(140 days)
The BTL-785S device has the following indications for use:
The BTL-785S 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-785S 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-785S 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-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-785S 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-785S with BTL-785-7 Handpiece used with hands-free applicators:
BTL-785-7-1 & BTL-785-7-7, BTL-785-7-2 & BTL-785-7-8 single-use applicators are intended to provide:
- Heating for the purpose of elevaing tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.
BTL-785-7-1 & BTL-785-7-2 single-use applicators are intended to provide:
- Non-invasive temporary reduction of facial wrinkles.
BTL-785-7-9 single-use applicator is intended to:
- Affect the appearance of lax tissue in the submental area.
The BTL-785S 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-785S device comes with five different types of applicators.
The BTL-785S device consists of the following main components:
- microprocessor-driven control unit
- radiofrequency generator
- user interface with 15.6" color touch screen
- applicators
- exchangeable applicator tips
The BTL-785S device, specifically with the BTL-785-7 handpiece and BTL-785-7-9 single-use applicator, was studied to support a new indication for use: "Affect the appearance of lax tissue in the submental area."
Here's an analysis of the acceptance criteria and the study results:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Secondary Endpoints) | Reported Device Performance |
|---|---|
| A score improvement of at least 1.0 grade point in at least 75% of treated subjects. | GAIS evaluation by three independent reviewers showed that a score of at least 1 point on the scale (referring to improved appearance) was documented in 51 of 56 subjects (91%). (Meets Criteria) |
| Evaluation of effect on submental skin laxity: measurable reduction in the submental area and visible improvement by independent reviewers. | At 3 months, 46 subjects (82%) exhibited a ≥ 20 mm² reduction in the submental area. Of those 46 subjects, 43 (93%) were identified by independent reviewers using GAIS as having visible improvement in the treated area at 3 months. (Meets Criteria) |
| Overall satisfaction with the study treatment outcome. | At 3 months, 56 (100%) subjects answered "satisfied" or "very satisfied" to the question "Overall how are you satisfied with the therapy?". 56 (100%) subjects answered "satisfied" or "very satisfied" to the question "Overall how satisfied are you with the chin-toning after the therapy". 55 subjects (98%) answered "satisfied" or "very satisfied" to the question "Overall how satisfied are you with the skin laxity of the treated area after the therapy". (Meets Criteria) |
| Therapy comfort (assessed by subjects' agreement with "I found the treatment comfortable" and pain sensation). | 54 subjects (96%) "agreed" or "strongly agreed" with the statement "I found the treatment comfortable". Pain sensation assessed by 10-point analogue scale yielded an average score of 0.46 ± 0.81 points, with 55 (98%) subjects falling into the none to mild pain range (0-3). (Meets Criteria) |
| Device safety (no adverse events). | No adverse events occurred throughout the whole clinical investigation. (Meets Criteria) |
2. Sample Size Used for the Test Set and the Data Provenance:
- Sample Size: N=56 subjects.
- Data Provenance: The study was a "single-center single-arm, open-label, interventional design" clinical investigation. The document does not explicitly state the country of origin, but given the FDA submission, it implicitly refers to data relevant for the U.S. market. It is a prospective clinical study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- Number of Experts: Three independent reviewers were used for the GAIS (Global Aesthetic Improvement Scale) evaluation.
- Qualifications of Experts: The document does not specify the qualifications of these experts (e.g., radiologist with 10 years of experience). It only states they were "independent reviewers."
4. Adjudication Method for the Test Set:
- The document states "GAIS evaluation by three independent reviewers." This implies a form of consensus or independent grading by multiple experts, but the specific adjudication method (e.g., arithmetic mean, majority vote, or whether disagreements were arbitrated) is not explicitly detailed. It does not mention "2+1" or "3+1" specifically.
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:
- No, a Multi Reader Multi Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done. This study focuses on the standalone performance of the device and its effect on patients. The device is a radiofrequency device, not an AI diagnostic tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone clinical performance study was done for the device when used with the BTL-785-7 handpiece and BTL-785-7-9 single-use applicator. The study assessed the device's direct effect on patient outcomes (appearance of lax tissue, satisfaction, comfort, and safety) without human interpretation of device output in a diagnostic sense.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
- The ground truth was established through a combination of:
- Expert Consensus: General Aesthetic Improvement Scale (GAIS) evaluation by three independent reviewers.
