(278 days)
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.
The proposed TENS Electrodes are non-sterile laminated, flexible structures composed of materials commonly used in this application: The electrodes are designed for single-patient application use. Because of the adhesive nature of the biocompatible hydrogel, no securing materials are required to secure the device to the patient's skin. The proposed device mainly consists of electrode pad and wire. The electrode pad is available in rectangular shape, round shape, and butterfly shape, etc.
The Cathay Manufacturing Corp. TENS Electrodes (K160081) were compared against a primary predicate device (K080276) and a reference device (K132588) to establish substantial equivalence. The study involved bench testing (non-clinical) to assess performance characteristics.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Test) | Acceptance Criteria (Threshold) | Reported Device Performance (K160081) |
|---|---|---|
| Performance Standard | Conforms to IEC 60601-1 and IEC 60601-2-10:2012 | Conforms to IEC 60601-1 and IEC 60601-2-10:2012 |
| Electrical impedance | Individual pad impedance below 200 ohms @ 60 kHz (for K160081). For predicates, "Pass if the needle of multi-meter moves" for x1k ohm range. | Met: Individual pad impedance below 200 ohms @ 60 kHz. (Also passed predicate test method). |
| Adhesive performance on steel ball | >= No.14 steel ball (Diameter: 11.112 mm) following AS07-003 / GB/T4852-2002 | Met: >= No.14 steel ball (Diameter: 11.112 mm) |
| Adhesive holding strength | A sample pad with 25mm length and 25 mm width; Hang a weight of 200g without detach within 30s | Met: Successfully held 200g weight for at least 30s. |
| Tensile Strength | Electrode is held up with a weight of 500g hung on the wire, and can hold on at least 1 minute | Met: Successfully held 500g weight for at least 1 minute. |
| Conformability | No more than 10% of the adhesive area of the device shall have separated from the skin surface at 1 h after application. | Met: No more than 10% separation after 1 hour. |
| Impedance Distribution uniformity | 1) No significant deviation between resistance values measured for each combination mode.2) Maximum and minimum values within ±10% of average value. | Met: No significant deviation; max/min values within ±10% of average. |
| Stability and shelf life | 2 year | 2 year (demonstrated to be equivalent) |
2. Sample Sizes Used for the Test Set and Data Provenance:
The document does not explicitly state the specific sample sizes (number of electrodes) used for each individual performance test (e.g., electrical impedance, tensile strength) on the subject device. It mentions "Largest model: CM100180FC (Rectangle shape: 100 x 180 mm); Smallest model: CM2222FC (square shape: 22 x 22 mm); Irregular representative: CM2542YC(crescent )" were used for testing electrode types, shapes, and sizes. This suggests at least one of each representative size and shape were included.
The data provenance is not specified beyond being "bench testing (non-clinical)." There is no information regarding the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts and Qualifications for Ground Truth:
This section is not applicable as the study described is a non-clinical bench testing study of TENS electrodes, not a study involving human-in-the-loop performance or expert interpretation of diagnostic images/data. Therefore, there was no ground truth requiring expert establishment.
4. Adjudication Method:
This section is not applicable for the same reasons as above. There was no expert review or adjudication of results required for this type of non-clinical bench testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks, which is not applicable to TENS electrodes' physical and electrical performance evaluation.
6. Standalone Performance Study:
Yes, a standalone performance study (i.e., algorithm only without human-in-the-loop performance) was done, but not for an AI algorithm. The "algorithm" in this context refers to the device itself and its intrinsic performance as measured by various physical and electrical tests. The bench testing evaluated the device's performance directly against the defined acceptance criteria without human interaction influencing the measurement results.
7. Type of Ground Truth Used:
The "ground truth" for this study was based on objective, quantitative measurements and established industry standards (e.g., IEC 60601-1, IEC 60601-2-10:2012, AS07-003 / GB/T4852-2002). The results of the tests (e.g., resistance values, weight held, adhesion percentage) served as the direct evidence of performance against these pre-defined benchmarks.
8. Sample Size for the Training Set:
This section is not applicable. The device in question is a physical medical device (TENS electrodes), not an AI algorithm that requires a training set. The "design" and "validation" mentioned relate to engineering and manufacturing processes, not machine learning model training.
