(207 days)
No
The device description and intended use focus on the conductive properties of the garment electrodes and their use with a TENS device. There is no mention of AI, ML, or any computational processing of signals or data.
No.
The electrodes are intended for use with a TENS stimulating device, which is therapeutic, but the electrodes themselves are conductive accessories, not the therapeutic device.
No
The device is described as an electrode for delivering stimulation signals, not for diagnosing conditions. It is intended for use with a TENS stimulating device.
No
The device description clearly describes physical components (conductive garments knitted from silver-coated Nylon yarn) and their physical properties (conductivity, elasticity, resistance). This indicates a hardware component, 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 deliver stimulation signals from a TENS device to the body surface for therapeutic purposes (pain relief, muscle stimulation, etc.). This is a direct interaction with the body for treatment, not for examining specimens from the body to diagnose or monitor a condition.
- Device Description: The device is a conductive garment designed to be worn on the body. It facilitates the delivery of electrical signals externally.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on specimens, or providing diagnostic information based on laboratory analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
Electrodes with silver conductive as Glove style, Wristbands Style, Wrist sleeve, Elbow Pads Style and Knee Pads Style, Elbow Sleeve, are intended for use with legally marketed TENS stimulating device. The electrodes with silver conductive will deliver stimulation signals generated by the stimulator to the body surface with which they are in contact. These body parts can include such as hands (gloves), feet (socks), wrist, elbow and knee.
Product codes
GXY
Device Description
Electrodes with silver conductive are conductive garments knitted from a continuous silver coated Nylon yarn into the form of gloves, socks, wrist sleeve and knee sleeve. The conductivity is derived from the silver content of the Nylon yarn. The electrodes are available in free size. The elongation property of the nylon yarn provides some elasticity which ensures firm skin contact. The electrodes can be used dry or wet when in contact with the skin. The entire surface of each electrode is very conductive having a resistance of less than 2ohms per inch. This low resistance provides low current density with uniform current distribution.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands (gloves), feet (socks), wrist, elbow and knee.
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)
Electrodes with snap / Electrodes with pigtail has been evaluated the safety and performance by lab bench testing as following:
- Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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 5, 2018
Shenzhen Konmed Technology Co., Ltd % Cecilia Ceng Manager Guangzhou GLOMED Biological Technology Co., Ltd. Suite 306, Kecheng Mansion, No.121 Science Road Guangzhou Science Park Guangzhou, Guangdong, 510006 China
Re: K171721
Trade/Device Name: Electrodes with silver conductive Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: Class II Product Code: GXY Dated: October 15, 2017 Received: October 30, 2017
Dear Ms. Ceng:
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
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); 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.
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) K171721
Device Name Electrodes with silver conductive
Indications for Use (Describe)
Electrodes with silver conductive as Glove style, Wristbands Style, Wrist sleeve, Elbow Pads Style and Knee Pads Style, Elbow Sleeve, are intended for use with legally marketed TENS stimulating device. The electrodes with silver conductive will deliver stimulation signals generated by the stimulator to the body surface with which they are in contact. These body parts can include such as hands (gloves), feet (socks), wrist, elbow and knee.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☐ For activities identified in 33 CFR 323.4(a)(2) | ☑ In waters where the Corps has regulatory authority |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
| Sponsor: | Shenzhen Konmed Technology Co., Ltd. |
|---|---|
| Subject Device: | Electrodes with silver conductive, model: KM-406: Glove Style; KM-407: Socks Style; |
| KM-408: Wristbands Style;KM-409: Elbow pads Style; KM-410 : Knee Pads Style | |
| Document Name: | FDA 510(k) Submission Report |
Chapter 5. 510(k) Summary
510(k) Summary
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Submitter's Information
510(k) Owner's Name: Shenzhen Konmed Technology Co., Ltd. Establishment Registration Number: Applying Address: 703B, Haide building A, Nanxin Road, Nanshan, China Tel: +86-020-66393598 Fax: +86-755-86704558 Contact Person: Tony (Manager) Email: 2519021651 @qq.com
Application Correspondent:
Contact Person: Ms. Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. Address: Suite 306, Kecheng Mansion, No.121 Science Road, Guangzhou Science Park, Guangzhou 510663, China Tel: +86-20-61099984 Email: regulatory@glomed-info.com
2. Subject Device Information
Trade Name: Electrodes with silver conductive Common Name: Cutaneous Electrode Review Panel: Neurology Model: KM-406: Glove Style: KM-407: Socks Style: KM-408: Wristbands Style: KM-409: Elbow pads Style: Product Code: GXY Regulation Class: II Regulation Number: 882.1320
3. Predicate Device Information
4
| Sponsor: | Shenzhen Konmed Technology Co., Ltd. |
|---|---|
| Subject Device: | Electrodes with silver conductive, model: KM-406: Glove Style; KM-407: Socks Style; |
| KM-408: Wristbands Style;KM-409: Elbow pads Style; KM-410 : Knee Pads Style | |
| Document Name: | FDA 510(k) Submission Report |
| Sponsor | Neurotron Medical, Inc |
|---|---|
| Device Name | Theraknit Garments |
| 510(k) Number | K053214 |
| Product Code | GXY |
| Regulation Number | 882.1320 |
| Regulation Class | II |
4. Device Description
Electrodes with silver conductive are conductive garments knitted from a continuous silver coated Nylon yarn into the form of gloves, socks, wrist sleeve and knee sleeve. The conductivity is derived from the silver content of the Nylon yarn. The electrodes are available in free size. The elongation property of the nylon yarn provides some elasticity which ensures firm skin contact. The electrodes can be used dry or wet when in contact with the skin. The entire surface of each electrode is very conductive having a resistance of less than 2ohms per inch. This low resistance provides low current density with uniform current distribution.
