The Bio-logic Ceegraph/Sleepscan Netlink Traveler is indicated for use in the recording and analysis of EEG tests. Typical routine EEG tests are 20-30 minutes in duration, but the Ceegraph/Sleepscan Netlink Traveler can also be used for longer tests, including continuous long-term EEG monitoring with patient video. Similarly, the Bio-logic Ceegraph/SleepScan Netlink Traveler is indicated for use in the recording and analysis of human physiological data necessary for the diagnosis of Sleep-related disorders. It is intended to record and present this data in a form that can improve the speed of diagnosis and assist in potential treatment decisions. In general, EEG and Sleep testing is indicated for use whenever it is necessary to measure and record a patient's electrophysiological data relating the electrical activity of the brain, by attaching multiple electrodes at various locations on the body.

The Netlink Traveler can be used for patients of all ages, from children to adults, including geriatric patients.

The use of the Ceegraph/Sleepscan Netlink Traveler is to be performed under the prescription and supervision of a physician or other trained health care professional.

Device Description

The Netlink Traveler patient connection module (headbox) consists of a molded plastic enclosure approximately 5.75 x 3.9 x 1.75 in size and weighing approximately 1 lb. The Netlink Traveler can be configured to perform up to 40 channel data recordings, having 32 AC channels, and an external 8 DC channels (oximetry, body position, etc.), and additional special channels. Power to the box is supplied by an internal battery, and an external medical-grade power supply/charger may also be connected. There are two primary modes of operation: "Ambulatory Mode" (no power or Ethernet) where data is stored to internal flash memory and "Headbox Mode" (data communicated to host computer via Ethernet). External power is not required in Ambulatory Mode because the Netlink Traveler always derives its power from the battery. However, connecting the Netlink Traveler to external power supply/charger is recommended when longer tests are required in order to extend battery capacity. The AC channel electrodes are connected to safety touch-proof jacks on either of the 2 optional electrode connection accessories, the quick-disconnect box and the Netlink Traveler Electrode Block. These are connected to the Netlink Traveler box via a 68-pin cable and connector. The DC channels connect on a separate 8-pin connector. Other connectors (Ethernet, photic strobe out, Netlink) are located on the side of the Netlink Traveler box.

The Netlink Traveler consists of a digital board, an analog board and an LCD display board. The analog board is very similar in function to the analog board marketed in the Netlink Predicate Device. This board provides signal amplification and conversion of the data from the 32 channel electrodes to digital. The 68-pin electrode array connector allows the use of existing patient connection hardware, such as the 32-channel electrode connection panel called the "quick disconnect box", and the new Netlink Traveler Electrode Block. The connection panel called the "quick disconnect box", and the new Netlink Traveler Electrode Block. The Electrode Block may be configured for several arrays and is especially designed to be worn comfortably by the patient. The digital board contains a microprocessor along with program and data memory, and provides control functions for reading and processing of the analog data, converting it to digital, and communicating it to the host computer and/or to the compact flash memory card. Additional features of the Netlink Traveler include the color LCD display to facilitate functions such as electrode impedance collection, setup and impedance features.

AI/ML Overview

The Bio-logic Ceegraph/Sleepscan Netlink Traveler is an EEG/Sleep recording device. The provided text is a 510(k) summary for this medical device, which addresses its safety and effectiveness.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria in a quantitative table format as per your request. Instead, it demonstrates substantial equivalence to predicate devices by comparing various parameters and highlighting similarities or differences. The underlying "acceptance criteria" are implicitly met by demonstrating that the new device is as safe and effective as the predicate devices, with no adverse effects on product safety and effectiveness.

