(146 days)
HPM-6000U 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 urinary incontinence in women.
The HPM-6000U is a non-invasive therapeutic device. The device produces electromagnetic field that interacts with the tissues of the human body. The electromagnetic field delivered in the muscular or neuronal tissue area is triggering the stimulation and tonisation.
The HPM-6000U is equipped with a color touch screen with wide view angle that significantly facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen, buttons and knob on the device. During the therapy the device keeps information about the applied therapy type, remaining therapy time and main therapy parameters on the screen.
The provided document is a 510(k) Premarket Notification for the HPM-6000U device, which is an electromagnetic stimulator for treating urinary incontinence in women. The document explicitly states that the substantial equivalence determination for the HPM-6000U is NOT based on clinical testing. Instead, its safety and efficacy were demonstrated by comparing its technical characteristics with a predicate device, the Neotonus Model 1000 Muscle Stimulator System (K973096).
Therefore, there is no study described in this document that proves the device meets specific acceptance criteria related to its clinical performance (e.g., sensitivity, specificity, accuracy) using a test set against a ground truth.
However, the document does contain information about non-clinical testing for compliance with safety standards and a comparison table of technical specifications between the HPM-6000U and the predicate device, which serves as the basis for its substantial equivalence claim.
Given the information provided in the document:
1. A table of acceptance criteria and the reported device performance:
Since no clinical efficacy study with specific performance acceptance criteria is detailed, the "acceptance criteria" here relate to technical specifications and safety standards compliance.
| Acceptance Criteria (Technical/Safety Standard) | Reported Device Performance (HPM-6000U) |
|---|---|
| Technical Specifications (Compared to Predicate Device) | |
| Primary Function: Stimulation of pelvic floor musculature | Stimulation of pelvic floor musculature |
| Principle of Action: Initiating action potential of nerves results in muscle contraction | Initiating action potential of nerves results in muscle contraction |
| Type of Energy: Magnetic field | Magnetic field |
| Energy Source | 100 - 240 V AC, 50 - 60 Hz, max 14 A |
| Type of Coil: Single magnetic coil | Single magnetic coil |
| Number of Magnetic Coils in the Applicator: 1 | 1 |
| Type of Applicator: Chair | Chair |
| Number of Applicators: 1 | 1 |
| Patient Position during Therapy: Sitting position | Sitting position |
| Position of Coil: Center of applicator seat | Center of applicator seat |
| Type of Operation: Continuous | Continuous |
| Magnetic Field Intensity | 0.7 - 2.5 T |
| Pulse Repetition Rate | 1 - 150 Hz |
| Step of Frequency Setting: 1 Hz | 1 Hz |
| Pulse Duration | 280 μs (± 20%) |
| Pulse Amplitude | 0 – 100 % |
| Shape of Stimulation Pulse: Sine, biphasic | Sine, biphasic |
| Therapy Time: 30 min | 30 min |
| Operating Temperature | +10 to +30 °C (50 - 86 °F) |
| Interface: Touch-screen | Touch-screen |
| Firmware controlled: Yes | Yes |
| Environmental Specifications: For indoor use only | For indoor use only |
| Clinical Use: Prescription Use | Prescription Use |
| External Exchangeable Fuse: Yes | Yes |
| Main Unit Dimensions: 500x970x580 mm (20x38x23 in) | 500x970x580 mm (20x38x23 in) |
| Applicator Dimensions: 730x730x730 mm (29x29x29 in) | 730x730x730 mm (29x29x29 in) |
| System Weight | 46 kg (101 lb) |
| Position: Vertical - On castors | Vertical - On castors |
| Electrical Protection | Class II, BF |
| Compliance with Safety Standards | |
| ISO 14971 (Risk Management) | Compliant |
| IEC 62304 (Software Life Cycle Processes) | Compliant |
| IEC 60601-1 (Basic Safety and Essential Performance) | Compliant |
| IEC 60601-1-2 (EMC Requirements and Tests) | Compliant |
| IEC 60601-1-6 (Usability) | Compliant |
| ISO 10993-1 (Biological Evaluation) | Compliant |
| ISO 10993-5 (In vitro Cytotoxicity) | Compliant |
| ISO 10993-10 (Irritation and Skin Sensitization) | Compliant |
2. Sample size used for the test set and the data provenance:
- Not applicable. No clinical test set data is provided as clinical testing was not performed for substantial equivalence. The comparison is based on the technical specifications of the device and its predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No clinical test set or ground truth established by experts is described.
