(153 days)
To be used for temporary relief of pain associated with sore and aching muscles in the back of neck, due to strain from exercise or normal household and work activities.
- Neck Pad is used in back of neck.
The subject device is intended to use on back of neck and it designed accord with human body cervical physiological curvature of streamlined ring design. It is a body-worn and home-use device. It uses low-frequency electronic therapy and designed to temporary relief of pain associated with sore and aching muscles in the back of neck. It only has one model: ST-304.
The trade name of the subject device is Transcutaneous electrical nerve stimulator.
The Transcutaneous electrical nerve stimulator (model: ST-304) consists of a main unit and Type C-USB charging cable. The main unit consists of shell, lithium battery (only 1pcs), neck electrodes pads (a pair of fixed neck electrodes pads), lower shell connector and control buttons and silicone pads. There are two fixed neck electrodes pads on the main unit. The material of neck electrodes pads is titanium material (Gr.2). There are only 1 pcs lithium battery in-build in main unit. The model of lithium battery is KRL 103040.
The neck electrodes pads (a pair of fixed neck electrodes pads) are a kind of Titanium material, and the detail content as following description and as the classify of ASTM F67 2017 it is under Gr2.
The Transcutaneous electrical nerve stimulator (model: ST-304) power supply is 3.7V DC using built-in lithium battery(1200mAh). The built-in lithium battery can be recharged. But the power adapter (Input: 100-240V~, 50/60Hz,0.7A, Output: 5V== 1000mA) is not the parts of the subject device so it shall be supplied by the user. There are two fixed neck electrodes pads on the main unit. The material of neck electrodes pads is Titanium material (Gr.2).
The Transcutaneous electrical nerve stimulator (model: ST-304) totally has 3 modes. The stimulation has 2 modes for stimulating and 15 output Intensity Levels for each mode, so the device can give certain electrical pulse through the neck electrodes pads on the intact skin of back neck to help users to temporary relief of pain. The heating only has 1 mode for heating and it can also provide a constant temperature of 32℃ to 38℃ to provide a warming sensation. The stimulation function and heating function can be used separately or simultaneously. The neck electrodes pads provide users with back of neck stimulation and heat to warm and comfort the muscles of the back of neck.
The main unit provides access to adjust the intensity up or down and adjust stimulating mode, put ON/OFF the main unit and heating function.
The Intensity level of electrical stimulation and heating function are easily controlled by the end user using manual, push-button controls. The push-button controls are consisted of four button which are Switch on/off button/mode switch button, heating button, Intensity increase button and Intensity decrease button.
The default stimulation time is 10 minutes, and the user cannot adjust but could turn off the device during working condition.
Transcutaneous electrical nerve stimulator (model: ST-304) has 2 types stimulation modes: Mode 1, Mode 2.
Before use the device to wipe the Electro Therapy Conductive Gel on the Neck Electrode Pads. But the Electro Therapy Conductive Gel is not the part of subject device so it shall be supplied by the user.
Principle of operation:
The Transcutaneous electrical nerve stimulator (model: ST-304) sends low-voltage electrical pulses to specific nerves via two fixed neck electrodes pads applied on the intact skin of back of neck and powered by rechargeable lithium battery. The purpose is to temporarily relieve pain. By adjusting the output voltage and frequency to produce the low-voltage electrical pulses and achieve the effect of electrotherapy. Voltage regulation is realized by the Boost Converter circuit, which controls the voltage amplitude by modifying the PWM control circuit. After that, the voltage is released to the electrode through the analog circuit, and the time change of the output voltage is controlled by modifying the PWM frequency to achieve the specific electrotherapy effect.
The provided text is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (TENS) device. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study.
Therefore, the document does not contain the information requested regarding:
- Acceptance criteria in the context of a clinical study or specific performance metrics for the device's intended use.
- A study that proves the device meets acceptance criteria. No clinical performance study is described.
- Sample size for test sets or training sets.
- Data provenance (country of origin, retrospective/prospective).
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
- Standalone algorithm performance.
- Type of ground truth used.
- How ground truth for the training set was established.
Instead, the document details non-clinical testing performed to demonstrate that the device is as safe and effective as its predicate devices, based on compliance with recognized consensus standards.
However, I can extract information related to the device's technical specifications and how they compare to predicate devices, which implicitly serves as the "acceptance criteria" and "device performance" for the substantial equivalence claim.
1. Table of Acceptance Criteria (Implicit for Substantial Equivalence) and Reported Device Performance:
The "acceptance criteria" for this 510(k) submission are implicitly defined by the technical specifications of the predicate devices. The "reported device performance" refers to the subject device's technical specifications. The discussion of differences (D1-D17) explains why these differences do not raise new questions of safety or effectiveness.
