The Bio-logic Ceegraph family is indicated for use in the recording and analysis of routine EEG tests. Typical EEG tests are 20-30 minutes in duration. but the Ceegraph system can also be used for longer tests. including continuous lone-term EEG monitoring with patient video. EEG testing is indicated for use whenever it is necessary to measure and record the electrical activity of a patient's brain by attaching multiple electrodes at various locations on the scalp.

The 128 Channel Data Recording system has a similar intended use to that of the 32 channel Ceegraph recording system.

It can be used for patients of all ages, from newborn infants through adults, to and including geriatric patients.

Device Description

The 128-Channel data collection system consists of a metal enclosure approximately 13.5' x 7.375' x 5.25" in size, weighing approximately 10.9 (when fully-equipped to handle all 128 channels). It can be configured to perform from 16 to 128 channel collection, depending on the hardware installed in the box. Power to the box is supplied with an external medical-grade power supply, which supplies regulated 12 volts and 5 volts DC to a connector at the rear of the box. Communication to the host computer is performed through a standard Ethernet interface connector capable of running at data rates up to 10 MHz (10 base-T). Four patient connectors are provided on the front of the box, each capable of interfacing to 32 channels of patient input. A sync connector is provided at the rear of the box, to provide synchronization and sampling rate information to external devices.

The system consists of a microprocessor board, a digital interface board, and up to eight (8) 16-channel analog boards connected to the system through a backplane interconnect board. The analog boards are identical to the 16-channel analog boards used in the patient connection module (headbox) of the predicate device. These boards provide patient isolation and signal amplification. Boards are connected in pairs to one of the four external connectors on the front of the unit. These 50-pin external connectors are identical to the auxiliary connector on the present headbox of the predicate device. This allows the use of existing patient connection hardware, such as electrode arrays and the 32-channel" electrode connection panel called the "quick disconnect box". The microprocessor board contains program and data memory and control functions for reading the analog data, converting it to digital, and communicating it to the host computer through the Ethernet cable. The digital interface board contains the interface to the A/D converters and the communications hardware.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the Bio-logic Ceegraph 128-Channel Recording System, based on the provided text:

Acceptance Criteria and Reported Device Performance

The device is a modification of a predicate device (Bio-logic Ceegraph Digital EEG System, 510(k) #K933233) and is intended to demonstrate equivalence in terms of safety and effectiveness, and that additional features provide utility and product performance which exceeds that of the predicate device.

Acceptance Criteria Category	Specific Test/Performance Metric	Reported Device Performance	Comments
Safety and Electrical	EMI/EMC Testing (multiple standards including CISPR, ENV, EN, Military Standard)	Completed satisfactorily with no adverse reports.	Demonstrates compliance with electromagnetic compatibility standards.
	Current Leakage Tests (ANSI/AAMI)	Completed satisfactorily with no adverse reports.	Ensures electrical safety for patient and operator.
	Dielectric Withstand Test (FDA Reviewer's Guidance and IEC 601-1)	Completed satisfactorily with no adverse reports.	Verifies insulation integrity against high voltage.
	Power Line Variations (FDA Reviewer's Guidance)	Completed satisfactorily with no adverse reports.	Assesses performance under fluctuating power conditions.
	Power Line Transients (FDA Reviewer's Guidance)	Completed satisfactorily with no adverse reports.	Evaluates resistance to sudden power disturbances.
	Electrostatic Discharge Tests (ESD) (FDA Reviewer's Guidance and EN60601-2)	Completed satisfactorily with no adverse reports.	Confirms resistance to static electricity.
Environmental	Temperature testing (FDA Reviewer's Guidance)	Completed satisfactorily with no adverse reports.	Assesses operational stability across temperature ranges.
Functional/Performance	Data Integrity Tests (demonstrate digital data is correct representation of analog signals)	Completed satisfactorily with no adverse reports.	Crucial for ensuring the accuracy of recorded EEG data.
Equivalence to Predicate	Substantially the same technical design approach as predicate device's patient connection module (headbox)	Confirmed through description of shared analog boards and updated digital components.	This is the overarching criterion for 510(k) clearance. The new device uses the same analog boards and has an updated digital design but the same core functionality for signal capture.

