(329 days)
No
The description focuses on the hardware and software control of magnetic field delivery, with no mention of AI or ML for data analysis, parameter optimization, or treatment personalization. The software is described as controlling the GUI and containing a microcomputer control system, which is typical for standard medical device operation.
Yes
The device description explicitly states, "The BTL-99-OC is a non-invasive therapeutic device..." and its intended use is "as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD)."
No
The device is described as a "non-invasive therapeutic device" intended for the "treatment" of OCD, not for diagnosis. While it mentions "MT threshold estimation," this appears to be a parameter setting for therapy rather than a diagnostic assessment of the patient's condition.
No
The device description clearly outlines hardware components including a main unit, generator unit, applicator(s), stimulation coil, and an applicator arm, in addition to the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of Obsessive-Compulsive Disorder (OCD) by delivering magnetic fields to induce electrical currents in the brain. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a non-invasive therapeutic device that applies magnetic fields externally. It does not involve the analysis of biological samples (like blood, urine, tissue, etc.) which is the hallmark of an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information based on in vitro testing.
In summary, the BTL-99-OC is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
BTL-99-OC is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).
Product codes
QCI
Device Description
The BTL-99-OC 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-99-OC 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 quides the Operator through the entire therapy procedure. The therapeutic parameters are set using the touch screen. During therapy, the screen displays information about the remaining therapy time and other therapy parameters.
The device functions with: M1 figure-of-8 coil applicator. The therapy is provided with the applicator attached to the applicator arm.
The BTL-99-OC composed of stimulation generator and stimulation coil. The stimulation generator is driven by software, which the operator controls through the GUI and contains a high voltage energy storage capacitor charging and discharging system, a power supply and a microcomputer control system. The software capabilities for administering treatment in the subject device are the comparable to these in the predicate devices. The stimulation coil is composed of a stimulation coil, an air forced cooling system and an applicator holder. The main unit BTL-99-OC with the M1 coil is intended to be used for both - MT threshold estimation and subsequent application of OCD therapy.
The BTL-99-OC is composed of:
- The main unit driven by software on chassis with 4 castors and with arm for coil positioning
- Stimulation Coil
- o Coil Figure-of-eight coil (M1 Coil)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human cerebral cortex
Indicated Patient Age Range
adult patients
Intended User / Care Setting
Not Found
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)
Non-clinical Performance Testing:
The subject device with M1 applicator and its technology remain identical to the device and its M1 applicator cleared under K212723. The proposed changes to BTL-99-OC, for adjunctive treatment of OCD, are limited to updates to the labelling and software to be possible use it safely and effectively as an adjunct treatment of OCD.
These changes were made to facilitate the safe and effective treatment of patients with OCD and do not raise any new or different questions of safety and effectiveness. All other aspects of the device remain unchanged and are identical to the currently cleared device, K212723.
Software verification & validation were performed in accordance with IEC 62304.
Device Performance verification: Tests and measurements were performed to verify that the subject device can operate reliably and safely even at maximum power while meeting the requirements of recognised international standards for electrical, mechanical, thermal safety, etc. Confirmed by test report according to international standard IEC 60601-1:2005+AMD1:2012+AMD2:2020.
The subject device with M1 coil has a lower induced field strength when compared to the predicate device output intensity set to 100%. The subject device at its maximum 100% output intensity setting is substantially equivalent to the predicate device with its stimulation coil and output intensity set at 50%. Performance verification and comparison of the subject device and the predicate was made by the real data measurements of the induced fields on a phantom head (filled with saline) and by comparing the outputs from COMSOL Multiphysics simulations.
Performance testing of the coil parameters of the subject and predicate devices was performed. The profiles and intensities of the induced fields (magnetic and electric) in the phantom head (filled with saline), in the different depths along the applicator central axis and planar measurements to obtain a 2D profiles of these fields at the different depths were taken at different distances (1-3cm) from the coil surface and these values were evaluated to determine substantial equivalency. For the same test scenarios described above, computer simulations were performed in COMSOL Multiphysics and the results were also compared.