| Characteristic | Predicate Device Standard (Implicit Acceptance Criteria) | Subject Device Performance (Transcutaneous Electrical Nerve Stimulator, model ST-304) |
|---|---|---|
| Safety and EMC Standards Compliance | Compliance with ANSI AAMI ES60601-1, ANSI AAMI IEC 60601-1-2, ANSI AAMI HA 60601-1-11, IEC 60601-2-10, IEC 62304. ISO 10993-5, ISO 10993-10, ISO 10993-1. | Compliant. The subject device has demonstrated compliance with all listed safety and EMC standards through testing. (Sections 7, D1, D2, D4, D8, D11, D12, D13, D14, D15, D16, D17) |
| Intended Use & Indications for Use | Temporary relief of pain associated with sore and aching muscles in the back of neck. | Same. "To be used for temporary relief of pain associated with sore and aching muscles in the back of neck, due to strain from exercise or normal household and work activities. - Neck electrodes Pads is used in back of neck." (Section 5, Table row "Intended Use & Indications for Use") |
| Power Source - Main Unit | 3.7Vdc, lithium battery (2200mAh for Predicate 1, 500mAh for Predicate 2). | 3.7Vdc, 1200mAh Rechargeable lithium battery. Different capacity (D1). |
| Patient Leakage Current (Normal Condition) | AC: 23.3 µA (Predicate 1), 54.5 µA (Predicate 2); DC: ≤ 1 µA (Predicate 1), 0.5 µA (Predicate 2). | Different, but compliant. Electrical safety demonstrated by passing ANSI AAMI ES60601-1 and IEC 60601-2-10 tests. (D2) |
| Output Intensity Level - Stimulating | Predicate 1: 50; Predicate 2: 50. | 15 levels. (D3) |
| Heating Temperature | Predicate 1: 30-40°C; Predicate 2: NA. | 32-38°C. Within the range of Predicate 1. (D3, D4) |
| Timer Range | 5-30 minutes. | 10 minutes. Covered by the range of predicate devices. (D5) |
| Maximum Output Voltage | Mode 1: 44V @ 500 Ω, 80V @ 2 kΩ, 112V @ 10 kΩ. Mode 2 (Predicate equivalent): Similar to Mode 1. | Mode 1: 44V @ 500 Ω, 80V @ 2 kΩ, 112V @ 10 kΩ. Mode 2: 42V @ 500 Ω, 78V @ 2 kΩ, 105V @ 10 kΩ. Small difference for Mode 2 but deemed safe and effective. (D9) |
| Maximum Output Current | Mode 1: 88mA @ 500 Ω, 40mA @ 2 kΩ, 11.2mA @ 10 kΩ. Mode 2 (Predicate equivalent): Similar to Mode 1. | Mode 1: 88mA @ 500 Ω, 40mA @ 2 kΩ, 11.2mA @ 10 KΩ. Mode 2: 84mA @ 500 Ω, 39mA @ 2 KΩ, 10.5mA @ 10 KΩ. Small difference for Mode 2 but deemed safe and effective. (D10) |
| Maximum Phase Charge (μC) | Predicate 1: 10.56 µC @ 500Ω; Predicate 2: 12.78 µC @ 500Ω. | Mode 1: 10.3µC @ 500Ω. Mode 2: 9.6µC @ 500Ω. Small differences acceptable and deemed safe and effective. (D11) |
| Maximum Current Density (mA/cm² r.m.s.) @ 500Ω | Predicate 1: 0.0326 mA/cm²; Predicate 2: 0.235 mA/cm². | Mode 1: 2.2mA/cm². Mode 2: 2.2mA/cm². Difference noted but deemed safe and effective. (D12) |
| Maximum Average Power Density (mW/cm²) @ 500Ω | Predicate 1: 0.0000266mW/cm²; Predicate 2: 1.38 mW/cm². | Mode 1: 0.36mW/cm². Mode 2: 0.32mW/cm². Difference noted (between predicates) but less than 0.25 Watts/cm² and deemed safe and effective. (D13) |
Since this is a 510(k) submission, the device's acceptance is based on demonstrating "substantial equivalence" to predicate devices, primarily through non-clinical testing and comparison of technical characteristics, not through clinical trials demonstrating specific performance criteria against a disease outcome.
Summary of Missing Information (as per your request, not present in the document):
- Sample size for the test set and the data provenance: Not applicable, as no clinical test set is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/imaging diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no clinical ground truth is established for efficacy.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical testing for electrical safety, EMC, biocompatibility, and software verification, as listed in Section 7. This testing demonstrates that despite minor technical differences, the device is as safe and effective as the predicate devices for its intended use.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the agency's name on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. The logo is simple and professional, reflecting the FDA's role in regulating food and drugs in the United States.
September 13, 2022
Shenzhen Future Electronic Co., Ltd % You Yijie Manager Oimmig Medical Consulting Service Co., Ltd RM. 1711, Building K, No. 101 Science Ave International Creative Valley Guangzhou, Guangdong 510663 China
Re: K221092
Trade/Device Name: Transcutaneous Electrical Nerve Stimulator Model: ST-304 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH Dated: August 12, 2022 Received: August 12, 2022
Dear You Yijie:
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,
Pamela D. Scott Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known)
K221092 Device Name
Transcutaneous Electrical Nerve Stimulator Model: ST-304
Indications for Use (Describe)
To be used for temporary relief of pain associated with sore and aching muscles in the back of neck, due to strain from exercise or normal household and work activities.
