(202 days)
K880088A
Not Found
No
The summary describes a hardware device designed to improve signal quality for existing EMG equipment by providing buffered electrode inputs closer to the signal source. There is no mention of software algorithms, data processing for interpretation, or any terms related to AI/ML.
No
The device is described as an accessory for an EMG instrument, intended to improve signal quality for diagnostic measurements, not to provide therapy.
Yes
The device performs measurements for electromyography (EMG), nerve conduction velocity (NCV), and evoked potentials, which are diagnostic procedures used to assess neurological function.
No
The device description explicitly details hardware components including a preamplifier, buffered electrode input box, extension cable, and connectors. It also mentions sterilization and physical connections, indicating it is a hardware device with potential software control or processing, but not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The described device is used to perform measurements related to the electrical activity of nerves and muscles (EMG, NCV, evoked potentials). It is a component that interfaces with electrodes placed on or near the body to acquire physiological signals.
- Intended Use: The intended use clearly states it's for "electromyography (EMG), nerve conduction velocity (NCV, F wave, and H reflex), and evoked potentials (brainstem, visual, and somatosensory), and repetitive nerve stimulation." These are all procedures that involve measuring electrical signals directly from the body, not analyzing samples taken from the body.
- Device Description: The description focuses on the hardware components (preamplifier, input box, cables) designed to improve signal acquisition from electrodes.
- Performance Studies: The performance studies evaluate the device's ability to accurately acquire and transmit physiological signals, not its ability to analyze biological samples.
Therefore, the device falls under the category of a physiological signal acquisition device used in electrodiagnostic procedures, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The general purpose of the proposed device is identical to the predicate device: "to perform the measurements needed for electromyography (EMG), nerve conduction velocity (NCV, F wave, and H reflex), and evoked potentials (brainstem, visual, and somatosensory), and repetitive nerve stimulation." The purpose of the proposed device is to allow compatibility with high-impedance electrodes. The design of the device provides inputs that can be made closer to the source of the signal for reduced signal noise during procedures requiring high-impedance electrodes.
Product codes (comma separated list FDA assigned to the subject device)
84GWP, 89IKN
Device Description
The proposed device consists of the existing four- /eight-channel preamplifier and a buffered electrode input box with extension cable. These components provide electrode inputs that are closer to the source of the signal during electromyographic (EMG) testing. The intent of this design is to reduce signal noise during procedures requiring high-impedance electrodes. The proposed device is for use with the Cadwell Excel (K880088A) EMG instrument.
All device components are reusable and supplied non-sterile. The extension cable with electrode input box is compatible with EtO sterilization guidelines for procedures requiring a sterile field. The input box is available with separate active and reference input connectors or a single phono jack connector.
The attached extension cable connects the input box to the preamplifier by way of a cable adapter. The existing preamplifier will be fitted with three pin DIN connectors to accept the cable adapter.
The extension cable with buffered electrode input box allows electrode inputs to be made closer to the source of the signal for reduced signal noise during procedures requiring high-impedance electrodes. The electrode input box is available with separate active (labeled .) and reference connectors or a single phono jack connector to accommodate recording electrodes with these connector types.
The input box is enclosed in a white polyethylene foam sheath. The sheath houses a circuit board consisting of a buffer circuit. two electrostatic discharge (ESD) networks (one on each side of the buffer circuit), and a separate circuit designed to limit fault currents.
The circuit board is attached to a polyvinyl chloride extension cable terminated in an eight-pin DIN connector. The input box and extension cable are connected to the preamplifier by way of a polyvinyl chloride cable adapter terminated in a three-pin DIN connector. The adapter cable does not qualify as a class II device.
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
Use of the proposed device is to be administered under the direction of a trained physician, surgeon, neurologist, or electrophysiologist in a suitable operating room or clinic.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The proposed device underwent engineering and clinical testing to validate that the device functions as a remote buffer preamplifier when used with the appropriate electrodiagnostic device. For validation procedures and results, please see Enclosure 3 of the previous submission dated October 16, 1996.
