(183 days)
K941911, K81480
K941911, K81480
No
The description focuses on basic electrical stimulation with preset programs and does not mention any adaptive or learning capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is described as providing electrical stimulation and neuromuscular re-education for the rehabilitation of weak pelvic floor muscles to treat urinary incontinence, which is a therapeutic purpose.
No.
The device's intended use is for electrical stimulation and neuromuscular re-education for muscle rehabilitation, not for diagnosing a condition.
No
The device description explicitly states it is a "small lightweight battery powered single channel neuromuscular stimulation device supplied with a vaginal two electrode stimulation probe," indicating it includes hardware components beyond just software.
Based on the provided information, the itouch Sure is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens from the human body. They are used to diagnose diseases or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease. Examples include blood tests, urine tests, and tissue biopsies.
- The itouch Sure is a neuromuscular stimulation device. It directly applies electrical stimulation to the pelvic floor muscles for therapeutic purposes (rehabilitation and treatment of incontinence). It does not analyze any biological specimens.
The description clearly indicates it's a device for electrical stimulation and neuromuscular re-education, which falls under the category of therapeutic devices, not diagnostic devices.
N/A
Intended Use / Indications for Use
The itouch Sure 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
Product codes
KPI
Device Description
The itouch Sure is a small lightweight battery powered single channel neuromuscular stimulation device supplied with a vaginal two electrode stimulation probe. The probe connects to the control unit by cable and plug.
The unit is intended for home use by the patient, and is designed with simplicity and ease of use in mind. It has four preset treatment programs, an adjustable 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 (vaginal electrode placement)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home use by the patient
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Innova Pelvic Floor Stimulation System by EMPI. K941911, Kegel 8 Pelvic Muscle Trainer by NE Services. K81480
Reference Device(s)
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
K103698 PG 1/3
510(k) Summary
JUN 2 1 2011
Date of Summary prepared: April 27th, 2011
: Submitter Tenscare Ltd 9 Blenheim Road, Longmead Business Park, Epsom, Surrey, KT19 9BE, Address . United Kingdom : +44(0)1372 723 434 Tel Fax : +44(0)1372 745 434 : E-Mail sales@tenscare.co.uk FDA Establishment registration no: 3003446042 Contact person: Andrew Brown
Address of the manufacturing facility:
EasyMed Instrument Ltd 5F/6F, Block A, Gupo Gongmao Building, Fengxin Road, Fengxiang Industrial District, Daliang, Shunde, Foshan, Guangdong, China, Zip: 528300
FDA Establishment registration no: 3004049909
Address of American Representative:
DEBORAH IAMPIETRO QRC CONSULTING ASSOCIATES 130 Gotzens Rd Conway, NH 03818 Phone: 603 4476086 ext Fax: 734 4236086 Email: grcassoc@aol.com
Submitted Device:
| Generic name: | Pelvic Floor Stimulator |
|---|---|
| Trade name: | TensCare itouch Sure |
| Common name: | itouch Sure 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 |
| Predicate Devices: | Innova Pelvic Floor Stimulation System by EMPI. K941911 |
| Kegel 8 Pelvic Muscle Trainer by NE Services. K81480 |
The class of the predicate Devices: Class II
Device Description:
The itouch Sure is a small lightweight battery powered single channel neuromuscular stimulation device supplied with a vaginal two electrode stimulation probe. The probe connects to the control unit by cable and plug.
1
The unit is intended for home use by the patient, and is designed with simplicity and ease of use in mind. It has four preset treatment programs, an adjustable treatment timer, a compliance monitor, and open circuit detectors.
The intended use of the device:
The itouch Sure 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
The intended use and indications for use of the new device are the same as those of the predicate devices.
