(189 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like training/test sets, performance metrics typically associated with AI/ML, or image processing. The description focuses on the hardware and user interface for setting therapy parameters.
Yes
The device description explicitly states, "The BTL-995-rTMS is a non-invasive therapeutic device."
No
The device is described as a "therapeutic device" used for the treatment of Major Depressive Disorder, not for diagnosis.
No
The device description explicitly states it consists of a main unit (master unit and generator unit) and applicator(s) (figure-of-8 coil and circular coil), which are hardware components.
Based on the provided information, the BTL-995-rTMS device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of Major Depressive Disorder by delivering magnetic fields to the brain. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device description focuses on the delivery of magnetic fields and the physical components of the system used for this purpose. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The BTL-995-rTMS does not perform any such analysis.
Therefore, the BTL-995-rTMS is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
BTL-995-rTMS is indicated to be used for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
Product codes (comma separated list FDA assigned to the subject device)
OBP
Device Description
The BTL-995-FTMS is a non-invasive therapeutic device that produces and delivers magnetic field to induce electrical currents targeting specific regions of the human cerebral cortex.
BTL-995-rTMS consists of a main unit and applicator(s). The main unit consists of a master unit and a generator unit. The main unit is equipped with a color touch screen that makes the device easy to use. The on-screen information guides the Operator through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen. During therapy, the screen displays information about the remaining therapy time and other therapy parameters.
The device functions with two applicator types: figure-of-8 coil applicator and circular coil applicator. The therapy is provided with the applicator attached to the applicator arm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human cerebral cortex
Dorsolateral prefrontal cortex
Indicated Patient Age Range
adult patients
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)
No clinical testing was performed for this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.5805 Repetitive transcranial magnetic stimulation system.
(a)
Identification. A repetitive transcranial magnetic stimulation system is an external device that delivers transcranial repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex to treat the symptoms of major depressive disorder without inducing seizure in patients who have failed at least one antidepressant medication and are currently not on any antidepressant therapy.(b)
Classification. Class II (special controls). The special control is FDA's “Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation System.” See § 882.1(e) for the availability of this guidance document.
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Image /page/0/Picture/2 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym and name on the right. The FDA acronym is in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 4, 2022
BTL Industries Inc. David Chmel VP of Operations 362 Elm Street Marlborough, Massachusetts 01752
Re: K212723
Trade/Device Name: BTL-995-rTMS Regulation Number: 21 CFR 882.5805 Regulation Name: Repetitive Transcranial Magnetic Stimulation System Regulatory Class: Class II Product Code: OBP Dated: February 9, 2022 Received: February 9, 2022
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 (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. You must comply with all the Act's
1
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-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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,
for Pamela Scott, PhD Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212723
Device Name BTL-995-rTMS
Indications for Use (Describe)
BTL-995-rTMS is indicated to be used for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
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/3/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three nested squares with the letters "BTL" inside the innermost square. To the right of the logo is the text "BTL Industries" in a simple, sans-serif font.
510(k) Summary
General Information
| Sponsor: | BTL Industries, Inc.
362 Elm Street
Marlborough, MA 01752
Tel: +1-866-285-1656
Fax: +1-888-499-2502 |
|------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Applicant: | BTL Industries, Inc.
362 Elm Street
Marlborough, MA 01752
Tel: +1-866-285-1656
Fax: +1-888-499-2502 |
| Contact Person: | David Chmel
BTL Industries, Inc.
chmel@btlnet.com |
| Summary Preparation
Date: | February 1, 2022 |
Device Name
| Trade/Proprietary Name: | BTL-995-rTMS |
|---|---|
| Primary Classification Name: | Transcranial Magnetic Stimulator |
| Classification Regulation: | 882.5805, Class II |
| Classification Product Code: | OBP |
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Image /page/4/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three interlocking blue squares on the left side of the image. To the right of the squares is the text "BTL Industries" in a dark gray sans-serif font.
Legally Marketed Predicate Device
The BTL-995-rTMS is a state-of-the-art device electromagnetic device with accessories 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:
- . MaqVita TMS Therapy System (K150641)
Product Description
The BTL-995-FTMS is a non-invasive therapeutic device that produces and delivers magnetic field to induce electrical currents targeting specific regions of the human cerebral cortex.
BTL-995-rTMS consists of a main unit and applicator(s). The main unit consists of a master unit and a generator unit. The main unit is equipped with a color touch screen that makes the device easy to use. The on-screen information guides the Operator through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen. During therapy, the screen displays information about the remaining therapy time and other therapy parameters.
