(148 days)
No
The description explicitly states that the device calculates an index based on EEG but "does not perform any data interpretation," which is a key characteristic of AI/ML applications in this context. The "Mentions AI, DNN, or ML" section also indicates "Not Found."
No
The device is described as a monitor intended for measuring the hypnotic state and level of consciousness, and it explicitly states that it "does not perform any data interpretation," and "all data interpretation is performed by a physician." This indicates it is a diagnostic or monitoring tool rather than a therapeutic device.
Yes
Explanation: The device monitors the hypnotic state of the brain and provides an index (CSI) used in the estimation of the level of consciousness. This involves acquiring and presenting data related to a patient's physiological state (EEG signals) for interpretation by a physician to diagnose or monitor a condition (level of consciousness under anesthesia/sedation).
No
The device description explicitly states it is a "non-invasive measurement tool" that performs "data acquisition of EEG signals." This implies the use of hardware (electrodes, amplifier, etc.) to acquire the physiological data, making it a hardware-based medical device with associated 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 CSM monitor acquires and processes EEG signals directly from the patient's brain (an anatomical site). This is a non-invasive measurement of physiological signals, not an analysis of a sample taken from the body.
- Intended Use: The intended use is to monitor the hypnotic state of the brain by acquiring EEG signals, which is a direct measurement of brain activity.
Therefore, the CSM monitor falls under the category of a medical device that measures physiological parameters, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CSM is intended for use in monitoring the state of the brain by data acquisition of EEG signals of the anaesthetized or sedated patient in all areas of the hospital. The CSM is a non-invasive measurement tool to be used by a trained professional to measure the level of consciousness during general anaesthesia or sedation by use of CSI.
The CSM monitor is intended for use in monitoring the hypnotic state of the brain by data acquisition of EEG signals of the anaesthetized or sedated patient in all areas of the hospital.
Product codes
OLW, OMC, DRT
Device Description
The Cerebral State Monitor (CSM) is a non-invasive measurement tool for use by trained healthcare professionals to measure the level of consciousness (LOC) in all areas of the hospital. Based on EEG, an index (CSI) is calculated, which is used in the estimation of LOC. The CSM displays the CSI but does not perform any data interpretation (i.e., all data interpretation is performed by a physician).
The following accessories are provide with the CSM:
- Danmeter Neuro Sensors
- 9V Alkaline battery ●
- Skin preparation
- Rechargeable 9V NiMH battery (Optional) .
- CSM Power (Optional) Mains Power supply ●
- CSM Capture (Optional) PC-SW. This software allows the physician to . format data on a PC, for documentation purposes.
- CSM Link (Optional) Wireless link to RS232 to host computer .
- CSM Printer (Optional) Thermal printer for documentation purposes ●
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained healthcare professionals / all areas of the hospital
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)
The performance data indicate that the Cerebral State Monitor - CSM meets all specified requirements, and is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
JAN 2 1 2005
K 042315
SUMMARY OF SAFETY AND EFFECTIVENESS Cerebral State Monitor - CSM
SUBMITTER INFORMATION
| A. | Company Name: | Danmeter A/S |
|---|---|---|
| B. | Company Address: | Kildemosevej 13 |
| DK-5000 Odense C | ||
| C. | Company Phone: | |
| Company Fax: | +45 63 11 29 30 | |
| +45 63 11 29 31 | ||
| D. | Contact Person: | Hanne Nielsen |
| Quality Manager | ||
| Danmeter A/S | ||
| E. | Date Summary Prepared: | August 19, 2004 |
DEVICE IDENTIFICATION
| A. | Generic Device Name: | Electroencephalograph |
|---|---|---|
| B. | Trade/Proprietary Name: | Cerebral State Monitor - CSM |
| C. | Classification: | Class II |
| D. | Product Code: | OLW, OMC, DRT |
SUBSTANTIAL EQUIVALENCE
The Cerebral State Monitor - CSM is of comparable type and is substantially equivalent to the following predicate devices:
| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|---|---|---|---|
| AEP Monitor | Danmeter A/S | ||
| (Reg. by: Alaris | |||
| Medical Systems) | K010965 | 6/27/2001 | |
| A-2000 EEG | |||
| Monitor with BIS | Aspect Medical | ||
| Systems | K974496 | 2/6/1998 |
l
1
DEVICE DESCRIPTION
The Cerebral State Monitor (CSM) is a non-invasive measurement tool for use by trained healthcare professionals to measure the level of consciousness (LOC) in all areas of the hospital. Based on EEG, an index (CSI) is calculated, which is used in the estimation of LOC. The CSM displays the CSI but does not perform any data interpretation (i.e., all data interpretation is performed by a physician).
The following accessories are provide with the CSM:
- Danmeter Neuro Sensors
- 9V Alkaline battery ●
- Skin preparation
- Rechargeable 9V NiMH battery (Optional) .
- CSM Power (Optional) Mains Power supply ●
- CSM Capture (Optional) PC-SW. This software allows the physician to . format data on a PC, for documentation purposes.
- CSM Link (Optional) Wireless link to RS232 to host computer .
- CSM Printer (Optional) Thermal printer for documentation purposes ●
INTENDED USE
The CSM is intended for use in monitoring the state of the brain by data acquisition of EEG signals of the anaesthetized or sedated patient in all areas of the hospital. The CSM is a non-invasive measurement tool to be used by a trained professional to measure the level of consciousness during general anaesthesia or sedation by use of CSI.
TECHNOLOGICAL CHARACTERISTICS
A comparison of the technological characteristics of the Cerebral State Monitor -CSM and the predicate devices has been performed. The results of this comparison demonstrate that the Cerebral State Monitor - CSM is equivalent to the marketed predicate devices.
PERFORMANCE DATA
The performance data indicate that the Cerebral State Monitor - CSM meets all specified requirements, and is substantially equivalent to the predicate devices.
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 stylized eagle or bird-like symbol, with three curved lines forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Hanne Nielsen Quality Manager Danmeter A/S Kildemosevej 13 DK-5000 Odense C Denmark
APR - 9 2012
Re: K042315
Trade/Device Name: Cerebral State Monitor Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLW, OMC, ORT Dated (Date on orig SE ltr): December 1, 2004 Received (Date on orig SE ltr): December 3, 2004
Dear Mr. Nielsen:
This letter corrects our substantially equivalent letter of January 21, 2005.
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.
3
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/ReportalProblem/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 vours.
Kesia Alexander
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
4
DEVICE SPECIFICATIONS
INDICATIONS FOR USE
| 510(k) Number: | K042315 (To Be Assigned by FDA) |
|---|---|
| Device Name: | Cerebral State Monitor - CSM |
| Indications for use: | The CSM monitor is intended for use in monitoring the |
| hypnotic state of the brain by data acquisition of EEG | |
| signals of the anaesthetized or sedated patient in all areas | |
| of the hospital. |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
メ Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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510(k) Number_________________________________________________________________________________________________________________________________________________________________