(197 days)
Not Found
No
The description explicitly states that the level of electrical stimulation is controlled by the end user using manual push-button controls, and there is no mention of AI, ML, or any automated decision-making based on data.
Yes
The device description and intended use clearly state that Unicare is used for "rehabilitation" and "treatment" of urinary incontinence by providing electrical stimulation to pelvic floor muscles, which are therapeutic actions.
No
The device description states that "This electrical muscle stimulation works as a rehabilitation and training for pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women," indicating a therapeutic rather than diagnostic purpose. There is no mention of the device being used to identify or diagnose a condition.
No
The device description explicitly states it is a "battery powered, single-channel, home-use electrical pelvic floor muscle stimulator" and includes hardware components like a control unit, vaginal probe, electrodes, cables, and plugs.
Based on the provided information, the Unicare device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Unicare's Function: Unicare is an electrical stimulator that delivers electrical impulses to the pelvic floor muscles. It is a therapeutic device used for rehabilitation and training of these muscles.
- No Sample Analysis: The device does not analyze any biological samples from the patient. It directly interacts with the body through a probe or electrodes to provide stimulation.
Therefore, Unicare falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Unicare 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.
Product codes
KPI
Device Description
Unicare is battery powered, single-channel, home-use electrical pelvic floor muscle stimulator. The device is supplied with a non-sterile, reusable (single-patient use) vaginal probe and self-adhesive electrodes which connect to the control unit by cable and plugs. The vaginal probe is inserted into the vagina. The optional self-adhesive electrodes is placed on patients' intact skin and is used for the treatment of only urge urinary incontinence in women. Electrical stimulation is delivered via the vaginal probe or the self-adhesive electrodes to the pelvic floor muscles. This electrical muscle stimulation works as a rehabilitation and training for pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women. The level of electrical stimulation of the Unicare can be controlled by the end user using manual push-button controls. This device is intended for over the counter (OTC) use.
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 Use
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
Non-Clinical Testing:
- Biocompatibility testing according to ISO 10993-1:2018 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and FDA Guidance "Use of International Standard ISO 10993-1" (2016).
- Electrical Safety testing according to IEC 60601-1: 2020 Medical electrical equipment - O Basic safety and essential performance
- Electromagnetic Compatibility testing according to IEC 60601-1-2: 2020 General O requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances -- Requirements and tests
- IEC 60601-2-10:2016 Particular requirements for the basic safety and essential O performance of nerve and muscle stimulators
- Software Verification and Validation Testing according to FDA's Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
- Additionally, battery service life and performance verification test data were submitted to establish performance and durability of the subject device.
All pre-determined acceptance criteria were met.
Key Metrics
Not Found
Predicate Device(s)
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" above the word "ADMINISTRATION".
October 20, 2023
TensCare Ltd Saskia Eldridge-Hinmers Regulatory Affairs Associate 9 Blenheim Road Epsom. Surrev KT19 9BE United Kingdom
Re: K230983 Trade/Device Name: Unicare (K-UNICARE-USA) Regulation Number: 21 CFR§ 876.5320 Regulation Name: Nonimplanted electrical continence device Regulatory Class: II Product Code: KPI Dated: April 12, 2023 Received: September 20, 2023
Dear Saskia Eldridge-Hinmers:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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,
Jessica K. Nguyen -S
Jessica K. Nguyen, Ph.D. 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 Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K230983
Device Name Unicare (K-UNICARE-USA)
Indications for Use (Describe)
Unicare 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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3
K230983 Page 1 of 3
510 (k) Summary
Submitter Information 1.
| 510 (k) submitter: | TensCare Ltd. | |
|---|---|---|
| Address: | 9 Blenheim Road, Epsom, | |
| Surrey, KT19 9BE, United Kingdom | ||
| Phone: +44(0)1372 723 434 | ||
| Fax: +44(0)1372 745 434 | ||
| Applicant Contact Person: | Saskia Eldridge-Hinmers | |
| Regulatory Affairs Associate | ||
| Phone: +44(0)7879424785 | ||
| Email : Saskia.Eldridge-Hinmers@tenscare.co.uk | ||
| American Representative: | Mr. Scott A Bednar | |
| QA/RA Consulting Group, Inc. | ||
| 3335 Tuscarawas Road, Beaver | ||
| Pennsylvania 15009 | ||
| Phone: 412-418-8066 | ||
| Email : sbednar@qaraconsultinggroup.com | ||
| Preparation date: | October 17, 2023 |
2. Device Name
| Trade Name of the Device: | Unicare (K-UNICARE-USA) |
|---|---|
| Common Name: | Nonimplanted electrical continence device |
| Regulation Name: | Nonimplanted electrical continence device |
| Regulation Number: | 21 CFR 876.5320 |
| Device Class: | II |
| Panel: | Gastroenterology/Urology |
| Product Code: | KPI |
3. Predicate Devices
| 510(k) Number: | K191312 |
|---|---|
| Trade Name of the Device: | Perfect PFE |
The predicate device has not been subject to a design related recall.
