(150 days)
AMPCARE 50709 Series of cutaneous electrodes are intended to be used to apply electrical stimulation current to the patient's skin. Example electrical stimulation current applications of these electrodes are: a) Transcutaneous Electrical Nerve Stimulation (TENS) for pain relief, b) Electrical muscle stimulation (EMS) for neck muscle stimulation, c) Functional electrical stimulation (FES), d) Galvanic stimulation, e) Microcurrent electrical nerve stimulation (MENS), f) Interferential (IF) stimulation, and g) Neuromuscular electrical stimulation (NMES), including for muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction.
The new AMPCARE 50709 Series Electrodes device is a family of cutaneous electrodes with various shapes and sizes, which are similar in design and construction to several predicate cutaneous electrodes. AMPCARE electrodes are non-sterile, self-adhering, and are for multiple use by a single patient, available with either pin/socket or snap connections. The new AMPCARE device is designed in accordance with the general design approach of the predicate devices referenced above. Specifically, each electrode in the AMPCARE 50709 Series is constructed with a non-conductive top layer, conductive center layer and adhesive bottom layer. The plastic liner at the bottom of the electrode is peeled away just prior to placement on the patient, consistent with the four predicate devices. The pin/socket connector version of the new device will be provided with a lead wire that is 21 CFR 898 compatible, containing a female recessed socket for electrical connection.
The provided document is a 510(k) summary for the AMPCARE 50709 Series Electrodes, which are cutaneous electrodes. This device is a Class II medical device, and the submission focuses on demonstrating substantial equivalence to predicate devices rather than proving a new clinical claim or performance. Therefore, the details requested in the prompt, which are typically associated with performance studies for algorithms or diagnostic devices, are not fully applicable to this type of submission.
However, I can extract the information relevant to the non-clinical testing performed to establish substantial equivalence.
Here's a breakdown based on the provided text, addressing the prompt's points where applicable:
1. Table of Acceptance Criteria and Reported Device Performance
For this 510(k) submission, the "acceptance criteria" are implied to be the performance demonstrated by the predicate devices. The "reported device performance" refers to the AMPCARE electrodes' performance in comparison to these predicates during non-clinical testing to demonstrate substantial equivalence.
| Performance Characteristic | Acceptance Criteria (Implied by Predicate Devices) | Reported Device Performance (AMPCARE 50709 Series) |
|---|---|---|
| Current Distribution | Uniform current distribution with no evidence of "hot spots" (as demonstrated by predicates) | Uniform current distribution with no evidence of "hot spots" |
| Electrical Impedance | Comparable to predicate device electrodes | Comparison testing performed; demonstrated suitability for use |
| Electrical Impedance Uniformity | Comparable to predicate device electrodes | Comparison testing performed; demonstrated suitability for use |
| Suitability for Electrical Stimulation Applications | Suitable for applications like TENS, EMS, FES, Galvanic, MENS, IF, NMES (as demonstrated by predicates) | Demonstrated suitability of use for each example of electrical stimulation current applications |
2. Sample size used for the test set and the data provenance:
The document does not specify the sample size for the test set (number of AMPCARE electrodes tested) or the data provenance (country of origin, retrospective/prospective). It only mentions "AMPCARE electrodes" generally.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to this type of non-clinical, substantial equivalence testing for a cutaneous electrode. There's no "ground truth" established by experts in the context of diagnostic or algorithmic performance. The testing involved physical and electrical properties of the electrodes.
4. Adjudication method for the test set:
This information is not applicable for the same reasons as point 3.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable. MRMC studies are relevant for diagnostic devices or AI algorithms where human interpretation is involved. This submission is for a physical electrode.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. This is not an algorithm or AI device.
7. The type of ground truth used:
For non-clinical testing of electrodes, the "ground truth" is typically defined by objective physical and electrical measurements (e.g., current distribution, impedance values) that meet established engineering standards or comparisons to legally marketed predicate devices. It is not expert consensus, pathology, or outcomes data in this context.
8. The sample size for the training set:
This information is not applicable. There is no "training set" as this is not an algorithmic or AI device requiring machine learning.
9. How the ground truth for the training set was established:
This information is not applicable for the same reasons as point 8.
Summary of Non-Clinical Testing Performed (from the document):
- Dispersion testing: Demonstrated "uniform current distribution with no evidence of 'hot spots'." This testing included predicate devices (Columbia K080386 and Uni-Patch K915333) for comparison.
- Electrical impedance testing: Performed on AMPCARE electrodes and predicate devices to demonstrate substantial equivalence and suitability for various electrical stimulation applications.
- Electrical impedance uniformity testing: Performed on AMPCARE electrodes and predicate devices to demonstrate substantial equivalence.
The conclusion of the submission is that AMPCARE considers its electrodes to be "substantially equivalent" to the predicate devices based on similarities in primary intended use, principles of operation, functional design, nonclinical test results, and established medical use. The FDA's letter concurs with this substantial equivalence determination.
