Pelvifine Pelvic Muscle Trainer

K163288 · Shenzhen Konmed Technology Co., Ltd. · KPI · Jan 18, 2018 · Gastroenterology, Urology

Device Facts

• Record ID: K163288
• Device Name: Pelvifine Pelvic Muscle Trainer
• Applicant: Shenzhen Konmed Technology Co., Ltd.
• Product Code: KPI · Gastroenterology, Urology
• Decision Date: Jan 18, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Pelvifine Pelvic Muscle Trainer (Model: KM518) is a non-implanted muscle stimulator designed to treat stress, urge and/or mixed urinary incontinence in women. It applies stimulation to the pelvic floor muscles and surrounding structures to improve strength and support.

Device Story

Pelvifine Pelvic Muscle Trainer (KM518) is a non-implanted, dual-channel electrical muscle stimulator for home use by women. Device delivers biphasic, rectangular electrical pulses to pelvic floor muscles via an internal probe to treat urinary incontinence. User selects between two channels: Channel B (Junior User, <5 uses) and Channel A (Senior User, >5 uses). Device offers 12 programmable modes with adjustable pulse width, rate, ramp-up time, and work/rest cycles. Output intensity is adjustable up to 100 levels. Healthcare providers use the device to facilitate pelvic floor muscle strengthening and support. Benefits include improved urinary control through neuromuscular stimulation.

Clinical Evidence

No clinical data. Safety and performance were established through bench testing, including electrical safety (IEC 60601-1, IEC 60601-2-10), electromagnetic compatibility (IEC 60601-1-2), biocompatibility (ISO 10993-5, ISO 10993-10), and usability testing (IEC 62366). Waveform characterization was performed per FDA guidance for powered muscle stimulators.

Technological Characteristics

Dual-channel electrical stimulator; 9Vdc battery powered. Main unit (ABS plastic) and probe (ABS plastic, stainless steel). Biphasic rectangular pulse waveform. Output: <80mA @ 500Ω, max 37Vdc. Pulse duration 150-220μs; frequency 10-40Hz. Type BF applied part. Software verification/validation per FDA guidance.

Indications for Use

Indicated for women with stress, urge, and/or mixed urinary incontinence to improve pelvic floor muscle strength and support.

Regulatory Classification

Identification

A nonimplanted electrical continence device is a device that consists of a pair of electrodes on a plug or a pessary that are connected by an electrical cable to a battery-powered pulse source. The plug or pessary is inserted into the rectum or into the vagina and used to stimulate the muscles of the pelvic floor to maintain urinary or fecal continence. When necessary, the plug or pessary may be removed by the user. This device excludes an AC-powered nonimplanted electrical continence device and the powered vaginal muscle stimulator for therapeutic use (§ 884.5940).

Predicate Devices

• InTone (K110179)
• YARLAP (K141643)
• ApexM (K150183)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

January 18, 2018

Shenzhen Konmed Technology Co., Ltd. % Cassie Lee Guangzhou Glomed Biological Technology Co., Ltd. Suite 306, Kecheng Mansion, No.121 Science Road Guangzhou Science Park Guangzhou, 510663 CN

Re: K163288

Trade/Device Name: Pelvifine Pelvic Muscle Trainer Regulation Number: 21 CFR§ 876.5320 Regulation Name: Nonimplanted Electrical Continence Device Regulatory Class: II Product Code: KPI Dated: December 19, 2017 Received: January 16, 2018

Dear Cassie Lee:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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.

