(203 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other indicators of AI/ML use.
No
The device is indicated for "computer aided scoring of sleep study recordings," which is a diagnostic/analytical function, not a therapeutic intervention. It assists in assessing a condition, not treating it.
Yes
The device is indicated for "computer aided scoring of sleep study recordings," a task that helps in the diagnosis of sleep disorders. Its intended use under physician supervision and in a sleep laboratory setting further supports its role in the diagnostic process.
Unknown
The provided summary lacks a device description, making it impossible to definitively determine if it is software-only. While the intended use is software-based ("computer aided scoring"), the summary doesn't explicitly state that the device is solely software and doesn't include any hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "computer aided scoring of sleep study recordings." This involves analyzing physiological data collected from a patient, not analyzing samples (like blood, urine, or tissue) in vitro (outside the body).
- Device Description: While "Not Found" for the description, the intended use clearly points away from in vitro analysis.
- Mentions image processing, AI, DNN, ML, Input Imaging Modality, Anatomical Site: The absence of these terms, while not definitive on its own, further supports the idea that it's not analyzing images or biological samples.
- Intended User / Care Setting: The users are "trained clinician" in a "hospital sleep laboratory or a free standing sleep laboratory." This aligns with the setting for sleep studies, not typically an IVD laboratory.
- Predicate Device: The predicate device is "Sleep Study Analysis (SSA) Version 96.10." This type of device is used for analyzing sleep data, which is consistent with the intended use of the current device and not an IVD.
In summary, the core function of this device is the analysis of physiological data from a sleep study, which is not considered an in vitro diagnostic activity.
N/A
Intended Use / Indications for Use
This product is indicated for use under the supervision of a Physician.
This product is indicated for use in the computer aided scoring of sloep study recordings.
SSA is intended for use in the adult population with suspected disorders of sleep.
SSA is intended for use in providing computer assisted human review of the following physiological parameters for the purpose of staging and identifying events in sleep:
Electroencephalogram
Electromyogram
Electrocardiogram
Respiratory Effort
Respiratory Air Flow
Pulse Oximetery
The clinical utility of SSA summary report output is to assist a trained clinician in the review of polysonnographic recordings so that the clinician may more easily identify steep stage events. SSA is indicated for use only when operated by a trained clinician who reviews and determines the presence of sleep stage events . SSA is in no way intended to replace a human clinician in discriminating the existence and type of any sleep event which may have occurred.
Product codes
OLZ
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
Adult population
Intended User / Care Setting
Trained clinician, hospital sleep laboratory or a free standing sleep laboratory.
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)
Not Found
Reference Device(s)
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Kay Spiekerman Eason Omega Results, Inc. 3322 Shorecrest, Suite 235 Dallas, Texas 75235
APR - 9 2012
Re: K963631
Trade/Device Name: Sleep Study Analysis (SSA) Version 96.10 Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLZ Dated (Date on orig SE ltr): December 31, 1996 Received (Date on orig SE Itr): January 3, 1997
Dear Ms. Eason:
This letter corrects our substantially equivalent letter of April 2, 1997.
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
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.
Malvina B. Eydelman, M.D.
Sincerely yours,
for
Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
:0(k) Number (if known): _____________________________________________________________________________________________________________________________________________________
tvice Name: Sleep Study Analyzer
dications For Use:
This product is indicated for use under the supervision of a Physician.
This product is indicated for use in the computer aided scoring of sloep study recordings.
PATIENT POPULATION
SSA is intended for use in the adult population with suspected disorders of sleep.
PHYSIOLOGICAL PARAMETERS
SSA is intended for use in providing computer assisted human review of the following physiological parameters for the purpose of staging and identifying events in sleep:
Electroencephalogram Electromyogram Electrocardiogram Respiratory Effort Respiratory Air Flow Pulse Oximetery
CLINICAL UTILITY OF SUMMARY REPORT OUTPUT
The clinical utility of SSA summary report output is to assist a trained clinician in the review of polysonnographic recordings so that the clinician may more easily identify steep stage events. SSA is indicated for use only when operated by a trained clinician who reviews and determines the presence of sleep stage events . SSA is in no way intended to replace a human clinician in discriminating the existence and type of any sleep event which may have occurred.
ENVIRONMENT OF USE
.
SSA is indicated for use in a hospital sleep laboratory or a free standing sleep laboratory.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Luk Nbaloo 3-31-97
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number
ﺴﺎ Prescription Use Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Formal 1-2-96)
OR