The SEDLine Sedation Monitor is indicated for use in the operating room (OR), intensive care unit (ICU), and clinical research laboratory. It is intended to monitor the state of the brain by real-time data acquisition and processing of EEG signals. The system includes the Patient State Index (PSI), a proprietary computed EEG variable that is related to the effect of anesthetic agents.

Device Description

SEDLine is an EEG monitor designed for use in the OR, ICU, EEG laboratory and for clinical research. It provides the ability to acquire and display real-time EEG waveforms, process the real time EEG data using digital signal processing techniques, display the processed EEG data in several different formats, and archive the real-time or processed EEG data for future review.

The SEDLine System consists of five components, the monitor, PSI algorithm, amplifier, patient cable and SEDTrace EEG Electrode Set. The device performs automatic self tests upon power up to ensure that the monitor and its components are functioning properly.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the SEDLine Sedation Monitor:

It's important to note that this document is a 510(k) summary for a medical device and not a detailed clinical study report. Therefore, some of the requested information, particularly regarding the specifics of clinical trials (like sample sizes for a test set, expert qualifications for ground truth, MRMC studies, and detailed training set information), is not present. The provided text primarily focuses on demonstrating substantial equivalence to a predicate device through technical similarities and compliance with safety standards, rather than extensive clinical performance data specific to diagnostic accuracy or reader improvement.

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria for clinical performance (e.g., minimum sensitivity or specificity targets with confidence intervals). Instead, it highlights the device's technical specifications and adherence to safety and performance standards as the basis for equivalency.

The "Test Results" section broadly states: "The following tests have been conducted in order to verify and validate the device: software, mechanical and electrical validation testing and EMC testing." It then lists compliance with several UL, CSA, and IEC standards for electrical safety and electromagnetic compatibility. This implies that the 'acceptance criteria' are primarily related to meeting these technical and safety standards, as well as demonstrating that the device functions as intended for monitoring EEG signals and calculating the PSI.

Given the information, here's a table summarizing what can be inferred:

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred from text)	Reported Device Performance
Safety	Compliance with recognized electrical safety standards.	UL 60601-1, CSA 22.2 No. 60601-1, IEC 60601-1, IEC 60601-2-26
Electromagnetic Compatibility (EMC)	Compliance with EMC standards.	FDA Reviewer Guidance for Premarket Notification Submissions, Section 7, Electromagnetic Compatibility dated November 1993
Functional Performance	Ability to acquire and display real-time EEG waveforms. Ability to process EEG data using digital signal processing. Ability to display processed EEG data in various formats. Ability to archive real-time or processed EEG data. Automatic self-tests upon power-up. PSI algorithm accurately converts EEG into a proprietary index related to anesthetic effects.	(Implied by device description and intended use) "The monitor provides signal processing and display capabilities for the 4 channels of real-time EEG data... calculates the processed parameters and displays the real-time EEG data and processed data." "Performs automatic self tests upon power up." "The PSI is an EEG variable that is related to the effect of anesthetic agents."
Software Validation	Software functions as intended and is validated.	"software... validation testing"
Mechanical Validation	Mechanical components function as intended and are validated.	"mechanical... validation testing"
Electrical Validation	Electrical components function as intended and are validated.	"electrical validation testing"
Predicate Equivalence	Similarities in function, processed parameters, PSI, self-tests, materials, and electrode locations to the predicate device.	All "Similarities" listed in the text (see below).

Similarities to Predicate Device (part of the equivalence argument):

Both systems are EEG monitors.
Both systems provide processed parameters (EMG, SR, ART, PSI).
Both systems include PSI, a proprietary computed EEG variable related to anesthetic effects.
Both conduct self-tests at startup.
Both electrodes use the same materials.
Both electrodes collect data from the same electrode locations.

Study Information

Based on the provided text, a detailed clinical study report proving specific diagnostic performance metrics (like sensitivity, specificity, or reader improvement) is not included. The document describes the device and its technical validation for substantial equivalence purposes.