{0}------------------------------------------------
AMPCARE
OCT 15 2012
5.510(k) SUMMARY - K121483
| Submitter: | AMPCARE, LLC1201 Richardson Drive, Suite 280Richardson, Texas 75080 | |
|---|---|---|
| Contact Person: | Russell CampbellCEO / PresidentTEL: 682-561-2444FAX: 817-923-1377rcampbell@ampcarellc.com | |
| Date Prepared: | May 17, 2012 revised September 13, 2012 | |
| Trade Name: | Reusable Cutaneous Electrode | |
| Common Name: | Cutaneous Electrode | |
| Classification Name: | GXY 882.1320 | Electrode, Cutaneous |
| Predicate Devices: | K915333 GXYK080386 GXYK852267 GXYK083756 GXY | Labeltape Meditect, Inc. (Uni-Patch / Covidien)Columbia Scientific Development, LLCAxelgaard Manufacturing Company, Ltd.SelectiveMed Components, Inc. (Guardian) |
| Device Description: | The new AMPCARE 50709 Series Electrodes device is a family of cutaneouselectrodes with various shapes and sizes, which are similar in design andconstruction to several predicate cutaneous electrodes. AMPCARE electrodes arenon-sterile, self-adhering, and are for multiple use by a single patient, available with |
AMPCARE 50709 Series of cutaneous electrodes are intended to be used to apply Statement of electrical stimulation current to the patient's skin. Example electrical stimulation Intended Use: current applications of these electrodes are: a) Transcutaneous Electrical Nerve Stimulation (TENS) for pain relief, b) Electrical muscle stimulation (EMS) for neck muscle stimulation, c) Functional electrical stimulation (FES), d) Galvanic stimulation, e) Microcurrent electrical nerve stimulation (MENS), f) Interferential (IF) stimulation, and g) Neuromuscular electrical stimulation (NMES), including for muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction.
either pin/socket or snap connections.
The new AMPCARE device is designed in accordance with the general design Summary of approach of the predicate devices referenced above. Specifically, each electrode in Technological the AMPCARE 50709 Series is constructed with a non-conductive top layer, Characteristics: conductive center layer and adhesive bottom layer. The plastic liner at the bottom of the electrode is peeled away just prior to placement on the patient, consistent with the four predicate devices. The pin/socket connector version of the new device will be provided with a lead wire that is 21 CFR 898 compatible, containing a female recessed socket for electrical connection.
{1}------------------------------------------------
AMPCARE
Summary of Non-Clinical Testing: Dispersion testing has demonstrated that the new AMPCARE device has uniform current distribution with no evidence of "hot spots" that could cause patient discomfort or injury. The Columbia (K080386) and Uni-Patch (K915333) electrodes were included in the dispersion testing for comparison purposes. Additional comparison testing to predicate device electrodes was performed to demonstrate suitability of use for each example of electrical stimulation current applications given in the Indications for Use. Both electrical impedance testing and electrical impedance uniformity testing was performed on AMPCARE electrodes as well as predicate device electrodes to demonstrate substantial equivalence.
Conclusion:
AMPCARE considers the AMPCARE 50709 Series Electrodes to be substantially equivalent to the predicate devices listed above. This conclusion is based on the similarities in primary intended use, principles of operation, functional design, nonclinical test results, and established medical use.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, topped by a bird-like shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 15 2012
AMPCARE, LLC % Ms. Diane Rutherford Submissions Manager Ken Block Consulting 1201 Richardson Drive, Suite 280 Richardson, TX 75080
Re: K121483
Trade/Device Name: AMPCARE 50709 Series Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Electrode, cutaneous Regulatory Class: Class II Product Code: GXY Dated: September 13, 2012 Received: September 14, 2012
Dear Ms. Rutherford:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must
{3}------------------------------------------------
Page 2- Ms. Diane Rutherford
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
12
Sincerely yours,
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
INDICATIONS FOR USE
510(k) Number: K121483
Device Name: AMPCARE 50709 Series Electrodes
Indications for Use:
AMPCARE 50709 Series of cutaneous electrodes are intended to be used to apply electrical stimulation current to the patient's skin. Example electrical stimulation current applications of these electrodes are:
a) Transcutaneous Electrical Nerve Stimulation (TENS) for pain relief
b) Electrical muscle stimulation (EMS) for neck muscle stimulation.
- c) Functional electrical stimulation (FES)
- d) Galvanic stimulation.
- e) Microcurrent electrical nerve stimulation (MENS).
- Interferential (IF) stimulation. 0
- g) Neuromuscular electrical stimulation (NMES), including for muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction.
Prescription Use X (21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDHR, Office of Device Evaluation (ODE)
Callaway
(Divisjon Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K121483
Page 1 of 1
§ 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).