The EEG monitor Narcotrend serves the purpose of registering and displaying EEG signals and thus monitoring the state of the brain. It was developed specifically for use in operating rooms, intensive care units, and for clinical research. The Narcotrend includes the Narcotrend Index, a processed EEG parameter which may be used as an aid in monitoring the effects of certain anesthetic agents.

Device Description

The Narcotrend is a stand-alone EEG monitor including the following components: Preamplifier, Monitor for data analysis and display, System lead (connects preamplifier and monitor), Patient lead (connects the electrodes with the preamplifier). The Narcotrend records and processes data of one or two channels of EEG. The monitor display includes the following: Raw EEG, Power spectrum, Processed EEG parameters including spectral parameters, EEG stage, and the Narcotrend Index (current values and trend plots).

AI/ML Overview

The provided 510(k) summary for the Narcotrend Compact 4.0 EEG Monitor includes some information related to acceptance criteria and supporting studies, but it lacks many of the specific details requested in the prompt. Here's a breakdown of what can be extracted and where there are gaps:

Acceptance Criteria and Device Performance Table:

The document states: "Results of randomized controlled clinical trials demonstrate equal effectiveness of the Narcotrend and the predicate device regarding the assessment of hypnotic drug effects during general anesthesia."

This is a high-level statement of the comparative effectiveness the device aims to achieve, but it doesn't provide specific quantitative acceptance criteria (e.g., specific accuracy thresholds, sensitivity, specificity, or agreement metrics) or the reported performance against those criteria.

Acceptance Criteria	Reported Device Performance
Qualitative: Equal effectiveness to predicate device in assessing hypnotic drug effects during general anesthesia.	"Results of randomized controlled clinical trials demonstrate equal effectiveness of the Narcotrend and the predicate device regarding the assessment of hypnotic drug effects during general anesthesia."
Quantitative (Missing from document)	(Missing from document)

Detailed Study Information:

Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: The document does not explicitly state the country of origin or whether the clinical trials were retrospective or prospective. "Randomized controlled clinical trials" typically imply prospective studies.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified.
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:
- The document mentions "randomized controlled clinical trials" comparing the Narcotrend to the predicate device. However, it does not explicitly state that this was an MRMC study or that it focused on the improvement of human readers with AI assistance. The Narcotrend is an EEG monitor with a processed index, which aids in monitoring. The comparison is between the device's performance (Narcotrend Index) and the predicate device's index (likely BIS), not necessarily human reader performance with/without AI. Therefore, the concept of "effect size of how much human readers improve with AI vs without AI assistance" as typically applied in AI-assisted diagnostic imaging studies isn't directly applicable or addressed in this context.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The study described compares the Narcotrend (device) to the predicate device. Both generate an index. The "Narcotrend Index" is a processed EEG parameter. The study inherently evaluates the performance of this algorithm/device in generating that index. Thus, it can be inferred that a standalone performance evaluation of the device's output (the index) was part of these clinical trials.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for assessing "hypnotic drug effects during general anesthesia" would typically involve clinical endpoints related to the depth of anesthesia, such as patient movement, hemodynamic responses to surgical stimuli, or clinical scales (e.g., Modified Observer's Assessment of Alertness/Sedation Scale - MOAA/S, or similar scales for depth of consciousness during anesthesia). The document does not explicitly state the specific ground truth used.
The sample size for the training set:
- Not specified. The document only mentions "clinical trials" which are typically for validation/testing, not training. Details about the development and training of the Narcotrend algorithm itself are not provided in this summary.
How the ground truth for the training set was established:
- Not specified, as information about a training set is absent.

Summary of Gaps:

The 510(k) summary provides a high-level claim of "equal effectiveness" but lacks granular details common in modern AI/ML device submissions, such as:

Specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy, concordance metrics).
Metrics of the Narcotrend's performance against these criteria.
Exact sample sizes for clinical trials.
Detailed demographics or provenance of study data.
Specific ground truth methodology.
Information on expert qualifications or adjudication.
Details regarding the training dataset or its ground truth establishment.

This is likely due to the age of the submission (2004), as regulatory expectations and reporting standards for clinical validation, particularly for software and AI-enabled devices, have evolved significantly since then. The focus for this older submission was primarily on demonstrating substantial equivalence to a predicate device through general clinical effectiveness without the granular statistical breakdowns common today.

