(88 days)
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.
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 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.
I am designed to extract acceptance criteria and information about studies that prove a device meets those criteria. However, the provided document is a 510(k) summary for a "Biofeedback Nerve and Muscle Stimulator" and does not contain acceptance criteria in the format typically associated with performance metrics for clinical studies.
Instead, this document focuses on demonstrating substantial equivalence to predicate devices by comparing technical characteristics (e.g., electrical output specifications, EMG performance, safety standards compliance) and indications for use. It outlines the non-clinical tests performed to ensure the device meets design specifications and relevant safety standards.
Therefore, many of the requested fields regarding acceptance criteria, sample size for test sets, expert ground truth, adjudication methods, MRMC studies, or specific effect sizes are not applicable in this context, as the document does not describe a clinical performance study with such endpoints.
Here's a breakdown of the information that is available in the provided text:
1. A table of acceptance criteria and the reported device performance
The document doesn't present specific acceptance criteria in a table; rather, it compares the technical specifications and performance characteristics of the proposed device ("Targeted device") against a "Predicate device" and "Reference devices." The "acceptance" can be inferred as being "similar" or "within the range" of the predicate devices.
| Item | Acceptance Criteria (Implied: Similar to/within range of Predicate) | Reported Device Performance (Targeted Device) | Predicate Device (STIWELL med4) Performance | Reference Device 1 (MyoTrac Infiniti System) Performance | Reference Device 2 (Kegel8) Performance |
|---|---|---|---|---|---|
| General | |||||
| Regulation number | Same as Predicate | 21 CFR 890.5850, 876.5320, 882.5050 | 21 CFR 890.5850, 876.5320, 882.5050, 882.5890, 882.5810 | 21 CFR 890.5850, 882.5050, 876.5320 | 21CFR876.5320 |
| Regulation description | Same as Predicate | Powered muscle stimulator; Nonimplanted electrical continence device; Biofeedback device | Powered muscle stimulator; Nonimplanted electrical continence device; Biofeedback device; Transcutaneous electrical nerve stimulator for pain relief; External functional neuromuscular stimulator | Powered muscle stimulator; Biofeedback device; Nonimplanted electrical continence device | Non-implanted electrical continence device |
| Product code | Same as Predicate | IPF, KPI, HCC | IPF, KPI, HCC, GZJ, GZI | IPF, HCC, KPI | KPI |
| Class | Same as Predicate | II | II | II | II |
| Indications for use | Similar to Predicate | As listed in section (6) | As listed in section (7) of comparison table in document | As listed in section (7) of comparison table in document | As listed in section (7) of comparison table in document |
| Patient population | Adult | Adult | Adult | Adult | Adult |
| Location for use | Prescription | Prescription | Prescription | Prescription | Prescription |
| Basic unit specification | |||||
| Power supply | Similar | 7.4V DC/1200mAh rechargeable lithium battery | Battery Pack Li-lon 11.1V | 4X AAA 1.5 Alkaline or rechargeable NiMH Battery pack 6VDC-15W Medical Class II power adapter | 9V PP3 |
| Method Line Current Isolation | Same | N/A | Medical Class II Power Adapter | N/A | N/A-powered |
| Leakage current | Same | N/A (Battery) | N/A (Battery) | N/A | N/A-powered |
| Number of output modes | Similar (Note 2) | 2 | 1 | / | 1 |
| Number of output channel | Same | 2 | 4 | / | 2 |
| Synchronous or Alternating? | Similar | Synchronous | Alternating | / | Synchronous/Alternating |
| Method of channel isolation | Same | Transformer | Transformer, inductive couplers | / | Individually isolated circuits |
| Software/Firmware/Microprocessor/Control? | Yes | Yes | Yes | Yes | Yes |
