(224 days)
Not Found
No
The description focuses on basic electrical stimulation with manual controls and preset programs, with no mention of adaptive algorithms, learning, or data analysis that would indicate AI/ML.
Yes
The device is designed to treat female stress urinary incontinence by applying electrical stimulation to strengthen pelvic floor muscles, which falls under the definition of a therapeutic device.
No
The device is a muscle stimulator designed to treat (not diagnose) female stress urinary incontinence by strengthening pelvic floor muscles. It provides electrical stimulation for therapeutic purposes, rather than to identify or characterize a medical condition.
No
The device description explicitly states it is a "hand-held, home-use device" and includes a "vaginal two electrode stimulation probe (Trainer)" that connects to a "control unit by cable and plug". This indicates the device is a physical hardware device with a software component, not a software-only medical device.
Based on the provided information, the KegelFit device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- KegelFit's Function: The KegelFit is a muscle stimulator that applies electrical stimulation directly to the pelvic floor muscles within the body. It is a therapeutic device designed to treat a condition (stress urinary incontinence) by strengthening muscles, not by analyzing biological samples.
The description clearly states its purpose is to deliver electrical stimulation to induce muscle contractions and strengthen the pelvic floor, which is a form of physical therapy or rehabilitation, not in vitro testing.
N/A
Intended Use / Indications for Use
KegelFit is a non-implanted muscle stimulator designed to treat female stress urinary incontinence. It applies stimulation to the pelvic floor muscles to improve strength and support. The KegelFit is intended for OTC sale.
Product codes (comma separated list FDA assigned to the subject device)
KPI
Device Description
The KegelFit is a hand-held, home-use device designed to treat female stress urinary incontinence. The device is supplied with a vaginal two electrode stimulation probe (Trainer). The trainer connects to the control unit by cable and plug and is inserted into the vagina by the end user. Electrical stimulation is delivered via stainless steel electrodes on the trainer 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 device is battery powered single channel home use neuromuscular stimulation. Electrical stimulation is delivered via stainless steel electrodes on the inflatable 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, and is designed with simplicity and ease of use in mind. It has two preset treatment programs, a preset treatment timer, a compliance monitor, and open circuit detectors.
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
Home use, Over-the-counter
The end user can control the electrical stimulation levels and the starting and stopping of each session.
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)
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern.
Electrical safety testing was conducted on KegelFit. The device complies with the IEC 60601-1 and IEC60601-1-11 standards for safety. The KegelFit has been tested to EN60601-1-2:2007 and found to be EMC testing: suitable for use in domestic establishments and in establishments directly connected to a low voltage power supply network which supplies buildings used for domestic purposes.
The biocompatibility evaluation for the itouch Sure vaqinal electrode (KeqelFit Trainer) was conducted in accordance with International Standard ISO 10993:2009 biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity and ISO 10993:2002 biological evaluation of medical devices-Part 10: Tests for irritation and delayed-type hypersensitivity.
A clinical literature evaluation was conducted to provide evidence of the safety and efficacv of electrical stimulation for the treatment of female stress urinary incontinence.
A detailed comparison of labeling between the KegelFit and the predicate device Apex was conducted to assess the safety of the KegelFit device for over-the-counter use. The objectives of this comparison were to: 1) determine if a subject can self-identify as having stress urinary incontinence using package labeling 2) self-limit usage if a contraindication is present.
An analysis of customer reviews of the predicate device itouch Sure from 13758 OTC sales in the EU was used to determine whether the subject can safely use the KeqelFit device using only the instructions for use (IFU) provided. A questionnaire was sent to a further 120 Ebay UK OTC customers.
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.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 20, 2015
Tenscare Ltd. % Linda Stamschor US Agent Akos (Meddiquest) 17957 615th Street Kellogg, MN 55945
Re: K142506 Trade/Device Name: Tenscare KegelFit Regulation Number: 21 CFR 876.5320 Regulation Name: Nonimplanted electrical continence device Regulatory Class: II Product Code: KPI Dated: November 6, 2014 Received: March 11, 2015
Dear Linda Stamschor,
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,
Herbert P. Lerner -S
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
Indications for Use
510(k) Number (if known) K142506
Device Name Tenscare KegelFit
Indications for Use (Describe)
KegelFit is a non-implanted muscle stimulator designed to treat female stress urinary incontinence.
