(257 days)
The device 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 BTL-398 is a non-invasive therapeutic device that delivers magnetic pulses to stimulate the pelvic floor muscles for the treatment of urinary incontinence in adult population. The BTL-398 device is intended for professional use in healthcare facilities as a prescription use only. The BTL-398 consists of a main unit and a Chair Applicator. The main unit consists of the electromagnetic field generators, the microprocessor-driven control unit, and the touch-screen control panel. The Chair Applicator is designed for non-invasive treatment of urinary incontinence. The magnetic coil is in the center of the seat, and its position is user-adjustable during therapy. Ongoing therapy is indicated by illuminated segments. The Chair Applicator is designed for precise patient positioning, ensuring the most appropriate posture before and during therapy. Prior to High-Intensity Focused Electromagnetic (HIFEM) therapy, the seat height and coil position can be adjusted using an attached remote controller. The Dynamic HFEM Technology (DHT) feature ensures the coil is optimally positioned at the right location beneath the patient before starting therapy. At the start of therapy, air is circulated through the seat cushion with the Pressure Wave Technology (PWT) feature (intensity of the PWT function is set based on patient feedback). The PWT feature helps patients maintain the correct therapeutic position during therapy. Both the PWT and DHT features can be readjusted, and the PWT feature can be turned off, at any time during the session. The touch screen display guides the user step-by-step through the entire therapy procedure. During therapy, the screen displays information about the applied therapy, remaining therapy time, and main therapy parameters. Therapy is administered through clothing.
The provided text is a 510(k) Premarket Notification from the FDA for a device called "BTL-398". This document primarily focuses on demonstrating substantial equivalence to a predicate device (HPM-6000UF) for regulatory clearance. It does not include information about clinical studies with human participants, AI components, or detailed performance data against acceptance criteria for such clinical or AI-specific assessments.
Therefore, many of the requested details about acceptance criteria, clinical study design, sample sizes, expert involvement, and ground truth establishment, particularly concerning AI or human-in-the-loop performance, cannot be extracted from this document. The document explicitly mentions "non-clinical testing" and "performance bench data," suggesting that equivalence was primarily established through engineering and electromagnetic performance tests, not clinical efficacy trials for the UI treatment itself.
However, I can extract information related to what was used for acceptance and testing:
Acceptance Criteria and Device Performance (Based on "Non-clinical Testing")
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Electrical Safety | Met IEC 60601-1: 2020 |
| Mechanical Strength | Met IEC 60601-1: 2020 |
| Thermal Safety | Met IEC 60601-1: 2020 |
| Electromagnetic Compatibility | Met IEC 60601-1-2: 2020 |
| Software Verification & Validation | Met FDA's 2023 Guidance ("Content of Premarket Submissions for Device Software Functions |
| Magnetic Field Strength | Bench data submitted, all pre-determined acceptance criteria met. (Specific values not detailed) |
| Coil Surface Temperature Controls | Bench data submitted, all pre-determined acceptance criteria met. (Specific values not detailed) |
| PWT feature | Bench data submitted, all pre-determined acceptance criteria met. (Specific functionality not detailed) |
Study Details (as per available information):
-
A table of acceptance criteria and the reported device performance:
(See table above) The document states, "All pre-determined acceptance criteria were met." However, it does not provide specific numerical targets or results for the bench performance tests (e.g., exact magnetic field strength measured vs. target range). It only confirms compliance with standards and successful completion of tests. -
Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of human subjects or AI test sets. The testing described is non-clinical bench testing of the device's electrical, mechanical, thermal, electromagnetic, and software functions.
- Data Provenance: N/A for clinical data. The data is from internal bench testing (performance bench data).
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth for clinical outcomes or diagnoses is not mentioned as this was primarily non-clinical testing. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. No human reader or expert adjudication process for clinical data or AI output is described. -
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:
No MRMC study was mentioned. The device is a non-invasive electromagnetic stimulator, not an imaging or diagnostic AI device that would typically involve human readers. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable for an AI algorithm. The device, the BTL-398, is a physical medical device. Its software functions were verified and validated, but this does not imply an AI component in the typical sense of diagnostic or image analysis AI. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the non-clinical tests, the "ground truth" was established based on engineering specifications and compliance with recognized standards (IEC 60601-1, IEC 60601-1-2) and FDA guidance for software verification and validation. For magnetic field strength, coil surface temperature, and PWT features, the ground truth would be the expected performance range derived from design specifications. -
The sample size for the training set:
Not applicable. No machine learning training set is mentioned. -
How the ground truth for the training set was established:
Not applicable. No machine learning training set is mentioned.