As a result of this comparison, the values of the induced E-field intensities are substantially equivalent within the compared range and have average difference is in the range of +/-10% at distances of 1 to 3 cm from the coil surface.
The subject device has been tested and it conforms with the special controls set and requested in 21 CFR 882.5802 Transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5802 Transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions.
(a)
Identification. A transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions is a prescription, non-implantable device that uses brief duration, rapidly alternating, or pulsed, magnetic fields to induce neural activity in the cerebral cortex. It is not intended for applying or focusing magnetic fields towards brain areas outside cerebral cortex (e.g., cerebellum). A repetitive transcranial magnetic stimulation system that is intended to treat major depressive disorder is classified in § 882.5805. A transcranial magnetic stimulation system for headache is classified in § 882.5808.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Performance testing must demonstrate electromagnetic compatibility, electrical safety, and thermal safety.
(2) Software verification, validation, and hazard analysis must be performed.
(3) The patient-contacting components of the device must be demonstrated to be biocompatible.
(4) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Magnetic pulse output testing;
(ii) Magnetic and electrical field testing;
(iii) Testing of the safety features built into the device; and
(iv) Testing of the sound levels patients are exposed to during device use.
(5) The physician and patient labeling must include the following:
(i) The risks and benefits associated with use of the device;
(ii) Detailed instructions to prevent seizures, to monitor the patient for seizure activity during treatment, and to provide seizure management care if one were to occur during treatment; and
(iii) A description of the ear protection to be worn by the patient during use of the device, including the type of protection and its noise reduction rating.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 1, 2024
BTL Industries Inc. David Chmel VP of Operations 362 Elm Street Marlborough, Massachusetts 01752
Re: K230657
Trade/Device Name: BTL-99-OC Regulation Number: 21 CFR 882.5802 Regulation Name: Transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions Regulatory Class: Class II Product Code: QCI Dated: February 20, 2023 Received: March 9, 2023
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).
1
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,
Robert Kang -S
for Pamela Scott, MS Assistant Director DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230657
Device Name BTL-99-OC
Indications for Use (Describe)
BTL-99-OC is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/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.
510(k) Summary K230657
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: | 30 January 2024 |
| Device Name | |
| Trade/Proprietary Name: | BTL-99-OC |
| Primary Classification Name: | Transcranial Magnetic Stimulation System For Obsessive-
Compulsive Disorder |
Classification Regulation: 882.5802, Class II Classification Product Code: QCI
4
Image /page/4/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 nested inside the other, with the letters "BTL" inside the innermost square. The text "BTL Industries" is written in a sans-serif font and is also blue.
Legally Marketed Predicate Device
The BTL-99-OC is a state-of-the-art 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 numbers:
-
. MagVenture TMS Therapy system - for treatment of OCD (K193006)
Reference device: -
BTL-995-rTMS (K212723)
Product Description
The BTL-99-OC 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-99-OC 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 quides the Operator through the entire therapy procedure. The therapeutic parameters are set using the touch screen. During therapy, the screen displays information about the remaining therapy time and other therapy parameters.
The device functions with: M1 figure-of-8 coil applicator. The therapy is provided with the applicator attached to the applicator arm.
The BTL-99-OC composed of stimulation generator and stimulation coil. The stimulation generator is driven by software, which the operator controls through the GUI and contains a high voltage energy storage capacitor charging and discharging system, a power supply and a microcomputer control system. The software capabilities for administering treatment in the subject device are the comparable to these in the predicate devices. The stimulation coil is composed of a stimulation coil, an air forced cooling system and an applicator holder. The main unit BTL-99-OC with the M1 coil is intended to be used for both - MT threshold estimation and subsequent application of OCD therapy.
