K Number

Device Name

Pelvifine Pelvic Muscle Trainer

Manufacturer

Shenzhen Konmed Technology Co., Ltd.

Date Cleared

2018-01-18

(422 days)

Product Code

KPI

Regulation Number

876.5320

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 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K110179, K141643, K150183

Reference Devices

K110179, K141643, K150183

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard electrical muscle stimulator with pre-set programs and user-controlled parameters, with no mention of adaptive learning, data analysis for personalized treatment, or any other characteristic typically associated with AI/ML.

Therapeutic

Yes

The device is designed to treat stress, urge, and/or mixed urinary incontinence in women by applying stimulation to pelvic floor muscles, which is a therapeutic purpose.

Diagnostic

The device is described as a non-implanted muscle stimulator designed to treat (not diagnose) urinary incontinence by strengthening pelvic floor muscles. Its function is therapeutic, not diagnostic.

SaMD (Software as a Medical Device)

The device description explicitly states it is a "dual-channel stimulator" and mentions electrical safety, electromagnetic compatibility, and waveform testing, all of which are associated with hardware components that deliver electrical stimulation.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to treat urinary incontinence by applying electrical stimulation to the pelvic floor muscles. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
Device Description: The device is described as a muscle stimulator.
Mechanism of Action: It works by applying electrical stimulation to muscles, not by analyzing biological samples.
Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of detecting or measuring substances or markers within these samples.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

KPI

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

pelvic floor muscles and surrounding structures

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K110179, K141643, K150183

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

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.

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,

Image /page/1/Picture/6 description: The image shows the name "Benjamin R. Fisher -S" in a large, bold font. The text is black and appears to be against a white background. The letters are clearly legible and evenly spaced.

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

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

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.

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 of

Comparison	Subject Device	Predicate Device Equivalent	Remark
Device Name and	Pelvic Muscle Trainer,	InTone	YARLAP
ApexM

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

| Elements of

Comparison	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 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.	The InControl InTone
device is a non-
implanted electrical
stimulator indicated for
use in the treatment of
female urinary
incontinence. It applies
electrical stimulation to
the pelvic floor
musculature and
surrounding structures.
It is intended for acute
and ongoing treatment
of mixed urinary
incontinence where the
following results may
improve urinary control:
strengthening of pelvic
floor muscles and
inhibition of the
dletrusor muscle
through reflexive
mechanisms. The
biofeedback feature can
be used for muscle re-
education purposes.	The device is intended
to provide electrical
stimulation and
neuromuscular re-
education for the
purpose of rehabilitation
of weak pelvic floor
muscles for the
treatment of stress, urge
and mixed urinary
incontinence in women
and to maintain urinary
continence in women.	ApexM 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.	SE
Note:
Identical
to
ApexM
Power Source(s)	9Vdc Battery	4/5 AA nickel metal
hydride battery	--	4 x AAA Alkaline
battery	SE
Note1
Method of Line
Current Isolation	Type BF Applied Part	Type BF Applied Part	Type BF Applied Part	Type BF Applied Part	SE
Patient
Leakage
Current	NC
SFC