Urinary Incontinence System

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with a flowing ribbon-like element connecting them. 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 {1}------------------------------------------------ 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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Image /page/1/Picture/8 description: The image shows the text "Herbert P. Lerner -S" in a large, bold font. The text is arranged horizontally, with the name "Herbert P. Lerner" appearing prominently. The "-S" is slightly smaller and separated by a hyphen. The background is plain and white. 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 {2}------------------------------------------------ #### 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) {3}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ ## 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.<br>Address: F19, No.1 Kesheng Road, Baiyun Torch Building,<br>No.1633 Beitai Road, Baiyun District, Guangzhou, CHINA. | | Submitter Contact: | Shenzhen Joyantech Consulting Co., Ltd.<br>4th Floor, Jinhui Building, Nanhai BLVD, Nanshan District,<br>Shenzhen, Guangdong, China.<br>Contact person: Mr. Field.Fu<br>E-Mail: cefda13485@163.com<br>Image: [logo] | | Manufacturing Site: | Guangzhou Finecure Medical Equipment Co., Ltd.<br>Address: F19, No.1 Kesheng Road, Baiyun Torch Building,<br>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<br>Equivalent Devices: | The Finecure Urinary Incontinence System is substantially<br>equivalent to: the InControl InTone (K110179) and the I touch | {5}------------------------------------------------ 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. {6}------------------------------------------------ # Equivalence Comparison to the Predicate | | Finecure Urinary Incontinence<br>System (new device) | InControl InTone K110179 | Itouch Sure<br>K103698 | Comparison | |------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended use &<br>Indications for<br>Use | The Urinary Incontinence System with<br>various treatment modalities is<br>intended to be used by males and<br>females for muscle contraction in the<br>treatment of stress incontinence, urge<br>incontinence, and mixed incontinence. | The InControl device is<br>non-implantedelectrical stimulator<br>indicated for use in the treatment<br>of female urinary incontinence. It<br>applies electrical stimulation to the<br>pelvic floor musculature and<br>surrounding structures. It is intended<br>for acute and ongoing treatment of<br>mixed urinary incontinence where<br>the following results may improve<br>urinary control: strengthening of<br>pelvic floor muscles, inhibition of the<br>detrus or muscle through reflexive<br>mechanisms. The biofeedback<br>feature can be used for muscle | The Itouch Sure is intended to<br>provide electrical stimulation<br>and neuromuscular re-education<br>for the purpose of rehabilitation<br>of weak pelvic floor muscles for<br>the treatment of stress, urge,<br>and mixed urinary incontinence<br>in women. The intended use and<br>indications for use of the new<br>device are the same as those of<br>the predicate devices. | Similar1 | | | Finecure Urinary Incontinence<br>System (new device) | InControl InTone K110179 | Itouch Sure<br>K103698 | Compariso<br>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 0~60V ( 500 ohm<br>load). | 50Vdc (500 ohm) | 0~45V ( 500 ohm load). | Different2 | | Output current | Max Output current (500 Ohm)<br>120mA | Max Output current (500 Ohm )<br>100mA | Max Output current (500 Ohm)<br>90mA | Identical | | Maximum Phase<br>Charge, (mC) | 36uC@500Ω | 50uC@500Ω | unknown | Equivalent | | Maximum<br>Current Density | 7.64mA/cm2 , for vaginal probe;<br>16.3 mA/cm2, fro anal probe. | 4.7mA/cm2 | unknown | Different3 | | Maximum<br>Average Power<br>Density | Pre2, 2.14mW/ cm2;<br>Pre4, 14.6mW/ cm2 ;<br>Pre5, 1.96mW/ cm2 ;<br>Pre7, 9.78mW/ cm2 | 14.3mW/cm2@500Ω | unknown | Equivalent | | | Finecure Urinary Incontinence<br>System (new device) | InControl InTone K110179 | Itouch Sure<br>K103698 | Compariso<br>n | | Electrode<br>Surface Area | For vaginal probe: $7.85×2=15.7 cm²$<br>For Anal probe: $3.68×2=7.36 cm²$ | $10.5 cm² x2$ | unknown | Equivalent | | Number of output<br>channels | 2 channels | 1 channel | unknown | Different4 | | Waveform | Dual phasic, rectangular pulse. | Dual phasic, rectangular pulses | Dual phasic, rectangular pulses | Same | | Session Duration<br>(min) | Mode:<br>Time(min)<br>PFS-Pre2, 0min/20min;<br>(Pelvic floor muscle<br>contraction )<br>PFS-Pre4, 0min/20min;<br>(Stress incontinence)<br>PFS-Pre5, 0min/32min;<br>(Urge incontinence) | 12 mins | Continuous/15/30 min | Equivalent:<br>For Pre2,<br>Pre4, Pre7,<br>the duration<br>is within the<br>predicate<br>K103698;<br>For Pre5,<br>the duration<br>is close to<br>the<br>predicate<br>K103698. | | | Finecure Urinary Incontinence<br>System (new device) | InControl InTone K110179 | Itouch Sure<br>K103698 | Comparison | | | PFS-Pre7<br>0min/20min.