Study Information

Based on the provided text, the documentation describes non-clinical testing designed to demonstrate substantial equivalence and enhanced performance. It is important to note that this is a 510(k) submission, which primarily focuses on demonstrating equivalence to a predicate device through non-clinical data, rather than requiring a full-scale clinical trial.

Sample size used for the test set and the data provenance:
- The document does not specify a "test set" in the context of patient data. The non-clinical testing was performed on the device itself.
- Data provenance is not applicable as it's a device performance test, not a clinical data set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was a non-clinical device performance study where "ground truth" was established by engineering standards and specifications (e.g., correct representation of analog signals).
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. There was no human interpretation or adjudication of a test set in the clinical sense mentioned. The tests were objective engineering and performance evaluations.
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. An MRMC study was not stated or implied. This device is a digital EEG recorder, not an AI-powered diagnostic tool requiring human reader studies to evaluate interpretative performance.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, effectively. The "Data Integrity Tests" assess the algorithm's (device's) ability to accurately represent analog signals digitally, independent of human interpretation at that stage. The entire suite of non-clinical tests are standalone performance evaluations of the device's hardware and software.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the data integrity tests, the "ground truth" would be the known analog input signals that are fed into the system. The device's digital output is then compared against these known inputs to verify accuracy.
- For other tests (EMI/EMC, leakage, etc.), the ground truth is adherence to established engineering standards and regulatory thresholds.
The sample size for the training set:
- Not applicable. This device is an EEG recording system, not a machine learning algorithm that requires a "training set" of data in the typical sense. Its function is to accurately capture and record signals, not to interpret or classify them using learned patterns from a dataset.
How the ground truth for the training set was established:
- Not applicable. As the device does not employ a machine learning model that requires training data and a corresponding ground truth, this question doesn't apply.

Summary

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K973883

Bio-logic One Bio-logic Plaza Mundelein, Illinois 60060-3700 1-800-323-8326 Fax: 847-949-8615

MAR - 5 1998

SECTION 2: SUMMARY AND CERTIFICATION

510(K) SUMMARY

SAFETY AND EFFECTIVENESS SUMMARY

Safety and effectiveness information concerning this Modification to Ceegraph for 128-Channel Recording is summarized below.

Because this is not a CLASS III device, the special certification defined for this section is not required.

PREPARED BY: Bio-logic Systems Corp One Bio-logic Plaza Mundelein, IL 60060

(847)-949-5200 TELEPHONE:

CONTACT PERSON: Norman E. Brunner

DATE ON WHICH THE SUMMARY WAS PREPARED: October 13, 1997

NAME OF DEVICE: Bio-logic CEEGRAPH 128-Channel Recording System.

Digital EEG Recorder. COMMON NAME:

Electroencephalograph (per CFR 882.1400). CLASSIFICATION NAME:

PREDICATE DEVICE: Bio-logic Ceegraph Digital EEG System , 510(k) #K933233.

DESCRIPTION OF THE DEVICE:

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INTENDED USE:

The Bio-logic Ceegraph family is intended for use in the recording and analysis of routine EEG tests. Typical EEG tests are 20-30 minutes in duration, but the Ceegraph system can also be used for longer tests, including continuous long-term EEG monitoring with patient video. EEG testing is intended for use whenever it is necessary to measure and record the electrical activity of a patient's brain by attaching multiple electrodes at various locations on the scalp. The 128 Channel Data Recording system has a similar intended use to that of the 32 channel Ceegraph recording system (predicate device). It can be used for patients of all ages, from newborn infants through adults, to and including geriatric patients.

