(389 days)
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.
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.
The provided document describes the acceptance criteria and the study conducted to prove that TENS/FES/NMES electrodes meet these criteria.
Here's the breakdown as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Impedance Levels (at 1K-Hz) | "comparable to all the legally marketed electrodes identified above [Medtronic ComfortEase (K851303), and the 3M Myocare (K905539) Muscle Stimulation Electrodes]." |
| Skin Sensitivity | "passed the required skin sensitivity testing criteria as specified in the Tripartite Biocompatibility Guidance for Medical Devices." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size used for the impedance or skin sensitivity testing.
The provenance of the data is from Uni-Patch internally, comparing their electrodes to existing legally marketed devices. It appears to be prospective testing conducted by Uni-Patch to support their 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The ground truth for impedance was established by direct measurement and comparison to similar devices, not by expert consensus on interpretations. For skin sensitivity, the "Tripartite Biocompatability Guidance for Medical Devices" sets the standard, which is a regulatory guideline, not expert consensus on individual cases.
4. Adjudication Method for the Test Set
Not applicable, as the acceptance criteria were based on quantitative measurements (impedance) and compliance with established biocompatibility guidelines. There was no need for an adjudication method as would be used for subjective assessments.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The evaluation focused on the technical performance characteristics of the device itself (impedance and biocompatibility) rather than how human readers' performance might improve with AI assistance. This device is an electrode, not an AI-powered diagnostic tool.
6. If a Standalone Performance Study Was Done
Yes, a standalone performance study was done for the device. The reported impedance levels and skin sensitivity test results reflect the performance of the Uni-Patch electrodes themselves, independent of any human interaction beyond the application of the electrode for testing.
7. The Type of Ground Truth Used
- Impedance: The ground truth was established by comparing the measured impedance values of the Uni-Patch electrodes to the measured impedance values of "legally marketed electrodes" (Medtronic ComfortEase and 3M Myocare) which are presumed to be safe and effective based on their prior approval.
- Skin Sensitivity: The ground truth was established by conformance to "Tripartite Biocompatability Guidance for Medical Devices," which provides established criteria for biocompatibility.
8. The Sample Size for the Training Set
Not applicable. This device is an electrode, not a machine learning algorithm, therefore there is no "training set" in the context of AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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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.
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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
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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
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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.
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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.
§ 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).