(197 days)
MFG-05 is intended to provide entirely non-invasive electromagnetic stimulation of the 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 MFG-05 is a non-invasive therapeutic device produces a magnetic field that interacts with the tissues of the human body. By stimulation of the pelvic floor musculature, the MFG-05 helps to treat of male and female urinary incontinence. The device housing protects the patient from electrical shock and mechanical injuries. The device is a mobile standalone equipment with four wheels. One applicator is available for therapy and is positioned centrally under the pelvic floor of the patient while the patient is wearing sport pants or any other pants without metallic parts. The device is for prescription use and used by a trained medical professional in a professional healthcare facility. The main body of MFG-05 is used to control the function of magnetic stimulation. It is operated with parameters such as frequency, time and intensity. These parameters can be controlled by the user on screen display and with the help of a rotary knob at the user control panel.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Expected Outcome) | Reported Device Performance (MFG-05) |
|---|---|---|
| Voluntary Standards Compliance | Compliance with various IEC/ISO standards for medical electrical equipment, usability, software lifecycle, and risk management. | The MFG-05 was investigated, tested, and complies with the following voluntary standards: ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text), IEC 60601-1-2 Edition 4.1 2020-09, IEC 60601-1-6 Edition 3.1 2013-10, IEC 60601-2-10 Edition 2.1 2016-04, IEC 62366-1 Edition 1.0 2015-02, IEC 62304 Edition 1.1 2015-06, ISO 14971 Third Edition 2019-12. |
| Performance Testing (Magnetic Field) | Applicator operates within magnetic field intensity specifications (0.5 - 1.5 T +/-20%). | Magnetic field testing confirmed that the applicator operates within the magnetic field intensity specifications (0.5 - 1.5 T +/-20%). |
| Performance Testing (Tissue Heating) | The tissue being treated by the device does not present an appreciable rise in temperature at maximum intensity to cause a risk to the patient. | SAR analysis and Tissue Heating study confirmed that the tissue being treated by the device does not present an appreciable rise in temperature at maximum intensity to cause a risk to the patient. |
| General Performance (Components & Subassemblies) | All components, subassemblies, and/or full devices and systems meet required specifications for completed tests. | Testing has been performed, and all components, subassemblies, and/or full devices and systems have met the required specifications for the completed tests. |
| Safety and Effectiveness | The device is as safe and effective as the predicate device (HPM-6000UF). Differences in technological characteristics do not raise new questions of safety or effectiveness. | The performance testing provided supports that the MFG-05 is as safe and effective as the predicate device, demonstrating substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The testing described is primarily device performance testing (e.g., electromagnetic compatibility, electrical safety, magnetic field intensity measurement, tissue heating simulation), not clinical studies involving patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not applicable or provided in the context of this regulatory submission. The document focuses on technical performance and compliance with recognized standards rather than expert-derived ground truth from clinical cases.
4. Adjudication Method for the Test Set
This information is not applicable or provided. The testing described is against technical specifications and standards, not a review of clinical cases requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. The device, MFG-05, is a therapeutic device for muscle stimulation, not an imaging or diagnostic device that typically involves human readers or AI assistance in interpretation. The document compares the device to a predicate based on technical characteristics and performance standards.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is not applicable to the MFG-05. The device is a physical therapeutic device, not an AI algorithm. Its performance is evaluated through physical and electrical testing.
7. The Type of Ground Truth Used
The "ground truth" for the performance testing is based on:
- Compliance with established voluntary standards: These standards define acceptable limits and testing methodologies for medical devices.
- Engineering specifications and design requirements: The device's performance (e.g., magnetic field intensity, temperature rise) is compared against its own design specifications.
- Comparison to predicate device's established performance: The safety and effectiveness are established by demonstrating that the MFG-05 performs comparably or within acceptable deviations from the legally marketed predicate device (HPM-6000UF).
8. The Sample Size for the Training Set
This information is not applicable as the MFG-05 is a physical medical device, not a machine learning or AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above.
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October 5, 2023
Zimmer MedizinSysteme GmbH % Scott Blood Principal Regulatory Consultant Ouality and Regulatory Services 151 Gleasondale Road Stow, MA 01775
K230780 Re: Trade/Device Name: MFG-05 Regulation Number: 21 CFR§ 876.5320 Regulation Name: Nonimplanted Electrical Continence Device Regulatory Class: II Product Code: KPI Dated: August 31, 2023 Received: September 5, 2023
Dear Scott Blood:
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).
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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
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Indications for Use
510(k) Number (if known) K230780
Device Name MFG-05
Indications for Use (Describe)
MFG-05 is intended to provide entirely non-invasive electromagnetic stimulation of the 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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K230780 Page 1 of 6
Image /page/3/Picture/1 description: The image shows the logo for Zimmer MedizinSysteme. The logo consists of the word "zimmer" in a sans-serif font, with a horizontal line above the "z". Below the word "zimmer" is the text "MedizinSysteme" in a smaller font. The logo is in gray color.
