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No
The document describes "Computer-assisted event marking and quantitative analysis" and "Computer-assisted reporting of simple measures," which are typical features of traditional software analysis and do not explicitly mention or imply the use of AI or ML algorithms. The language used is consistent with rule-based or algorithmic analysis, not learning-based systems.
No.
The software is for recording, reviewing, analyzing, and reporting physiological signals for sleep monitoring, not for treating a condition.
No
The document explicitly states, "In no way are any of the software functions represented as being in and of themselves diagnostic." While it assists in analysis and reporting, it does not make diagnostic judgments.
Yes
The description explicitly states "Luna™ software" and details its functions related to digital recording, selection, marking, analysis, and reporting of physiological signals. While it requires a PC and data acquisition board, the device being cleared is the software itself, which processes and presents data from these external hardware components. The predicate device is also described as "software".
Based on the provided information, this device 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.
- Device Function: The Luna™ software is described as being used for sleep recordings (polysomnography). It processes and analyzes physiological signals like EEG, respiratory, and oximetry signals, which are collected directly from the patient's body, not from in vitro samples.
- Intended Use: The intended use focuses on recording, reviewing, annotating, and analyzing these physiological signals for sleep studies. It explicitly states it's not intended to replace conventional devices for critical care or intra-operative settings, further indicating it's not performing in vitro tests.
- Lack of IVD Language: The description and intended use do not mention any analysis of biological samples or the detection of substances within those samples, which are hallmarks of IVD devices.
Therefore, the Luna™ software, as described, 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 indications for use of the Luna™ software for Windows® 95 are the same as those of Stellate Systems' ECLIPSE Version 3.0 software for MS-DOS®.
J.una™ can be used only in conjunction with Stellate Systems' HARMONIE™ software package.
Luna™ may be used for sleep recordings (polysomnography) in research or clinical cuvironments for:
- · Digital rooording of high-level output signals (such as EBO, respiratory and oximety signals) from the Digital recording of might-level cations (society costs of amplifiers, by means of a personal computer (PC) and PC-based data acquisition board.
- · Selection of recorded signal sections for on-sereen review, annotation and marking of sleep stages.
- · Manual event-marking and annotation of polygraphic signal sections.
- · Computer-assisted event marking and quantitative analysis of EEG, respiratory and oximelry 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 software is not intended to replace conventional devices or methods used for sloup monitoring in critical care or intra-operative scilings.
The software requires competent user input, and its output must be reviewed and interpreted by trained The sollware requires or neurologists who will excruise professional judgment in using this information.
The software does not make any judgment of normality of the displayed signals or of the results of an analysis. In no way are any of the software functions represented as being in and of themselves diagnostic.
Product codes
OLT, OLV
Device Description
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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
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Intended User / Care Setting
research or clinical cuvironments. The software requires competent user input, and its output must be reviewed and interpreted by trained or neurologists.
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
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 eagle with three stripes representing the department's mission. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002
Mr. George Papagiannis Stellate Systems 345 Victoria Avenue, Suite 505 Westmount, Quebec, Canada, H3Z 2N2
Re: K982351 Trade/Device Name: Luna Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLT, OLV Dated (Date on orig SE ltr): July 2, 1998 Received (Date on orig SE Itr): July 6, 1998
Dear Mr. Papagiannis:
This letter corrects our substantially equivalent letter of July 29, 1998.
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.
APR - 9 2012
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 (OS) 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/CDRH0ffices/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
Image /page/1/Picture/7 description: The image shows a stylized signature in black ink on a white background. The signature appears to be a single, flowing stroke that forms a loop at the top and extends downward in a curved line. There is a horizontal stroke that intersects the loop, adding a distinct feature to the signature.
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
Stellate Systems
Indications For Use
The indications for use of the Luna™ software for Windows® 95 are the same as those of Stellate Systems' ECLIPSE Version 3.0 software for MS-DOS®.
J.una™ can be used only in conjunction with Stellate Systems' HARMONIE™ software package.
Luna™ may be used for sleep recordings (polysomnography) in research or clinical cuvironments for:
- · Digital rooording of high-level output signals (such as EBO, respiratory and oximety signals) from the Digital recording of might-level cations (society costs of amplifiers, by means of a personal computer (PC) and PC-based data acquisition board.
- · Selection of recorded signal sections for on-sereen review, annotation and marking of sleep stages.
- · Manual event-marking and annotation of polygraphic signal sections.
- · Computer-assisted event marking and quantitative analysis of EEG, respiratory and oximelry 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 software is not intended to replace conventional devices or methods used for sloup monitoring in critical care or intra-operative scilings.
The software requires competent user input, and its output must be reviewed and interpreted by trained The sollware requires or neurologists who will excruise professional judgment in using this information.
The software does not make any judgment of normality of the displayed signals or of the results of an analysis. In no way are any of the software functions represented as being in and of themselves diagnostic.
Prescription Use
(Per 21 CFR 801.109)
t
Sion-Off ision of General Restorative Devices 510(k) Number
大982351