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You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K163288

Device Name

Pelvifine Pelvic Muscle Trainer, Model: KM518

Indications for Use (Describe)

The Pelvifine Pelvic Muscle Trainer (Model: KM518) is a non-implanted muscle stimulator designed to treat stress, urge and/or mixed urinary incontinence in women. It applies stimulation to the pelvic floor muscles and surrounding structures to improve strength and support.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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| Sponsor: | Shenzhen Konmed Technology Co., Ltd. |
|-----------------|--------------------------------------|
| Subject Device: | Pelvic Muscle Trainer, Model: KM518 |
| Document Name: | 510(k) Summary |

# Chapter 5. 510(k) Summary

# 510(k) Summary

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

## 1. Submitter's Information

510(k) Owner's Name: Shenzhen Konmed Technology Co., Ltd. Establishment Registration Number: Applying Address: 703B, Haide building A, Nanxin Road, Nanshan, Shenzhen, China Tel: [phone] Fax: [phone] Contact Person: Tony (Manager) Email: [e-mail]

## Application Correspondent:

Contact Person: Ms. Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. Address: Suite 306, Kecheng Mansion, No.121 Science Road, Guangzhou Science Park, Guangzhou 510663, China Tel: [phone] Email: [e-mail]

## 2. Subject Device Information

| Trade Name: | Pelvifine Pelvic Muscle Trainer |
|----------------------|--------------------------------------------------------|
| Common Name: | Pelvic Floor Muscle Stimulator |
| Classification name: | Stimulator, Electrical, Non-Implanted for Incontinence |
| Review Panel: | Gastroenterology/Urology |
| Product Code: | KPI |
| Regulation Class: | II |
| Regulation Number: | 21 CFR 876.5320 |

## 3. Predicate Device Information

| Sponsor | InControl Medical, LLC | International Trade<br>Group, Incorporated | InControl Medical, LLC |
|--------------------------|------------------------|--------------------------------------------|------------------------|
| Device Name and<br>Model | InTone | YARLAP | ApexM |
| 510(k) Number | K110179 | K141643 | K150183 |

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| Sponsor: | Shenzhen Konmed Technology Co., Ltd. |
|-----------------|--------------------------------------|
| Subject Device: | Pelvic Muscle Trainer, Model: KM518 |
| Document Name: | 510(k) Summary |

| Product Code | KPI | KPI | KPI |
|-------------------|-----------------|-----------------|-----------------|
| Regulation Number | 21 CFR 876.5320 | 21 CFR 876.5320 | 21 CFR 876.5320 |
| Regulation Class | II | II | II |

## 2. Device Description

The Pelvifine Pelvic Muscle Trainer is a product designed to give women the opportunity to strengthen their pelvic floor muscles.

This device is a dual-channel stimulator combining several treatment programs into one unit. Channel B is for the Junior User (who use the device no more than 5 times) and Channel A is for the Senior User (who use the device more than 5 times). It offers full control of Pulse Widths, Rates, Ramp up times, and Work/Rest cycles.

# 5. Intended Use / Indications for Use

The Pelvifine Pelvic Muscle Trainer (Model: KM518) is a non-implanted muscle stimulator designed to treat stress, urge and/or mixed urinary incontinence in women. It applies stimulation to the pelvic floor muscles and surrounding structures to improve strength and support.

## 6. Test Summary

The Pelvifine Pelvic Muscle Trainer (Model: KM518) has been evaluated the safety and performance by lab bench testing and usability testing as following:

- � Electrical safety test according to IEC 60601-1 and IEC 60601-2-10 standards
- � Electromagnetic compatibility test according to IEC 60601-1-2 standard
- � Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards
- � Usability test according to IEC 62366 standard
- � 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 characterize the output specifications of the device according to Guidance for Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use and Guidance for Powered Muscle Stimulator for Muscle Conditioning

# 7. Comparison to predicate device and conclusion

The technological characteristics, features, specifications, materials, mode of operation, and intended use of subject device is substantially to the predicate devices identified above.

The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.

| Elements of<br>Comparison | Subject Device | Predicate Device Equivalent | Remark |
|---------------------------|------------------------|-----------------------------|-----------------|
| Device Name and | Pelvic Muscle Trainer, | InTone | YARLAP<br>ApexM |

