(146 days)
No
The provided text describes a non-invasive electromagnetic stimulator with a user interface for setting parameters. There is no mention of AI, ML, image processing, or any data-driven decision-making or learning capabilities. The substantial equivalence is based on technical characteristics compared to a predicate device, not performance studies that would typically be associated with AI/ML validation.
Yes
The device description explicitly states, "The HPM-6000U is a non-invasive therapeutic device." Additionally, its intended use is for "rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of urinary incontinence in women," which is a therapeutic purpose.
No
The provided text explicitly states that the device is "intended to provide entirely non-invasive electromagnetic stimulation" for "rehabilitation" and "restoration of neuromuscular control" and further describes it as a "non-invasive therapeutic device." There is no mention of it being used to diagnose conditions.
No
The device description explicitly states it is a "non-invasive therapeutic device" that "produces electromagnetic field" and is "equipped with a color touch screen with wide view angle that significantly facilitates the use of the device." This indicates the presence of hardware components beyond just software.
Based on the provided information, the HPM-6000U is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide non-invasive electromagnetic stimulation of pelvic floor muscles for the treatment of urinary incontinence. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device produces an electromagnetic field to stimulate and tone tissue. This is a physical therapy mechanism, not a method for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The HPM-6000U's function is to directly treat a condition through physical stimulation.
N/A
Intended Use / Indications for 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.
Product codes
KPI
Device 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.
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
Prescription Use
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Neotonus Model 1000 Muscle Stimulator System (K973096)
Reference Device(s)
Not Found
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).
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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
1
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
2
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 Drive
Framingham, MA 01702
Tel: +1-866-285-1656
Fax: +1-888-499-2502 |
|------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Applicant: | BTL Industries, Inc.
47 Loring Drive
Framingham, MA 01702
Tel: +1-866-285-1656
Fax: +1-888-499-2502 |
| Contact Person: | Jan Žársky
Director
BTL Industries, Inc.
zarsky@btlnet.com |
| Summary Preparation
Date: | July 19, 2016 |
Device Name
| Trade/Proprietary Name: | HPM-6000U |
|---|---|
| Primary Classification Name: | Stimulator, Electrical, Non-Implantable, For |
| Incontinence | |
| 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 medical
devices |
|---------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 62304 | Medical device software - Software life cycle processes |
| IEC 60601-1 | Medical electrical equipment - Part 1: General requirements
for basic safety and essential performance |
| IEC 60601-1-2 | Medical electrical equipment – Part 1-2: General requirements
for basic safety and essential performance - Collateral
standard: Electromagnetic compatibility – Requirements and
tests |
| IEC 60601-1-6 | Medical electrical equipment – Part 1-6: General requirements
for basic safety and essential performance - Collateral
standard: Usability |
| ISO 10993-1 | Biological evaluation of medical devices – Part 1: Evaluation
and testing within a risk management process |
| ISO 10993-5 | Biological evaluation of medical devices - Part 5: Tests for in
vitro cytotoxicity |
| ISO 10993-10 | Biological evaluation of medical devices - Part 10: Tests for
irritation 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 1000 |
| Muscle Stimulator System | ||
| Company name | BTL Industries, Inc. | Neotonus, Inc. |
| Product Code | ||
| and Regulation | Gastroenterology-Urology | |
| Devices | ||
| 21 CFR 876.5320 | ||
| KPI - Stimulator, Electrical, | ||
| Non-Implantable, For | ||
| Incontinence | Gastroenterology-Urology | |
| Devices | ||
| 21 CFR 876.5320 | ||
| KPI - Stimulator, Electrical, | ||
| Non-Implantable, For | ||
| Incontinence | ||
| 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. | Neotonus Model 1000 Muscle | |
| Stimulator System 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. | ||
| 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 | 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 1000 |
| Muscle Stimulator System | ||
| Company name | BTL Industries, Inc. | Neotonus, Inc. |
| Magnetic Coils | ||
| in the Applicator | ||
| 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 | Up to 2.2 T |
| Pulse Repetition | ||
| Rate | 1 - 150 Hz | 1 – 55 Hz |
| Step of | ||
| Frequency | ||
| Setting | 1 Hz | 1 Hz |
| Pulse Duration | 280 μs (± 20%) | 275 μs |
| Pulse Amplitude | 0 – 100 % | 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) | +10 to +30 °C (50 - 86 °F) |
| Interface | Touch-screen | Graphical Display |
| Firmware | ||
| controlled | Yes | Yes |
| Environmental | ||
| Specifications | 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 1000 |
| Muscle Stimulator System | ||
| Company name | BTL Industries, Inc. | Neotonus, Inc. |
| External | ||
| Exchangeable | ||
| Fuse | Yes | Yes |
| Main Unit | ||
| Dimensions | ||
| (W×H×D) | 500×970×580 mm | |
| (20×38×23 in) | 580×170×320 mm | |
| (23×7×12.5 in) | ||
| Applicator | ||
| Dimensions | ||
| (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 |
| Electrical | ||
| Protection | 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.
7
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.