Urinary Incontinence System

• K Number: K142369
• Device Name: Urinary Incontinence System
• Manufacturer: GUANGZHOU FINECURE MEDICAL EQUIPMENT CO., LTD
• Date Cleared: 2015-06-17 ( 296 days)
• Product Code: KPI
• Regulation Number: 876.5320

Intended Use

The Urinary Incontinence System with various treatment modalities is intended to be used by males and females for muscle contraction in the treatment of stress incontinence, urge incontinence, and mixed incontinence.

Device Description

The Finecure Urinary Incontinence System is a non-implanted, electrical, pelvic floor muscle stimulator. It is intended to strengthen the pelvic floor muscles by electrical stimulation in the treatment for urinary incontinence. The system has several preset modes that correspond to different conditions associated with urinary incontinence. The Urinary Incontinence System can be used in the clinical setting and the home care environment. The System is composed of enclosure, display screen, PCB, rotary switch, and other electronic components. The system is to be used with pelvic floor probes and anorectal probes.

Predicate Devices

K110179, K103698

Reference Devices

K130691

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on electrical stimulation with preset modes and does not mention any adaptive or learning capabilities.

Therapeutic

Yes

The device description explicitly states its intended use is for "muscle contraction in the treatment of stress incontinence, urge incontinence, and mixed incontinence" by strengthening pelvic floor muscles through electrical stimulation, which directly addresses a medical condition.

Diagnostic

No
The device description states that the system is an electrical pelvic floor muscle stimulator intended to strengthen muscles for the treatment of urinary incontinence. It does not mention any diagnostic capabilities or functions.

SaMD (Software as a Medical Device)

No

The device description explicitly lists hardware components such as "enclosure, display screen, PCB, rotary switch, and other electronic components" and states it is an "electrical, pelvic floor muscle stimulator," indicating it is a hardware device with software control, not a software-only device.

IVD (In Vitro Diagnostic)

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

Here's why:

• IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
• Device Function: The Finecure Urinary Incontinence System is an electrical stimulator that directly interacts with the body (pelvic floor muscles) to cause muscle contraction. It does not analyze samples taken from the body.
• Intended Use: The intended use is for muscle contraction in the treatment of urinary incontinence, not for diagnostic testing of samples.
• Device Description: The description clearly states it's a "non-implanted, electrical, pelvic floor muscle stimulator."

Therefore, this device falls under the category of a therapeutic medical device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Urinary Incontinence System with various treatment modalities is intended to be used by males and females for muscle contraction in the treatment of stress incontinence, and mixed incontinence.

Product codes (comma separated list FDA assigned to the subject device)

KPI

Device Description

The Finecure Urinary Incontinence System is a non-implanted, electrical, pelvic floor muscle stimulator. It is intended to strengthen the pelvic floor muscles by electrical stimulation in the treatment for urinary incontinence. The system has several preset modes that correspond to different conditions associated with urinary incontinence. The Urinary Incontinence System can be used in the clinical setting and the home care environment. The System is composed of enclosure, display screen, PCB, rotary switch, and other electronic components. The system is to be used with pelvic floor probes and anorectal probes.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

pelvic floor muscles

Indicated Patient Age Range

Not Found

Intended User / Care Setting

clinical setting and the home care environment.

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 testing for Urinary Incontinence System included performance, software, electrical safety, EMC, biocompatibility and bench. Urinary Incontinence System successfully passed all testing.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K110179, K103698

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K130691

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 17, 2015

Guangzhou Finecure Medical Equipment Co., Ltd % Field Fu Shenzhen Joyantech Consulting Co., Ltd. 4th Floor, Jinhui Building, Nanhai Blvd. Nanshan District Shenzhen, Guangdong China

Re: K142369

Trade/Device Name: Urinary Incontinence System Regulation Number: 21 CFR 876.5320 Regulation Name: Nonimplanted electrical continence device Regulatory Class: II Product Code: KPI Dated: Mav 4, 2015 Received: May 15, 2015

Dear Field Fu,

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 (reporting of medical device

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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for

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K142369

Device Name Urinary Incontinence System

Indications for Use (Describe)

The Urinary Incontinence System with various treatment modalities is intended to be used by males and females for muscle contraction in the treatment of stress incontinence, and mixed incontinence.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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SECTION 05 510(K) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR§807.92