Sample size used for the test set and the data provenance:
- Not specified. The document mentions "software, mechanical and electrical validation testing and EMC testing," but does not detail any clinical test set or its sample size.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. There is no mention of a clinical test set requiring expert-established ground truth in this document.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. No clinical test set requiring adjudication is described.
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:
- No such study is mentioned or implied. The SEDLine Sedation Monitor provides a Patient State Index (PSI) as a computed EEG variable related to anesthetic agents, not an AI that assists human readers in interpreting images or data. The device itself is the 'AI' portion (the PSI algorithm), providing a quantitative output.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The PSI algorithm within the SEDLine monitor would function in a standalone manner to compute the PSI value from EEG signals. The output (the PSI number, EMG, SR, ART values, and EEG waveforms) is then presented to the human clinician. The "performance" in this context is the accuracy and reliability of these computed values in reflecting the brain state as intended. The document states the PSI "is related to the effect of anesthetic agents," implying its ability to provide this standalone metric.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated for the PSI algorithm's "ground truth." For devices that measure a physiological state (like depth of anesthesia), ground truth is typically correlated with clinical outcomes, pharmacokinetic/pharmacodynamic studies of anesthetic agents, and expert clinical assessment of patient response to simulation scenarios. The statement "The PSI is an EEG variable that is related to the effect of anesthetic agents" suggests that its development and validation would have involved correlating PSI values with known anesthetic concentrations/doses and their clinical effects, but the specifics are not in this document.
The sample size for the training set:
- Not specified. There is no mention of a training set size for the PSI algorithm. Algorithm development often involves data sets for training, but this is not detailed in a 510(k) summary focused on substantial equivalence.
How the ground truth for the training set was established:
- Not specified. Similar to the point above, the method for establishing ground truth for any potential training data used for the PSI algorithm is not described.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 9 2005

Ms. Dawn E. Frazer, Vice President Regulatory Affairs and Quality Assurance Physiometrix, Inc. Five Billerica Park 101 Billerica Avenue North Billerica, Massachusetts 01862

Re: K051874

Trade/Device Name: SEDLine Sedation Monitor with Frontal PSI and SEDTrace EEG Electrode Set Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph electrode/lead tester Regulatory Class: II Product Code: GWO Dated: August 8, 2005 Received: August 9, 2005

Dear Ms. Frazer:

This letter corrects our substantially equivalent letter of September 2, 2005.

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. Iisting 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 Acts requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 - Ms. Dawn E. Frazer

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 Office of Compliance at (240) 276-0115 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
Barbara Buend

Mark N. Melkersen Acting 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

Applicant:	Physiometrix, Inc.
510(k) Number (if known)	Not assigned K051874
Device Name	SEDLine Sedation Monitor with Frontal PSI and SEDTrace EEGElectrode Set
Indications For Use	The SEDLine Sedation Monitor is indicated for use in the operatingroom (OR), intensive care unit (ICU), and clinical researchlaboratory. It is intended to monitor the state of the brain by real-time data acquisition and processing of EEG signals. The systemincludes the Patient State Index (PSI), a proprietary computed EEGvariable that is related to the effect of anesthetic agents.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
X
(Per 21 CFR 801.109)

OR Over-The-Counter Use __
Chas bare Buchnd forman
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number K051874

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K051874

510(K) SUMMARY

Date:	July 7, 2005
	SEP 02 2005
Company:	Physiometrix, Inc.Five Billerica Park101 Billerica AvenueN. Billerica, MA 01862www.physiometrix.com
Contact:	Dawn E. FrazerVice PresidentRegulatory Affairs & Quality Assurance(978) 670-2422 x243dfrazer@physiometrix.com
Subject Device:	SEDLine Sedation Monitor with Frontal PSI and SEDTrace EEG Electrode Set
Classification:	Class II, 21 CFR Part 882.1400, ElectroencephalographClass II, CFR 21 Part 882.1320, Cutaneous Electrodes
Intended Use:	The SEDLine Sedation Monitor is indicated for use in the operating room (OR),intensive care unit (ICU), and clinical research laboratory. It is intended tomonitor the state of the brain by real-time data acquisition and processing of EEGsignals. The system includes the Patient State Index (PSI), a proprietarycomputed EEG variable that is related to the effect of anesthetic agents.
Description:	SEDLine is an EEG monitor designed for use in the OR, ICU, EEG laboratory andfor clinical research. It provides the ability to acquire and display real-time EEGwaveforms, process the real time EEG data using digital signal processingtechniques, display the processed EEG data in several different formats, and archive the real-time or processed EEG data for future review.The SEDLine System consists of five components, the monitor, PSI algorithm,amplifier, patient cable and SEDTrace EEG Electrode Set. The device performsautomatic self tests upon power up to ensure that the monitor and its components are functioning properly.