| Automatic Overload trip | Yes | Yes | Yes | / | Not publicly available |
| Automatic no-load trip | Yes | Yes | Yes | / | Not publicly available |
| Patient override control method | Yes (similar to Predicate) | Yes | Yes (Stop Button) | / | Not publicly available |
| Indicator display | Yes | Yes | Yes | / | Yes |
| Automatic Shut Off | Yes | Yes | Yes | / | Yes |
| Timer range | Similar | 1-99min, adjustable | 2-120min | / | Up to 90 |
| Dimensions | Different (Note 3) | KM530: 140.5×25.5×69mm; KM531: 146.5×29×74mm | 175×95×30mm | / | 6.2cm W x 2.3cm D x 10.8cm H |
| Weight | Different (Note 3) | KM530: 192 g; KM531: 230g | 440g | / | 0.07 Kg without battery, 0.1KG with battery |
| Housing material and construction | Plastic | Plastic | Plastics | / | / |
| Compliance with voluntary standards | Same | IEC 60601-1, 60601-1-2, 60601-1-11, 60601-2-10, 60601-2-40 | IEC 60601-1, 60601-1-2, 60601-2-10 | / | IEC 60601-1, 60601-1-2, 60601-2-10 |
| Compliance with 21CFR 898 | Yes | Yes | Yes | Yes | Yes |
| Output specifications | |||||
| Waveform | Similar | Pulsed symmetric, asymmetric, biphasic square wave | Pulsed symmetrical, rectangular wave | Asymmetrical Balanced Pulsed Current | Biphasic, Rectangular |
| Maximum output voltage | Similar (within range of predicate) | 47.2V @ 500Ω, 108V @ 2kΩ, 150V@ 10kΩ | 50V @500Ω, 115V@2kΩ, N/A | / | 45V @ 500Ω, 100V @ 2kΩ, 190V @ 10kΩ |
| Maximum output current | Similar (within range of predicate) | 94.4mA @ 500Ω, 54mA @ 2kΩ, 15mA@ 10kΩ | 100mA@500Ω, 58mA@2kΩ, N/A | 100mA | 90mA @ 500Ω, 50mA @ 2kΩ, 19mA @ 10kΩ |
| Net Charge (per pulse) | Similar (Note 4) | For pulsed symmetric, biphasic: 0µC @ 500Ω; For pulsed asymmetric, biphasic: 15.68μC @ 500Ω | 0µC @ 500Ω | / | 0 [μC] @ 500Ω |
| Maximum Phase Charge (500Ω) | Similar | 51.4µC @ 500Ω | EMS: 40µC @500Ω, Incontinence: 50µC @ 500Ω | 60μC | 40.5µC @ 500Ω |
| Maximum current density (500Ω) | Similar | 6.01mA/ cm²@ 500Ω | EMS: 12.5mA/cm²@ 500Ω, Incontinence: 4.7mA/cm²@ 500Ω | St-Cloud Vaginal 6.76mA/cm², Femelex Vaginal 4.76mA/cm², St-Cloud Rectal 19.72mA/cm² | 14.1 [mA/cm²] |
| Maximum power density (500Ω) | Similar | 0.012W(12mW) cm2@ 500Ω | EMS: 7.9mW/cm²@ 500Ω, Incontinence: 23.5μW/cm²@ 500Ω | St-Cloud Vaginal 22.84mW/cm², Femelex Vaginal 11.32mW/cm², St-Cloud Rectal 194mW/cm² | 57 [mW/cm²] |
| Pulse frequency | Similar | 2-100Hz | 1-140Hz | 12.5,50,100,200Hz | 2 to 100Hz |
| Pulse duration | Similar | 50-450μs | 50-400μs | 0.2ms | 50 to 450 [μsec] Program dependent |
| Biofeedback performance | |||||
| Number of EMG channel | Same | 2 | 2 | 2 | / |
| EMG sampling rate | Same | 3kHZ | 3kHz | / | / |
| EMG detection | Same | Bipolar | Bipolar | Bipolar | / |
| EMG range (μV) | Similar | 0.2-2000μV | 1-2000μV | 0-5, 0-10, 5-10, 0-20, 5-20, 10-20, 0-50, 10-50, 0-100, 50-100,0-200, 50-200, 100-200, 0-500,100-500, 0-1000, 0-2000 | / |
| EMG bandwidth | Same | 20Hz-500Hz | 70-480Hz | 20Hz-500Hz | / |
| EMG signal processing | Same | Root mean square (RMS) | AVR (Average Rectified Value) | Root mean square (RMS) | / |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. The document describes non-clinical engineering and bench tests, not a clinical study involving human subjects or data sets that would have a "sample size" or "data provenance" in the traditional sense. Tests were conducted to verify compliance with design specifications and relevant standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. Ground truth, in this context, would refer to defined engineering specifications and international standards, not expert assessments of clinical cases. The "experts" would be the engineers and regulatory compliance personnel who developed and tested the device and verified its adherence to the standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are relevant for studies where there is ambiguity or disagreement in truth determination, typically in clinical assessments. This document pertains to objective engineering and electrical performance tests.