The assigned 510(k) number is:	(applicant leave blank)
Submission Date:	May 7, 2015
Submitter:	Guangzhou Finecure Medical Equipment Co., Ltd.
Address: F19, No.1 Kesheng Road, Baiyun Torch Building,
No.1633 Beitai Road, Baiyun District, Guangzhou, CHINA.
Submitter Contact:	Shenzhen Joyantech Consulting Co., Ltd.
4th Floor, Jinhui Building, Nanhai BLVD, Nanshan District,
Shenzhen, Guangdong, China.
Contact person: Mr. Field.Fu
E-Mail: [e-mail]
Image: [logo]
Manufacturing Site:	Guangzhou Finecure Medical Equipment Co., Ltd.
Address: F19, No.1 Kesheng Road, Baiyun Torch Building,
No.1633 Beitai Road, Baiyun District, Guangzhou, CHINA.
Device Name:	Urinary Incontinence System
Common Name:	Pelvic floor muscle stimulator
Classification Name:	Nonimplanted electrical continence device
Regulation:	21 CFR §876.5320
Product Code:	KPI
Type/Model of the device	P3-9632E1 and P3-9632E2
Substantially
Equivalent Devices:	The Finecure Urinary Incontinence System is substantially
equivalent to: the InControl InTone (K110179) and the I touch

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Intended Use The Urinary Incontinence System with various treatment Indications for Use: modalities is intended to be used by males and females for muscle contraction in the treatment of stress incontinence, urge incontinence, and mixed incontinence.

Device Description: The Finecure Urinary Incontinence System is a non-implanted, electrical, pelvic floor muscle stimulator. It is intended to strengthen the pelvic floor muscles by electrical stimulation in the treatment for urinary incontinence. The system has several preset modes that correspond to different conditions associated with urinary incontinence. The Urinary Incontinence System can be used in the clinical setting and the home care environment. The System is composed of enclosure, display screen, PCB, rotary switch, and other electronic components. The system is to be used with pelvic floor probes and anorectal probes.

Technology Comparison to predicate device

The Finecure Urinary Incontinence System is employ the same technological characteristics compare to InControl InTone (K110179) and Itouch Sure ( K103698) in the following table for determine the device whether substantially equivalent to the predicate devices.

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Equivalence Comparison to the Predicate

| | Finecure Urinary Incontinence
System (new device) | InControl InTone K110179 | Itouch Sure
K103698 | Comparison |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use &
Indications for
Use | The Urinary Incontinence System with
various treatment modalities is
intended to be used by males and
females for muscle contraction in the
treatment of stress incontinence, urge
incontinence, and mixed incontinence. | The InControl device is
non-implantedelectrical 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, inhibition of the
detrus or muscle through reflexive
mechanisms. The biofeedback
feature can be used for muscle | The Itouch Sure 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. The intended use and
indications for use of the new
device are the same as those of
the predicate devices. | Similar1 |
| | Finecure Urinary Incontinence
System (new device) | InControl InTone K110179 | Itouch Sure
K103698 | Compariso
n |
| | | re-education purposes. | | |
| Power Source | 6LR61/AM9V Alkalescent battery | 4/5 AA nickel metal hydride battery | 2 ×1.5AA | Equivalent |
| Output voltage | Adjustable, from 060V ( 500 ohm
load). | 50Vdc (500 ohm) | 045V ( 500 ohm load). | Different2 |
| Output current | Max Output current (500 Ohm)
120mA | Max Output current (500 Ohm )
100mA | Max Output current (500 Ohm)
90mA | Identical |
| Maximum Phase
Charge, (mC) | 36uC@500Ω | 50uC@500Ω | unknown | Equivalent |
| Maximum
Current Density | 7.64mA/cm2 , for vaginal probe;
16.3 mA/cm2, fro anal probe. | 4.7mA/cm2 | unknown | Different3 |
| Maximum
Average Power
Density | Pre2, 2.14mW/ cm2;
Pre4, 14.6mW/ cm2 ;
Pre5, 1.96mW/ cm2 ;
Pre7, 9.78mW/ cm2 | 14.3mW/cm2@500Ω | unknown | Equivalent |
| | Finecure Urinary Incontinence
System (new device) | InControl InTone K110179 | Itouch Sure
K103698 | Compariso
n |
| Electrode
Surface Area | For vaginal probe: $7.85×2=15.7 cm²$
For Anal probe: $3.68×2=7.36 cm²$ | $10.5 cm² x2$ | unknown | Equivalent |
| Number of output
channels | 2 channels | 1 channel | unknown | Different4 |
| Waveform | Dual phasic, rectangular pulse. | Dual phasic, rectangular pulses | Dual phasic, rectangular pulses | Same |
| Session Duration
(min) | Mode:
Time(min)
PFS-Pre2, 0min/20min;
(Pelvic floor muscle
contraction )
PFS-Pre4, 0min/20min;
(Stress incontinence)
PFS-Pre5, 0min/32min;
(Urge incontinence) | 12 mins | Continuous/15/30 min | Equivalent:
For Pre2,
Pre4, Pre7,
the duration
is within the
predicate
K103698;
For Pre5,
the duration
is close to
the
predicate
K103698. |
| | Finecure Urinary Incontinence
System (new device) | InControl InTone K110179 | Itouch Sure
K103698 | Comparison |
| | PFS-Pre7
0min/20min.
(Mixed incontinence) | | | |
| Pulse Rate (PR,
Hz) | | 50Hz | 10/20/35/50Hz | Equivalent: |
| | Mode: | | | For Pre2,
Pre4, Pre5: |
| | PFS-Pre2
(muscle contraction) 35Hz; | | | the
frequency is
respectively
same as the |
| | PFS-Pre4(Stress UI):50Hz; | | | predicate
K103698; |
| | PFS-Pre5(Urge UI):10Hz; | | | For Pre7,
the
frequency |
| | PFS-Pre7 (Mixed UI): 50Hz | | | same as
the
predicate
K110179; |
| | Finecure Urinary Incontinence
System (new device) | InControl InTone K110179 | Itouch Sure
K103698 | Compariso
n |
| Pulse Width | Mode:
PW(µS)
PFS-Pre2(muscle contraction) :
250us;
PFS-Pre4(Stress UI):300us;
PFS-Pre5(Urge UI) :200us;
PFS-Pre7 (Mixed):200us; | 200µS/phase | 200/250/300/phase | Equivalent |
| Time
ON and OFF | Mode: ON and OFF time
PFS-Pre2, ON:15secs, OFF:5secs ;
PFS-Pre4,ON:10secs, OFF:10secs;
PFS-Pre5, ON:10secs, OFF:10secs;
PFS-Pre7 ON:10secs, OFF:10secs; | ON:20secs
OFF:10secs | unknown | Equivalent
(Within
range) |
| Applicable
Patients | Male and female | Female | Female | Equivalent |
| Regulated
current
of
voltage? | Regulated voltage | Regulated voltage | Regulated voltage | Same |
| Firmware
controlled? | Yes | Yes | Yes | Same |
| Automatic
Shut
Off? | Yes | Yes | Yes | Same |

