XLTEK POLYSOMNOGRAPHY HEADBOX, MODEL # PSG-40

K991900 · Excel Tech. , Ltd. · OLV · Jul 12, 1999 · Neurology

Device Facts

• Record ID: K991900
• Device Name: XLTEK POLYSOMNOGRAPHY HEADBOX, MODEL # PSG-40
• Applicant: Excel Tech. , Ltd.
• Product Code: OLV · Neurology
• Decision Date: Jul 12, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2

Intended Use

The XLTek PSG-40 may be used for 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 annotation 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 PSG-40 is not intended to replace conventional devices or methods used for sleep monitoring in critical care or intraoperative settings. The PSG-40 requires competent user input, and its oulput must be reviewed and interpreted by trained polysomnographers or neurologists who will exercise professional judgement in using this information. The PSG-40 does not make any judgement of normality of the displayed signals or the results of an analysis. In no way are any of the functions represented as being in and of themselves diagnostic.

Device Story

Device is a polysomnography headbox for digital recording of physiological signals; inputs include EEG, respiratory, and oximetry signals from transducers or amplifiers. System performs computer-assisted event marking, quantitative analysis, and reporting of signal measures (magnitude, time, frequency, statistical measures). Used in clinical or research environments by trained polysomnographers or neurologists. Output is reviewed by clinicians to support professional judgment; device does not provide diagnostic conclusions or normality assessments. Benefits include streamlined data review and quantitative analysis of sleep study data.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Polysomnography headbox for signal acquisition. Interfaces with conventional polygraphic recorders, transducers, and amplifiers. Supports digital signal processing for EEG, respiratory, and oximetry data. Connectivity via standard signal input/output pathways. Software-based analysis for event marking and quantitative reporting.

Indications for Use

Indicated for sleep recordings (polysomnography) in research or clinical environments. Not intended for sleep monitoring in critical care or intraoperative settings. Requires review and interpretation by trained polysomnographers or neurologists.

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

Mr. Mark T. Zajac, P. Eng. Quality Engineer and Regulatory Affairs Excel Tech Ltd. 2892 Portland Drive Oakville, Ontario Canada L6H 5W8

APR - 9 2012

Re: K991900

Trade/Device Name: XLTEK PSG-40 Polysomnography Headbox Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLV Dated (Date on orig SE ltr): June 3, 1999 Received (Date on orig SE Itr): June 4, 1999

Dear Mr. Zajac:

This letter corrects our substantially equivalent letter of July 12, 1999.

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. Mark T. Zajac

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 (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/CDRH/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

Image /page/1/Picture/7 description: The image shows a signature on the left side and some text on the right side. The text includes the words "Director" and "Officer", suggesting that the signature may be from a director or officer of an organization. The signature is illegible, but it appears to be written in cursive.

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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## EXCEL TECH, LTD. 510(K) NOTIFICATION OF A NEW DEVICE : "XLTEK PSG-40 POLYSOMNOGRAPHY HEADBOX"

## ATTACHMENT # 1 STATEMENT OF INDICATIONS FOR USE

Page __ 1_ of ________________________________________________________________________________________________________________________________________________________________

| 510(k) Number (if known): | K991900 |
|---------------------------|---------------------------------------|
| Device Name: | XLTEK PSG-40 Polysomnography Head box |

Indications for Use :

...

The XLTek PSG-40 may be used for 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 annotation 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 PSG-40 is not intended to replace conventional devices or methods used for sleep monitoring in critical care or intraoperative settings.

The PSG-40 requires competent user input, and its oulput must be reviewed and interpreted by trained polysomnographers or neurologists who will exercise professional judgement in using this information.

The PSG-40 does not make any judgement of normality of the displayed signals or the results of an analysis. In no way are any of the functions represented as being in and of themselves diagnostic.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| ion Sign-Off | |
|-----------------------------------|---------|
| on of General Restorative Devices | |
| 510(k) Number | K991900 |

| Prescription Use | X | OR | Over-The Counter Use |
|----------------------|---|----|----------------------|
| (Per 21 CFR 801.109) | | | |

(Optional Format 1-2-96)