Perfect PFE
Device Facts
| Record ID | K191312 |
|---|---|
| Device Name | Perfect PFE |
| Applicant | Tenscare, Ltd. |
| Product Code | KPI · Gastroenterology, Urology |
| Decision Date | Nov 1, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.5320 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
Perfect PFE 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.
Device Story
Hand-held, home-use neuromuscular electrical stimulator; treats female urinary incontinence. Device includes control unit and reusable, single-patient use vaginal dual-electrode probe. User inserts probe; device delivers electrical stimulation via stainless steel electrodes to induce pelvic floor muscle contraction. Stimulation strengthens muscles; improves ability to hold contractions; aids user in identifying target muscles for self-directed exercises. User controls stimulation levels via manual push-button interface. Features four preset treatment programs, timer, compliance monitor, and open-circuit detectors. Powered by two AA batteries. Benefits include improved muscle strength and continence control.
Clinical Evidence
Bench testing only. No clinical data provided. Testing included electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), home healthcare environment requirements (IEC 60601-1-11), nerve/muscle stimulator performance (IEC 60601-2-10), and biocompatibility (ISO 10993-1, -5, -10).
Technological Characteristics
Battery-powered (2x AA) single-channel neuromuscular stimulator. Stainless steel electrodes on reusable vaginal probe. Four preset programs (Stress, Tone, Mixed, Urge). Max output 45V/0.09A @ 500Ω. Complies with IEC 60601-1, 60601-1-2, 60601-1-11, 60601-2-10, 62304, and ISO 10993. Software life cycle per IEC 62304.
Indications for Use
Indicated for women with weak pelvic floor muscles requiring rehabilitation for stress, urge, or mixed urinary incontinence, and for maintenance of urinary continence.
Regulatory Classification
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).
Predicate Devices
Submission Summary (Full Text)
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November 1, 2019
TensCare Ltd. Andrew Brown Quality Manager 9 Blenheim Road, Longmead Business Park Epsom, Surrey, KT19 9BE Gb UNITED KINGDOM
Re: K191312
Trade/Device Name: Perfect PFE Regulation Number: 21 CFR 876.5320 Regulation Name: Nonimplanted Electrical Continence Device Regulatory Class: II Product Code: KPI Dated: August 5. 2019 Received: August 13, 2019
Dear Andrew Brown:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-
combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for
Angel Soler-Garcia, Ph.D. Acting Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality 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) K191312
Device Name Perfect PFE
Indications for Use (Describe)
Perfect PFE 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.
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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# 510(k) Summary
Date of Submission prepared: November 1st 2019
| Submitter : | Tenscare Ltd |
|---------------------------------------|-------------------------------------------------------------------------------------|
| Address: | 9 Blenheim Road, Longmead Business Park, Epsom,<br>Surrey, KT19 9BE, United Kingdom |
| Tel : | +44(0)1372 723 434 |
| Fax : | +44(0)1372 745 434 |
| E-Mail : | andrew@tenscare.co.uk |
| FDA Establishment<br>Registration No: | 3003446042 |
| Contact person: | Andrew Brown |
## Address of the manufacturing facility:
l
EasyMed Instruments Co Ltd 3/F, 5F/6F, Block A, Gupo Gongmao Building, Fengxin Road, Fengxiang Industrial District, Daliang, 528300 Shunde, Foshan, Guangdong, China
FDA Establishment Registration No: 3004049909
### Address of American Representative:
Stephanie McNeil 5828 Lakeshore Road Fort Gratiot Michigan 48059 USA Phone: 001 800 308 7390 Email: compliance@tenscare.com
#### ll Submitted Device:
| Trade name: | Perfect PFE |
|------------------------|-----------------------------------------------------------------|
| Common name: | Pelvic Floor Stimulator |
| Classification number: | 21 CFR 876.5320 |
| Classification name: | Nonimplanted electrical continence device |
| Product Code: | KPI (Stimulator, electrical, non-implantable, for incontinence) |
| Classification Panel: | Gastroenterology and Urology |
| Regulatory Class: | Class II |
#### ��� Predicate Device:
| Predicate Device (1): | Primary Predicate |
|-----------------------|--------------------------------|
| Trade/Device Name: | Tenscare KegelFit |
| Manufacturer: | TensCare Ltd |
