DEEG-LITE

K972202 · Grass-Telefactor Product Group · GWQ · Jul 23, 1997 · Neurology

Device Facts

• Record ID: K972202
• Device Name: DEEG-LITE
• Applicant: Grass-Telefactor Product Group
• Product Code: GWQ · Neurology
• Decision Date: Jul 23, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2

Intended Use

The DEEG-LITE is intended primarily to be used for the long term digital recording of voltages produced by the brain and measured on the scalp (EEG) for subsequent diagnostic review with a digital workstation supplied by the manufacturer (Telefactor Beekeeper) or similar compatible device. The DEEG-LITE is intended for use with patients with suspected seizure disorders, and sleep disorders.

Device Story

DEEG-LITE is a portable EEG recorder; captures brain electrical signals via scalp electrodes; processes signals through a MicroCoder (high-resolution A/D converter, DSP, and programmable logic); records data on digital media for clinician review. Used in clinical settings; operated by trained technologists/clinicians. System includes a laptop with LCD, power supply, and 32-channel amplifier/recorder. Clinicians evaluate recorded EEG data on a digital workstation to assist in diagnosing seizure and sleep disorders. Patient safety is managed via medical-grade power supply, floating patient ground (4000V isolation), and capacitor-coupled input circuits to prevent DC current leakage and electrolytic lesions.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing, electrical safety compliance (UL2601-1, IEC601-1), and technical comparison of the amplifier and software recognition algorithms to the predicate device.

Technological Characteristics

System includes a laptop computer, MicroCoder (A/D converter, DSP, programmable logic), and 32-channel EEG amplifier. Operates on low-voltage power supply. Patient isolation provided by capacitor-coupled inputs (single-fault tolerant) and 4000V isolation from third-wire ground. Software includes MicroSzAC recognition algorithm. Complies with UL2601-1 and IEC601-1 electrical safety standards.

Indications for Use

Indicated for patients with suspected seizure disorders and sleep disorders requiring long-term digital EEG recording.

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

• Telefactor Corporation's BEEHIVE- EEG-Recorder (K884937)

Submission Summary (Full Text)

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K972202

**JUL 23**

## Section 2: 510(K) Summary & Certification

## 2.0 Summary

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2.0 Summary is submitted in accordance with the requirements of 807.92 by Telefactor This summary is submitted in accordined will are restion 510(k) Application.

- DEEG-LITE Trade Name: 8.
- Common Name: Portable EEG Recorder b.
- Establishment registration number: 2523420 C.
- Address of the manufacturing facility: d.

1094 New Dehaven Street West Conshohocken, PA 19428

Contact person: James S. Bryan Chief Engineer Tel: [phone] FAX: [phone]

- Product Classification (per CDRH Database): e. Product Category: ELECTROENCEPHALOGRAPH Regulation Number: 882. 1400 Medical Specialty: NE Product Code: GWQ, OLV Product class: Class II Device Tier: 2
- This device claims equivalence to: Telefactor Corporation's BEEHIVE- EEG-Recorder for f. which previously granted 510(k) number is: K884937.
- Brief functional description of the device: DEEG-LITE receives signals from an EEG 8. Brief Tunchoual description on the digital media for subsequent evaluation by a qualified clinician.
- Intended use for the device: The DEEG-LITE is intended primarily to be used for the long h. Intention and 107 the devices with suspected seizure disorders, and sleep disorders.

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- Technological characteristics: The DEEG-LITE system consists of (a) a laptop computer supporters su Technological characteristics: Ine DELS-LITE i with liquid crystal display, (b) a MicroCoder which consists on trocessor) and XII, NY
as: a high resolution Analog to Digital converter, a DSP (Digital Signal Processor) and as: a high resolution Analog to Digital converter, a Dr (a weatable, 32 chamel EEG
programmable logic devices, (c) a power supply and (d) a weatable, 32 chamel EEG programmable logic devices, (c) a power supply and (c) a wefartor, BEEHIVE system (510(k)
amplifier/recorder identical to that used with the current Telefactor BEEHIVE syste #884937). The DEEG-LITE system operates on a safe low voltage power supply, as #884937). The DEEG-LITE system operates on a "sale 10% venug" - " " system which is based on a standard desk-top personal computer.
- Brief statement of substantial equivalence to Telefactor BEEHIVE: The DEG-LITE
System j. Brief statement of substantial equivalcal to the Telefactor BEEHIVE System. As with system has recording performatice with the supplements! SZAC software package
BEEHIVE, DEEG-LITE may also be supplied with the supplements beformance exactly BEEHIVE, DEEG-LITE may also be suppose which has the recognition performance exactly (called "MicroSzAC" in this embodiment), mich are roosydo) since same recognition equivalent to that of Telefoctor S2AC systems. As with Beehive, the DEEG-LITE may be
algorithm is used in the software for both systems. As with Beshoediment). algorithm is used in the software for bour systems: 10 %Nice Liat' in this embodiment),
set up with a specific recording montage (referred to as "Nice Liat" in this exhibit w set up with a specific recording montage (control vest harte normally applied when utilizing the additional electrodes, sensors and correce and as extrement BEEHIVE and DEEG-LITE in so far as patient safety is concerned.