The table below summarizes the comparison points provided in the document between the Netlink Traveler and its predicate devices:

Parameter for comparison	Netlink Traveler's Reported Performance (vs. Predicate Devices)
Intended Use	No differences (similar to both Netlink and Traveler predicate devices).
Patient Population	No differences (similar to both Netlink and Traveler predicate devices).
Recording capacity	Up to 32 AC channels, 4 DC channels, and 4 special channels (oximetry, etc.). The Netlink predicate had up to 40 channels with 8 DC. The Traveler predicate had up to 24 AC channels with no DC.
Host Computer to Headbox Connection	No differences (similar to Netlink predicate device). Traveler predicate did not connect to host except for setup via serial port.
Computer Control Software	Uses same Ceegraph and Sleepscan (Vision) software as Netlink predicate, with minor additions for new hardware. Traveler predicate used a separate setup application.
Patient Information and Tracking	Uses P&TI ACCESS database (similar to Netlink predicate). Traveler predicate used DB4, compatible via import.
Safety Characteristics	No differences (basic patient connection and isolation circuits are the same for both predicate devices).
Power Source	Battery powered (similar to Traveler predicate). Netlink predicate used a medical-grade power supply.
Data Quality	18-bit resolution. Traveler predicate had 12-bit resolution. No differences noted against Netlink predicate.
Patient Connections	Electrode connections located on Electrode Block or optional Quick-Disconnect box. Netlink predicate had direct headbox connections. Traveler predicate used montage cables.
Impedance display on headbox	Uses an LCD display. Netlink predicate used LEDs. Traveler predicate did not provide this.
Physical Characteristics	Smaller than both Netlink and Traveler predicate devices.
Product Labeling	Similar safety, information, and warning labels; differences due to box size/shape.
Anatomical sites	No differences (similar to both Netlink and Traveler predicate devices).

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide details on a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). The safety and effectiveness analysis primarily relies on design control processes, hazard/risk analysis (FMECA), and comparison to predicate devices, rather than a separate clinical or performance test set with a defined sample size.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. As there is no explicitly defined "test set" with ground truth establishment described, this detail is absent.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention an MRMC comparative effectiveness study involving human readers with and without AI assistance. The device is a digital EEG/Sleep recorder, not an AI-assisted diagnostic tool that would typically undergo such a study for improved human reader performance. The software "does not make any final decisions that result in any automatic forms of diagnosis or treatment."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The document does not report a standalone performance study. The device is a data acquisition system. While it contains an embedded microprocessor that performs control functions for reading and processing analog data, it does not function as a standalone diagnostic algorithm. Its output, specifically from the software, "does not make any final decisions that result in any automatic forms of diagnosis or treatment."

7. Type of Ground Truth Used

The document does not describe the use of a "ground truth" in the context of a performance study. The safety and effectiveness are established through design controls, risk analysis, and substantial equivalence to legally marketed predicate devices. For a device like an EEG/Sleep recorder, the "ground truth" would implicitly be the accurate physical recording of electrophysiological signals, which is assessed through hardware design, signal processing specifications (e.g., 18-bit resolution), and adherence to relevant standards.

8. Sample Size for the Training Set

The document does not describe a training set. This device is developed based on engineering principles and comparison to predicate devices, not through machine learning models requiring training data.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as no training set or machine learning model is described in the provided document.

In summary:

The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices and adherence to design and risk management standards (ISO-13483, FDA QSR Design Control, EN-14971). It does not contain details about specific clinical performance studies, test sets, ground truth establishment, or AI-related metrics (like MRMC studies) that are common for devices involving diagnostic algorithms or AI. The Netlink Traveler is primarily a data acquisition device, and its safety and effectiveness are supported by its design, risk analysis, and comparison to existing, cleared devices.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Bio-logic Systems Corp. The logo is in black and white and features the company name in a stylized font. The word "Bio-logic" is on the top line, and "SYSTEMS CORP" is on the bottom line. There is a registered trademark symbol to the right of the word "Bio-logic."

AUG 26 2005

One Bio-logic Plaza Mundelein, IL 60060-3700 1-800-323-8326 Fax: 847-949-8615 www.bio-logic.com

KOS 2066

SECTION 2: SUMMARY AND CERTIFICATION

510(K) SUMMARY

SAFETY AND EFFECTIVENESS SUMMARY

Safety and effectiveness information concerning the Ceegraph/Sleepscan Netlink Traveler device is summarized below.

