(284 days)
The BTL-785W device has the following indications for use:
The BTL-785W 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-785W 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-785W 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-785W 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 hemostass. 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-785-7 hands-free applicator of BTL-785W used with BTL-785-7-1, BTL-785-7-2, BTL-785-7-3 and BTL-785-7-4, BTL-785-7-5, BTL-785-7-6 single use electrodes 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-785W 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 guides 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-785W device comes with five different types of applicators. The BTL-785W 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.
The provided document is a 510(k) summary for the BTL-785W device, an electrosurgical cutting and coagulation device. It primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and performance data related to electrical safety and the ability to achieve and maintain superficial skin temperature.
Therefore, the document DOES NOT describe a study that involves ground truth establishment by experts, adjudication methods, multi-reader multi-case (MRMC) studies, or standalone algorithm performance for AI/ML-based medical devices.
Instead, the "Performance Data" section (page 7) details a series of compliance tests against various IEC and ISO standards related to electrical safety, electromagnetic disturbances, biological evaluation, and sterility, and non-clinical performance for the new applicator.
Given the information in the document, it's impossible to fill out the requested table and answer the questions related to AI/ML device testing criteria (sample sizes for test/training sets, expert ground truth, adjudication, MRMC studies, standalone performance), as these types of studies were not conducted or reported for this device.
Here's what can be extracted and inferred from the document based on the prompt's categories, with significant portions marked as 'N/A' due to the nature of the device and testing described:
Acceptance Criteria and Device Performance (Based on provided information)
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Electrical Safety | IEC 60601-1 (General requirements for basic safety and essential performance) | Device complied with applicable medical device safety standards. |
| IEC 60601-1-2 (Electromagnetic disturbances) | Device complied with applicable medical device safety standards. | |
| IEC 60601-2-2 (HF surgery equipment) | Device complied with applicable medical device safety standards. | |
| IEC 60601-2-5 (Ultrasonic physiotherapy equipment) | Device complied with applicable medical device safety standards. | |
| Usability | IEC 60601-1-6 (Usability) | Device complied with applicable medical device safety standards. |
| Software Life Cycle | IEC 62304 (Medical device software) | Device complied with applicable medical device safety standards. |
| Risk Management | ISO 14971 (Application of risk management to medical devices) | Device complied with applicable medical device safety standards. |
| Biological Evaluation | ISO 10993-1, -5, -7, -10, -11 (Biocompatibility tests) | Device complied with applicable medical device safety standards. |
| Sterilization | ISO 11135 (Ethylene oxide sterilization) | Device complied with applicable medical device safety standards. |
| Packaging | ISO 11607-1, -2 (Packaging for sterilized medical devices) | Device complied with applicable medical device safety standards. |
| Functional Performance (BTL-785-7 applicator) | Achieve and maintain superficial skin temperature (40 - 45°C) for required therapy time. | Testing data demonstrated that the device is capable of achieving therapeutic parameters substantially equivalent to the cleared predicate device. |
| Maximum RF and Output Power (compared to predicate) | The maximum RF power and output power of the BTL-785-7 is lower than the predicate, but internal tests demonstrated equivalent treatment temperature. | |
| Technological Equivalence | Same technological characteristics as predicate (RF generator, computer, touch-screen, applicators, monopolar mode, waveform, frequency, RF tip properties). | The BTL-785W device has the same technological characteristics as its predicate device. No technological modifications to the device and its applicators. |
Detailed Answers to Specific Questions:
1. A table of acceptance criteria and the reported device performance
- (Provided above)
2. Sample size(s) used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Test set/Study Type: The performance data primarily refers to compliance with safety standards (IEC, ISO) and internal non-clinical testing for the new applicator's ability to achieve and maintain target temperature. This is not a typical "test set" in the context of AI/ML or clinical efficacy studies with human subjects.
- Sample Size: Not specified for any particular test. Compliance with standards typically involves engineering tests, material tests, and functional tests on device prototypes or production units, not a "sample size" of patient data. For the BTL-785-7 applicator, it states "internal tests" were done, but no number of subjects or runs is provided.
