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 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.

AI/ML Overview

The provided text is a 510(k) Summary for the Pelvifine Pelvic Muscle Trainer. It describes the device, its intended use, and a comparison to predicate devices to demonstrate substantial equivalence for regulatory approval.

However, this document does not contain information about clinical study acceptance criteria, device performance results from a clinical study, sample sizes for test or training sets, ground truth establishment, expert qualifications, or MRMC studies. The "Test Summary" section explicitly states that the device was evaluated by lab bench testing and usability testing, not clinical studies assessing its efficacy in treating urinary incontinence.

Therefore, I cannot fulfill your request for the comprehensive information about acceptance criteria and a study proving the device meets them, as the provided document does not contain this type of data.

The relevant section, "6. Test Summary," states:
"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"

This clearly indicates a focus on technical and safety performance, not clinical efficacy. The substantial equivalence argument relies on the similarity of the new device's technical specifications and intended use to those of already approved predicate devices, rather than on proving its therapeutic effectiveness through a new clinical trial.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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: +86-755-86704558 Fax: +86-755-86704558 Contact Person: Tony (Manager) Email: 2519021651@qq.com

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: +86-20-61099984 Email: regulatory@glomed-info.com

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 TradeGroup, Incorporated	InControl Medical, LLC
Device Name andModel	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

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 ofComparison	Subject Device	Predicate Device Equivalent	Remark
Device Name and	Pelvic Muscle Trainer,	InTone	YARLAPApexM

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

Elements ofComparison	Subject Device	Predicate Device Equivalent			Remark
Model	Model: KM518
510(k) Number	K163288	K110179	K141643	K150183
Intended Use &Indications for Use	Pelvic Muscle Trainer(Model: KM518) is anon-implanted musclestimulator designed totreat stress, urge and/ormixed urinaryincontinence in women.It applies stimulation tothe pelvic floor musclesand surroundingstructures to improvestrength and support.	The InControl InTonedevice is a non-implanted electricalstimulator indicated foruse in the treatment offemale urinaryincontinence. It applieselectrical stimulation tothe pelvic floormusculature andsurrounding structures.It is intended for acuteand ongoing treatmentof mixed urinaryincontinence where thefollowing results mayimprove urinary control:strengthening of pelvicfloor muscles andinhibition of thedletrusor musclethrough reflexivemechanisms. Thebiofeedback feature canbe used for muscle re-education purposes.	The device is intendedto provide electricalstimulation andneuromuscular re-education for thepurpose of rehabilitationof weak pelvic floormuscles for thetreatment of stress, urgeand mixed urinaryincontinence in womenand to maintain urinarycontinence in women.	ApexM is a non-implanted musclestimulator designed totreat stress, urge and/ormixed urinaryincontinence in women.It applies stimulation tothe pelvic floor musclesand surroundingstructures to improvestrength and support.	SENote:IdenticaltoApexM
Power Source(s)	9Vdc Battery	4/5 AA nickel metalhydride battery	--	4 x AAA Alkalinebattery	SENote1
Method of LineCurrent Isolation	Type BF Applied Part	Type BF Applied Part	Type BF Applied Part	Type BF Applied Part	SE
PatientLeakageCurrent	NCSFC	< 100 $ μ $ A< 500 $ μ $ A	N/A (battery)	--	N/A (battery)	SENote 1
Number of OutputChannels	2 (only the selected onechannel will work duringoperation)	1	--	1	SENote 2
Number of OutputModes	12	1	--	1	SENote 2
Output IntensityLevel	100	--	--	--	SENote 2
Timer Range	15~20 minutes	12 minutes	--	10~15 minutes	SENote 2
Weight	Main Unit: 300gProbe: 200g	--	--	--	SENote 2
Dimensions	Main Unit:150mm x 73mm x20mmProbe:145mm x 25mm x	Insertion Unit: 12.2" x2.5" x 4.0"Inflatable Probe: 5.5" x2.2" x 2.5"	--	Insertion Unit :12.2"x 2.5"x 4.0"Inflatable Probe:5.5"x 2.2"x 2.5"	SENote 2

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

Elements ofComparison	Subject Device	Predicate Device Equivalent	Device Equivalent	Remark
	25mm
Electrode SurfaceArea	7.85cm² (x 2)	10.5cm² (x 2)	6.4cm² (x 2)	6.00cm² ± 0.5cm² (x 2) SE Note 3
Housing Materialsand Construction	Main unit:ABS plasticProbe Material: ABSplastic, Stainless steel	ABS plastics	--	Main unit:ABS plasticInsertion Material:Silicone, Plastics SE Note 4
Waveform andShape	Rectangular pulses,Biphasic	Rectangular pulses,Biphasic	Rectangular pulses,Biphasic	Rectangular pulses,Monophasic SE Note:Identical to InTone
Maximum OutputVoltage	37Vdc @500Ω	50Vdc @500Ω	--	40Vdc @500Ω SE Note 3
Maximum OutputCurrent	<80 mA @500Ω	100mA @500Ω	80mA±10% @ 500Ω50mA±10% @ 2kΩ19mA±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 (perpulse)	0 µC @ 500Ω	--	0μC @ 500Ω	-- SE Note 3
Maximum PhaseCharge	19.8 µC @ 500Ω	20μC @ 500Ω	20μC @ 500Ω	16μC @ 500Ω SE Note 3
Maximum CurrentDensity	9.48 mA/cm²	4.7 mA/cm²	12.5mA/cm²(Vaginal)	13.3 mA/cm² SE Note 3
Maximum AveragePower Density	3.09 mW/cm²	4.8 mW/cm²	3.5 mW/cm²	5.33 mW/cm² SE Note 3
Biocompatibility	All user directlycontacting materials arecompliance withISO10993-5 andISO10993-10requirements.	All user directlycontacting materials arecompliance withISO10993-5 andISO10993-10requirements.	All user directlycontacting materials arecompliance withISO10993-5 andISO10993-10requirements.	All user directlycontacting materials arecompliance withISO10993-5 andISO10993-10requirements. SE
Electrical Safety	Comply with IEC 60601-1 and IEC 60601-2-10	Comply with IEC60601-1 and IEC60601-2-10	Comply with IEC 60601-1 and IEC 60601-2-10	Comply with IEC60601-1 and IEC60601-2-10 SE
EMC	Comply with IEC 60601-1-2	Comply with IEC60601-1-2	Comply with IEC 60601-1-2	Comply with IEC60601-1-2 SE

Utility	Predicate deviceK141643	Subject device	Rate Hz	Pulse us	Work Sec.	Rest Sec.	Time Min.*	Max. W/cm²80mA	Ave. W/cm²30mA	Ave. W/cm²45mA	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

Regulation Number and Section

§ 876.5320 Nonimplanted electrical continence device.

(a)
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).(b)
Classification. Class II (performance standards).