(150 days)
No
The summary describes a passive electrode device and its physical construction and testing, with no mention of AI or ML.
Yes
The device is intended to apply electrical stimulation current to the patient's skin for various therapeutic applications such as pain relief (TENS) and muscle re-education (NMES), directly indicating a therapeutic purpose.
No
Explanation: The device is described as cutaneous electrodes intended to apply electrical stimulation current to the patient's skin for various therapeutic purposes (e.g., TENS, EMS), not for diagnosing conditions.
No
The device description explicitly states it is a family of "cutaneous electrodes" which are physical hardware components applied to the skin. The summary details their construction and physical characteristics, not software functionality.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the AMPCARE 50709 Series electrodes are applied to the patient's skin to deliver electrical stimulation. This is an external application to the body, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: The text does not mention any analysis of biological samples, detection of biomarkers, or diagnostic purposes related to analyzing bodily fluids or tissues.
The device is a therapeutic device used for electrical stimulation, not a diagnostic device.
N/A
Intended Use / 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), 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.
Product codes
GXY
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's skin, neck muscle, pharyngeal
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K915333, K080386, K852267, K083756
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
AMPCARE
OCT 15 2012
5.510(k) SUMMARY - K121483
| Submitter: | AMPCARE, LLC
1201 Richardson Drive, Suite 280
Richardson, Texas 75080 | |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Russell Campbell
CEO / President
TEL: 682-561-2444
FAX: 817-923-1377
rcampbell@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 GXY
K080386 GXY
K852267 GXY
K083756 GXY | Labeltape Meditect, Inc. (Uni-Patch / Covidien)
Columbia Scientific Development, LLC
Axelgaard Manufacturing Company, Ltd.
SelectiveMed Components, Inc. (Guardian) |
| Device Description: | 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 | |
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
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