Biofeedback Nerve and Muscle Stimulator
Device Facts
| Record ID | K202648 |
|---|---|
| Device Name | Biofeedback Nerve and Muscle Stimulator |
| Applicant | Shenzhen Konmed Technology Co., Ltd. |
| Product Code | IPF · Physical Medicine |
| Decision Date | Dec 8, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5850 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
As a powered muscle stimulator the Biofeedback Nerve and Muscle Stimulator is indicated for the following conditions: · Relaxation of muscle spasm · Prevention or retardation of disuse atrophy ·Increasing local blood circulation · Muscle re-education ·Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis · Maintaining or increasing range of motion As a biofeedback device the Biofeedback Nerve and Muscle Stimulator is indicated for the following conditions: · Biofeedback, relaxation and muscle re-education purposes As a nonimplanted electrical continence device the Biofeedback Nerve and Muscle Stimulator is indicated for the following conditions: · Acute and ongoing treatment of stress, urge or mixed urinary incontinence and where the following results may improve urinary control: Inhibition of the detruser muscles through reflexive mechanisms and strengthening of pelvic floor muscles. ·Incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles such as the abdominal and the gluteus muscles.
Device Story
Battery-powered biofeedback and neuromuscular electrical stimulation (NMES) device (models KM530, KM531). Inputs: EMG signals via vaginal probe or skin electrodes. Operation: Device processes EMG signals to provide biofeedback (games, EMG testing) or triggers electrical stimulation (ETS) when thresholds are met; also offers passive STIM programs. Used in clinical or home settings under prescription. Output: Dual-channel EMG acquisition and dual-channel electrical stimulation. Healthcare providers use output to monitor muscle activity and guide rehabilitation; patients use biofeedback for muscle re-education and incontinence management. Benefits: Improved urinary control, muscle strengthening, and rehabilitation.
Clinical Evidence
Bench testing only. No clinical data provided. Compliance verified via electrical safety (IEC 60601-1, 60601-1-2, 60601-1-11, 60601-2-10, 60601-2-40) and biocompatibility (ISO 10993-5, ISO 10993-10) for patient-contacting components (electrode patches, vaginal probe). Software verification and validation performed per FDA guidance.
Technological Characteristics
Battery-powered (7.4V/1200mAh Li-ion). Dual-channel EMG acquisition (3kHz sampling, 20-500Hz bandwidth, RMS processing) and dual-channel electrical stimulation. Materials: ABS plastic, stainless steel (probe); fabric/foam/conductive hydrogel (electrodes). Connectivity: Wired. Standards: IEC 60601-1, 60601-1-2, 60601-1-11, 60601-2-10, 60601-2-40. Software: Microprocessor-controlled with automatic overload/no-load trip and patient override.
Indications for Use
Indicated for adults requiring muscle stimulation (spasm, atrophy, circulation, re-education, post-surgical thrombosis prevention, range of motion), biofeedback/relaxation training, or treatment of stress, urge, or mixed urinary incontinence via pelvic floor muscle strengthening and detrusor inhibition. Also indicated for EMG assessment of pelvic floor and accessory muscles.
Regulatory Classification
Identification
A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.
Predicate Devices
- STIWELL med4/ Model: 900101S (K080950)
Reference Devices
Submission Summary (Full Text)
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December 8, 2020
Shenzhen Konmed Technology Co., Ltd. % Tracy Che Registration Engineer Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90, Qianhai Road Shenzhen, Guangdong 518052 China
Re: K202648
Trade/Device Name: Biofeedback Nerve and Muscle Stimulator Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF, KPI, HCC Dated: September 7, 2020 Received: September 11, 2020
Dear Tracy Che:
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.
