(129 days)
No
The description focuses on the physical characteristics and intended use of the probe electrodes for EMG feedback and electrical stimulation, with no mention of AI or ML for data analysis, interpretation, or treatment planning.
Yes
The device is described as being intended for the "rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence," which indicates a therapeutic purpose.
Yes
The device is intended to "provide electromyographic feedback from pelvic musculature", which is a form of physiological measurement used for assessment and informing treatment.
No
The device description explicitly details physical hardware components (vaginal and rectal probes made of stainless steel, ABS, and PVC) that are inserted into the body for electromyographic feedback and electrical stimulation. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Well-Life Probe Electrode for Stimulation/EMG Probe is used to interact directly with the body (pelvic musculature) for the purpose of providing electromyographic feedback or electrical stimulation. It does not analyze specimens taken from the body.
- Intended Use: The intended use is for rehabilitation and restoration of neuromuscular control, not for diagnosing a condition based on analyzing a biological sample.
The device is a therapeutic and biofeedback device, not a diagnostic one that analyzes samples in vitro.
N/A
Intended Use / Indications for Use
Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA) include Vaginal Probe SA-2876, SA-25145, SA-20100, SA-3478, SA-2687 & Rectal Probe SA-1483, SA-19108, SA-1563, SA-2486 are intended to provide electromyographic feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of week pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.
Product codes (comma separated list FDA assigned to the subject device)
KPI, HIR
Device Description
Well-Life Probe Electrodes for Stimulation/EMG Probes (Model: SA) contains two types of products, Vaginal Probe and Rectal Probe. The Well-Life Probe Electrode for Stimulation/EMG Probe are intended to provide electromyographic feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of week pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.
Well-Life Probe Electrode for Stimulation/EMG (Vaginal Probe) SA-2876, SA-25145, SA-20100, SA-3478, SA-2687 are lightweight cylinders consisting of two or three independent conductive rings or plates that are paired and isolated, physically, and electrically. The cylinder is shaped with a waist and handle for positioning in the vaginal canal for incontinence treatment and easy removal after treatment. It is watertight to allow for washing with soap and water between uses. The electrode is designed for repeated intermittent use by a single user in home or clinic up to 300 times, 15 minutes per session equal to 10 months of daily operation. It does not require sterilization, but does require washing before and after reuse according to the cleaning method as recommended in the user manual.
Well-Life Probe Electrode for Stimulation/EMG (Rectal Probe) SA-1483, SA-19108, SA-1563, SA-2486 are lightweight cylinders consisting of two or three independent conductive rings that are paired and isolated, physically, and electrically. The cylinder is shaped with a waist and handle for positioning in the rectal canal for incontinence treatment and easy removal after treatment. It is watertight to allow for washing with soap and water before and after uses. The electrode is designed for repeated intermittent use by a single user in home or clinic up to 300 times, 15 minutes per session equal to 10 months of daily operation. It does not require sterilization, but does require washing before and after reuse according to the cleaning method in user manual. The probe is constructed of stainless steel, acrylonitrile butadiene styrene (ABS), and polyvinyl chloride (PVC).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic musculature, vaginal canal, rectal canal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
single user in home or clinic
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)
Non-clinical testing was conducted to verify that the subject devices met all design specifications, demonstrated safety based on current industry standards, and to demonstrate substantial equivalence to the predicate. The following tests were performed:
-
- Biocompatibility Patient contacting components are in compliance with ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, including cytotoxicity (ISO 10993-5 Third Edition 2009-06-01), sensitization (ISO 10993-10 Fourth edition 2021-11), irritation (ISO 10993-10 Fourth edition 2021-11) and Sample preparation and reference materials (ISO 10993-12 Fourth Edition 2012-07-01).
-
- Recommendations and requirements outlined in the FDA guidance "Design Considerations for Devices Intended for Home Use," 21 CFR Part 801, and 21 CFR Part 809.10 were followed. A comparison to the instructions of the reference device which have been validated for OTC use were conducted to support OTC instructions in the labeling. Based on the similarity of the Well-Life Probe Electrode to the predicate and reference devices with respect to design, indications for use, cleaning instructions, and labeling materials, additional usability testing was determined not to be necessary.
-
- Recommendations and requirements outlined in the FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" were followed for reprocessing and cleaning instructions in the labeling.
-
- Performance Bench Testing was performed to verify the performance to specifications of the proposed device and included the following:
- Performance Bench testing was performed to verify the performance to specifications with ANSI AAMI NS4:2013(R)2017.
- ASTM F1980-16 "Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices" was followed for accelerated aging of the subject device. After accelerated aging, functional performance testing was conducted on aged samples to support the proposed shelf life of 2 years.
- Testing was performed to verify the performance to specifications of the proposed device to subclause 8.5.2.3, Patient Leads of Patient Cables of IEC 60601-1:2005, MOD to comply with 21 CFR 898. Electromagnetic Compatibility (EMC) and Electrical Safety Testing beyond subclause 8.5.2.3, Patient Leads of Patient Cables of IEC 60601-1:2005, MOD was not determined to be necessary because the subject device is an individual component of an electrical system that does not generate or control electrical power, similar to the predicate device.