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

(847)-949-5200 TELEPHONE:

Norman E. Brunner CONTACT PERSON:

DATE ON WHICH THE SUMMARY WAS PREPARED: July 28, 2005

Netlink Traveler. NAME OF DEVICE:

Digital EEG/Sleep Recorder. COMMON NAME:

Electroencephalograph (per CFR 882.1400). CLASSIFICATION NAME:

PREDICATE DEVICE: Bio-logic Ceegraph Netlink (K002570), Sleepscan Netlink (K003681), Ceegraph Traveler (K954954) and Sleepscan Traveler (K962103).

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DESCRIPTION OF THE DEVICE:

The Netlink Traveler patient connection module (headbox) consists of a molded plastic enclosure The Netink Traveler patient connections models (18) in 1 can be configured to ... approximately 5.75 x 3.9 x 1.75 in size and weighing approximels, and additional special
perform up to 40 channel data recordings, having 32 AC channels, and an extern perform up to 40 chainer data recordings, having 52 r 10 crimeral battery, and an external
channels (oximetry, body position, etc.). Power to the box is supplied by an extern channels (oximery, body position, cle.). Fower to the other are wo primary modes of operation:
medical-grade power supply/charger may also be connected since interest and "H medical-grade power supply/charger may also be evines data stored to internal flash memory and "Headbox "Ambulatory Mode" (no power of Ethemet). External power s not required in Ambulatory
Mode" (data communicated to host computer via Ethernet). Hawaya, connecting the Mode" (data communicated to nost computer tha power from the battery. However, comecting the Mode because the Nethink Traveler always derives in ede to extend battery capacity. There are connected to external power supplyicharger is recommended when baskers, the AC channel electrodes are connected to safety touch-proof jacks on either of the 2 optional electrode connection accessories, the quick-adisonia of 8 pinned safety touch-proof jacks on eliter of the 2 optional encreating the Netlink Traveler box via a 68-pin cable
box and the Netlink Traveler Electrode Block. These connected to box and the Nellink Traveler Electrode Blook. "Mede of channel box, which is then connected to the eve and connector. The DC chamers comect on a separator. Other connectors (Ethernet, photic strobe out, Nethills Traveler through a soparated on the side of the Netlink Traveler box.

The Netlink Traveler consists of a digital board, an analog board and an LCD display board. The analog I he Netilink Traveler consists of a digital oourd, and market in the Netlink Precticate Device. This board is board is very similar in runction to the analog to digital. The 68-pin electrode array
provides signal amplification and conversion of the data from the 22 channel ologits o provides signal ampiritation and conversion of the data ware, such as the 32-channel electrode
connector allows the use of existing patient connection hardware, such as The s connection panel called the "quick disconnect box", and the new Netlink Traveler Electrode Block. The comection patier cared the "quick disconnect of "," and is especially designed to be worn and deta Electrode Block may be comigated for several arrers a microprocessor along with program and data
comfortably by the patient. The digital board contains a microprocessor alon comfortably by the patient. The argual obtart of the analog data, converting it to digital, and memory, and provides control runchous for reading and promoty card . Additional features of the communicating it to the nost compact and one of categor
Netlink Traveler include the color LCD display to facilitate functions such as electrode impedance Nethink Traveler Include the Color LCD ulsplay to activate various collection, setup and impedance features.

INTENDED USE:

The Bio-logic Ceegraph/Sleepscan Netlink Traveler is indicated for use in the recording and analysis of EEG The Blo-Iogic Ceegraph'sleepscall Nethills Haration, but the Ceegraph/Sleepscan Netlink Traveler
tests. Typical routine EEG tests are 20-30 minutes in duration, but the coun tests. Typical for longer tests, including continuous long-term EEG monitoring with patient video.
can also be used for longer tests, including continuous long-term EEG monit can also be used for longer tests, mending continued for use in the recording and Similany, the Bio-iogic Ceegraph steckland Nethin Traility Prefects of Sleep-related disorders. It is intended to andiysis of numan physiological and necessary of the speed of diagnosis and assist in potential record and present uns una are a rom that cated tor use whenever it is necessary to treatment decisions. In general; EDS and Steep relating the electrical activity of the brain, by attaching multiple electrodes at various locations on the body.