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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) 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,
for Heather Dean, PhD Assistant Director DHT5B: Division of Physical Medicine- Acute Injury Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
### 510(k) Number (if known) K202648
Device Name
Biofeedback Nerve and Muscle Stimulator (Model: KM530, KM531)
Indications for Use (Describe)
As a powered muscle stimulator the Biofeedback Nerve and Muscle Stimulator is indicated for the following conditions:
· Relaxation of muscle spasm
· Prevention or retardation of disuse atrophy
·Increasing local blood circulation
· Muscle re-education
·Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
· Maintaining or increasing range of motion
As a biofeedback device the Biofeedback Nerve and Muscle Stimulator is indicated for the following conditions: · Biofeedback, relaxation and muscle re-education purposes
As a nonimplanted electrical continence device the Biofeedback Nerve and Muscle Stimulator is indicated for the following conditions:
· Acute and ongoing treatment of stress, urge or mixed urinary incontinence and where the following results may improve urinary control: Inhibition of the detruser muscles through reflexive mechanisms and strengthening of pelvic floor muscles.
·Incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles such as the abdominal and the gluteus muscles.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|----------------------------------------------|
| | Prescription Use (Part 21 CFR 801 Subpart D) |
| | Over-The-Counter Use (21 CFR 801 Subpart C) |
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# 510 (k) Summary
# K202648
This "510(k) Summary" of 510(k) safety and effectiveness information is submitted in accordance with requirements of Title 21, CFR Section 807.92.
# (1) Applicant information:
| 510(k) owner's name: | Shenzhen Konmed Technology Co., Ltd. |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 601, Building B4, Shenchengtou Creative Factory Life Science Park<br>Julongshan A Road, Xiuxin Block, Kengzi Street, Pingshan District,<br>Shenzhen, Guangdong, CHINA, 518118 |
| Contact person: | Shuishan Yin |
| Title | General manager |
| Phone number: | +86 755 8670 4556 |
| Fax number: | +86 755 8670 4556 |
| Email: | 2519021651@qq.com |
| Date of summary prepared: | December 3, 2020 |
# (2) Reason for the submission
New device, there were no prior submissions for the device.
# (3) Proprietary name of the device
| Trade name/model: | Biofeedback Nerve and Muscle Stimulator/ KM530, KM531 | |
|--------------------|-------------------------------------------------------------------------------------------------|--|
| Common name: | Powered muscle stimulator<br>Non-implantable electrical continence device<br>Biofeedback device | |
| Regulation number: | 21 CFR 890.5850<br>21 CFR 876.5320<br>21 CFR 882.5050 | |
| Product code: | IPF, KPI, HCC | |
| Review panel: | Physical Medicine<br>Gastroenterology/Urology<br>Neurology | |
| Regulation class: | Class II | |
# (4) Predicate and reference device
#### > Predicate device
| Sponsor | Otto Bock Healthcare Product GmbH |
|---------|-----------------------------------|
|---------|-----------------------------------|
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| Device Name and Model | STIWELL med4/ Model: 900101S |
|-----------------------|---------------------------------------------------------------------------------------------|
| 510(k) Number | K080950 |
| Product Code | IPF, GZI, KPI, GZJ, HCC |
| Regulation Number | 21 CFR 890.5850<br>21 CFR 876.5320<br>21 CFR 882.5050<br>21 CFR 882.5890<br>21 CFR 882.5810 |
| Regulation Class | II |
- V Reference device
| Sponsor | Thought Technology Ltd | Mantra International (HK) Ltd |
|-----------------------|-------------------------------------------------------|-------------------------------|
| Device Name and Model | MyoTrac Infiniti System | Kegel8 |
| 510(k) Number | K053434 | K081480 |
| Product Code | IPF, KPI, HCC | KPI |
| Regulation Number | 21 CFR 890.5850<br>21 CFR 882.5050<br>21 CFR 876.5320 | 21CFR876.5320 |
| Regulation Class | II | II |
# (5) Description/ Design of device:
This Biofeedback Nerve and Muscle Stimulator is a new type of biofeedback and neuromuscular electrical stimulation therapy device through the evaluation of myoelectric signal acquisition, multimedia biofeedback training, electromyography triggered electrical stimulation, passive electrical stimulation training and treatment.
