DIGITAL CONDUCTANCE METER

K924313 · The Jayms Co. · HCC · Mar 14, 1996 · Neurology

Device Facts

• Record ID: K924313
• Device Name: DIGITAL CONDUCTANCE METER
• Applicant: The Jayms Co.
• Product Code: HCC · Neurology
• Decision Date: Mar 14, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5050
• Device Class: Class 2

Indications for Use

The intended use of the DCM is for relaxation training during the biofeedback process. The purpose of the skin conductance data is for the patient to receive visual and audio feedback and for the data to be recorded for reviewing and for monitoring.

Device Story

Device functions as ohmmeter measuring skin conductance/resistance; provides visual and audio feedback to patient and operator. Input: skin resistance signals via low-voltage circuit. Processing: ohmmeter circuit (selectable DC or AC mode) converts resistance to data; PC-based system displays, prints, and stores conductance data; allows protocol entry and recall. Output: visual/audio feedback signals. Used in clinical/training settings by operators/patients for relaxation training. Benefits: facilitates biofeedback response monitoring and patient relaxation.

Clinical Evidence

No clinical data. Substantial equivalence based on technological characteristics and functional comparison to legally marketed pre-1976 and predicate biofeedback devices.

Technological Characteristics

Ohmmeter circuit with selectable DC or AC output. PC-based hardware for data processing, display, and storage. Non-invasive, low-voltage operation. Audio and video feedback components.

Indications for Use

Indicated for patients undergoing relaxation training via biofeedback. Non-invasive, low-voltage skin resistance measurement.

Regulatory Classification

Identification

A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.

Predicate Devices

• AT64 Skin Conductance Response (SCR) (Autogenic Systems Inc.)
• Biofeedback System/3 (Davicon)
• Feedback Electrodermal Response Model EDR-100 (K770790)

Submission Summary (Full Text)

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MAR 14 1996

Digital Conductance Meter - The Jayms Company

K924313

# I. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DATA FOR THE Digital Conductance Meter (Revised 7 November 1995)

Commercially available biofeedback devices measure the resistance of the skin and are used for relaxation training. These devices operate with a direct current to measure the resistance or an alternating current to measure impedance. Several biofeedback devices were marketed prior to 28 May 1976; and other substantially equivalent devices have been marketed since 1976, pursuant to the FDA's 510(k) process.

The Digital Conductance Meter (DCM) has the same technological features as other predicate Class II Biofeedback devices. Like the predicate devices, the DCM is functionally an ohmmeter. Like the predicate devices, the DCM is noninvasive and uses a low voltage to measure skin resistance. The DCM has the same electrical characteristics as predicate devices that are legally marketed as safe.

The intended use of the DCM is for relaxation training during the biofeedback process. The purpose of the skin conductance data is for the patient to receive visual and audio feedback and for the data to be recorded for reviewing and for monitoring. During operation of the predicate devices, the visual and audio feedback conveys information to the patient and the operator about the biofeedback response.

Like predicate devices, the DCM uses ohmmeter, audio and video hardware that conveys information about the skin conductance value during biofeedback. Predicate devices include the AT64 Skin Conductance Response (SCR) by Autogenic Systems Inc. (620 Wheat Lane, Wood Dale, IL, 60191) and the Biofeedback System/3 by Davicon (755 Middlesex, Billerica, MA). Those biofeedback devices were marketed prior to 1976. The DCM is also equivalent to the biofeedback functions of the Feedback Electrodermal Response Model EDR-100 (K770790) by Bio-Feedback Systems, Inc. (2736 47th Street, Boulder, CO, 80301).

In design, the Digital Conductance Meter, the AT64 SCR and the Davicon Biofeedback System/3 use a personal computer. The DCM and the System/3 use the computer to display, print and store conductance data. The System/3 and the DCM also allow a description of a protocol to be entered and saved for later recall. The AT64 SCR uses a personal computer to print data.

The materials of the DCM are equivalent to the materials used by other biofeedback. The materials form the ohmmeter circuit, display circuit and audio circuit. The DCM ohmmeter circuit can be selected for direct current (DC)

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Digital Conductance Meter - The Jayms Company

output which is substantially equivalent to the AT64 SCR ohmmeter circuit or selected for alternating current (AC) output which is substantially equivalent to the EDR-100 and the System/3 ohmmeter circuits. The DCM has audio and video feedback signals which are substantially equivalent to the tones and the displays of the pre-1976 and predicate devices.

The use of the Digital Conductance Meter is equivalent to the use of the pre-1976 and predicate biofeedback devices. The biofeedback process is noninvasive and uses a low voltage to measure skin resistance. The pre-1976 and predicate biofeedback devices on the market have shown biofeedback to be safe and effective for relaxation training.

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