(275 days)
The BTL-785F device has the following indications for use:
The BTL-785F with BTL-785-1 applicator is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The BTL-785-1-4 massage device is intended to provide a temporary reduction in the appearance of cellulite.
The BTL-785F with BTL-785-2 applicator is indicated to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.
The BTL-785F with BTL-785-3 applicator is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.
The Applicator BTL-785-4 of BTL-785F device used with tips BTL-785-4-1, BTL-785-4-5 and BTL-785-4-6 is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. The Applicator BTL-785-4 of BTL-785F device used with tips BTL-785-4-4, BTL-785-4-7 and BTL-785-4-8 is intended for dermatological procedures requiring fractional treatment of the skin. At higher energy levels greater than 62 mJ/pin, use of the BTL-785-4 applicator is limited to Skin Types I-IV.
The BTL-785F is a state-of-the-art radiofrequency device that enables the application of therapy by a high-frequency field.
The control unit of the system is equipped with a large color touch screen that significantly facilitates the use of the device. The on-screen information quides the user step by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen of the device. During the therapy the device displays information about the applied therapy type, remaining therapy time and main therapy parameters on the screen. For easier control, the hand-pieces are equipped with buttons, enabling operation of the device during therapy. The energy flow's quality is indicated by the illuminated treatment tip. The BTL-785F device comes with four different types of applicators.
The BTL-785F device consists of the following main components:
- microprocessor-driven control unit
- radiofrequency generator
- user interface with 15.6" color touch screen
- applicators for an application of radiofrequency
- exchangeable applicator tips
Here's a breakdown of the acceptance criteria and study information for the BTL-785F device, based on the provided FDA 510(k) summary:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance | Study Type/Method |
|---|---|---|---|
| Electrical Safety | IEC 60601-1 | Complies with standard | Bench testing |
| IEC 60601-1-2 | Complies with standard | Bench testing | |
| IEC 60601-2-2 | Complies with standard | Bench testing | |
| IEC 60601-2-5 | Complies with standard | Bench testing | |
| IEC 60601-1-6 | Complies with standard | Bench testing | |
| Software Life Cycle | IEC 62304 | Complies with standard | Documentation Review |
| Risk Management | ISO 14971 | Complies with standard | Documentation Review |
| Biocompatibility | ISO 10993-1 | Complies with standard | Bench testing |
| ISO 10993-5 | Complies with standard | Bench testing | |
| ISO 10993-7 | Complies with standard | Bench testing | |
| ISO 10993-10 | Complies with standard | Bench testing | |
| ISO 10993-11 | Complies with standard | Bench testing | |
| Sterilization | ISO 11135 | Complies with standard | Documentation Review |
| Packaging | ISO 11607-1 | Complies with standard | Documentation Review |
| ISO 11607-2 | Complies with standard | Documentation Review | |
| Therapeutic Efficacy | Achieve and maintain therapeutic temperature on different treated areas for at least 10min | Device demonstrated ability to achieve and maintain therapeutic temperature for at least 10 minutes | Bench testing |
| Power Output & Geometry | Power output of generator and geometry of 785-4 applicator identical to predicate | Demonstrated to be identical to predicate | Bench testing |
Study Details
Based on the provided document, the BTL-785F device primarily relies on bench testing and compliance with recognized international standards to demonstrate substantial equivalence and meet acceptance criteria. The document does not describe a clinical study with human subjects in the traditional sense of a comparative effectiveness study.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in terms of patient data or samples from a clinical trial. The testing described is primarily bench testing for engineering and safety compliance. Therefore, there is no information on a sample size for a "test set" in a clinical context, nor is there information on data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the document describes bench testing against engineering standards, not a diagnostic or prognostic device requiring expert-established ground truth on human data.
4. Adjudication Method for the Test Set
This information is not applicable as the document describes bench testing against engineering standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no indication of an MRMC comparative effectiveness study being performed for the BTL-785F device. The submission focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and compliance with safety and performance standards.