Summary

{0}------------------------------------------------

K 033543

510(k) Summary

As required by 21 CFR 807.92

Date: 2003-10-29

SEP 17 2004

General Company Information

MT MonitorTechnik GmbH u. Co. KG Maienbaß 27 D-24576 Bad Bramstedt Germany

Tel: +49 (0) 4192 201753 Fax: +49 (0) 4192 201754 Email: monitortechnik@t-online.de

Name of contact: Friedmund Wieland

Device

Trade name:	Narcotrend Compact 4.0
Common name:	EEG Monitor
Classification:	Product code: OLW, OMC, OLT
	CFR Section: 882.1400 Electroencephalograph
	Classification Panel: Neurology
	Device Class: Class II

Name of legally marketed device for which a claim of substantial equivalence is made

The Narcotrend is of comparable type and is substantially equivalent to the following predicate device:

Name:	A-2000 EEG Monitor with BIS
Manufacture:	Aspect Medical Systems
510(k) No.:	K974496
Date cleared:	1998-02-06

{1}------------------------------------------------

Device description

The Narcotrend is a stand-alone EEG monitor including the following components:

· Preamplifier
· Monitor for data analysis and display
. System lead (connects preamplifier and monitor)
· Patient lead (connects the electrodes with the preamplifier)

The Narcotrend records and processes data of one or two channels of EEG. The monitor display includes the following:

· Raw EEG
· Power spectrum
· Processed EEG parameters including spectral parameters, EEG stage, and the Narcotrend Index (current values and trend plots)

Intended use

The EEG monitor Narcotrend serves the purpose of registering and displaying EEG signals and thus monitoring the state of the brain.

It was developed specifically for use in operating rooms, intensive care units, and for clinical research.

The Narcotrend includes the Narcotrend Index, a processed EEG parameter which may be used as an aid in monitoring the effects of certain anesthetic agents.

Summary of technological characteristics compared to predicate device

The Narcotrend and the predicate device are similar in the following ways:

· Both devices record and display the EEG.
· Both monitors provide processed EEG parameters including a numerical EEG index which serves as an aid in assessing the hypnotic effects of certain anesthetic agents.
· Both devices conduct self-tests and electrode checks (automatic and manual).
· Both devices have capabilities for marking events and reviewing stored data.
· Both devices have capabilities for printer support and data transfer via RS232 serial port.
· Both systems have two main components, a monitor and a preamplifier.

The Narcotrend and the predicate device are different in the following ways:

· The Narcotrend is operated via touch screen while the predicate device is operated via keys.
· The Narcotrend includes a high resolution color monitor while the predicate device has a monochrome monitor.

{2}------------------------------------------------

· By default, the Narcotrend uses standard single-use ECG electrodes while the predicate device uses specially designed EEG sensors placed on the forehead.
· The Narcotrend can record and display two channels of EEG while the predicate device uses one channel of EEG.

Summary of nonclinical testing for the device

The Narcotrend complies with the safety standards below and is therefore safe and effective for the intended use. The device has been thoroughly tested including electrical safety, electromagnetic compatibility, mechanical and environmental tolerance, software validation and verification of specifications. Verification with the following mandatory and voluntary standards and guidelines has been made:

· IEC 60601-1, Medical electrical equipment Part 1: General requirements for safety
· IEC 60601-1-2. Medical electrical equipment Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
· IEC 60601-1-4, Medical electrical equipment Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems
· IEC 60601-2-26, Medical electrical equipment Part 2: Particular requirements for the safety of electroencephalographs
· Electroencephalograph Devices, Guidance for 510(k) Content, Draft Document, Version 1.0, November 3,1997
· Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 29, 1998

Summary of clinical testing for the device

Results of randomized controlled clinical trials demonstrate equal effectiveness of the Narcotrend and the predicate device regarding the assessment of hypnotic drug effects during general anesthesia.

Conclusion

The summary above shows that there are no new questions of safety and effectiveness for the Narcotrend as compared to the predicate device. We believe that the submitted device is substantially equivalent to the predicate device, and is safe for its intended use.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads facing right, representing health, services, and human needs. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Friedmund Wieland President MT MonitorTechnik GmbH u. Co. KG Maienbas 27 D-24576 Bad Bramstedt Germany

APR - 9 2012

Re: K033543

Trade/Device Name: Narcotrend Model Compact 4.0 Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLW, OMC, OLT Dated (Date on orig SE ltr): June 18, 2004 Received (Date on orig SE ltr): June 21, 2004

Dear Mr. Wieland:

This letter corrects our substantially equivalent letter of September 17, 2004.

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.

{4}------------------------------------------------

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 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/ucm115809.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,

Kesia Alexander

Image /page/4/Picture/8 description: The image shows a stylized letter 'J' in a cursive font, positioned to the left of three lines of text. The text is aligned vertically and appears to be part of a document or signature. The letter 'J' is large and prominent, with a flowing design that includes a loop extending below the baseline.

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

{5}------------------------------------------------

Page ! of I

510(k) Number (if known): K 0 3 3 5 43

Device Name: Name: Narcotrend Compact 4.0

Indications For Use:

The EEG monitor Narcotrend serves the purpose of registering and displaying EEG signals and thus monitoring the state of the brain.

It was developed specifically for use in operating rooms, intensive care units and for clinical research.

The Narcotrend includes the Narcotrend Index, a processed EEG parameter which may be used as an aid in monitoring the effects of certain anesthetic agents.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) OVEV

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

K033543 510(k) Number.

(Optional Format 3-10-98)

Regulation Number and Section

§ 882.1400 Electroencephalograph.

(a)
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.(b)
Classification. Class II (performance standards).