CEEGRAPH/SLEEPSCAN NETLINK TRAVELER

{0}------------------------------------------------ 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). {1}------------------------------------------------ #### 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 {2}------------------------------------------------ ## 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. {3}------------------------------------------------ · ・ | Parameter for | Similarity or Difference –<br>Netlink Predicate Device | Similarity or Difference -<br>Traveler Predicate Device | |-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | comparison | | | | Intended Use | No differences. | No differences. | | Population | No differences. | No differences. | | Recording capacity | The Netlink predicate device has up to<br>40-channel capacity with 8 DC<br>channels. The Netlink Traveler has up<br>to 32 channels of AC, 4 channels of DC<br>and 4 special channels (oximetry, etc.). | This Predicate Device has up to 24<br>channels for AC "head" channels, but<br>no DC channels. | | Host Computer to<br>Headbox Connection. | No differences. | This predicate device does not connect<br>to a host computer except for setup.<br>The connection is through a serial<br>port. | | Computer Control<br>Software | Netlink uses the same Ceegraph and<br>Sleepscan (Vision) software as this<br>Predicate Device, with minor additions<br>for control of the new hardware. | The Traveler predicate device uses a<br>special setup application, separate<br>from the Ceegraph and Sleepscan<br>applications. | | Patient information<br>and tracking | No differences. The P&TI ACCESS<br>database is used for both devices. | The Traveler predicate device uses a<br>simple DB4 database for patient and<br>test information. This database is<br>compatible with the newer ACCESS-<br>compatible database through the<br>import feature. | | Safety Characteristics | No differences. The basic patient<br>connection and isolation circuits are the<br>same for both products. | No differences. The basic patient<br>connection and isolation circuits are<br>the same for both products. | | Power Source | The Netlink predicate device uses a<br>medical grade power supply whereas the<br>Netlink Traveler is battery powered. | No differences. Both devices are<br>battery powered. | | Data Quality | No differences. | Predicate device has 12 bit resolution,<br>whereas Netlink Traveler has 18 bit. | | Patient Connections | This predicate device has electrode<br>connections directly on the headbox,<br>whereas the electrode connections for<br>Netlink Traveler are located on the<br>Electrode Block or optional Quick-<br>Disconnect box. | This Predicate Device requires the use<br>of one of several patient montage<br>cables. There are no electrode jacks<br>located directly on the box. | | Impedance display on<br>headbox. | The Netlink predicate devices uses an<br>array of LED's for impedance display.<br>Netlink Traveler uses an LCD display. | Not provided for on this Predicate<br>Device | | Physical<br>Characteristics | The Netlink predicate device is larger<br>than Netlink Traveler. | This predicate device is larger than<br>Netlink Traveler. | | Product Labeling | Similar safety, information and warning<br>labels. Different size and shape of box<br>requires some different labels. | Similar safety, information and<br>warning labels. Different size and<br>shape of box requires some different<br>labels. | | Anatomical sites | No differences. | No differences. | {4}------------------------------------------------ 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. {5}------------------------------------------------ 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 {6}------------------------------------------------ #### 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