6. Standalone (Algorithm Only) Performance
The BTL-785F is an electrosurgical cutting and coagulation device and a massager, not an AI/algorithm-based diagnostic or prognostic device. Therefore, a "standalone algorithm performance" study is not applicable. The device's performance is inherently tied to its physical operation and interaction with tissue.
7. Type of Ground Truth Used
The "ground truth" for the performance claims in this submission is established by:
- International Standards: Compliance with detailed specifications outlined in standards like IEC 60601 series, ISO 14971, and ISO 10993 series.
- Engineering Specifications: The ability to achieve and maintain specific therapeutic temperatures and to match the power output and geometry of predicate devices.
8. Sample Size for the Training Set
This information is not applicable as the BTL-785F device is not an AI/machine learning product and therefore does not have a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as the BTL-785F device is not an AI/machine learning product and therefore does not have a "training set."
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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 & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
August 21, 2020
BTL Industries, Inc. David Chmel VP of Operations 362 Elm Street Marlborough, Massachusetts 01752
Re: K193201
Trade/Device Name: BTL-785F Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI, PBX Dated: May 21, 2020 Received: May 26, 2020
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.
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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 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 (QS) 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.
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control 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) K193201
Device Name BTL-785F
Indications for Use (Describe)
The BTL-785F device has the following indications for use:
The BTL-785F with BTL-785-1 applicator is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The BTL-785-1-4 massage device is intended to provide a temporary reduction in the appearance of cellulite. The BTL-785F with BTL-785-2 applicator is indicated to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.
The BTL-785F with BTL-785-3 applicator is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.
The Applicator BTL-785-4 of BTL-785F device used with tips BTL-785-4-1, BTL-785-4-5 and BTL-785-4-6 is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. The Applicator BTL-785-4 of BTL-785F device used with tips BTL-785-4-4, BTL-785-4-7 and BTL-785-4-8 is intended for dermatological procedures requiring fractional treatment of the skin. At higher energy levels greater than 62 mJ/pin, use of the BTL-785-4 applicator is limited to Skin Types I-IV.
| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) | Type of Use (Select one or both, as applicable) | |
|---|---|---|
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Image /page/3/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three interlocking squares in blue, with the letters "BTL" inside the leftmost square. 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.362 Elm StreetMarlborough, MA 01752Tel: +1-866-285-1656Fax: +1-888-499-2502 |
|---|---|
| Applicant: | BTL Industries, Inc.362 Elm StreetMarlborough, MA 01752Tel: +1-866-285-1656Fax: +1-888-499-2502 |
| Contact Person: | David ChmelBTL Industries, Inc.chmel@btlnet.com |
| Summary Preparation Date: | August 21, 2020 |
Device
| Trade/Proprietary Name: | BTL-785F |
|---|---|
| Primary Classification Name: | Electrosurgical cutting and coagulation device andaccessories |
| Classification Regulation: | 21 CFR 878.4400, Class II |
| Classification Product Code: | GEI, PBX |
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Image /page/4/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 the leftmost square. To the right of the squares is the text "BTL Industries" in a gray, sans-serif font.
Legally Marketed Predicate Devices
The BTL-785F is a state-of-the-art radiofrequency device with accessories, and is substantially equivalent to the three current products that are already cleared for distribution in the USA under the following 510(k) Premarket Notification numbers:
Product Description
The BTL-785F is a state-of-the-art radiofrequency device that enables the application of therapy by a high-frequency field.
The control unit of the system is equipped with a large color touch screen that significantly facilitates the use of the device. The on-screen information quides the user step by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen of the device. During the therapy the device displays information about the applied therapy type, remaining therapy time and main therapy parameters on the screen. For easier control, the hand-pieces are equipped with buttons, enabling operation of the device during therapy. The energy flow's quality is indicated by the illuminated treatment tip. The BTL-785F device comes with four different types of applicators.
The BTL-785F device consists of the following main components:
- . microprocessor-driven control unit
- . radiofrequency generator
- user interface with 15.6" color touch screen .
