(185 days)
No
The document does not mention AI, ML, or related terms, and the description of the device's functionality and testing does not suggest the use of such technologies. The "calibration" mentioned in the performance studies appears to be a standard device calibration process, not an AI/ML training process.
Yes
The "Device Description" explicitly states that the Pelvic Floor Muscle Stimulator (MagBelle AF180) is a "non-invasive therapeutic device." Additionally, its "Intended Use / Indications for Use" describes its purpose as "rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of male and female urinary incontinence," indicating a therapeutic function.
Yes
The device has a "Kegel biofeedback training function" which measures pelvic floor muscle strength. This measurement is used to identify normal versus weak pelvic floor muscle strength, indicating a diagnostic capability.
No
The device description explicitly states it consists of a "main unit and the chair applicator" and produces an "electromagnetic field," indicating it is a hardware device with software control, 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 Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Pelvic Floor Muscle Stimulator (MagBelle AF180) is a therapeutic device that uses electromagnetic stimulation to directly treat pelvic floor muscles. It does not analyze samples taken from the body.
- Intended Use: The intended use is for the rehabilitation and restoration of neuromuscular control of pelvic floor muscles for the treatment of urinary incontinence. This is a therapeutic application, not a diagnostic one.
- Device Description: The description focuses on the physical components and how it delivers electromagnetic stimulation to the body.
- Performance Studies: The performance studies described involve measuring and comparing muscle strength, which is a physiological measurement, not an in vitro test.
Therefore, the MagBelle AF180 falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Pelvic Floor Muscle Stimulator (Model name: MagBelle AF180) is intended to provide entirely non-invasive electromagnetic stimulation of pelvic floor musculature for the purpose of rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of male and female urinary incontinence.
Product codes
KPI
Device Description
The Pelvic Floor Muscle Stimulator (model: MagBelle AF180) is a non-invasive therapeutic device which produces electromagnetic field that interacts with the tissues in the pelvic region of the human body. The electromagnetic field delivered in the muscular tissue area triggers the muscle stimulation.
MagBelle AF180 consists of the main unit and the chair applicator. The MagBelle AF180 is equipped with a color touch screen that facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters can also be set using the touch screen, buttons and knob on the device. During the device keeps information about the applied therapy type, remaining therapy time and main therapy parameters on the screen. The subject device should only be used under the continued supervision or licensed practitioner. The device supports 3 different function modes: Magnetic stimulation function, Kegel biofeedback training function and Triggering magnetic stimulation function of Magnetic stimulation function and Kegel biofeedback training function).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic floor musculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital/Clinics only
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
To verify the Kegel Biofeedback functionality, the sponsor tested the subject device in 100 urinary incontinence patients (male and female, age range: 22-70) in a hospital set-up. All the patients' pelvic floor muscles strength was tested manually by a clinician by using modified Oxford Grading Scale. Then, the patients' pelvic floor muscle strength was measured by using the subject device. Thus, the Kegel biofeedback mode of the subject device was calibrated to identify the values of the biofeedback signal corresponding to normal and weak pelvic floor muscle strength. The pelvic floor muscle strength measured by the subject device was also compared to the pelvic floor muscle strength measured by a reference device, K201014 (MyOnyx System).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Clinical Data Summary (device functionality verification).
Sample Size: 100 urinary incontinence patients (male and female, age range: 22-70).