510(k) Summary MFG-05
-
- Basic Information-Submitter:
| 510(k) Owner: | Zimmer MedizinSysteme GmbHJunkersstrasse 989231 Neu-UlmGermanyEstablishment Registration: 8010720 |
|---|---|
| Ms. Ute KilletManager Regulatory AffairsPhone: +49-7319761-625Fax: +49-731-9761-118E-Mail: u.killet@zimmer.de | |
| Official Contact: | Mr. Scott BloodPrinciple ConsultantPhone: 978.729.5978Fax: +49-731-9761-118E-mail: scottqara@gmail.com |
| Date Summary Prepared: | October 5, 2023 |
| 2. Device Name: | |
| Trade Name: MFG-05Common Name: Stimulator, Electrical, Non-implantable, For IncontinenceRegulation Name: Nonimplanted electrical continence deviceRegulation Number: 21 CFR 876.5320Product Code: KPIClassification: Class II | |
| 3. Predicate Devices: | |
| Company Name: HPM-6000UF-K181497BTL Industries, Inc.The predicate has not been subject to a design-related recall | |
| Reference Device: emField - K203488Company Name: Zimmer MedizinSysteme GmbH |
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- Device Description: 4.
The MFG-05 is a non-invasive therapeutic device produces a magnetic field that interacts with the tissues of the human body. By stimulation of the pelvic floor musculature, the MFG-05 helps to treat of male and female urinary incontinence.
The device housing protects the patient from electrical shock and mechanical injuries. The device is a mobile standalone equipment with four wheels. One applicator is available for therapy and is positioned centrally under the pelvic floor of the patient while the patient is wearing sport pants or any other pants without metallic parts. The device is for prescription use and used by a trained medical professional in a professional healthcare facility. The main body of MFG-05 is used to control the function of magnetic stimulation. It is operated with parameters such as frequency, time and intensity. These parameters can be controlled by the user on screen display and with the help of a rotary knob at the user control panel.
Indications for Use Statement:
MFG-05 is intended to provide entirely non-invasive electromagnetic stimulation of the pelvic floor musculature for the purpose of rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of male urinary incontinence.
| ATTRIBUTE | SUBJECT DEVICE | PREDICATE DEVICE | REFERENCE DEVICE |
|---|---|---|---|
| Zimmer MedizinSystemeGmbHMFG-05This Submission | BTL Industries, Inc.HPM-6000UFK181497 | Zimmer MedizinSystemeGmbHemFieldK203488 | |
| Intended Use | MFG-05 is intended toprovide entirely non-invasive electromagneticstimulation of the pelvicfloor musculature for thepurpose of rehabilitation ofweak pelvic muscles andrestoration ofneuromuscular control forthe treatment of male andfemale urinaryincontinence. | HPM-6000UF is intendedto provide entirely non-invasive electromagneticstimulation of the pelvicfloor musculature for thepurpose of rehabilitation ofweak pelvic muscles andrestoration ofneuromuscular control forthe treatment of male andfemale urinaryincontinence. | The emField is indicated tobe used for:Relaxation of muscle spasms;Prevention or retardation of disuse atrophy;Increasing local blood circulation;Muscle re-education;Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; andMaintaining or increasing range of motion. |
The Indications for Use statement of MFG-05 is identical to that of the predicate device.
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-
- Technological Characteristics:
The MFG-05 device has similar technological characteristics and principles of operation as its predicate device. The MFG-05 device and its predicate device are comprised of a system console and one applicator. The system console consists of electromagnetic field generators, a computer and the touch-screen control panel. The technological similarities and differences between the subject device and the predicate device are described below in the comparison table
- Technological Characteristics:
The MFG-05 device was developed based on the reference device (emField) and has equivalent technology and principles of operation as the reference device. The emField device allows the use of one large applicator or one small applicator to be used only one at a time. The MFG-05 has the small applicator removed. The MFG-05 and its reference device generate both a magnetic field by applying a strong current to an applicator. The subject device has all features of the reference device.
The technological characteristics of the MFG-05 does not raise any different questions of safety or effectiveness.