- Neck Pad is used in back of neck.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
PSC Publishing Services (301) 443-6740 EF
{3}------------------------------------------------
510(k) Summary
1. Submitter's Information
Establishment Registration Information
Name: SHENZHEN FUTURE ELECTRONIC CO.,LTD Address: Bldg B. Qiangchengda Industrial Park, No. 30, Youtian Road, Longgang SHENZHEN Guangdong, CN 518116 Registration Number: 3014344342
Contact Person of applicant
Name: Zhao Qihong Address: Bldg B. Qiangchengda Industrial Park, No. 30, Youtian Road, Longgang SHENZHEN Guangdong, CN 518116 TEL: +86-134 1094 7296 FAX: +86-134 1094 7296 Email: zhaoqihong@futuresz.com.cn
Contact Person of the Submission:
Name: Yijie You Address: RM.1711, Building K, No.101 Science Ave International Creative Valley Development Zone, Guangzhou China TEL: +86 020-8224 5821 FAX: +86 020-8224 5821 Email: Jet.you@qimmiq-med.com
Date prepared: Mar. 4, 2022
2. Device Information
| Trade Name: | Transcutaneousstimulator | electrical | nerve |
|---|---|---|---|
| Model: | ST-304 | ||
| Regulation name: | Stimulator, Nerve, Transcutaneous, Over-The-Counter | ||
| Review Panel: | Neurology | ||
| Product Code: | NUH | ||
| Regulation Class: | II | ||
| Regulation Number: | 21CFR 882.5890 |
3. Predicate Device Information
Primary Predicate Device
{4}------------------------------------------------
| 510(k) submitter/holder: | Shenzhen OSTO Technology Company Limited |
|---|---|
| 510(K) Number: | K210756 |
| Trade Name: | Neck Care Therapy |
| Model: | AST-905H |
| Classification name: | Stimulator, Nerve, Transcutaneous, Over-The-Counter |
| Review panel: | Neurology |
| Product code: | NUH |
| Regulation Class: | II |
| Regulation Number: | 21 CFR 882.5890 |
Secondary Predicate Device
| 510(k) submitter/holder: | Shenzhen OSTO Technology Company Limited |
|---|---|
| 510(K) Number: | K172897 |
| Trade Name: | Neck Care Therapy |
| Model: | 905B |
| Classification name: | Stimulator, Nerve, Transcutaneous, Over-The-Counter |
| Review panel: | Neurology |
| Product code: | NUH, NGX |
| Regulation Class: | II |
| Regulation Number: | 21 CFR 882.5890, 890.5850 |
4. Device description
The subject device is intended to use on back of neck and it designed accord with human body cervical physiological curvature of streamlined ring design. It is a body-worn and home-use device. It uses low-frequency electronic therapy and designed to temporary relief of pain associated with sore and aching muscles in the back of neck. It only has one model: ST-304.
The trade name of the subject device is Transcutaneous electrical nerve stimulator.
The Transcutaneous electrical nerve stimulator (model: ST-304) consists of a main unit and Type C-USB charging cable. The main unit consists of shell, lithium battery (only 1pcs), neck electrodes pads (a pair of fixed neck electrodes pads), lower shell connector and control buttons and silicone pads. There are two fixed neck electrodes pads on the main unit. The material of neck electrodes pads is titanium material (Gr.2). There are only 1 pcs lithium battery in-build in main unit. The model of lithium battery is KRL 103040.
The neck electrodes pads (a pair of fixed neck electrodes pads) are a kind of Titanium material, and the detail content as following description and as the classify of ASTM F67 2017 it is under Gr2:
| Titanium material (Gr.2) | Value |
|---|---|
| -------------------------- | ------- |
| Content | |
|---|---|
| Main Components | Ti |
| Remainder |
{5}------------------------------------------------
| Al | / | ||||
|---|---|---|---|---|---|
| V | / | ||||
| Impurity Elements | Fe | 0.235 | |||
| C | 0.008 | ||||
| N | 0.012 | ||||
| O | 0.130 | ||||
| H | 0.0043 | ||||
| Other Impurities | each | ≤ 0.1 | total | ≤ 0.3 |
The Transcutaneous electrical nerve stimulator (model: ST-304) power supply is 3.7V DC using built-in lithium battery(1200mAh). The built-in lithium battery can be recharged. But the power adapter (Input: 100-240V~, 50/60Hz,0.7A, Output: 5V== 1000mA) is not the parts of the subject device so it shall be supplied by the user. There are two fixed neck electrodes pads on the main unit. The material of neck electrodes pads is Titanium material (Gr.2).
The following power adapter is recommended:
Manufacturer: ShenZhen RiHuiDa Power Supply Co., Ltd
Model: RHD 10W050100U
UL certificate: E474213 Specification: Input: 100-240V ~, 50/60Hz,0.7A Output :5V = 1000mA
The Transcutaneous electrical nerve stimulator (model: ST-304) totally has 3 modes. The stimulation has 2 modes for stimulating and 15 output Intensity Levels for each mode, so the device can give certain electrical pulse through the neck electrodes pads on the intact skin of back neck to help users to temporary relief of pain. The heating only has 1 mode for
heating and it can also provide a constant temperature of 32℃ to 38℃ to provide a
warming sensation. The stimulation function and heating function can be used separately or simultaneously. The neck electrodes pads provide users with back of neck stimulation and heat to warm and comfort the muscles of the back of neck.
The main unit provides access to adjust the intensity up or down and adjust stimulating mode, put ON/OFF the main unit and heating function.
The Intensity level of electrical stimulation and heating function are easily controlled by the end user using manual, push-button controls. The push-button controls are consisted of four button which are Switch on/off button/mode switch button, heating button, Intensity increase button and Intensity decrease button.
