(176 days)
Not Found
No
The device description and performance studies focus on the physical properties and electrical conductivity of the electrode, with no mention of AI or ML algorithms for data processing, analysis, or decision-making.
Yes
The device is described as an interface for electrical stimulators (TENS, EMS, etc.) which are used for therapeutic purposes (e.g., pain relief, muscle stimulation), indicating it facilitates therapy.
No
Explanation: The device is described as a "Self-Adhesive Electrode" intended for "transmitting electrical current" from "electrical stimulators" to the patient's skin. It acts as an interface for stimulation, not for diagnostic purposes.
No
The device description clearly outlines multiple physical components (conductive carbon film, adhesive, fabric, hydrogel, leadwire, snap button, etc.) and describes their material composition and assembly. This indicates a hardware device, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide a conductive interface for electrical stimulation devices (TENS, EMS, etc.) applied to the patient's skin. This is a therapeutic or physical therapy application, not a diagnostic one.
- Device Description: The description details the physical components and how the electrode functions to transmit electrical current. There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information.
- Lack of Diagnostic Elements: There are no mentions of analyzing biomarkers, detecting diseases, or providing any kind of diagnostic result.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This self-adhesive electrode does not perform any of these functions.
N/A
Intended Use / Indications for Use
Self-Adhesive Electrode is intended for use as a reusable, conductive adhesive interface between the patient's skin and the marketed electrical stimulators (i.e.TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF or IFC(Interferential current) or PGF (Pulsed Galvanic Stimulation) for transmitting electrical current, for OTC (Over-The-Counter) or Prescription use.
Product codes (comma separated list FDA assigned to the subject device)
GXY
Device Description
Self-Adhesive Electrode are composed of conductive carbon film and adhesive Electrodes composed of Aluminum foil film,Adhesive Electrodes manufactured by Roundwhale are multi-layer reusable, flexible structures composed of laminated materials commonly used in this application:
- Top layer: Fabric/Foam/ Tan fabric
- Middle layer: Conductive film (Silver coated Carbon Film/Carbon film/Aluminum foil film)
- Bottom layer: Biocompatible self-adhesive conductive hydrogel
- Connection: Leadwire/snap button/magnetic button
- double sides adhesive tape: Which is used for attaching the non-woven fabrics and conducting film
- Release film: Release film is a protective layer for the hydrogel.
The electrodes are designed for single-patient/multiple application use. Because of the adhesive nature of the biocompatible conductive hydrogel, no securing materials are required to secure the device to the patient's skin.
For the electrical connection, Roundwhale provides lead wire type and snap button/Magnetic button type:
- Leadwire assembly: The electrode is connected to the electrical stimulator by lead wire, at least 40 mm long wire with a standard connector: 0.08"/0.1"(2mm/2.5mm) diameter female socket connector with insulating outer. By design, the insulated outer jacket prevents the connection to earth or hazardous voltages. The lead wire assembly is in compliance with the requirements of FDA performance standard 21 CFR part 898 by testing under ANSI/A AMI ES60601-1, subclause 8.5.2.3.
- Snap button/Magnetic button assembly: With 2.5~5mm diameter male socket. The snap button and the magnetic button provide different types of physical contact with the source of stimulation current via spring tension or magnetic force among male and female connectors. Either method is similar to the lead wire connection providing the friction to create the physical contact.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
General [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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data includes "Non-Clinical Data".
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrate that the proposed device complies with the following standards:
Biocompatibility testing:
- Cytotoxicity -ISO 10993-5:2009
- Skin Sensitization -ISO 10993-23:2021
- Skin Irritation -ISO 10993-10:2021
Safety and EMC:
- ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021], Medical electrical equipment - Part 1: General requirementsfor basic safety and essential performance
The submitted sample(s) complied with the requirements of ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021], Cl.8.5.2.3
Bench Testing:
-
Electrical & Impedance Tests: Neutral Electrode (NE) contact impedance
The Self-Adhesive Electrode was tested to assure the current is equally distributed. The Self-Adhesive Electrode was also tested for Impedance to assure proper electrical connection to the skin.
The submitted sample(s) complied with the requirements of IEC 60601-2-2:2017 section 201.15.101.6 -
NE adhesion: (a) Pull test b) Conformability test
The Self-Adhesive Electrode was tested for initial adhesion force after using multiple times.
The submitted sample(s) complied with the requirements of IEC 60601-2-2:2017 section 201.15.101.7 -
Connector & Mechanical tests
The Self-Adhesive Electrode has a Snap or magnetic surface with the purpose to clamp the Self-Adhesive Electrode. This connection was tested to assure multiple use and also to assure the TENS stay fixed to the Self-Adhesive Electrode during use. -
Packaging tests
Real-Time Shelf Life Test Report
The Self-Adhesive Electrode was tested for storage conditions:
- The Self-Adhesive Electrode should not be stored at temperatures lower than 41°P(+5°C) or higher than 80.6°F (+27°C).