The Netlink Traveler can be used for patients of all ages, from children to adults, including geriatric patients.

The use of the Ceegraph/Sleepscan Netlink Traveler is to be performed under the prescription and supervision of a physician or other trained health care professional.

Page 9 ರಿಗ

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PATIENT POPULATION: Adults, children and infants.

SAFETY AND EFFECTIVENESS SUMMARY

To meet required safety and effectiveness issues, the Netlink Traveler was designed and incorporated into the untended I o meet required salety and enectiveliess issues, the readers which are intended product line in accordance with the Bio-logic mich and included Hazard/Risk analysis for the spaysis for the to meet ISO-13483 and FDA QSR Design Control specificality Analysis (FMECA) approach, and Netlink Traveler was performed dsing the Fanale Hoods Sonne with EN-14971, the International Standard for Risk Management.

The Nellink Traveler patient-connection hardware utilizes many of the same design principles and circuit The Netlink Traveler patient-connection hardware atmises mary of there are no newlydesigns as are used in the Dio-logic Cecegraph and Steeped or injured through the use of this infroduced hardware-related them of which and parties of power supply, but power is supplied
device. The Netlink Traveler utilizes a medical-grade by Aletink Traveler finat device. The Netinik Traveler unitzes a medical grade cawere control of all Netlink Traveler hardions is directly to the unit from the internal battery. "Bired inside the Netlink Traveler box,
provided from the embedded microprocessor and its program code locations to the provided from the embedded interopiocssor and the program. By harfwares-specific functions to the instead of directly from the nost computer program. By disable and the real-time demands, and performance and reliability are improved.

The Netlink Traveler software does not make any final decisions that result in any automatic forms of I he Netink Traveler software docs not marketing mar accommendations" are subject to review by a
diagnosis or treatment. All Ceegraph and Sleepscan program in and is modifie diagnosis or treatheilt. An Cceglaph and Dicepsian program program, and may be modified, qualified nealth care professional, such as an ELOT FO Trained user. The provides additional finationality to any this an hom overridoen of delect as delemined by a named user. The program program program other data analysis to suit his or her requirements.

The chart on the next page provides a summary comparison of the technological characteritics of the new I he chart on the next page provides a summaly comparate that this new Netlink Traveler mounted acvice refacted to the predicate as which would adversely affect product safety and effectiveness.

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・

Parameter for	Similarity or Difference –Netlink Predicate Device	Similarity or Difference -Traveler Predicate Device
comparison
Intended Use	No differences.	No differences.
Population	No differences.	No differences.
Recording capacity	The Netlink predicate device has up to40-channel capacity with 8 DCchannels. The Netlink Traveler has upto 32 channels of AC, 4 channels of DCand 4 special channels (oximetry, etc.).	This Predicate Device has up to 24channels for AC "head" channels, butno DC channels.
Host Computer toHeadbox Connection.	No differences.	This predicate device does not connectto a host computer except for setup.The connection is through a serialport.
Computer ControlSoftware	Netlink uses the same Ceegraph andSleepscan (Vision) software as thisPredicate Device, with minor additionsfor control of the new hardware.	The Traveler predicate device uses aspecial setup application, separatefrom the Ceegraph and Sleepscanapplications.
Patient informationand tracking	No differences. The P&TI ACCESSdatabase is used for both devices.	The Traveler predicate device uses asimple DB4 database for patient andtest information. This database iscompatible with the newer ACCESS-compatible database through theimport feature.
Safety Characteristics	No differences. The basic patientconnection and isolation circuits are thesame for both products.	No differences. The basic patientconnection and isolation circuits arethe same for both products.
Power Source	The Netlink predicate device uses amedical grade power supply whereas theNetlink Traveler is battery powered.	No differences. Both devices arebattery powered.
Data Quality	No differences.	Predicate device has 12 bit resolution,whereas Netlink Traveler has 18 bit.
Patient Connections	This predicate device has electrodeconnections directly on the headbox,whereas the electrode connections forNetlink Traveler are located on theElectrode Block or optional Quick-Disconnect box.	This Predicate Device requires the useof one of several patient montagecables. There are no electrode jackslocated directly on the box.
Impedance display onheadbox.	The Netlink predicate devices uses anarray of LED's for impedance display.Netlink Traveler uses an LCD display.	Not provided for on this PredicateDevice
PhysicalCharacteristics	The Netlink predicate device is largerthan Netlink Traveler.	This predicate device is larger thanNetlink Traveler.
Product Labeling	Similar safety, information and warninglabels. Different size and shape of boxrequires some different labels.	Similar safety, information andwarning labels. Different size andshape of box requires some differentlabels.
Anatomical sites	No differences.	No differences.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a family of people.