- Objective Measurement/Outcomes Data: Measurable reduction in the submental area (≥ 20 mm²).
- Patient-Reported Outcomes/Feedback: Subject satisfaction with therapy outcomes and comfort levels.
8. The Sample Size for the Training Set:
- The document does not provide information on a "training set" as it pertains to an AI/algorithm development. This was a clinical study designed to demonstrate the safety and efficacy of the physical device for a specific indication, not to train an AI model.
9. How the Ground Truth for the Training Set Was Established:
- As mentioned in point 8, there is no information about a training set or how ground truth for a training set was established, as this was not an AI/algorithm development study.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 28, 2024
BTL Industries, Inc. David Chmel CEO North America 362 Elm Street Marlborough, Massachusetts 01752
Re: K233604
Trade/Device Name: Btl-785s Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI, PBX Dated: February 27, 2024 Received: February 27, 2024
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}------------------------------------------------
2
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,
Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2024.03.28 11:09:32 -04'00' Mark Trumbore, 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
{2}------------------------------------------------
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K233604
Device Name BTL-785S
Indications for Use (Describe) The BTL-785S device has the following indications for use:
The BTL-785S 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-785S 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-785S 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-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-785S 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-785S with BTL-785-7 Handpiece used with hands-free applicators:
BTL-785-7-1 & BTL-785-7-7, BTL-785-7-2 & BTL-785-7-8 single-use applicators are intended to provide:
- Heating for the purpose of elevaing tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.
BTL-785-7-1 & BTL-785-7-2 single-use applicators are intended to provide:
- Non-invasive temporary reduction of facial wrinkles.
BTL-785-7-9 single-use applicator is intended to:
- Affect the appearance of lax tissue in the submental area.
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.
{3}------------------------------------------------
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."
{4}------------------------------------------------
Image /page/4/Picture/1 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 words "BTL Industries" are written in gray to the right of the squares.
510(k) Summary
K233604
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 PreparationDate: | March 27, 2024 |
| Device | |
| Trade/Proprietary Name: | BTL-785S |
| Primary Classification Name: | Electrosurgical cutting and coagulation device and accessories |
| Classification Regulation: | 21 CFR 878.4400, Class II |
Classification Product Code: GEI, PBX
{5}------------------------------------------------
Legally Marketed Predicate Device
The BTL-785S 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-785X Original 510(k) Sponsor: BTL Industries Inc. 510(k) Number: K222556
Reference device: SculpSure Original 510(k) Sponsor: Cynosure 510(k) Number: K182741
Product Description
The BTL-785S 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-785S device comes with five different types of applicators.
The BTL-785S device consists of the following main components:
- · microprocessor-driven control unit
- · radiofrequency generator
- user interface with 15.6" color touch screen
- · applicators
- · exchangeable applicator tips
Technological characteristics
The BTL-785S device has identical technological characteristics compared to its primary predicate device. The BTL-785S device and the predicate are comprised of a system console and applicators.
The system console consists of the RF generator, computer, and a touch-screen control panel. The device is accompanied by the followinq applicators:
- . BTL-785-1 applicator providing treatment by integration of radiofrequency, ultrasound and active cooling. Suitable for the treatment of large body areas.
510(k) Summary
{6}------------------------------------------------
- BTL-785-2 applicator providing treatment by integration of radiofrequency and ultrasound. . Suitable for the treatment of small areas.
- BTL-785-3 applicator providing radiofrequency treatment. The therapy is provided with single o use tips only.
- BTL-785-4 applicator delivering radiofrequency via an array of microneedles and/or superficial 0 pins. Therapy is provided with single use tips only.
- BTL-785-7 hands-free applicators providing treatment by integration of radiofrequency heating . and muscle stimulation resulting in induced muscle workout. Muscle workout naturally increases local blood circulation. Suitable for the treatment of face and small and sensitive areas. The therapy is provided with single use electrodes only.
