(132 days)
Not Found
No
The device description and performance studies focus solely on the physical and electrical properties of the electrode pads, with no mention of AI or ML capabilities.
No.
The document states that SM Electrodes are accessories to transcutaneous electrical stimulation devices (like TENS and EMS devices), which are the therapeutic devices. The electrodes themselves "transmit electrical current" but do not generate the therapeutic effect directly; they act as a conduit for other devices.
No
The device, SM Electrodes, is described as an accessory intended to transmit electrical current to patient skin for use with "transcutaneous electrical stimulation devices" like TENS and EMS. These stimulation devices are typically used for therapeutic or muscle stimulation purposes, not for diagnosing medical conditions. The provided information focuses on the physical components, safety standards, and performance in transmitting electrical current, without mentioning any diagnostic capabilities or intended uses for detection, measurement, or analysis of physiological parameters for diagnostic purposes.
No
The device description clearly outlines physical components (top cover material, connector snap button, conductive carbon film, conductive hydrogel media, carrier line) and describes their function in transmitting electrical current. This indicates a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device Intended Use: The intended use of the SM Electrodes is to "transmit electrical current to patient skin for use with transcutaneous electrical stimulation devices." This is a direct interaction with the patient's body (in vivo), not an examination of specimens outside the body (in vitro).
- Device Description: The description details how the electrode transmits electrical current through conductive gel applied to the skin. This further confirms its in vivo application.
The device is an accessory for transcutaneous electrical stimulation devices, which are used for therapeutic purposes by applying electrical current to the skin. This falls under the category of medical devices used for treatment or stimulation, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
SM Electrodes are intended to transmit electrical current to patient skin for use with transcutaneous electrical stimulation devices. Some common types of the stimulation devices include, but are not limit to TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The electrode is for OTC (Over-The -Counter) or Prescription use.
Product codes (comma separated list FDA assigned to the subject device)
GXY
Device Description
SM Electrode pad is used as an accessory to the TENS or EMS device unit, which transmits electrical current to patient skin. The electrical current of electrode pad is first transmitted via the snap button then transmitted to the conductive gel which is adhered to patient skin.
SM Electrode Pad is composed of a top cover material, connector snap button, conductive carbon film, conductive hydrogel media, and a carrier line.
It is non-sterile and intended for single adult patient multiple application use. The SM Electrode has various shapes and sizes.
To connect with a nerve or muscle stimulator, this SM Electrode Pad has male snap button. The electrical pad connecting two separated gels together through a non-woven fabric has a pair of male snap button and the diameter is 3mm. The electrical pad with only one male snap button are to be used in pairs and the diameter of snap button is 4mm.
When not in use, the hydrogel face is covered by a PET(polyethylene terephthalate) carrier line.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient skin
Indicated Patient Age Range
adult
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
Bench tests were conducted on SM Electrodes to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- Shelf life testing per ASTM F1980:2016.
- ANSI AAMI ISO 10993-5:2009/(R) 2014, Biological evaluation of medical devices -- Part 5: Tests for In Vitro Cytotoxicity. (Biocompatibility)
- ISO 10993-10 Third Edition 2010-08-01, Biological evaluation of medical devices - Part 10: Tests for Irritation and Skin Sensitization. (Biocompatibility)
- ANSI AAMI IEC 60601-2-2:2009, Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
- Contact Impedance test per 201.15.101.6
- Adhesion test per 201.15.101.7
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical data was not including in this submission.
Bench tests were conducted on SM Electrodes to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- Shelf life testing per ASTM F1980:2016.
- ANSI AAMI ISO 10993-5:2009/(R) 2014, Biological evaluation of medical devices -- Part 5: Tests for In Vitro Cytotoxicity. (Biocompatibility)
- ISO 10993-10 Third Edition 2010-08-01, Biological evaluation of medical devices - Part 10: Tests for Irritation and Skin Sensitization. (Biocompatibility)
- ANSI AAMI IEC 60601-2-2:2009, Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
- Contact Impedance test per 201.15.101.6
- Adhesion test per 201.15.101.7
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.