There are two models of Biofeedback Nerve and Muscle Stimulator which are KM530 and KM531. Their intended use, working principle, product structure and major parameters are all same, apart from the difference of product appearance, and KM531 has several more programs than KM530.
The device is battery-powered with a display screen and offers the user a choice of EMG Test (Only for EMG acquisition, not for electrical stimulation), EMG Game (6 biofeedback responsebased vivid games, active training for the user to contract the muscles of the treatment area, no electrical stimulation is generated), ETS (electromyography triggered stimulation; Only when the EMG value reaches the set threshold, the electrical stimulation is triggered; This module is a combination of active and passive treatment module, which exercise the self-contracting ability of the user), and STIM (Neuromuscular stimulation with fixed programs and customized programs of which parameters can be adjusted under the directions of physicians or professionals).
The device is supplied with vaginally inserted probe used with the device to stimulate the muscle of the pelvic floor (the probe is identical to that used in the model KM518 with 510(k) number
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K163288). Anal probe is optional, user can choose to purchase qualified probe. The device is supplied with biofeedback reference lead wire with skin electrodes. The device main unit connects directly to the vaginal electrode and reference wire by cable and plug. The device provides independent dual-channel EMG signals acquisition and dual-channel electrical stimulation output which is convenient for the treatment of different sites.
# (6) Indications for use:
As a powered muscle stimulator the Biofeedback Nerve and Muscle Stimulator is indicated for the following conditions:
- Relaxation of muscle spasm
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Immediate post- surgical stimulation of calf muscles to prevent venous thrombosis
- Maintaining or increasing range of motion
As a biofeedback device the Biofeedback Nerve and Muscle Stimulator is indicated for the following conditions:
- Biofeedback, relaxation and muscle re-education purposes
As a nonimplanted electrical continence device the Biofeedback Nerve and Muscle Stimulator is indicated for the following conditions:
● Acute and ongoing treatment of stress, urge or mixed urinary incontinence and where the following results may improve urinary control: Inhibition of the detruser muscles through reflexive mechanisms and strengthening of pelvic floor muscles.
● Incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles such as the abdominal and the gluteus muscles.
| Component<br>name | Material of Component | Body Contact Category | Contact Duration |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|--------------------|
| Electrode<br>patches | Three layers:<br>1. Insulation backing<br>material:<br>Fabric/Foam/Tan fabric<br>2. Conductive film:<br>Carbon film/Carbon film<br>coated with silver/Aluminum<br>foil film | Surface-contacting<br>device: Intact skin | Less than 24 hours |
# (7) Materials
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| 3. Conductive hydrogel<br>(A, T or U gel) | | | |
|-------------------------------------------|------------------------------|---------------------------------------------|--------------------|
| Vaginal probe | ABS plastic, stainless steel | Surface-contacting device: Mucosal membrane | Less than 24 hours |
We have selected 510(k) cleared electrode patches to be used with our device, its 510(k) number is K160138 (model: OCWN2505), and its biocompatibility complies with ISO 10993. The vaginal probe is the same probe with that used in another model KM518 manufactured by our company, which has already obtained 510(k) number K163288 on 01/18/2018, biocompatibility test reports were submitted during that application. For details, please refer to "Biocompatibility Discussion".