9. How the Ground Truth for the Training Set was Established:
This section is not applicable for the same reason as above. There was no training set for an AI algorithm.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 19, 2016
Cathay Manufacturing Corp. % Mr. Fan, Tao Consultant Shanghai YunTao Management Consultant Room 202, No. 14, Lane 986, Gaosi Road Pudong District Shanghai, 201203 China
Re: K160081
Trade/Device Name: TENS Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: September 3, 2016 Received: September 19, 2016
Dear Mr. Fan. Tao:
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 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
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Part 807): labeling (21 CFR Part 801 and Part 809): 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801and Part 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michaelリ. Hoffmann -A
Carlos L. Peña, PhD, MS for 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) K160081
Device Name TENS Electrodes
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 stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It's for OTC use.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
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
| Submitter: | CATHAY MANUFACTURING CORP.No. 328, Xishe Road, Maogang Town, Songjiang AreaShanghai, CN 201607 |
|---|---|
| Contact: | Mr. Fan, TaoPhone: (86)18616806984Fax: (86)-21-57876338fant01@uwellmed.com |
| Date Prepared: | Oct. 18, 2016 |
| Device Trade Name: | TENS Electrodes |
| Device Common Name: | Neurostimulation Electrodes |
| Classification name: | Cutaneous Electrodes |
| Class: | II |
| Regulation: | 882.1320 |
| Product Code: | GXY |
Primary Predicate Device:
| Device | Company | Product Code | 510(k) Number |
|---|---|---|---|
| SELF-ADHESIVEELECTRODES | CATHAY HealthcareEquipment Manufacturing Inc. | GXY | K080276 |
A Reference Device Chosen:
| Top-Rank Adhesive | Top-Rank Health Care Co., | GXY | K132588 |
|---|---|---|---|
| Electrodes | Ltd |
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1. Indication 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).
It's for OTC use.
2. Product Description:
The proposed TENS Electrodes are non-sterile laminated, flexible structures composed of materials commonly used in this application:
The electrodes are designed for single-patient application use. Because of the adhesive nature of the biocompatible hydrogel, no securing materials are required to secure the device to the patient's skin.
The proposed device mainly consists of electrode pad and wire. The electrode pad is available in rectangular shape, round shape, and butterfly shape, etc.
| Shape | Product Model | Shape | Product Model |
|---|---|---|---|
| Image: Shape | ☐ CM2040FC ☐ CM5570FC | Image: Shape | ☐ CM2222FC ☐ CM6060FC |
| ☐ CM3050FC ☐ CM5575FC | ☐ CM3232FC ☐ CM6565FC | ||
| ☐ CM3060FC ☐ CM5590FC | ☐ CM4040FC ☐ CM7070FC | ||
| ☐ CM4050FC ☐ CM6070FC | ☐ CM4545FC ☐ CM7575FC | ||
| ☐ CM4060FC ☐ CM6080FC | ☐ CM4848FC ☐ CM8080FC | ||
| ☐ CM4070FC ☐ CM6090FC | ☐ CM5050FC ☐ CM8585FC | ||
| ☐ CM4080FC ☐ CM60100FC | ☐ CM5555FC ☐ CM9090RC | ||
| ☐ CM4090FC ☐ CM7080FC | Image: Shape | ☐ CM22RC ☐ CM60RC | |
| ☐ CM40100FC ☐ CM70100FC | ☐ CM25RC ☐ CM65RC | ||
| ☐ CM4580FC ☐ CM70120FC | ☐ CM32RC ☐ CM70RC | ||
| ☐ CM4590FC ☐ CM75125FC | ☐ CM40RC ☐ CM75RC | ||
| ☐ CM45100FC ☐ CM80100FC | ☐ CM45RC ☐ CM85RC | ||
| ☐ CM5060FC ☐ CM80110FC | ☐ CM50RC ☐ CM90RC | ||
| ☐ CM5070FC ☐ CM80120FC | Image: Shape | ☐ CM55RC | |
| ☐ CM5090FC ☐ CM80130FC | ☐ CM4050TC ☐ CM5580SC | ||
| ☐ CM50100FC ☐ CM90120FC | Image: Shape | ☐ CM4560TC ☐ CM7090TC | |
| ☐ CM50130FC ☐ CM90130FC | ☐ CM4570SC | ||
| ☐ CM5565FC ☐ CM100180FC | ☐ CM2542YC | ||
wire: _ 0 2. Omn Packaging : 22PCS 04PCS 6PCS 88PCS
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| ELEMENTOFCOMPARISON | SUBJECT DEVICE | Primary Predicate Device | A Reference Device chosen | |
|---|---|---|---|---|
| K080276 | K132588 | |||
| SELF-ADHESIVEELECTRODES | Top-Rank Adhesive Electrodes | |||