- Data Provenance: Not specified. "Internal tests" suggests in-house testing by the manufacturer. Retrospective/prospective is not applicable as this is not a clinical data collection study for performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- N/A. This device and its testing do not involve establishing ground truth from expert interpretations of medical images or conditions. The "ground truth" for the performance claims would be objective measurements (e.g., temperature readings, power output, compliance with standard specifications) in a laboratory or bench testing environment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Adjudication methods are relevant for subjective human interpretations (e.g., reading medical images) where discrepancies might arise. This is not applicable to the engineering and bench tests described.
5. 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
- N/A. An MRMC study is relevant for AI-assisted diagnostic or interpretative devices. This document describes a radiofrequency device for therapeutic purposes, and no AI component is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- N/A. This device is hardware for energy delivery, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Objective Measurements/Standards Compliance. For electrical safety and performance, the "ground truth" is adherence to predefined engineering specifications and regulatory standards (IEC, ISO) and the ability to physically achieve and maintain a certain temperature. This is not a disease diagnosis or outcome that would require expert consensus or pathology.
8. The sample size for the training set
- N/A. The device is not an AI/ML model and therefore does not have a "training set."
9. How the ground truth for the training set was established
- N/A. This question is not applicable as there is no training set mentioned or implied for this device.
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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 and Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the words "FDA U.S. FOOD & DRUG" in a larger font size and "ADMINISTRATION" in a smaller font size below.
March 7, 2022
David Chmel VP of Operations BTL Industries, Inc. 362 Elm Street Marlborough, Massachusetts 01752
Re: K211639
Trade/Device Name: BTL-785W Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI, PBX Dated: October 28, 2021 Received: November 29, 2021
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/cdrl/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
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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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211639
Device Name BTL-785W
Indications for Use (Describe)
The BTL-785W device has the following indications for use:
The BTL-785W 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-785W 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-785W 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-785W 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 hemostass. 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-785-7 hands-free applicator of BTL-785W used with BTL-785-7-1, BTL-785-7-2, BTL-785-7-3 and BTL-785-7-4, BTL-785-7-5, BTL-785-7-6 single use electrodes 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.
| 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.
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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 containing the letters "BTL" in white. The squares are arranged in a triangular pattern. 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:
Device
| Trade/Proprietary Name: | BTL-785W |
|---|---|
| Primary Classification Name: | Electrosurgical cutting and coagulation device and accessories |
| Classification Regulation: | 21 CFR 878.4400, Class II |
| Classification Product Code: | GEI, PBX |
March 4, 2022
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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 and the text "BTL Industries" on the right. The geometric design is made up of three interlocking squares, each with the letters "BTL" inside. The text "BTL Industries" is written in a sans-serif font and is a dark gray color.
Legally Marketed Predicate Device
The BTL-785W is a state-of-the-art radiofrequency device with accessories, and is substantially equivalent to the following products that are already cleared for distribution in the USA under the following 510(k) Premarket Notification numbers:
- BTL-785F (K193201) ●
- EXILIS 5000 (K092191) ●
- TempSure System, (K200241), FlexSure single-use Applicator
Product Description
The BTL-785W 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 guides 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-785W device comes with five different types of applicators.
The BTL-785W 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 ●
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Image /page/6/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three interlocking blue squares on the left, with the letters "BTL" inside the squares. To the right of the squares is the text "BTL Industries" in a gray, sans-serif font. The logo is simple and modern, and the use of blue and gray gives it a professional look.
Indications for Use
The BTL-785W device has the following indications for use:
The BTL-785W 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-785W 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-785W 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 BTL-785W with BTL-785-4 applicator 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-785W device used with tips BTL-785-4-3. 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-785W with BTL-785-7 hands-free applicator used with BTL-785-7-2, BTL-785-7-3, BTL-785-7-4, BTL-785-7-5 and BTL-785-7-6 single-use electrodes 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.
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Image /page/7/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three interconnected squares with the letters "BTL" inside the leftmost square. To the right of the logo is the text "BTL Industries" in a sans-serif font.
