(210 days)
XinBo Electrodes (Model: Neck Therapy Pro - II; Neck Therapy Pro - II; Neck Therapy Pro - III, Neck Therapy Pro - IV) are cutaneous electrodes to be used with legally marketed TENS stimulating devices for which stimulation of the back of the neck and upper back is appropriate. They will deliver the stimulation signals generated by the back of the neck, upper back and shoulder surface areas with which they are in contact.
The electrodes can be use together with any legally marketed TENS stimulating devices for which stimulation of the back of the neck and upper back is appropriate. For the silver coated Nylon yarn electrodes, they can be used dry or wet when in contact with the skin. The entire surface of each electrodes is very conductive having a resistance of less than 7 ohms per inch; For the model "Neck Therapy Pro - III", conductive silicone rubber having a resistance of less than 7 ohms per inch, these low resistance provides low current density with uniform current distribution.
The provided text describes XinBo Electrodes, a device classified as a cutaneous electrode (product code GXY, regulation number 882.1320), and its 510(k) submission for demonstrating substantial equivalence to legally marketed predicate devices.
However, the document does not contain information about the acceptance criteria or a study proving the device meets these criteria in the context of an AI/ML medical device where performance metrics like accuracy, sensitivity, or specificity would typically be evaluated against a ground truth established by experts.
The document details the following about the XinBo Electrodes:
- Device Type: Cutaneous electrodes for use with TENS stimulating devices.
- Intended Use: Deliver stimulation signals to the back of the neck, upper back, and shoulder surface areas.
- Testing Conducted:
- Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards.
- Electrode wire compliance with 21 CFR 898 by IEC 60601-1 (version 3.1, clause 8.5.2.3) evaluation.
- Performance test (hot spots verification test) according to manufacturer self-requirements.
- Usability study according to IEC 60601-1-6, IEC 62366, and "FDA Guidance for Applying Human Factors and Usability Engineering to Medical Devices."
The document focuses on the physical and electrical safety and performance of the electrodes themselves, rather than the performance of an AI/ML algorithm or a diagnostic tool. Therefore, the requested information about acceptance criteria for AI/ML performance, study design with test sets, expert ground truth, MRMC studies, or standalone algorithm performance is not applicable or present in this document.
The document confirms that the device is "Substantial Equivalent" to predicate devices based on technological characteristics, features, specifications, materials, and intended use, and that the conducted bench testing and usability studies found no new safety or effectiveness issues.
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April 19, 2018
Guangzhou Xinbo Electronic Co., Ltd. % Ms. Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. Suite 306, Kecheng Mansion, No.121 Science Road Guangzhou Science Park Guangzhou, Guandong, 510006 Cn
Re: K172887
Trade/Device Name: XinBo Electrode (Model: Neck Therapy Pro - I. Neck Therapy Pro - II. Neck Therapy Pro - III, Neck Therapy Pro - IV) Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: January 14, 2018 Received: January 19, 2018
Dear Ms. Cassie Lee:
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.