The results of engineering tests 1 and 2 indicate that the input impedance is greater than 10 Mohms when the active and reference connectors are subjected to ten strikes of 8-kV ESD each.
The following tests were carried out with the proposed device connected to the intended electrodiagnostic instrument. The results from test 3 show that the gain is not affected by passing the signal through the proposed device. The results of test 4 show that the patient auxiliary current is well below the regulatory limits set forth by IEC 601-1 for BF connections. The results of test 5 show that the measured value of peak-to-peak noise is less than the allowed valued.
Clinical results from test 6 show that the proposed device does not distort the morphology of the nerve conduction waveform, nor does it significantly affect the onset time, peak time, or amplitude when compared to the signal that does not pass through the proposed device. Additional clinical results in test 7 indicate that the proposed device does not distort the morphology of the EMG waveform when compared to the signal that does not pass through the proposed device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Cadwell Excel (K880088A)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.1870 Evoked response electrical stimulator.
(a)
Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.(b)
Classification. Class II (performance standards).
0
JAN 1 3 1997
Section 2 - Summary and Certification
December 20, 1996
A. 510(k) Summary of Safety and Effectiveness
The proposed device consists of the existing four- /eight-channel preamplifier and a buffered electrode input box with extension cable. These components provide electrode inputs that are closer to the source of the signal during electromyographic (EMG) testing. The intent of this design is to reduce signal noise during procedures requiring high-impedance electrodes. The proposed device is for use with the Cadwell Excel (K880088A) EMG instrument.
All device components are reusable and supplied non-sterile. The extension cable with electrode input box is compatible with EtO sterilization guidelines for procedures requiring a sterile field. The input box is available with separate active and reference input connectors or a single phono jack connector.
The attached extension cable connects the input box to the preamplifier by way of a cable adapter. The existing preamplifier will be fitted with three pin DIN connectors to accept the cable adapter.
1. Submitter Name and Identification
Cadwell Laboratories, Inc. 909 North Kellogg Street Kennewick, WA 99336 (800) 245-3001 Contact: Chris Bolkan Establishment Registration Number: 3020018
2. Proposed Device Name and Part Number
Trade Name (Proprietary Name): Cadwell Excel and Cadwell Excel Plus
| Proposed Device | Order Number |
|---|---|
| Four-Channel Preamplifier | |
| OR | 199085-200 |
| Eight-Channel Preamplifier | 199088-200 |
| Buffered Input Box with Extension Cable | 197112-200 |
| Cable Adapter | 199155-200 |
Common Name or Usual Name: Electromyography and Evoked Potential Equipment.
Classification: Type II
| Name | Number |
|---|---|
| Electromyograph | 84GWP |
| Electromyograph, Diagnostic | 89IKN |
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3. Identification of the Substantially Equivalent Device
Reason for Premarket Notification: Modification to an existing device.
Modification of Existing Device: The proposed device is a modification to the existing Cadwell Excel (K880088A) device. The Cadwell four- /eight-channel preamplifier with buffered input box allows electrode inputs to be made closer to the signal source for reduced noise during procedures requiring high-impedance electrodes. The proposed device complies with the same safety standards as the existing device.
Safety of the Cadwell Excel (K880088A) Device
The original device complies with the following safety standards for medical equipment:
- IEC 601-1 Medical Electrical Equipment. Part 1. General requirements for safety. Type: Class 1 or grounded equipment, continuous operation, with B and BF applied parts.
- IEC 878 (1988) Graphic symbols for electrical equipment in medical practice.
- NFPA 99. Standard for Health Care Facilities.
The original device complies with the following general safety standards for electrical equipment:
ANSI/NFPA No. 70 (1990) National electric code.
- UL 796 Standard for printed wiring boards.
- UL 94 Standard for tests for flammability of plastic materials for parts in devices and appliances.
Safety of the Cadwell Excel (K880088A) Four- /Eight-Channel Preamplifier Device
The original device complies with the following standards:
IEC 601-1 isolated applied part Type BF.