Button function description:
{6}------------------------------------------------
Switch on/off button/mode switch button(
-
- Long press about (2 seconds) to turn on or turn off the Transcutaneous electrical nerve stimulator (model: ST-304) and sound "Di". When turn on the device or in the working condition the button indicator light is blue and turn off the device button indicator will close.
-
- When battery is low capacity(<3.5V ), the indicator of the button will be flashing in blue light 3 times for 5 seconds and with long "Di" sound every two minutes. At the same time when short press the button will sound "Di". When the battery is charging the button will be flashing in green. When the battery is charged the button will be in green light always. The device can't be used when it is charging.
-
- When the capacity of battery<3.1V, the device shown prompt sound, shut down.
-
- Pulse mode adjusted:
Short press the button( Di, Di-Di-Di-Di-Di-Di-Di" sound about 3 second will be heard .When Mode 2 is chosen, intermittent " Di-, Di-, Di-, Di-- " sound for 3 seconds will be heard.
Heating button(纽
- Short press the button to start heating and button indication is green. If start heating successfully, the Transcutaneous Electrical Nerve Stimulator (ST-304) will sound "Di". Short press to stop heating and button indication lights off, if stopping heating successfully, the Transcutaneous Electrical Nerve Stimulator (ST-304) will sound "Di Di".
Intensity increase button (
-
- Short press " = ", " " " " " button to add or subtract pulse intensity, 1-15 level adjustable. Level 1 is the lowest intensity and the Level 15 is the highest intensity.
-
- After press " " "or " " " " " " " button, the sound "Dit" will be heard. When turn on the device, there is
without any pulse output, after short press " ■ " one time then enter into the working condition and will be output pulse in level 1 intensity. When the Intensity increase to 15 level, then short press the" = " one more time will sound "Di Di", it means the device is in the highest Intensity level (15 Intensity level).
The default stimulation time is 10 minutes, and the user cannot adjust but could turn off the device during working condition.
Transcutaneous electrical nerve stimulator (model: ST-304) has 2 types stimulation modes: Mode 1, Mode 2.
{7}------------------------------------------------
When turn on the device, the device turns into default setting, the stimulation mode is Mode 2 and there is without any pulse output, after short press " " one time then enter into the working condition and will be output pulse at level 1 intensity.
These stimulation modes can be selected by short pressing the Switch on/off button/mode switch button
( ( ). The two stimulation modes are the same in indication for use.
Before use the device to wipe the Electro Therapy Conductive Gel on the Neck Electrode Pads. But the Electro Therapy Conductive Gel is not the part of subject device so it shall be supplied by the user.
The following Electro Therapy Conductive Gel are recommended:
Manufacturer: Guangzhou Xinbo Electronic Co., Ltd.
Trade/Device Name: DR-HO'S Electro Therapy Conductive Gel
Model Name: DHGEL
FDA clearance with a 510(k) number: K200402
Accessory
| Name | Specification/model | Quantity(pcs) |
|---|---|---|
| Type C -USBcharging cable | length 1m,24AWG(0.16*11) | 1 |
Principle of operation:
The Transcutaneous electrical nerve stimulator (model: ST-304) sends low-voltage electrical pulses to specific nerves via two fixed neck electrodes pads applied on the intact skin of back of neck and powered by rechargeable lithium battery. The purpose is to temporarily relieve pain. By adjusting the output voltage and frequency to produce the low-voltage electrical pulses and achieve the effect of electrotherapy. Voltage regulation is realized by the Boost Converter circuit, which controls the voltage amplitude by modifying the PWM control circuit. After that, the voltage is released to the electrode through the analog circuit, and the time change of the output voltage is controlled by modifying the PWM frequency to achieve the specific electrotherapy effect.
Note: PWM means Pulse Width Modulation
5. Indications for Use
To be used for temporary relief of pain associated with sore and aching muscles in the back of neck, due to strain from exercise or normal household and work activities.
- Neck electrodes Pads is used in back of neck.