The BTL-99-OC is composed of:
- . The main unit driven by software on chassis with 4 castors and with arm for coil positioning
- Stimulation Coil
- o Coil Figure-of-eight coil (M1 Coil)
Indications for Use
BTL-99-OC is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).
5
Image /page/5/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three nested blue squares with the letters "BTL" inside the innermost square. To the right of the square logo is the text "BTL Industries" in a gray, sans-serif font.
Non-clinical Testing (Performance, Bench Testing)
The BTL-99-OC device has been thoroughly evaluated for electrical safety. The device has been found to comply with the following applicable medical device safety standards:
IEC 60601-1:2005+AMD1:2012+AMD2:2020
Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2: 2014+AMD1:2020
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: 2010+AMD1:2013
Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability -
IEC 62304:2006+A1:2015
Medical device software - Software life cycle processes -
ISO 14971:2019
Medical devices - Application of risk management to medical devices
Biological evaluation of medical devices
Biological evaluation of the subject device is based on the materials used, which are the same as those used in the previously cleared reference device. BTL-99-OC and its M1 applicator (the patient contacting part) in its final finished form is identical to BTL-995-rTMS device and its M1 applicator [K212723] in formulation, processing, sterilization, and geometry and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents, etc.)
6
Image /page/6/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" inside the innermost square. To the right of the square logo is the text "BTL Industries" in a dark gray sans-serif font. The logo is simple and modern, and the use of blue and gray gives it a professional look.
Non-clinical Performance Testing
The subject device with M1 applicator and its technology remain identical to the device and its M1 applicator cleared under K212723. The proposed changes to BTL-99-OC, for adjunctive treatment of OCD, are limited to updates to the labelling and software to be possible use it safely and effectively as an adjunct treatment of OCD.
These changes were made to facilitate the safe and effective treatment of patients with OCD and do not raise any new or different questions of safety and effectiveness. All other aspects of the device remain unchanged and are identical to the currently cleared device, K212723.
Software verification & validation
The software V&V procedures were performed in accordance with IEC 62304 which is considered a well-established method used in the software development.
Device Performance verificationTests and measurements have been performed to verify that the subject device can operate reliably and safely even at maximum power while meeting the requirements of recognised international standards for electrical, mechanical, thermal safety, etc. Confirmed by test report according to international standard IEC 60601-1:2005+AMD1:2012+AMD2:2020
The subject device with M1 coil has a lower induced field strength when compared to the predicate device output intensity set to 100%. The subject device at its maximum 100% output intensity setting is substantially equivalent to the predicate device with its stimulation coil and output intensity set at 50%. Performance verification and comparison of the subject device and the predicate was made by the real data measurements of the induced fields on a phantom head (filled with saline) and by comparing the outputs from COMSOL Multiphysics simulations.
Performance testing of the coil parameters of the subject and predicate devices was performed The profiles and intensities of the induced fields (magnetic and electric) in the phantom head (filled with saline), in the different depths along the applicator central axis and planar measurements to obtain a 2D profiles of these fields at the different depths were taken at different distances (1-3cm) from the coil surface and these values were evaluated to determine substantial equivalency. For the same test scenarios described above, computer simulations were performed in COMSOL Multiphysics and the results were also compared.
As a result of this comparison, the values of the induced E-field intensities are substantially equivalent within the compared range and have average difference is in the range of +/-10% at distances of 1 to 3 cm from the coil surface.
The subject device has been tested and it conforms with the special controls set and requested in 21 CFR 882.5802 Transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions.
7
Image /page/7/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three blue squares, each containing the letters "BTL" in white. The squares are arranged in a row, with the first square slightly offset to the left. To the right of the squares is the text "BTL Industries" in a dark gray sans-serif font.
Technological Characteristics
The BTL-99-OC device has the same intended use and principles of operation to its predicate device. The BTL-99-OC 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-99-OC 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.