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| Sponsor: | Shenzhen Konmed Technology Co., Ltd. |
|-----------------|--------------------------------------|
| Subject Device: | Pelvic Muscle Trainer, Model: KM518 |
| Document Name: | 510(k) Summary |

| Elements of<br>Comparison | Subject Device | Predicate Device Equivalent | | | Remark | |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|--------------|
| Model | Model: KM518 | | | | | |
| 510(k) Number | K163288 | K110179 | K141643 | K150183 | | |
| Intended Use &<br>Indications for Use | Pelvic Muscle Trainer<br>(Model: KM518) is a<br>non-implanted muscle<br>stimulator designed to<br>treat stress, urge and/or<br>mixed urinary<br>incontinence in women.<br>It applies stimulation to<br>the pelvic floor muscles<br>and surrounding<br>structures to improve<br>strength and support. | The InControl InTone<br>device is a non-<br>implanted electrical<br>stimulator indicated for<br>use in the treatment of<br>female urinary<br>incontinence. It applies<br>electrical stimulation to<br>the pelvic floor<br>musculature and<br>surrounding structures.<br>It is intended for acute<br>and ongoing treatment<br>of mixed urinary<br>incontinence where the<br>following results may<br>improve urinary control:<br>strengthening of pelvic<br>floor muscles and<br>inhibition of the<br>dletrusor muscle<br>through reflexive<br>mechanisms. The<br>biofeedback feature can<br>be used for muscle re-<br>education purposes. | The device is intended<br>to provide electrical<br>stimulation and<br>neuromuscular re-<br>education for the<br>purpose of rehabilitation<br>of weak pelvic floor<br>muscles for the<br>treatment of stress, urge<br>and mixed urinary<br>incontinence in women<br>and to maintain urinary<br>continence in women. | ApexM is a non-<br>implanted muscle<br>stimulator designed to<br>treat stress, urge and/or<br>mixed urinary<br>incontinence in women.<br>It applies stimulation to<br>the pelvic floor muscles<br>and surrounding<br>structures to improve<br>strength and support. | SE<br>Note:<br>Identical<br>to<br>ApexM | |
| Power Source(s) | 9Vdc Battery | 4/5 AA nickel metal<br>hydride battery | -- | 4 x AAA Alkaline<br>battery | SE<br>Note1 | |
| Method of Line<br>Current Isolation | Type BF Applied Part | Type BF Applied Part | Type BF Applied Part | Type BF Applied Part | SE | |
| Patient<br>Leakage<br>Current | NC<br>SFC | < 100 $ μ $ A<br>< 500 $ μ $ A | N/A (battery) | -- | N/A (battery) | SE<br>Note 1 |
| Number of Output<br>Channels | 2 (only the selected one<br>channel will work during<br>operation) | 1 | -- | 1 | SE<br>Note 2 | |
| Number of Output<br>Modes | 12 | 1 | -- | 1 | SE<br>Note 2 | |
| Output Intensity<br>Level | 100 | -- | -- | -- | SE<br>Note 2 | |
| Timer Range | 15~20 minutes | 12 minutes | -- | 10~15 minutes | SE<br>Note 2 | |
| Weight | Main Unit: 300g<br>Probe: 200g | -- | -- | -- | SE<br>Note 2 | |
| Dimensions | Main Unit:<br>150mm x 73mm x<br>20mm<br>Probe:<br>145mm x 25mm x | Insertion Unit: 12.2" x<br>2.5" x 4.0"<br>Inflatable Probe: 5.5" x<br>2.2" x 2.5" | -- | Insertion Unit :<br>12.2"x 2.5"x 4.0"<br>Inflatable Probe:<br>5.5"x 2.2"x 2.5" | SE<br>Note 2 | |

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| Sponsor: | Shenzhen Konmed Technology Co., Ltd |
|-----------------|-------------------------------------|
| Subject Device: | Pelvic Muscle Trainer, Model: KM518 |
| Document Name: | 510(k) Summary |