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.
Not Found
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left, and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square. The full name of the agency is "U.S. Food & Drug Administration".
March 26, 2019
Hong Qiangxing (Shen Zhen) Electronics Limited % Doris Dong Manager Shanghai CV Technology Co., Ltd. Room 903, No. 19 Dongbao Road, Songjiang Area Shanghai, 201613 China
Re: K183154
Trade/Device Name: SM Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: March 8, 2019 Received: March 21, 2019
Dear Doris Dong:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Vivek J. Pinto -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K183154
Device Name SM Electrodes
Indications for Use (Describe)
SM Electrodes are intended to transmit electrical current to patient skin for use with transcutaneous electrical stimulation devices. Some common types of the stimulation devices include, but are not limit to TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The electrode is for OTC (Over-The -Counter) or Prescription use.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
বী।
[Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
[As required by 21 CFR 807.92]
1. Submission Information:
| 510(k) Number: | K183154 |
|---|---|
| Date: | March 26, 2019 |
| Type of 510(k) Submission: | Traditional |
| Basis for 510(k) Submission: | New device |
| Submitter/Manufacturer: | Hong Qiangxing(Shen Zhen) Electronics Limited |
| 4F, Jingcheng Building, Xicheng Industrial Zone, Xixiang Road, Bao'an | |
| District, Shenzhen City, Guangdong, China 518126 | |
| Contactor: | Doris Dong (Consultant) |
| Shanghai CV Technology Co., Ltd. | |
| Rm. 903, No. 19 Dongbao Rd., Songjiang Area, Shanghai, 201613 China | |
| E-mail: doris_d@126.com | |
| Tel: 86 21-31261348 |
2. Device Description:
| Proprietary Name: | SM Electrodes |
|---|---|
| Common Name: | Cutaneous electrode |
| Classification Name: | Cutaneous electrode |
| Product Code: | GXY |
| Device Class: | II |
| Regulation Number: | 21 CFR 882.1320 |
| Review Panel: | Neurology |
| Indications for use: | SM Electrodes are intended to transmit electrical current to patient skin for |
| use with transcutaneous electrical stimulation devices. Some common | |
| types of the stimulation devices include, but are not limit to TENS | |
| (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical | |
| Muscular Stimulation). The electrode is for OTC (Over-The -Counter) or | |
| Prescription use. | |
| Device Description: | SM Electrode pad is used as an accessory to the TENS or EMS device |
| unit, which transmits electrical current to patient skin. The electrical | |
| current of electrode pad is first transmitted via the snap button then | |
| transmitted to the conductive gel which is adhered to patient skin. |
SM Electrode Pad is composed of a top cover material, connector snap
button, conductive carbon film, conductive hydrogel media, and a carrier
line.
It is non-sterile and intended for single adult patient multiple application
use. The SM Electrode has various shapes and sizes.
To connect with a nerve or muscle stimulator, this SM Electrode Pad has
male snap button. The electrical pad connecting two separated gels
together through a non-woven fabric has a pair of male snap button and the
diameter is 3mm. The electrical pad with only one male snap button are to |
4
be used in pairs and the diameter of snap button is 4mm.
When not in use, the hydrogel face is covered by a PET(polyethylene terephthalate) carrier line.
3. Predicate Device Identification
K152648--Ennova Self-adhesive Electrode--January 12, 2016 K182111--DL Adhesive Electrode--January 17, 2019
4. Non-Clinical Test Conclusion
Bench tests were conducted on SM Electrodes to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
-
Shelf life testing per ASTM F1980:2016.