{8}------------------------------------------------
6. Summary of technological characteristics of device compared to the predicate devices (K210756 and
K172897)
| Characteristic | Subject device(TranscutaneousElectrical NerveStimulator, model ST-304) | Predicate device 1(K210756, Neck CareTherapy, model: AST-905H) | Predicate device 2(K172897, Neck Care Therapy,905B) | Discussion of difference | |
|---|---|---|---|---|---|
| Manufacturer | Shenzhen FutureElectronic Co., Ltd | Shenzhen OSTO TechnologyCo., Ltd | Shenzhen OSTO TechnologyCo., Ltd | / | |
| Picture | Image: Subject device | Image: Predicate device 1 | Image: Predicate device 2 | / | |
| Classification | 21 CFR 882.5890 | 21 CFR 882.5890 | 21 CFR 882.5890, 21 CFR890.5850 | Same | |
| Prescription/OTC | OTC | OTC | OTC | Same | |
| Product Code | NUH | NUH | NUH, NGX | Same | |
| FDA Class | II | II | II | Same | |
| Intended Use & Indicationsfor Use | To be used for temporaryrelief of pain associatedwith sore and achingmuscles in the back ofneck, due to strain fromexercise or normal | To be used for temporaryrelief of pain associated withsore and aching muscles inthe shoulder, waist, back ofneck, back,arm, and leg, due to strain | To be used for temporary reliefof pain associated with sore andaching muscles in the shoulder,waist, back of neck, back, | SameBoth of subject device andpredicate devices can be used inback of neck. | |
| Characteristic | Subject device(TranscutaneousElectrical NerveStimulator, model ST-304) | Predicate device 1(K210756, Neck CareTherapy, model: AST-905H) | Predicate device 2(K172897, Neck Care Therapy, 905B) | Discussion of difference | |
| household and work activities.- Neck electrodes Pads isused in back of neck. | from exercise or normalhousehold and workactivities.- Neck Pad is used in back ofneck.- Meridian Pad is used inshoulder, waist, back, armand leg. | arm, and leg, due to strain fromexercise or normal householdand work activities.- Neck Pad is used in back ofneck.- Meridian Pad is used inshoulder, waist, back, and arm. | |||
| target population | adults | adults | adults | Same | |
| Power Source | Main Unit: 3.7Vdc,1200mAh Rechargeablelithium batteryPower Adaptor:Input: 100-240V~,50/60Hz,0.7AOutput :5V $=$ 1000mA | Main Unit: 3.7Vdc,2200mAh lithium batteryPower Adaptor:Input: 100~240Vac,50/60Hz, 0.2A;Output: 5Vdc, 1ARemote Control:Battery: 3Vdc, 1.5V, AAA x2 | Main Unit:Power Adaptor:Input:100~240Vac,50/60Hz,0.2A;Output: 5Vdc, 1ABattery: 3.7Vdc, 500mAhRemote Control:Battery: 3Vdc, AAA x 2Unit Input: 5Vdc,1A | DifferentSee D1 | |
| Method of linecurrent isolation | Type BF AppliedPart | Type BF AppliedPart | Type BF AppliedPart | Same | |
| PatientLeakageCurrent | Normalcondition | AC:23.3 $\mu$ ADC: $\le$ 1 $\mu$ A | AC:54.5 $\mu$ ADC:0.5 $\mu$ A | AC:54.5 $\mu$ ADC:0.5 $\mu$ A | DifferentSee D2 |
| Single fault | AC: 6.7 $\mu$ A, | AC:120.0 $\mu$ A | AC:120.0 $\mu$ A | Different | |
| Characteristic | Subject device(TranscutaneousElectrical NerveStimulator, model ST-304) | Predicate device 1(K210756, Neck CareTherapy, model: AST-905H) | Predicate device 2(K172897, Neck Care Therapy,905B) | Discussion of difference | |
| condition | DC: $\u2264$ 1 \u03bcA | DC:0.6 \u03bc A | DC:0.6 \u03bc A | See D2 | |
| Average current throughelectrodes when device ison but no pulses are beingapplied | < 0.01 \u03bc A | < 0.01 \u03bc A | < 0.01 \u03bc A | Same | |
| Number of OutputModes | 3 | 3 | 2 | Same | |
| Output Intensity Level | For stimulating:15For heating:1 | For stimulating:50For heating:3 | 50 steps | DifferentSee D3 | |
| Heating temperature | 32-38°C | 30-40°C | NA | DifferentSee D4 | |
| Numberof OutputChannels | Number1SynchronousorAlternating? | 1Synchronous | 1Synchronous | Same | |
| Method ofChannelIsolation | Voltage TransformIsolation | Voltage TransformIsolation | Voltage TransformIsolation | Same | |
| Regulated Current orRegulated Voltage? | Voltage Control | Voltage Control | Voltage Control | Same | |
| Software/Firmware/Microprocessor Control? | Yes | Yes | Yes | Same | |
| Automatic Overload Trip? | No | No | No | Same | |
| Automatic No-Load Trip? | No | No | No | Same | |
| Characteristic | Subject device(TranscutaneousElectrical NerveStimulator, model ST-304) | Predicate device 1(K210756, Neck CareTherapy, model: AST-905H) | Predicate device 2(K172897, Neck Care Therapy, 905B) | Discussion of difference | |
| Automatic Shut Off? | Yes | Yes | Yes | Same | |
| User Override Control? | Yes | Yes | Yes | Same | |
| Indicator | On/Off Status? | Yes | Yes | Yes | Same |
| Display | Low Battery? | Yes | Yes | Yes | Same |
| Voltage/ CurrentLevel? | Yes | Yes | Yes | Same | |
| Timer Range(minutes) | 10min | 5-30 min | 5-30 min | DifferentSee D5 | |
| ANSI AAMI ES60601-1ES60601-1:2005/(R)2012and A1:2012,C1:2009/(R)2012 andA2:2010/(R)2012(Consolidated Text) | Yes | Yes | Yes | Same | |
| ANSI AAMI ES60601-1-2 :2014 | Yes | Yes | Yes | Same | |
