(804 days)
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Unknown
The summary mentions "Automated analysis of physiological signals" but does not provide enough detail to confirm if this automation utilizes AI/ML techniques. The absence of keywords like AI, ML, DNN, or descriptions of training/test sets makes it impossible to definitively determine the presence of AI/ML.
No
The document states the software assists in diagnosis but explicitly states it "does not provide any diagnostic conclusion" and its alerts "are not intended for use as life support." It is for analysis and reporting, not for treating a condition.
Yes
The software "allows recording, displaying, analysis, printing and storage of physiological signals to assist in the diagnosis of various sleep disorders and sleep related respiratory disorders." This clearly indicates its role in the diagnostic process. While it states it "does not provide any diagnostic conclusion," it explicitly assists in diagnosis.
Yes
The description explicitly states "The Sleepworks software works in conjunction with Connex, Trex or Netlink amplifiers intended for polysomnography studies." and describes the software's functions (recording, displaying, analysis, printing, storage). It does not mention any hardware components being part of the Sleepworks device itself, only that it interfaces with external hardware (amplifiers).
Based on the provided information, the Sleepworks software 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.
- Sleepworks function: The Sleepworks software analyzes physiological signals (like brain waves, heart rate, breathing) recorded during polysomnography studies. These signals are collected directly from the patient's body, not from a sample taken from the body.
- Intended Use: The intended use clearly states it assists in the diagnosis of sleep disorders and sleep-related respiratory disorders by analyzing physiological signals. It does not mention analyzing any in vitro samples.
Therefore, the Sleepworks software 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 Sleepworks software works in conjunction with Connex, Trex or Netlink amplifiers intended for polysomnography studies. The software allows recording, displaying, analysis, printing and storage of physiological signals to assist in the diagnosis of various sleep disorders and sleep related respiratory disorders.
The Sleepworks allows:
- Automated analysis of physiological signals that is intended for use only in adults. .
- An optional Audio / visual alert for user defined threshold on calibrated DC input. . These alerts are not intended for use as life support such as vital signs monitoring or continuous medical surveillance in intensive care units.
- Sleep report templates are provided which summarize recorded and scored sleep . data using simple measures including count, average, maximum and minimum values as well as data ranges for trended values;
SleepWorks software does not provide any diagnostic conclusion about the patient's condition and is intended to be used only by qualified and trained medical practitioners. in research and clinical environments.
Product codes
OLZ
Device Description
The Sleepworks software works in conjunction with Connex, Trex or Netlink amplifiers intended for polysomnography studies. The software allows recording, displaying, analysis, printing and storage of physiological signals to assist in the diagnosis of various sleep disorders and sleep related respiratory disorders.
The Sleepworks allows:
- Automated analysis of physiological signals that is intended for use only in adults. .
- An optional Audio / visual alert for user defined threshold on calibrated DC input. . These alerts are not intended for use as life support such as vital signs monitoring or continuous medical surveillance in intensive care units.
- Sleep report templates are provided which summarize recorded and scored sleep . data using simple measures including count, average, maximum and minimum values as well as data ranges for trended values;
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
adults
Intended User / Care Setting
qualified and trained medical practitioners. in research and clinical environments.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure with outstretched arms, possibly representing health and well-being.
Public Health Service
APR 1 9 2011
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Natus Medical Incorporated c/o Ms. Goldy Singh Director of Quality and Regulatory 2568 Bristol Circle Oakville, Ontario Canada L6H 5S1
Re: K090277
Trade/Device Name: Natus SleepWorks Regulation Number: 21 CFR 882.1400 Regulation Name: Automatic Event Detection Software for Polysomnograph with Electroencephalograph Regulatory Class: Class II Product Code: OLZ Dated: October 1, 2010 Received: November 30, 2010
Dear Ms. Singh:
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 - Ms. Goldy Singh
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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Kesia Alexander
jr
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
Indications for Use
510(k) Number (if known): K090277
Device Name: Natus SleepWorks
Indications For Use:
The Sleepworks software works in conjunction with Connex, Trex or Netlink amplifiers intended for polysomnography studies. The software allows recording, displaying, analysis, printing and storage of physiological signals to assist in the diagnosis of various sleep disorders and sleep related respiratory disorders.
The Sleepworks allows:
- Automated analysis of physiological signals that is intended for use only in adults. .
- An optional Audio / visual alert for user defined threshold on calibrated DC input. . These alerts are not intended for use as life support such as vital signs monitoring or continuous medical surveillance in intensive care units.
- Sleep report templates are provided which summarize recorded and scored sleep . data using simple measures including count, average, maximum and minimum values as well as data ranges for trended values;
SleepWorks software does not provide any diagnostic conclusion about the patient's condition and is intended to be used only by qualified and trained medical practitioners. in research and clinical environments.
Prescription Use (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)
Sde
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
| 510(k) Number | K090277 |
|---|---|
| --------------- | --------- |
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