The device functions with two applicator types: figure-of-8 coil applicator and circular coil applicator. The therapy is provided with the applicator attached to the applicator arm.
Indications for Use
BTL-995-rTMS is indicated to be used for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
Clinical Testing
No clinical testing was performed for this device.
Non-clinical Testing (Performance, Bench Testing)
The BTL-995-rTMS device has been thoroughly evaluated for electrical safety. The device has been found to comply with the following applicable medical device safety standards:
| 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 disturbances
– Requirements and tests |
| IEC 60601-1-6 | Medical electrical equipment – Part 1-6: General requirements for basic safety
and essential performance – Collateral standard: Usability |
| IEC 62304 | Medical device software - Software life cycle processes |
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Image /page/5/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 squares, each containing the letters B, T, and L respectively.
| ISO 14971 | Medical devices – Application of risk management to medical devices |
|---|---|
| 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 |
Technological Characteristics
The BTL-995-rTMS device has the same intended use and principles of operation to its predicate device. The BTL-995-rTMS device and its predicate are comprised of a system console, arm for applicator positioning and applicator(s).
The mechanism of action and technological similarities and differences between the BTL-995rTMS device and the predicate device are described below in the comparison table. The differences do not raise any new types of safety or effectiveness questions.
| 510(k) number | K212723 | K150641 |
|---|---|---|
| Device name | ||
| Company name | BTL-995-rTMS | |
| BTL Industries, Inc. | MagVita TMS Therapy System | |
| Tonica Elektronik A/S | ||
| Product Code | ||
| and Regulation | Neurology | |
| 21 CFR 882.5805 | ||
| OBP - Transcranial Magnetic | ||
| Stimulator | Neurology | |
| 21 CFR 882.5805 | ||
| OBP - Transcranial Magnetic | ||
| Stimulator | ||
| Indications for Use | BTL-995-rTMS is indicated to be | |
| used for the treatment of Major | ||
| Depressive Disorder in adult | ||
| patients who have failed to achieve | ||
| satisfactory improvement from prior | ||
| antidepressant medication in the | ||
| current episode. | The MagVita TMS Therapy System is | |
| indicated for the treatment of Major | ||
| Depressive Disorder in adult patients | ||
| who have failed to receive satisfactory | ||
| improvement from prior | ||
| antidepressant medication in the | ||
| current episode. | ||
| Clinical use | Prescription use | Prescription use |
| Area of brain to be stimulated | Dorsolateral prefrontal cortex | Dorsolateral prefrontal cortex |
| Applicator: | ||
| Configuration | biphasic | biphasic |
| Core material | air | air |
Comparison with the Predicate Device
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Image /page/6/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three interconnected blue squares, each containing the letters "B", "T", and "L" respectively. To the right of the square logo is the text "BTL Industries" in a dark gray sans-serif font.
| 510(k) number | K212723 | K150641 |
|---|---|---|
| Device name | ||
| Company name | BTL-995-rTMS | |
| BTL Industries, Inc. | MagVita TMS Therapy System | |
| Tonica Elektronik A/S | ||
| Major | ||
| Depressive | ||
| Disorder | Magnetic Field Intensity: 120% of | |
| patient's measured hand Motor | ||
| Threshold (MT). | Magnetic Field Intensity: 120% MT | |
| (MT=Motor Threshold intensity) | ||
| Frequency: 10 Hz | Frequency: 10 Hz | |
| Treatment train duration: 4 sec | Treatment train duration: 4 sec | |
| Inter-train interval: 11-26 sec | Inter-train interval: 26 sec | |
| Number of pulses administered per | ||
| session: 3000 | Number of pulses administered per | |
| session: 3000 | ||
| Mobile console | yes | yes |
| System software with GUI | yes | yes |
| Coil positioning system | yes | yes |
| Cooling | Air cooled | |
| Used for both MT determination and | ||
| treatment. | Liquid cooled | |
| Used for both MT determination and | ||
| treatment. | ||
| Electrical safety | Complies with IEC60601-1 and IEC | |
| 60601-1-2 | Complies with IEC60601-1 and IEC | |
| 60601-1-2 |
Substantial Equivalence
The BTL-995-rTMS device has the same intended use as its predicate device. The technological characteristics of the predicate device are similar to the BTL-995-rTMS device. Any differences between the predicate device and BTL-995-rTMS have no significant influence on safety and effectiveness of the BTL-995-rTMS device. Therefore, the BTL-995-rTMS is substantially equivalent to the predicate device.
Conclusion
Based upon the intended use and the known technical data provided in this pre-market notification, the BTL-995-rTMS device has been shown to be substantially equivalent to the currently marketed predicate device.