It applies stimulation to the pelvic floor muscles to improve strength and support.
The KegelFit is intended for OTC sale.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
3
Section5 510(k) Summary
Date of Summary prepared: 7th April 2015
| 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 |
| : | andrew.brown@tenscare.co.uk | |
| FDA Establishment registration no: 3003446042 | ||
| Contact person: | : | Andrew Brown |
Address of the manufacturing facility:
EasyMed Instruments Co Ltd 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:
Linda Stamschror 17957 615th Street Kellogg Minnesota 55945 USA
Phone: 507 767 2258 Email: wallisfowler@gmail.com
ll Submitted Device:
| Generic name: | Pelvic Floor Stimulator |
|---|---|
| Trade name: | TensCare KegelFit |
| Common name: | KegelFit Pelvic Floor Exerciser |
| Classification name: | Stimulator, Electrical, Non-implantable, for Incontinence – |
| Title 21, Code of Federal Regulations Sec.876.5320 ProCode: 78 KPI | |
| Device Classification: | Class II |
4
��� Predicate Devices:
| 510(k) | Name | Product Code | Class | Use | Manufacturer |
|---|---|---|---|---|---|
| Primary Predicate | |||||
| K141158 | Apex | KPI | II | OTC | InControl Medical, LLC |
| 3225 Gateway Road, Ste. 250 | |||||
| Brookfield, WI 53045 USA | |||||
| Secondary Predicate | |||||
| K103698 | itouch Sure | ||||
| Pelvic | |||||
| Floor | |||||
| Exerciser | KPI | II | Prescription | Tenscare Ltd | |
| 9 Blenheim Road, Epsom,Surrey, | |||||
| KT19 9BE, UK |
Device Description: IV
The KegelFit is a hand-held, home-use device designed to treat female stress urinary incontinence. The device is supplied with a vaginal two electrode stimulation probe (Trainer). The trainer connects to the control unit by cable and plug and is inserted into the vagina by the end user. Electrical stimulation is delivered via stainless steel electrodes on the trainer 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 device is battery powered single channel home use neuromuscular stimulation. Electrical stimulation is delivered via stainless steel electrodes on the inflatable 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, and is designed with simplicity and ease of use in mind. It has two preset treatment programs, a preset treatment timer, a compliance monitor, and open circuit detectors.
5
V The intended use of the device:
KegelFit is a non-implanted muscle stimulator designed to treat female stress urinary incontinence. It applies stimulation to the pelvic floor muscles to improve strength and support.
The intended use and indications for use of the new device are the same as those of the predicate device Apex K141158
KegelFit for over-the-counter use was evaluated for safety in two ways:-
-Ability to self-diagnose and identify whether contraindication apply was established by detailed comparison with labeling and instructional packaging of the predicate device Apex K141158
-Ability to use effectively was established by analysis of customer reviews over 4 years and 13758 OTC sales of the predicate device itouch Sure K103698 through Amazon UK. The user manual was revised three times over this period in response to customer feedback and to comply with EN60601-1-11.
The device labeling and packaging (which includes a box, detailed instructions for use, and laminated quick reference guide) allow the end user to accurately self-diagnose and use the product to treat stress urinary incontinence.
VI Equivalence Comparison to the Predicate Devices
Electrical muscle stimulation is the technological principle for both KeqelFit and the predicate devices, Apex (K141158) and itouch Sure (K103698). It is based on the use of the electrical muscle stimulator to strengthen the pelvic floor muscles.
Table 6 below summarizes the shared and unique technological elements between the KegelFit, itouch Sure, and Apex devices. The technology, engineering, performance and user interface for KegelFit is substantially equivalent to the predicate devices.
Intended Use has been changed from prescription to OTC and from all types of incontinence only, and the available settings and labeling have been modified to allow for this change. The intended use, labeling and user interface for KegelFit is substantially equivalent to the predicate device Apex.
