(62 days)
K894042A
K894042A
No
The device description and performance studies focus on the physical properties and electrical performance of TENS/NMES/FES electrodes, with no mention of AI or ML.
Yes
The device description explicitly states "Transcutaneous Electrical Nerve Stimulation (TENS) and Muscle Stimulation (NMES/FES) Electrodes," both of which are therapeutic modalities.
No
Explanation: The device description states it is for "Transcutaneous Electrical Nerve Stimulation (TENS) and Muscle Stimulation (NMES/FES) Electrodes", which are therapeutic, not diagnostic. The performance studies focus on safety (skin irritation) and effectiveness (impedance levels) for these therapeutic applications. There is no indication of diagnosis.
No
The device description explicitly states "Transcutaneous Electrical Nerve Stimulation (TENS) and Muscle Stimulation (NMES/FES) Electrodes," which are hardware components. The performance studies also focus on the physical properties and biocompatibility of the electrodes and gels.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: This section is "Not Found," which is a key indicator of the device's purpose.
- Device Description: The description clearly states "Transcutaneous Electrical Nerve Stimulation (TENS) and Muscle Stimulation (NMES/FES) Electrodes." These are devices used for applying electrical stimulation to the body, not for testing samples in vitro (outside the body).
- Anatomical Site: The anatomical site is "skin," which is where the electrodes are applied for TENS/NMES/FES. IVDs typically involve testing biological samples like blood, urine, or tissue.
- Performance Studies: The performance studies focus on skin irritation and electrode impedance, which are relevant to the function of TENS/NMES/FES electrodes, not IVD performance metrics like sensitivity or specificity.
In summary, the description and performance information point to a device used for therapeutic electrical stimulation applied to the skin, not for diagnostic testing of samples in vitro.
N/A
Intended Use / Indications for Use
Not Found
Product codes
Not Found
Device Description
Not Found
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
The first safety issue was to determine if the gel, which is used to adhere the electrode to the skin, would cause any skin irritation. The RG-60 Series gels used in this family of electrodes have passed the required skin sensitivity testing criteria as specified in the Tripartite Biocompatibility Guidance For Medical Devices. These tests include Cytotoxicity, Dermal Sensitization Study (Buehler Patch Test), Repeat Insult Patch Test, and Primary Skin Irritation Test. The gels used in the Uni-Patch TENS and Muscle Stimulation Electrodes have already been used in cutaneous electrodes manufactured by Uni-Patch. Therefore, Uni-Patch considers the RG-60 Series gels used in the manufacturing of their TENS and Muscle Stimulation Electrodes to be acceptable for short-term contact with the skin.
There are no published performance standards for TENS or Muscle Stimulation Electrodes, so Uni-Patch used impedance levels as the criteria for effectiveness testing. When measuring the electrodes impedance, driven at IK-Hz, we have determined that the electrode impedance values were comparable to all the electrodes tested.
Key Metrics
Not Found
Predicate Device(s)
Axelgaard Manufacturing Company Pals® Plus Reusable Neurostimulation Electrode, LMI Spec T.E.N.S. Repositionable Pin-Type TENS Electrode (K894042A)
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
Image /page/0/Picture/0 description: The image shows the logo for UNI-PATCH Medical Supplies. The logo features a symbol resembling a keyhole on the left, followed by the text "UNI-PATCH" in a simple, sans-serif font. Below the text is a horizontal line, and beneath that, the words "Medical Supplies" are printed in a smaller font.
SEP 5 1996
510(k) Premarket Notification Amendment to Repositionable TENS, NMES, and FES Electrodes
SUMMARY OF SAFETY AND EFFECTIVENESS
Uni-Patch considers their Transcutaneous Electrical Nerve Stimulation (TENS) and Muscle Stimulation (NMES/FES) Electrodes to be as safe and effective as the Axelgaard Manufacturing Company Pals® Plus Reusable Neurostimulation Electrode and the LMI Spec T.E.N.S. Repositionable Pin-Type TENS Electrode (K894042A) with Promeon RG-60 Series gel of which were previously found to be substantially equivalent via a 510(k) Premarket Notification. The safety issues analyzed were skin irritation. The effectiveness of the electrodes was determined by comparing impedance levels.
The first safety issue was to determine if the gel, which is used to adhere the electrode to the skin, would cause any skin irritation. The RG-60 Series gels used in this family of electrodes have passed the required skin sensitivity testing criteria as specified in the Tripartite Biocompatibility Guidance For Medical Devices. These tests include Cytotoxicity, Dermal Sensitization Study (Buehler Patch Test), Repeat Insult Patch Test, and Primary Skin Irritation Test. The gels used in the Uni-Patch TENS and Muscle Stimulation Electrodes have already been used in cutaneous electrodes manufactured by Uni-Patch. Therefore, Uni-Patch considers the RG-60 Series gels used in the manufacturing of their TENS and Muscle Stimulation Electrodes to be acceptable for short-term contact with the skin.
There are no published performance standards for TENS or Muscle Stimulation Electrodes, so Uni-Patch used impedance levels as the criteria for effectiveness testing. When measuring the electrodes impedance, driven at IK-Hz, we have determined that the electrode impedance values were comparable to all the electrodes tested.
Therefore, Uni-Patch considers its TENS and Muscle Stimulation Electrodes (NMES/FES) to be as safe and effective as the above mentioned TENS/NMES Electrodes.
July 18, 1996
P.O. Box 271 1313 West Grant Blvd. Wabasha, MN 55981-0271 ■ 1-800-328-9454 ■ 612-565-2601 ■ Fax 612-565-3971
A TYCO INTERNATIONAL LTD. COMPANY