- American Electroencephalographic Society Guidelines for Clinical Evoked Potential Studies, 1984. Section III. Standards for Clinical Evoked Potential Equipment: Minimal Standards, Amplifier Averager. Section IV. Standards for Clinical Evoked Potential Recording: Calibration.
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Effectiveness of the Cadwell Excel (880088A) Device
The original device is designed to perform the measurements needed for electromyography (EMG), nerve conduction velocity (NCV. F wave, and H reflex), evoked potentials (brainstem, visual, somatosensory) and repetitive nerve stimulation. The effectiveness of these clinical protocols is described in standard medical school textbooks. Please refer to the following texts for additional information.
- Aminoff MJ: Electrodiagnosis in Clinical Neurology, Churchill Livingstone Inc., 1980.
- Chiappa KH: Evoked Potentials in Clinical Medicine, ed 2. Raven Press, 1990.
- Delisa JA: Manual of Nerve Conduction Velocity and Somatosensory Evoked Potentials, ed 2. Raven Press, 1987.
- Johnson EW: Practical Electromyography, ed 2, Williams & Wilkins, 1988.
- Kimura J: Electrodiagnosis in Diseases of Nerve and Muscle: Principles and Practice, ed 2. A Davis Company, 1989.
- Spehlmann R: Evoked Potential Primer: Visual, Auditory, and Somatosensory Evoked Potentials in Clinical Diagnosis, Butterworth Publishers, 1985.
- Regan D: Human Brain Electrophysiology: Evoked Potentials and Evoked Magnetic Fields in Science and Medicine. Elsevier Science Publishing Co., Inc., 1989.
4. Description of the Proposed Device
The extension cable with buffered electrode input box allows electrode inputs to be made closer to the source of the signal for reduced signal noise during procedures requiring high-impedance electrodes. The electrode input box is available with separate active (labeled .) and reference connectors or a single phono jack connector to accommodate recording electrodes with these connector types.
The input box is enclosed in a white polyethylene foam sheath. The sheath houses a circuit board consisting of a buffer circuit. two electrostatic discharge (ESD) networks (one on each side of the buffer circuit), and a separate circuit designed to limit fault currents.
3
The circuit board is attached to a polyvinyl chloride extension cable terminated in an eight-pin DIN connector. The input box and extension cable are connected to the preamplifier by way of a polyvinyl chloride cable adapter terminated in a three-pin DIN connector. The adapter cable does not qualify as a class II device.
5. Statement of Intended Use
The general purpose of the proposed device is identical to the predicate device: "to perform the measurements needed for electromyography (EMG), nerve conduction velocity (NCV, F wave, and H reflex), and evoked potentials (brainstem, visual, and somatosensory), and repetitive nerve stimulation." The purpose of the proposed device is to allow compatibility with high-impedance electrodes. The design of the device provides inputs that can be made closer to the source of the signal for reduced signal noise during procedures requiring high-impedance electrodes.
Duration of Use
The four- /eight-channel preamplifier with buffered input box is designed for use during the duration of the procedure only. This device is not for chronic use and is labeled accordingly.
Intended Use Environment
Use of the proposed device is to be administered under the direction of a trained physician, surgeon, neurologist, or electrophysiologist in a suitable operating room or clinic.
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6. Comparison of Device Technological Characteristics
The proposed device is a modification to the preamplifier of the Cadwell Excel (K880088A) device. Physical modifications to the predicate device are in the following areas:
- The recording component (electrode input box) from the 1. existing preamplifier is placed at the end of the extension cable. The proposed device provides closer electrode inputs for reduced signal noise during procedures requiring high-impedance electrodes.
-
- The proposed input box and extension cable are compatible with EtO sterilization requirements.
-
- To accommodate the proposed input box and extension cable, the existing preamplifier requires a hardware upgrade from the existing five-pin DIN connector to a three-pin DIN connector. The proposed device also requires a preamplifier cable adapter. The cable adapter does not qualify as a class II device.
