(296 days)
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 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.
The provided document is a 510(k) Summary for a Urinary Incontinence System. It describes the device and its equivalence to predicate devices, but it does not contain details of a clinical study with acceptance criteria for device performance related to urinary incontinence treatment efficacy.
The "Testing Summary" section on page 12 focuses entirely on non-clinical tests (biocompatibility, electrical safety, EMC, home healthcare environment, bench testing, and software verification), confirming the device meets safety and design requirements. There is no mention of a study involving human subjects or clinical outcomes for treating incontinence.
Therefore, many of the requested details cannot be extracted from this document as the type of study implied by the request (a study proving the device meets acceptance criteria for its intended use) was not performed or at least not described within this 510(k) summary.
Here's a breakdown of what can be extracted and what is missing:
Acceptance Criteria and Study Details (Based on available document)
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in terms of clinical performance (e.g., reduction in incontinence episodes) for the Urinary Incontinence System. The acceptance criteria mentioned are related to engineering and safety standards, and the reported "performance" refers to the device passing these tests.
| Acceptance Criterion Type (from document) | Reported Device Performance (from document) |
|---|---|
| Biocompatibility Safety | Host shell (ABS) and Membrane Touch Switch (PET) are identical to materials approved in K130691, implying biocompatibility. |
| Electrical Safety | Complies with IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007). |
| Electromagnetic Compatibility Testing | Complies with IEC 60601-1-2:2007. |
| Home healthcare environment Testing | Complies with IEC 60601-1-11: 2010. |
| Bench testing | Device meets design requirements. |
| Software verification and validation | Meets the requirements of design. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided as the document does not describe a clinical study with a test set of human subjects. The "test set" refers to the hardware and software units tested against engineering standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable/provided as there was no clinical study described that would require expert-established ground truth for patient outcomes. The "ground truth" for the engineering tests would be the specifications and standards themselves, assessed by engineers or testing laboratories.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided as there was no clinical study with human readers/assessors described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable/provided. No MRMC or comparative effectiveness study involving human readers or AI assistance is mentioned. The device is a physical therapeutic device, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. The device is a physical medical device for electrical stimulation, not an algorithm, and the safety/performance tests described did not involve evaluating its efficacy in a standalone algorithmic context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" is adherence to established international and national engineering standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11) and the manufacturer's own design specifications. There is no ground truth related to clinical outcomes or expert consensus on clinical data mentioned in this document.
8. The sample size for the training set
This information is not applicable/provided as no clinical studydata (training or test) is described.
9. How the ground truth for the training set was established
This information is not applicable/provided as no clinical study data (training or test) is described.
Summary of Document Focus:
This 510(k) submission primarily focuses on demonstrating substantial equivalence to predicate devices based on:
- Similar intended use and indications for use.
- Comparison of technological characteristics (e.g., power source, output parameters, waveform, pulse rate).
- Non-clinical testing to ensure the device meets safety (electrical, EMC, biocompatibility) and performance standards for its design, especially in the home healthcare environment.
The document does not include details of clinical performance studies demonstrating the effectiveness of the Urinary Incontinence System in treating stress, urge, or mixed incontinence in human subjects, or any associated acceptance criteria for these clinical outcomes. The FDA generally clears Class II devices, like this one, based on substantial equivalence to existing legally marketed devices, often without requiring new clinical efficacy studies if the technological characteristics and safety profiles are similar.
{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.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.FuE-Mail: cefda13485@163.comImage: [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 |
| SubstantiallyEquivalent Devices: | The Finecure Urinary Incontinence System is substantiallyequivalent 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 IncontinenceSystem (new device) | InControl InTone K110179 | Itouch SureK103698 | Comparison | |
|---|---|---|---|---|
