(87 days)
Hambrecht Associates Multi-Channel Electroencephalographic Telemetry System
Not Found
No
The summary describes a system for measuring and transmitting EEG signals and includes performance studies focused on signal integrity and filter accuracy. There is no mention of AI, ML, or any algorithms that would interpret or analyze the EEG data using such techniques.
No
The device is described as an EEG system intended for "measuring and transmitting electroencephalogram (EEG) signals," and its "Description of the test set" focuses on evaluating its ability to measure and transmit known signals, not on direct therapeutic intervention.
No.
The device is used for measuring and transmitting EEG signals, but there is no indication that it interprets or analyzes these signals to provide a diagnosis. The performance studies focus on signal quality and transmission accuracy, not diagnostic accuracy.
No
The device description explicitly lists multiple hardware components in addition to the software, including a Transmitter, Receiver Assembly, Patient Accessories (electrodes, headband, battery), and a PC Operator Interface (including a cable and optional PC).
Based on the provided information, the Crystal-EEG Model 10 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is "measuring and transmitting electroencephalogram (EEG) signals." This involves measuring electrical activity from the brain, which is a physiological signal from within the body.
- Device Description: The device components are designed to acquire and transmit these physiological signals.
- Input Imaging Modality: The input is "Electroencephalogram (EEG) signals," which are bioelectric signals, not images.
- Anatomical Site: The anatomical site is the "Head," where the EEG electrodes are placed to measure brain activity.
- Lack of In Vitro Testing: The performance studies described are bench testing evaluating the device's ability to measure and transmit signals, not testing on biological samples (like blood, urine, or tissue) outside of the body.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, or tissue) in vitro (outside of the body) to provide information for diagnostic purposes. The Crystal-EEG Model 10 measures signals in vivo (within the body).
N/A
Intended Use / Indications for Use
The Crystal-EEG Model 10 is a mobile, intermediate range, wireless, EEG system intended to be used for measuring and transmitting bioelectric signals such as electroencephalogram (EEG). It allows extended EEG monitoring without having the subject tethered with wires.
The Crystal-EEG Model 10 is a mobile, intermediate range, wireless EEG system intended to be used for measuring and transmitting electroencephalogram (EEG) signals.
Product codes
OMC
Device Description
The Crystal-EEG Model 10 is a mobile, intermediate range, wireless, EEG system used for measuring and transmitting bioelectric signals such as electroencephalogram (EEG). It consists of a Transmitter, a Receiver Assembly which consists of the receiver, receiver cable, and power supply; the Software; Patient Accessories consisting of EEG Electrodes, headband, battery, and battery connector; and a PC Operator Interface which consists of Operator Interface Software, Transmitter Set-up Cable, and a Personal Computer (optional).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Bench Testing: The noise amplitude of the various channels of three Crystal-EEG Model 10 Transmitters was evaluated by shorting the input channels of the transmitter units together. The transmitted signal (noise) at the receiver end was recorded. The RMS of the noise was in the order of I uVolt.
The Crystal-EEG Model 10 unit was then evaluated in its ability to measure and transmit known signals provided by a signal generator.
The next step was to verify the functional accuracy of the low and high pass filters. The frequency of a sine wave was varied between 0.12 and 80 Hz and the peak values of the sine waves recorded. These data verif ; the accuracy of the implemented filters by showing expected levels of attenuation at the both ends of the spectrum.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Hambrecht Associates Multi-Channel Electroencephalographic Telemetry System
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/0 description: The image shows the logo for Cleveland Medical Devices Inc. The logo is black and white and features the company name in a serif font. The letters "CM" are larger and bolder than the rest of the text. There is a line underneath the company name.
11000 CEDAR AVENUE • SUITE 439 • CLEVELAND, OHIO • PHONE: (216) 791-8720 • FAX: (216) 791-6746
510(K) SUMMARY
MAY 22 1997
| A) Submitter's Name: | Cleveland Medical Devices Inc. |
|---|---|
| B) Address: | 11000 Cedar Ave. Suite 439 |
| Cleveland, Ohio 44106 | |
| C) Phone and Fax numbers: | Phone: (216) 791-6720 |
| Fax: (216) 791-6744 | |
| D) Contact Person: | Robert N. Schmidt |
| E) Preparation Date: | February 21, 1997 |
| F) Classification Name: | Electroencephalograph |
| Common / Usual Name: | Electroencephalograph |
| Proprietary Name: | Crystal-EEG™ Model 10 |
| Classification: | Class II |
Regulation:
882.1400
(a) 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)
- G) Substantial Equivalence: The design concept of the Crystal-EEG Model 10 is substantially equivalent in design to:
Hambrecht Associates Multi-Channel Electroencephalographic Telemetry System
H) Description: The Crystal-EEG Model 10 is a mobile, intermediate range, wireless, EEG system used for measuring and transmitting bioelectric signals such as electroencephalogram (EEG). It consists of a Transmitter, a Receiver Assembly which consists of the receiver, receiver cable, and power supply; the Software; Patient Accessories consisting of EEG Electrodes, headband, battery, and battery connector; and a PC Operator Interface which consists of Operator Interface Software, Transmitter Set-up Cable, and a Personal Computer (optional).