The KegelFit is a relabelled version of the itouch Sure(K103698). The components, electronics, and accessories are identical. The display and software have been modified in line with the change in Intended Use. The physical differences between the two versions of the product are:
| KegelFit | Itouch Sure | Explanation | |
|---|---|---|---|
| Program name | TRAIN | STRES | To be less technical, and stress the need for Kegel exercises. |
| Program name | X | URGE | Removed as Urge and Mixed are not included in the Intended Use |
| Program name | X | MIXED | Removed as Urge and Mixed are not included in the Intended Use |
| Treatment | |||
| Timer | Default 20 min , | ||
| 10 min selectable | Default 20 min, up to 60 min selectable | Only adverse report received was of over-use leading to muscle cramping. IFU amended. | |
| Longer treatment times removed. | |||
| Keypad | On/Off Colour coded | ON/OFF buttons colour coded to clarify operation |
6
The KegelFit is substantially equivalent to the itouch Sure, which has been approved for home and hospital use on prescription.
Safety and effectiveness for home use with professional instruction is therefore established.
The KegelFit packaging and instructions for use are substantially equivalent to that of the Apex for the relevant criteria:-
- . How well the lay user can self-select themselves as being appropriate users
- Whether the lay user can understand all indications, contraindications, warnings and . precautions, and be able to identify whether they are within any contraindicated group.
This Substantial Equivalence is established by detailed comparison of labeling in Section 12. The KegelFit uses identical or substantially equivalent wording, frequency of use, and positioning of Intended Audience, Contraindications, Warnings and Cautions.
The final comparison is that of the ability of the lay user to be able to apply the treatment safely and correctly according to the instructions for use without training.
TensCare presents analysis of Customer Reviews from OTC sales of 13,768 units of itouch Sure through Amazon UK and 21 customer questionnaires sent to 120 users of itouch Sure as evidence that the lay user finds the device easy to use and the instructions easy to follow.
7
Table 6. Substantial Equivalence Comparison Table
| Features/
| Function | A KegelFit K142506 | B Itouch Sure | C Apex K141158 | Comparison A/B | Impact on safety and performance | Comparison A/C | Impact on safety and performance |
|---|---|---|---|---|---|---|---|
| Intended Use | |||||||
| An explicit | |||||||
| description of all | |||||||
| clinical functions | |||||||
| performed by | |||||||
| the device, | The Itouch Sure is a non-implanted | ||||||
| electrical stimulator indicated for | |||||||
| use in the treatment of female | |||||||
| urinary incontinence. It applies | |||||||
| electrical | |||||||
| stimulation to the pelvic floor | |||||||
| musculature and surrounding | |||||||
| structures | |||||||
| Indications for | |||||||
| Use | |||||||
| Explain when the | |||||||
| device is to be | |||||||
| clinically used | |||||||
| and the intended | |||||||
| patient | |||||||
| population | KegelFit is a non-implanted | ||||||
| muscle stimulator designed to | |||||||
| treat female stress urinary | |||||||
| incontinence. It applies | |||||||
| stimulation to the pelvic floor | |||||||
| muscles to improve strength | |||||||
| and support. | The Itouch Sure is indicated for | ||||||
| acute and ongoing treatment of | |||||||
| stress, urge or mixed urinary | |||||||
| incontinence and where the | |||||||
| following results may improve | |||||||
| urinary control: | |||||||
| • Improvement of urethral | |||||||
| sphincter closure | |||||||
| • Strengthening of pelvic floor | |||||||
| muscles | |||||||
| • Inhibition of the detruser | |||||||
| (bladder) muscle through reflexive | |||||||
| mechanisms | Apex is a non-implanted muscle | ||||||
| stimulator designed to treat | |||||||
