Trade Name: Neurosign 400 Motor Nerve Monitor Regulatory Class: II Product Code: 77 ETN Dated: April 29, 1999 Received: May 7, 1999
Dear Dr. Jalinous:
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 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 (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 requirements, as set forth in the Quality System Regulation (QS) 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 - Dr. Reza Jalinous
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) 594-4613. 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,
A. Ralph Rosenthal
A. Ralph Rosenthal. M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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CATION CALINDICATIONS FOR USE
510(k) Number (if known): 12991583
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- Sales of the same
Device Name:
Neurosign 400, 4 channel Motor Nerve Monitor
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- Indications For Use:
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To locate and identify cranial motor nerves during ENT and intra-cranial procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Ophthalmic Devices | |
| 510(k) Number | K991583 |
| Prescription Use:(Per 21 CFR 801.109) | OR | Over-The-Counter Use: |
|---|---|---|
| ------------------------------------------- | ---- | ----------------------- |
Prescription Use:
(Per 21 CFR 801.109)
§ 874.1820 Surgical nerve stimulator/locator.
(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.