Performance Data
The BTL-785W 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 basic safety andessential performance |
|---|---|
| IEC 60601-1-2 | Medical electrical equipment – Part 1-2: General requirements for basic safetyand essential performance - Collateral standard: Electromagnetic disturbances- Requirements and tests |
| IEC 60601-2-2 | Medical electrical equipment - Part 2-2: Particular requirements for the basicsafety and essential performance of high frequency surgery equipment and highfrequency surgical accessories |
| IEC 60601-2-5 | Medical electrical equipment - Part 2-5: Particular requirements for the basicsafety and essential performance of ultrasonic physiotherapy equipment |
| IEC 60601-1-6 | Medical electrical equipment – Part 1-6: General requirements for basic safetyand 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 testing withina risk management process |
| ISO 10993-5 | Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity |
| ISO 10993-7 | Biological evaluation of medical devices - Part 7: Ethylene oxide sterilizationresiduals |
| ISO 10993-10 | Biological evaluation of medical devices – Part 10: Tests for irritation and skinsensitization |
| 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 thedevelopment, validation and routine control of a sterilization process for medicaldevices |
| ISO 11607-1 | Packaging for terminally sterilized medical devices - Part 1: Requirements formaterials, sterile barrier systems and packaging systems |
| ISO 11607-2 | Packaging for terminally sterilized medical devices - Part 2: Validationrequirements for forming, sealing and assembly processes |
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Image /page/8/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three overlapping blue squares, each containing the letters "B", "T", and "L" respectively. To the right of the squares is the text "BTL Industries" in a dark gray, sans-serif font.
BTL-785-7 applicator non-clinical performance data
The new BTL-785-7 applicator was tested to achieve superficial skin temperature (40 - 45°C ) and maintain it for required therapy time. The testing data demonstrated that the device is capable to achieve therapeutic parameters substantially equivalent to the currently cleared predicate device for requested intended use.
Technological Characteristics
The BTL-785W device has similar technological characteristics compared to its predicate device. The BTL-785W device and the predicates are comprised of a system console and applicator(s). The system console consists of the RF generator, computer, and a touch-screen 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 devices have the same properties regarding their RF tips, including material, size, biocompatibility and sterilization method where applicable.
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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 the letters B, T, and L. 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 gray, sans-serif font.
Comparison with the Predicate Device
| 510(k) numberDevice nameCompany name | K211639BTL-785WBTL Industries, Inc. | K193201BTL-785FBTL Industries, Inc. | K200241TempSure SystemFlexSure single-use ApplicatorCynosure, LLCReference device | Significantdifference |
|---|---|---|---|---|
| Product Codeand Regulation | General & Plastic Surgery21 CFR 878.4400GEI - Electrosurgical, Cutting &Coagulation & AccessoriesPBX - Massager, Vacuum,Radiofrequency Induced Heat | General & Plastic Surgery21 CFR 878.4400GEI - Electrosurgical, Cutting &Coagulation & AccessoriesPBX - Massager, Vacuum,Radiofrequency Induced Heat | General & Plastic Surgery21 CFR 878.4400GEI - Electrosurgical, Cutting &Coagulation & AccessoriesPBX - Massager, Vacuum,Radiofrequency Induced Heat | None |
| Indications forUse | The BTL-785W device has thefollowing indications for use:The BTL-785W with BTL-785-1applicator is intended to provideheating for the purpose ofelevating tissue temperature forselected medical conditions suchas temporary relief of pain, musclespasms, and increase in localcirculation. The BTL-785-1-4massage device is intended toprovide a temporary reduction inthe appearance of cellulite.The BTL-785W with BTL-785-2applicator is indicated to provideheating for the purpose of | The BTL-785F device has thefollowing indications for use:The BTL-785F with BTL-785-1applicator is intended to provideheating for the purpose ofelevating tissue temperature forselected medical conditions suchas temporary relief of pain, musclespasms, and increase in localcirculation. The BTL-785-1-4massage device is intended toprovide a temporary reduction inthe appearance of cellulite.The BTL-785F with BTL-785-2applicator is indicated to provideheating for the purpose of | The TempSure™ System hasthe following indications for use:The 10mm, 15mm, and 20mmSmart Handpieces are indicatedfor non-ablative treatment ofmild to moderate facial wrinklesand rhytids.The 18mm, 25mm, 30mm,60mm Smart Handpieces andFlexSure™ applicators provideheating for the purpose ofelevating tissue temperature forselected medical conditionssuch as temporary relief of pain, | Not significant,please seediscussion andconclusion below. |
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Image /page/10/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.
