CRYSTAL-EEG MODEL 10 (MODEL 10) by CLEVELAND MEDICAL DEVICES, INC.

The Crystal-EEG Model 10 is a mobile, intermediate range, wireless EEG system intended to be used for measuring and transmitting electroencephalogram (EEG) signals.

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).

AI/ML Overview

The provided document describes the Crystal-EEG Model 10, an electroencephalograph (EEG) system. The acceptance criteria and the study proving the device meets these criteria are outlined in the "Bench Testing" section.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Noise Amplitude: Low noise in transmitted signals.	The RMS of the noise for all 24 channels (8 channels per transmitter for three transmitters with shorted input channels) was in the order of 1 µVolt. (Figure 1 shows the visual representation of this low noise, fluctuating around 0 µV).
Signal Transmission Accuracy: Ability to accurately measure and transmit known signals (sine waves).	The device successfully measured and transmitted known analog sine waves at 5 Hz and 20 Hz, showing that "the sine waves were measured and transmitted across the link." (Figures 2 and 3 visually represent these transmitted sine waves).
Filter Functional Accuracy: Accurate function of low and high pass filters, demonstrating expected attenuation at spectral ends.	The system's frequency response was evaluated by varying a sine wave frequency from 0.12 Hz to 80 Hz and recording peak amplitudes. The data in Table 1 shows expected levels of attenuation at both low (e.g., 12 µV at 0.12 Hz for a 100 µV input) and high frequencies (e.g., 3 µV at 80 Hz for a 100 µV input), verifying the accuracy of the implemented filters. The peak amplitudes at central frequencies (e.g., 98-100 µV between 10-20 Hz) indicate accurate unattenuated transmission within the intended band.

Study Information

Sample size used for the test set and the data provenance:
- Noise Testing: Three Crystal-EEG Model 10 Transmitters were used, totaling 24 channels (8 channels/Transmitter). The input channels were shorted.
- Signal Transmission Testing: Details on the number of individual tests or channels used for sine wave transmission are not explicitly stated beyond "one typical channel" for the 5 Hz and 20 Hz examples.
- Filter Accuracy Testing: One Crystal-EEG Model 10 unit was evaluated.
- Data Provenance: The testing was "Bench Testing," implying a controlled laboratory environment. The country of origin of the data is not specified but is presumed to be internal testing by Cleveland Medical Devices Inc. in Cleveland, Ohio, USA, where the company is located. The nature of the testing is prospective, as it involved actively generating and measuring signals.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- No human experts were used to establish the ground truth for the bench testing. The ground truth was established by known electrical signals (shorted inputs for noise, signal generator for sine waves with known frequencies and amplitudes). This is an objective, instrumental ground truth, not reliant on expert interpretation.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. As the ground truth was established by objective electrical measurements and signal generation, no human adjudication was required.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This device is an electroencephalograph (EEG) system, a medical device for measuring bioelectric signals. The provided document details its technical performance characteristics through bench testing. It is not an AI-assisted diagnostic tool, and therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this submission.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, this was effectively a standalone performance evaluation of the device's hardware and software components (apart from the PC operator interface being optional, the core function is the device itself). The "Bench Testing" specifically assesses the device's ability to measure, transmit, and process electrical signals without human interpretation as part of the primary test.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Objective Instrumental Ground Truth: The ground truth was established by known electrical parameters.
  - For noise: A shorted input represents a theoretically "zero signal" condition, allowing measurement of intrinsic system noise.
  - For signal transmission: A signal generator provides precisely controlled sine waves of known frequency and amplitude.
  - For filter accuracy: A signal generator provides sine waves of known frequencies and a theoretical model predicts the expected attenuation based on the filter design.
The sample size for the training set:
- Not applicable. The device described is an EEG signal acquisition and transmission system, not a machine learning or AI-based system that requires a "training set" in the conventional sense. The "Bench Testing" focuses on the fundamental electrical performance characteristics of the hardware and integrated software.
How the ground truth for the training set was established:
- Not applicable, as there was no training set.

Summary

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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

K970672

510(K) SUMMARY

MAY 22 1997

A) Submitter's Name:	Cleveland Medical Devices Inc.
B) Address:	11000 Cedar Ave. Suite 439Cleveland, Ohio 44106
C) Phone and Fax numbers:	Phone: (216) 791-6720Fax: (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).

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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-ChannelElectroencephalographicTelemetry System
1) Transmitter andReceiver 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.

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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'.

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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

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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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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)

Over-The-Counter Use

Regulation Number and Section

§ 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).