Technological Comparison:
| | Itouch Sure | EMPI Innova
K941911 | Kegel 8
K81480 |
|--------------------------|------------------------------------------------------------------|----------------------------------------------------------------------------------|-----------------------------------------------------------|
| Intended Use | Treatment of urinary
incontinence | Treatment of urinary
incontinence | Treatment of urinary
incontinence |
| Programmable
features | Intensity, program
session length | Intensity, 12.5/50 Hz,
Duty cycle: 5-5/5-10
session length | Intensity,
session length, Hz, us,
Work, Rest, Ramp |
| Preset Programs | 4 | | 9 +manual |
| Power source | 2x1.5V AA | 9V PP3 | 9V PP3 |
| Mode of operation | Intermittent | Intermittent | Intermittent |
| Frequency Hz | 10/20/35/50 | 12.5/50 | 2-100 |
| Pulse Width uS | 200/250/300 | 300 | 50-450 |
| Duty cycle | 5/10 and 3/6 | 5-5/5-10 | Selectable |
| Output current | 0-45V = 0-90mA
over 500 Ohm | 0-60mA (100mA
override) | 0-90 mA nominal |
| Intensity steps | 200 | Rotary | 100 |
| Timing control | | Continuous/15/30 min | |
| Output type | Constant current
160-500 Ω,
Constant voltage
500-1500 Ω | Nominally constant
current up to 1kΩ | Nominally constant
current |
| No of electrodes | 1 | 1 (optional anal probe) | 2 |
| Usage conditions | Intermittent | Intermittent | Intermittent |
| Controls | 6 Push buttons +
lock button on side | Two rotary intensity
Duty cycle slider switch
Intensity override
switch | 6 Push buttons + 2
concealed buttons |
| Probe length mm | 88 | | 87 |
| Probe diameter mm | 28 | | 26 |
| Electrode orientation | Axial | | Axial |
| Electrode material | Stainless Steel | | Stainless Steel |
| Electrode placement | Vaginal | | Vaginal |
| Waveform Type | Bi-phasic | Bi-phasic | Bi-phasic |
| Waveform Shape | Rectangular at
positive | Irregular Rectangular | Rectangular at positive |
2
| Output waveforms: | The Sure output waveform is substantially equivalent to that of the
Kegel 8. The difference in shape of negative phase is not clinically
significant. |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility | The materials of the vaginal electrode are exactly the same as the
materials of the Kegel 8 probe by NE Systems.
Body material: Acrylonitrile-Butadiene-Styrene copolymer (ABS)
Conductor Material: Stainless steel
Biocompatibility tests to ISO 10993-5:2009 and -10:2002 on the
vaginal electrode have shown no cytotoxicity, negligible vaginal
irritation, and no sensitisation. |
| Labelling Comparison: | The Labelling is substantially equivalent to that of the predicate
devices. |
| Safety information: | 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 guidance.
Detailed and strictly controlled testing has been carried out.
Test results, Risk Analysis, and FMEA analysis show that the new unit
itouch Sure is safe with no hazard.
itouch Sure has been marketed in Europe since April 2009. During this
period a review of Customer Complaints, Returned Product and the
results of Post Market Feedback, has demonstrated that the product
has performed as intended, to its' Specified Requirements.
The new device itouch Sure controls the output at constant voltage
above 500 Ω load. Below this it controls the output at a pseudo
constant current, with output voltage reducing to zero as load reduces.
This characteristic reliably makes the device safe. |
| EMC testing: | The Sure has been tested to EN60601-1-2:2007 and found to be
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. |
| Submitted times: | This is the first submission to FDA for this new device |
| Conclusion: | The itouch Sure unit is substantially equivalent to the predicate
devices and any differences between the devices do not pose any
new questions of safety and effectiveness. |
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. Andrew Brown Regulatory Affairs Manager Tenscare Ltd. 9 Blenheim Road Epsom. Surrey UNITED KINGDOM KT19 9BE
JUN 2 1 2011
Re: K103698
Trade/Device Name: Tenscare itouch Sure Pelvic Floor Exerciser Regulation Number21 CFR §876.5320 Regulation Name: Non-implanted electrical continence device Regulatory Class: II Product Code: KPI Dated: May 18, 2011 Received: May 18, 2011
Dear Mr. 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. 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 of medical device-related
4
Page 2
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
Strict are 607) productionDevices/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 Small Manufacturers, International and Consumer Assistance 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,
Hubert Lenoir MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Section 4 Indications for Use
510(k) Number (if known):
Device Name
: Tenscare itouch Sure Pelvic Floor Exerciser
Indications for Use
The itouch Sure 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
Halum
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K103698
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)