5. Intended Use / Indications for Use
Electrodes with silver conductive as Glove style, Wristbands Style, Elbow Pads Style and Knee Pads Style, are intended for use with legally marketed TENS stimulating device. The electrodes with silver conductive will deliver stimulation signals generated by the stimulator to the body surface with which they are in contact. These body parts can include such as hands (gloves), feet (socks), wrist, elbow and knee.
6. Test Summary
Electrodes with snap / Electrodes with pigtail has been evaluated the safety and performance by lab bench testing as following:
- Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards �
7. Comparison to predicate device and conclusion
The technological characteristics, features, specifications, and intended use of Electrode is substantially equivalent to the predicate devices quoted above.
The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
| Elements of
| Comparison | Subject Device | Predicate Device | Remark |
|---|---|---|---|
| Device Name and | |||
| Model | Electrodes with silver conductive | ||
| Model: | |||
| KM-406: Glove Style | |||
| KM-407: Socks Style | Theraknit Garments | -- |
5
| Sponsor: | Shenzhen Konmed Technology Co., Ltd. |
|---|---|
| Subject Device: | Electrodes with silver conductive, model: KM-406: Glove Style; KM-407: Socks Style; |
| KM-408: Wristbands Style;KM-409: Elbow pads Style; KM-410 : Knee Pads Style | |
| Document Name: | FDA 510(k) Submission Report |
| | KM-408: Wristbands Style
KM-409: Elbow pads Style
KM-410 : Knee Pads Style | | |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| 510(k) Number | Applying | K053214 | -- |
| Product Code | GXY | GXY | SE |
| Intended Use /
Indications for Use | Electrodes with silver conductive
as Glove style, Socks style,
Wristbands Style, Wrist sleeve,
Elbow Pads Style and Knee Pads
Style, Elbow Sleeve, are intended
for use with legally marketed
TENS stimulating device. The
electrodes with silver conductive
will deliver stimulation signals
generated by the stimulator to the
body surface with which they are
in contact. These body parts can
include such as hands (gloves),
feet (socks), wrist, elbow and
knee. | The TheralKnit Garment electrodes
are cutaneous to be used with
legally marketed TENS stimulating
device. The knitted garment
electrodes will deliver the
stimulation signals generated by the
stimulator to the body surface with
which they are in contact. These
body parts can include hand
(glove), feet (socks), elbow or knee
(sleeve), arm, leg, shoulder, back
(pads). | SE |
| Design (Shape) | KM-406: Glove Style
KM-407: Socks Style
KM-408: Wristbands Style
KM-409: Elbow pads Style
KM-410: knee Pads Style | Electrode A: Glove Style
Electrode B: Socks Style
Electrode C: Sleeve Style
Electrode D: Pads Style | SE
Note1 |
| Size | One size
Below is size for when without
stretched:
KM-406: 200 (cm2)
KM-407: 285 (cm2)
KM-408: 95 (cm2)
KM-409: 160 (cm2)
KM-410: 236 (cm2) | All sizes | SE
Note 1 |
| Conductive surface | One size
Below is size for when without
stretched:
KM-406: 400 (cm2)
KM-407: 570 (cm2)
KM-408: 190 (cm2)
KM-409: 320 (cm2)
KM-410: 472 (cm2) | All sizes | SE
Note 1 |
| Impedance
Parameters | 2 ohms resistance per inch | 7 ohms resistance per inch | SE
Notes 2 |
| Patient Contacting
Material | Silver plated nylon | Silver plated nylon | SE |
| Biocompatibility | Complied with ISO 10993-5, ISO
10993-10 | Complied with ISO 10993-5, ISO
10993-10 | SE |
6
| Sponsor: | Shenzhen Konmed Technology Co., Ltd. |
|---|---|
| Subject Device: | Electrodes with silver conductive, model: KM-406: Glove Style; KM-407: Socks Style; |
| KM-408: Wristbands Style;KM-409: Elbow pads Style; KM-410 : Knee Pads Style | |
| Document Name: | FDA 510(k) Submission Report |
| Washable or not | Washable | Washable | SE |
|---|---|---|---|
| Labeling | Confirm to 21 CFR Part 801 | Confirm to 21 CFR Part 801 | SE |
| Re-usable | For single patient | For single patient | SE |
Comparison in Detail(s):
Note 1:
Although the "Shape", " Conductive surface" and "Size" of subject device are different from the predicate devices, they are all complying with ISO 10993 requirements. So the differences of the function specifications will not raise any safety or effectiveness issue.
Note 2:
Although the "Impedance Parameters "are a little different from the predicate devices. The resistance of the knitted garment for both the subject device and the predicate devices are less than 7 ohms/inch which is very low relative to the delivery of the stimulation current. So they are both safe and effective.
Note 3:
" SE" means substantially equivalent.
Conclusion
The subject device Electrodes with silver conductive has all features of the predicate devices. The few differences do not affect the safety and effectiveness of the subject device. Thus, the subject device is substantially equivalent to the predicate devices.