| 510(k) Number: | K142506 |
| Product Code: | KPI |
| Type of Use: | Over-The-Counter Use (OTC Use) |
| Regulatory Class: | Class II |
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| Predicate Device (2): | Secondary Predicate |
|-----------------------|-----------------------------------------------------|
| Trade/Device Name: | Yarlap |
| Manufacturer: | International Trade Group, Inc. |
| 510(k) Number: | K141643 |
| Product Code: | KPI |
| Type of Use: | Prescription Use and Over-The-Counter Use (OTC Use) |
| Regulatory Class: | Class II |
#### Device Description: IV
The Perfect PFE is a hand-held, home-use device designed to treat stress, urge and mixed urinary continence in women and maintain urinary continence in women. The device is supplied with a reusable (single-patient use) vaginal, dual-electrode, stimulation probe. The probe connects to the control unit by cable and plug and is inserted into the end user. The probe has a recommended usage duration of 6 months.
The device is battery powered, single channel, home use neuromuscular stimulation. Electrical stimulation is delivered via stainless steel electrodes on the probe to induce a contraction of the pelvic floor muscles. Muscle stimulation is used to train and strengthen the pelvic floor muscles in a controlled manner. Muscle stimulation is used to improve the ability of muscles to hold a contraction for an extended period of time and is a treatment for urinary incontinence. During a session, stimulation is delivered to specific muscles to encourage their contraction. This contraction strengthens the muscles and also helps the end user recognize which muscles to activate during self-directed contractions. The level of electrical stimulation is easily controlled by the end user using manual, push-button controls.
The unit is intended for home use by the patient. It has four preset treatment programs, a preset treatment timer, a compliance monitor, and open circuit detectors.
Accessories: Lead Wire (L-CPT) Liberty Loop vaginal probe (X-VPL)
#### > Indications for Use of the device:
The Perfect PFE 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.
The Perfect PFE is intended for OTC use.
#### VI Equivalence Comparison to the Predicate Devices:
Electrical muscle stimulation is the technological principle for both the Perfect PFE and the predicate devices KegelFit (K142506) and Yarlap (K141643). It is based on the use of the electrical muscle stimulator to strengthen the pelvic floor muscles.
The intended use and indications for use of the Perfect PFE are the same as those of the predicate devices.
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The technical characteristics of Perfect PFE are similar to those of the predicate devices in design, intended use and function. The predicate device KegelFit (K142506), Yarlap (K141643) and the Perfect PFE are devices apply an electrical current via probe to a patient's pelvic floor muscles.
The stimulation parameters of Perfect PFE are similar to those of predicate devices KegelFit (K142506) and Yarlap (K141643). Perfect PFE has 4 programs, the parameters of the Stress and Tone programs are the same as those of predicate device KeqelFit (K142506). The Urge program of Perfect PFE has employed similar parameters to the predicate device Yarlap (K141643). The parameters of the Mixed program of Perfect PFE is similar to both KegelFit (K142506) and Yarlap (K141643).
Table 1 below summarizes the shared and unique technological elements between the Perfect PFE. KeqelFit (K142506), and Yarlap (K141643) devices. The technology, engineering, and performance for Perfect PFE are substantially equivalent to the predicate devices.
From the view of safety and effectiveness, the Perfect PFE uses preset programs that are substantially equivalently to the predicate devices. The output characteristics of Perfect PFE are similar to those of predicate device KegelFit (K142506), and Yarlap (K141643), see Table 1. The Perfect PFE is designed to comply with relevant safety applicable recognized consensus standards; the output energy is controlled well within the safety and effectiveness ranges specified by relevant FDA quidance. Detailed and strictly controlled testing has been carried out. The maximum power density of Perfect PFE and predicate device KegelFit (K142506), and Yarlap (K141643) are less than 0.25 watts per square centimeter of electrode conductive surface area to reduce the risk of thermal burns. Furthermore, the test results, risk analysis, and FMEA analysis show that the potential hazards of the Perfect PFE have been adequately mitigated.