# (8) Technological characteristics and substantial equivalence:
| Item | Targeted device | Predicate device 1 | Reference device 1 | Reference device<br>2 | Remark |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Trade name | Biofeedback Nerve<br>and<br>Muscle<br>Stimulator | STIWELL med4/<br>Model: 900101S | MyoTrac<br>Infiniti<br>System | Kegel8 | / |
| 510 (k)<br>number | K202648 | K080950 | K053434 | K081480 | / |
| Manufacturer | Shenzhen Konmed<br>Technology Co.,<br>Ltd | Otto Bock<br>Healthcare Product<br>GmbH | Thought Technology<br>Ltd | Mantra<br>International (HK)<br>Ltd | / |
| Regulation<br>number | 21 CFR 890.5850<br>21 CFR 876.5320<br>21 CFR 882.5050 | 21 CFR 890.5850<br>21CFR876.5320<br>21CFR882.5050<br>21CFR882.5890<br>21CFR882.5810 | 21 CFR 890.5850<br>21 CFR 882.5050<br>21CFR876.5320 | 21CFR876.5320 | Same |
| Regulation<br>description | Powered muscle<br>stimulator;<br>Nonimplanted<br>electrical continence<br>device;Biofeedback<br>device | Powered muscle<br>stimulator;<br>Nonimplanted<br>electrical continence<br>device;Biofeedbackd<br>evice;<br>Transcutaneouselectr<br>icalnervestimulatorfo<br>rpainrelief;Externalfu<br>nctionalneuromuscul<br>arstimulator | Powered muscle<br>stimulator;Biofeedb<br>ackdevice;<br>Nonimplanted<br>electrical continence<br>device | Non-implanted<br>electrical<br>continence device | Same |
| Product code | IPF, KPI, HCC | IPF, KPI, HCC,<br>GZJ,GZI | IPF, HCC, KPI | KPI | Same |
| Class | II | II | II | II | Same |
| Indications<br>for use/<br>Intended use | | | | | |
| | As a powered<br>muscle stimulator<br>the Biofeedback<br>Nerve and Muscle<br>Stimulator is<br>indicated for the<br>following<br>conditions:<br>· Relaxation of<br>muscle spasm<br>· Prevention or<br>retardation of disuse<br>atrophy<br>· Increasing local<br>blood circulation<br>· Muscle re-<br>education<br>· Immediate post-<br>surgical stimulation<br>of calf muscles to<br>prevent venous<br>thrombosis<br>· Maintaining or<br>increasing range of<br>motion<br>As a biofeedback<br>device the<br>Biofeedback Nerve<br>and Muscle<br>Stimulator is<br>indicated for the<br>following<br>conditions:<br>· Biofeedback,<br>relaxation and<br>muscle re-education<br>purposes<br>As a nonimplanted<br>electrical continence<br>device the<br>Biofeedback Nerve<br>and Muscle | The STIWELL med4<br>is a neuromuscular<br>electronic stimulator<br>indicated for use<br>under medical<br>supervision for<br>adjunctive therapy in<br>the treatment of<br>medical diseases and<br>conditions.<br>As a powered muscle<br>stimulator the<br>STIWELL med4 is<br>indicated for the<br>following conditions:<br>· Relaxation of<br>muscle spasm<br>· Prevention or<br>retardation of disuse<br>atrophy<br>· Increasing local<br>blood circulation<br>· Muscle re-<br>education<br>· Immediate post-<br>surgical stimulation<br>of calf muscles to<br>prevent venous<br>thrombosis<br>· Maintaining or<br>increasing range of<br>motion<br>As a transcutaneous<br>electrical nerve<br>stimulator for pain<br>relief the STIWELL<br>med4 is indicated for<br>the<br>followingconditions:<br>· Symptomatic relief<br>and management of<br>chronic (long-term),<br>intractable pain<br>· Adiunctive | The MyoTrac<br>Infiniti system is<br>indicated for acute<br>and ongoing<br>treatment ofstress,<br>urge or mixed<br>urinary incontinence<br>and where the<br>following results<br>mayimprove urinary<br>control: Inhibition of<br>the detruser muscle<br>through reflexive<br>mechanisms,<br>strengthening of<br>pelvic floor muscle.