XLTEK CONNEX IP HEADBOX, MODEL 1054

K042223 · Excel Tech. , Ltd. · OMB · Sep 16, 2004 · Neurology

Device Facts

• Record ID: K042223
• Device Name: XLTEK CONNEX IP HEADBOX, MODEL 1054
• Applicant: Excel Tech. , Ltd.
• Product Code: OMB · Neurology
• Decision Date: Sep 16, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.1400
• Device Class: Class 2

Intended Use

The XLTEK Connex Headbox works in conjunction with Excel Tech Sleep software. This Connex headbox is used to acquire and review sleep recordings (polysomnography) in research or clinical environments for: - Digital recording of high-level output signals (such as EEG, respiratory and oximetry signals) from conventional polygraphic recorders, signal transducers or amplifiers. - Selection of recorded signal sections for on-screen review, annotation and marking of sleep stages. - Computer-assisted event marking and quantitative analysis of EEG, respiratory and oximetry signals. - Computer-assisted reporting of simple measures obtained from the recorded signals (such as magnitude, time and frequency and simple statistical measures of marked events) The Connex is not intended to replace conventional devices or methods used for sleep monitoring in critical care or intraoperative settings. The Connex requires competent user input, and its output must be reviewed and interpreted by trained polysomnographers or trained medical professionals who will exercise professional judgment in using this information. The Connex does not make any judgment of normality of the displayed signals or the result of an analysis. In no way are any of the functions represented as being in and of themselves diagnostic.

Device Story

XLTEK Connex is a headbox device used with Excel Tech Sleep software for polysomnography. It acquires high-level signals including EEG, respiratory, and oximetry from transducers or amplifiers. The system enables digital recording, on-screen review, annotation, and marking of sleep stages. It performs computer-assisted event marking and quantitative analysis of signals, providing reports on magnitude, time, frequency, and statistical measures. Used in clinical or research settings by trained polysomnographers or medical professionals. The device does not provide diagnostic judgments or assess signal normality; output requires professional interpretation to support clinical decision-making. Benefits include streamlined data review and quantitative analysis of sleep study signals.

Clinical Evidence

No clinical data provided; device relies on bench-level functional verification of signal acquisition and software analysis capabilities.

Technological Characteristics

The device is an electroencephalograph (Product Code: OMB, OLV, OLZ, OLT) consisting of a headbox for signal acquisition. It functions as a digital recording system for EEG, respiratory, and oximetry signals. It integrates with Excel Tech Sleep software for signal processing and analysis. It is a prescription-use device intended for clinical or research environments.

Indications for Use

Indicated for patients undergoing polysomnography in clinical or research environments for the acquisition, review, and analysis of EEG, respiratory, and oximetry signals. Not intended for use in critical care or intraoperative settings.

Regulatory Classification

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.

Submission Summary (Full Text)

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

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Excel-Tech Ltd. c/o Ms. Nicole Landreville, Eng. Regulatory Affairs Senior Manager 2568 Bristol Circle Oakville, Ontario Canada, L6H 5S1

Re: K042223

Trade/Device Name: XLTEK Connex Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OMB. OLV. OLZ, OLT Dated (Date on orig SE ltr): August 16, 2004 Received (Date on orig SE ltr): August 17, 2004 APR - 9 2012

Dear Ms. Landreville:

This letter corrects our substantially equivalent letter of September 16, 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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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 [phone] or [phone] or at its Internet address

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

**Sincerely yours,**

Kesia Alexander

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Malvina B. Eydelman, 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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## STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known):

K04223

Device Name: XLTEK Connex

Indications for Use:

The XLTEK Connex Headbox works in conjunction with Excel Tech Sleep software. This Connex headbox is used to acquire and review sleep recordings (polysomnography) in research or clinical environments for:

- Digital recording of high-level output signals (such as EEG, respiratory and oximetry . signals) from conventional polygraphic recorders, signal transducers or amplifiers.
- Selection of recorded signal sections for on-screen review, annotation and marking of . sleen stages.
- Computer-assisted event marking and quantitative analysis of EEG, respiratory and . oximetry signals.
- Computer-assisted reporting of simple measures obtained from the recorded signals (such . as magnitude, time and frequency and simple statistical measures of marked events)

The Connex is not intended to replace conventional devices or methods used for sleep monitoring in critical care or intraoperative settings.

The Connex requires competent user input, and its output must be reviewed and interpreted by trained polysomnographers or trained medical professionals who will exercise professional judgment in using this information.

The Connex does not make any judgment of normality of the displayed signals or the result of an analysis. In no way are any of the functions represented as being in and of themselves diagnostic.

Prescription Use X (Per 21 CFR 801.109) OR

Over-The Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost

(Division Sign-Off) Division of General. Restorative. and Neurological Devices

(Optional Format 1-2-96)

510(k) Number_K0 42223