The proposed device and the predicate device have nearly identical technical specifications and characteristics. The modification consists of adding a remote electrode input box for use with a single, high-impedance electrode. The input box connects to the existing preamplifier by way of an extension cable and cable adapter. The cable adapter requires a three-pin DIN connector in place of the standard five-pin DIN connector currently on the preamplifier.
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| Criteria | Cadwell Excel with the existing
four-/eight-channel
preamplifier | Cadwell Excel with the proposed
four-/eight-channel
preamplifier and buffered input
box |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Safety | Designed to comply with
requirements of UL 2601-1, CSA
C22.2 No. 601.1-M90, and IEC
601-1. Type BF. | Designed to comply with
requirements of UL 2601-1, CSA
C22.2 No. 601.1-M90, and IEC
601-1. Type BF. |
| Electrode inputs | 20 buffered electrode inputs with
built-in full montage selection or
5-pin DIN connector. | 20 buffered electrode
inputs with built-in full
montage selection. One remote buffered
electrode input with
separate active and
reference pin jack
connectors or single phono
jack connector. Preamplifier fitted with 3-
pin DIN connector. |
| Isolation mode
rejection | > 110 dB. | > 110 dB. |
| Sensitivities | 2 micro V/div to 25 mV/div in
13 steps. | 2 micro volts/div to 25 mV/div
in 13 steps. |
| Noise | 0.6 micro volts RMS (3 micro V
peak to peak) from 10 Hz to 2
kHz typical. | 0.6 micro volts RMS (3 micro
volts peak to peak) from 10 Hz
to 2 kHz typical. |
| Input impedance | > 10,000 Mohms | > 10,000 Mohms |
| Impedance
measurement | Built-in individual electrode
impedance measurement,
including ground. | Built-in individual electrode
impedance measurement,
including ground. |
| Calibration | Built-in calibration signal 10
micro V to 50 mV peak to peak,
sine or square wave in 13 steps. | Built-in calibration signal 10
micro V to 50 mV peak to peak,
sine or square wave in 13 steps. |
| Artifact suppression | Automatic or manual stimulus
artifact suppression. | Automatic or manual stimulus
artifact suppression. |
| Low-cut filters | 2-pole filter. Selectable at 0.04,
0.1, 1, 3, 10, 30, 100, 500 Hz. | 2-pole filter. Selectable at 0.04,
0.1, 1, 3, 10, 30, 100, 500 Hz. |
| High-cut filters | Two-channel mode: 2 pole
Butterworth--100, 200, 500 Hz;
1, 2, 3, 10, 20 kHz. Four- and
eight-channel mode: 2 pole
Butterworth--70, 100, 200, 500
Hz; 1, 2, 3, 10, 20 kHz. | Two-channel mode: 2 pole
Butterworth--100, 200, 500 Hz;
1, 2, 3, 10, 20 kHz. Four- and
eight-channel mode: 2 pole
Butterworth--70, 100, 200, 500
Hz; 1, 2, 3, 10, 20 kHz. |
.
ﺮ
រើ
6
Testing and Validation
The proposed device underwent engineering and clinical testing to validate that the device functions as a remote buffer preamplifier when used with the appropriate electrodiagnostic device. For validation procedures and results, please see Enclosure 3 of the previous submission dated October 16, 1996.
Conclusion
The results of engineering tests 1 and 2 indicate that the input impedance is greater than 10 Mohms when the active and reference connectors are subjected to ten strikes of 8-kV ESD each.
The following tests were carried out with the proposed device connected to the intended electrodiagnostic instrument. The results from test 3 show that the gain is not affected by passing the signal through the proposed device. The results of test 4 show that the patient auxiliary current is well below the regulatory limits set forth by IEC 601-1 for BF connections. The results of test 5 show that the measured value of peak-to-peak noise is less than the allowed valued.
Clinical results from test 6 show that the proposed device does not distort the morphology of the nerve conduction waveform, nor does it significantly affect the onset time, peak time, or amplitude when compared to the signal that does not pass through the proposed device. Additional clinical results in test 7 indicate that the proposed device does not distort the morphology of the EMG waveform when compared to the signal that does not pass through the proposed device.