| female stress urinary | |||||||
| incontinence. | |||||||
| It applies stimulation to the pelvic | |||||||
| floor muscles to improve strength | |||||||
| and support. | Substantially | ||||||
| equivalent | None: | ||||||
| Both devices apply | |||||||
| electrical stimulation to | |||||||
| strengthen the pelvic | |||||||
| floor muscles, as | |||||||
| supported by literature, | |||||||
| see Section20.1 Clinical | |||||||
| Evaluation Report | Identical | None: | |||||
| Features/ | |||||||
| Function | A Kegelfit | B Itouch Sure | C Apex K141158 | Comparison | |||
| A/B | Impact on safety and | ||||||
| performance | Comparison | ||||||
| A/C | Impact on safety and | ||||||
| performance | |||||||
| Primary | |||||||
| Function | Delivery of electrical | ||||||
| stimulation | Delivery of electrical stimulation | Delivery of electrical stimulation | Identical | None | Identical | None | |
| Warnings or | |||||||
| Precautions | (See product labeling) | (See product labeling) | Substantially | ||||
| Equivalent | The Warnings and | ||||||
| Cautions were based on | |||||||
| the predicate Apex | |||||||
| which was validated | |||||||
| through human factors | |||||||
| and Usability Testing. | |||||||
| Only minor changes | |||||||
| were made to allow for | |||||||
| the technical difference | |||||||
| between the products | |||||||
| Contra- | |||||||
| indications | |||||||
| Explain when the | |||||||
| device is not | |||||||
| to be clinically | |||||||
| used | • Do not use if you are | ||||||
| pregnant. | |||||||
| • Do not use if you are | |||||||
| attempting to get pregnant | |||||||
| • Do not use if you have a | |||||||
| cardiac demand pacemaker | |||||||
| or implanted defibrillator. | |||||||
| • Do not use if you have | |||||||
| symptoms of active urinary | Contraindications | ||||||
| Should not be used if you have any | |||||||
| of the following conditions: | |||||||
| • If you are pregnant or trying to | |||||||
| become pregnant | |||||||
| • If you have a heart pacemaker or | |||||||
| a heart rhythm problem | |||||||
| • If you have: | |||||||
| An active urinary tract infection | |||||||
| Infections or lesions in the area of | |||||||
| electrode placement | • Do not use if you are pregnant | ||||||
| • Do not use if you are | |||||||
| attempting to get pregnant | |||||||
| • Do not use if you have a cardiac | |||||||
| demand pacemaker or implanted | |||||||
| defibrillator | |||||||
| • Do not use if you have | |||||||
| symptoms of active urinary tract | |||||||
| infection, vaginal infections, or | |||||||
| localized lesions | Substantially | ||||||
| equivalent | None | Identical | None | ||||
| infections, or localized lesions | |||||||
| • Do not use if you have a | |||||||
| diagnosis of extra-urethral or | |||||||
| overflow incontinence | |||||||
| • Do not use if you have | |||||||
| severe urine retention | |||||||
| • Do not use if you have poor | |||||||
| sensation in the pelvic region | |||||||
| • Do not use if you have | |||||||
| cognitive disabilities, i.e.; | |||||||
| Alzheimer's disease or | |||||||
| dementia | |||||||
| • Do not use if you are unable | |||||||
| to properly insert the Trainer | |||||||
| • Do not use if you have | |||||||
| active pelvic cancer | |||||||
| • Do not use it you have an | |||||||
| intestinal clamp | |||||||
| • You must be 6 weeks post | |||||||
| pelvic surgery or vaginal | |||||||
| childbirth to use this device | |||||||
| • Do not use this device for | |||||||
| diagnostic purposes or critical | |||||||
| patient monitoring | |||||||
| • This device is not (external) | |||||||
| defibrillator-proof | History of urinary retention or | ||||||
| post-void residual volume greater | |||||||
| than 200cc | |||||||
| • Diminished sensory perception | |||||||
| • Inability to understand the | |||||||
| directions for use or operate the | |||||||
| device correctly | |||||||
| • If you have been diagnosed or | |||||||