Key Results: Pelvic floor muscle conditions evaluated by both the subject and the reference devices were found to be comparable to each other.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
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September 21, 2023
Nanjing Vishee Medical Technology Co., Ltd. Lisa Tan Regulatory Affairs Building 9, No.19, Ningshuang Road, Yuhuatai District Nanjing, Jiangsu 210012 China
Re: K230767
Trade/Device Name: Pelvic Floor Muscle Stimulator Regulation Number: 21 CFR§ 876.5320 Regulation Name: Non-Implanted Electrical Continence Device Regulatory Class: II Product Code: KPI Dated: August 17, 2023 Received: August 21, 2023
Dear Lisa Tan:
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,
Angel A. Soler-garcia -S
For 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
Indications for Use
510(k) Number (if known) K230767
Device Name Pelvic Floor Muscle Stimulator
Indications for Use (Describe)
Pelvic Floor Muscle Stimulator (Model name: MagBelle AF180) is intended to provide entirely non-invasive electromagnetic stimulation of pelvic floor musculature for the purpose of rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of male and female urinary incontinence.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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K230767 Page 1 of 4
510 (k) Summary
Submitter Information 1.
| 510 (k) submitter: | Nanjing Vishee Medical Technology Co., Ltd. | |
|---|---|---|
| Address: | Building 9, No.19, Ningshuang Road, Yuhuatai | |
| District, Nanjing, Jiangsu 210012, China | ||
| Applicant Contact Person: | Mr. Kai Qiu | |
| Phone: +86 025696708 | ||
| Email : qiukai@vishee.com | ||
| Correspondent Contact: | Mrs. Lisa Tan | |
| Phone: +86 19850817942 | ||
| Email : tanyumei@vishee.com | ||
| Preparation date: | September 12, 2023 | |
| 2. | Device Name |
| Trade Name of the Device: | Pelvic Floor Muscle Stimulator |
|---|---|
| Common Name: | Nonimplanted electrical continence device |
| Classification Name: | Non-Implanted Electrical Continence Device |
| Classification Regulation: | 21 CFR 876.5320 |
| Device Class: | II |
| Panel: | Gastroenterology/Urology |
| Product Code: | KPI |
3. Predicate and Reference Devices
| 510(k) Number | Trade Name of the Device | |
|---|---|---|
| Predicate: | K181497 | HPM-6000UF |
| Reference: | K201014 | MyOnyx System |
The predicate device was never subjected to a design related recall.
Device Description 4.
The Pelvic Floor Muscle Stimulator (model: MagBelle AF180) is a non-invasive therapeutic device which produces electromagnetic field that interacts with the tissues in the pelvic region of the human body. The electromagnetic field delivered in the muscular tissue area triggers the muscle stimulation.
MagBelle AF180 consists of the main unit and the chair applicator. The MagBelle AF180 is equipped
4
with a color touch screen that facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters can also be set using the touch screen, buttons and knob on the device. During the device keeps information about the applied therapy type, remaining therapy time and main therapy parameters on the screen. The subject device should only be used under the continued supervision or licensed practitioner. The device supports 3 different function modes: Magnetic stimulation function, Kegel biofeedback training function and Triggering magnetic stimulation function of Magnetic stimulation function and Kegel biofeedback training function).
ਨ. Indications For Use
Pelvic Floor Muscle Stimulator (Model name: MagBelle AF180) is intended to provide entirely noninvasive electromagnetic stimulation of pelvic floor musculature for the purpose of rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of male and female urinary incontinence.