4. Adjudication method for the test set:
- Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a therapeutic device, not an AI-assisted diagnostic tool for human readers. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. The device is a physical therapeutic device, not an algorithm. Its performance is based on its physical/electromagnetic output, not an algorithm's classification or detection capabilities.
7. The type of ground truth used:
- Not applicable. For the substantial equivalence, the "ground truth" is implied to be the established safety and effectiveness of the legally marketed predicate device, as demonstrated through its technical specifications and intended use.
8. The sample size for the training set:
- Not applicable. No training set for an algorithm is mentioned as this is a physical medical device.
9. How the ground truth for the training set was established:
- Not applicable.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, often associated with medicine and healthcare. The seal is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 13, 2016
BTL Industries, Inc. % Jan Zarsky Director 47 Loring Drive Framingham, MA 01702
Re: K162010 Trade/Device Name: HPM-6000U Regulation Number: 21 CFR 876.5320 Regulation Name: Nonimplanted Electrical Continence Device Regulatory Class: Class II Product Code: KPI Dated: September 15, 2016 Received: September 16, 2016
Dear Jan Zarsky,
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. 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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Joyce M. Whang -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) Not known K162010 Device Name HPM-6000U
Indications for Use (Describe)
HPM-6000U 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 urinary incontinence in women.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three blue squares, each rotated 45 degrees, with the letters "BTL" inside. To the right of the squares is the text "BTL Industries" in a dark gray sans-serif font.
510(k) Summary
General Information
| Sponsor: | BTL Industries, Inc.47 Loring DriveFramingham, MA 01702Tel: +1-866-285-1656Fax: +1-888-499-2502 |
|---|---|
| Applicant: | BTL Industries, Inc.47 Loring DriveFramingham, MA 01702Tel: +1-866-285-1656Fax: +1-888-499-2502 |
| Contact Person: | Jan ŽárskyDirectorBTL Industries, Inc.zarsky@btlnet.com |
| Summary PreparationDate: | July 19, 2016 |
Device Name
| Trade/Proprietary Name: | HPM-6000U |
|---|---|
| Primary Classification Name: | Stimulator, Electrical, Non-Implantable, ForIncontinence |
| Classification Regulation: | 21 CFR 876.5320, Class II |
| Classification Product Code: | KPI |
Legally Marketed Predicate Devices
The HPM-6000U is a non-invasive therapeutic device, and is substantially equivalent to the current product that is already cleared for distribution in the USA under the following 510(k) Premarket Notification number:
Neotonus Model 1000 Muscle Stimulator System (K973096)
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Product Description
The HPM-6000U is a non-invasive therapeutic device. The device produces electromagnetic field that interacts with the tissues of the human body. The electromagnetic field delivered in the muscular or neuronal tissue area is triggering the stimulation and tonisation.
The HPM-6000U is equipped with a color touch screen with wide view angle that significantly facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen, buttons and knob on the device. During the therapy the device keeps information about the applied therapy type, remaining therapy time and main therapy parameters on the screen.
Intended Use
HPM-6000U 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 urinary incontinence in women.
Non-clinical Testing
The HPM-6000U device has been thoroughly evaluated for electrical safety. The HPM-6000U has been found to comply with the following applicable medical device safety standards:
| ISO 14971 | Medical devices - Application of risk management to medicaldevices |
|---|---|
| IEC 62304 | Medical device software - Software life cycle processes |
| IEC 60601-1 | Medical electrical equipment - Part 1: General requirementsfor basic safety and essential performance |
| IEC 60601-1-2 | Medical electrical equipment – Part 1-2: General requirementsfor basic safety and essential performance - Collateralstandard: Electromagnetic compatibility – Requirements andtests |
| IEC 60601-1-6 | Medical electrical equipment – Part 1-6: General requirementsfor basic safety and essential performance - Collateralstandard: Usability |
| ISO 10993-1 | Biological evaluation of medical devices – Part 1: Evaluationand testing within a risk management process |
| ISO 10993-5 | Biological evaluation of medical devices - Part 5: Tests for invitro cytotoxicity |
| ISO 10993-10 | Biological evaluation of medical devices - Part 10: Tests forirritation and skin sensitization |
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Image /page/5/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three blue squares nested inside each other, with the letters "BTL" in white inside the innermost square. To the right of the logo is the text "BTL Industries" in a gray, sans-serif font.
Clinical testing
The substantial equivalence determination for the HPM-6000U is not based on clinical testing. The device safety and efficacy was demonstrated by comparison of technical characteristics between the HPM-6000U and the predicate device.