- Accelerated Aging
The Self-Adhesive Electrode was tested for accelerate aging in worst storage condition to assure within the expiration date the electrode function as expected.
- ASTM F1980 (Reapproved 2016), Standard guide for accelerated aging of sterile barrier systems for medical devices. (Sterility)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
adhesion testing (peel strength): ≥7N
A.C. Impedance:
§ 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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 19, 2023
Shenzhen Roundwhale Technology Co., Ltd. Amos Zou RA Manager 202,2/F, Building 27, Dafa Industrial Park, Longxi Community Longgang Street, Longgang District Shenzhen, Guangdong 518108 China
Re: K222252
Trade/Device Name: Self-adhesive Electrode Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: Class II Product Code: GXY Dated: December 19, 2022 Received: December 19, 2022
Dear Amos Zou:
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.
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,
Image /page/1/Picture/5 description: The image shows the name "Tushar Bansal -S" in a large, sans-serif font. The text is black and stands out against a background that appears to have a faint watermark or design. The name is likely the focus of the image, possibly indicating a person's name or a title.
for Heather Dean, PhD Assistant Director, Acute Injury 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
2
Indications for Use
510(k) Number (if known) K22252
Device Name Self-adhesive Electrode
Indications for Use (Describe)
Self-Adhesive Electrode is intended for use as a reusable, conductive adhesive interface between the patient's skin and the marketed electrical stimulators (i.e.TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF or IFC(Interferential current) or PGF (Pulsed Galvanic Stimulation) for transmitting electrical current, for OTC (Over-The-Counter) or Prescription use.
Type of Use (Select one or both, as applicable)
| X Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| X Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Department of Health and Human Services Centre of Device and Radiological Health Office of Device Evaluation Traditional 510(k) section
510(K) SUMMARY
as required by section 21 CFR 807.92
1. Submitter of 510(K):
Sponsor
| Company Name: | Shenzhen Roundwhale Technology Co., Ltd. |
|---|---|
| Address: | 202,2/F,Building 27, Dafa Industrial Park, Longxi community, Longgang street, |
| Longgang district, Shenzhen, China. | |
| Contact person: | Zeng Chunming |
| TEL: | +86-755-23212776 |
| FAX: | +86-755-23212776 |
| E-mail: | zcm@roovjoy.com |
| Date of Prepared: | 12/8/2022 |
Application Correspondent:
| Company Name: | Shenzhen Roundwhale Technology Co., Ltd. |
|---|---|
| Address: | 202,2/F,Building 27, Dafa Industrial Park, Longxi community, Longgang street, |
| Longgang district, Shenzhen, China. | |
| Contact person: | Amos Zou |
| TEL: | +86-15015249549 |
| E-mail: | Amos.zou@139.copm |
| Date of Prepared: | 12/8/2022 |
Proposed Device and code: 2.
| Device Trade Name: | Self-Adhesive Electrode |
|---|---|
| Model Series | Self-Adhesive Electrode with lead wire; |
| Self-Adhesive Electrode with Snap/Magnetic connector; | |
| Regulation Medical Specialty | Neurology |
4
| Product Code: | GXY |
|---|---|
| Regulation number | 21 CFR 882.1320 |
| Device Class | II |
| 510(k) | K222252 |
3. Predicate Device:
| 510(K) | Trade Name | Submitter | Product Code |
|---|---|---|---|
| K180865 | ZMI Self-adhesive | ZMI Electronics, Ltd. | GXY |
| K160138 | Adhesive Electrodes | GMDASZ Manufacturing Co., Ltd | GXY |
4. Description of Proposed Device:
Self-Adhesive Electrode are composed of conductive carbon film and adhesive Electrodes composed of Aluminum foil film,Adhesive Electrodes manufactured by Roundwhale are multi-layer reusable, flexible structures composed of laminated materials commonly used in this application:
| No. | Description | Material Composition |
|---|---|---|
| 1 | Top layer | Fabric/Foam/ Tan fabric |
| 2 | Middle layer | Conductive film (Silver coated Carbon Film/Carbon film/Aluminum foil film) |
| 3 | Bottom layer | Biocompatible self-adhesive conductive hydrogel |
| 4 | Connection | Leadwire/snap button/magnetic button |
| 5 | double sides | |
| adhesive tape | Which is used for attaching the non-woven fabrics and conducting film | |
| 6 | Release film | Release film is a protective layer for the hydrogel. |
The electrodes are designed for single-patient/multiple application use. Because of the adhesive nature of the biocompatible conductive hydrogel, no securing materials are required to secure the device to the patient's skin.