5. 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 device is a Biofeedback Nerve and Muscle Stimulator, not an AI-assisted diagnostic or interpretive device for human "readers." No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This device is not an algorithm, but a physical medical device. Its "standalone" performance refers to its ability to meet its technical specifications and safety standards independent of user interaction (e.g., electrical output, EMG acquisition accuracy, battery performance), which was evaluated through the non-clinical tests mentioned. Specific quantitative standalone performance metrics beyond "meets design specifications" are not provided in this summary.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical tests, the "ground truth" was based on:
- Design Specifications: The manufacturer's own internal design requirements for the device.
- International Standards: Compliance with recognized international standards for medical electrical equipment (e.g., IEC 60601 series) and biological evaluation of medical devices (e.g., ISO 10993 series).
- Predicate Device Characteristics: The performance parameters and characteristics of legally marketed predicate devices, against which the new device was compared to establish substantial equivalence.
8. The sample size for the training set
- Not Applicable. This document does not describe the development of an AI algorithm or a study with a training set.
9. How the ground truth for the training set was established
- Not Applicable. No training set was used.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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 ParkJulongshan A Road, Xiuxin Block, Kengzi Street, Pingshan District,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 stimulatorNon-implantable electrical continence deviceBiofeedback device | |
| Regulation number: | 21 CFR 890.585021 CFR 876.532021 CFR 882.5050 | |
| Product code: | IPF, KPI, HCC | |
| Review panel: | Physical MedicineGastroenterology/UrologyNeurology | |
| Regulation class: | Class II |
(4) Predicate and reference device
> Predicate device
| Sponsor | Otto Bock Healthcare Product GmbH |
|---|---|
| --------- | ----------------------------------- |
{4}------------------------------------------------
| Device Name and Model | STIWELL med4/ Model: 900101S |
|---|---|
| 510(k) Number | K080950 |
| Product Code | IPF, GZI, KPI, GZJ, HCC |
| Regulation Number | 21 CFR 890.585021 CFR 876.532021 CFR 882.505021 CFR 882.589021 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 890.585021 CFR 882.505021 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
{5}------------------------------------------------
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.
| Componentname | Material of Component | Body Contact Category | Contact Duration |
|---|---|---|---|
| Electrodepatches | Three layers:1. Insulation backingmaterial:Fabric/Foam/Tan fabric2. Conductive film:Carbon film/Carbon filmcoated with silver/Aluminumfoil film | Surface-contactingdevice: Intact skin | Less than 24 hours |
(7) Materials
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| 3. Conductive hydrogel(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 device2 | Remark |
|---|---|---|---|---|---|
| Trade name | Biofeedback NerveandMuscleStimulator | STIWELL med4/Model: 900101S | MyoTracInfinitiSystem | Kegel8 | / |
| 510 (k)number | K202648 | K080950 | K053434 | K081480 | / |
| Manufacturer | Shenzhen KonmedTechnology Co.,Ltd | Otto BockHealthcare ProductGmbH | Thought TechnologyLtd | MantraInternational (HK)Ltd | / |
| Regulationnumber | 21 CFR 890.585021 CFR 876.532021 CFR 882.5050 | 21 CFR 890.585021CFR876.532021CFR882.505021CFR882.589021CFR882.5810 | 21 CFR 890.585021 CFR 882.505021CFR876.5320 | 21CFR876.5320 | Same |
| Regulationdescription | Powered musclestimulator;Nonimplantedelectrical continencedevice;Biofeedbackdevice | Powered musclestimulator;Nonimplantedelectrical continencedevice;Biofeedbackdevice;Transcutaneouselectricalnervestimulatorforpainrelief;Externalfunctionalneuromuscularstimulator | Powered musclestimulator;Biofeedbackdevice;Nonimplantedelectrical continencedevice | Non-implantedelectricalcontinence device | Same |