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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); 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 medical devices and radiation-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
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Indications for Use
510(k) Number (if known) K172887
Device Name XinBo Electrodes
Indications for Use (Describe)
XinBo Electrodes (Model: Neck Therapy Pro - II; Neck Therapy Pro - II; Neck Therapy Pro - III, Neck Therapy Pro - IV) are cutaneous electrodes to be used with legally marketed TENS stimulating devices for which stimulation of the back of the neck and upper back is appropriate. They will deliver the stimulation signals generated by the back of the neck, upper back and shoulder surface areas with which they are in contact.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Indoor Use (Applicable to OFF!® Insect Repellents Only) | |
| Outdoor Use (Applicable to OFF!® Insect Repellents Only) |
| | 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
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: Guangzhou Xinbo Electronic Co., Ltd. Establishment Registration Number: K172887 Address: 2nd Building, Juntuo Industry Park, XinqyeDadao, Nancun Town, Panyu District, Guangzhou City, Guangdong Province, China Contact Person: Li Huifang (Manager) Email: drtvsammy@hotmail.com
Application Correspondent:
Contact Person: Ms. Cecilia Ceng / 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: XinBo Electrodes Common Name: Cutaneous Electrode Review Panel: Neurology Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV Regulation Number: 882.1320
3. Predicate Device Information
| Sponsor | Neurotron Medical, Inc | DRTV Asia Ltd. | AMPCAXE, LLC |
|---|---|---|---|
| Device Name | Theraknit Garments | Dr-Ho's Foot PadElectrode | AMPCARE 50709Series Electrodes |
| 510(k) Number | K053214 | K151693 | K121483 |
| Product Code | GXY | GXY | GXY |
| RegulationNumber | 882.1320 | 882.1320 | 882.1320 |
| Regulation Class | II | II | II |
4. Device Description
The electrodes can be use together with any legally marketed TENS stimulating devices for which stimulation of the back of the neck and upper back is appropriate. For the silver coated Nylon yarn electrodes, they can be used dry or wet when in contact with the skin. The entire surface of each
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electrodes is very conductive having a resistance of less than 7 ohms per inch; For the model "Neck Therapy Pro - III", conductive silicone rubber having a resistance of less than 7 ohms per inch, these low resistance provides low current density with uniform current distribution.
5. Intended Use / Indications for Use
XinBo Electrodes (Models: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV) are cutaneous electrodes to be used with legally marketed TENS stimulating devices for which stimulation of the back of the neck and upper back is appropriate. They will deliver the stimulation signals generated by the stimulator to the back of the neck, upper back and shoulder surface areas with which they are in contact.
6. Test Summary
XinBo Electrodes have been evaluated the safety and performance by lab bench testing as following:
- Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards �
- The electrode wire is compliance with 21 CFR 898 by IEC 60601-1 (version 3.1, clause 8.5.2.3) � evaluation.
- � Performance test (hot spots verification test) according to manufacturer self-requirements.
- � Usability study according to IEC 60601-1-6, IEC 62366, and "FDA Guidance for Applying Human Factors and Usability Enqineering to Medical Devices"
7. Comparison to predicate device and conclusion
The technological characteristics, features, specifications, materials, and intended use of subject device are substantially equivalent to the predicate devices.
The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
| Elements ofComparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Predicate Device 3 | Remark |
|---|---|---|---|---|---|
| Device Nameand Model | XinBo Electrodes(Models: NeckTherapy Pro - I, NeckTherapy Pro - II, NeckTherapy Pro - III, NeckTherapy Pro - IV) | Theraknit Garments | Dr-Ho's Foot PadElectrode | AMPCARE 50709Series Electrodes | -- |
| 510(k) Number | K172887 | K053214 | K151693 | K121483 | -- |
| Product Code | GXY | GXY | GXY | GXY | SE |
| OTC or Rx-only | OTC | Rx-only | OTC | Rx-only | SE |
