(63 days)
K844618B, K881114
Not Found
No
The device description focuses on electrical stimulation parameters and hardware features, with no mention of AI or ML algorithms for data analysis, decision-making, or adaptive control.
Yes
The device is indicated for the symptomatic relief and management of chronic, intractable pain, which constitutes a therapeutic use.
No
Explanation: The device is indicated for symptomatic relief and management of pain. There is no mention of it being used to diagnose a medical condition.
No
The device description explicitly details hardware components such as channels, electrodes, a 9-volt battery, transformers, and controls for pulse amplitude and balance. It also describes physical outputs and waveforms. This indicates it is a hardware device with potentially embedded software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the symptomatic relief and management of pain. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a TENS (Transcutaneous Electrical Nerve Stimulation) unit, which applies electrical stimulation to the body. This is a physical therapy modality, not a method for examining specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for the diagnosis, treatment, or prevention of disease. The QuadraTENS does not fit this description.
N/A
Intended Use / Indications for Use
The QuadraTENS Model QT-42 neuromuscular stimulator may be used for the symptomatic relief and management of chronic (long-term) intractable pain and as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain problems.
Product codes (comma separated list FDA assigned to the subject device)
GZJ
Device Description
The QuadraTENS Model QT-42 is a 2 channel version of the BioTENS with the addition of a burst mode. Like the BioTENS, it is also intended to be used by or on the order of a licensed practitioner. The burst mode has been added specifically because a single stimulus is sometimes insufficient. By adding a second channel, the QuadraTENS Model QT-42 can be applied simultaneously to another separately enervated area on the same patient. The low frequency stimulation (1.0 Hz rate) of the QuadraTENS Model QT-42, the same as its predecessor BioTENS, is applied to a patient through surface electrodes. The QuadraTENS Model QT-42 is designed and manufactured in compliance with FDA GMP regulations, ISO 9000 and ISO 13485 standards as well as RoHS. The Unit is powered by a single 9 volt battery. It produces a symmetrical bipolar pulse with a factory-set pulse-width of 600 microseconds and a rate of 1 pulse/second. The transformer-coupled outputs, which are equivalent to the both the BioTENS and the EMPI Model 989, apply 0.0 milliamps of net dc current to the patient. In the burst mode, a fixed train of 8 pulses with a repetition rate of 800 Hz is output once/second. The nominal pulse amplitude is controlled separately for each channel and ranges from 0.0 ma to a maximum of 40 milliamps peak. The 2 channels are isolated from each other and their output pulses are staggered in time to prevent any current from flowing between channels, which results in zero crosstalk. Each channel also includes a balance control that adjusts the amplitudes of the positive and negative half waves differentially. The balance is used to equalize the responses at each electrode site.
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
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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)
Design qualification testing was performed for the following purposes:
- Validation test of automatic stand-by mode for safety
- Validation of symmetric bipolar waveform with zero net DC
- Validation test of non-crossover between the separate channel outputs
- Validation test of constant current outputs
The results of each test validate that the design meets all specifications, is equivalent to current legally marketed devices and is acceptable for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
K844618B, K881114
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
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).
0
page 1:4
AUG 2 8 2006
QuadraTENS Model OT-42 510(k) Summary Statement
- This summary prepared by:
John C. Radke (contact person) President/Official Correspondent
Revised on August 25, 2006
Submitted by BioResearch Associates, Inc. 9275 N. 49th Street Suite 150 Brown Deer, WI 53223 PH: (414) 357-7525 FX: (414) 357-7545
QuadraTENS™ Model QT-42 2.
four lead-wires)
(a two channel TENS device with
Transcutaneous Electrical Neural Stimulator and Stimulator
Device: stimulator, nerve, transcutaneous, for pain relief Regulation Description: Transcutaneous electrical nerve stimulator for pain relief
Regulation Medical Specialty: Neurology Review Panels: Neurology Product Codes: GZJ Submission Type: 510(k) traditional Regulation Number: 21 CFR 882.5890 Device Class: II GMP exempt? [No]
3. Legally marketed equivalent devices
BioTENSTM 510(k) number = K844618B (TENS) Empi Model 989 510(k) number = K881114 (burst mode feature)
- The QuadraTENS Model QT-42 is a 2 channel version of the BioTENS with the addition of a burst mode. Like the BioTENS, it is also intended to be used by or on the order of a licensed practitioner. The burst mode has been added specifically because a single stimulus is sometimes insufficient. By adding a second channel, the QuadraTENS Model QT-42 can be applied simultaneously to another separately enervated area on the same patient.
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"Dentist".
1
The low frequency stimulation (1.0 Hz rate) of the QuadraTENS Model QT-42, the same as its predecessor BioTENS, is applied to a patient through surface electrodes.
The QuadraTENS Model QT-42 is designed and manufactured in compliance with FDA GMP regulations, ISO 9000 and ISO 13485 standards as well as RoHS. The Unit is powered by a single 9 volt battery. It produces a symmetrical bipolar pulse with a factory-set pulse-width of 600 microseconds and a rate of 1 pulse/second. The transformer-coupled outputs, which are equivalent to the both the BioTENS and the EMPI Model 989, apply 0.0 milliamps of net dc current to the patient.
Image /page/1/Figure/3 description: The image shows an oscilloscope display with a square wave signal. The vertical scale is set to 5.00V per division, and the horizontal scale is set to 100 microseconds per division. The signal has a frequency of less than 10Hz, and the coupling is set to DC. The bandwidth limit is off at 60MHz, and the probe is set to 1X.
Fig. 1. Wave-shape and pulse-width of QuadraTENS Model QT-42 in single pulse mode applied across a 1,000 Ohm load (peak current shown = 15ma)
In the burst mode, a fixed train of 8 pulses with a repetition rate of 800 Hz is output once/second. The nominal pulse amplitude is controlled separately for each channel and ranges from 0.0 ma to a maximum of 40 milliamps peak. The 2 channels are isolated from each other and their output pulses are staggered in time to prevent any current from flowing between channels, which results in zero crosstalk. Each channel also includes a balance control that adjusts the amplitudes of the positive and negative half waves differentially. The balance is used to equalize the responses at each electrode site.
2
Image /page/2/Figure/1 description: The image shows an oscilloscope display with a waveform. The display indicates settings such as 'Type Vector', 'Persist Off', and 'Format YT'. The waveform is a periodic signal, and the display shows 'CH1 1.00V' and 'M 1.00ms', with a frequency of '