(185 days)
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.
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).
The provided text describes a 510(k) premarket notification for a "Pelvic Floor Muscle Stimulator" (MagBelle AF180). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving independent effectiveness through a comprehensive clinical study with extensive statistical analysis of acceptance criteria. Therefore, the details requested in the prompt, such as specific acceptance criteria and detailed study outcomes with statistical measures, are not fully elaborated in the provided document in the typical format of a standalone clinical trial report.
However, based on the information provided, here's a summary of the available details regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "All pre-determined acceptance criteria were met" for non-clinical testing. For the clinical data, the acceptance criterion was implicitly that the subject device's pelvic floor muscle strength measurements were "comparable" to a reference device. Specific quantitative criteria and detailed performance metrics are not provided in this regulatory summary.
| Acceptance Criteria Category | Specific Criteria (as implied) | Reported Device Performance (as implied) |
|---|---|---|
| Non-Clinical Testing | ||
| Biocompatibility | Compliance with ISO 10993-1:2018 and FDA Guidance | Successfully completed |
| Electrical Safety | Compliance with IEC 60601-1: 2020 | Successfully completed |
| Electromagnetic Compatibility | Compliance with IEC 60601-1-2: 2020 | Successfully completed |
| Nerve and Muscle Stimulator Specific Requirements | Compliance with IEC 60601-2-10:2016 | Successfully completed |
| Software Verification and Validation | Compliance with FDA Guidance for Software in Medical Devices | Successfully completed |
| Service Life Verification | Device meets expected service life parameters | Test completed successfully |
| Stimulation Coil Surface Temperature Rise | Temperature rise within acceptable limits | Test completed successfully |
| Maximum Magnetic Field Strength | Magnetic field strength within specified range | Test completed successfully |
| Cybersecurity | Device meets cybersecurity requirements | Test completed successfully |
| Clinical Data (Kegel Biofeedback Functionality) | ||
| Pelvic Floor Muscle Strength Measurement Comparison | Measurements by subject device are comparable to a reference device (K201014 MyOnyx System) and manual Oxford Grading Scale. | Pelvic floor muscle conditions evaluated by both the subject and the reference devices were found to be comparable to each other. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Kegel Biofeedback functionality test: 100 urinary incontinence patients (male and female, age range: 22-70).
- Data Provenance: The study was conducted "in a hospital set-up," implying a prospective study. The country of origin of the data is not explicitly stated but is likely China, given the submitter's location.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: At least one clinician was involved in manually testing pelvic floor muscle strength using the modified Oxford Grading Scale. The document doesn't specify the number of additional clinicians or their specific qualifications (e.g., years of experience, specialty beyond "clinician").
4. Adjudication Method for the Test Set
- The document implies a comparison method where the subject device's measurements were calibrated and compared against manual assessment by a clinician and a reference device. It does not describe a formal expert adjudication method like "2+1" or "3+1." The clinician's manual assessment appears to serve as a form of ground truth or benchmark activity.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not performed or described. This device is a therapeutic device, not an AI diagnostic algorithm that assists human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The device itself is a standalone therapeutic device with a "Kegel Biofeedback functionality." The study assessed the performance of this functionality in measuring pelvic floor muscle strength, comparing its output to manual assessment and a reference device. This qualifies as evaluating a standalone function of the device.
7. The Type of Ground Truth Used
- For the Kegel Biofeedback functionality, the ground truth was established by:
- Expert Clinical Assessment: Manual testing of pelvic floor muscle strength by a clinician using the modified Oxford Grading Scale.
- Comparison to a Reference Device: Measurements from the subject device were compared to those from the legally marketed reference device, K201014 (MyOnyx System).
8. The Sample Size for the Training Set
- The document does not explicitly mention a "training set" in the context of the clinical data presented. The 100 patients were used for verification and calibration of the Kegel biofeedback mode, which might imply a form of internal "training" or adjustment during development, but it's not described as a distinct training set for an AI/algorithm in the traditional sense. The focus here is on device function verification.
9. How the Ground Truth for the Training Set Was Established
- As a training set is not explicitly mentioned, the method for establishing its ground truth is also not described. However, for the verification of the Kegel biofeedback mode, the calibration and comparison process involved manual assessment by a clinician and comparison with a reference device.
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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.
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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
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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, YuhuataiDistrict, Nanjing, Jiangsu 210012, China | |
| Applicant Contact Person: | Mr. Kai QiuPhone: +86 025696708Email : qiukai@vishee.com | |
| Correspondent Contact: | Mrs. Lisa TanPhone: +86 19850817942Email : 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
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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 & PredicateDevice(s): | K230767 (Subject Device) | K181497 (PredicateDevice) | K201014 (ReferenceDevice) |
|---|---|---|---|
| Device Name | Pelvic Floor MuscleStimulator | HPM-6000UF | MyOnyx System |
| Indication for Use | Pelvic Floor MuscleStimulator (model: MagBelleAF180) is intended to provideentirely non-invasiveelectromagnetic stimulationof pelvic floor musculaturefor the purpose ofrehabilitation of weak pelvicmuscles and restoration ofneuromuscular control for thetreatment of male and femaleurinary incontinence. | HPM-6000UF is intended toprovide entirely non-invasiveelectromagnetic stimulationof pelvic floor musculaturefor the purpose ofrehabilitation of weak pelvicmuscles and restoration ofneuromuscular control for thetreatment of male and femaleurinary incontinence. | The MyOnyx System isindicated for acute and ongoingtreatment of stress, urge, ormixed urinary incontinence,where urinary control may beimproved through electricalstimulation that strengthens thepelvic floor muscles or inhibitsthe detrusor muscle throughreflexive mechanisms. Thesystem also uses EMG-based orpressure-based biofeedback tohelp control and strengthen thepelvic floor muscles in thetreatment of urinaryincontinence. |
| Function | Pelvic floor musclestimulation | Pelvic floor musclestimulation | Pelvic floor muscle stimulation |
| Prescription UseOnly | 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 isselected by the clinicianbased on the patient'ssymptoms. | Specific therapy mode isselected by the clinicianbased on the patient'ssymptoms. | Specific therapy mode isselected by the clinician basedon the patient's symptoms |
| Kegel ExerciseMode | Present | Absent | Present |
| Applicator | Chair | Chair | Vaginal and Anal probes |
Comparison of the Technological Characteristics with Predicate and Reference Devices: 6.
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| Stimulation source | Magnetic coil | Magnetic coil | Current |
|---|---|---|---|
| Magnetic fieldstrength | 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 Pulseintensity (dB/dt) | Up to 24 mT/ μs±20% | Up to 28 mT/ μs±20% | Not Applicable |
| Pulse amplitudeadjustment | 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 |
| Applicatordimensions(WxHxD) | 28x48x28 in. | 29x29x29 in. | 28 mm diameter (VaginalProbe) and 19.6 mm diameter(Anal probe) |
| TreatmentEnvironment | Hospital/Clinics only | Hospital/Clinics only | Under medical supervisiononly |
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:
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- 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.
§ 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).