| Intended Use /Indications forUse | XinBo Electrodes(Models: NeckTherapy Pro - I, NeckTherapy Pro - II, NeckTherapy Pro - III, NeckTherapy Pro - IV) arecutaneous electrodes | The TheraKnitGarment Electrodesare cutaneouselectrodes to be usedwith legally marketedTENS stimulatingdevice. The knitted | The CutaneousElectrodes, "Dr-Ho'sFoot Pad Electrodes",are intended to beused with legallymarketed electricalstimulating devices | AMPCA RE 50709Series of cutaneouselectrodes areintended to be used toapply electricalstimulation current tothe patient's skin. | SE |
| to be used with legallymarketed TENSstimulating devices forwhich stimulation ofthe back of the neckand upper back isappropriate. They willdeliver the stimulationsignals generated bythe stimulator to theback of the neck,upper back andshoulder surfaceareas with which theyare in contact. | garment electrodeswill deliver thestimulation signalsgenerated by thestimulator to the bodysurface with whichthey are in contact.These body parts caninclude hand (glove),feet (socks), elbow orknee (sleeve), arm,leg, shoulder, back(pads). | such astranscutaneouselectrical nervestimulators orpowered musclestimulators. Thecutaneous electrodeswill deliver thestimulation signalsgenerated by thestimulator to thebottom of the feetwhich they are incontact with. | Example electricalstimulation currentapplications of theseelectrodes are:a) TranscutaneousElectrical NerveStimulation (TENS)for pain reliefb) Electrical musclestimulation (EMS) forneck musclestimulation.c) Functionalelectrical stimulation(FES)d) Galvanicstimulatione) Microcurrentelectrical nervestimulation (MENS)J) Interferential (IF)stimulationg) Neuromuscularelectrical stimulation(NMES), including formuscle re-educationby application ofexternal stimulation tothe musclesnecessary forpharyngealcontraction. | ||
| Body Parts toUse on | Back of the neck,upper back andshoulder | Hand, feet, elbow orknee, arm, leg,shoulder, back | Bottom of the feet | Back of the neck | SE |
| Design(Shape) | Model A: NeckTherapy Pro - IModel B: NeckTherapy Pro - IIModel C: NeckTherapy Pro - IIIModel D: NeckTherapy Pro - IV | Electrode A: GloveStyleElectrode B: SocksStyleElectrode C: SleeveStyleElectrode D: PadsStyle | Electrode A: foot-shaped Electrode | SENote 1 | |
| Dimensions | Model A:For the whole product:260 x 297.8 mmFor only the electronicpads part: 4electrodes on eachmodels, two of themare: 65 mm indiameter, the othertwo of them areirregularly: 75 mm indiameter and about105 mm longModel B:For the whole product: | SENote 1 | |||
| 208 x115 x110 mmFor only the electronicpads part: 2electrodes on eachmodels, eachelectrode is: 50 mm indiameterModel C:For the whole product:264.2 x 298.5 mmFor each theelectronic pads part: 6electrodes on eachmodels, eachelectrode is: 48 x26.2mm²Model D:For the whole product:300x 450 x 110mmFor each electronicpads part: 4electrodes on eachmodels, eachelectrode is: 45 mm indiameter | |||||
| Impedance | For Model A: 7 ohms | 7 ohms resistance per inch | <7 ohms per inch | <7 ohms per inch | SE |
| Parameters | per inchFor Model B: 7 ohmsper inchFor Model C: Lessthan 7 ohms per inchFor Model D: 7 ohmsresistance per inch | ||||
| PatientContactingMaterial | For Model A: Silverplated nylon (SilverFibre Knitted Fabric),cotton (Crystal SuperCashmere)For Electrode B: Silverplated nylon (SilverFibre Knitted Fabric),cotton (Crystal SuperCashmere andMutispandex)For Electrode C:Conductive siliconerubber, PU FoamFor Electrode D: Silverplated nylon (SilverFibre Knitted Fabric),cotton (Crystal SuperCashmere) | Silver plated nylon | Conductive siliconerubber | -- | SENote 1 |
| Lead Wire | Lead wire with female | Lead wire with female | Connector Lead wire | -- | SE |
| Type and | socket, or snap button | socket, or snap button | .080" female socket | ||
| Characteristics | with male snap connector | with male snap connector | connector | ||
| OperatingEnvironment | Temperature: 5 | Temperature: 5 | Temperature: 5 | -- | SE |
| StorageEnvironment | Temperature: -20 | Temperature: -20 | Temperature: -20 | -- | SE |
| Biocompatibility | Complied with ISO10993-5, ISO 10993-10 | Complied with ISO10993-5, ISO 10993-10 | Complied with ISO10993-5, ISO 10993-10 | Complied with ISO10993-5, ISO 10993-10 | SE |
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Comparison in Detail(s):
Note 1:
Although the "Design (shape)", "Dimensions", and "Patient Contacting Material" are a little different from the predicate devices, they all comply with ISO 10993 requirements. So the differences will not raise any safety or effectiveness issue.
Final Conclusion:
The subject device XinBo Electrodes (Models: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro -III, Neck Therapy Pro -IV) are Substantial Equivalent to the predicate devices.
8. Date of the summary prepared: April 20, 2018
§ 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).