-
ANSI AAMI ISO 10993-5:2009/(R) 2014, Biological evaluation of medical devices -- Part 5: Tests for In Vitro Cytotoxicity. (Biocompatibility)
-
ISO 10993-10 Third Edition 2010-08-01, Biological evaluation of medical devices - Part 10: Tests for Irritation and Skin Sensitization. (Biocompatibility)
-
ANSI AAMI IEC 60601-2-2:2009, Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
Contact Impedance test per 201.15.101.6
Adhesion test per 201.15.101.7
5. Substantial Equivalent Based on Assessment of Clinical Performance Data:
Clinical data was not including in this submission.
| 6. Substantially Equivalent Comparison Conclusion | |||
|---|---|---|---|
| New Device | Predicate Device 1 | Predicate Device 2 | |
| 501(k) number | K183154 | K152648 | K182111 |
| Trade Name: | SM Electrodes | Ennova Self-adhesive Electrode | DL Adhesive Electrode |
| Common | |||
| Name: | Cutaneous electrode | Cutaneous electrode | Cutaneous electrode |
| Classification | |||
| Name: | Cutaneous electrode | Cutaneous electrode | Cutaneous electrode |
| Product Code: | GXY | GXY | GXY |
| Regulation | |||
| Number: | 882.1320 | 882.1320 | 882.1320 |
| Medical | |||
| Specialty: | Neurology | Neurology | Neurology |
| Device Class: | II | II | II |
| Indications for | |||
| use: | SM Electrodes are intended to | ||
| transmit electrical current to | |||
| patient skin for use with | |||
| transcutaneous electrical | Ennova Self-adhesive Electrode | ||
| is intended to transmit electrical | |||
| current to patient skin for use | |||
| with transcutaneous electrical | DL Adhesive Electrode is | ||
| intended to transmit electrical | |||
| current to patient skin for use | |||
| with transcutaneous electrical |
6. Substantially Equivalent Comparison Conclusion
5
SM Electrodes; Hong Qiangxing(Shen Zhen) Electronics Limited
| Hong Qiangxing(Shen Zhen) Electronics Limited | ||||||
|---|---|---|---|---|---|---|
| stimulation devices. Some | ||||||
| common types of the stimulation | ||||||
| devices include, but are not limit | ||||||
| to TENS (Transcutaneous | ||||||
| Electrical Nerve Stimulation) and | ||||||
| EMS (Electrical Muscular | ||||||
| Stimulation). The electrode is for | ||||||
| OTC (Over-The -Counter) or | ||||||
| Prescription use. | stimulation devices. Some | |||||
| common types of the stimulation | ||||||
| devices include, but are not limit | ||||||
| to TENS (Transcutaneous | ||||||
| Electrical Nerve Stimulation) and | ||||||
| EMS (Electrical Muscular | ||||||
| Stimulation). The electrode is for | ||||||
| OTC (Over-The -Counter) or | ||||||
| Prescription use. | stimulation devices. Some | |||||
| common types of the stimulation | ||||||
| devices include, but are not | ||||||
| limited to TENS | ||||||
| (Transcutaneous Electrical Nerve | ||||||
| Stimulation) and EMS | ||||||
| (Electrical Muscular | ||||||
| Stimulation). The electrode is for | ||||||
| OTC (Over-The -Counter) or | ||||||
| Prescription use. | ||||||
| Target | ||||||
| population: | Single patient use and multiple | |||||
| application | Single patient use and multiple | |||||
| application | Single patient use and multiple | |||||
| application | ||||||
| Prescription | ||||||
| use | OTC and Prescription use | OTC and Prescription use | OTC and Prescription use | |||
| Design (shape | ||||||
| & connection): | Round, rectangle, butterfly, oval, | |||||
| according to customized | ||||||
| specification. | ||||||
| Snap button with male snap | ||||||
| connector | Round, rectangle, oval, butterfly | |||||