| Product code | IPF, KPI, HCC | IPF, KPI, HCC,GZJ,GZI | IPF, HCC, KPI | KPI | Same |
| Class | II | II | II | II | Same |
| Indicationsfor use/Intended use | |||||
| As a poweredmuscle stimulatorthe BiofeedbackNerve and MuscleStimulator isindicated for thefollowingconditions:· Relaxation ofmuscle spasm· Prevention orretardation of disuseatrophy· Increasing localblood circulation· Muscle re-education· Immediate post-surgical stimulationof calf muscles toprevent venousthrombosis· Maintaining orincreasing range ofmotionAs a biofeedbackdevice theBiofeedback Nerveand MuscleStimulator isindicated for thefollowingconditions:· Biofeedback,relaxation andmuscle re-educationpurposesAs a nonimplantedelectrical continencedevice theBiofeedback Nerveand Muscle | The STIWELL med4is a neuromuscularelectronic stimulatorindicated for useunder medicalsupervision foradjunctive therapy inthe treatment ofmedical diseases andconditions.As a powered musclestimulator theSTIWELL med4 isindicated for thefollowing conditions:· Relaxation ofmuscle spasm· Prevention orretardation of disuseatrophy· Increasing localblood circulation· Muscle re-education· Immediate post-surgical stimulationof calf muscles toprevent venousthrombosis· Maintaining orincreasing range ofmotionAs a transcutaneouselectrical nervestimulator for painrelief the STIWELLmed4 is indicated forthefollowingconditions:· Symptomatic reliefand management ofchronic (long-term),intractable pain· Adiunctive | The MyoTracInfiniti system isindicated for acuteand ongoingtreatment ofstress,urge or mixedurinary incontinenceand where thefollowing resultsmayimprove urinarycontrol: Inhibition ofthe detruser musclethrough reflexivemechanisms,strengthening ofpelvic floor muscle.It is also indicatedduringincontinencetreatment forassessing EMGactivity of the pelvicfloor and accessorymuscles such as theabdominal or glutealmuscles.The MyoTracInfiniti system isalso indicated for theongoing treatment ofthefollowingconditions:Relaxation ofMuscleSpasms, Preventionor retardation ofdisuse atrophy,increasing localblood circulation,immediate post-surgicalstimulation of calfmuscles to preventvenous thrombosis,Maintaining orincreasingrange of | The 'Kegel8' PelvicMuscle Trainer isintended to provideelectricalstimulation andneuromuscular re-education forthe purpose ofrehabilitation ofweak pelvic floormuscles for thetreatment of stressurge and mixedurinaryincontinence inWomen. | Similar,theindications foruse ofthetargeteddevice iswithinthat ofthepredicatedevice |
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| Stimulator isindicated for thefollowingconditions: | treatment in themanagement of post-surgical pain andpost traumatic acutepain. | motion and StrokeRehab by Muscle re-education. It is alsoused forBiofeedback,Relaxation &MuscleRe-Education purposes. |
|---|---|---|
| • Acute and ongoingtreatment of stress,urge or mixedurinary incontinenceand where thefollowing resultsmay improveurinary control:Inhibition of thedetruser musclesthrough reflexivemechanisms andstrengthening ofpelvic floor muscles• Incontinencetreatment forassessing EMGactivity of the pelvicfloor andaccessorymusclessuch as theabdominal and thegluteus muscles | As a biofeedbackdevice the STIWELLmed4 is indicated forthe followingconditions:• Biofeedback,relaxation andmuscle re-educationpurposesAs an externalfunctionalneuromuscularstimulator theSTIWELL med4 isindicated for thefollowing conditions:• Helps to relearnvoluntary motorfunctions of theextremitiesAs a nonimplantedelectrical continencedevice the STIWELLmad4 is indicated forthe followingconditions:• Acute and ongoingtreatment of stress,urge or mixedurinary incontinenceand where thefollowing resultsmay improve urinarycontrol: Inhibition ofthe detruser musclesthrough reflexivemechanisms andstrengthening ofpelvic floor muscles |
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| · Incontinencetreatment forassessing EMGactivity of the pelvicfloor and accessorymuscles such as theabdominal and thegluteus muscles | ||||||
|---|---|---|---|---|---|---|
| Patientpopulation | Adult | Adult | Adult | Adult | Prescription | Same |
