(196 days)
No
The summary describes a passive electrode for electrical stimulation and does not mention any AI or ML components or functions.
No
The device is described as a "disposable, conductive adhesive interface" intended for use with electrical stimulators (TENS and EMS). It is an accessory to apply electrical stimulation and does not perform the therapeutic action itself.
No
Explanation: The device is described as an "adhesive interface" and "disposable, conductive adhesive interface" intended to apply electrical stimulation current, not to diagnose a condition. It is used in conjunction with TENS and EMS devices, which are therapeutic, not diagnostic.
No
The device description clearly states it is an "adhesive electrode" which is a physical component, not software. The performance studies also focus on physical properties like biocompatibility, shelf life, and pull tests.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for applying electrical stimulation current to the patient's skin using external electrical stimulators (TENS and EMS). This is a therapeutic or physical therapy application, not a diagnostic test performed on samples taken from the body.
- Device Description: The description reinforces that the device is placed on the skin to deliver electrical pulses. This is an external application, not an in vitro test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's condition based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The proposed device is intended for use as the disposable, conductive interface between the patient's skin and the electrical stimulator to apply electrical stimulation current, and is intended to be used with marketed electrical stimulator, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation).
Product codes
GXY
Device Description
The adhesive electrode is placed onto human skin and connected with electrical stimulators by lead wires. The electrical pulses are passed across the intact surface of the skin to activate the underlying nerves.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
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
Biocompatibility testing: Biocompatibility of the adhesive electrode was evaluated in accordance with ISO 10993-1:2018 for the body contact category of "Surface-contacting devices: Skin" with a contact duration of "Limited (
§ 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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.
August 31, 2021
Shaoxing Yingtuo Healthcare Co., Ltd. Haze XU Management Representative, Quality Department NO.176 Shungeng Road, Baiguan Street, Shangyu Area Shaoxing City, Zhejiang Province 312300 China
Re: K210448
Trade/Device Name: adhesive electrode Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: July 29, 2021 Received: August 5, 2021
Dear Haze XU:
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/cfpm/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.
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
1
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Heather L. Dean -S
Heather Dean, PhD Assistant Director. Acute Injurv Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210448
Device Name adhesive electrode
Indications for Use (Describe)
The proposed device is intended for use as the disposable, conductive interface between the patient's skin and the electrical stimulator to apply electrical stimulation current, and is intended to be used with marketed electrical stimulator, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation).
| 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) |
||X| Prescription Use (Part 21 CFR 801 Subpart D)
|X| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
I Submitter
| 510(K) Number: | K210448 |
|---|---|
| Device submitter: | Shaoxing Yingtuo Healthcare Co.,Ltd. |
| NO.176 Shungeng Road, Baiguan Street, Shangyu | |
| Area, Shaoxing City, Zhejiang Province, P.R. CHINA. |
- Contact person: Haze XU Phone:+86 13735374377 E-mail: haze@sxyingtuo.com
II Device
Trade Name of Device: adhesive electrode Common name: Cutaneous Electrode Classification: Class II, 21 CFR 882.1320 Product Code: GXY
III Predicate Device
| Trade name: | TENS Electrodes |
|---|---|
| Common name: | Cutaneous Electrode |
| Classification: | Class II, 21 CFR 882.1320 |
| Product Code: | GXY |
| Premarket Notification: | K160081 |
| Company name: | CATHAY MANUFACTURING CORP |
IV Device description
The adhesive electrode is placed onto human skin and connected with electrical stimulators by lead wires. The electrical pulses are passed across the intact surface of the skin to activate the underlying nerves.
V Indications for use
The proposed device is intended for use as the disposable, conductive adhesive interface between the patient's skin and the electrical stimulator to apply electrical stimulation current, and is intended to be used with marketed electrical stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation).
VI Comparison of technological characteristics with the predicate devices
The adhesive electrode has the same intended use and principle operation, the technology, design and performance specifications are either identical or substantially equivalent to existing legally marketed predicate devices. The differences between the adhesive electrode and predicate devices do not alter suitability of the proposed device for its intended use.