42
1
- The Crystal-EEG Model 10 is a mobile, intermediate range, I) Intended Use: wireless, EEG system intended to be used for measuring and transmitting bioenests, without wireless, EEG system intended to or accessed allows extended EEG monitoring without having the subject tethered with wires.
- J) Summary of Safety and Effectiveness of Crystal-EEG Model 10: Summary of Safety and Effectiveness on Crystal-EEG Model 10 reflects data available The Summary of Salety and Enecuveies on Organed, but cautions of the consisted in and presented at the time the submission was propares alterations of the conclusions or recommendations set forth.
The Crystal-EEG Model 10 is similar in operation and function to Hambrecht Associates Multi-Channel Electroencephalographic Telemetry System
| | Crystal-EEG Model 10 | Hambrecht Associates Multi-
Channel
Electroencephalographic
Telemetry System |
|-----------------------------------------|--------------------------------------|---------------------------------------------------------------------------------------|
| 1) Transmitter and
Receiver Assembly | 8 channel | 4 channels |
| | Dynamic range of inputs is +/-300 μV | Dynamic range of inputs is 5-250 μV |
| | Radiofrequency 902-928 MHz | Radiofrequency 88-108 MHz |
| | Operating Range 10-20 feet | Operating Range 200 feet |
| 2) Software | three modules | None |
| 3) PC Operator Interface | Optional | None |
The noise amplitude of the various channels of three K) Bench Testing: Crystal-EEG Model 10 Transmitters was evaluated by shorting the input channels of the transmitter units together. The transmitted signal (noise) at the receiver end was recorded. Figure 1 shows the results for the 24 channels of transmitted data (8 channels/Transmitter). The RMS of the noise was in the order of I uVolt.
2
Image /page/2/Figure/1 description: The image shows a graph of noise when 24 channels are shorted. The x-axis is labeled "Seconds" and ranges from 0 to 1. The y-axis is labeled "Micro-Volts" and ranges from -10 to 10. There are multiple lines plotted on the graph, all of which appear to be fluctuating around 0.
The Crystal-EEG Model 10 unit was then evaluated in its ability to measure and transmit known The Crystal-ELO Model 10 mill was Liver orovided by a signal generator. Figures 2 and 3 show two examples of such data from one typical channel with the analog sine waves at 5 and 20 show two examples of such cases the sine waves were measured and transmitted across the link.
Image /page/2/Figure/3 description: The image shows a sine wave with a frequency of 5 Hz. The x-axis represents time in seconds, ranging from 0 to 1, while the y-axis represents micro-volts, ranging from -150 to 100. The sine wave has a peak amplitude of approximately 100 micro-volts and a trough amplitude of approximately -100 micro-volts. The figure is labeled as 'Figure 2. 5 Hz Sine Wave'.
3
Image /page/3/Figure/1 description: The image shows a graph of a 20 Hz sine wave. The x-axis represents time in seconds, ranging from 0 to 1. The y-axis represents micro-volts, ranging from -150 to 150. The sine wave oscillates between approximately -100 and 100 micro-volts.
The next step was to verify the functional accuracy of the low and high pass filters. The frequency of a sine wave was varied between 0.12 and 80 Hz and the peak values of the sine waves recorded. Table 1 shows the measured peak value for each frequency. These data verif ; the accuracy of the implemented filters by showing expected levels of attenuation at the both ends of the spectrum.
| Sine Wave Frequency (Hz.) | Peak Amplitude (uV) |
|---|---|
| 0.12 | 12 |
| 0.2 | 22 |
| 0.4 | 45 |
| 0.7 | 69 |
| 1.0 | 83 |
| 2.0 | 95 |
| 5.0 | 97 |
| 10 | 98 |
| 20 | 100 |
| 30 | 72 |
| 40 | 18 |
| 50 | 6 |
| 60 | 5 |
| 80 | 3 |
| Table 1. Frequency Response of the System to | ||
|---|---|---|
| 100 uV Amplitude Sine Waves |
..............................................................................................................................................................................
દ
ﺔ ﺍﻟﻤﺮﺍﺟﻊ
4
Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Robert N. Schmidt Cleveland Medical Devices, Inc. 11000 Cedar Avenue, Suite 439 Cleveland, Ohio 44106
Re: K970672 Trade/Device Name: Crystal -EEGTM Model 10 Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OMC Dated (Date on orig SE Itr): February 19, 1997 Received (Date on orig SE Itr): February 24, 1997
APR - 9 2012
Dear Mr. Schmidt:
This letter corrects our substantially equivalent letter of May 22, 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. Iisting 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.
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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.
Malvin
Director
Division
and
Office
Sincerely yours,
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
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Page 1 of 1
510(k) Number (if known): K970672
Crystal-EEG™Model 10 Device Name:
Indications For Use: ........ The Crystal-EEG Model: 10 is a mobile, intermediate range, .... -・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ ﺎ wireless EEG system intended to be used for measuring and transmitting electroencephalogram (EEG) signals.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Antras J. Callahan
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number K970672
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The-Counter Use