| Intended use &Indications forUse | The Urinary Incontinence System withvarious treatment modalities isintended to be used by males andfemales for muscle contraction in thetreatment of stress incontinence, urgeincontinence, and mixed incontinence. | The InControl device isnon-implantedelectrical stimulatorindicated for use in the treatmentof female urinary incontinence. Itapplies electrical stimulation to thepelvic floor musculature andsurrounding structures. It is intendedfor acute and ongoing treatment ofmixed urinary incontinence wherethe following results may improveurinary control: strengthening ofpelvic floor muscles, inhibition of thedetrus or muscle through reflexivemechanisms. The biofeedbackfeature can be used for muscle | The Itouch Sure is intended toprovide electrical stimulationand neuromuscular re-educationfor the purpose of rehabilitationof weak pelvic floor muscles forthe treatment of stress, urge,and mixed urinary incontinencein women. The intended use andindications for use of the newdevice are the same as those ofthe predicate devices. | Similar1 |
| Finecure Urinary IncontinenceSystem (new device) | InControl InTone K110179 | Itouch SureK103698 | Comparison | |
| 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 ohmload). | 50Vdc (500 ohm) | 0~45V ( 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 PhaseCharge, (mC) | 36uC@500Ω | 50uC@500Ω | unknown | Equivalent |
| MaximumCurrent Density | 7.64mA/cm2 , for vaginal probe;16.3 mA/cm2, fro anal probe. | 4.7mA/cm2 | unknown | Different3 |
| MaximumAverage PowerDensity | Pre2, 2.14mW/ cm2;Pre4, 14.6mW/ cm2 ;Pre5, 1.96mW/ cm2 ;Pre7, 9.78mW/ cm2 | 14.3mW/cm2@500Ω | unknown | Equivalent |
| Finecure Urinary IncontinenceSystem (new device) | InControl InTone K110179 | Itouch SureK103698 | Comparison | |
| ElectrodeSurface 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 outputchannels | 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 musclecontraction )PFS-Pre4, 0min/20min;(Stress incontinence)PFS-Pre5, 0min/32min;(Urge incontinence) | 12 mins | Continuous/15/30 min | Equivalent:For Pre2,Pre4, Pre7,the durationis within thepredicateK103698;For Pre5,the durationis close tothepredicateK103698. |
| Finecure Urinary IncontinenceSystem (new device) | InControl InTone K110179 | Itouch SureK103698 | Comparison | |
| PFS-Pre70min/20min.(Mixed incontinence) | ||||
| Pulse Rate (PR,Hz) | 50Hz | 10/20/35/50Hz | Equivalent: | |
| Mode: | For Pre2,Pre4, Pre5: | |||
| PFS-Pre2(muscle contraction) 35Hz; | thefrequency isrespectivelysame as the | |||
| PFS-Pre4(Stress UI):50Hz; | predicateK103698; | |||
| PFS-Pre5(Urge UI):10Hz; | For Pre7,thefrequency | |||
| PFS-Pre7 (Mixed UI): 50Hz | same asthepredicateK110179; | |||
| Finecure Urinary IncontinenceSystem (new device) | InControl InTone K110179 | Itouch SureK103698 | Comparison | |
| 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 |
| TimeON and OFF | Mode: ON and OFF timePFS-Pre2, ON:15secs, OFF:5secs ;PFS-Pre4,ON:10secs, OFF:10secs;PFS-Pre5, ON:10secs, OFF:10secs;PFS-Pre7 ON:10secs, OFF:10secs; | ON:20secsOFF:10secs | unknown | Equivalent(Withinrange) |
| ApplicablePatients | Male and female | Female | Female | Equivalent |
| Regulatedcurrentofvoltage? | Regulated voltage | Regulated voltage | Regulated voltage | Same |
| Firmwarecontrolled? | Yes | Yes | Yes | Same |
| AutomaticShutOff? | 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 TouchSwitch (PET material) of the Urinary IncontinenceSystem(P3-9632E1 and P3-9632E2) are respectivelyidentical with the enclosure (ABS) and LCD cover (PET)of Combo Electrical Stimulation (P0-9612) as it wasapproved 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 inaccordance with applicable clause of IEC 60601-1: 2005+ CORR. 1 (2006) + CORR. 2 (2007), Medical electricalequipment –Part 1:General requirements for basic safetyand essential performance.Test results indicated that the Urinary IncontinenceSystem comply with the applicable clauses of theStandards. |
| ElectromagneticCompatibility Testing | Finecure Urinary Incontinence System were tested inaccordance with applicable clause of IEC60601-1-2:2007, Medical electrical equipment - Part 1-2:General requirements for basic safety and essentialperformance - Collateral standard: Electromagneticcompatibility - Requirements and tests.Test results indicated that the Urinary IncontinenceSystem comply with the applicable clauses of theStandards. |
| Home healthcareenvironment Testing | Finecure Urinary Incontinence System were tested inaccordance with applicable clause of IEC 60601-1-11:2010 MEDICAL ELECTRICAL EQUIPMENT - Part 1-11:General requirements for basic safety and essentialperformance - Collateral Standard: Requirements formedical electrical equipment and medical electricalsystems used in the home healthcare environment.Test results indicated that the Urinary IncontinenceSystem comply with the applicable clauses of theStandards. |
| Bench testing | The bench test had been conducted on UrinaryIncontinence System, the test results indicated that thedevice meet design requirements. |
| Software verification andvalidation | The software verification and validation was performedon Urinary Incontinence System, the test resultsindicated that the Urinary Incontinence System meet therequirements of design. |
| Non-Clinical Summary | Non-clinical tests consist of Electrical safety (IEC60601-1), EMC(IEC 60601-1-2), Performance (IEC60601-2-10), safety in the home healthcareenvironment (IEC 60601-1-11) and bench test(manufacturer specification), the test results show thatthe proposed device complied with the requirements ofstandards aforesaid. The materials contacting withbody is identical with the materials used in ComboElectrical Stimulation (P0-9612) as it was approved in[K130691,12/20/2013], the test for compatibility wasnot conducted. |
{12}------------------------------------------------
Conclusion
Based on the comparison and performance testing, the proposed device is Substantially Equivalent (SE) to the predicate device.
§ 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).