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510k Summary

Version: A/0

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Version: A/0

510k Summary

9

Guangzhou Finecure Medical Equipment Co., Ltd.

Product: Urinary Incontinence System

Version: A/0

510k Summary

10

Product: Urinary Incontinence System

Version: A/0

510k Summary

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Testing Summary

The testing for Urinary Incontinence System included performance, software, electrical safety, EMC, biocompatibility and bench. Urinary Incontinence System successfully passed all testing.

| Biocompatibility Safety | The Host shell (ABS material) and Membrane Touch
Switch (PET material) of the Urinary Incontinence
System(P3-9632E1 and P3-9632E2) are respectively
identical with the enclosure (ABS) and LCD cover (PET)
of Combo Electrical Stimulation (P0-9612) as it was
approved in [K130691,12/20/2013] in formulation,
processing, and no other chemicals have been added
(e.g., plasticizers, fillers, color additives, cleaning agents,
mold release agents, etc.). |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Electrical Safety | Finecure Urinary Incontinence System were tested in
accordance with applicable clause of IEC 60601-1: 2005

• CORR. 1 (2006) + CORR. 2 (2007), Medical electrical
  equipment –Part 1:General requirements for basic safety
  and essential performance.
  Test results indicated that the Urinary Incontinence
  System comply with the applicable clauses of the
  Standards. |
  | Electromagnetic
  Compatibility Testing | Finecure Urinary Incontinence System were tested in
  accordance with applicable clause of IEC
  60601-1-2:2007, Medical electrical equipment - Part 1-2:
  General requirements for basic safety and essential
  performance - Collateral standard: Electromagnetic
  compatibility - Requirements and tests.
  Test results indicated that the Urinary Incontinence
  System comply with the applicable clauses of the
  Standards. |
  | Home healthcare
  environment Testing | Finecure Urinary Incontinence System were tested in
  accordance with applicable clause of IEC 60601-1-11:
  2010 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.
  Test results indicated that the Urinary Incontinence
  System comply with the applicable clauses of the
  Standards. |
  | Bench testing | The bench test had been conducted on Urinary
  Incontinence System, the test results indicated that the
  device meet design requirements. |
  | Software verification and
  validation | The software verification and validation was performed
  on Urinary Incontinence System, the test results
  indicated that the Urinary Incontinence System meet the
  requirements of design. |
  | Non-Clinical Summary | Non-clinical tests consist of Electrical safety (IEC
  60601-1), EMC(IEC 60601-1-2), Performance (IEC
  60601-2-10), safety in the home healthcare
  environment (IEC 60601-1-11) and bench test
  (manufacturer specification), the test results show that
  the proposed device complied with the requirements of
  standards aforesaid. The materials contacting with
  body is identical with the materials used in Combo
  Electrical Stimulation (P0-9612) as it was approved in
  [K130691,12/20/2013], the test for compatibility was
  not conducted. |

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Conclusion

Based on the comparison and performance testing, the proposed device is Substantially Equivalent (SE) to the predicate device.