Comparison with the Predicate Device
| DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | |
|---|---|---|---|
| 510(k) number | K230657 | K193006 | K212723 |
| Device name | BTL-99-OC | MagVenture TMS Therapy - For | |
| Treatment Of OCD, MagVenture TMS | |||
| Therapy System | BTL-995-rTMS | ||
| Company name | BTL Industries, Inc. | Tonica Elektronik A/S | BTL Industries, Inc. |
| Product Code | |||
| and Regulation | Neurology | ||
| 21 CFR 882.5802 | |||
| QCI - Transcranial Magnetic Stimulation | |||
| System for Obsessive-Compulsive | |||
| Disorder | Neurology | ||
| 21 CFR 882.5802 | |||
| QCI - Transcranial Magnetic Stimulation | |||
| System for Obsessive-Compulsive | |||
| Disorder | Neurology | ||
| 21 CFR 882.5805 | |||
| OBP - Transcranial Magnetic Stimulator | |||
| Indications for Use | BTL-99-OC is intended to be used as an | ||
| adjunct for the treatment of adult patients | |||
| suffering from Obsessive-Compulsive | |||
| Disorder (OCD). | The MagVenture TMS Therapy System is | ||
| intended to be used as an adjunct for the | |||
| treatment of adult patients suffering from | |||
| Obsessive-Compulsive Disorder (OCD). | BTL-995-rTMS is indicated to be used for | ||
| Ithe treatment of Major Depressive Disorder | |||
| in adult patients who have failed to achieve | |||
| satisfactory improvement from prior | |||
| antidepressant medication in the current | |||
| episode. | |||
| DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | |
| 510(k) number | K230657 | K193006 | K212723 |
| Device name | BTL-99-OC | MagVenture TMS Therapy - For | |
| Treatment Of OCD, MagVenture TMS | |||
| Therapy System | BTL-995-rTMS | ||
| Clinical use | Prescription use | Prescription use | Prescription use |
| Area of brain to be | |||
| stimulated | Dorsomedial Prefrontal cortex | Dorsomedial prefrontal cortex | Dorsolateral prefrontal cortex |
| Applicator: | |||
| Waveform | biphasic | biphasic | biphasic |
| Core material | air | air | air |
| Treatment of: | Obsessive-Compulsive Disorder | Obsessive-Compulsive Disorder | Major depressive disorder |
| Magnetic Field Intensity: Not exceeding | |||
| 100% of patient's measured Leg Motor | |||
| Threshold (MT). | Magnetic Field Intensity: 100% of Leg MT | ||
| (Leg Motor Threshold) | Magnetic Field Intensity: 120% of patient's | ||
| measured hand Motor Threshold (MT). | |||
| Therapy | |||
| parameters | Frequency: 20 Hz | ||
| (Up to 150Hz*) | Frequency: 20Hz | Frequency: 10Hz | |
| (Up to 150Hz) | |||
| Treatment train duration: 2 sec | |||
| (Up to 60s*) | Treatment train duration: 2 sec | Treatment train duration: 4 sec | |
| (Up to 60s) | |||
| Inter-train interval: 20 sec | Inter-train interval: 20 sec | Inter-train interval: 11-26 sec | |
| DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | |
| 510(k) number | K230657 | K193006 | K212723 |
| Device name | BTL-99-OC | MagVenture TMS Therapy – For | |
| Treatment Of OCD, MagVenture TMS | |||
| Therapy System | BTL-995-rTMS | ||
| (Up to 120 s*) | (Up to 120 s) | ||
| Number of trains: 50 | |||
| (Up to 99*) | Number of trains: 50 | Number of trains: 75 | |
| (Up to 99) | |||
| Numbers of pulses: 2000 | |||
| (Maximum depends on the combination of | |||
| set parameters*) | Numbers of pulses: 2000 | Numbers of pulses: 3000 | |
| Total therapy duration: 18 min | |||
| (Maximum depends on the combination of | |||
| set parameters*) | Total therapy duration: 18 min | Total therapy duration: 19 - 37min | |
| Number of pulses administered per | |||