- . applicators for an application of radiofrequency
- . exchangeable applicator tips
Indications for Use
The BTL-785F device has the following indications for use:
The BTL-785F with BTL-785-1 applicator is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The BTL-785-1-4 massage device is intended to provide a temporary reduction in the appearance of cellulite.
The BTL-785F with BTL-785-2 applicator is indicated to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.
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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 square logo is the text "BTL Industries" in a dark gray sans-serif font. The logo is simple and modern, and the colors are clean and professional.
The BTL-785F with BTL-785-3 applicator is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.
The Applicator BTL-785-4 of BTL-785F device used with tips BTL-785-4-1, BTL-785-4-2, BTL-785-4-5 and BTL-785-4-6 is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.
The Applicator BTL-785-4 of BTL-785F device used with tips BTL-785-4-3. BTL-785-4-4. BTL-785-4-7 and BTL-785-4-8 is intended for dermatological procedures requiring fractional treatment of the skin. At higher energy levels greater than 62 mJ/pin, use of the BTL-785-4 applicator is limited to Skin Types I-IV.
Performance Data
The BTL-785F device has been thoroughly evaluated for electrical safety. The device has been found to comply with applicable medical device safety standards:
| IEC 60601-1 | Medical electrical equipment – Part 1: General requirements for basicsafety and essential performance |
|---|---|
| IEC 60601-1-2 | Medical electrical equipment - Part 1-2: General requirements for basicsafety and essential performance - Collateral standard:Electromagnetic disturbances - Requirements and tests |
| IEC 60601-2-2 | Medical electrical equipment - Part 2-2: Particular requirements for thebasic safety and essential performance of high frequency surgeryequipment and high frequency surgical accessories |
| IEC 60601-2-5 | Medical electrical equipment - Part 2-5: Particular requirements for thebasic safety and essential performance of ultrasonic physiotherapyequipment |
| IEC 60601-1-6 | Medical electrical equipment - Part 1-6: General requirements for basicsafety and essential performance - Collateral standard: Usability |
| IEC 62304 | Medical device software - Software life cycle processes |
| ISO 14971 | Medical devices – Application of risk management to medical devices |
| ISO 10993-1 | Biological evaluation of medical devices - Part 1: Evaluation and testingwithin a risk management process |
| ISO 10993-5 | Biological evaluation of medical devices - Part 5: Tests for in vitrocytotoxicity |
| ISO 10993-7 | Biological evaluation of medical devices - Part 7: Ethylene oxidesterilization residuals |
| ISO 10993-10 | Biological evaluation of medical devices – Part 10: Tests for irritationand skin sensitization |
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Image /page/6/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of a geometric design on the left and 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 written in a sans-serif font and is gray in color.
| ISO 10993-11 | Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity |
|---|---|
| ISO 11135 | Sterilization of health-care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ISO 11607-1 | Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| ISO 11607-2 | Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes |
Bench testing has been performed in order to demonstrate that the device is able to achieve and maintain therapeutic temperature on different treated areas for at least 10min. Bench testing has been performed in order to demonstrate that the power output of the
generator and geometry of the 785-4 applicator is identical to the same of the predicate.
Technoloqical Characteristics
The BTL-785F device has similar technological characteristics compared to its predicate devices. The BTL-785F device and the predicates are comprised of a system console and applicator(s). The system console consists of the RF generator, computer, and the touchscreen control panel. The device is accompanied by four applicators enabling connection to exchangeable tips.
The compared devices' applicators use the RF signal of the same monopolar mode of operation, waveform and frequency. The maximum power intensity level of BTL-785F device in some cases differs to the predicates; nevertheless, based on the performance tests, the current device is able to reach the required treatment temperature and maintain it throughout the recommended treatment time. Therefore the current device is able to achieve substantial equivalent intended use based on identical mechanism of action.
The compared devices have similar properties regarding their RF tips, including material, size, biocompatibility properties and sterilization method where applicable.
The BTL-785F device is used with a larger neutral electrode compared to the predicate device. This approach prevents overheating and assures higher level of safety compared to the predicate device.
The differences do not raise any new questions of safety nor effectiveness.