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## Summary of Safety 2.1

Electrical safety for EEG monitoring equipment is well specified by the UL2601-1 and IEC601-1 Electrical sately for EEO momoring equipment is ween carried out with careful attention to compliance with these standards.

The kinds of hazards that exist for such equipment can be subdivided as follows:

- Failure of isolation from mains voltages resulting in a harmful electrical shock or burn. (1)
- Failure of insulation from low voltage circuits that can cause small currents that may not be (2) ranule of institution from 10% ver a period of several hours or days may result in an electrolytic lesion forming on the skin. Such lesions unless infected are no threat to health, but can result in a painful experience for the patient and may leave visible scarring on the skin.
- Failures as in (2) above but when used with electrodes implanted on the surface of the brain or (3) I and os as an (2) 2007 or diagnostic purposes may produce serious lesions resulting in disability or an epileptogenic focus.
- Abrasions of the scalp from application of electrodes and subsequent abuse or accidents (4) involving pressure on the head where electrodes contact the skin.

Mains hazards as described in (1) above are avoided by following the appropriate standards for Manis nazards as accession in (1) 2601-1. Figure 1 on page 7 shows a simplified schematic for system. Electrical energy for the patient connected device is provided from a medical grade power system Libertiver cating 100 the patient connected amplifier. The equipment will pass a suppy the provided to weekdown test from mains to patient electrodes. Further, the patient ground is floating with an isolation of 4000 volts from third wire ground, so that inadvertent patient contact with other equipment at mains voltages will not produce current in excess of 50 micro amperes through the patient ground leads.

To protect failure mode (2) above, the Telefactor CTE amplifier used in the system has patient input circuits, shown in Figure 2 on page 8, which connect to the patient only through capacitors that block all direct current. The system is single fault toleran; that is to say that failure of only one capacitor will not produce harmful currents. Failure of two capacitors simultaneously is required to produce currents that might result in electrolytic lesions.

For all the reasons cited in the foregoing paragraph the CTE amplifiers are safe from mode (3) failures when used in a hospital environment.

Injury from application of scalp electrodes themselves, as mentioned in item (4) above, is beyond the scope of this discussion since it does not involve Telefactor equipment but is dependent on electrodes supplied by other vendors and on the skill of the technologist applying the electrodes.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle or bird-like symbol with three curved lines representing the wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the bird symbol.

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

Mr. James S. Bryan Chief Engineer Telefactor Corporation 1094 New Dehaven Avenue W. Conshohocken, Pennsylvania 19428

Re: K972202

Trade/Device Name: DEEG-LITE Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLV, GWQ Dated (Date on orig SE ltr): June 5, 1997 Received (Date on orig SE ltr): June 11, 1997 APR - 9 2012

Dear Mr. Bryan:

This letter corrects our substantially equivalent letter of July 23, 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. James S. Bryan

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/Resourcesfor You/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,
Kesia Alexander

Image /page/4/Picture/7 description: The image shows the name and title of Malvina B. Eydelman, M.D., who is the Director of the Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices. The office is the Office of Device Evaluation, and the center is the Center for Devices and Radiological Health. The text is black and the background is white.

Enclosure

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1 Page

K 972202 510(k) Number (if known):

.DBEG-LITE Device Name:_

Indications For Use:

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this device is intended for use in rong-term digital recording of voltages produced by the brain and measured on the scalp (EEG) for subsequent diagnostic review with a digital workstation supplied by the manufacturer (Telefactor Beekeeper) or similar compatible device.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

(Divinon Sign-On)
Division of Cardiovascular, Respiratory.
and Neurological Devices
510(k) Number K972202

Prescription Use X :Per 21 CFR 801 109) ਟੈਸ

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)