K Number
K022037Device Name
XLTEK SLEEP SYSTEM
Manufacturer
Date Cleared
2002-09-10
(78 days)
Regulation Number
882.1400AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Sleep Headbox works in conjunction with Excel Tech Sleep software. This Sleep System 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 SLEEP System is not intended to replace conventional devices or methods used for sleep monitoring in critical care or intraoperative settings.
The SLEEP System 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 SLEEP System does not make any judgment of normality or abnormality 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 Description
The SLEEP Headbox is a digital polysomnograph headbox used in conjunction with XLTEK SLEEP Software to acquire and review sleep recordings.
More Information
Not Found
No
The description mentions "Computer-assisted event marking and quantitative analysis" but explicitly states the system "does not make any judgment of normality or abnormality" and is not diagnostic. There is no mention of AI, ML, or related terms, and the system requires trained professional interpretation.
No
The device is described as a system for acquiring, reviewing, annotating, and analyzing sleep recordings (polysomnography) for research or clinical environments. It is explicitly stated that the system "does not make any judgment of normality or abnormality of the displayed signals or the result of an analysis" and "In no way are any of the functions represented as being in and of themselves diagnostic." Furthermore, it is "not intended to replace conventional devices or methods used for sleep monitoring in critical care or intraoperative settings." This indicates its role is for data acquisition and analysis support, not for direct treatment or diagnosis.
No
The document explicitly states, "In no way are any of the functions represented as being in and of themselves diagnostic." It clarifies that the system is used to acquire and review sleep recordings, and its output must be reviewed and interpreted by trained medical professionals who will exercise professional judgment.
No
The device description explicitly states "The SLEEP Headbox is a digital polysomnograph headbox used in conjunction with XLTEK SLEEP Software," indicating a hardware component (the headbox) is part of the device.
Based on the provided information, the Sleep Headbox, as part of the SLEEP System, is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Sleep Headbox and SLEEP System acquire and review physiological signals directly from the patient (EEG, respiratory, oximetry). They are used for recording and analyzing these signals, not for testing samples taken from the body.
- Intended Use: The intended use focuses on acquiring, reviewing, annotating, and analyzing physiological signals for sleep recordings (polysomnography). It explicitly states it does not make judgments of normality or abnormality and is not represented as being diagnostic in and of itself.
- Lack of Specimen Handling: There is no mention of the device handling or analyzing any biological specimens.
Therefore, the Sleep Headbox and SLEEP System fall under the category of devices that monitor and analyze physiological signals directly from the patient, which are not considered IVDs.
N/A
Intended Use / Indications for Use
The Sleep Headbox works in conjunction with Excel Tech Sleep software. This Sleep System 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 SLEEP System is not intended to replace conventional devices or methods used for sleep monitoring in critical care or intraoperative settings.
The SLEEP System 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 SLEEP System does not make any judgment of normality or abnormality 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.
Product codes (comma separated list FDA assigned to the subject device)
OLV, GWQ
Device Description
The SLEEP Headbox is a digital polysomnograph headbox used in conjunction with XLTEK SLEEP Software to acquire and review sleep recordings
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
research or clinical environments, trained polysomnographers or trained medical professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
XLTEK PSG-40 Polysomnography Headbox K9991900, Masimo Radical Pulse Oximeter K992340/K000126, XLTEK Ambulatory EEG K982479
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Ku22037
**XILTEK**
SPECIAL 510(K)
SLEEP SYSTEM
SPECIAL 510(K) DEVICE MODIFICATION
JUNE 17, 2002
## Section F – 510(k) SUMMARY
SEP 1 0 2002
PAGE 49 of 53
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR § 807.92.
| Name: | Cameron Mahon
Vice President, Customer Satisfaction |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | XLTEK
2568 Bristol Circle
Oakville, Ontario
Canada, L6H 5S1 |
| Telephone: | (905) 829-5300 |
| Fax: | (905) 829-5304 |
| E-mail: | research@xltek.com |
| Common Names: | Sleep Headbox |
| Classification Name: | Electroencephalograph |
| Predicate Devices: | XLTEK PSG-40 Polysomnography Headbox
K9991900 |
| | Masimo Radical Pulse Oximeter
[K992340](https://510k.innolitics.com/search/K992340)/[K000126](https://510k.innolitics.com/search/K000126) |
| | XLTEK Ambulatory EEG
[K982479](https://510k.innolitics.com/search/K982479) |
| Description: | The SLEEP Headbox is a digital polysomnograph
headbox used in conjunction with XLTEK SLEEP
Software to acquire and review sleep recordings |
pg 1 of 2
**1**
| | SPECIAL 510(K)
SLEEP SYSTEM |
|------------------------------------|--------------------------------|
| SPECIAL 510(K) DEVICE MODIFICATION | JUNE 17, 2002
PAGE 50 of 53 |
Substantial Equivalence: The SLEEP Headbox is substantially equivalent to the XLTEK PSG-40 ([K991900](https://510k.innolitics.com/search/K991900)) incorporating Masimo pulse oximetry technology ([K992340](https://510k.innolitics.com/search/K992340)/K0000126). It comprises circuitry that is substantially equivalent to the XLTEK Ambulatory EEG ([K982479](https://510k.innolitics.com/search/K982479)). These modifications do not affect the predicate device's intended use, safety, or fundamental scientific technology.
## Indications for Use:
The Sleep Headbox works in conjunction with Excel Tech Sleep software. This Sleep System 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 t 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 SLEEP System is not intended to replace conventional devices or methods used for sleep monitoring in critical care or intraoperative settings.
The SLEEP System 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 SLEEP System does not make any judgment of normality or abnormality 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.
pg 2 of 2
**2**
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle in flight, with its wings and body represented by thick, curved lines. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a sans-serif font. The text is arranged to follow the curve of the circle, with "DEPARTMENT OF" at the bottom, "HEALTH & HUMAN SERVICES" on the left side, and "USA" at the top.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Excel-Tech Ltd. Sonja Markez Regulatory Affairs 2568 Bristol Circle Oakville, Ontario Canada, L6H 5S1
APR - 9 2012
Re: [K022037](https://510k.innolitics.com/search/K022037)
Trade/Device Name: XLTEK Sleep System Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLV, GWQ Dated (Date on orig SE Itr): August 9, 2002 Received (Date on orig SE ltr): August 12, 2002
Dear Ms. Markez:
This letter corrects our substantially equivalent letter of September 10, 2002. 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.
**3**
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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
for
Sincerely vours.
Keoia Alexander
Malvina B. Evdelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
**4**
Image /page/4/Picture/0 description: The image shows the word "TEK" in a stylized font. The letters are bold and have a textured fill. To the left of the word "TEK" is a design of intersecting lines.
SPECIAL 510(K) DEVICE MODIFICATION
SPECIAL 510(K) SLEEP SYSTEM JUNE 17, 2002
PAGE 51 of 53
## Section G - INDICATIONS FOR USE
510(k) Number (if known): KORR C 37
Device Name:
SLEEP System
Indications for Use:
The Sleep Headbox works in conjunction with Excel Tech Sleep software. This Sleep System 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 oximenty . 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 SLEEP System is not intended to replace conventional devices or methods used for sleep monitoring in critical care or intraoperative settings.
The SLEEP System 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 SLEEP System 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use (Per 218 CFR 801.109)
(Optional Format 1-2-96)
Over-The Counter Use
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_ KOZZD37