As such:
1. the Perfect PFE has similar technological characteristics and intended uses as the predicate KegelFit (K142506) and Yarlap (K141643): and
2. the information submitted to the FDA for the Perfect PFE does not raise different questions about safety or effectiveness and performance testing demonstrates with reasonable assurance based on established controls that the device is at least as safe and effective as a legally marketed device.
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## Table 1 Substantial Equivalence Comparison Table
| Attribute | Subject Device | Predicate Device (1) | Predicate Device (2) | Comparison |
|-------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Product Name | Perfect PFE | KegelFit | Yarlap | |
| 510(K) number | (to be assigned) | K142506 | K141643 | |
| Product Code | KPI | KPI | KPI | Substantially<br>equivalent |
| Regulation No. | 21 CFR 876.5320 | 21 CFR 876.5320 | 21 CFR 876.5320 | Substantially<br>equivalent |
| Indications<br>for<br>Use | Perfect PFE is intended to<br>provide electrical stimulation<br>and neuromuscular re-<br>education for the purpose of<br>rehabilitation of weak pelvic<br>floor muscles for the<br>treatment of stress, urge and<br>mixed urinary incontinence in<br>women and to maintain<br>urinary continence in women. | KegelFit is a non-implanted<br>muscle stimulator designed<br>to treat female stress urinary<br>incontinence.<br>It applies stimulation to the<br>pelvic floor muscles to<br>improve strength and<br>support.<br>The KegelFit is intended for<br>OTC sale. | The device is intended to<br>provide electrical stimulation<br>and neuromuscular re-<br>education for the purpose of<br>rehabilitation of weak pelvic<br>floor muscles for the<br>treatment of stress, urge<br>and mixed urinary<br>incontinence in women and<br>to maintain urinary<br>continence in women. | Substantially<br>equivalent |
| Prescriptive<br>or<br>OTC | OTC | OTC | Rx and OTC | Substantially<br>equivalent |
| Number of output<br>modes | 4 | 2 | 6 | Substantially<br>equivalent |
| Number of output<br>channels | 1 | 1 | 2 | Substantially<br>equivalent |
| Frequency (Hz) | Stress: 50Hz<br>Tone: 35Hz<br>Mixed: 10Hz/50 Hz<br>Urge: 10Hz | Stress: 50Hz<br>Tone: 35Hz | Stress: 12Hz / 35Hz<br>Urge: 10Hz / 12Hz<br>Mixed: 12Hz / 20Hz | Substantially<br>equivalent |
| Attribute | Subject Device | Predicate Device (1) | Predicate Device (2) | Comparison |
| Pulse Width (μς) | Stress: 300μs<br>Tone: 250μs<br>Mixed: 200µs / 300µs<br>Urge: 200µs | Stress: 300μς<br>Tone: 250μs | Stress: 200µs / 250µs<br>Urge: 200µs<br>Mixed: 200µs / 250µs | Substantially<br>equivalent |
| Maximum Output<br>Voltage (V) | 45V @ 500Ω | 45V @ 500Ω | 40V @ 500Ω | Substantially<br>equivalent |
| Maximum Output<br>Current (A) | 0.09A @ 500Ω | 0.09A @ 500Ω | 0.08A @ 500Ω | Substantially<br>equivalent |
| Maximum Phase<br>Charge (μC) | 24.29 @ 500Ω | 23.88 @ 500Ω | 20.85 @ 500Ω | Substantially<br>equivalent |
| Maximum Current<br>Density, (mA/cm²) | 21.2 @ 500Ω<br>(Area=4.24cm²) | 10.5 @ 500Ω<br>(Area=8.58cm²) | 12.5@ 500Ω<br>(Area=6.4cm²) | Substantially<br>equivalent |
| Maximum Power<br>Density, (W/cm²) | 0.0116 @ 500Ω<br>(Area=4.24cm²) | 0.00584 @ 500Ω<br>(Area=8.58cm²) | 0.0035 @ 500Ω<br>(Area=6.4cm²) | Substantially<br>equivalent |
| Power Source | 2 Alkaline AA 1.5V Batteries | 2 Alkaline AA 1.5V Batteries | 9V Alkaline Batteries | Substantially<br>equivalent |
| Electrode<br>lead<br>wires and patient<br>cable compliance<br>with 21 CFR 898 | Yes | Yes | Yes | Substantially<br>equivalent |
