(389 days)
K871222, K901575A
No
The document describes a simple electrode for electrical stimulation and explicitly states "Mentions AI, DNN, or ML: Not Found".
Yes
The device is described as being used in conjunction with electrical stimulating therapy for symptomatic relief and management of chronic/acute pain and muscle stimulation therapy, which are therapeutic applications.
No
Explanation: The device description and intended use clearly state that the electrode is used to conduct electrical stimulation for therapeutic purposes (pain relief, muscle stimulation) or for establishing electrical contact with a stimulator (TENS, FES, NMES). There is no mention of it being used to identify, diagnose, or monitor a medical condition or disease.
No
The device description explicitly details physical components like conductive hydrogel, a conductive lead wire, and a non-conductive cloth backing material, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to conduct electrical stimulation to a patient's skin for therapeutic purposes (pain relief, muscle stimulation, etc.). This is a direct interaction with the patient's body for treatment.
- Device Description: The device is an electrode designed to deliver electrical current to the skin.
- Lack of In Vitro Activity: IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a patient's health. This device does not perform any such analysis on biological samples.
- Anatomical Site: The anatomical site is the patient's skin, indicating direct application to the body.
The device described is a therapeutic device used for electrical stimulation, not a diagnostic device used for testing biological samples.
N/A
Intended Use / Indications for Use
To conduct electrical stimulation to a patient's skin.
Single patient use.
Repositionable, self-adhering.
Over the counter use.
The electrode is used in conjunction with electrical stimulating therapy for the symptomatic relief and management of chronic pain or some types of acute pain, muscle stimulation therapy for the relaxation of muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, and maintaining or increasing range of motion.
Product codes (comma separated list FDA assigned to the subject device)
GXY
Device Description
The device provides a means for establishing electrical contact between the lead connected to a TENS, FES, or NMES stimulation device and the skin. The device consists of conductive hydrogel, a conductive lead wire, a non-conductive cloth backing material with a printed conductor on the side contacting the hydrogel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
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)
Uni-Patch used impedance levels as the criteria for effectiveness testing. When measuring the electrode impedance, driven at 1K-Hz, we have determined that the electrode impedance values were comparable to all the legally marketed electrodes identified above.
Additionally, the Hydrogel used in the Uni-Patch electrodes has passed the required skin sensitivity testing criteria as specified in the Tripartite Biocompatability Guidance for Medical Devices. The Hydrogel used in Uni-Patch's electrodes has been used extensively throughout the industry for over fifteen years.
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.
K871222, K901575A
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.
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
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which is a stylized representation of a human figure. The figure is composed of three overlapping profiles, suggesting a sense of community and support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
SEP 1 7 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Keith J. Geolat Manager of Quality Assurance and Regulatory Affairs Uni-Patch Medical Supplies Post Office. Box 271 1313 West Grant Boulevard Wabasha, Minnesota 55981
Re: K983097
Trade Name: TENS/FES/NMES Electrodes Regulatory Class: II Product Code: GXY Dated: June 16, 1999 Received: June 22, 1999
Dear Mr. Geolat:
We have reviewed your Section 510(k) notification of intent to market the device referenced above we have reviewed your Section 170(k) notically equivalent (for the indications for use stated in
and we have determined the device is substantially equivalent (for the snatem and we have determined the device is substantially courtered (on May 28, 1976, the enactment the enclosure) to devices marketed in microate donices that have been reclassified in accordance date of the Medical Device Antendinents, or to ac need and Act (Act). You may, therefore, market answere of with the provisions of the rederal rood, Drug, aisons of the Act. The general controls provisions of
the device, subject to the general controls provisions of the Act. The g the device, subject to the general concess provinsion, listing of devices, good manufacturing are Act merade requirements sions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premaket II your device is classifica (see above) into only in the sixisting major regulations affecting your Approval), It may be subject to such additions, Title 21, Parts 800 to 895. A substantially
device can be found in the Code of Federal Regulations, Title 21, Canada supportu device can be found in the Code of Pederal Reguith the current Good Manufacturing Practice equirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requirement, as set form in the Quality Bystein reguliare (QS) inspections, the Food and Drug
regulation (21 CFR Part 820) and that, through periodic (QS) inspections with th regulation (FDA) will verify such assumptions. Failure to comply with the GMP regulation Administration (1127) will vertify such assumpliems announcements concerners concerning may result in regulatory action: "In addition, a be a this response to your premarket notification your device in the Federal Kegister. Ticaso note: Intel rections 531 through 542 of the Act
submission does not affect any obligation you might have under ather Foderal laws submission does not affect any other Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket I his letter will anow you to begin marketing your device to a legally marketed notification. The FDA Inding of Substantial equivalence on Jour device to proceed to the market.
