(76 days)
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No
The summary explicitly states that the software does not make judgments of normality and is not represented as being diagnostic, which is inconsistent with typical AI/ML applications in this domain. Furthermore, there are no mentions of AI, DNN, ML, training sets, test sets, or performance metrics commonly associated with AI/ML devices.
No
The software is explicitly stated to "assist in the scientific analysis of the electroencephalogram (EEG)" and "does not make any judgment of normality of the displayed EEG or the results of an analysis. It is not intended EEG monitoring used in critical care or intra-operative settings. In no way is the software or its function represented as being in and of itself diagnostic." This indicates it's a tool for analysis and research, not for treatment or direct therapeutic intervention.
No
The "Intended Use / Indications for Use" section explicitly states, "In no way is the software or its function represented as being in and of itself diagnostic." The software assists in the scientific analysis of EEG and offers recording and review capabilities, but it does not make judgments of normality or provide diagnoses.
Yes
The device description explicitly states "HARMONIE and Sensa EEG Software" and the intended use describes software programs for EEG analysis and recording using a personal computer and data acquisition boards. While it interacts with hardware (PC, data acquisition boards), the device itself, as described, is the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the software is for the "scientific analysis of the electroencephalogram (EEG) in the field of human and animal neurophysiology." It also emphasizes that it "does not make any judgment of normality of the displayed EEG or the results of an analysis" and is "not intended EEG monitoring used in critical care or intra-operative settings." Most importantly, it explicitly states, "In no way is the software or its function represented as being in and of itself diagnostic."
- Lack of Diagnostic Claim: An IVD is a medical device used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This software does not perform such tests or provide diagnostic information. It assists in the analysis and review of EEG data.
- Focus on Analysis and Review: The description highlights features like digital EEG recording, selection of sections of interest, display, playback, and review capabilities. These are tools for analyzing existing data, not for performing diagnostic tests on biological samples.
Therefore, based on the provided text, the HARMONIE and Sensa software is a tool for neurophysiological research and analysis of EEG data, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
HARMONIE™ and Sensa™ is a set of software programs which represent an improved implementation of Stellate Systems' RHYTHM and MONITOR software. The software remains consistent with its original design objectives:
- · to assist in the scientific analysis of the electroencephalogram (EEG) in the field of human and animal neurophysiology.
- · to offer digital EEG recording by means of a personal computer and PC-based data acquisition boards.
- · to assist in the selection of EEG sections of potential interest and offer a variety of display, playback and review capabilities.
- · to complement the conventional continuous EEG recording, not replace it.
The software does not make any judgment of normality of the displayed EEG or the results of an analysis. It is not intended EEG monitoring used in critical care or intra-operative cettings. In no way is the software or its function represented as being in and of itself divenestic
Product codes
OMB, OLT
Device Description
HARMONIE and Sensa Software is a set of software programs, an improved implementation of Stellate Systems' RHYTHM and MONITOR software. Its design objectives include assisting in the scientific analysis of EEG in human and animal neurophysiology, offering digital EEG recording via personal computer and PC-based data acquisition boards, and assisting in the selection of EEG sections of potential interest with various display, playback, and review capabilities. It is intended to complement conventional continuous EEG recording.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Electroencephalogram (EEG)
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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 and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 25,2013
Stellate Systems c/o Mr. George Papagiannis 345 Victoria Avenue, Suite 505 Westmount. Ouebec Canada H3Z 2N2
Re: K960273
Trade/Device Name: Harmonie and Sensa EEG Software Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OMB. OLT Dated (Date on orig SE Itr): January 17, 1996 Received (Date on orig SE Itr): January 19, 1996
Dear Mr. Papagiannis:
This letter corrects our substantially equivalent letter of April 4, 1996.
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 (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.
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
1
Page 2 - Mr. George Papagiannis
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/Industrv/default.htm.
Sincerely yours.
Joyce M. Whang
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
2
Device: HARMONIE and Sensa Software
510(k) Number: K960273
Indications For Use
-
- 2017
HARMONIE™ and Sensa™ is a set of software programs which represent an improved implementation of Stellate Systems' RHYTHM and MONITOR software. The software remains consistent with its original design objectives:
- · to assist in the scientific analysis of the electroencephalogram (EEG) in the field of human and animal neurophysiology.
- · to offer digital EEG recording by means of a personal computer and PC-based data acquisition boards.
- · to assist in the selection of EEG sections of potential interest and offer a variety of display, playback and review capabilities.
- · to complement the conventional continuous EEG recording, not replace it.
The software does not make any judgment of normality of the displayed EEG or the results of an analysis. It is not intended EEG monitoring used in critical care or intra-operative cettings. In no way is the software or its function represented as being in and of itself divenestic
(Division Sign-Off)
Division of Cardiovaso and Neurological Devic 510(k) Number
Acting Group Leader
PNDG