(105 days)
No
The description mentions "automated algorithms" but does not specifically use terms like AI, ML, or deep learning, nor does it describe characteristics typically associated with AI/ML development (training/test sets, performance metrics like AUC).
No
The device is intended for diagnostic evaluation and analysis of physiological signals to assess sleep quality, not for treating any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the Sleep Profiler is intended "for the diagnostic evaluation by a physician to assess sleep quality in adults only." Furthermore, the device is described as analyzing physiological signals and automatically scoring sleep study results, which are integral to diagnostic processes.
Yes
The device is explicitly described as a "software-only device" in both the Intended Use and Device Description sections. It analyzes previously recorded physiological signals and does not include any hardware components for signal acquisition.
Based on the provided information, the Sleep Profiler is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Sleep Profiler's function: The Sleep Profiler analyzes physiological signals (EEG, pulse, actigraphy, snoring) recorded during sleep. These are signals directly measured from the body, not specimens taken from the body.
- Intended Use: The intended use is for the "diagnostic evaluation by a physician to assess sleep quality in adults only." This involves analyzing in-vivo physiological data, not in-vitro analysis of specimens.
Therefore, the Sleep Profiler falls under the category of a medical device that analyzes physiological data, but it does not meet the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Sleep Profiler is intended for the diagnostic evaluation by a physician to assess sleep quality in adults only. The Sleep Profiler is a software-only device to be used under the supervision of a clinician to analyze physiological signals and automatically score sleep study results, including the staging of sleep, detection of arousals and snoring.
Product codes
OLZ
Device Description
The Sleep Profiler is a software application that analyzes previously recorded physiological signals obtained during sleep. The Sleep Profiler software can analyze any EDF files meeting defined specifications, including signals acquired with the Advanced Brain Monitoring X4 System.
Automated algorithms are applied to the raw signals in order to derive additional signals and· interpret the raw and derived signal information. The software automates recognition of: a) sleep stage, b) snoring frequency and severity, c) pulse rate, d) cortical (EEG), sympathetic (pulse) and behavioral (actigraphy and snoring) arousals. A single channel of electrocardiography, electrooculargraphy, electromyography, or electroencephalography can be optionally presented for visual inspection and interpretation. The software identifies and rejects periods with poor electroencephalography signal quality. The full disclosure recording of derived signals and automated analyses can be visually inspected and edited prior to the results being integrated into a sleep study report.
Medical and history information can be input from a questionnaire. Responses are analyzed to provide a pre-test probability of Obstructive Sleep Apnea (OSA) (a condition that cannot be diagnosed with Sleep Profiler) so an appropriate referral to a sleep physician is made. The automated analyses of physiological data are integrated with the questionnaire data, medical and history information to provide a comprehensive report. Several report formats are available depending on whether the user has acquired more than one night of data, wishes to obtain a narrative summary report or provide patient reports.
The capability to enter or edit patient information, call the application to generate a study report, and/or download a report is provided using either the desktop PC application or in a web-based module which emulates the desktop functionality. The same analysis and report generation software is used for both the desktop and web-portal applications.
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
adults only
Intended User / Care Setting
physician / clinician
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)
SUMMARY OF NON-CLINICAL TESTS:
Support for the substantial equivalence of the Sleep Profiler was provided as a result of risk management and software testing.
The Sleep Profiler software has been thoroughly tested through verification of specifications and validation. The key metric for software verification was confirmation of identical performance using either the desktop or portal for the key functions associated with the web-based software:
- Enter questionnaire responses,
- Edit study data
- Initiate generation of a study report
- Download a study report
The results of the verification and validation activities that have been performed demonstrate that the software meets requirements for safety, function, and intended use.
SUMMARY OF CLINICAL TESTS:
The modifications to the Sleep Profiler that are the subject of this premarket submission did not require clinical studies to support substantial equivalence. The functionality of the modified device was completely evaluated by performing nonclinical verification and validation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K120450 Sleep Profiler
Reference Device(s)
K112514 Apnea Risk Evaluation System (ARES), Model 610
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K130007
Advanced Brain Monitoring, Inc. Sleep Profiler
510(k) Summary
APR 1 7 2013
In accordance with 21 CFR 807.92 the following summary of information is provided:
DATE: January 31, 2012
SUBMITTER:
Advanced Brain Monitoring 2237 Faraday Avenue, Suite 100 Carlsbad, CA 92008 T 760.720.0099 F 760.720.3337
PRIMARY CONTACT PERSON:
Adrienne Lenz, RAC Founder Pathway Regulatory Consulting, LLC T 262-290-0023
SECONDARY CONTACT PERSON:
Dan Levendowski President and Co-founder Advanced Brain Monitoring, Inc.
