(38 days)
Not Found
Not Found
No
The description focuses on "computer-assisted" analysis and reporting of simple measures, without mentioning AI, ML, or advanced learning capabilities. The device explicitly states it does not make judgments of normality or provide diagnoses.
No
The device is used for recording, reviewing, analyzing, and reporting sleep signals for diagnostic purposes, and it explicitly states it is not intended to be therapeutic.
No
The document explicitly states, "In no way are any of the functions represented as being in and of themselves diagnostic." While it records, analyzes, and reports signals, it requires professional judgment for interpretation and does not make diagnostic judgments.
Unknown
The provided text describes the intended use and indications for use of the device, which are software-based functions (recording, review, analysis, reporting). However, the "Device Description" section is "Not Found," which is crucial for determining if the device includes any hardware components or is purely software. Without a device description, it's impossible to definitively classify it as software-only.
Based on the provided information, the XLTek PSG-40 is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- PSG-40 Function: The description clearly states the PSG-40 is used for recording and analyzing physiological signals (EEG, respiratory, oximetry) from the body, not for testing samples taken from the body.
- Intended Use: The intended use focuses on sleep recordings and analysis of these physiological signals, not on analyzing biological samples.
- Lack of Sample Analysis: There is no mention of the device analyzing any type of biological sample.
Therefore, the XLTek PSG-40 falls under the category of a medical device used for physiological monitoring and analysis, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
OLV
Device Description
Not Found
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 neurologists
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.
Not Found
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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, enclosed in a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the top and left side of the circle.
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.
1
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 (800) 638-2041 or (301) 796-7100 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
2
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)