Summary of what the document focuses on:
The entire document pertains to establishing substantial equivalence of the BTL-398 to a predicate device (HPM-6000UF) through non-clinical testing. The key differences noted between the subject device (BTL-398) and the predicate are the inclusion of a "PWT feature" (Pressure Wave Technology for patient positioning) and a "DHT Feature" (Dynamic HFEM Technology for coil adjustment). The non-clinical tests were conducted to ensure these new features and the overall device design do not raise new questions of safety or effectiveness.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out as "U.S. Food & Drug Administration".
February 10, 2025
BTL Industries, Inc. David Chmel CEO North America 362 Elm Street Marlborough, Massachusetts 01752
Re: K241516 Trade/Device Name: Btl-398 Regulation Number: 21 CFR 876.5320 Regulation Name: Nonimplanted Electrical Continence Device Regulatory Class: II Product Code: KPI Dated: May 28, 2024 Received: January 8, 2025
Dear David Chmel:
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 medical devices and radiation-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
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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
Enclosure
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Indications for Use
510(k) Number (if known) K241516
Device Name Btl-398
Indications for Use (Describe)
The device is intended to provide entirely non-invasive electromagnetic stimulation of pelvic flor 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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Image /page/4/Picture/0 description: The image contains the logo for BTL Industries. The logo consists of three interconnected squares with the letters "BTL" inside. To the right of the logo is the text "BTL Industries" in a sans-serif font.
Traditional 510(k) Summary
1. Submitter Information
| Applicant | BTL Industries, Inc.362 Elm StreetMarlborough, MA 01752Tel: +1-866-285-1656Fax: +1-888-499-2502 |
|---|---|
| Official Correspondent | David ChmelBTL Industries, Inc.chmel@btlnet.com |
| Date Prepared: | February 7, 2025 |
2. Device Name
| Trade/Proprietary Name: | BTL-398 |
|---|---|
| Common Name: | BTL-398 |
| Primary Classification Name: | Nonimplanted electrical continence device |
| Classification Regulation: | 21 CFR 876.5320, Class II |
| Classification Product Code: | KPI |
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Image /page/5/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of a geometric design on the left, followed by the text "BTL Industries" on the right. The geometric design is made up of three nested squares, with the letters "B", "T", and "L" inside the innermost square. The text "BTL Industries" is in a sans-serif font and is a dark gray color.
3. Predicate Device Identification
K181497 HPM-6000UF BTL Industries, Inc.
The predicate device was never subjected to a design related recall.
4. Device Description
The BTL-398 is a non-invasive therapeutic device that delivers magnetic pulses to stimulate the pelvic floor muscles for the treatment of urinary incontinence in adult population. The BTL-398 device is intended for professional use in healthcare facilities as a prescription use only.
The BTL-398 consists of a main unit and a Chair Applicator. The main unit consists of the electromagnetic field generators, the microprocessor-driven control unit, and the touch-screen control panel. The Chair Applicator is designed for non-invasive treatment of urinary incontinence. The magnetic coil is in the center of the seat, and its position is user-adjustable during therapy. Ongoing therapy is indicated by illuminated segments.
The Chair Applicator is designed for precise patient positioning, ensuring the most appropriate posture before and during therapy. Prior to High-Intensity Focused Electromagnetic (HIFEM) therapy, the seat height and coil position can be adjusted using an attached remote controller. The Dynamic HFEM Technology (DHT) feature ensures the coil is optimally positioned at the right location beneath the patient before starting therapy. At the start of therapy, air is circulated through the seat cushion with the Pressure Wave Technology (PWT) feature (intensity of the PWT function is set based on patient feedback). The PWT feature helps patients maintain the correct therapeutic position during therapy. Both the PWT and DHT features can be readjusted, and the PWT feature can be turned off, at any time during the session. The touch screen display guides the user step-by-step through the entire therapy procedure. During therapy, the screen displays information about the applied therapy, remaining therapy time, and main therapy parameters. Therapy is administered through clothing.
5. Indications for Use
The device 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.
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Image /page/6/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of a blue geometric design on the left and the text "BTL Industries" on the right. The geometric design is made up of three interlocking squares, with the letters "B", "T", and "L" inside the squares. The text "BTL Industries" is written in a gray, sans-serif font.