{7}------------------------------------------------
Page 4 of 13
Indications for Use
The BTL-785S device has the following indications for use:
The BTL-785S 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-785S 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-785S 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-785S 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-785S 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, the use of the BTL-785-4 applicator is limited to Skin Types I-IV.
The BTL-785S with BTL-785-7 Handpiece used with hands-free applicators:
BTL-785-7-1 & BTL-785-7-7, BTL-785-7-2 & BTL-785-7-8 single-use applicators are 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.
BTL-785-7-1 & BTL-785-7-2 single-use applicators are intended to provide: -
Non-invasive temporary reduction of facial wrinkles. ●
BTL-785-7-9 single-use applicator is intended to: -
.
-
Affect the appearance of lax tissue in the submental area.
{8}------------------------------------------------
stries
Performance Data
The BTL-785S 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 |
{9}------------------------------------------------
BTL-785S with BTL-785-7 handpiece and BTL-785-7-9 single-use applicator clinical performance data
A clinical study was conducted to demonstrate the performance, clinical efficacy and safety of the BTL-785-7-9 non-invasive single-use applicator for its effect on the appearance of lax tissue in the submental area. This study has a single-center single-arm, open-label, interventional design.
The study was conducted at a single site. All the enrolled participants were treated with the BTL-785-7-9 non-invasive single-use applicator.
In total, N=56 subjects respected the study schedule and completed all the required study treatment visits and follow-up visits.
No adverse events occurred throughout the whole clinical investigation.
The analysis of baseline and 3-month photography data indicates clinically favorable cosmetic results achieving the secondary endpoints:
A score improvement of at least 1.0 grade point in at least 75% of treated subjects. GAIS evaluation by three independent reviewers showed that a score of at least 1 point on the scale (referring to improved appearance) was documented in 51 of 56 subjects (91%).
Evaluation of effect on appereance of lax skin in submental area. At 3 months, 46 subjects (82%) exhibited a ≥ 20 mm² reduction in the submental area. The tissue lift and the response rate vielded consistent results for both the right and left side of the face. Furthermore, of those 46 subjects with tissue lift ≥ 20 mm², 43 (93%) were identified by the independent reviewers by using GAIS as having visible improvement in the treated area at 3 months.
The overall satisfaction with the study treatment outcome and therapy comfort. At 3 months, the vast majority of subjects reported their satisfaction with the therapy outcomes as 56 (100%) subjects answered "satisfied" or "very satisfied" to the question "Overall how are you satisfied with the therapy?". The 56 subjects (100%) answered "satisfied or "very satisfied" to the question "Overall how satisfied are you with the chin-toning after the therapy" and 55 subjects (98%) answered "satisfied" of "very satisfied" to the question "Overall how satisfied are you with the skin laxity of the treated area after the therapy". In total 54 subjects (96%) "agreed" or "strongly agreed" with the statement "I found the treatment comfortable".
Pain sensation assessed by 10-point analogue scale yielded an average score of 0.46 ± 0.81 points. Scores of 55 (98%) subjects fell into the none to mild pain range (0-3).
Based on 3-month follow-ups, the treatment with the BTL-785S device equipped with BTL-785-7 handpiece and BTL-785-7-9 single-use applicator has shown to be both safe and effective for its effect on the appearance of lax tissue in the submental area with high satisfaction levels.
{10}------------------------------------------------
Image /page/10/Picture/1 description: The image shows the logo for BT. The logo consists of three interconnected blue squares, each containing a letter: B, T, and L. To the right of the square logo is the text "BT" in a gray sans-serif font.