K211639
| elevating tissue temperature forselected medical conditions suchas temporary relief of pain, musclespasms, and increase in localcirculation. | elevating tissue temperature forselected medical conditions suchas temporary relief of pain, musclespasms, and increase in localcirculation. | muscle spasms, and increase inlocal circulation.The massage device is intendedto provide a temporary reductionin the appearance of cellulite |
|---|---|---|
| The BTL-785W with BTL-785-3applicator is intended to provideheating for the purpose ofelevating tissue temperature forselected medical conditions suchas temporary relief of pain, musclespasms, and increase in localcirculation. | The BTL-785F with BTL-785-3applicator is intended to provideheating for the purpose ofelevating tissue temperature forselected medical conditions suchas temporary relief of pain, musclespasms, and increase in localcirculation. | |
| The Applicator BTL-785-4 of BTL-785W device used with tips BTL-785-4-1, BTL-785-4-2, BTL-785-4-5 and BTL-785-4-6 is indicated foruse in dermatological and generalsurgical procedures forelectrocoagulation andhemostasis.The Applicator BTL-785-4 of BTL-785W device used with tips BTL-785-4-3, BTL-785-4-4, BTL-785-4-7 and BTL-785-4-8 is intended fordermatological proceduresrequiring fractional treatment ofthe skin. At higher energy levelsgreater than 62 mJ/pin, use of theBTL-785-4 applicator is limited toSkin Types I-IV.The BTL-785W with BTL-785-7hands-free applicator used withBTL-785-7-1, BTL-785-7-2, BTL-785-7-3, BTL-785-7-4, BTL-785-7-5 and BTL-785-7-6 single-use | 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 foruse in dermatological and generalsurgical procedures forelectrocoagulation andhemostasis.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 fordermatological proceduresrequiring fractional treatment ofthe skin. At higher energy levelsgreater than 62 mJ/pin, use of theBTL-785-4 applicator is limited toSkin Types I-IV. | |
| electrodes is intended to provideheating for the purpose ofelevating tissue temperature for |
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Image /page/11/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 interlocking squares, each with a "B", "T", and "L" inside. The text "BTL Industries" is in a sans-serif font and is a dark gray color.
| selected medical conditions suchas temporary relief of pain, musclespasms, and increase in localcirculation. | ||||
|---|---|---|---|---|
| Principle ofAction | Application of the heat to thetissue via RF energy.Massaging of body parts withmassage attachment. (785-1applicator only)Radiofrequency accompanied byelectromagnetic stimulation (785-7applicator only) | Application of the heat to thetissue via RF energy.Massaging of body parts withmassage attachment. (785-1applicator only) | Application of the heat to thetissue via RF energy.Massaging of body parts withmassage attachment. | None |
| Clinical Use | Prescription use | Prescription use | Prescription use | None |
| Energy Source | 100 - 120 V AC,50/60 Hz200 - 240 V AC,50/60 Hz | 100 - 120 V AC,50/60 Hz200 - 240 V AC,50/60 Hz | 100 - 120 V AC,50/60 Hz200 - 240 V AC,50/60 Hz | None |
| Type of EnergyApplied | Electromagnetic Energy -Radiofrequency | Electromagnetic Energy -Radiofrequency | Electromagnetic Energy -Radiofrequency | None |
| Frequency | 3.2 MHz ± 5%(BTL-785-1, BTL-785-2, and BTL-785-3, BTL-785-7)1 MHz ± 5%(BTL-785-4) | 3.2 MHz ± 5%(BTL-785-1, BTL-785-2, and BTL-785-3)1 MHz ± 5%(BTL-785-4) | 4.0 MHz Sin-wave CW, FullyRectified,Partially Rectified, and 1.7 MHzfor Bipolar | Not significantlydifferent |
| Mode ofOperation | Monopolar | Monopolar | Monopolar, Bipolar | None |
| User Interface | Color Touch-screen | Color Touch-screen | Color Touch-screen | None |