| IEC 60601-2-10 Edition 2.12016-04 | Yes | Yes | Yes | Same | |
| Weight | 145g (only main unit) | For Main Unit:AST-905H: 178gFor Electrode:Patch Electrode: 44g | Main Unit:AST-905B: 222gElectrode:Patch Electrode: 44g | DifferentSee D6 | |
| Dimensions (mm)(W x H x D) | Main unit: 145 (W) × 140 (L) × 53 (H) (mm) | AST-905H:173.4156.343.4 mmFor Electrode: | Main Unit:AST-905B: 187.216967.3 mmElectrode: Patch Electrode: 8.9 | DifferentSee D7 | |
| Characteristic | Subject device(TranscutaneousElectrical NerveStimulator, model ST-304) | Predicate device 1(K210756, Neck CareTherapy, model: AST-905H) | Predicate device 2(K172897, Neck Care Therapy,905B) | Discussion of difference | |
| Neck electrode pad:$3,0cm×4,0cm$Effective area for eachNeck electrodepad: $10cm²$ | Meridian Pad: $8.9*5.8cm$Effective area: $50.04cm²$Neck Pad: $42.3 mm x29.5$mm | cm $*5.8 cm$ | |||
| Housing Materials andConstruction | For Neck electrode pad:Titanium material (Gr2) | For Electrode Pads:White silica gel, Blackconductive silicone,Transparentconductive adhesivesilicone, TransparentPET siliconeFor Neck Pad: Stainlesssteel | Electrode Pads:White silica gel, Black conductivesilicone, Transparent conductiveadhesive silicone, TransparentPET siliconeSticky metal sheet: Stainlesssteel | DifferentSee D8 | |
| For Unit Housing: ABSPlastic and silica gel | For Unit Housing: ABSplastic | Housing unit: ABS plastic | |||
| Characteristic | Subject device(TranscutaneousElectrical NerveStimulator, model ST-304) | Predicate device 1(K210756, Neck CareTherapy, model: AST-905H) | Predicate device 2(K172897, Neck Care Therapy, 905B) | Discussion of difference | |
| Waveform | Mode 1:Pulsed, symmetric, biphasicMode 2: Pulsed, symmetric, biphasic | Pulsed, symmetric, biphasic | Pulsed, symmetric, biphasic | Same | |
| Shape (e.g., rectangular, spike, rectified sinusoidal) | Mode 1:Rectangular, with interphase intervalMode 2:Rectangular, with interphase interval | Rectangular, with interphase interval | Rectangular, with interphase interval | Same | |
| Maximum OutputVoltage (± 10%) | Mode 1:$44V @ 500 Ω$$80V @ 2 kΩ$$112V @ 10 kΩ$Mode 2:$42V @ 500 Ω$$78V @ 2 kΩ$$105V @ 10 kΩ$ | $44V±10% @ 500 Ω$$80V±10% @ 2kΩ$$112V±10% @ 10kΩ$ | $44V±10% @ 500 Ω$$80V±10% @ 2kΩ$$112V±10% @ 10kΩ$ | DifferentSee D 9 | |
| Maximum OutputCurrent (± 10%) | Mode 1:$88mA @ 500 Ω$$40mA @ 2 kΩ$ | $88mA @ 500 Ω$$40mA @ 2 kΩ$$11.2mA @ 10 kΩ$ | $88mA @ 500 Ω$$40mA @ 2 kΩ$$11.2mA @ 10 kΩ$ | DifferentSee D10 | |
| Characteristic | Subject device(TranscutaneousElectrical NerveStimulator, model ST-304) | Predicate device 1(K210756, Neck CareTherapy, model: AST-905H) | Predicate device 2(K172897, Neck Care Therapy,905B) | Discussion of difference | |
| 11.2mA @ 10 KΩ | |||||
| Mode 2:84mA @ 500 Ω39mA @ 2 KΩ10.5mA @ 10 KΩ | |||||
| Pulse Width | Mode 1:120 μ s ± 10% | 120 μ s | 120 μ s | Same | |
| Mode 2:120 μ s ± 10% | |||||
| Frequency | Mode 1:77.3Hz ±10% | 77.3Hz | 77.3Hz | Same | |
| Mode 2:77.3Hz ±10% | |||||
| Net Charge (µC/pulse) | Mode 1:0 µC @ 500ΩMethod: balancedwaveform | 0 µC @ 500ΩMethod: balanced waveform | 0 µC @ 500ΩMethod: balanced waveform | Same | |
| Mode 2:0 µC @ 500ΩMethod: balancedwaveform | |||||
| Maximum Phase Charge(μC) | Mode 1:10.3µC@ 500ΩMode 2: | 10.56 (µC) @ 500Ω | 12.78 (μC) @ 500Ω | DifferentSee D 11 | |
| Characteristic | Subject device(TranscutaneousElectrical NerveStimulator, model ST-304) | Predicate device 1(K210756, Neck CareTherapy, model: AST-905H) | Predicate device 2(K172897, Neck Care Therapy,905B) | Discussion of difference | |
| 9.6μC@ 500Ω | |||||
| Maximum Current Density,(mA / cm², r.m.s.) @ 500Ω | Mode 1:2.2mA/cm² | 0.0326 mA/cm² | 0.235 mA/cm² | DifferentSee D 12 | |
| Mode 2:2.2mA/cm² | |||||
| Maximum Average PowerDensity (mW/cm²) | Mode 1:0.36mW/cm² @500Ω | 0.0000266mW/cm² @500Ω | 1.38 mW/cm² | DifferentSee D 13 | |
| Mode 2:0.32mW/cm² @500Ω | |||||
| BurstMode(i.e.,pulsetrains) | Pulses per burst | N/A, no burst mode | Not public | Not public | DifferentSee D14 |
| Bursts persecond | |||||
| Burst duration(seconds) | |||||
| Duty Cycle [Line(b) x Line (c) | |||||
| ON Time (seconds) | 240u s ± 10% | Not public | Not public | DifferentSee D 15 | |
| OFF Time (seconds) | 12.8ms ±10% | Not public | Not public | DifferentSee D 16 | |
| Characteristic | Subject device(TranscutaneousElectrical NerveStimulator, model ST-304) | Predicate device 1(K210756, Neck CareTherapy, model: AST-905H) | Predicate device 2(K172897, Neck Care Therapy,905B) | Discussion of difference | |
| Operating Environment | Temperature: 10~38°CHumidity: 30% -75%RHAtmospheric Pressure:860 hPa -1060 hPa | Temperature: 10~40°CHumidity: 15% - 90%RHAtmospheric Pressure: 700hPa to 1060 hPa | Temperature: 5~40°CHumidity: 15% - 90%RHAtmospheric Pressure: 700 hPato 1060 hPa | DifferentSee D 17 | |