| Indications forUse | The proposed device isintended for use as thedisposable, conductiveadhesive interface betweenthe patient's skin and theelectrical stimulator to applyelectrical stimulationcurrent, and is intended tobe used with marketedelectrical stimulators, i.e.TENS (TranscutaneousElectrical NerveStimulation) and EMS(Electrical MuscularStimulation).It's for OTC use | The electrotherapyelectrodes areintended to be used toapply electricalstimulation current tothe patient's skin orrecord physiologicalsignals | Adhesive electrodes areintended for use as thedisposable, conductiveadhesive interface betweenthe patient's skin and theelectrical stimulator. Top-RankAdhesive Electrodes areintended to be used withmarketed ElectricalStimulators, i.e. TENS(Transcutaneous ElectricalNerve Stimulation) andEMS(Electrical MuscularStimulation). It's for OTC use. | |
| OTC orPrescription | For OTC Use | For Prescription use | For OTC use | |
| Sterility | Non-sterile | Non-sterile | Non-sterile | |
| Design Features | Substrate / Wire/ Hydro-Gel | Substrate / Wire/ Hydro-Gel | Substrate /Wire/Hydro-Gel | |
| Scrim / Conductive Fiber | Scrim / Conductive Fiber | Scrim/Conductive Fiber | ||
| Carbon Conductive Film / Liner | Carbon Conductive Film / Liner | Carbon Conductive Film / Liner | ||
| Materials:Substrate;Wire:Hydro-gel;Scrim;Conductivefiber;Carbonconductivefilm;Liner | Non-woven fabric+ adhesive | Non-woven fabric+ adhesive | Non-woven fabric+ adhesive | |
| Wire & Terminal coated PVC | Wire & Terminal coated PVC | Wire & Terminal coated PVC | ||
| Hydro-gel | Hydro-gel | Hydro-gel | ||
| PET fabric | PET fabric | PET fabric | ||
| Carbon fiber + reinforcingfiber | Carbon fiber + reinforcing fiber | Carbon fiber + reinforcing fiber | ||
| Poly-isobutylene, CarbonBlack | Poly-isobutylene, Carbon Black | Poly-isobutylene, Carbon Black | ||
| Transparent PET linercoated silicon | Transparent PET liner coatedsilicon | Transparent PET liner coated silicon | ||
| Biocompatibility | Conforms toISO10993 | Conforms toISO10993 | Conforms toISO10993 | |
| Labeling | confirm to 21 CFR Part 801 | confirm to 21 CFR Part 801 | confirm to 21 CFR Part 801 | |
| Performance | Conforms to IEC 60601-1andIEC 60601-2-10:2012,Part 2 Particularrequirements for the basicsafety and essentialperformance of nerve andmuscle stimulators. | Conforms to IEC 60601-1andIEC 60601-2-10:2012,Part 2 Particularrequirements for the basicsafety and essentialperformance of nerve andmuscle stimulators. | Conforms to IEC 60601-1andIEC 60601-2-10:2012,Part 2 Particular requirements for thebasic safety and essentialperformance of nerve and musclestimulators. | |
| Electricalimpedance | Individual pad impedancebelow 200 ohms @ 60kHz | By linking the connector togel using a multi-meter. Setthe range at x1k ohm.Pass if the needle of multi-meter moves | By linking the connector to gel usinga multi-meter. Set the range at x1kohm.Pass if the needle of multi-metermoves | |
| ELEMENTOFCOMPARISON | SUBJECT DEVICE | Primary Predicate Device | A Reference Device chosen | |
| K080276 | K132588 | |||
| SELF-ADHESIVEELECTRODES | Top-Rank Adhesive Electrodes | |||
| Electrode types,shapes, andsizes used fortesting | Largest model:CM100180FC (Rectangleshape: 100 x 180 mm);Smallest model:CM2222FC(squareshape: 22 x 22 mm);Irregular representative:CM2542YC(crescent ) | Largest and irregular model:CM100200 (butterfly shape:100 x 200 mm)Smallest model:CM2222 (Square shape: 22x 22 mm) | A most common used sample:AF5050WP(Square Shape: 50 x50mm) | |
| To | Adhesiveperformance on | >= No.14 steel ball(Diameter: 11.112 mm)following AS07-003 /GB/T4852-2002 | >= No.14 steel ball(Diameter: 11.112 mm)following AS07-003 /GB/T4852-2002 | >= No.14 steel ball (Diameter:11.112 mm) following AS07-003 /GB/T4852-2002 |
| Adhesiveholding strengthperformance | A sample pad with 25mmlength and 25 mm width;Hang a weight of 200gwithout detach within 30s | A sample pad with 25mmlength and 25 mm width;Hang a weight of 200gwithout detach within 30s | A sample pad with 25mm length and25 mm width:Hang a weight of 200g withoutdetach within 30s | |
| Tensile Strength | Electrode is held up with aweight of 500g hung onthe wire, and can hold onat least 1 minutes | Electrode is held up with aweight of 500g hung on thewire, and can hold on at least1 minutes | Electrode is held up with a weight of500g hung on the wire, and can holdon at least 1 minutes | |
| Test | Conformability | No more than 10% of theadhesive area of thedevice shall haveseparated from the skinsurface at 1 h afterapplication. | No more than 10% of theadhesive area of the deviceshall have separated fromthe skin surface at 1 h afterapplication. | No more than 10% of the adhesivearea of the device shall haveseparated from the skin surface at 1h after application. |
