The BISx is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatic patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals.

The BIS may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.

Device Description

The BISx is a component that processes up to two channels of EEG and computes the Bispectral (BIS) Index and other EEG parameters (same as predicate device), uniting the functionality of the Digital Signal Converter (DSC-XP) and the BIS algorithm into a single enclosure. The BISx mates on one side with Aspect's BIS sensors (up to 2 channel, all currently marketed). On the other side, the BISx attaches to OEM (other equipment manufacturers) patient monitoring systems, allowing them to display Aspect's proprietary BIS Index on their integrated patient monitoring display.

Combining the functions of the DSC-XP and the BIS algorithm into a single enclosure provides our OEM Business Partners with a more durable, more compact, and less expensive way to include the BIS Index parameter into their patient monitoring systems.

AI/ML Overview

The provided text describes a 510(k) summary for the BISx EEG Monitor, focusing on its substantial equivalence to a predicate device, the Aspect Medical Systems A-2000 (XP) EEG Monitor with BIS System. The summary primarily details the device's technical specifications, intended use, and a comparison with the predicate device, along with verification and validation testing.

Based on the provided document, the following information regarding acceptance criteria and device performance can be extracted:

A table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
Risk analysis	PASS
Software validation	PASS
Electronic verification	PASS
Mechanical/environmental validation	PASS
Device is substantially equivalent to predicate device	Yes, all tests/analyses PASS, device determined substantially equivalent.
Safe for its intended use	Yes, all tests/analyses PASS, device determined safe and effective for intended use.

Note: The document states "Results show all tests/analyses PASS. Therefore, the device is substantially equivalent to the predicate device, and safe for its intended use." This serves as the overarching performance statement for the listed criteria.

Sample size used for the test set and the data provenance: Not specified in the provided text. The document refers to "analysis/verifications/validations" but does not detail the specific test sets, their sample sizes, or data provenance (e.g., country of origin, retrospective/prospective nature).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified in the provided text.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not specified in the provided text.
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 specified in the provided text. The device is a monitor intended for data acquisition and display, not an AI-assisted diagnostic tool that aids human readers in interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes the BISx as a component that processes EEG and computes the Bispectral (BIS) Index, uniting the functionality of a Digital Signal Converter and the BIS algorithm. The testing described ("Software validation," "Electronic verification") would inherently assess the standalone performance of these components and the algorithm. However, no specific "standalone performance study" with clear metrics like sensitivity/specificity for a clinical endpoint is detailed. The focus is on the device's equivalence to a predicate, which implies its computational output is comparable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not specified in the provided text. The "ground truth" for the verification and validation tests would be the established engineering and functional specifications for the device's performance, but the clinical "ground truth" (e.g., actual anesthetic depth for BIS index accuracy) is not discussed in the context of specific studies for this submission. The device is intended to monitor the state of the brain; its clinical efficacy is primarily established through its predicate.
The sample size for the training set: Not applicable for this submission. The BISx is described as building upon existing and validated BIS technology from the predicate device. There is no mention of a particular "training set" in the context of machine learning model development for this specific submission. The BIS algorithm itself would have been developed and validated previously.
How the ground truth for the training set was established: Not applicable for this submission (see point 8).

Summary

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K040183

FEB 2 5 2004

510(k) SUMMARY

Date Prepared: January 14, 2004

Company Name and Address

Aspect Medical Systems, Inc. 141 Needham St. Newton, MA 02464

Christine M. Vozella Contact Person: Regulatory Affairs/Quality Assurance 1775 Rockies Ct. Lafayette, CO 80026 Home office telephone (direct dial): (303) 926-5624 Fax #: (303) 604-6477

Device Name

Proprietary Name: BISx EEG Monitor Common Name:

Classification

Electroencephalograph (EEG) monitors and their software have been classified by the Neurological Devices Panel as Class II devices (21 CFR 882.1400)

Predicate Device

Aspect Medical Systems A-2000 (XP) EEG Monitor with BIS System This 510(k), #K030267, received FDA clearance January 13, 2004

Device Description

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Indications for Use

BISx is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatic patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals.

Summary of Technological Characteristics Compared to Predicate Device

Similarities

The indications for use are identical. ●
The fundamental technology has not changed, in that the BIS technology remains ● the same
. The BISx has the same operating principal in that both acquire raw EEG using the same signal processing, both filter and digitize EEG, and both calculate BIS,
Functionality is the same in that there is a DSC (digital signal processor) and BIS . algorithm that function using the same technology as the predicate device.
Both have 2 channel maximum EEG monitoring capability. .

Minor Differences

DSC-XP and BIS algorithm are housed together in a single enclosure. In the . predicate device, the algorithm resides within the Monitor, and the DSC-XP is a separate enclosure.
The BISx has 2 printed circuit boards. In the predicate device, there are 4 printed . circuit boards (2 in the DSC-XP, and 2 in the Monitor).
Source code differs in that there are additional commands and additional . messages that have been incorporated in the BISx, such as: new command for a sensor impedance check, and a command for a hardware id. " new
There are additional communication protocols ●
There is more memory in the BISx. Also, the DSP processor is faster. .

Testing

The following analysis/verifications/validations were performed:

Risk analysis
Software validation
Electronic verification
Mechanical/environmental validation

Results show all tests/analyses PASS. Therefore, the device is substantially equivalent to the predicate device, and safe for its intended use.

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Conclusion

Based on the above, Aspect Medical Systems believes the BISx is substantially
f the same and instructive to levice, and is sofa and effective for its intended use, Based on the above, Aspect Medical Systems belleves the 212. In a see and effective for its intended use.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the caduceus. The logo is simple and recognizable, and it is used to represent the U.S. Department of Health & Human Services.

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

Aspect Medical Systems Inc. c/o Mr. Ned E. Devine Entela Inc. 3033 Madison Avenue, SE Grand Rapids, Michigan 49548

Re: K040183

Trade/Device Name: BISX Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLW, OMC, ORT, OLT Dated (Date on orig SE Itr): February 11, 2004 Received (Date on orig SE ltr): February 12, 2004

APR - 9 2012

Dear Mr. Devine:

This letter corrects our substantially equivalent letter of February 25, 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.

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Page 2 - Mr. Ned E. Devine

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 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/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.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Kesia Alexander

Malvina B. Evdelman, M.D. Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: BISx

Indications For Use:

The BISx is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

of Device Evaluation (ODE)

for Made A. Millheim

Restorative,

Page 1 of

510(k) Number

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).