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Comparison with the Predicate Device
| 510(k) number | K193201 | K150720 | K092191 | K180359 | 1 MHz ± 5%(BTL-785-4) | ||||
|---|---|---|---|---|---|---|---|---|---|
| Device name | BTL-785F | XP3000 | Exilis 5000 | BTL-FR2000 | Mode ofOperation | Monopolar | Monopolar | Monopolar | Monopolar |
| Company name | BTL Industries, Inc. | BTL Industries, Inc. | BTL Industries, Inc. | BTL Industries, Inc. | User Interface | Color Touch-screen15.6" 1920x1080 px | Color Touch-screen8.4" 640x480 px | Color Touch-screen8.4" 640x480 px | Color Touch-screen8.4" 640x480 px |
| General & PlasticSurgery21 CFR 878.4400 | General & PlasticSurgery21 CFR 878.4400 | General & PlasticSurgery21 CFR 878.4400 | General & PlasticSurgery21 CFR 878.4400 | MaximumOutput Power | 125 W (BTL-785-1-2)140 W (BTL-785-1-1)62 W (BTL-785-2-1)53 W (BTL-785-2-2)62 W (BTL-785-2-3)48 W (BTL-785-3-1)30 W (BTL-785-4-1, 2,5, 6)25 W (BTL-785-5-4, 8)20 W (BTL-785-4-3, 7) | 120 W (215/3)170 W (215/1) | 170W | 30 W (N1, N2)25 W (P2)20 W (P1) | |
| Product Codeand Regulation | GEI - Electrosurgical,Cutting & Coagulation& AccessoriesPBX - Massager,Vacuum,RadiofrequencyInduced Heat | PBX - Massager,Vacuum,RadiofrequencyInduced Heat | GEI -Electrosurgical,Cutting &Coagulation &Accessories | GEI - Electrosurgical,Cutting &Coagulation &Accessories | EffectiveTreatmentTemperature | 40 - 45°C(104 - 113°F) | 40 - 45°C(104 - 113°F) | 39 - 42°C(102 - 108°F) | 60 - 80°C(140°F-176°F) |
| SkinTemperatureMonitoring | Integratedthermometer +patient's feedback(BTL-785-1, 2, 3) | Integratedthermometer +patient's feedback(Handpiece 215/1)Based on patient'sfeedback(Handpiece 215/3) | Skin temperaturemeasurement | N/A | |||||
| Indications forUse | The BTL-785F devicehas the followingindications for use:The BTL-785F withBTL-785-1 applicatoris intended to provideheating for thepurpose of elevatingtissue temperature forselected medicalconditions such astemporary relief ofpain, muscle spasms,and increase in localcirculation. The BTL-785-1-4 massagedevice is intended toprovide a temporaryreduction in theappearance ofcellulite.The BTL-785F withBTL-785-2 applicatoris indicated to provideheating for thepurpose of elevatingtissue temperature forselected medicalconditions such astemporary relief ofpain, muscle spasms,and increase in localcirculation.The BTL-785F withBTL-785-3 applicatoris intended to provideheating for thepurpose of elevating | The XP3000 deviceis intended toprovide heating forthe purpose ofelevating tissuetemperature forselected medicalconditions such astemporary relief ofpain, musclespasms, andincrease in localcirculation. TheXP3000 massagedevice is intended toprovide a temporaryreduction in theappearance ofcellulite. | The EXILIS device isindicated for theprimary treatment ofdermatologic andgeneral surgicalprocedures for non-invasive treatment ofwrinkles and rhytids. | The Applicator 786-1of BTL-FR2000device is indicated foruse in dermatologicaland general surgicalprocedures forelectrocoagulationand hemostasis.The Applicator 786-2of BTL-FR2000device is intended fordermatologicalprocedures requiringfractional treatment ofthe skin. | The UltrasonicTip Pre-heatingFunction | Yes (BTL-785-1, 2) | No | No | No |
| MassageAttachment | Yes (BTL-785-1) | Yes | Yes | No | |||||