| Elements of<br>Comparison | Subject Device | Predicate Device Equivalent | Device Equivalent | Remark |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| | 25mm | | | |
| Electrode Surface<br>Area | 7.85cm² (x 2) | 10.5cm² (x 2) | 6.4cm² (x 2) | 6.00cm² ± 0.5cm² (x 2) SE Note 3 |
| Housing Materials<br>and Construction | Main unit:<br>ABS plastic<br>Probe Material: ABS<br>plastic, Stainless steel | ABS plastics | -- | Main unit:<br>ABS plastic<br>Insertion Material:<br>Silicone, Plastics SE Note 4 |
| Waveform and<br>Shape | Rectangular pulses,<br>Biphasic | Rectangular pulses,<br>Biphasic | Rectangular pulses,<br>Biphasic | Rectangular pulses,<br>Monophasic SE Note:<br>Identical to InTone |
| Maximum Output<br>Voltage | 37Vdc @500Ω | 50Vdc @500Ω | -- | 40Vdc @500Ω SE Note 3 |
| Maximum Output<br>Current | <80 mA @500Ω | 100mA @500Ω | 80mA±10% @ 500Ω<br>50mA±10% @ 2kΩ<br>19mA±10% @10kΩ | 80mA @500Ω SE Note 3 |
| Pulse Duration | 150μs, 200μs, 220μs | 200μs | 200-250μs | 200μs SE Note 3 |
| Pulse frequency | 10~40Hz | 50Hz | 10~35Hz | 13, 50Hz SE Note 3 |
| Net Charge (per<br>pulse) | 0 µC @ 500Ω | -- | 0μC @ 500Ω | -- SE Note 3 |
| Maximum Phase<br>Charge | 19.8 µC @ 500Ω | 20μC @ 500Ω | 20μC @ 500Ω | 16μC @ 500Ω SE Note 3 |
| Maximum Current<br>Density | 9.48 mA/cm² | 4.7 mA/cm² | 12.5mA/cm²<br>(Vaginal) | 13.3 mA/cm² SE Note 3 |
| Maximum Average<br>Power Density | 3.09 mW/cm² | 4.8 mW/cm² | 3.5 mW/cm² | 5.33 mW/cm² SE Note 3 |
| Biocompatibility | All user directly<br>contacting materials are<br>compliance with<br>ISO10993-5 and<br>ISO10993-10<br>requirements. | All user directly<br>contacting materials are<br>compliance with<br>ISO10993-5 and<br>ISO10993-10<br>requirements. | All user directly<br>contacting materials are<br>compliance with<br>ISO10993-5 and<br>ISO10993-10<br>requirements. | All user directly<br>contacting materials are<br>compliance with<br>ISO10993-5 and<br>ISO10993-10<br>requirements. SE |
| Electrical Safety | Comply with IEC 60601-<br>1 and IEC 60601-2-10 | Comply with IEC<br>60601-1 and IEC<br>60601-2-10 | Comply with IEC 60601-<br>1 and IEC 60601-2-10 | Comply with IEC<br>60601-1 and IEC<br>60601-2-10 SE |
| EMC | Comply with IEC 60601-<br>1-2 | Comply with IEC<br>60601-1-2 | Comply with IEC 60601-<br>1-2 | Comply with IEC<br>60601-1-2 SE |

| Utility | Predicate device<br>K141643 | Subject device | Rate Hz | Pulse us | Work Sec. | Rest Sec. | Time Min.* | Max. W/cm²<br>80mA | Ave. W/cm²<br>30mA | Ave. W/cm²<br>45mA | maximum phase charge |
|---------|-----------------------------|----------------|---------|----------|-----------|-----------|------------|--------------------|--------------------|--------------------|----------------------|
|---------|-----------------------------|----------------|---------|----------|-----------|-----------|------------|--------------------|--------------------|--------------------|----------------------|

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| Sponsor: | Shenzhen Konmed Technology Co., Ltd. |
|-----------------|--------------------------------------|
| Subject Device: | Pelvic Muscle Trainer, Model: KM518 |
| Document Name: | 510(k) Summary |