| according to customized | ||||||
| specification. | ||||||
| Lead wire with female socket, or | ||||||
| snap button with male snap | ||||||
| connector | Round, rectangle, butterfly, oval, | |||||
| according to customized | ||||||
| specification. | ||||||
| Lead wire with female socket, or | ||||||
| snap button with male snap | ||||||
| connector | ||||||
| Materials: | - Top cover material |
- Electrically conductive carbon
cloth - Biocompatible conductive
hydrogel - Electrode carrier liner | | - Top cover material
- Electrically conductive carbon
cloth - Biocompatible conductive
hydrogel - Electrode carrier liner | | - Top cover material
- Electrically conductive carbon
cloth - Biocompatible conductive
hydrogel - Electrode carrier liner | |
| Electrode Pad
Size | Round | Min.Ø20mm;
Max.Ø70mm | Round | Min.Ø32mm;
Max.Ø70mm | Round | Min.Ø18mm;
Max.Ø85mm |
| | Rectangle | Min.50×50mm;
Max.170×100mm | Rectangle | Min.40×40mm;
Max.100×130mm | Rectangle | Min.40×40mm;
Max.40×350mm |
| | Oval | Min.43×30mm;
Max.120×76mm | Oval | Min.50×120mm;
Max.100×240mm | Oval | 50×78mm |
| | Butterfly | 165×79mm | Butterfly | Min.55×75mm;
Max.95×165mm | Butterfly | Min.93×150mm;
Max.110×150mm |
| Connector retention force | | | | | | |
| --Lead wire
with female
socket | NA | | 10.80N | | 10.85N | |
| --snap button
with male snap
connector | 9.62N | | 9.60N | | 9.61N | |
| Hydrogel
thickness | 1.0mm ± 0.2mm | | 1.0mm ± 0.2mm | | 1.0mm ± 0.2mm | |
| Standards met: | 1. Impedance test, | | 1. Lead wires test per 8.5.2.3 of | | 1.Lead wires test per8.5.2.3 of | |
| | Conformability test and Fluid | | | | | |
6
SM Electrodes; Hong Qiangxing(Shen Zhen) Electronics Limited
| | tolerance test per 201.15.101.6
and 201.15.101.7 of ANSI AAMI
IEC 60601-2-2:2009;
2. Impedance Test (Dispersion
Test) per FDA requirement;
3. Peel strength test according to
manufacturer's requirement;
4. Shelf life test per ASTM
F1980:2016; | 2. Impedance test,
Conformability test and Fluid
tolerance test per 201.15.101.6
and 201.15.101.7 of IEC
60601-2-2:2009
3. Impedance Test (Dispersion
Test) per FDA requirement;
4. Peel strength test according to
manufacturer's requirement;
5. Shelf life test per ASTM
F1980:2011; | 2.Impedance test, Conformability
test and Fluid tolerance test per
201.15.101.6 and 201.15.101.7
of ANSI AAMI IEC
60601-2-2:2017
3. Impedance Test (Dispersion
Test) per FDA requirement;
4. Peel strength test according to
manufacturer's requirement;
5.Shelf life test per ASTM
F1980:2016; |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibili
ty | ISO10993-5:2009;
ISO10993-10:2010 | ISO10993-5:2009;
ISO10993-10:2010 | ISO10993-5:2009;
ISO10993-10:2010 |
| Sterility
Status: | Non-sterile | Non-sterile | Non-sterile |
| Electrical
safety | NA | Lead wire meets Clause 8.5.2.3
of AAMI/ANSI ES60601-1 | Lead wire meets Clause 8.5.2.3
of AAMI/ANSI ES60601-1 |
| Other
Performance | Good electrical conductivity,
good adhesive property | Good electrical conductivity,
good adhesive property | Good electrical conductivity,
good adhesive property |
The Conclusions:
Based on the successful biocompatibility testing, electrode current distribution test results, SM Electrodes are safe and effective when used as an interface between a user's skin and an approved nerve and muscle stimulation device. The conclusions drawn from the non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as the legally marketed devices identified in the submission. Thus the subject device is substantially equivalent to the predicate devices.