DEVICE:
TRADE NAME: Sleep Profiler
COMMON/USUAL NAME: automatic event detection software for polysomnograph with electroencephalograph
CLASSIFICATION NAMES: 882.1400 Electroencephalograph
PRODUCT CODE: OLZ
PREDICATE DEVICE(S): K120450 Sleep Profiler K112514 Apnea Risk Evaluation System (ARES), Model 610
DEVICE DESCRIPTION:
The Sleep Profiler is a software application that analyzes previously recorded physiological signals obtained during sleep. The Sleep Profiler software can analyze any EDF files meeting defined specifications, including signals acquired with the Advanced Brain Monitoring X4 System.
Automated algorithms are applied to the raw signals in order to derive additional signals and· interpret the raw and derived signal information. The software automates recognition of: a) sleep stage, b) snoring frequency and severity, c) pulse rate, d) cortical (EEG), sympathetic (pulse) and behavioral (actigraphy and snoring) arousals. A single channel of electrocardiography, electrooculargraphy, electromyography, or electroencephalography can be optionally presented for visual inspection and interpretation. The software identifies and rejects periods with poor electroencephalography signal quality. The full disclosure recording of derived signals and automated analyses can be visually inspected and edited prior to the
1
results being integrated into a sleep study report.
Medical and history information can be input from a questionnaire. Responses are analyzed to provide a pre-test probability of Obstructive Sleep Apnea (OSA) (a condition that cannot be diagnosed with Sleep Profiler) so an appropriate referral to a sleep physician is made. The automated analyses of physiological data are integrated with the questionnaire data, medical and history information to provide a comprehensive report. Several report formats are available depending on whether the user has acquired more than one night of data, wishes to obtain a narrative summary report or provide patient reports.
The capability to enter or edit patient information, call the application to generate a study report, and/or download a report is provided using either the desktop PC application or in a web-based module which emulates the desktop functionality. The same analysis and report generation software is used for both the desktop and web-portal applications.
INTENDED USE:
Sleep Profiler is intended for the diagnostic evaluation by a physician to assess sleep quality in adults only. The Sleep Profiler is a software-only device to be used under the supervision of a clinician to analyze physiological signals and automatically score sleep study results, including the staging of sleep, detection of arousals and snoring.
TECHNOLOGY:
The Sleep Profiler software is identical to the previously cleared Sleep Profiler (K120450). A web-based module was developed to provide the user with an interface to enter and edit patient information and generate or download reports from a portal thus delivering the same functions provided by the PC software. The web-interface module runs on a cloud server and uses the same fundamental technology as the ARES Model 610 portal (K112514). No changes were made to the software used to analyzed the signals or generate study reports. The technologies used in the Sleep Profiler are used in the same manner as the predicate products and do not raise new questions of safety and effectiveness.
DETERMINATION OF SUBSTANTIAL EQUIVALENCE:
SUMMARY OF NON-CLINICAL TESTS:
Support for the substantial equivalence of the Sleep Profiler was provided as a result of risk management and software testing.
The Sleep Profiler software has been thoroughly tested through verification of specifications and validation. The key metric for software verification was confirmation of identical performance using either the desktop or portal for the key functions associated with the web-based software:
- . Enter questionnaire responses,
- . Edit study data
- . Initiate generation of a study report
- . Download a study report
The results of the verification and validation activities that have been performed demonstrate that the software meets requirements for safety, function, and intended use.
SUMMARY OF CLINICAL TESTS:
The modifications to the Sleep Profiler that are the subject of this premarket submission did not require clinical studies to support substantial equivalence. The functionality of the modified device was completely evaluated by performing nonclinical verification and validation.
CONCLUSION:
Advanced Brain Monitoring considers the Sleep Profiler software to be as safe, as effective. and substantially equivalent to the predicate device.
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
April 17,2013
Public Health Service
Food and Drug Administration 10903 New Hamnshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Advanced Brain Monitoring Inc. c/o Ms. Adrienne Lenz Pathway Regulatory Consulting, LLC W324 S3649 County Road E Dousman, WI 53118
Re: K130007
Trade/Device Name: Sleep Profiler Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLZ Dated: February 15, 2013 Received: February 19, 2013
Dear Ms. Lenz:
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.
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
3
Page 2 – Ms. Adrienne Lenz
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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,
Joyce M. Whang -S
for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K130007
Device Name: Sleep Profiler
Indications For Use:
Sleep Profiler is intended for the diagnostic evaluation by a physician to assess sleep quality in adults only. The Sleep Profiler is a software-only device to be used under the supervision of a clinician to analyze physiological signals and automatically score sleep study results, including the staging of sleep, detection of arousals and snoring.
Prescription Use X (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)
Joyce M. Whang -S
(Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)
510(k) Number K130007
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