| Storage Environment | Temperature: -25~70°CHumidity: ≤90%RHAtmospheric Pressure: 860hPa -1060 hPa | Temperature: -25~70°CHumidity: ≤90%RHAtmospheric Pressure: 860hPa -1060 hPa | Temperature: -25~70°CHumidity: ≤90%RHAtmospheric Pressure: 860 hPa-1060 hPa | Same | |
| Biocompatibility | Biocompatibility testaccording to ISO 10993-5and ISO 10993-10 | Biocompatibility testaccording to ISO 10993-5and ISO 10993-10 | Biocompatibility test according toISO 10993-5 and ISO 10993-10 | Same | |
| Electrical Safety | Comply with ANSI AAMIES60601-1: 2005/(R)2012and A1: 2012 andIEC60601-2-10 Edition 2.12016-04 | Comply with IEC 60601-1and IEC 60601-2-10 | Comply with IEC 60601-1 andIEC 60601-2-10 | Same | |
| EMC | Comply with ANSI AAMIIEC 60601-1-2:2014 | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Same |
{9}------------------------------------------------
{10}------------------------------------------------
{11}------------------------------------------------
{12}------------------------------------------------
Output Specifications – Comparison with Predicate Devices
{13}------------------------------------------------
{14}------------------------------------------------
{15}------------------------------------------------
{16}------------------------------------------------
{17}------------------------------------------------
The discussion of differences exist between the subject and predicate device is listed in following:
- D1: The subject device has demonstrated electromagnetic compatibility and electrical safety by ANSI AAMI ES60601-1 and ANSI AAMI IEC 60601-1-2 testing. Therefore, the difference does not raise the issue of product's safety and effectiveness.
- D2: The subject device has demonstrated electrical safety by passing ANSI AAMI ES60601-1 and IEC 60601-2-10 tests. Therefore, the difference does not raise the issue of product's safety and effectiveness.
- D3: The subject device and predicate devices have differences in Intensity Level for stimulation modes. However, both of subject device and predicate devices have the same indications, frequency, waveform, shape and pulse width. The Maximum Output Voltage and Maximum Output Current of subject device under stimulation modes are equivalent and with the same range as that of the predicate devices.
The heating level of subject device is only one but the Heating temperature range of subject device is within the range of that of the predicate device1(K210756, Neck Care Therapy, model: AST-905H).
Furthermore, the subject device has demonstrated electrical safety by passing ANSI AAMI ES60601-1 and IEC 60601-2-10 tests.
Therefore, the difference will not affect the safety and effectiveness of the subject device compared to the predicate device.
The heating temperature range of subject device is within the range of the predicate device 1(K210756, Neck Care Therapy, model: AST-905H).
- D4: The subject device has demonstrated electrical safety by passing ANSI AAMI ES60601-1 and IEC 60601-2-10 tests. Therefore, the difference will not affectiveness of the subject device compared to the predicate device.
- D5: The timer range of subject device is covered by the range of predicate devices, so the difference doesn't affect the safety and effectiveness of the subject device compared to the predicate device.
- D6: The Weight will not affect the safety and effectiveness of the subject device compared to the predicate device.
- D7: The dimensions will not affect the safety and effectiveness of the subject device compared to the predicate device.
- D8: The Housing Materials and Construction forms the basic construction and ensure the basic safety of device, since the proposed device has demonstrated electrical safety by passing ANSI AAMI ES60601-1 and IEC 60601-2-10 tests, the difference will not affect the safety of the subject device compared to the predicate device.
- D9: There is a small difference in the maximum output voltage for Mode 2 of the subject device compared to the predicate devices. The predicate devices are safe and effective with its output voltage range. Although there is a small difference, the performance testing and electrical safety testing conducted according to ANSI AAMI ES60601-1 and IEC 60601-2-10 for the subject device has demonstrated that the subject device is as safe and effective as the predicate device. Therefore, the difference does not raise the issue of product's safety and effectiveness.
- D10: There is a small difference in the output current of Mode 2 of the subject device compared to the predicate devices. The predicate devices are safe and effective with its output current range. Although there is a small difference, the performance testing and electrical safety testing to ANSI AAMI ES60601-1 and IEC 60601-2-10 for the subject device has demonstrated that the subject device is as safe and effective with its output current as the predicate device. Therefore, the difference does not raise the issue of product's safety and effectiveness.