| Maximum OutputPower | 125 W (BTL-785-1-2,)140 W (BTL-785-1-1,) | 125 W (BTL-785-1-2)140 W (BTL-785-1-1) | 300W (Surgical)120W (Wrinkles)300W (Tissue Heating) | Not significant,please see |
| 62 W (BTL-785-2-1)53 W (BTL-785-2-2)62 W (BTL-785-2-3) | 62 W (BTL-785-2-1)53 W (BTL-785-2-2)62 W (BTL-785-2-3) | discussion andconclusion below. | ||
| 48 W (BTL-785-3-1) | 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) | 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 (BTL-785-7) | ||||
| EffectiveTreatmentTemperature | 40 - 45°C | 40 - 45°C | 42 - 44°C | not significant |
| Skin TemperatureMonitoring | Integrated thermometer + patient'sfeedback(BTL-785-1, 2, 3) | Integrated thermometer + patient'sfeedback(BTL-785-1, 2, 3) | Temperature-SensitiveHandpiece | None |
| Ultrasonic TipPre-heatingFunction | Yes (BTL-785-1, 2) | Yes (BTL-785-1, 2) | Yes | None |
| MassageAttachment | Yes (BTL-785-1) | Yes (BTL-785-1) | Yes | None |
| Number ofMicroneedles | 6 x 6 | 6 x 6 | N/A | None |
| Handsfreeapplicator | Yes | No | Yes | None |
| Depth ofMicroneedleElectrodes | 0.5 - 4 mm | 0.5 - 4 mm | N/A | None |
| Number of Pinsof SuperficialTips | 3264 | 3264 | N/A | None |
| SterilizationMethod | Ethylene oxide | Ethylene oxide | N/A | None |
| Neutral ElectrodeArea | 169 cm² | 169 cm² | 203 cm² | not significant |
| System Weight | 60 kg(132 lb) | 60 kg(132 lb) | 13.6 kg(30 lb) - generator weight only | not significant |
| SystemDimension(W×H×D) | 1370 mm x 670 x 670(53.94" x 26.38" x 26.38") | 1370 mm x 670 x 670(53.94" x 26.38" x 26.38") | 450 x 310 x 580 mm(18" x 12" x 22.5") | not significant |
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Image /page/12/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 with a smaller square inside of it.
K211639
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Image /page/13/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 nested squares, with the letters "BTL" inside the innermost square. The text "BTL Industries" is written in a sans-serif font and is also blue.
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Image /page/14/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three interconnected blue squares, each containing the letters "BTL". To the right of the square logo is the text "BTL Industries" in a dark gray sans-serif font. The overall design is modern and corporate.
Introduction of New Applicator BTL-785-7
This submission introduces the new applicator BTL-785W with BTL-785-7 applicator used with BTL-785-7-1, BTL-785-7-2, BTL-785-7-3, BTL-785-7-5 and BTL-785-7-6 single-use electrodes 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.
Maximum RF and Output Power and EMS (BTL-785-7 applicator)
The maximum radiofrequency power as well as the maximum output power of the BTL-785-7 handsfree applicator is lower than the predicate. Nevertheless, the results of internal tests demonstrate that the device is able to achieve an equivalent treatment temperature and maintain it for the time required. The predicate device uses mechanical manipulation of the muscles. while the BTL-785-7 applies muscle stimulation resulting in induced muscle workout naturally increases local blood circulation.
We believe the difference does not raise any new questions of safety or effectiveness.
Substantial Equivalence
The BTL-785W device has the same technological characteristics and similar intended use compared to the predicate device. Any differences between the predicate device and BTL-785W device have no significant influence on safety or effectiveness of the BTL-785W device.
There are no technological modifications done to the device and its applicators compared to the predicate device.
Therefore, the BTL-785W 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-785W device has been shown to be substantially equivalent to currently cleared predicate device 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.