PATIENT POPULATION: Adults, children and infants.

SUMMARY OF TECHNOLOGICAL CHARACTERISTICS:

The 128-Channel Data Recording System uses substantially the same technical design approach as that of the predicate device patient connection module (headbox). The predicate device employs a microprocessor-based digital control board, a patient interface board, and two 16-channel analog boards. The same analog boards are used in the 128-Channel system, which can accommodate up to eight of them. The digital board is an updated design incorporating a more powerful microprocessor and more memory, and the digital control. interfacing and communications functions are contained on two boards instead of one, as in the predicate device. The method of communication to the host computer is through high-speed Ethernet cable, whereas the predicate device uses an RS-422 serial communication interface.

Both the predicate device and the 128-Channel System require only low-voltage DC power for operation. Patient isolation is provided through the use of optical isolators on the interface board. In addition, the 128-Channel System connects to the host computer through a transformer-coupled Ethernet connector, which provides a second level of isolation.

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SUMMARY OF NON-CLINICAL TESTING:

The following is a list of tests performed on the 128-Channel Data Recording System to demonstrate that the performance of the system is equivalent to that of the predicate device in terms of safety and effectiveness, and that the additional features provide utility and product performance which exceeds that of the predicate device. All tests were completed satisfactorily with no adverse reports.

1. EMI/EMC Testing per FDA Reviewer's Guidance (November, 1993):
- a.) CISPR 11 Conducted and CISPR 11 A Radiated Emissions
- b.) ENV 50140 Radiated Susceptibility Test
- c.) EN 61000-4-4 Transient Susceptibility Test
- d.) EN 61000-4-5 Surge Susceptibility Test
- e.) EN 61000-4-6 and CS114 Conducted Immunity Tests
- f.) RE101 Magnetic Emissions Test
- g.) RS101 and 60 Hz Magnetic Susceptibility Tests
- h.) EN 61000-4-8 Voltage Fluctuations Test
- i.) Reviewer's Guide Quasi-static Fields Test
- i.) Military Standard 461C CS02 Test
- k.) EN 60555-2 Power Line Harmonics Test Prescan
Current Leakage Tests per ANSI/AAMI, Safe Current Limits for Electromedical Apparatus. 2.
- 3. Dielectric Withstand Test per FDA Reviewer' Guidance and IEC 601-1.
- Power Line Variations per FDA Reviewer's Guidance. 4.
- Power Line Transients per FDA Reviewer's Guidance. રું.
  તમારી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, આંગણ
- Temperature testing per FDA Reviewer's Guidance. 6.
- 1. Electrostatic Discharge Tests (ESD) per FDA Reviewer's Guidance and EN60601-2.
- 1. Data Integrity Tests to demonstrate that digital data collected is a correct representation of the analog signals that are applied at the patient inputs.

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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 symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR -- 5 1000

Mr. Norman E. Brunner Vice-President of R&D Bio-logic Systems Corporation One Bio-logic Plaza 60060-3700 Mundelein, Illinois

Re: K973883 Bio-logic Ceegraph 128-Channel Recording Trade Name: System Regulatory Class: II Product Code: GWO January 26, 1998 Dated: Received: January 27, 1998

Dear Mr. Brunner:

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 The general controls provisions of the Act 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 requlations 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 (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 requlations.

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Page 2 - Mr. Brunner

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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INDICATIONS FOR USE STATEMENT

K973883 510(k) Number (if known):

Device Name: BIO-LOGIC MODIFICATION TO CEEGRAPH FOR 128 CHANNEL DATA RECORDING

Indications For Use:

The 128 Channel Data Recording system has a similar intended use to that of the 32 channel Ceegraph recording system.

It can be used for patients of all ages, from newborn infants through adults, to and including geriatric patients.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

tocallos

n Sign-Off) Divisio Division of General Restorative Devices 973885 510(k) Number ..

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use _______

(Optional Format 1-2-96)

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).