4
Device Description 4.
Unicare is battery powered, single-channel, home-use electrical pelvic floor muscle stimulator. The device is supplied with a non-sterile, reusable (single-patient use) vaginal probe and self-adhesive electrodes which connect to the control unit by cable and plugs. The vaginal probe is inserted into the vagina. The optional self-adhesive electrodes is placed on patients' intact skin and is used for the treatment of only urge urinary incontinence in women. Electrical stimulation is delivered via the vaginal probe or the self-adhesive electrodes to the pelvic floor muscles. This electrical muscle stimulation works as a rehabilitation and training for pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women. The level of electrical stimulation of the Unicare can be controlled by the end user using manual push-button controls. This device is intended for over the counter (OTC) use.
5. Indications For Use
Unicare 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 & Predicate
| Device(s): | K230983 (Subject Device) | K191312 (Predicate Device) |
|---|---|---|
| Device Name | Unicare | Perfect PFE |
| Indication for Use | Unicare 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. | 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. |
| Function | Pelvic floor muscle stimulation | Pelvic floor muscle stimulation |
| Prescription Use | ||
| Only/OTC | OTC | OTC |
| Power source | Rechargeable Li-ion 3.7V 80 mAh | 2xAA batteries |
| Maximum Output | ||
| Current (500Ω load) | 99.0 mA +/- 10% | 90mA |
| Maximum current | ||
| density/electrode | ||
| (mA/cm²) | 23.35 mA/cm² | 21.4 mA/cm² |
| Maximum average | ||
| power density/electrode | ||
| (mW/cm²) @ 500Ω | 11.9 mW/cm² | 15.34 mW/cm² |
| Output waveform type | Symmetrical Bi-phasic rectangular | Asymmetrical Bi-phasic rectangular |
| Stimulation frequencies | Stress: 50Hz | |
| Urge: 10Hz | ||
| Mixed: half Stress program & half Urge program | ||
| Tone: 35Hz | Stress: 50Hz | |
| Urge: 10Hz | ||
| Mixed: half Stress program & half Urge program | ||
| Tone: 35Hz |
6. Comparison of the Technological Characteristics with Predicate Device:
5
| Pulse width | Stress: 300µs | Stress: 300µs |
|---|---|---|
| Urge: 200µs | ||
| Mixed: half Stress program & half Urge program | Urge: 200µs | |
| Mixed: half Stress program & half Urge program | ||
| Tone: 250µs | Tone: 250µs | |
| Vaginal probe Electrode surface area (per individual electrode) | 4.24 cm² | 4.24 cm² |
| Treatment duration | Maximum 20 min | 10 or 20 min |
| (default = 20 min) | ||
| Treatment Environment | Home use | Home use |
As evidenced by the above table, both the subject and the predicate devices have the same intended use, but the subject and predicate devices have different technological characteristics. However, performance testing was conducted on the subject device, and it was established that the differences in technological characteristics between the subject and the predicate does not raise different questions of safety or effectiveness.
7. Non-Clinical Testing
Below is a list of the tests that were performed and successfully completed for the subject device per the below guidance and standards:
- o Biocompatibility testing according to ISO 10993-1:2018 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and FDA Guidance "Use of International Standard ISO 10993-1" (2016).
- Electrical Safety testing according to IEC 60601-1: 2020 Medical electrical equipment - O Basic safety and essential performance
- Electromagnetic Compatibility testing according to IEC 60601-1-2: 2020 General O requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances -- Requirements and tests
- IEC 60601-2-10:2016 Particular requirements for the basic safety and essential O performance of nerve and muscle stimulators
- o Software Verification and Validation Testing according to FDA's Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
Additionally, battery service life and performance verification test data were submitted to establish performance and durability of the subject device.
All pre-determined acceptance criteria were met.
Conclusions 8.
Based on the information presented in this submission, it can be concluded that the subject device is substantially equivalent to the predicate.