1
Page 2 - Mr. Keith J. Geolat
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and IT you desire specific data or never your ostic devices), please contact the Office of Compliance at additionally 007.10 for in This are nestions on the promotion and advertising of your device, (301) 594-4037. Tructionally, 101 quest 21.01.1594-4639. Also, please note the regulation
(201) 594-4037. Traditional (201) 594-4639. Also, please note the cegalation prease contact the Office of Compitance as (2011) 11:10 PM 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small information on your responsionnies ander the rise not not (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
[signature]
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
P
Enclosure
2
Page 1 of 1
K962332 510(k) Number (if known):
TENS / FES / NMES Electrodes Device Name:
Indications For Use:
To conduct electrical stimulation to a patient's skin.
Single patient use.
Repositionable, self-adhering.
Over the counter use.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use X
(Optional Format 1-2-96)
Division Sign Off
(Division Sign-Off) Division of General Restorative Device 510(k) Number
3
September 9, 1999
510(k) Summary
1) Establishment Address, Contact, and Registration Number:
Uni-Patch 1313 West Grant Blvd. Wabasha, MN 55981
Registration Number: 2183164
Contact: Keith Geolat - Manager of Quality Assurance & Regulatory Affairs Phone: (651) 565-2601
2) Device Name
- A. Classification: Electrode, Cutaneous, Classification Number: 84 GXY Class II
- B. Common/Usual: TENS, FES, NMES Stimulating Electrodes
3) Substantial Equivalence
The Uni-Patch TENS, FES, and NMES Electrodes with conductive gel are substantially equivalent to electrodes that have already been found to be substantially equivalent through the 510(k) premarket notification process. Uni-Patch currently manufactures and distributes the following electrodes carrying the same indication for use.
Tantone Multi-Day 633 TENS Electrode - K871222 Reusable TENS Paravertebral Pad 641 Back Electrode - K901575A
Uni-Patch proposes to manufacture and market this electrode family with conductive gel using similar designs and compositions of previously annoved devices.
4) Device Description
The device provides a means for establishing electrical contact between the lead connected to a TENS, FES, or NMES stimulation device and the skin. The device consists of conductive hydrogel, a conductive lead wire, a non-conductive cloth backing material with a printed conductor on the side contacting the hydrogel.
4
5) Intended Use
The electrode is used in conjunction with electrical stimulating therapy for the symptomatic relief and management of chronic pain or some types of acute pain, muscle stimulation therapy for the relaxation of muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, and maintaining or increasing range of motion.
6) Technological Characteristics Comparison
Uni-Patch has compared our electrode to other legally marketed electrodes that carry the TENS and NMES indication; the Medtronic ComfortEase (K851303), and the 3M Myocare (K905539) Muscle Stimulation Electrodes.
There are no published performance standards for TENS, FES, or NMES electrodes, so Uni-Patch used impedance levels as the criteria for effectiveness testing. When measuring the electrode impedance, driven at 1K-Hz, we have determined that the electrode impedance values were comparable to all the legally marketed electrodes identified above. (See attached data.)
i Additionally, the Hydrogel used in the Uni-Patch electrodes has passed the required skin sensitivity testing criteria as specified in the Tripartite Biocompatability Guidance for Medical Devices. The Hydrogel used in Uni-Patch's electrodes has been used extensively throughout the industry for over fifteen years.
Based on this testing Uni-Patch considers its TENS, FES, NMES stimulating Bacted on as safe and effective as the Medtronic ComfortEase and the 3M Myocare Muscle Stimulation electrodes.