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 Description

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)

AI/ML Overview

This document is a 510(k) Premarket Notification from TensCare Ltd. for their device, the "Perfect PFE," a non-implanted electrical continence device. The FDA determined the device to be substantially equivalent to legally marketed predicate devices.

The request asks for details on the acceptance criteria and the study proving the device meets these criteria. However, this document primarily focuses on demonstrating substantial equivalence to existing predicate devices (TensCare KegelFit and Yarlap), rather than presenting a performance study with acceptance criteria in the typical sense for a novel medical device. The 510(k) pathway for medical device clearance in the US does not generally require clinical trials to prove efficacy if substantial equivalence to a legally marketed predicate device can be demonstrated.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable to this type of submission. The "study" here is primarily a comparison against predicate devices and adherence to recognized safety standards.

Here's how the information maps to your request based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission based on substantial equivalence, the "acceptance criteria" are generally met by demonstrating that the new device is as safe and effective as the predicate device. This is primarily done through a comparison of technological characteristics, intended use, and adherence to relevant safety standards. The "performance" is shown by meeting these comparisons and standards.

Acceptance Criterion (Demonstrating Substantial Equivalence)	Reported Device Performance (as demonstrated by comparison/testing)
Similar Intended Use & Indications for Use	Perfect PFE's indications are "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." This is either identical or substantially equivalent to predicates.
Similar Technological Characteristics	Perfect PFE's design, function (electrical muscle stimulation, single-channel, battery-powered, home-use), and stimulation parameters (frequency, pulse width, max voltage, max current, max phase charge) are similar or substantially equivalent to the predicate devices (KegelFit and Yarlap) as shown in Table 1, page 6. The differences in specific parameters (e.g., number of output modes, channels, specific frequencies within programs) are argued to not raise new safety/effectiveness concerns.
Compliance with Safety Standards	The device complies with relevant safety consensus standards: ANSI AAMI ES60601-1 (general safety), IEC 60601-1-2 (EMC), IEC 60601-1-11 (home healthcare), IEC 60601-2-10 (nerve and muscle stimulators), ISO 14971 (risk management), IEC 60601-1-6 (usability - though further usability testing was not done due to similarity), IEC 62304 (software life cycle processes), and ISO 10993-1 (biocompatibility, confirmed by cytotoxicity, sensitization, and irritation tests).
No New Questions of Safety or Effectiveness	The submission asserts that the information presented and performance testing (standard compliance) demonstrate with reasonable assurance that the device is at least as safe and effective as a legally marketed device and does not raise different questions about safety or effectiveness.
Probe Substantial Equivalence and Safety	The vaginal probe (Liberty Loop) is "similar in size, materials, and electrode position" to the predicate probe (Liberty vaginal probe), and both are reusable for single-patient use. The difference in shape (oval loop vs. solid) does not impact substantial equivalence for treating incontinence.
Maximum Power Density	The maximum power density of Perfect PFE is less than 0.25 watts per square centimeter of electrode conductive surface area, which is within the safe range for reducing thermal burns, similar to the predicate devices.

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size for Test Set: Not applicable. This submission relies on demonstrating substantial equivalence to predicate devices and compliance with recognized standards, not a specific clinical test set to evaluate performance metrics like sensitivity or specificity.
Data Provenance: Not applicable in the context of a "test set" for performance evaluation. The data presented is primarily engineering specifications, comparison tables, and adherence to international safety standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Number of Experts: Not applicable. "Ground truth" in the context of clinical performance data for a diagnostic/treatment device is not required for this type of 510(k) submission, as it's based on substantial equivalence rather than novel performance claims.
Qualifications of Experts: N/A

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. No clinical test set requiring adjudication was performed.

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

MRMC Study: Not applicable. This device is an electrical stimulator for home use, not an AI-assisted diagnostic imaging device that would typically undergo MRMC studies.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: Not applicable. This is a physical medical device, not a software algorithm that operates in a standalone manner.

7. The Type of Ground Truth Used

Type of Ground Truth: Not applicable. Clinical "ground truth" (e.g., pathology, outcomes data) is not part of a substantial equivalence demonstration for a device of this type, which is cleared based on its similarity to existing cleared devices and adherence to safety standards.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device does not use an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set was established

How Ground Truth Established: Not applicable.

