(284 days)
No
The document describes a radiofrequency device with a microprocessor-driven control unit and user interface, but there is no mention of AI or ML capabilities in the intended use, device description, or performance studies.
Yes
The device is intended to provide heating for the temporary relief of pain and muscle spasms, and to increase local circulation, which are therapeutic effects. It also has indications for electrocoagulation and hemostasis, and fractional treatment of the skin, all of which are medical procedures. Additionally, it aims for a temporary reduction in the appearance of cellulite.
No
The provided text indicates that the device is intended for therapeutic purposes, such as elevating tissue temperature for temporary relief of pain, muscle spasms, and increasing local circulation, as well as for electrocoagulation and hemostasis. It describes the device as providing "application of therapy" and "therapy procedure." There is no mention of the device being used to identify or determine a medical condition or disease, which would be the function of a diagnostic device.
No
The device description explicitly details hardware components such as a control unit, radiofrequency generator, touch screen, applicators, and exchangeable applicator tips. This indicates it is a physical medical device with integrated software, not a software-only device.
Based on the provided information, the BTL-785W device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- BTL-785W Function: The BTL-785W device uses radiofrequency energy to heat tissue for therapeutic purposes (pain relief, muscle spasms, circulation, cellulite reduction, electrocoagulation, hemostasis, fractional skin treatment). It directly interacts with the patient's body and does not analyze samples taken from the body.
- Intended Use: The stated intended uses are all related to direct treatment of the patient's body, not the analysis of in vitro samples.
- Device Description: The description focuses on the physical components and how it applies radiofrequency energy to the body.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, reagents, or any other typical components or processes associated with IVD devices.
Therefore, the BTL-785W is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
GEI, PBX
Device 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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 and essential performance
IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-2-2 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgery equipment and high frequency surgical accessories
IEC 60601-2-5 Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
IEC 60601-1-6 Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
IEC 62304 Medical device software - Software life cycle processes
ISO 14971 Medical devices - Application of risk management to medical devices
ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
ISO 10993-5 Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity
ISO 10993-7 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
ISO 10993-10 Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization
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
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA 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
1
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
2
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.
3
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4
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 Street
Marlborough, MA 01752
Tel: +1-866-285-1656
Fax: +1-888-499-2502 |
|---------------------|-----------------------------------------------------------------------------------------------------------------|
| Applicant: | BTL Industries, Inc.
362 Elm Street
Marlborough, MA 01752
Tel: +1-866-285-1656
Fax: +1-888-499-2502 |
| Contact Person: | David Chmel
BTL Industries, Inc.
chmel@btlnet.com |
| Summary Preparation | |
Date:
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
5
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 ●
6
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.
7
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 and
essential performance |
|---------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1-2 | Medical electrical equipment – Part 1-2: General requirements for basic safety
and essential performance - Collateral standard: Electromagnetic disturbances
- Requirements and tests |
| IEC 60601-2-2 | Medical electrical equipment - Part 2-2: Particular requirements for the basic
safety and essential performance of high frequency surgery equipment and high
frequency surgical accessories |
| IEC 60601-2-5 | Medical electrical equipment - Part 2-5: Particular requirements for the basic
safety and essential performance of ultrasonic physiotherapy equipment |
| IEC 60601-1-6 | Medical electrical equipment – Part 1-6: General requirements for basic safety
and essential performance - Collateral standard: Usability |
| IEC 62304 | Medical device software - Software life cycle processes |
| ISO 14971 | Medical devices - Application of risk management to medical devices |
| ISO 10993-1 | Biological evaluation of medical devices – Part 1: Evaluation and testing within
a risk management process |
| ISO 10993-5 | Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity |
| ISO 10993-7 | Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization
residuals |
| ISO 10993-10 | Biological evaluation of medical devices – Part 10: Tests for irritation and skin
sensitization |
| 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 |
8
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.