| treated for cervical, or any pelvic, | |||||||
| cancer | |||||||
| • Recent history of vaginal bleeding | |||||||
| between menstrual periods | |||||||
| • If you have, or have had epilepsy | • Do not use if you have a | ||||||
| diagnosis of extra-urethral or | |||||||
| overflow incontinence | |||||||
| • Do not use if you have severe | |||||||
| urine retention | |||||||
| • Do not use if you have poor | |||||||
| sensation in the pelvic region | |||||||
| • Do not use if you have cognitive | |||||||
| disabilities, i.e.; Alzheimer's | |||||||
| disease or dementia | |||||||
| • Do not use if you are unable to | |||||||
| properly insert the device per | |||||||
| instructions | |||||||
| • Do not use if you have active | |||||||
| pelvic cancer | |||||||
| • Do not use if you have an | |||||||
| intestinal clamp | |||||||
| • You must be 6 weeks post- | |||||||
| pelvic surgery or vaginal | |||||||
| childbirth to use this device | |||||||
| • Do not use this device for | |||||||
| diagnostic purposes or critical | |||||||
| patient monitoring | |||||||
| • This device is not (external) | |||||||
| defibrillator-proof | |||||||
| • If any discomfort occurs when | |||||||
| inserting the probe, consult your | |||||||
| treating physician. | |||||||
| Features/ | |||||||
| Function | A Kegelfit | B Itouch Sure | C Apex K141158 | Comparison | |||
| A/B | Impact on safety and | ||||||
| performance | Comparison | ||||||
| A/C | Impact on safety and | ||||||
| performance | |||||||
| Labeling | |||||||
| Summary | |||||||
| Clarity to insure | |||||||
| safer or more | User Manual | ||||||
| Retail Box | |||||||
| Contraindications insert | User Manual | ||||||
| Retail Box | |||||||
| Contraindications insert | Substantially | ||||||
| equivalent | None: | ||||||
| The operating | |||||||
| instructions part of the | |||||||
| user manual is based on | |||||||
| the predicate, itouch | |||||||
| Sure,with references to | |||||||
| Urge and Mixed | |||||||
| programs removed. | |||||||
| Illustrations and Quick | |||||||
| Start guide were added | |||||||
| to further improve | |||||||
| usability | Substantially | ||||||
| equivalent | None. | ||||||
| See comparison table of | |||||||
| the self-diagnosis, | |||||||
| contraindications and | |||||||
| warnings. | |||||||
| effective use | Device controls | Device controls | |||||
| Environ- | |||||||
| mental | |||||||
| Specific- | |||||||
| ations | For indoor use only | For indoor use only | For indoor use only | Identical | None | Identical | None |
| Power Source | 2 AA Alkaline battery | 2 AA Alkaline battery | 4 AAA Alkaline battery | Identical | None | Substantially | None |
| equivalent | Battery insertion was | ||||||
| validated through | |||||||
| analysis of customer | |||||||
| reviews | |||||||
| Method of line | |||||||
| current | |||||||
| isolation | N/A (battery) | N/A (battery) | N/A (battery) | Identical | None | Identical | None |
| Patient | |||||||
| leakage | |||||||
| current | N/A (battery) | N/A (battery) | N/A (battery) | Identical | None | Identical | None |
| Number of | |||||||
| Output Modes | Two | Four | One | Substantially | |||
| Equivalent. | None | ||||||
| Matches alteration in | |||||||
| Intended Use | Substantially | ||||||
| equivalent | None. Customer reviews | ||||||
| indicate no difficulty in | |||||||
| using more than one | |||||||
| program | |||||||
| Number of | |||||||
| output | |||||||
| channels | 1 | 1 | 1 | Identical | None | Identical | None |
| Regulated | |||||||
| current or | |||||||
| voltage? | Regulated current | Regulated current | Regulated voltage | Identical | None | Substantially | |
| equivalent | None | ||||||
| Both regulated current | |||||||
| and voltage have been | |||||||
| shown to be safe and | |||||||
| effective | |||||||
| Firmware | |||||||
| controlled? | Yes | Yes | Yes | Identical | None | Identical | None |
| Automatic | |||||||