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#### Vaginal Electrodes Substantial Equivalence and Safety: VII
The vaginal probe used with the subject device (i.e., the Liberty Loop vaginal probe) is similar in size, materials, and electrode position to the Liberty vaginal probe used with the KegelFit predicate device (K142506). Additionally, both probes are reusable, for single-patient use only. The main difference is that the subject Liberty Loop vaginal probe has an oval loop shape that can be squeezed during Kegel exercises, while the predicate Liberty vaginal probe is solid (not compressible). Despite this difference, the subject and predicate vaginal probes are substantially equivalent with respect to treating urinary incontinence.
#### Performance Tests: VIII
| FDA recognition No. | Standard Title |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 19-4 | ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012,<br>C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text)<br>Medical electrical equipment - Part 1: General requirements for<br>basic safety and essential performance (IEC 60601-1:2005, MOD) |
| 19-8 | IEC 60601-1-2 Edition 4.0 2014-02<br>Medical electrical equipment - Part 1-2: General requirements for<br>basic safety and essential performance - Collateral Standard:<br>Electromagnetic disturbances - Requirements and tests |
| 19-14 | IEC 60601-1-11 Edition 2.0 2015-01<br>Medical electrical equipment - Part 1-11: General requirements for<br>basic safety and essential performance - Collateral Standard:<br>Requirements for medical electrical equipment and medical<br>electrical systems used in the home healthcare environment. |
| 17-16 | IEC 60601-2-10 Edition 2.1 2016-04<br>Medical electrical equipment - Part 2-10: Particular requirements for<br>the basic safety and essential performance of nerve and muscle<br>stimulators |
| 5-40 | ISO 14971: Second Edition 2007-03-01 Medical devices-<br>Application of Risk Management To Medical Devices. |
| 5-89 | IEC 60601-1-6 Edition 3.1 2013-10<br>Medical electrical equipment - Part 1-6: General requirements for<br>basic safety and essential performance - Collateral standard:<br>Usability |
| 13-79 | IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION<br>Medical device software - Software life cycle processes |
| 2-220 | ANSI AAMI ISO 10993-1:2009/(R)2013<br>Biological evaluation of medical devices - Part 1: Evaluation and<br>testing within a risk management process |
| | Three hincomnatibility tests conducted. |
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- -Cytotoxicity (per ISO 10993-5)
- Sensitization (per ISO 10993-10) -
- -Irritation (per ISO 10993-10)
# IX Usability Study:
Based on the similarity of the Perfect PFE to the predicates with respect to design, indications for use, and labeling materials, usability testing was determined not to be necessary for this 510(k) submission.
# X Conclusion:
- � The Perfect PFE has similar technological characteristics and intended uses as the predicate KegelFit (K142506) and Yarlap (K141643); and
- ◆ The labelling of the Perfect PFE is concordant with the predicate devices and FDA requirements; and
- � The information and performance testing submitted to the FDA for the Perfect PFE does not raise different questions about safety or effectiveness and demonstrates with reasonable assurance based on established controls that the device is at least as safe and effective as a legally marketed device.
Therefore, the Perfect PFE is substantially equivalent to the predicate devices.