<br>(Mixed incontinence) | | | | | Pulse Rate (PR,<br>Hz) | | 50Hz | 10/20/35/50Hz | Equivalent: | | | Mode: | | | For Pre2,<br>Pre4, Pre5: | | | PFS-Pre2<br>(muscle contraction) 35Hz; | | | the<br>frequency is<br>respectively<br>same as the | | | PFS-Pre4(Stress UI):50Hz; | | | predicate<br>k103698; | | | PFS-Pre5(Urge UI):10Hz; | | | For Pre7,<br>the<br>frequency | | | PFS-Pre7 (Mixed UI): 50Hz | | | same as<br>the<br>predicate<br>k110179; | | | Finecure Urinary Incontinence<br>System (new device) | InControl InTone K110179 | Itouch Sure<br>K103698 | Compariso<br>n | | Pulse Width | Mode:<br>PW(µS)<br>PFS-Pre2(muscle contraction) :<br>250us;<br>PFS-Pre4(Stress UI):300us;<br>PFS-Pre5(Urge UI) :200us;<br>PFS-Pre7 (Mixed):200us; | 200µS/phase | 200/250/300/phase | Equivalent | | Time<br>ON and OFF | Mode: ON and OFF time<br>PFS-Pre2, ON:15secs, OFF:5secs ;<br>PFS-Pre4,ON:10secs, OFF:10secs;<br>PFS-Pre5, ON:10secs, OFF:10secs;<br>PFS-Pre7 ON:10secs, OFF:10secs; | ON:20secs<br>OFF:10secs | unknown | Equivalent<br>(Within<br>range) | | Applicable<br>Patients | Male and female | Female | Female | Equivalent | | Regulated<br>current<br>of<br>voltage? | Regulated voltage | Regulated voltage | Regulated voltage | Same | | Firmware<br>controlled? | Yes | Yes | Yes | Same | | Automatic<br>Shut<br>Off? | Yes | Yes | Yes | Same | {7}------------------------------------------------ 510k Summary Version: A/0 {8}------------------------------------------------ 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 {11}------------------------------------------------ ### 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<br>Switch (PET material) of the Urinary Incontinence<br>System(P3-9632E1 and P3-9632E2) are respectively<br>identical with the enclosure (ABS) and LCD cover (PET)<br>of Combo Electrical Stimulation (P0-9612) as it was<br>approved in [K130691,12/20/2013] in formulation,<br>processing, and no other chemicals have been added<br>(e.g., plasticizers, fillers, color additives, cleaning agents,<br>mold release agents, etc.). | |------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Electrical Safety | Finecure Urinary Incontinence System were tested in<br>accordance with applicable clause of IEC 60601-1: 2005<br>+ CORR. 1 (2006) + CORR. 2 (2007), Medical electrical<br>equipment –Part 1:General requirements for basic safety<br>and essential performance.<br>Test results indicated that the Urinary Incontinence<br>System comply with the applicable clauses of the<br>Standards. | | Electromagnetic<br>Compatibility Testing | Finecure Urinary Incontinence System were tested in<br>accordance with applicable clause of IEC<br>60601-1-2:2007, Medical electrical equipment - Part 1-2:<br>General requirements for basic safety and essential<br>performance - Collateral standard: Electromagnetic<br>compatibility - Requirements and tests.<br>Test results indicated that the Urinary Incontinence<br>System comply with the applicable clauses of the<br>Standards. | | Home healthcare<br>environment Testing | Finecure Urinary Incontinence System were tested in<br>accordance with applicable clause of IEC 60601-1-11:<br>2010 MEDICAL ELECTRICAL EQUIPMENT - Part 1-11:<br>General requirements for basic safety and essential<br>performance - Collateral Standard: Requirements for<br>medical electrical equipment and medical electrical<br>systems used in the home healthcare environment.<br>Test results indicated that the Urinary Incontinence<br>System comply with the applicable clauses of the<br>Standards. | | Bench testing | The bench test had been conducted on Urinary<br>Incontinence System, the test results indicated that the<br>device meet design requirements. | | Software verification and<br>validation | The software verification and validation was performed<br>on Urinary Incontinence System, the test results<br>indicated that the Urinary Incontinence System meet the<br>requirements of design. | | Non-Clinical Summary | Non-clinical tests consist of Electrical safety (IEC<br>60601-1), EMC(IEC 60601-1-2), Performance (IEC<br>60601-2-10), safety in the home healthcare<br>environment (IEC 60601-1-11) and bench test<br>(manufacturer specification), the test results show that<br>the proposed device complied with the requirements of<br>standards aforesaid. The materials contacting with<br>body is identical with the materials used in Combo<br>Electrical Stimulation (P0-9612) as it was approved in<br>[K130691,12/20/2013], the test for compatibility was<br>not conducted. | {12}------------------------------------------------ ### Conclusion Based on the comparison and performance testing, the proposed device is Substantially Equivalent (SE) to the predicate device.