(1296 days)
No
The device description explicitly states it has the same technological features as predicate devices and functions as an ohmmeter, with no mention of AI or ML. The "Mentions AI, DNN, or ML" section is also marked as "Not Found".
No
The device is used for relaxation training during the biofeedback process, which is a technique for teaching individuals to control involuntary bodily functions. While biofeedback can have therapeutic benefits, the device itself is described as an ohmmeter for measuring skin resistance and is intended for training, not direct treatment of a disease or condition. The intended use as "relaxation training during the biofeedback process" and the description as an "ohmmeter" align more with a training or measurement device than a direct therapeutic device.
No
The device's intended use is for "relaxation training during the biofeedback process," and it measures "skin resistance." It is described as functionally an ohmmeter. These characteristics do not indicate that it is used to diagnose a disease or condition, but rather for training/monitoring purposes.
No
The device description explicitly states it is an ohmmeter that uses a low voltage to measure skin resistance, indicating the presence of hardware components for electrical measurement.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "relaxation training during the biofeedback process." This is a therapeutic or training purpose, not a diagnostic one.
- Device Description: The device measures skin resistance, which is a physiological parameter. IVDs are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, providing diagnostic information, or being used in a laboratory setting.
The device is clearly described as a biofeedback device, which falls under a different regulatory category than IVDs.
N/A
Intended Use / 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. During operation of the predicate devices, the visual and audio feedback conveys information to the patient and the operator about the biofeedback response.
Product codes
Not Found
Device Description
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. Like predicate devices, the DCM uses ohmmeter, audio and video hardware that conveys information about the skin conductance value during biofeedback. 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) 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Feedback Electrodermal Response Model EDR-100 (K770790) by Bio-Feedback Systems, Inc.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5050 Biofeedback device.
(a)
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.(b)
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.
0
MAR 1 4 1996
Digital Conductance Meter - The Jayms Company
K9243/3
- SUMMARY OF SAFETY AND EFFECTIVENESS DATA FOR THE I. 510 (k) 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 Billerica, MA). Those biofeedback devices were Middlesex, marketed prior to 1976. The DCM is also equivalent to the bioteedback functions of the Feedback Electrodermal Response Model EDR-100 (K770790) by Bio-Feedback Systems, (2736 47th Street, Boulder, CO, Inc. 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)
1
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.
ﺮ :