| SUBJECT DEVICE | PREDICATE DEVICE | REFERENCE DEVICE | |
|---|---|---|---|
| TechnologicalCharacteristics | Zimmer MedizinSystemeGmbHMFG-05This Submission | BTL Industries, Inc.HPM-6000UFK181497 | Zimmer MedizinSystemeGmbHemFieldK203488 |
| Clinical Use | Prescription Use | Prescription Use | Prescription Use |
| ApplicablePatients | Male and Female, Adultsonly | Male and Female, Adults only | Adults only |
| PrimaryFunction | Muscle stimulation | Muscle stimulation | Muscle stimulation |
| Principle ofAction | Initiating action potential ofnerves results in musclecontraction | Initiating action potential ofnerves results in musclecontraction | Initiating action potential ofnerves results in musclecontraction |
| Type of Energy | Magnetic field | Magnetic field | Magnetic field |
| Energy Source | 100 - 120 V AC, 50/60 Hz,max. 2.7 kVA; 220 - 240 VAC, 50/60Hz, max. 2.7 kVA | 100 - 240 V AC, 50 - 60 Hz,max 14 A | 100-240 V AC, 50-60 Hz,max 12.5 A |
| Number ofoutput channels | 1 | 1 | 2 |
| Magnetic FieldIntensity | Applicator:0.5 - 1.5 T +/-20% | 0.7 - 2.5 T | Large applicator:0.5 – 1.5 T +/-20%Small applicator:0.5 - 2.0 T +/-20% |
| Pulse RepetitionRate | 1 – 150 Hz | 1 – 150 Hz | 1 – 150 Hz |
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| SUBJECT DEVICE | PREDICATE DEVICE | REFERENCE DEVICE | |
|---|---|---|---|
| TechnologicalCharacteristics | Zimmer MedizinSystemeGmbHMFG-05This Submission | BTL Industries, Inc.HPM-6000UFK181497 | Zimmer MedizinSystemeGmbHemFieldK203488 |
| Pulse Width | 400 us (+/- 20%) | 280 us (+/- 20%) | Large applicator:400 us +/- 20%Small applicator:250 us +/- 20% |
| Shape ofStimulationPulse | Symmetrical Biphasic SineWave | Dual phase, rectangularpulses | Symmetrical Biphasic SineWave |
| Therapy Time | Up to 60 min | Up to 60 min | Up to 60 min |
| Interface | Touchscreen | Touchscreen | Touchscreen |
| Firmwarecontrolled | Yes | Yes | Yes |
| Software Levelof Concern | Moderate | Moderate | Moderate |
| EnvironmentalSpecifications | For indoor use only | For indoor use only | For indoor use only |
| Feedback | By patient | By patient | By patient |
| OperatingTemperature | 10° C to 30° C(50° F to 86° F) | +10° C to +30° C(50° F to 86°F) | 10° C to 30° C |
| Main UnitDimensions(WxHxD) | 455x1000x417 mm | 500×970×580 mm(20×38×23 in) | 542x501x993 mm |
| ApplicatorDimensions(WxHxD) | 170x48x402 mm | 730x730x730 mm(29x29x29 in) | 161x41.5x300.5 mm |
| System Weight | Approx. 60 kg (No SafeWorking Load) | 46 kg (101 lb) | Approx. 60 kg |
There are a few technological differences between the subject device and the predicate device, including differences in stimulation waveform parameters (i.e., magnetic field intensity, pulse width) and main unit dimensions. Performance testing were provided to demonstrate that these different do not affect the safety or performance of the device as compared to the predicate device.
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6. Performance data
The MFG-05 has been investigated and tested against and complies with the following voluntary standards:
| Standards | StandardsOrganization | Standards Title |
|---|---|---|
| ES60601-1:2005/(R)2012& A1:2012,C1:2009/(R)2012 &A2:2010/(R)2012 (Cons.Text) | ANSI/AAMI | Medical electrical equipment – Part 1: General requirements forbasic safety and essential performance |
| 60601-1-2 Edition 4.12020-09 | IEC | Medical electrical equipment – Part 1-2: General requirements forbasic safety and essential performance – Collateral standard:Electromagnetic disturbances – Requirements and tests |
| 60601-1-6 Edition 3.12013-10 | IEC | Medical electrical equipment – Part 1-6: General requirements forbasic safety and essential performance - Collateral standard:Usability |
| 60601-2-10 Edition 2.12016-04 | IEC | Medical electrical equipment - Part 2-10: Particular requirements forthe basic safety and essential performance of nerve and musclestimulators |
| 62366-1 Edition 1.02015-02 | IEC | Medical devices - Part 1: Application of usability engineering tomedical devices |
| 62304 Edition 1.1 2015-06 | IEC | Medical devices software -software life cycle processes |
| 14971 Third Edition2019-12 | ISO | Medical devices – Application of risk management to medical devices |
The following table shows a comparison of the performance testing in comparison to the predicate device:
| SUBJECT DEVICE | PREDICATE DEVICE | |
|---|---|---|
| Standards | Zimmer MedizinSytemeGmbH | BTL Industries, Inc. |
| MFG-05This Submission | HPM-6000UFK181497 | |
| ANSI/AAMIES60601-1 | X | X |
| IEC 60601-1-2 | X | X |
| IEC 60601-2-10 | X | X |
| ISO 10993-1ISO 10993-5ISO 10933-10 | Not applicable (no patient-contactingmaterials) | X |
According to this comparison table all required performance tests were conducted and show substantial equivalence with the predicate device.
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Preclinical Testing Results
The following tests were performed on the subject device in addition to the testing listed above:
- Performance testing per IEC 60601-2-10 ●
- Magnetic Field testing
- SAR analysis and Tissue Heating study
The testing above confirmed that the applicator operates within the magnetic field intensity specifications and that the tissue being treated by the device does not present an appreciable rise in temperature at maximum intensity to cause a risk to the patient.
Testing has been performed and all components, subassemblies and/or full devices and systems have met the required specifications for the completed tests.
-
- Conclusion:
There are no differences with respect to the indications for use and many of the technological characteristics between the MFG-05 and the predicate device. The minor differences mentioned above do not raise new questions of safety or effectiveness. The performance testing provided supports that the MFG-05 is as safe and effective as the predicate device, and therefore is substantially equivalent.
- Conclusion:
§ 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).