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| | adhesive electrode
(subject device) | TENS Electrodes
K160081 (predicate device) | Discussion |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Device feature | (subject device) | K160081 (predicate device) | Discussion |
| Intended use | The proposed device is intended for
use as the disposable, conductive
adhesive interface between the
patient's skin and the electrical
stimulator to apply electrical
stimulation current, and is intended
to be used with marketed electrical
stimulators, i.e. TENS
(Transcutaneous Electrical Nerve
Stimulation) and EMS (Electrical
Muscular Stimulation). | The proposed device is
intended for use as the
disposable, conductive
adhesive interface between
the patient's skin and the
electrical stimulator to apply
electrical stimulation
current, and is intended to be
used with marketed electrical
stimulators, i.e. TENS
(Transcutaneous Electrical
Nerve Stimulation) and EMS
(Electrical Muscular
Stimulation). It's for OTC
use | Substantially
equivalent. |
| Surface area | (Length * width):
20mm40mm, 22mm22mm
25mm35mm, 25mm42mm
25mm60mm, 30mm40mm
30mm50mm, 30mm60mm
30mm70mm, 32mm32mm
40mm40mm, 40mm50mm
40mm60mm, 40mm70mm
40mm80mm, 40mm90mm
40mm100mm, 40mm110mm,
40mm120mm, 40mm130mm,
45mm45mm, 45mm55mm
45mm60mm, 45mm70mm
45mm80mm, 45mm90mm
45mm100mm, 48mm48mm
48mm86mm, 50mm50mm
50mm60mm, 50mm70mm
50mm80mm, 50mm90mm
50mm100mm, 50mm110mm
50mm120mm, 50mm130mm
55mm55mm, 55mm65mm
55mm70mm, 55mm75mm
55mm80mm, 55mm90mm
55mm100mm, 55mm110mm | Largest model:
CM100180FC (Rectangle
shape: 100 x 180 mm);
Smallest model:
CM2222FC(square shape: 22
x 22 mm);
Irregular representative:
CM2542YC(crescent ); | Substantially
equivalent.
The
surface area of
the device does
not
alter
its
intended use. |
| | adhesive electrode
(subject device) | TENS Electrodes
K160081 (predicate device) | Discussion |
| Device feature | 55mm120mm, 55mm130mm
60mm60mm, 60mm70mm
60mm80mm, 60mm90mm
60mm100mm, 60mm110mm
60mm120mm, 60mm130mm
65mm65mm, 70mm70mm
70mm80mm, 70mm90mm
70mm100mm, 70mm110mm
70mm120mm, 70mm130mm
75mm75mm, 75mm125mm
80mm80mm, 80mm100mm
80mm110mm, 80mm120mm
80mm130mm, 85mm85mm
85mm180mm, 90mm90mm
90mm120mm, 90mm130mm
100mm120mm, 100mm125mm
100mm130mm, 100mm140mm
100mm180mm, 105mm155mm
124mm*130mm. | | |
| | (Diameter):
22mm, 25mm, 32mm, 40mm,
45mm, 50mm, 55mm, 60mm,
65mm, 70mm, 75mm, 80mm,
85mm, 90mm | | |
| Components | Substrate/Wire/Hydrogel/Scrim/Conductive Fiber/Carbon conductive film/Liner | Substrate/Wire/Hydro-gel/Scrim/Conductive
Fiber/Carbon conductive film/Liner | Identical |
| Materials | Non-woven Fabric + Adhesive | Non-woven Fabric +
Adhesive | Identical |
| | Wire and Terminal coated PVC | Wire and Terminal coated
PVC | Identical |
| | Hydrogel | Hydro-gel | Identical |
| | PET Fabric | PET Fabric | Identical |
| | Carbon fiber + Reinforcing fiber | Carbon fiber + Reinforcing
fiber | Identical |
| | Poly-isobutylene, Carbon Black | Poly-isobutylene, Carbon... | Substantially |
| Device feature | adhesive electrode
(subject device) | TENS Electrodes
K160081 (predicate device) | Discussion |
| | Graphite, Additives | Black | equivalent. |
| Current(mArms) | 58.81 | Not Publicly Available | / |
| Charge( $ \mu $ C) | 17.40 | Not Publicly Available | / |
| power
densities(mW/mm2) | 448.32 | Not Publicly Available | / |
| Biocompatibility | Comply with ISO 10993 series | Comply with ISO 10993 series | Identical |
| Sterility | Non-sterile | Non-sterile | Identical |
| Re-usable | For single patient | For single patient | Identical |
| Shelf life | 3 years | 2 years | Substantially
equivalent. |
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VII Summary of Non-clinical tests:
Biocompatibility testing
Biocompatibility of the adhesive electrode was evaluated in accordance with ISO 10993-1:2018 for the body contact category of "Surface-contacting devices: Skin" with a contact duration of "Limited (