Image /page/3/Picture/5 description: The image shows a medical device with a screen displaying the number 65. Several wires and attachments are laid out on the table in front of the device. The device appears to be used for medical diagnostics or monitoring. The lighting in the image is dim, creating a spotlight effect on the device and its components.

Monitor

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The monitor provides signal processing and display capabilities for the 4 channels of real-time EEG data acquired from the preamplifier.

The monitor dimensions are 9" W x 8" H x 6" D. The color display area is 3.8" H x 5.2" W. In addition to the display area, the front panel is configured with a number of buttons to allow for configuration of the display and data acquisition settings. The monitor includes a base and a clamp that can be used to secure the unit on a flat surface or on a pole (respectively).

The processor is a PC-based CPU that processes the EEG data, calculates the processed parameters and displays the real-time EEG data and processed data. Processed parameters include Electromyograph (EMG), Artifact (ART), Suppression Ratio (SR), and the Patient State Index (PSI).

The monitor is powered through either standard wail outlet through a power cable or by the internal back-up battery power.

PSI Algorithm

The PSI algorithm in the SEDLine Monitor is used to convert EEG acquired from four active (F7, F8, Fp1 and Fp2), ground (FpZ) and reference (AFZ) into a proprietary index, the PSI. The PSI is an EEG variable that is related to the effect of anesthetic agents.

Patient Module

The patient module is an electrically isolated, low noise, high gain, analog to digital signal converter that can process up to 4 channels of real-time data.

The preamplifier dimensions are 4.25" W x 1.75" D x 5.5" H. The patient module includes a clamp that can be used to secure the unit. The clamp can accommodate a pole, bed rail or bed sheet with a thickness of up to 1". The preamplifier is connected to the patient and monitor through flexible, shielded cabling.

Patient Cable

The patient cable is used to connect the patient module to the SEDTrace. The cable is 6 feet in length and terminated on one end with a 12 pin round connector design to mate with the patient module, and on the other end with a custom connector designed to mate with the SEDTrace.

SEDTrace

The SEDTrace is an EEG Electrode Set designed for use with the SEDLine System. It is comprised of six EEG electrodes that are located in a flexible substrate. The SEDTrace connects to the patient cable with a custom connector.

SEDLine Sedation Monitor with Frontal PSI (K033999) Predicate Device: PSArray2 EEG Electrode Set (K020670)
The subject device is similar to the predicate device in the following way(s): Similarities:
Both systems are EEG monitors. a.

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	b.	Both systems provide a variety of processed parameters, EMG, SR, ART and PSI.
	c.	Both systems include the PSI, a proprietary computed EEG variable that is related to the affects of anesthetics.
	d.	Both conduct self tests at start up to assure that the device is operating.
	e.	Both electrodes use the same materials.
	f.	Both electrodes collect data from the same electrode locations.
Differences:		The subject device is different from the predicate device in the following way(s):
	a.	The connection system from the electrode set to the patient cable has been modified.
Test Results:		The following tests have been conducted in order to verify and validate the device: software, mechanical and electrical validation testing and EMC testing.
		The PSA4000 has been testing in accordance with the following standards.
		• UL 60601-1
		• CSA 22.2 No. 60601-1
		• IEC 60601-1
		• IEC 60601-2-26

FDA Reviewer Guidance for Premarket Notification Submissions, Section 7, . Electromagnetic Compatibility dated November 1993.

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).