<br>It is also indicated<br>duringincontinence<br>treatment for<br>assessing EMG<br>activity of the pelvic<br>floor and accessory<br>muscles such as the<br>abdominal or gluteal<br>muscles.<br>The MyoTrac<br>Infiniti system is<br>also indicated for the<br>ongoing treatment of<br>thefollowing<br>conditions:<br>Relaxation ofMuscle<br>Spasms, Prevention<br>or retardation of<br>disuse atrophy,<br>increasing local<br>blood circulation,<br>immediate post-<br>surgical<br>stimulation of calf<br>muscles to prevent<br>venous thrombosis,<br>Maintaining or<br>increasingrange of | The 'Kegel8' Pelvic<br>Muscle Trainer is<br>intended to provide<br>electrical<br>stimulation and<br>neuromuscular re-<br>education for<br>the purpose of<br>rehabilitation of<br>weak pelvic floor<br>muscles for the<br>treatment of stress<br>urge and mixed<br>urinary<br>incontinence in<br>Women. | Similar,<br>the<br>indications for<br>use of<br>the<br>targeted<br>device is<br>within<br>that of<br>the<br>predicate<br>device |
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| Stimulator is<br>indicated for the<br>followingconditions<br>: | treatment in the<br>management of post-<br>surgical pain and<br>post traumatic acute<br>pain. | motion and Stroke<br>Rehab by Muscle re-<br>education. It is also<br>used for<br>Biofeedback,<br>Relaxation &<br>MuscleRe-<br>Education purposes. |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| • Acute and ongoing<br>treatment of stress,<br>urge or mixed<br>urinary incontinence<br>and where the<br>following results<br>may improve<br>urinary control:<br>Inhibition of the<br>detruser muscles<br>through reflexive<br>mechanisms and<br>strengthening of<br>pelvic floor muscles<br>• Incontinence<br>treatment for<br>assessing EMG<br>activity of the pelvic<br>floor and<br>accessorymuscles<br>such as the<br>abdominal and the<br>gluteus muscles | As a biofeedback<br>device the STIWELL<br>med4 is indicated for<br>the following<br>conditions:<br>• Biofeedback,<br>relaxation and<br>muscle re-education<br>purposes<br>As an external<br>functional<br>neuromuscular<br>stimulator the<br>STIWELL med4 is<br>indicated for the<br>following conditions:<br>• Helps to relearn<br>voluntary motor<br>functions of the<br>extremities<br>As a nonimplanted<br>electrical continence<br>device the STIWELL<br>mad4 is indicated for<br>the following<br>conditions:<br>• Acute and ongoing<br>treatment of stress,<br>urge or mixed<br>urinary incontinence<br>and where the<br>following results<br>may improve urinary<br>control: Inhibition of<br>the detruser muscles<br>through reflexive<br>mechanisms and<br>strengthening of<br>pelvic floor muscles | |
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| | | | · Incontinence<br>treatment for<br>assessing EMG<br>activity of the pelvic<br>floor and accessory<br>muscles such as the<br>abdominal and the<br>gluteus muscles | | | |
|------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|---------------------|---------------------|
| Patient<br>population | Adult | Adult | Adult | Adult | Prescription | Same |
| Location for<br>use | Prescription | Prescription | Prescription | Prescription | Prescription | Same |
| Basic unit specification | | | | | | |
| Power<br>supply | 7.4V DC/1200mAh<br>rechargeable lithium<br>battery | Battery Pack Li-lon<br>11.1V | 4X AAA 1.5<br>Alkaline or<br>rechargeable NiMH<br>Battery pack<br>6VDC-15W Medical<br>Class II power<br>adapter | 9V PP3 | | Different<br>Note 1 |
| Method<br>Line Current<br>Isolation | N/A | Medical Class II<br>Power Adapter | N/A | N/A-<br>powered | Battery | Same |
| Leakage<br>current<br>- Normal<br>condition<br>- Single fault<br>condition | N/A (Battery) | N/A (Battery) | N/A | N/A-<br>powered | Battery | Same |