6. Comparison with the Predicate Device
| 510(k) number | K241516 | K181497 |
|---|---|---|
| Device name | BTL-398 | HPM-6000UF |
| Companyname | BTL Industries, Inc. | BTL Industries, Inc. |
| Type | Subject device | Primary predicate |
| Product Code andRegulation | Gastroenterology-Urology21 CFR 876.5320Nonimplanted Electrical ContinenceDeviceKPI - Stimulator, Electrical, Non-Implantable, For Incontinence | Gastroenterology-Urology21 CFR 876.5320Nonimplanted Electrical ContinenceDeviceKPI - Stimulator, Electrical, Non-Implantable, For Incontinence |
| Indications forUse | The device is intended to provideentirely non-invasive electromagneticstimulation of pelvic floor musculaturefor the purpose of rehabilitation of weakpelvic muscles and restoration ofneuromuscular control for the treatmentof male and female urinaryincontinence. | HPM-6000UF is intended to provideentirely non-invasive electromagneticstimulation of pelvic floor musculaturefor the purpose of rehabilitation ofweak pelvic muscles and restoration ofneuromuscular control for thetreatment of male and female urinaryincontinence. |
| Clinical Use | Prescription Use | Prescription Use |
| Intendedpopulation | Adult Male and Female | Adult Male and Female |
| PrimaryFunction | Pelvic floor muscle stimulation | Pelvic floor muscle stimulation |
| Principle ofAction | Initiating the action potential of nervesresults in muscle contraction | Initiating the action potential ofnerves results in musclecontraction |
| Type of Energy | Magnetic field (Therapy) + air (PWTfeature for proper patient positioning) | Magnetic field (Therapy) |
| Energy Source | 100 - 240 V AC, 50 - 60 Hz | 100 - 240 V AC, 50 - 60 Hz |
| Number ofoutputchannels | 1 | 1 |
| Magnetic FieldIntensity | 0.7 - 2.5 T | 0.7 - 2.5 T |
| Pulse RepetitionRate | 1 – 150 Hz | 1 – 150 Hz |
| Pulse Width | 280 μς (± 20%) | 280 μς (± 20%) |
| Shape ofStimulation Pulse | Dual-phase, sine pulses | Dual-phase, sine pulses |
| Therapy Time | Up to 30 min | Up to 30 min |
| PWT feature | Yes | No |
| PWT intensity | 0-100% | N/A |
| PWT repetition rate | Up to 40 Hz | N/A |
| OperatingTemperature | +10 to +30 °C(50 - 86 °F) | +10 to +30 °C(50 - 86 °F) |
| Applicator type | Chair applicator | Chair applicator |
| Main UnitDimensions(W×H×D) | 580 × 1380 × 580 mm(23 × 54 × 23 in) | 500 × 970 × 580 mm(20 × 38 × 23 in) |
| ApplicatorDimensions(W×H×D) | 730 x 850 x 730 mm(29 x 33,5 x 29 in) | 730 x 730 x 730 mm(29 x 29 x 29 in) |
| System Weight | 99 kg (216 lb) | 82 kg (181 lb) |
| Applicator heightadjustment | 17 to 22 in (42 to 55 cm) | 17 to 22 in (42 to 55 cm) |
| Coil adjustment(DHT Feature) | Yes100±5mm in horizontal direction | No |
| Therapy Modes | • Basic Mode:Frequency: 1-150 Hz, Pulse: 0.01-60 s,Pause: 0-60s, PWT: 1-40 Hz• Sequence Mode:○ Amplitude modulation with PWT1-40 Hz○ Frequency modulation with PWT1-40 Hz• Single Mode:Frequency: 1-150 Hz, Number of pulses:1-1000 | • Basic Mode:Frequency: 1-150 Hz, Pulse: 0.01-60 s,Pause: 0-60s• Sequence Mode:○ Amplitude modulation○ Frequency modulation• Single Mode:Frequency: 1-150 Hz, Number of pulses:1-1000 |
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Image /page/7/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of a stylized graphic of three nested squares rotated to form a diamond shape, with the letters "BTL" inside the innermost square. To the right of the graphic is the text "BTL Industries" in a simple, sans-serif font.
K241516
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Image /page/8/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 square logo is the text "BTL Industries" in a gray sans-serif font.
Image /page/8/Picture/2 description: The image is a rectangular shape divided into three equal sections. The rectangle is bordered by a thick black line on the top and bottom. The three sections are separated by thin black vertical lines.
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. The differences in technological characteristics between the subject and the predicate does not raise different questions of safety or effectiveness. Performance testing was conducted to establish substantial equivalence of the subject device to the predicate device.
7. Summary of Non-clinical Testing
Below is a list of the tests that were performed and successfully completed for the subject device per the specified guidance and standards:
- Electrical Safety testing, mechanical strength testing and thermal safety testing to ● IEC 60601-1: 2020 - Medical electrical equipment -Basic safety and essential performance.
- Electromagnetic Compatibility testing according to IEC 60601-1-2: 2020 General ● requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances -- Requirements and tests.
- . Software Verification and Validation Testing according to FDA's Guidance (2023) . "Content of Premarket Submissions for Device Software Functions | FDA"
Additionally, performance bench data was submitted for device performance i.e., magnetic field strength testing, coil surface temperature testing/controls and PWT feature testing.
All pre-determined acceptance criteria were met.
8. Conclusion
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).