| Mixed | Mode 1 | -- | 12 | 200 | 5 | 5 | 15 | 1.2 | 0.17 | 0.38 | 20 C @ 500Ω |
|--------|--------|-------|----|-----|---|----|----|------|------|------|---------------|
| Mixed | Mode 2 | -- | 20 | 250 | 8 | 8 | 20 | 2.5 | 0.35 | 0.79 | 20 C @ 500Ω |
| Mixed | -- | P04 | 10 | 220 | 5 | 5 | 20 | 1.1 | 0.31 | 0.47 | 19.8 C @ 500Ω |
| Mixed | -- | P05 | 10 | 220 | 5 | 5 | 20 | 1.1 | 0.31 | 0.47 | 19.8 C @ 500Ω |
| Mixed | -- | P06_1 | 10 | 220 | 4 | 4 | 20 | 1.02 | 0.31 | 0.47 | 19.8 C @ 500Ω |
| Mixed | -- | P06_2 | 20 | 220 | 4 | 4 | | 1.2 | 0.63 | 0.94 | 19.8 C @ 500Ω |
| Mixed | -- | P07_1 | 20 | 220 | 5 | 5 | 20 | 1.2 | 0.63 | 0.94 | 19.8 C @ 500Ω |
| Mixed | -- | P07_2 | 20 | 220 | 5 | 5 | | 1.2 | 0.63 | 0.94 | 19.8 C @ 500Ω |
| Mixed | -- | P07_3 | 20 | 220 | 5 | 5 | | 1.2 | 0.63 | 0.94 | 19.8 C @ 500Ω |
| Mixed | -- | P07_4 | 10 | 220 | 4 | 4 | | 1.2 | 0.32 | 0.47 | 19.8 C @ 500Ω |
| Mixed | -- | P08 | 20 | 220 | 5 | 5 | 20 | 1.2 | 0.63 | 0.94 | 19.8 C @ 500Ω |
| Urge | Mode 3 | -- | 12 | 200 | 5 | 10 | 15 | 1.2 | 0.17 | 0.38 | 20 C @ 500Ω |
| Urge | Mode 4 | -- | 10 | 200 | 6 | 12 | 20 | 1.0 | 0.14 | 0.32 | 20 C @ 500Ω |
| Urge | -- | P03 | 10 | 200 | 6 | 12 | 15 | 0.9 | 0.28 | 0.42 | 19.8 C @ 500Ω |
| Stress | Mode 5 | -- | 12 | 250 | 5 | 15 | 15 | 1.5 | 0.21 | 0.47 | 20 C @ 500Ω |
| Stress | Mode 6 | -- | 35 | 200 | 6 | 18 | 20 | 3.5 | 0.5 | 1.11 | 20 C @ 500Ω |
| Stress | -- | P01 | 40 | 220 | 6 | 15 | 20 | 2.3 | 1.23 | 1.87 | 19.8 C @ 500Ω |
| Stress | -- | P02 | 10 | 220 | 5 | 15 | 20 | 1 | 0.31 | 0.46 | 19.8 C @ 500Ω |

* The treatment times listed for the subject device are for Channel B has a 3-minute treatment time.

## Comparison in Detail(s):

## Note 1:

Although the "Power Source(s)", "Patient Leakage Current", "Weight", and "Dimensions", a little different from the predicate devices, the differences will not raise any safety or effectiveness issue.

## Note 2:

Although the "Number of Output Modes" "Output Intensity Level", "Timer Range", "Weight" and "Dimensions" of subject device are different from the predicate devices, the differences will not raise any safety or effectiveness issue.

## Note 3:

Although the "Electrode Surface Area", "Maximum Output Voltage", "Maximum Output Current", "Pulse Duration", "Pulse Frequency", "Net Charge (per pulse)", "Maximum Phase Charge", "Maximum Current Density", "Maximum Average Power Density" are a little different from the predicate devices, the differences will not raise any safety or effectiveness issue.

#### Note 4:

Although the "Housing Materials and Construction" are a little different from the predicate devices, the differences will not raise any safety or effectiveness issue.

## Note 5:

The stimulation parameters for "specific urinary incontinence type" of subject device and predicate device are very similar , so the differences will not significantly impact safety and effectiveness.

## Finial Conclusion:

The subject device "Pelvifine Pelvic Muscle Trainer" is Substantial Equivalent to the predicate devices.

#### 8. Date of the summary prepared: December 19, 2017