| Overload Trip? | No | No | No | identical | None: | identical | None: |
| Automatic No- | |||||||
| Load Trip? | Yes | Yes | No | identical | None: | Substantially | |
| equivalent | None: | ||||||
| KegelFit offers additional | |||||||
| user protection | |||||||
| Automatic | |||||||
| Shut Off? | Yes | Yes | No | Identical | None | Substantially | |
| Equivalent. | Apex user must switch | ||||||
| off at end of session | |||||||
| Patient Override | |||||||
| Control? | Yes | Yes | No | Identical | None | Substantially | |
| Equivalent. | None. Customer reviews | ||||||
| indicate no difficulty in | |||||||
| using this facility | |||||||
| Indicator | |||||||
| Display | |||||||
| • On/Off Status | |||||||
| • Low Battery | Yes | ||||||
| Yes | Yes | ||||||
| Yes | Yes (via display illumination) | ||||||
| No | Identical | None | Substantially | ||||
| equivalent | None: | ||||||
| Kegelfit offers additional | |||||||
| information. | |||||||
| Message is easily | |||||||
| understood and | |||||||
| customer reviews | |||||||
| indicate no difficulty in | |||||||
| using this facility | |||||||
| Display |
- Voltage/Current
Level? | Yes LCD | Yes LCD | Yes combination of two LEDs | Identical | None | Substantially
equivalent | LCD readout is much
simpler than
combination of static
and flashing LEDs |
| Waveform, | Bi-phasic | Bi-phasic | Monophasic, alternating polarity, | Identical | None | Substantially
equivalent | None.
Both waveforms are |
| shape | Rectangular at positive | Rectangular at positive | square pulse | Identical | None | Substantially
equivalent | approved in predicate
devices |
| Frequency
• Mixed
• Stress
• Urge | - Hz
50 Hz
-Hz | 20 Hz
50 Hz
10 Hz | 50 Hz | Substantially
equivalent | None | Substantially
equivalent | None.
Both predicate devices
have been approved as
safe and effective. |
| • Tone | 35 Hz | 35Hz | | | | | |
| Pulse width | | | | | | | No special requirement
demonstrated for home
use |
| • Mixed | | 250μs | | | | | |
| • Stress | 300μs | 300μs | 200 μs | | | | |
| • Urge | | 250μs | | | | | |
| • Tone | 250μs | 250μs | | | | | |
| Time On +ramp | | | | Substantially
equivalent | Programs removed in
line with change in
intended use | Substantially
equivalent | None.
All settings have been
approved for use on
predicate devices |
| • Mixed | | 7 seconds on | | | | | |
| • Stress | 7 seconds on | 7 seconds on | 1 second on | | | | |
| • Urge | | 7 seconds on | | | | | |
| • Tone | 5 seconds on | 5 seconds on | | | | | |
| Time Off | | | | Substantially
equivalent | Programs removed in
line with change in
intended use | Substantially
equivalent | None.
All settings have been
approved for use on
predicate devices |
| • Mixed | | 10 seconds off | 2 seconds off | | | | |
| • Stress | 10 seconds off | 10 seconds off | | | | | |
| • Urge | | 10 seconds off | | | | | |
| • Tone | 6 seconds off | 6seconds off | | | | | |
| Total Session
Time | Default 20 minutes
Adjustable to 10 minutes. | Default 20 minutes
Adjustable to 10,20,30,45,60 and 90
minutes | Total session time of 10-15
minutes
• 5-10 minutes electrical
stimulation
• 5 minutes self-directed
contraction (recommended) | Substantially
equivalent | None.
Longer session times
removed in response to
customer feedback | Substantially
equivalent | None |
| Compliance*
with 21 CFR 898
Cable and lead
requirements. | Yes | Yes | N/A | Identical | None | Substantially
Equivalent. | None
No leads in Apex device |
| Max output
voltage (500Ω) | 45V | 45V | 34.2 V | Identical | None | Substantially
equivalent | None.
Both predicate devices |
| Max output
current (500Ω) | 90mA | 90mA | 68.2 mA | Identical | None | Substantially
equivalent | have been approved as
safe and effective. |
| Maximum
phase charge
(500Ω) | 18.6 μC | 18.6 μC | 13.6 μC | Identical | None | Substantially
equivalent | Apex is monophasic, so
net charge=max charge |
| Electrode
surface area | 8.58 cm2 | 8.58 cm2 | 5.88 cm2 | Identical | None | Substantially
equivalent | None.