| Number of<br>output modes | 2 | 1 | / | 1 | | Different<br>Note 2 |
| Number of<br>output<br>channel | 2 | 4 | / | 2 | | Same |
| Synchronous<br>or<br>Alternating? | Synchronous | Alternating | | Synchronous/<br>Alternating | | Similar |
| Method of<br>channel<br>isolation | Transformer | Transformer,<br>inductive couplers | / | Individually<br>isolated circuits | | Same |
| Software/<br>Firmware/ | Yes | Yes | Yes | Yes | | Same |
| Microprocess<br>or Control? | | | | | | |
| Automatic<br>Overload<br>trip | Yes | Yes | / | Not<br>publicly<br>available | Same | |
| Automatic<br>no-load trip | Yes | Yes | / | Not<br>publicly<br>available | Same | |
| Patient<br>override<br>control<br>method | Yes | Yes (Stop Button) | / | Not<br>publicly<br>available | Similar | |
| Indicator<br>display<br>-On/Off<br>status<br>-Low battery<br>-Output<br>mode<br>-Time to cut-<br>off<br>-Voltage/<br>current level | Yes | Yes | / | Yes | Same | |
| Automatic<br>Shut Off | Yes | Yes | / | Yes | Same | |
| Timer range | 1-99min, adjustable | 2-120min | / | Up to 90 | Similar | |
| Dimensions | KM530:<br>140.5×25.5×69mm<br>KM531:<br>146.5×29×74mm | 175×95×30mm | / | 6.2cm W x 2.3cm<br>D x 10.8cm H<br>[2.4" W x 0.9" D x<br>4.25" H] | Different<br>Note 3 | |
| Weight | KM530: 192 g<br>KM531: 230g | 440g | / | 0.07<br>Kg without<br>battery, 0.1KG<br>with battery | Different<br>Note 3 | |
| Housing<br>material and<br>construction | Plastic | Plastics | / | / | Same | |
| Compliance<br>with<br>voluntary<br>standards | IEC 60601-1;<br>IEC 60601-1-2;<br>IEC 60601-2-10;<br>IEC 60601-1-11;<br>IEC 60601-2-40 | IEC 60601-1;<br>IEC 60601-1-2;<br>IEC 60601-2-10 | / | IEC 60601-1;<br>IEC 60601-1-2;<br>IEC 60601-2-10 | Same | |
| Compliance<br>with 21CFR<br>898 | Yes | Yes | Yes | Yes | Same | |
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| Output specifications | | | | | |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| Waveform | Pulsed symmetric,<br>asymmetric,<br>biphasic square<br>wave | Pulsed symmetrical,<br>rectangular wave | Asymmetrical<br>Balanced Pulsed<br>Current | Biphasic,<br>Rectangular | Similar |
| Maximum<br>output<br>voltage | 47.2V @ 500Ω<br>108V @ 2kΩ<br>150V@ 10kΩ | 50V @500Ω<br>115V@2kΩ<br>N/A | / | 45V @ 500Ω<br>100V @ 2kΩ<br>190V @ 10kΩ | Similar<br>Within<br>the range<br>of<br>predicate<br>device |
| Maximum<br>output<br>current | 94.4mA @ 500Ω<br>54mA @ 2kΩ<br>15mA@ 10kΩ | 100mA@500Ω<br>58mA@2kΩ<br>N/A | 100mA | 90mA @ 500Ω<br>50mA @ 2kΩ<br>19mA @ 10kΩ | Similar<br>Within<br>the range<br>of<br>predicate<br>device |
| Net Charge<br>(per pulse) | For pulsed<br>symmetric,<br>biphasic: 0µC @<br>500Ω;<br>For pulsed<br>asymmetric,<br>biphasic:<br>15.68μC @ 500Ω | 0µC @ 500Ω | / | 0 [μC] @ 500Ω | Similar<br>Note 4 |
| Maximum<br>Phase<br>Charge<br>(500Ω) | 51.4µC @ 500Ω | EMS: 40µC @500Ω<br>Incontinence: 50µC<br>@ 500Ω | 60μC | 40.5µC @ 500Ω | Similar |
| Maximum<br>current<br>density<br>(500Ω) | 6.01mA/ cm²@<br>500Ω | EMS: 12.5mA/cm²@<br>500Ω<br>Incontinence:<br>4.7mA/cm²@ 500Ω | St-Cloud Vaginal<br>6.76mA/cm²<br>Femelex Vaginal<br>4.76mA/cm²<br>St-Cloud Rectal<br>19.72mA/cm² | 14.1 [mA/cm²] | Similar |
| Maximum<br>power<br>density<br>(500Ω) | 0.012W(12mW)<br>cm2@ 500Ω | /<br>EMS: 7.9mW/cm²@<br>500Ω<br>(0.0079W/cm²@<br>500Ω)<br>Incontinence:<br>23.5μW/cm²@ 500Ω | St-Cloud Vaginal<br>22.84mW/cm²<br>Femelex Vaginal<br>11.32mW/cm²<br>St-Cloud Rectal<br>194mW/cm² | 57 [mW/cm²]<br>At maximum<br>frequency of<br>100Hz, pulse width<br>450µS and current<br>of 90mA<br>PC Electrode area:<br>6.4 cm2 | Similar |