- Performance Testing Bench- Tensile strength of cable connection test per ANSI AAMI EC53:2013/(R)2020 related test methods for lead wire strength of cable connection test to ensure the safety of related electrical connection of products.
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.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 29, 2022
Well-Life Healthcare Limited Jenny Hsieh Official Correspondent 6F., No. 168. de St., Jhonghe District New Taipei City, 235 Taiwan
Re: K222528
Trade/Device Name: Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA) Regulation Number: 21 CFR§ 876.5320 Regulation Name: Nonimplanted Electrical Continence Device Regulatory Class: II Product Code: KPI, HIR Dated: November 17, 2022 Received: November 30, 2022
Dear Jenny Hsieh:
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.
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.
1
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-regulatoryinformation/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 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
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K222528
Device Name
Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA)
Indications for Use (Describe)
Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA) include
Vaginal Probe SA-2876, SA-25145, SA-20100, SA-3478, SA-2687 & Rectal Probe SA-1483,
SA-19108, SA-1563, SA-2486 are intended to provide electromyographic feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of week pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.
Type of Use (Select one or both, as applicable)
X 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."
Form Approved: 0MB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
3
510(k) Summary
| Type of Submission: | Traditional |
|---|---|
| Preparation date: | 12/28/2022 |
| Submitter: | Well-Life Healthcare Ltd. |
| Address: | 6F. No.168, Lide St., Jhonghe District, New Taipei |
| City, 23512, Taiwan | |
| Phone: | +886-2-22266981 |
| Fax: | +886-2-22266965 |
| Contact: | Jenny Hsieh |
| (Jenny@welllifehealthcare.com.tw) | |
| Registration number: | 3006850006 |
4. Identification of the device:
| 510(K) No | K222528 |
|---|---|
| Device Name: | Well-Life Probe Electrode for Stimulation/EMG |
| Probe (Model: SA) | |
| Common or usual name: | Incontinence Stimulation/EMG Electrode |
| Probe | |
| Model: | Vaginal Probe: |
| SA-2876, SA-25145, SA-20100, SA-3478, SA- | |
| 2687 | |
| Rectal Probe: | |
| SA-1483, SA-19108, SA-1563, SA- 2486 | |
| Classification name: | Nonimplanted Electrical Continence Device |
| Classification Panel: | Gastroenterology-Urology |
| Device Classification: | II |
| Regulation Number: | 21 CFR Part 876.5320 |
| Product Code | KPI & HIR |
5. Identification of the Predicate and Reference Devices:
| Predicate Device: | |
|---|---|
| 510(K) No | K122194 |
| Predicate Device Name: | LIFE-CARE VAGINAL PROBE, LIFE-CARE |
| ANAL PROBE. The predicate has not been subject | |
| to a design-related recall. | |
| Model: | Everyway Incontinence Stimulation Electrode, |
| model PR-02/02A, PR-03/03/A, PR-04/04A, PR- | |
| 10A, PR-11A, PR-14A, for Life-Care Vaginal | |
| Probe & PR-06/06A, PR-12A, PR-13/13A for Life- | |
| Care Anal Probe. |
4
| Classification name: | Nonimplanted Electrical Continence Device |
|---|---|
| Classification Panel: | Gastroenterology-Urology |
| Device Classification: | II |
| Regulation Number: | 21 CFR Part 876.5320 |
| Product Code | KPI & HIR |
| Reference Device: | |
|---|---|
| 510(K) No | K191312 |
| Reference Device Name: | TensCare Ltd. Perfect PFE |
| Model: | Vaginal Probe: |
| Liberty Loop Vaginal Probe (X-VPL) | |
| Electrical Stimulator: | |
| Perfect PFE | |
| Classification name: | Nonimplanted Electrical Continence Device |
| Classification Panel: | Gastroenterology-Urology |
| Device Classification: | II |
| Regulation Number: | 21 CFR Part 876.5320 |
| Product Code | KPI |
6. Intended Use and Indications for use of the Subject Device:
Intended Use
Electrical stimulation of the pelvic floor muscles for the treatment of urinary incontinence. Electromyographic (EMG) sensing of the pelvic floor muscles.
Indications for use
Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA) include Vaginal Probe SA-2876, SA-25145, SA-20100, SA-3478, SA-2687 & Rectal Probe SA-1483, SA-19108, SA-1563, SA-2486 are intended to provide electromyographic feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of week pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.
5
7. Description of the Device:
Well-Life Probe Electrodes for Stimulation/EMG Probes (Model: SA) contains two types of products, Vaginal Probe and Rectal Probe. The Well-Life Probe Electrode for Stimulation/EMG Probe are intended to provide electromyographic feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of week pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.
Well-Life Probe Electrode for Stimulation/EMG (Vaginal Probe) SA-2876, SA-25145, SA-20100, SA-3478, SA-2687 are lightweight cylinders consisting of two or three independent conductive rings or plates that are paired and isolated, physically, and electrically. The cylinder is shaped with a waist and handle for positioning in the vaginal canal for incontinence treatment and easy removal after treatment. It is watertight to allow for washing with soap and water between uses. The electrode is designed for repeated intermittent use by a single user in home or clinic up to 300 times, 15 minutes per session equal to 10 months of daily operation. It does not require sterilization, but does require washing before and after reuse according to the cleaning method as recommended in the user manual.