Both predicate devices |
| Max current
density | 10.46 mA/cm2 | 10.46 mA/cm2 | 11.6 mA/cm2 | Identical | None | Substantially
equivalent | have been approved as
safe and effective. |
| Max average
power density
(500Ω) | 5.84 mW/cm2 | 5.84 mW/cm2 | 3.95 mW/cm2 | Identical | None | Substantially
equivalent | No special requirement
for home use |
| Dimensions
(Insertion Unit) | Trainer
Weight: 0.7 oz (20 gm)
Length:2.87" (73 mm)
(inserted part)
Width:1.1" (28mm) dia
(widest point) | Trainer
Weight: 0.7 oz (20 gm)
Length:2.87" (73 mm) (inserted
part)
Width:1.1" (28mm) dia (widest
point) | Overall Insertion Unit: 12.2"x
2.5"x 4.0" | Identical | None | Substantially
equivalent | None |
| Control
housing
material | ABS plastics | ABS plastics | N/A | Identical | None | N/A | |
| Insertion
material | ABS plastics
Stainless steel | ABS plastics
Stainless steel | Silicone, plastics
Stainless steel | Identical | None | Substantially
equivalent | |
| Packaging or
Expiration | N/A | N/A | 1 year for insertion unit | Identical | None | Substantially
equivalent | None:
Expiration dating is not |
| Dating | | | | | | | needed based on the |
| | | | | | | | stability of the
materials chosen. |
| Sterilization | N/A | N/A | N/A | Identical | None | Identical | None |
| Features/
Function | A Kegelfit | B Itouch Sure | C Apex K141158 | Comparison
A/B | Impact on safety and
performance | Comparison
A/C | Impact on safety and
performance |
| Operational
Method:
Clinical
Use
e.g., ambulatory
use, home use | Home use, Over-the-counter | Clinic or Home use, under direction
of physician | Home use, Over-the-counter | Substantially
equivalent | None:
An over-the-counter
indication does not
impact safety because
the stimulation is
controlled by the end
user per end user
response.
Safety features are built
into the design of the
device for the maximum
output, overload and
short circuit, and
automatic shut-off. | Identical | None |
| Patient
Interaction:
Functions
Controllable:
An explanation of
how the device
interacts with
the patient. | The end user can control the
electrical stimulation levels
and the starting and stopping
of each session. However, the
device will stop on its own
once the session is normally
completed. | The patient can control the
electrical stimulation levels and the
starting and stopping of each
session. However, the device will
stop on its own once the session is
normally completed. | The end user can control the
electrical stimulation levels and
the duration of the stimulation
session. | Substantially
equivalent | None.
Option to increase
treatment time has been
removed to improve
simplicity of use.
User feedback indicated
that some users were
tempted to over-use to
speed recovery | Substantially
equivalent | None:
Control is by pushbutton
in both devices.
Customer Reviews show
that the additional
buttons in the KegelFit
are clear and easy to
understand.
KegelFit also displays
intensity, treatment time
remaining, and low
battery warning. |
| Patient
Interaction:
Programming
Capability
Whether the
device can be
programmed and
to what extent | Electrical stimulation levels
are set by the end user
End user can choose between
two stimulation programs.
End user can reduce the
session timer | Electrical stimulation levels are set
by the end user
End user can choose between four
stimulation programs.
End user can reduce or increase the
session timer | Electrical stimulation levels are
set by the end user | Substantially
equivalent | None.
Both stimulation
programs are proven
safe and effective.
Reduced timer setting is
the same as that
recommended for the
Apex. | Substantially
equivalent | None.
Although Kegelfit offers
a choice of programs,
both are effective for
stress incontinence. |
| Patient
Interaction:
Operator
Requirements
Knowledge or
training required
of the operator, | Intended as part of a
complete therapy
program with physician
coaching. No special
knowledge or training;
instruction manual provided | Over-the-counter device. No special knowledge or training required;
instruction manual provided | Over-the-counter device. No
special knowledge or training
required; instruction manual
provided | Substantially
equivalent | None:
The KegelFit device has
fewer optional settings.