The below table is a summary of the study design and results:
| Study design | Single-center single-arm, open-label, interventional design |
|---|---|
| Sample size | 56 patients completed all study treatments and follow-up visits. |
| Number of treatmentsand follow-up visits | 4 treatments and 2 follow-ups at 1 and 3 months |
| Secondary endpoints | To evaluate the safety of the BTL-785F device with the BTL-785-7-9applicator |
| To evaluate the effect on submental skin laxity. | |
| To assess the participants' satisfaction from the therapy outcome. | |
| To assess how comfortable the therapy is. | |
| Secondary endpointresults | GAIS evaluation by three independent reviewers showed that a score of atleast 1 point on the scale (referring to improved appearance) wasdocumented in 51 of 56 subjects (91%). |
| At 3 months, 46 subjects (82%) exhibited a $\ge$ 20 mm² reduction in thesubmental area. In addition 43 (93%) of responders were identified by theindependent reviewers by using GAIS as having visible improvement in thetreated area at 3 months. | |
| At 3 months, the vast majority of subjects reported their satisfaction withthe therapy outcomes and found the treatment comfortable (fell into thenone to moderate pain) |
{11}------------------------------------------------
Image /page/11/Picture/2 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 logo is the text "BTL Industries" in a gray sans-serif font. The logo is simple and modern, and the colors are clean and professional.
Comparison with the Predicate Device
| 510(k) number | Not assigned | K222556 | K182741 |
|---|---|---|---|
| Device name | BTL-785S | BTL-785X | SculpSure |
| Companyname | BTL Industries, Inc. | BTL Industries, Inc. | Cynosure |
| Type | Subject device | Primary predicate | Reference device |
| Product Codeand Regulation | General & Plastic Surgery21 CFR 878.4400GEI - Electrosurgical,Cutting & Coagulation &AccessoriesPBX - Massager, Vacuum,Radiofrequency InducedHeat | General & Plastic Surgery21 CFR 878.4400GEI - Electrosurgical,Cutting & Coagulation &AccessoriesPBX - Massager, Vacuum,Radiofrequency InducedHeat | General & Plastic Surgery21 CFR 878.5400PKT - Laser for disruption ofadipocyte cells for aestheticuse |
| Indications forUse | The BTL-785S device hasthe following indications foruse:The BTL-785S with BTL-785-1 applicator is intendedto provide heating for thepurpose of elevating tissuetemperature for selectedmedical conditions such astemporary relief of pain,muscle spasms, andincrease in local circulation.The BTL-785-1-4 massagedevice is intended to providea temporary reduction in theappearance of cellulite.The BTL-785S with BTL-785-2 applicator is indicatedto provide heating for the | The BTL-785X device hasthe following indications foruse:The BTL-785X with BTL-785-1 applicator is intendedto provide heating for thepurpose of elevating tissuetemperature for selectedmedical conditions such astemporary relief of pain,muscle spasms, andincrease in local circulation.The BTL-785-1-4 massagedevice is intended to providea temporary reduction in theappearance of cellulite.The BTL-785X with BTL-785-2 applicator is indicatedto provide heating for the | The Cynosure SculpSure™is intended for non-invasivelipolysis of the abdomen,flanks, back, and thighs inindividuals with a BodyMass Index (BMI) of 30 orless.In addition, the device isintended for non-invasivelipolysis of the submentalarea in individuals with aBMI of 49 or less.The device is intended toaffect the appearance ofvisible fat bulges in theabdomen, flanks, back,thighs and submental area.When using the petite maskfor non-invasive lipolysis ofthe submental area, thedevice can also affect the |
| purpose of elevating tissuetemperature for selectedmedical conditions such astemporary relief of pain,muscle spasms, andincrease in local circulation. | purpose of elevating tissuetemperature for selectedmedical conditions such astemporary relief of pain,muscle spasms, andincrease in local circulation. | appearance of lax tissue inthe submental area. | |