Summary

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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)

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,Surrey, KT19 9BE, United Kingdom
Tel :	+44(0)1372 723 434
Fax :	+44(0)1372 745 434
E-Mail :	andrew@tenscare.co.uk
FDA EstablishmentRegistration No:	3003446042
Contact person:	Andrew Brown

Address of the manufacturing facility:

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 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:

the Perfect PFE has similar technological characteristics and intended uses as the predicate KegelFit (K142506) and Yarlap (K141643): and
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	Substantiallyequivalent
Regulation No.	21 CFR 876.5320	21 CFR 876.5320	21 CFR 876.5320	Substantiallyequivalent
IndicationsforUse	Perfect PFE is intended toprovide electrical stimulationand neuromuscular re-education for the purpose ofrehabilitation of weak pelvicfloor muscles for thetreatment of stress, urge andmixed urinary incontinence inwomen and to maintainurinary continence in women.	KegelFit is a non-implantedmuscle stimulator designedto treat female stress urinaryincontinence.It applies stimulation to thepelvic floor muscles toimprove strength andsupport.The KegelFit is intended forOTC sale.	The device is intended toprovide electrical stimulationand neuromuscular re-education for the purpose ofrehabilitation of weak pelvicfloor muscles for thetreatment of stress, urgeand mixed urinaryincontinence in women andto maintain urinarycontinence in women.	Substantiallyequivalent
PrescriptiveorOTC	OTC	OTC	Rx and OTC	Substantiallyequivalent
Number of outputmodes	4	2	6	Substantiallyequivalent
Number of outputchannels	1	1	2	Substantiallyequivalent
Frequency (Hz)	Stress: 50HzTone: 35HzMixed: 10Hz/50 HzUrge: 10Hz	Stress: 50HzTone: 35Hz	Stress: 12Hz / 35HzUrge: 10Hz / 12HzMixed: 12Hz / 20Hz	Substantiallyequivalent
Attribute	Subject Device	Predicate Device (1)	Predicate Device (2)	Comparison
Pulse Width (μς)	Stress: 300μsTone: 250μsMixed: 200µs / 300µsUrge: 200µs	Stress: 300μςTone: 250μs	Stress: 200µs / 250µsUrge: 200µsMixed: 200µs / 250µs	Substantiallyequivalent
Maximum OutputVoltage (V)	45V @ 500Ω	45V @ 500Ω	40V @ 500Ω	Substantiallyequivalent
Maximum OutputCurrent (A)	0.09A @ 500Ω	0.09A @ 500Ω	0.08A @ 500Ω	Substantiallyequivalent
Maximum PhaseCharge (μC)	24.29 @ 500Ω	23.88 @ 500Ω	20.85 @ 500Ω	Substantiallyequivalent
Maximum CurrentDensity, (mA/cm²)	21.2 @ 500Ω(Area=4.24cm²)	10.5 @ 500Ω(Area=8.58cm²)	12.5@ 500Ω(Area=6.4cm²)	Substantiallyequivalent
Maximum PowerDensity, (W/cm²)	0.0116 @ 500Ω(Area=4.24cm²)	0.00584 @ 500Ω(Area=8.58cm²)	0.0035 @ 500Ω(Area=6.4cm²)	Substantiallyequivalent
Power Source	2 Alkaline AA 1.5V Batteries	2 Alkaline AA 1.5V Batteries	9V Alkaline Batteries	Substantiallyequivalent
Electrodeleadwires and patientcable compliancewith 21 CFR 898	Yes	Yes	Yes	Substantiallyequivalent

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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,C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text)Medical electrical equipment - Part 1: General requirements forbasic safety and essential performance (IEC 60601-1:2005, MOD)
19-8	IEC 60601-1-2 Edition 4.0 2014-02Medical electrical equipment - Part 1-2: General requirements forbasic safety and essential performance - Collateral Standard:Electromagnetic disturbances - Requirements and tests
19-14	IEC 60601-1-11 Edition 2.0 2015-01Medical electrical equipment - Part 1-11: General requirements forbasic safety and essential performance - Collateral Standard:Requirements for medical electrical equipment and medicalelectrical systems used in the home healthcare environment.
17-16	IEC 60601-2-10 Edition 2.1 2016-04Medical electrical equipment - Part 2-10: Particular requirements forthe basic safety and essential performance of nerve and musclestimulators
5-40	ISO 14971: Second Edition 2007-03-01 Medical devices-Application of Risk Management To Medical Devices.
5-89	IEC 60601-1-6 Edition 3.1 2013-10Medical electrical equipment - Part 1-6: General requirements forbasic safety and essential performance - Collateral standard:Usability
13-79	IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSIONMedical device software - Software life cycle processes
2-220	ANSI AAMI ISO 10993-1:2009/(R)2013Biological evaluation of medical devices - Part 1: Evaluation andtesting 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.

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).