AUG 2 6 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Norman E. Brunner Vice-President of Research and Development Bio-Logic Systems Corp. One Bio-logic Plaza Mundelein, Illinois 60060-3700

Re: K052066

Trade/Device Name: Ceegraph/Sleepscan Netlink Traveler Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: GWQ Dated: August 16, 2005 Received: August 17, 2005

Dear Mr. Brunner:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your become on (c) } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } dications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regardy to regardent date of the Medical Device Amendments, or to conninered pror to may 20, 1978, the excordance with the provisions of the Federal Food, Drug, de vices that have been recuire approval of a premarket approval application (PMA). and Cosmeter rest (110) and be device, subject to the general controls provisions of the Act. The I ou may, dierely mains of the Act include requirements for annual registration, listing of general controls provision 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 If your device is elassinod (600 world). 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 r tease be actived that i bremination that your device complies with other requirements of the Act that I Drivias Intactions and regulations administered by other Federal agencies. You must or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic roral in and quind provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2- Mr. Norman E. Brunner

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin marketing your avones of your device of your device to a legally premarket notification. THE PDA Indian of substanced equice 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 of If you desire specific advice for your ac not on 5. Also, please note the regulation entitled, and their contact the Office of Compullion at (210) = 16 = 1 = 1 807.97). You may obtain "Misbranding by relefence to premations in this and (* * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * other general Information on your responsible and its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at the local demansing http:// Manufacturers, miernational and Consults: 144011. 144911. 1441

Sincerely yours,

Barbara Ruchs

Mark N. Melkerson 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

510(k) Number (if known):

K052066

Device Name: Ceegraph/Sleepscan Netlink Traveler.

Indications For Use:

The Bio-logic Ceegraph/Sleepscan Nettink Traveler is indicated for use in the The Bio-logic Ceegraph/Seepscall Netillin Trurolier EEG tests are 20-30 minutes in
recording and analysis of EEG tests. Typical routine lease he used for longer recording and analysis of EEO tests. Typisk Traveler can also be used for longer duration, but the Ceegraphroleepsean Netina with patient video. Similarly, tests, including continuous long-lem LLC monion is indicated for use in the recording the Bio-logic CeegraphirSleepScan Netink Treasury for the diagnosis of Sleep-related and analysis of numan priysiological data necessary of in a form that can improve the disorders. It is intended to record and probential treatment decisions. In general, EEG and speed of diagnosis and assist in potential train assary to measure and record a Sleep testing is indicated for use whence the electrical activity of the brain, by pattent's cleotrophyological at various locations on the body.

The Netlink Traveler can be used for patients of all ages, from children to adults, including geriatric patients.

The use of the Ceegraph/Sleepscan Netlink Traveler is to be performed under the The use of the Ceegraphiolecpsban rother trained health care professional.

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Karlaue Buemus for MXM

Division of Gen al, Restorative. and Neurological Devices

Page 1 of 1

510(k) Number_ Kos 2064

Page 5

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).