CRYSTAL-EEG MODEL 10 (MODEL 10)

K970672 · Cleveland Medical Devices, Inc. · OMC · May 22, 1997 · Neurology

Device Facts

• Record ID: K970672
• Device Name: CRYSTAL-EEG MODEL 10 (MODEL 10)
• Applicant: Cleveland Medical Devices, Inc.
• Product Code: OMC · Neurology
• Decision Date: May 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2

Intended 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). The system allows extended EEG monitoring without having the subject tethered with wires.

Device Story

Crystal-EEG Model 10 is a mobile, wireless EEG system for extended patient monitoring. Input: bioelectric signals via scalp electrodes. System components: transmitter, receiver assembly, patient accessories (electrodes, headband, battery), and optional PC operator interface. Operation: transmitter captures EEG signals; wireless transmission (902-928 MHz) to receiver; receiver outputs signals for display/analysis. Used in clinical settings to eliminate tethering wires. Healthcare providers use the PC interface to set up the transmitter and monitor data. Benefits: enables patient mobility during EEG recording.

Clinical Evidence

Bench testing only. Evaluated noise amplitude by shorting 24 input channels across three transmitters, resulting in RMS noise of ~1 uV. Functional accuracy verified using a signal generator to transmit analog sine waves (5 Hz and 20 Hz). Frequency response tested across 0.12-80 Hz range to verify filter attenuation performance. No clinical data provided.

Technological Characteristics

8-channel wireless EEG telemetry system. Operates at 902-928 MHz. Dynamic input range +/-300 uV. Includes transmitter, receiver, and optional PC interface. Implements low and high pass filters for signal conditioning. Software consists of three modules for system operation.

Indications for Use

Indicated for measuring and transmitting electroencephalogram (EEG) signals in patients requiring extended EEG monitoring.

Regulatory Classification

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.

Predicate Devices

• Hambrecht Associates Multi-Channel Electroencephalographic Telemetry System

Submission Summary (Full Text)

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11000 CEDAR AVENUE • SUITE 439 • CLEVELAND, OHIO 44106 • PHONE: [phone] • FAX: [phone]

K970672

# 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: [phone]
Fax: [phone]

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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Cleveland Medical Devices Inc.

I) Intended 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). The system allows extended EEG monitoring without having the subject tethered with wires.

J) Summary of Safety and Effectiveness of Crystal-EEG Model 10: The Summary of Safety and Effectiveness on Crystal-EEG Model 10 reflects data available and presented at the time the submission was prepared, but caution should be exercised in interpreting the data. The results of future studies may require 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 |

K) 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. 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 $1\mathrm{uVolt}$.

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Cleveland Medical Devices Inc.

Figure 1. Noise when 24 channels shorted

The Crystal-EEG Model 10 unit was then evaluated in its ability to measure and transmit known analog waveforms. The analog signals were provided 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 Hz, respectively. For both cases the sine waves were measured and transmitted across the link.

Figure 2. 5 Hz Sine Wave

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Cleveland Medical Devices Inc.

Figure 3. 20 Hz sine wave

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 verify the accuracy of the implemented filters by showing expected levels of attenuation at the both ends of the spectrum.

Table 1. Frequency Response of the System to 100 uV Amplitude Sine Waves

| 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 |

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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 -EEG™ Model 10
Regulation Number: 21 CFR 882.1400
Regulation Name: Electroencephalograph
Regulatory Class: II
Product Code: OMC
Dated (Date on orig SE ltr): February 19, 1997
Received (Date on orig SE ltr): 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, 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.

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Page 2 - Mr. Robert N. Schmidt

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,


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

Device Name: Crystal-EEG™Model 10

Indications For Use: The Crystal-EEG Model 10 is a mobile, intermediate range, 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)

[Signature: Thomas J. Callahan]
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K970672

Prescription Use ☑ OR Over-The-Counter Use
(Per 21 CFR 801.109)