| The BTL-785S with BTL-785-3 applicator is intendedto provide heating for thepurpose of elevating tissuetemperature, for selectedmedical conditions such astemporary relief of pain,muscle spasms, andincrease in local circulation. | The BTL-785X with BTL-785-3 applicator is intendedto provide heating for thepurpose of elevating tissuetemperature for selectedmedical conditions such astemporary relief of pain,muscle spasms, andincrease in local circulation. | ||
| The applicator BTL-785-4 ofBTL-785S device used withtips BTL-785-4-1, BTL-785-4-2, BTL-785-4-5 and BTL-785-4-6 is indicated for usein dermatological andgeneral surgical proceduresfor electrocoagulation andhemostasis. | The Applicator BTL-785-4 ofBTL-785X device used withtips BTL-785-4-1, BTL-785-4-2, BTL-785-4-5 and BTL-785-4-6 is indicated for usein dermatological andgeneral surgical proceduresfor electrocoagulation andhemostasis. | ||
| The applicator BTL-785-4 ofBTL-785S device used withtips BTL-785-4-3, BTL-785-4-4, BTL-785-4-7 and BTL-785-4-8 is intended fordermatological proceduresrequiring fractional treatmentof the skin. | The Applicator BTL-785-4 ofBTL-785X device used withtips BTL-785-4-3, BTL-785-4-4, BTL-785-4-7 and BTL-785-4-8 is intended fordermatological proceduresrequiring fractional treatmentof the skin. | ||
| At higher energy levelsgreater than 62 mJ/pin, theuse of the BTL-785-4applicator is limited to SkinTypes I-IV. | At higher energy levelsgreater than 62 mJ/pin,use of the BTL-785-4applicator is limited to SkinTypes I-IV. | ||
| The BTL-785X with BTL-785-7 hands-free applicator | |||
| The BTL-785S with BTL-785-7 handpiece used withhands-free applicators:BTL-785-7-1 & BTL-785-7-7,BTL-785-7-2 & BTL-785-7-8single-use applicators areintended to provide:Heating for thepurpose of elevatingtissue temperaturefor selected medicalconditions such astemporary relief ofpain, muscle spasms,and increase in localcirculation. BTL-785-7-1 & BTL-785-7-2single-use applicators areintended to provide: Non-invasivetemporary reductionof facial wrinkles. BTL-785-7-9 single-useapplicator is intended to: Affect theappearance of laxtissue in thesubmental area. | used with BTL-785-7-1 andBTL-785-7-2 single-useelectrodes is intended toprovide: heating for thepurpose of elevatingtissue temperaturefor selected medicalconditions such astemporary relief ofpain, musclespasms, andincrease in localcirculation. non-invasivetemporary reductionof facial wrinkles. | ||
| Principle ofAction | Application of the heat to thetissue via RF energy.Massaging of body partswith massage attachment.(785-1 applicator only).Radiofrequency | Application of the heat to thetissue via RF energy.Massaging of body partswith massage attachment.(785-1 applicator only).Radiofrequency | Application of the heat to thetissue via Laser energy. |
| accompanied by | accompanied by | ||
| electromagnetic stimulation(785-7 applicator only). | electromagnetic stimulation(785-7 applicator only). | ||
| Clinical Use | Prescription use | Prescription use | Prescription use |
| 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 | 200-240V~, Single Phase |
| Type of EnergyApplied | Electromagnetic Energy –Radiofrequency | Electromagnetic Energy –Radiofrequency | Laser energy - Diode Laser |
| Frequency | 3.2 MHz ± 5%(BTL-785-1, BTL-785-2, andBTL-785-3, BTL-785-7) | 3.2 MHz ± 5%(BTL-785-1, BTL-785-2, andBTL-785-3, BTL-785-7) | N/A |
| 1 MHz ± 5%(BTL-785-4) | 1 MHz ± 5%(BTL-785-4) | ||
| Mode ofOperation | Monopolar | Monopolar | N/A |
| User Interface | Color Touch-screen | Color Touch-screen | Color Touch-screen |
| 140 W (BTL-785-1-1)62 W (BTL-785-2-1) | 140 W (BTL-785-1-1)62 W (BTL-785-2-1) | N/A | |
| MaximumOutput Power | 48 W (BTL-785-3-1) | 48 W (BTL-785-3-1) | |
| 30 W (BTL-785-4-1, 2, 5, 6) | 30 W (BTL-785-4-1, 2, 5, 6) | ||
| 25 W (BTL-785-4-4, 8) | 25 W (BTL-785-4-4, 8) | ||
| 20 W (BTL-785-4-3, 7) | 20 W (BTL-785-4-3, 7) | ||
| 42.5 W (BTL-785-7) | 39.8 W (BTL-785-7) | ||
| EffectiveTreatmentTemperature(BTL-785-1,BTL-785-2,BTL-785-3,BTL-785-7) | 40 - 45°C(104 - 113°F) | 40 - 45°C(104 - 113°F) | Up to 47°C |
| SkinTemperatureMonitoring | Integrated thermometer +patient's feedback(BTL-785-1, 2, 3 –integrated thermometer) | Integrated thermometer +patient's feedback(BTL-785-1, 2, 3) | N/A |