| Device & Predicate
Device(s): | K230767 (Subject Device) | K181497 (Predicate
Device) | K201014 (Reference
Device) |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Pelvic Floor Muscle
Stimulator | HPM-6000UF | MyOnyx System |
| Indication for Use | Pelvic Floor Muscle
Stimulator (model: MagBelle
AF180) is intended to provide
entirely non-invasive
electromagnetic stimulation
of pelvic floor musculature
for the purpose of
rehabilitation of weak pelvic
muscles and restoration of
neuromuscular control for the
treatment of male and female
urinary incontinence. | HPM-6000UF is intended to
provide entirely non-invasive
electromagnetic stimulation
of pelvic floor musculature
for the purpose of
rehabilitation of weak pelvic
muscles and restoration of
neuromuscular control for the
treatment of male and female
urinary incontinence. | The MyOnyx System is
indicated for acute and ongoing
treatment of stress, urge, or
mixed urinary incontinence,
where urinary control may be
improved through electrical
stimulation that strengthens the
pelvic floor muscles or inhibits
the detrusor muscle through
reflexive mechanisms. The
system also uses EMG-based or
pressure-based biofeedback to
help control and strengthen the
pelvic floor muscles in the
treatment of urinary
incontinence. |
| Function | Pelvic floor muscle
stimulation | Pelvic floor muscle
stimulation | Pelvic floor muscle stimulation |
| Prescription Use
Only | Yes | Yes | Yes |
| Type of energy | Magnetic field | Magnetic field | Electrical |
| Power source | 100-240 V AC, 50-60 Hz,
max 12 A | 100-240 V AC, 50-60 Hz,
max 14 A | Max 140mA @ 5Vdc
(700mW) |
| Therapy Process | Specific therapy mode is
selected by the clinician
based on the patient's
symptoms. | Specific therapy mode is
selected by the clinician
based on the patient's
symptoms. | Specific therapy mode is
selected by the clinician based
on the patient's symptoms |
| Kegel Exercise
Mode | Present | Absent | Present |
| Applicator | Chair | Chair | Vaginal and Anal probes |
Comparison of the Technological Characteristics with Predicate and Reference Devices: 6.
5
| Stimulation source | Magnetic coil | Magnetic coil | Current |
|---|---|---|---|
| Magnetic field | |||
| strength | 0.7-2.5 T | 0.7-2.5 T | Not Applicable |
| Pulse repetition rate | 1-150 Hz | 1-150 Hz | 5-80 Hz |
| Pulse width | $340 \mu s \ (\pm 20 \mu s)$ | $280 \mu s \ (\pm 20 %)$ | 150-400 μs |
| Variation of Pulse | |||
| intensity (dB/dt) | Up to 24 mT/ μs±20% | Up to 28 mT/ μs±20% | Not Applicable |
| Pulse amplitude | |||
| adjustment | 0-100% | 0-100% | Not Applicable |
| Pulse shape | Sine, biphasic | Sine, biphasic | Symmetrical, rectangular, |
| bipolar, biphasic | |||
| Interface | Touch screen | Touch screen | LCD |
| Firmware controlled | Yes | Yes | Yes |
| Applicator | |||
| dimensions | |||
| (WxHxD) | 28x48x28 in. | 29x29x29 in. | 28 mm diameter (Vaginal |
| Probe) and 19.6 mm diameter | |||
| (Anal probe) | |||
| Treatment | |||
| Environment | Hospital/Clinics only | Hospital/Clinics only | Under medical supervision |
| only |
As evidenced by the above table, both the subject and the predicate devices have similar 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:
- Biocompatibility testing according to ISO 10993-1:2018 Biological evaluation of medical O 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 for the Content of Premarket Submissions for Software Contained in Medical Devices"
Additionally, performance bench data was submitted for device performance and durability of the subject device. This data included:
6
- o Service life verification test
- o Stimulation Coil Surface Temperature Rise Test
- 0 Maximum Magnetic Field Strength Test
- o Cybersecurity testing
All pre-determined acceptance criteria were met.
Clinical Data Summary 8.
To verify the Kegel Biofeedback functionality, the sponsor tested the subject device in 100 urinary incontinence patients (male and female, age range: 22-70) in a hospital set-up. All the patients' pelvic floor muscles strength was tested manually by a clinician by using modified Oxford Grading Scale. Then, the patients' pelvic floor muscle strength was measured by using the subject device. Thus, the Kegel biofeedback mode of the subject device was calibrated to identify the values of the biofeedback signal corresponding to normal and weak pelvic floor muscle strength. The pelvic floor muscle strength measured by the subject device was also compared to the pelvic floor muscle strength measured by a reference device, K201014 (MyOnyx System). Pelvic floor muscle conditions evaluated by both the subject and the reference devices were found to be comparable to each other.
9. Conclusions
Based on the information presented in this submission, it can be concluded that the subject device is substantially equivalent to the predicate.