| ImpedanceDistributionuniformity test | 1) No significant deviationbetween resistancevalues measured for eachcombination mode.2) The maximum valueand the minimum valueshould be within ±10% ofaverage value | 1) No significant deviationbetween resistance valuesmeasured for eachcombination mode.2) The maximum value andthe minimum value should bewithin ±10% of averagevalue | 1) No significant deviation betweenresistance values measured for eachcombination mode.2) The maximum value and theminimum value should be within±10% of average value | |
| Stability andshelf life | 2 year | 2 year | 2 year | |
| Re-usable | For single patient | For single patient | For single patient | |
| Intendedpopulation | No specified population | No specified population | No specified population |
4. Summary of Technology Characteristics and Performance Testing (Comparison to the Primary Predicate Device and Reference Device)
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| ComparisonSummary | Compare to primary predicate device specified in K080276, our device and thepredicate device are same in Essential Components, raw materials, physicalfeatures, and same manufacturing processes. One difference is that our proposeddevice does not claim for recording physiological signals as the predicate devicedoes. Another difference is predicate device is intended for prescription use, and ourproposed product is for Over-the-Counter (OTC) use.Our product and the predicate device are the same in intended for use, essentialcomponents, physical and general safety features based on ISO internationalstandards. The hydro-gel used in K080276 is not different from what is used inCATHAY TENS Electrodes.Compare to both primary predicate device and reference device, the proposeddevice has different test method for electrical impedance. However, this test methodis a more sensitive & improved test method. Previously, proposed device testmethod for electrical impedance was exactly the same as predicate device andreference device, and all tests can pass previous test method also. |
|---|---|
| Compare to the primary predicate device and reference device, the subject deviceis constructed in the same manner,is constructed of same or similar materials,have same or similar indications for use, andhave similar performance characteristicsAny minor visual, dimensional or labeling differences between the primarypredicate device and reference device and the proposed electrodes do not pose riskto their performance and usage. |
5. Bench Testing (non-clinical):
Compare to primary predicate product specified in K080276, our device and the predicate device are same in Essential Components, raw materials, physical features, and same manufacturing processes. The biocompatibility performance equivalence evidence of proposed electrode can be demonstrated.
The proposed TENS Electrodes evaluated through Electrode Performance testing (Electrical Impedance Performance, Adhesive Performance, and Tensile Strenght), Biocompatibility testing, Stability testing, and Reuse testing.
The comparison tests conclusively prove that the proposed electrode is similar / equivalence as performance efficient at electrical impedance, adhesive performances, tensile strength, conformability, and impedance distribution uniformity performance as the primary predicate device and reference device.
For lead wires & cables used in proposed device, the safety performances are demonstrated by the Third party, TUV Rheiland, through testing following IEC
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60601-1:2005+CORR. 1(2006) + CORR.2(2007) + AM1(2012), Part 1General requirements for basic safety and essential performance, and IEC 60601-2-10:2012, Part 2 Particular requirements for the basic safety and essential performance of nerve and muscle stimulators.
The results of bench testing & type testing provide reasonable assurance that the proposed device has been designed and validated to assure conformance to the requirements for its indication for use.
6. Conclusion:
Based on the indication for use, technology characteristics, and performance testing, the proposed product, TENS Electrodes, has been shown to be appropriate for its indication for use and is considered to be substantially equivalent to the primary predicate device and reference device.
§ 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).