In both cases, no special
knowledge or training is
required. | Identical | None |
| Software Level
of Concern | Moderate | Moderate | Moderate | Identical | None | Identical | None |
8
9
10
11
12
VII Testing Summary
The following performance testing was provided in support of the substantial equivalence. The testing for KegelFit included software, electrical safety, biocompatibility and clinical. KegelFit successfully passed all testing.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, We determine that the level of concern of the new device KegelFit is Moderate; the decision-making process is as follows:
Prior to mitigation of hazards, a failure of the Software Device cannot result in death or serious injury, either to a patient or to a user of the device. Therefore not level of concern is not Major.
But, prior to mitigation of hazards, a failure of the Software Device can result in Minor injury, such as electrical shock, either to a patient or to a user of the device.
We determine that the level of concern of the new device KegelFit is Moderate.
Electrical Safety Testing:
Electrical safety testing was conducted on KegelFit. The device complies with the IEC 60601-1 and IEC60601-1-11 standards for safety
The KegelFit has been tested to EN60601-1-2:2007 and found to be EMC testing: suitable for use in domestic establishments and in establishments directly connected to a low voltage power supply network which supplies buildings used for domestic purposes.
Biocompatibility Testing:
The same vaginal electrode is used as with the itouch Sure Bodv material:
Acrylonitrile-Butadiene-Styrene copolymer (ABS) GE MG47 Conductor Material: Stainless steel
The biocompatibility evaluation for the itouch Sure vaqinal electrode (KeqelFit Trainer) was conducted in accordance with International Standard ISO 10993:2009 biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity and ISO 10993:2002 biological evaluation of medical devices-Part 10: Tests for irritation and delayed-type hypersensitivity. See section 14.
13
Clinical Testing: A clinical literature evaluation was conducted to provide evidence of the safety and efficacv of electrical stimulation for the treatment of female stress urinary incontinence. See section 20.1 Labelling Comparison: The Labelling is substantially equivalent to that of the predicate device Apex for self diagnosis and identification of contraindications and to the predicate device itouch Sure for operating instructions. A detailed comparison of labeling between the KegelFit and the predicate device Apex was conducted to assess the safety of the KegelFit device for over-the-counter use. The objectives of this comparison were to: 1) determine if a subject can self-identify as having stress urinary incontinence using package labeling 2) self-limit usage if a contraindication is present
Customer Review Analysis:
An analysis of customer reviews of the predicate device itouch Sure from 13758 OTC sales in the EU was used to determine whether the subject can safely use the KeqelFit device using only the instructions for use (IFU) provided. A questionnaire was sent to a further 120 Ebay UK OTC customers.
Risk Management Summary
KeqelFit has been designed according to EasyMed's internal procedures with traceability between the design inputs, design outputs, verification and validation activities. KegelFit has been evaluated for risks according to EasyMed's internal procedures based on ISO 14971. The risks associated with KegelFit were reduced to as low as possible and the risk/benefit analysis was acceptable.
Conclusion
The non-clinical data supports the safety of the device, and the hardware and software verification and validation demonstrates thatKegelFit performs as intended in the specified use conditions.
The clinical literature evaluation, as well as the technological comparison to the predicate device, supports the use of electrical stimulation as an effective treatment of stress urinary incontinence in women.
Both KeqelFit and the predicate device Apex are intended for over-the-counter use. A comparison of labeling and instructions was completed to support the safety of the product labeling for selfdiagnosis and use.
An analysis of Customer Reviews of OTC sales in the EU of the predicate device itouch Sure was completed to support the Usability of the device without training. In addition, customer questionnaires were sent to 120 users of itouch Sure who purchased OTC through ebay UK, and 21 responses were received and analysed. The data included within this submission supports the use of KegelFit for over-the-counter as safe and effective. The KegelFit unit is substantially equivalent to the predicate devices and any differences between the devices do not pose any new questions of safety and effectiveness.
Submitted times: This is the first submission to FDA for this new device