(213 days)
No
The summary describes a TENS electrode and its physical characteristics and performance compared to a predicate device. There is no mention of AI, ML, or any software-based analysis or processing.
Yes.
The device is used as a stimulating electrode, indicating a therapeutic application.
No
Explanation: The "Intended Use / Indications for Use" section states that the device is "designed to be used in monitoring applications." While it mentions "ECG tracings," this is described in the context of affecting the quality of the tracings for monitoring, not for diagnostic interpretation by the device itself. The "Device Description" also clarifies its use "as an ECG or stimulating electrode," which are functions for signal acquisition and delivery, not diagnosis.
No
The device description explicitly states the device is a physical electrode made of a conductive coated polymer with an attached leadware and adhesive, indicating it is a hardware component, not software only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "monitoring applications" and as an "ECG or stimulating electrode." These are applications that involve direct interaction with the patient's body for physiological monitoring or stimulation, not for testing samples in vitro (outside the body).
- Device Description: The description details the physical components of an electrode designed to be placed on the skin.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process that would be performed in vitro.
The device is clearly intended for external, on-body use for monitoring and stimulation purposes.
N/A
Intended Use / Indications for Use
The Taylor TENS electrode is designed to be used in monitoring applications. This type of application places the emphasis on the patient's comfort. We recommend that the patient's skin be clean, dry, and shaved, if necessary. It has been shown that a mild abrasion with a prep pad or with fine sandpaper will reduce the inter electrode impedance, which can cause the pickup of 60 cycle neise, known as baseline hum. This means that the way a patient's skin is prepared for the electrode, will affect the quality of how the users ECG tracings come out and the performance during stimulation procedures.
Product codes
84GXY
Device Description
The Taylor TENS Electrode is intended to be used as an ECG or stimulating electrode. The electrode is a Silver/ Silver Chioride conductive coated carbon filled polymer, with an attached leadware. The adhesive that is being used is a hypo-allergenic hydrogel which allows for an adequate hold to the patient. This product meets all of the applicable AAM Standards.
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
The Taylor TENS electrode is for Health Care Professionals only.
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)
Comparative testing was done on Taylor TENS electrode and the Classic ECG/ Stimulating No. 1700 Series alsotrode. Test results indicate that the Taylor TENS electrode provides an equivalent level or better in performance when compared to the legally marketed predicals device when tested to the accuracy requirements as specified in the contents of the premarket notification submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Summery of Safety and Effectiveness
Manufacturer/ Submitter
Tavior Industries, Inc. 2995 S. Moorland Road New Berlin, W1 53151 USA
Contact Name/ Telephone Number Michael Ballard President Taylor Industries, Inc.
Phone (414) 821-5169
October 23, 1995 Date
General Device Information
Common/ Usual Name
This device is commonly known as a stimulation electrode.
Trade/ Proprietary Name
Taylor Industries, Inc's trade/ proprietary name for this device is the Taylor TENS (Transcutaneous Electrical Nerve Stimulator) Electrode.
Classification Name(s)
The Taylor TENS Electrode's classification name, classification panel, and regulation is:
21 CFR 882.1320
Cutaneous Electrode
84GXY
Device Classification
Similar devices have been determined to be Class II devices according to the Neurological Devices Classification Panel. It is believed that this electrode will be considered to be a Class II device.
Performance Standards
Performance standards (Section 514 of the Act) have not yet been established for the device that is the subject of this premarket notification submission.
Legally Marketed Predicate Device
The Taylor TENS Electrode is substantially equivalent, with similar indications for use to the following devices which are currently legally marketed and in commercial distribution:
*K800518 Classic Medical Products Classic ECG/ Stimulating No. 1700 Series Electrode
Device Description
The Taylor TENS Electrode is intended to be used as an ECG or stimulating electrode. The electrode is a Silver/ Silver Chioride conductive coated carbon filled polymer, with an attached leadware. The adhesive that is being used is a hypo-allergenic hydrogel which allows for an adequate hold to the patient. This product meets all of the applicable AAM Standards.
Intended Use
The Taylor TENS electrode is designed to be used in monitoring applications. This type of application places the emphasis on the patient's comfort. We recommend that the patient's skin be clean, dry, and shaved, if necessary. It has been shown that a mild abrasion with a prep pad or with fine sandpaper will reduce the inter electrode impedance, which can cause the pickup of 60 cycle
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neise, known as baseline hum. This means that the way a patient's skin is prepared for the electrode, will affect the quality of how the users ECG tracings come out and the performance during stimulation procedures.
The Taylor TENS electrode is for Health Care Professionals only. It is intended for single patient use only.
Conclusion
Comparative testing was done on Taylor TENS electrode and the Classic ECG/ Stimulating No. 1700 Series alsotrode. Test results indicate that the Taylor TENS electrode provides an equivalent level or better in performance when compared to the legally marketed predicals device when tested to the accuracy requirements as specified in the contents of the premarket notification submission.
Taylor Industries, Inc. feels that the Taylor TENS Electrode is as safe and effective, and performs substantially equivalent to the legally marketed predicate device.
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