(281 days)
Not Found
No
The summary 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 device description, intended use, or performance studies.
Yes
The device is indicated for various medical conditions such as temporary relief of pain, muscle spasms, increased local circulation, electrocoagulation and hemostasis, and temporary reduction of facial wrinkles and cellulite, all of which are therapeutic purposes.
No
The provided text describes the BTL-785X as a therapeutic device used for heating tissue, reducing cellulite, electrocoagulation, hemostasis, and temporary reduction of wrinkles. It does not mention any function for diagnosing medical conditions.
No
The device description explicitly states it is a "radiofrequency device" with a "microprocessor-driven control unit," "radiofrequency generator," "user interface with 15.6" color touch screen," and "applicators." These are all hardware components, indicating it is not a software-only device.
Based on the provided information, the BTL-785X device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended uses described for the BTL-785X and its various applicators are all related to therapeutic treatments applied directly to the patient's body. These include heating for pain relief, muscle spasms, increased circulation, cellulite reduction, electrocoagulation, hemostasis, and temporary reduction of facial wrinkles.
- Device Description: The device description details a radiofrequency device that applies a high-frequency field to the patient. It describes components like a control unit, generator, user interface, and applicators that are used for direct patient treatment.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on biological samples outside of the body to provide diagnostic information. The BTL-785X is a therapeutic device that applies energy to the body.
N/A
Intended Use / Indications for Use
The BTL-785X device has the following indications for use:
The BTL-785X 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-785X 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-785X 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 with BTL-785-4 applicator used with tips 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-785X device used with tips BTL-785-4-4, 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-785X with BTL-785-7 hands-free applicator used with forehead BTL-785-7-1 and cheek BTL-785-7-2 singleuse 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.
-
non-invasive temporary reduction of facial wrinkles
Product codes (comma separated list FDA assigned to the subject device)
PBX, GEI
Device Description
The BTL-785X 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-785X device comes with five different types of applicators.
The BTL-785X 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
Technological characteristics
The BTL-785X device has identical technological characteristics compared to its predicate device. The BTL-785X 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 following applicators:
- . BTL-785-1 applicator providing treatment by integration of radiofrequency, ultrasound and active cooling. Suitable for the treatment of large body areas.
- 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 . use tips only.
- BTL-785-4 applicator delivering radiofrequency via an array of microneedles and/or superficial pins. Therapy is provided with single use tips only.
- . BTL-785-7 hands-free applicator providing treatment by integration of radiofrequency heating and muscle stimulation resulting in induced muscle workout naturally increases local blood circulation. Suitable for the treatment of small and sensitive areas. The therapy is provided with single use electrodes only.
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.
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
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A clinical study was conducted to demonstrate the performance, clinical efficacy and safety of the BTL-785-7 hands-free applicator for non-invasive temporary reduction of wrinkles. 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 hands-free applicator.
In total, N=42 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 study's primary efficacy endpoint was determined at the 3-month follow-up with three of the three blinded evaluators finding a statistically significant reduction of at least 1.0 score in the average score of FWES score at the 3-months follow-up compared to baseline. The average FWES score of the subjects showed an overall improvement of 1.44 points (p
§ 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). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
May 31, 2023
BTL Industries Inc. David Chmel VP of Operations 362 Elm Street Marlborough, Massachusetts 01752
Re: K222556
Trade/Device Name: Btl-785x Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: PBX, GEI Dated: April 12, 2023 Received: May 3, 2023
Dear David Chmel:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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
1
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 medical devices and radiation-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,
Image /page/1/Figure/6 description: The image shows a digital signature. The signature is for Mark Trumbore -S. The date of the signature is 2023.05.31, and the time is 13:44:10 -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
Enclosure
2
Indications for Use
510(k) Number (if known) K222556
Device Name BTL-785X
Indications for Use (Describe)
The BTL-785X device has the following indications for use:
The BTL-785X 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-785X 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-785X 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 with BTL-785-4 applicator used with tips 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-785X device used with tips BTL-785-4-4, 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-785X with BTL-785-7 hands-free applicator used with forehead BTL-785-7-1 and cheek BTL-785-7-2 singleuse 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.
-
non-invasive temporary reduction of facial wrinkles
| 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 nested squares on the left side, with the letters "BTL" inside the innermost square. To the right of the squares is the text "BTL Industries" in a simple, sans-serif font. The logo is clean and modern, with a focus on geometric shapes and clear typography.
510(k) Summary
K222556
General Information
Classification Product Code:
| 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: | May 29, 2023 |
| Device | |
| Trade/Proprietary Name: | BTL-785X |
| Primary Classification Name: | Electrosurgical cutting and coagulation device and accessories |
| Classification Regulation: | 21 CFR 878.4400, Class II |
GEI, PBX
5
Legally Marketed Predicate Device
The BTL-785X 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:
Product Description
The BTL-785X 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-785X device comes with five different types of applicators.
The BTL-785X 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
Technological characteristics
The BTL-785X device has identical technological characteristics compared to its predicate device. The BTL-785X 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 following applicators:
- . BTL-785-1 applicator providing treatment by integration of radiofrequency, ultrasound and active cooling. Suitable for the treatment of large body areas.
- BTL-785-2 applicator providing treatment by integration of radiofrequency and ultrasound. . Suitable for the treatment of small areas.
6
- BTL-785-3 applicator providing radiofrequency treatment. The therapy is provided with single . use tips only.
- BTL-785-4 applicator delivering radiofrequency via an array of microneedles and/or superficial pins. Therapy is provided with single use tips only.
- . BTL-785-7 hands-free applicator providing treatment by integration of radiofrequency heating and muscle stimulation resulting in induced muscle workout naturally increases local blood circulation. Suitable for the treatment of small and sensitive areas. The therapy is provided with single use electrodes only.
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.
Indications for Use
The BTL-785X device has the following indications for use:
The BTL-785X 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-785X 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-785X 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-785X 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-785X 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.
7
The BTL-785X with BTL-785-7 hands-free applicator used with BTL-785-7-1 and BTL-785-7-2, singleuse 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.
- . non-invasive temporary reduction of facial wrinkles.
Performance Data
The BTL-785X 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 |
8
| ISO 11607-1 | Packaging for terminally sterilized medical devices - Part 1: Requirements for |
|---|---|
| materials, sterile barrier systems and packaging systems |
- Packaging for terminally sterilized medical devices Part 2: Validation ISO 11607-2 requirements for forming, sealing and assembly processes
BTL-785-7 applicator clinical performance data
A clinical study was conducted to demonstrate the performance, clinical efficacy and safety of the BTL-785-7 hands-free applicator for non-invasive temporary reduction of wrinkles. 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 hands-free applicator.
In total, N=42 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 study's primary efficacy endpoint was determined at the 3-month follow-up with three of the three blinded evaluators finding a statistically significant reduction of at least 1.0 score in the average score of FWES score at the 3-months follow-up compared to baseline. The average FWES score of the subjects showed an overall improvement of 1.44 points (p