FAMILY OF CRYSTAL 20 MONITORS MODEL #CS20-600,900,1300,1400,2400 & 120

K042039 · Cleveland Medical Devices, Inc. · OLV · Nov 17, 2004 · Neurology

Device Facts

• Record ID: K042039
• Device Name: FAMILY OF CRYSTAL 20 MONITORS MODEL #CS20-600,900,1300,1400,2400 & 120
• Applicant: Cleveland Medical Devices, Inc.
• Product Code: OLV · Neurology
• Decision Date: Nov 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2

Intended Use

The Family of Crystal 20 Monitors are intended for monitoring and recording of physiological signals to aid in research and/or diagnostic purposes. The device is not intended for use as life support equipment such as vital signs monitoring in intensive care units.

Device Story

Family of Crystal 20 Monitors are programmable physiological signal acquisition systems. Input: signals from electrodes/sensors (EEG, ECG, EMG, etc.). Operation: Patient Module acquires, digitizes, encodes, and transmits data via wireless (WMTS/ISM bands) or wired connection to a Computer Unit. Computer Unit performs error detection/correction and sends data to PC interface for real-time monitoring or storage/analysis. Used in clinical/research settings by healthcare professionals. Benefits: enables flexible, multi-channel physiological data collection for diagnostic assessment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Modular system consisting of Patient Module (up to 32 channels, A/D conversion, on-board memory), Computer Unit, and Interface Software. Connectivity: Wired or wireless (902-928 MHz, 2.4-2.484 GHz, 608-614 MHz, 1395-1400 MHz, 1429-1432 MHz). Power: 120 VAC for hard-wired models. No-touch electrode connectors.

Indications for Use

Indicated for monitoring and recording physiological signals (EEG, EOG, EMG, ENG, ECG, PSG, airflow, pulse oximetry, respiratory effort, temperature, blood pressure) for research or diagnostic purposes. Not for use as life support or intensive care vital signs 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

• Crystal Monitor Model 16 (K013863)
• Siesta System (K003175)

Submission Summary (Full Text)

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## 510(k) SUMMARY

K042039

The Summary of Safety and Effectiveness information on the Family of Crystal 20 Monitors® is being submitted in accordance with the requirements of 21 C.F.R. §807.92 and reflects data available and represented at the time the submission was prepared, but caution should be exercised in interpreting the data. The results of future studies and or tests may require alterations of the conclusions or recommendations set forth.

| Applicant | Cleveland Medical Devices Inc. | |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | 4415 Euclid Avenue | |
| | Cleveland, Ohio 44103 | |
| Telephone | [phone] | |
| Facsimile | [phone] | |
| Date | July 26, 2004 | |
| Name | Robert N. Schmidt, President | |
| Classification | 882.1400 | |
| Predicate: | Crystal Monitor Model 16, K013863 and Siesta System, K003175 | |
| Description: | The Family of Crystal 20 Monitors® are designed to monitor physiological<br>signals such as cardiovascular, neurological, and muscular for the purpose<br>of research and diagnostic purposes. The Crystal 20 Monitor is a device<br>that is programmable to the type of physiological signals being monitored<br>such as EEG, EOG, EMG, ENG, ECG, PSG, airflow, pulse oximetry,<br>respiratory effort, temperature, blood pressure, etc. The signals are<br>communicated between the patient module and the computer unit using<br>wireless technology based on frequencies such as but not limited to 902-<br>928 MHz, 2.4 - 2.484 GHZ, Wireless Medical Telemetry Bands (WMTS),<br>608-614 MHz, 1395-1400 MHz, or 1429-1432 MHz. The<br>communication between the patient module and computer unit can also be<br>wired (instead of wireless). The Family of Crystal 20 Monitors® will<br>consist of three major components: | |
| | 1. Patient Module;<br>2. Computer Unit; and<br>3. Interface Software | |
| | 1. The Patient Module can have up to 32 channels and the ability to<br>either transmit only (one-way) or transmit and receive (two-way). The<br>basic functional feature of the component is to acquire signals from<br>commercially available electrodes / sensors that are attached to the<br>subject, perform analog-to-digital conversion (when appropriate),<br>encode, format, and transmit the signals to the Computer Unit. The<br>Patient Unit will also have on-board memory capability that will<br>permit the physiological data to be stored inside the patient unit. The<br>Patient Module will contain no-touch connectors to enable connections<br>to commercially available electrodes / sensors.<br>2. The Computer Unit will have the ability to only receive (one-way) or<br>receive and transmit (two-way). The basic functional feature of this<br>component is to receive data packets, performs error detection and<br>correction, and then sends the data to the PC Operator interface where<br>the data can be monitored in real time or stored and analyzed at a later<br>time. | |

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Cleveland Medical Devices, Inc. c/o Mr. Robert N. Schmidt President 4415 Euclid Avenue Cleveland, Ohio 44103

Re: K042039

Trade/Device Name: Family of Crystal 20 Monitors Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLV, GWO Dated (Date on orig SE ltr): November 5, 2004 Received (Date on orig SE ltr): November 8, 2004

APR - 9 2012

Dear Mr. Schmidt:

This letter corrects our substantially equivalent letter of November 17, 2004.

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 vours. 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): | K042039 |
|---------------------------|-------------------------------|
| Device Name: | Family of Crystal 20 Monitors |

The various types of model versions within the Family of Crystal 20 Monitors would be as follows:

| # | Wireless Model Option | Transmission Frequencies | Bands |
|---|-------------------------|--------------------------|-------|
| 1 | CS20 - 600 | 608 - 614 MHz | WMTS |
| 2 | CS20 - 900 | 902 - 928 MHz | ISM |
| 3 | CS20 - 1300 | 1395 - 1400 MHz | WMTS |
| 4 | CS20 - 1400 | 1429 - 1432 MHz | WMTS |
| 5 | CS20 - 2400 | 2400 - 2484 MHz | ISM |
| | Hard-Wired Model Option | Operating Voltage | |
| 6 | CS20 - 120 | 120 VAC | |

## Indications For Use:

The Family of Crystal 20 Monitors are intended for monitoring and recording of physiological signals to aid in research and/or diagnostic purposes.

The device is not intended for use as life support equipment such as vital signs monitoring in intensive care units.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

**510(k) Number** KU42039

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter-Use __

(Optional Format 1-2-96)

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