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| Pulse frequency | 2-100Hz | 1-140Hz | 12.5,50,100,200Hz | 2 to 100Hz | Similar |
|------------------------------------|------------------------|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|---------|
| Pulse duration | 50-450μs | 50-400μs | 0.2ms | 50 to 450 [μsec]<br>Program dependent | Similar |
| Biofeedback performance | | | | | |
| Number of EMG channel | 2 | 2 | 2 | / | Same |
| EMG sampling rate | 3kHZ | 3kHz | / | / | Same |
| EMG detection (bipolar/ monopolar) | Bipolar | Bipolar | Bipolar | / | Same |
| EMG range (μV) | 0.2-2000μV | 1-2000μV | 0-5, 0-10, 5-10, 0-<br>20, 5-20, 10-20, 0-<br>50, 10-50, 0-100,<br>50-100,0-200, 50-<br>200, 100-200, 0-<br>500,100-500, 0-<br>1000, 0-2000 | / | Similar |
| EMG bandwidth | 20Hz-500Hz | 70-480Hz | 20Hz-500Hz | / | Same |
| EMG signal processing | Root mean square (RMS) | AVR (Average Rectified Value) | Root mean square (RMS) | / | Same |
# Comparison in details:
Note 1: The targeted device uses lithium battery for power supply which is the same as the predicate device, although the voltage of the two batteries are different, the lithium battery used in the targeted device has been tested according to IEC 62133, so this difference should not raise any problems.
Note 2: The number of output modes are defined by the manufacturer, although it's different from that of the predicate device, the output parameters are similar to that of the predicate device, so this difference should not raise safety and effectiveness problem.
Note 3: Although the appearance, weight and dimensions are different between the targeted and predicate device, these differences are insignificant and do not raise any problems.
Note 4: Although the parameter is different from that of the predicate device, the targeted device has passed IEC 60601-1 and IEC 60601-2-10, so this difference should not affect safety and effectiveness.
# Conclusion:
Biofeedback Nerve and Muscle Stimulator is substantially equivalent to the predicate devices.
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# (9) Non-clinical studies and tests performed:
Non-clinical testings have been conducted to verify that the Biofeedback Nerve and Muscle Stimulator meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate device. The testing results demonstrate that the targeted device complies with the following standards:
- A ANSI AAMI ES 60601-1, Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
- A IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
- A IEC 60601-1-11, Medical electrical equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- > IEC 60601-2-10. Medical electrical equipment -- Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
- A IEC 60601-2-40, Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment
The body-contacting components of this device are electrode patches and vaginal probe. For these components, FDA 510(k) clearance and test reports have been provided. So we have reason to believe that the electrode patches and vaginal probe are safe for the users. They comply with the following standards.
- A ISO 10993-5, Biological Evaluation of Medical Devices -- Part 5: Tests for InVitro Cytotoxicity
- A ISO 10993-10, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.
We have also conducted:
- > Software verification and validation test according to the requirements of the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices"
- The waveform test report has also been conducted to verify the output specifications of…