| treatment: 58000 | |||
| (Maximum depends on the combination of | |||
| set parameters*) | Number of pulses administered per | ||
| treatment: 58000 | Number of pulses administered per | ||
| treatment: 90000 | |||
| Therapy sessions: | 29 | 29 | 30 |
| DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | |
| 510(k) number | K230657 | K193006 | K212723 |
| Device name | BTL-99-OC | MagVenture TMS Therapy – For | |
| Treatment Of OCD, MagVenture TMS | |||
| Therapy System | BTL-995-rTMS | ||
| 5 daily sessions for 5 weeks, and 4 daily | |||
| session in the 6th week | 5 daily sessions for 5 weeks, and 4 daily | ||
| session in the 6th week | 5 daily sessions for 6 weeks | ||
| Mobile console | yes | yes | Yes |
| System software | |||
| with GUI | yes | yes | yes |
| Coil positioning | |||
| system | yes | yes | yes |
| Air cooled | Liquid cooled | Air cooled | |
| Cooling | Used for both MT determination and | ||
| treatment. | Used for both MT determination and | ||
| treatment. | Used for both MT determination and | ||
| treatment. | |||
| Temperature | |||
| sensor | Yes, the system automatically reduces | ||
| the output intensity of the device if the | |||
| maximum temperature (41°C) of the parts | |||
| in contact with the patient could be | |||
| exceeded. | Not known | Yes, the system automatically reduces the | |
| output intensity of the device if the | |||
| maximum temperature (41°C) of the parts in | |||
| contact with the patient could be exceeded. | |||
| M1 coil | D-B80 coil | M1 coil | |
| Type: Figure of 8 coil | Type: Figure of 8 coil | Type: Figure of 8 coil | |
| Inner diameter: 10 mm | Inner diameter: 67 mm | Inner diameter: 10 mm | |
| Coil parameters | Outer diameter: 98 mm | Outer diameter: 95 mm | Outer diameter: 98 mm |
| N = 2 wings 20 turns | N = 2 wings 2 layers 4 & 3 turns | N = 2 wings 20 turns | |
| Core material: Air | Core material: Air | Core material: Air | |
| DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | |
| 510(k) number | K230657 | K193006 | K212723 |
| Device name | BTL-99-OC | MagVenture TMS Therapy – For | |
| Treatment Of OCD, MagVenture TMS | |||
| Therapy System | BTL-995-rTMS | ||
| Amplitude in | |||
| Standard Motor | |||
| Threshold (SMT) | |||
| units | |||
| (1 SMT is the output | |||
| setting of a rTMS | |||
| device that | |||
| corresponds to an | |||
| induced electric field | |||
| of 130V/m at a point | |||
| located at the fixed | |||
| distance (3cm) of | |||
| the target along the | |||
| central axis of the | |||
| coil measured with | |||
| a pick-up loop) | 0 - 1.5 SMT | 0 - 3 SMT | 0 - 1.5 SMT |
| Peak magnetic | |||
| field strength | |||
| at 2 cm | 290 mT | 230 mT | |
| Maximum dB/dt | |||
| (on the | |||
| applicator/scalp | |||
| surface when | |||
| 1.5SMT is set as | |||
| target output | |||
| intensity) | 6 800 T/s | 7 400 T/s | 6 800 T/s |
| Electrical safety | Complies with IEC60601-1 and IEC | ||
| 60601-1-2. | Complies with IEC60601-1 and IEC | ||
| 60601-1-2. | Complies with IEC60601-1 and IEC 60601- | ||
| 1-2. |
8
Image /page/8/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three blue diamonds nested inside each other on the left side of the image. To the right of the diamonds is the text "BTL Industries" in a sans-serif font.
9
Image /page/9/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, each with the letters "B", "T", and "L" inside. The text "BTL Industries" is written in a sans-serif font and is also blue.