| tissue temperature forselected medicalconditions such astemporary relief ofpain, muscle spasms,and increase in localcirculation.The Applicator BTL-785-4 of BTL-785Fdevice used with tipsBTL-785-4-1, BTL-785-4-2, BTL-785-4-5and BTL-785-4-6 isindicated for use indermatological andgeneral surgicalprocedures forelectrocoagulationand hemostasis.The Applicator BTL-785-4 of BTL-785Fdevice used with tipsBTL-785-4-3, BTL-785-4-4, BTL-785-4-7and BTL-785-4-8 isintended fordermatologicalprocedures requiringfractional treatment ofthe skin. At higherenergy levels greaterthan 62 mJ/pin, use ofthe BTL-785-4applicator is limited toSkin Types I-IV. | Number ofMicroneedles | 6 x 6 | N/A | N/A | 6 x 6 | ||||
| Principle ofAction | Application of the heatto the tissue via RFenergy.Massaging of bodyparts with massageattachment. (785-1applicator only) | Application of theheat to the tissuevia RF energy.Massaging of bodyparts with massageattachment. | Application of theheat to the tissue viaRF energy.Massaging of bodyparts with massageattachment. | Delivering the RFenergy through theskin results in anelectro-thermalreaction. The heatingeffect causescollagen coagulationand encouragesskin's natural healingprocess. | Depth ofMicroneedleElectrodes | 0.5 - 4 mm | N/A | N/A | 0.5 – 3.5 mm |
| Clinical Use | Prescription use | Prescription use | Prescription use | Prescription use | Number of Pinsof SuperficialTips | 32 | N/A | N/A | 32 |
| Energy Source | 100 - 120 V AC,50/60 Hz200 - 240 V AC,50/60 Hz | 100 - 240 V AC,50 – 60 Hz | 100-120 V AC, 5 A,50/60 Hz208-240 V AC, 2.5 A,50 Hz | 100 - 240 V AC,50 – 60 Hz | 64 | N/A | N/A | 64 | |
| Type of EnergyApplied | ElectromagneticEnergy -Radiofrequency | ElectromagneticEnergy -Radiofrequency | ElectromagneticEnergy -Radiofrequency | ElectromagneticEnergy -Radiofrequency | SterilizationMethod | Ethylene oxide | N/A | N/A | Ethylene oxide |
| Frequency | 3.2 MHz ± 5%(BTL-785-1, BTL-785-2, and BTL-785-3) | 3.25 MHz ± 50 kHz | 3.25 MHz ± 50 kHz | 1 MHz ± 5% |
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Image /page/8/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three overlapping squares with the letters "BTL" inside. To the right of the squares is the text "BTL Industries" in a sans-serif font. The logo is simple and modern.
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Image /page/9/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three blue squares, each containing a letter of the company's name. The letters are white and are stacked on top of each other. To the right of the squares is the company's name in gray text.
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Image /page/10/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three interlocking squares in blue, with the letters "BTL" inside the squares. 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 colors are clean and professional.
| NeutralElectrode Area | 169 cm² | 118 cm² | 118 cm² | 118 cm² |
|---|---|---|---|---|
| System Weight | 60 kg(132 lb) | 30 kg(66 lb) | 15.3 kg(33.7 lb) | 7.3 kg(16 lb) |
| SystemDimension(WxHxD) | 1370 mm x 670 x 670(53.94" x 26.38"x 26.38") | 1000 x 600 x 600mm(39.37" x 23.62"x 23.62") | 230 x 390 x 260 mm(9.06" x 15.35" x10.24") | 1000 x 600 x 600 mm(39.37" x 23.62"x 23.62") |
Substantial Equivalence
The BTL-785F device has similar technological characteristics and intended use compared to the predicate devices. Any differences between the predicate devices and BTL-785F device have no significant influence on safety or effectiveness of the BTL-785F device. Therefore, the BTL-785F device is substantially equivalent to the predicate devices.
Conclusion
Based upon the intended use, comparison of technical characteristics and performance testing provided in this pre-market notification, the BTL-785F device has been shown to be substantially equivalent to currently marketed predicate devices for requested intended use.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.