For the electrical connection, Roundwhale provides lead wire type and snap button/Magnetic button type:
-
Leadwire assembly:
The electrode is connected to the electrical stimulator by lead wire, at least 40 mm long wire with a standard connector: 0.08"/0.1"(2mm/2.5mm) diameter female socket connector with insulating outer. By design, the insulated outer jacket prevents the connection to earth or hazardous voltages. The lead wire assembly is in compliance with the requirements of FDA performance standard 21 CFR part 898 by testing under ANSI/A AMI ES60601-1, subclause 8.5.2.3. -
Snap button/Magnetic button assembly:
With 2.5~5mm diameter male socket. The snap button and the magnetic button provide different types of physical contact with the source of stimulation current via spring tension or magnetic force among male and female connectors. Either method is similar to the lead wire connection providing the friction to create the physical contact.
ર. Indications for Use
Self-Adhesive Electrode is intended for use as a reusable, conductive adhesive interface between the patient's skin and the marketed electrical stimulators (i.e.TENS (Transcutaneous Electrical Nerve Stimulation), EMS
5
(Electrical Muscular Stimulation), IF or IFC (Interferential current) or PGF (Pulsed Galvanic Stimulation) for transmitting electrical current, for OTC (Over-The-Counter) or Prescription use.
6. Technical and Performance
The following table compares the device to the predicate device with basic technological characteristics.
Comparison to predicate device 1#:
| Element of
Comparison | Subject Device | Predicate Device | Comm
ent |
|----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| 510(k) | K222252 | K180865 | N/A |
| Company | Shenzhen Roundwhale Technology Co., Ltd. | ZMI Electronics, Ltd. | N/A |
| Device Name | Self-adhesive Electrode | ZMI Self-adhesive Electrodes | N/A |
| Model name | ● Self-adhesive Electrode with leadwire;
● Self-adhesive Electrode with Snap
/Magnetic connector; | SAE Type | N/A |
| Shape | ● Round(50±0.5mm),
● Rectangular(5030±0.5mm),
● Square(5050±0.5mm,4040±0.5mm),
● Oval(4080±0.5mm) | ● Round, Rectangular, Square, Oval, and
Butterfly | similar
1# |
| Color | White | White, Red, Black, and Tan | similar
4# |
| Regulation
Number | 882.1320 | 882.1320 | Same |
| Product Code | GXY | GXY | Same |
| Classification
Name | Cutaneous electrode | Cutaneous electrode | Same |
| Indications for
Use | Self-Adhesive Electrode is intended for use
as a reusable, conductive adhesive
interface between the patient's skin and the
marketed electrical stimulators (i.e.TENS
(Transcutaneous Electrical Nerve
Stimulation), EMS (Electrical Muscular
Stimulation), IF or IFC(Interferential
current) or PGF (Pulsed Galvanic
Stimulation) for transmitting electrical
current, for OTC (Over-The-Counter) or
Prescription use. | ZMI Self-adhesive Electrodes are
intended for as a reusable, conductive
adhesive interface between the patient's
skin and the marketed electrical
stimulators (i.e. TENS (Transcutaneous
Electrical Nerve Stimulation), EMS
(Electrical Muscular Stimulation), IF
(Interferential) or PGF (Pulsed Galvanic
Stimulation) for transmitting electrical
current, for OTC (Over-The-Counter) or
Prescription use. | SE |
| OTC or
Prescription | OTC and Prescription | OTC and Prescription | Same |
| Target
Population | General [Adult] | General [Adult] | Same |
| Design
Feature | Six layers:
- Insulation backing material:
Fabric/Foam/Tan fabric - Conductive film: Aluminum foil film
/Carbon film/Carbon film coated with
silver/ - Conductive hydrogel
4.Connection
5.double sides adhesive tape
6.Release liner | Three layers:
1.Insulation backing material:
Fabric/Foam/Tan fabric
2.Conductive film: Aluminum foil
film/Carbon film/Carbon film coated with
silver/
3.Conductive hydrogel | similar
2# |
| Electrical
Connection | Leadwire
Snap button
Magnetic button | Leadwire
Snap button
Magnetic button | Same |
| Lead Wire
connector | .080"/0.1"(2mm/2.5mm) female socket
or Pin connector | .080" (2mm) female socket connector | similar
3# |
| Non-sterile | Non-sterile | Non-sterile | Same |
| Reusable | Reusable | Reusable | Same |
| Packaging | Re-sealable bag packed | Re-sealable bag packed | Same |
| Adhesive
Type | Self-adhesive | Self-adhesive | Same |
| Biocompatibi
lity | Complies with ISO10993 | Complies with ISO10993 | Same |
| adhesion
testing (peel
strength ) | ≥7N | ≥7N | Same |
| A.C.
Impedance |