9
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) number
Device name
Company name | K211639
BTL-785W
BTL Industries, Inc. | K193201
BTL-785F
BTL Industries, Inc. | K200241
TempSure System
FlexSure single-use Applicator
Cynosure, LLC
Reference device | Significant
difference |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Product Code
and Regulation | General & Plastic Surgery
21 CFR 878.4400
GEI - Electrosurgical, Cutting &
Coagulation & Accessories
PBX - Massager, Vacuum,
Radiofrequency Induced Heat | General & Plastic Surgery
21 CFR 878.4400
GEI - Electrosurgical, Cutting &
Coagulation & Accessories
PBX - Massager, Vacuum,
Radiofrequency Induced Heat | General & Plastic Surgery
21 CFR 878.4400
GEI - Electrosurgical, Cutting &
Coagulation & Accessories
PBX - Massager, Vacuum,
Radiofrequency Induced Heat | None |
| 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 | 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 | The TempSure™ System has
the following indications for use:
The 10mm, 15mm, and 20mm
Smart Handpieces are indicated
for non-ablative treatment of
mild to moderate facial wrinkles
and rhytids.
The 18mm, 25mm, 30mm,
60mm Smart Handpieces and
FlexSure™ applicators provide
heating for the purpose of
elevating tissue temperature for
selected medical conditions
such as temporary relief of pain, | Not significant,
please see
discussion and
conclusion below. |
10
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 for
selected medical conditions such
as temporary relief of pain, muscle
spasms, and increase in local
circulation. | elevating tissue temperature for
selected medical conditions such
as temporary relief of pain, muscle
spasms, and increase in local
circulation. | muscle spasms, and increase in
local circulation.
The massage device is intended
to provide a temporary reduction
in the appearance of cellulite |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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-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-
785W 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-
785W 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.
The BTL-785W with BTL-785-7
hands-free applicator used with
BTL-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 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. | |
| electrodes is intended to provide
heating for the purpose of
elevating tissue temperature for | | |
11
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 such
as temporary relief of pain, muscle
spasms, and increase in local
circulation. | | | |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|-------------------------------------|
| Principle of
Action | Application of the heat to the
tissue via RF energy.
Massaging of body parts with
massage attachment. (785-1
applicator only)
Radiofrequency accompanied by
electromagnetic stimulation (785-7
applicator only) | Application of the heat to the
tissue via RF energy.
Massaging of body parts with
massage attachment. (785-1
applicator only) | Application of the heat to the
tissue via RF energy.
Massaging of body parts with
massage attachment. | None |
| | | | | |
| | | | | |
| Clinical Use | Prescription use | Prescription use | Prescription use | None |
| Energy Source | 100 - 120 V AC,
50/60 Hz
200 - 240 V AC,
50/60 Hz | 100 - 120 V AC,
50/60 Hz
200 - 240 V AC,
50/60 Hz | 100 - 120 V AC,
50/60 Hz
200 - 240 V AC,
50/60 Hz | None |
| Type of Energy
Applied | 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, Fully
Rectified,
Partially Rectified, and 1.7 MHz
for Bipolar | Not significantly
different |
| Mode of
Operation | Monopolar | Monopolar | Monopolar, Bipolar | None |
| User Interface | Color Touch-screen | Color Touch-screen | Color Touch-screen | None |
| Maximum Output
Power | 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 and
conclusion 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) | | | |
| Effective
Treatment
Temperature | 40 - 45°C | 40 - 45°C | 42 - 44°C | not significant |
| Skin Temperature
Monitoring | Integrated thermometer + patient's
feedback
(BTL-785-1, 2, 3) | Integrated thermometer + patient's
feedback
(BTL-785-1, 2, 3) | Temperature-Sensitive
Handpiece | None |
| Ultrasonic Tip
Pre-heating
Function | Yes (BTL-785-1, 2) | Yes (BTL-785-1, 2) | Yes | None |
| Massage
Attachment | Yes (BTL-785-1) | Yes (BTL-785-1) | Yes | None |
| Number of
Microneedles | 6 x 6 | 6 x 6 | N/A | None |
| Handsfree
applicator | Yes | No | Yes | None |
| Depth of
Microneedle
Electrodes | 0.5 - 4 mm | 0.5 - 4 mm | N/A | None |
| Number of Pins
of Superficial
Tips | 32
64 | 32
64 | N/A | None |
| Sterilization
Method | Ethylene oxide | Ethylene oxide | N/A | None |
| Neutral Electrode
Area | 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 |
| System
Dimension
(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.