Well-Life Probe Electrode for Stimulation/EMG (Rectal Probe) SA-1483, SA-19108, SA-1563, SA-2486 are lightweight cylinders consisting of two or three independent conductive rings that are paired and isolated, physically, and electrically. The cylinder is shaped with a waist and handle for positioning in the rectal canal for incontinence treatment and easy removal after treatment. It is watertight to allow for washing with soap and water before and after uses. The electrode is designed for repeated intermittent use by a single user in home or clinic up to 300 times, 15 minutes per session equal to 10 months of daily operation. It does not require sterilization, but does require washing before and after reuse according to the cleaning method in user manual. The probe is constructed of stainless steel, acrylonitrile butadiene styrene (ABS), and polyvinyl chloride (PVC).
6
| Elements of
| Comparison | Subject Device | Predicate Device | Reference Device | Remark |
|---|---|---|---|---|
| 510K number | K222528 | K122194 | K191312 | ------ |
| Device Name | Well-Life Probe | |||
| Electrode for | ||||
| Stimulation/EMG | ||||
| Probe Model: SA | ||||
| Vaginal Probe: | ||||
| SA-2876, SA-25145, | ||||
| SA-20100, SA-3478, SA- | ||||
| 2687 | ||||
| Rectal Probe (Rectal | ||||
| Probe): | ||||
| SA-1483, SA- | ||||
| 19108, SA-1563, | ||||
| SA-2486 | Vaginal Probe: | |||
| PR-02/ PR-02A, PR-03/ | ||||
| PR-03A, PR-04/ PR- | ||||
| 04A. | ||||
| PR-10A, PR-11A, PR- | ||||
| 14A | ||||
| Anal Probe: | ||||
| PR-06/06A, PR-12A, | ||||
| PR-13/13A | Vaginal Probe: | |||
| Liberty Loop Vaginal | ||||
| Probe (X-VPL) | ||||
| Electrical Stimulator: | ||||
| Perfect PFE | ||||
| Product Code | KPI & HIR | KPI & HIR | KPI | Same as Predicate |
| Prescriptive or | ||||
| Over-the- | ||||
| Counter (OTC) | OTC and RX | RX | OTC and RX | Instructions are |
| equivalent to | ||||
| K191212 and | ||||
| include information | ||||
| for suitable | ||||
| stimulator | ||||
| selection | ||||
| Regulation No | 21 CFR Part 876.5320 | 21 CFR Part 876.5320 | 21 CFR Part 876.5320 | Same as Predicate |
| Indications | ||||
| for Use | Well-Life Probe | |||
| Electrode for | ||||
| Stimulation/EMG Probe | ||||
| (Model: SA) include | ||||
| Vaginal Probe SA-2876, | ||||
| SA-25145, SA-20100, | ||||
| SA-3478, SA-2687 & | ||||
| Rectal Probe SA-1483, | ||||
| SA-19108, SA-1563, | ||||
| SA-2486 are intended to | ||||
| provide | ||||
| electromyographic | ||||
| feedback from pelvic | ||||
| musculature or electrical | ||||
| stimulation to pelvic | ||||
| musculature for the | ||||
| purpose of rehabilitation | ||||
| of week pelvic floor | ||||
| muscles and restoration | ||||
| of neuromuscular | ||||
| control during the | ||||
| treatment of urinary | ||||
| incontinence. | The everyway | |||
| incontinence stimulation | ||||
| electrode, model pr- | ||||
| 02/02a, pr-03/03a, pr- | ||||
| 04/04a, pr-10a, pr-11a, pr- | ||||
| 14a for life-care vaginal | ||||
| probe & pr-06/06a, pr- | ||||
| 12a, pr-13/13a for life- | ||||
| care anal probe are | ||||
| intended to provide | ||||
| electromyographic | ||||
| feedback from pelvic | ||||
| musculature or electrical | ||||
| stimulation to pelvic | ||||
| musculature for the | ||||
| purpose of rehabilitation | ||||
| of weak pelvic floor | ||||
| muscles and restoration of | ||||
| neuromuscular control | ||||
| during the treatment of | ||||
| urinary incontinence. | 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. | Same as Predicate | |||
| Intended Use | Electrical stimulation of | |||
| the pelvic floor muscles | ||||
| for the treatment of | ||||
| urinary incontinence. | ||||
| EMG sensing of the | ||||
| pelvic floor | ||||
| muscles. | Electrical stimulation of | |||
| the pelvic floor muscles | ||||
| for the treatment of | ||||
| urinary incontinence. | ||||
| EMG sensing of the | ||||
| pelvic floor muscles. | Perfect PFE is intended | |||
| to provide electrical | ||||
| stimulation and | ||||
| neuromuscular | ||||
| reeducation 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. | Same as Predicate | |||
| Contact | ||||
| Duration | Intermittent mucosal | |||
| contact |