10
Image /page/10/Picture/0 description: The image contains the logo for BTL Industries. The logo consists of three nested diamond shapes with the letters "BTL" inside the innermost diamond. To the right of the logo is the text "BTL Industries" in a sans-serif font. The logo and text are in a dark blue color.
11
Image /page/11/Picture/0 description: The image contains the logo for BTL Industries. The logo consists of three stylized, interconnected squares with the letters "BTL" inside the leftmost square. To the right of the logo, the words "BTL Industries" are written in a modern, sans-serif font. The logo and text are in a dark blue-gray color, set against a white background.
12
Image /page/12/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three nested squares, each rotated 45 degrees, with the letters "BTL" inside. To the right of the logo is the text "BTL Industries" in a sans-serif font. The logo and text are both in a dark gray color.
- Information marked with an asterisk is information range/capabilities of the subject device, maximum parameters have not been cleared for treatment according to the subject device – they are not intended for use in the adjunct treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).
Differences in maximum achievable amplitudes of SMT
Subject & Reference Devices: Intensity Setting = 0% -> 0 SMT Intensity Setting = 100% -> 1.5 SMT
Predicate Device: Intensity Setting = 0% -> 0 SMT Intensity Setting = 100% -> 3 SMT
(1 SMT is the output setting of a rTMS device that corresponds to an induced electric field of 130V/m at a point located at the fixed distance (3cm) of the target along the central axis of the coil measured with a pick-up loop)
The relationship between intensity setting and induced current in target distance is linear. Therefore, the presented comparison of SMT intensities between the subject and predicate device is possible: Subject device Intensity Setting corresponding to 100% = 1.5 SMT (output intensity at target distance) and consequently
Predicate Device Intensity Setting corresponding to 50% = 1.5 SMT (output intensity at target distance) These values indicate the predicate device need a lower intensity setting to achieve the same level of induced current in the targeted tissue as the subject device.
Although the value of the set intensity on the subject device looks visually higher compared the predicate (100% vs. 50%) it is an equivalent setting in terms of output stimulation parameters. It means in terms of the shape and intensity of the resulting electric and magnatic fields and therefore the intensity of the induced currents in the target tissue, since the achieved SMT values at this setting are substantially equivalent. In addition, identical coil specifications were used and cleared for the reference device coil and therefore, this difference does not affectiveness or safety of the subject device.
13
Image /page/13/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" inside the innermost square. To the right of the squares is the text "BTL Industries" in a dark gray sans-serif font. The logo is simple and modern, and the use of blue and gray gives it a professional look.
Substantial Equivalence
The BTL-99-OC device has the same intended use as its predicate device. The technological characteristics of the predicate device are similar to the BTL-99-OC device.
The subject device is substantially equivalent to the predicate device in the comparable range of the set output intensity. Specifically, the subject device's range of 0-100%MSO (maximum stimulator output) at a distance of 3 cm in the central axis from the coil is equal to 0-1.5 SMT, which is equivalent to the predicate device's range of 0-50%MSO at a distance of 3 cm in the central axis from the coil is equal to 0-1.5 SMT.
An output setting in this 0-1.5 SMT range results in the substantially equivalent output performance and both devices have comparable intensities and profiles of induced electric and magnetic fields.
dB/dt values of the subject device compared to the predicate device measured on the scalp and at distance of 3 cm in the central axis from the coil when output intensities are set to 1.5SMT in both devices are comparable in their ratio 1.79:1 (6.8kT/s) and 1.95:1 (7.4kT/s:3.8kT/s)
The device can be considered clinically safe even at 100%MSO, when according to the measured data it generates 1.5SMT at a distance of 3 cm in the central axis from the coil, which is within the range of values achieved by the predicate device.
Any differences between the predicate device and BTL-99-OC have no significant influence on safety and effectiveness of the BTL-99-OC device. Therefore, the BTL-99-OC 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-99-OC device has been shown to be substantially equivalent to the currently marketed predicate device.