- D11: The small difference in Maximum Phase Charge between the subject device and predicate devices are acceptable and the subject device has demonstrated electrical safety by passing ANSI AAMI ES60601-1 and IEC 60601-2-10 tests. Therefore, the difference does not raise the issue of product's safety and effectiveness.
- D12: The proposed device has a small difference in maximum current density than the predicate devices. The subject device has also demonstrated electrical safety by passing ANSI AAMI ES60601-1 and IEC 60601-2-10 tests.
{18}------------------------------------------------
Therefore, the difference does not raise the issue of product's safety and effectiveness.
- D13: There is a small difference in the Maximum Average Power between the subject device and predicate devices. The Maximum Average Power Density of the subject device is greater than predicate device 1 (Neck Care Therapy, model AST-905H) and smaller than the predicate device 2 (K172897, Neck Care Therapy, 905B), at the same time the Maximum Average Power Density of subject device is less than 0.25 Watts/cm². Furthermore, the subject device has demonstrated electrical safety by passing ANSI AAMI ES60601-1 and IEC 60601-2-10 tests. Therefore, the difference does not raise the issue of product's safety and effectiveness.
- D14: The difference regarding Burst Mode between the subject devices are acceptable given that the subject device has demonstrated electrical safety by passing ANSI AAMI ES60601-1 and IEC 60601-2-10 tests. Therefore, the difference does not raise the issue of product's safety and effectiveness.
- D15: The difference in the ON Time between the subject devices is acceptable given that the subject device has demonstrated electrical safety by passing ANSI AAMI ES60601-1 and IEC 60601-2-10 tests. Therefore, the difference does not raise the issue of product's safety and effectiveness.
- D16: The difference in the OFF Time between the subject devices is acceptable given that the subject device has demonstrated electrical safety by passing ANSI AAMI ES60601-1 and IEC 60601-2-10 tests. Therefore, the difference does not raise the issue of product's safety and effectiveness.
- D17: There are differences in the Operating Environment between the subject device and predicate devices. However, the subject device and predicate devices are comply with ANSI AAMI ES60601- 1:2005((R)2012 and A1:2012, ANSI AAMI IEC 60601-1-2:2014, ANSI AAMI HA 60601-1-11:2015 and IEC 60601-2-10 Edition 2.1 2016-04. Therefore, the differences don't raise the issue of product's safety and effectiveness.
7. Discussion of Non-Clinical Tests Performed for Safety and effectiveness are
as follows
The recognized consensus standards for safety of medical equipment: ANSI AAMI ES60601-1, ANSI AAMI HA 60601-1-11 and for safety, IEC 60601-1-2 for electromagnetic compatibility, ISO 10993-5 and ISO 10993-10 for material biological compatibility, IEC 60601-2-10 for performance and IEC 62304 are complied, and see below table for details:
| Standards | Standards Name |
|---|---|
| ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012 | Medical Electrical Equipment - Part 1: General RequirementsFor Basic Safety And Essential Performance |
| ANSI AAMI IEC 60601-1-2:2014 | Medical Electrical Equipment -- Part 1-2: General RequirementsFor Basic Safety And Essential Performance -- CollateralStandard: Electromagnetic Disturbances -- Requirements AndTests |
| ANSI AAMI HA 60601-1-11:2015 | Medical Electrical Equipment - Part 1-2: General RequirementsFor Basic Safety And Essential Performance - CollateralStandard: Electromagnetic Disturbances - Requirements AndTests |
{19}------------------------------------------------
| IEC 60601-2-10 Edition 2.12016-04 | Medical electrical equipment - Part 2-10: Particularrequirements for the basic safety and essential performance ofnerve and muscle stimulators |
|---|---|
| --------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------- |
| IEC 62304 Edition 1.1 2015-06 CONSOLIDATEDVERSION | Medical device software - Software life cycle processes |
|---|---|
| ISO 10993-5 Third edition2009-06-01 | Biological evaluation of medical devices - Part 5: Tests for invitro cytotoxicity |
| ISO 10993-10 Third Edition2010-08-01 | Biological evaluation of medical devices - Part 10: Tests forirritation and skin sensitization |
| ISO 10993-1 Fifth edition2018-08 | Biological evaluation of medical devices - Part 1: Evaluation andtesting within a risk management process |
Software verification and validation was performed for the subject device with Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff, May 2005.
The Output Waveform test was performed for the subject device with Guidance Document for Powered Muscle Stimulator 510(k)s.
8. Discussion of Clinical Accuracy Testing Performed
FUTURE determined that bench and non-clinical testing were sufficient to demonstrate that Transcutaneous Electrical Nerve Stimulator, model: ST-304 is as safe and effective as the predicate device.
9. Conclusions
The electrical safety, EMC, biocompatibility, software verification, basic unit characteristics, and output specifications information provided is sufficient to demonstrate substantial equivalence to the predicate devices. As the Transcutaneous Electrical Nerve Stimulator, model: ST-304 is nearly identical to the predicate devices, differences in their characteristics do not raise new questions regarding safety and effectiveness with identical indications for use and essentially identical technological characteristics, the Transcutaneous Electrical Nerve Stimulator, model: ST-304 is substantially equivalent to the predicate devices.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).