| Ultrasonic TipPre-heatingFunction | Yes (BTL-785-1, 2) | Yes (BTL-785-1, 2) | N/A |
| MassageAttachment | Yes (BTL-785-1) | Yes (BTL-785-1) | N/A |
| Number ofMicroneedles | 6 x 6 | 6 x 6 | N/A |
| Handsfreeapplicator | Yes | Yes | Yes |
| Depth ofMicroneedleElectrodes | 0.5 — 4 mm | 0.5 — 4 mm | N/A |
| Number of Pinsof SuperficialTips | 3264 | 3264 | N/A |
| SterilizationMethod | Ethylene oxide | Ethylene oxide | N/A |
{12}------------------------------------------------
T
Image /page/12/Picture/2 description: The image shows a logo for an organization, possibly a company or institution, featuring a stylized design. The logo consists of three interconnected geometric shapes, each resembling a square or diamond with rounded corners. Inside each shape is a letter: "B" in the first, "T" in the second, and "L" in the third, spelling out the acronym "BTL". The logo is rendered in a solid blue color, providing a clean and professional appearance.
{13}------------------------------------------------
Image /page/13/Picture/2 description: The image shows a logo with the letters B, T, and L arranged within three interconnected diamond shapes. The letters are in a sans-serif font and are colored in blue, matching the color of the diamond outlines. The diamonds are positioned horizontally, creating a visual chain or sequence.
{14}------------------------------------------------
Image /page/14/Picture/0 description: The image shows a logo for an organization, possibly a company or institution, featuring three interconnected diamond shapes. Each diamond contains a letter: 'B' in the first, 'T' in the second, and 'L' in the third, spelling out 'BTL'. The logo is rendered in a solid blue color, giving it a clean and professional appearance.
{15}------------------------------------------------
Image /page/15/Picture/0 description: The image shows a logo with the letters B, T, and L inside of three nested squares. The squares are arranged in a way that the letters are visible. The logo is blue and the background is white.
{16}------------------------------------------------
Image /page/16/Picture/2 description: The image shows the logo for BTL Indus. The logo consists of three blue squares that are nested inside of each other. To the right of the squares is the text "BTL Indus" in gray.
| NeutralElectrode Area | 169 cm² | 169 cm² | N/A |
|---|---|---|---|
| System Weight | 65 kg(143 lb) | 65 kg(143 lb) | Not known |
| 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") | Not known |
New Indication for Use for BTL-785-7 and its applicator BTL-785-7-9
The BTL-785S with BTL-785-7 handpiece and its single-use applicators has new indication for use to affect the appearance of lax skin in submental area.
The new indication for BTL-785-7 and its BTL-785-7-9 applicator:
- Affect the appearance of lax tissue in the submental area. ●
is supported by a clinical data from clinical trial involving 56 subjects, who have been treated and completed 3-month follow-up. The new indication is proposed based on the positive feedback from the participants, as well as the results achieved in the study. Additionally, the safety of the device has been evaluated during the clinical investigation and no new risks have been identified. The difference does not raise any new questions of safety or effectiveness.
Substantial Equivalence
The BTL-785S device has the same technological characteristics and similar intended use compared to the primary predicate device and similar mode of action and intended use compared to reference device. Any differences between the predicate device and BTL-785S device have no significant influence on safety or effectiveness of the BTL-785S device.
Therefore, the BTL-785S device is substantially equivalent to the predicate device.
Conclusion
Based upon the intended use, comparison of technical characteristics and performance testing provided in this premarket notification, the BTL-785S device has been shown to be substantially equivalent to the currently cleared predicate device.
§ 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.