Comparison with the Predicate Device
| 510(k) number | Not Assigned | K973096 |
|---|---|---|
| Device name | HPM-6000U | Neotonus Model 1000Muscle Stimulator System |
| Company name | BTL Industries, Inc. | Neotonus, Inc. |
| Product Codeand Regulation | Gastroenterology-UrologyDevices21 CFR 876.5320KPI - Stimulator, Electrical,Non-Implantable, ForIncontinence | Gastroenterology-UrologyDevices21 CFR 876.5320KPI - Stimulator, Electrical,Non-Implantable, ForIncontinence |
| Intended Use | HPM-6000U is intended toprovide entirely non-invasive electromagneticstimulation of pelvic floormusculature for thepurpose of rehabilitation ofweak pelvic muscles andrestoration ofneuromuscular control forthe treatment of urinaryincontinence in women. | Neotonus Model 1000 MuscleStimulator System is intendedto provide entirely non-invasive electromagneticstimulation of pelvic floormusculature for the purposeof rehabilitation of weak pelvicmuscles and restoration ofneuromuscular control for thetreatment of urinaryincontinence in women. |
| Primary Function | Stimulation of pelvic floormusculature | Stimulation of pelvic floormusculature |
| Principle ofAction | Initiating action potential ofnerves results in musclecontraction | Initiating action potential ofnerves results in musclecontraction |
| Type of Energy | Magnetic field | Magnetic field |
| Energy Source | 100 - 240 V AC, 50 - 60Hz, max 14 A | 110 V AC, 50 - 60 Hz,max 12 A |
| Type of Coil | Single magnetic coil | Single magnetic coil |
| Number of | 1 | 1 |
| 510(k) number | Not Assigned | K973096 |
| Device name | HPM-6000U | Neotonus Model 1000Muscle Stimulator System |
| Company name | BTL Industries, Inc. | Neotonus, Inc. |
| Magnetic Coilsin the Applicator | ||
| Type ofApplicator | Chair | Chair |
| Number ofApplicators | 1 | 1 |
| Patient Positionduring Therapy | Sitting position | Sitting position |
| Position of Coil | Center of applicator seat | Center of applicator seat |
| Type ofOperation | Continuous | Continuous |
| Magnetic FieldIntensity | 0.7 - 2.5 T | Up to 2.2 T |
| Pulse RepetitionRate | 1 - 150 Hz | 1 – 55 Hz |
| Step ofFrequencySetting | 1 Hz | 1 Hz |
| Pulse Duration | 280 μs (± 20%) | 275 μs |
| Pulse Amplitude | 0 – 100 % | 0 - 100 % |
| Shape ofStimulationPulse | Sine, biphasic | Sine, biphasic |
| Therapy Time | 30 min | 30 min |
| OperatingTemperature | +10 to +30 °C (50 - 86 °F) | +10 to +30 °C (50 - 86 °F) |
| Interface | Touch-screen | Graphical Display |
| Firmwarecontrolled | Yes | Yes |
| EnvironmentalSpecifications | For indoor use only | For indoor use only |
| Clinical Use | Prescription Use | Prescription Use |
| 510(k) number | Not Assigned | K973096 |
| Device name | HPM-6000U | Neotonus Model 1000Muscle Stimulator System |
| Company name | BTL Industries, Inc. | Neotonus, Inc. |
| ExternalExchangeableFuse | Yes | Yes |
| Main UnitDimensions(W×H×D) | 500×970×580 mm(20×38×23 in) | 580×170×320 mm(23×7×12.5 in) |
| ApplicatorDimensions(W×H×D) | 730x730x730 mm(29x29x29 in) | 700x1250x785 mm(27.5x49x31 in) |
| System Weight | 46 kg (101 lb) | 42.5 kg |
| Position | Vertical - On castors | Horizontal |
| ElectricalProtection | Class II, BF | Class II |
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Image /page/6/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three nested squares with the letters BTL inside them. To the right of the logo is the text "BTL Industries" in a simple, sans-serif font.
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Substantial Equivalence
Based upon the intended use and known technical information provided in this pre-market notification, the HPM-6000U device has been shown to be substantially equivalent to currently marketed predicate device. Thorough Substantial Equivalence Discussion is provided in Section 12.
Conclusion
Based on the aforementioned information, the HPM-6000U is safe and effective and substantially equivalent to the identified predicate device.
§ 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).