| Location foruse | Prescription | Prescription | Prescription | Prescription | Prescription | Same |
| Basic unit specification | ||||||
| Powersupply | 7.4V DC/1200mAhrechargeable lithiumbattery | Battery Pack Li-lon11.1V | 4X AAA 1.5Alkaline orrechargeable NiMHBattery pack6VDC-15W MedicalClass II poweradapter | 9V PP3 | DifferentNote 1 | |
| MethodLine CurrentIsolation | N/A | Medical Class IIPower Adapter | N/A | N/A-powered | Battery | Same |
| Leakagecurrent- Normalcondition- Single faultcondition | N/A (Battery) | N/A (Battery) | N/A | N/A-powered | Battery | Same |
| Number ofoutput modes | 2 | 1 | / | 1 | DifferentNote 2 | |
| Number ofoutputchannel | 2 | 4 | / | 2 | Same | |
| SynchronousorAlternating? | Synchronous | Alternating | Synchronous/Alternating | Similar | ||
| Method ofchannelisolation | Transformer | Transformer,inductive couplers | / | Individuallyisolated circuits | Same | |
| Software/Firmware/ | Yes | Yes | Yes | Yes | Same | |
| Microprocessor Control? | ||||||
| AutomaticOverloadtrip | Yes | Yes | / | Notpubliclyavailable | Same | |
| Automaticno-load trip | Yes | Yes | / | Notpubliclyavailable | Same | |
| Patientoverridecontrolmethod | Yes | Yes (Stop Button) | / | Notpubliclyavailable | Similar | |
| Indicatordisplay-On/Offstatus-Low battery-Outputmode-Time to cut-off-Voltage/current level | Yes | Yes | / | Yes | Same | |
| AutomaticShut Off | Yes | Yes | / | Yes | Same | |
| Timer range | 1-99min, adjustable | 2-120min | / | Up to 90 | Similar | |
| Dimensions | KM530:140.5×25.5×69mmKM531:146.5×29×74mm | 175×95×30mm | / | 6.2cm W x 2.3cmD x 10.8cm H[2.4" W x 0.9" D x4.25" H] | DifferentNote 3 | |
| Weight | KM530: 192 gKM531: 230g | 440g | / | 0.07Kg withoutbattery, 0.1KGwith battery | DifferentNote 3 | |
| Housingmaterial andconstruction | Plastic | Plastics | / | / | Same | |
| Compliancewithvoluntarystandards | IEC 60601-1;IEC 60601-1-2;IEC 60601-2-10;IEC 60601-1-11;IEC 60601-2-40 | IEC 60601-1;IEC 60601-1-2;IEC 60601-2-10 | / | IEC 60601-1;IEC 60601-1-2;IEC 60601-2-10 | Same | |
| Compliancewith 21CFR898 | Yes | Yes | Yes | Yes | Same |
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| Output specifications | |||||
|---|---|---|---|---|---|
| Waveform | Pulsed symmetric,asymmetric,biphasic squarewave | Pulsed symmetrical,rectangular wave | AsymmetricalBalanced PulsedCurrent | Biphasic,Rectangular | Similar |
| Maximumoutputvoltage | 47.2V @ 500Ω108V @ 2kΩ150V@ 10kΩ | 50V @500Ω115V@2kΩN/A | / | 45V @ 500Ω100V @ 2kΩ190V @ 10kΩ | SimilarWithinthe rangeofpredicatedevice |
| Maximumoutputcurrent | 94.4mA @ 500Ω54mA @ 2kΩ15mA@ 10kΩ | 100mA@500Ω58mA@2kΩN/A | 100mA | 90mA @ 500Ω50mA @ 2kΩ19mA @ 10kΩ | SimilarWithinthe rangeofpredicatedevice |
| Net Charge(per pulse) | For pulsedsymmetric,biphasic: 0µC @500Ω;For pulsedasymmetric,biphasic:15.68μC @ 500Ω | 0µC @ 500Ω | / | 0 [μC] @ 500Ω | SimilarNote 4 |
| MaximumPhaseCharge(500Ω) | 51.4µC @ 500Ω | EMS: 40µC @500ΩIncontinence: 50µC@ 500Ω | 60μC | 40.5µC @ 500Ω | Similar |
| Maximumcurrentdensity(500Ω) | 6.01mA/ cm²@500Ω | EMS: 12.5mA/cm²@500ΩIncontinence:4.7mA/cm²@ 500Ω | St-Cloud Vaginal6.76mA/cm²Femelex Vaginal4.76mA/cm²St-Cloud Rectal19.72mA/cm² | 14.1 [mA/cm²] | Similar |
| Maximumpowerdensity(500Ω) | 0.012W(12mW)cm2@ 500Ω | /EMS: 7.9mW/cm²@500Ω(0.0079W/cm²@500Ω)Incontinence:23.5μW/cm²@ 500Ω | St-Cloud Vaginal22.84mW/cm²Femelex Vaginal11.32mW/cm²St-Cloud Rectal194mW/cm² | 57 [mW/cm²]At maximumfrequency of100Hz, pulse width450µS and currentof 90mAPC Electrode area: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]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, 0-20, 5-20, 10-20, 0-50, 10-50, 0-100,50-100,0-200, 50-200, 100-200, 0-500,100-500, 0-1000, 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 the A device according to Guidance Document for Powered Muscle Stimulator 510(k)s
(10) Conclusion
Based on the above analysis and tests performed, it can be concluded that the performance and function of Biofeedback Nerve and Muscle Stimulator are normal, it is Substantially Equivalent (SE) to the predicate device.
§ 890.5850 Powered muscle stimulator.
(a)
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.(b)
Classification. Class II (performance standards).