BTL-785F

K193201 · Btl · GEI · Aug 21, 2020 · General, Plastic Surgery

Device Facts

• Record ID: K193201
• Device Name: BTL-785F
• Applicant: Btl
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Aug 21, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BTL-785F with BTL-785-1 applicator is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The BTL-785-1-4 massage device is intended to provide a temporary reduction in the appearance of cellulite. The BTL-785F with BTL-785-2 applicator is indicated to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The BTL-785F with BTL-785-3 applicator is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The Applicator BTL-785-4 of BTL-785F device used with tips BTL-785-4-1, BTL-785-4-5 and BTL-785-4-6 is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. The Applicator BTL-785-4 of BTL-785F device used with tips BTL-785-4-4, BTL-785-4-7 and BTL-785-4-8 is intended for dermatological procedures requiring fractional treatment of the skin. At higher energy levels greater than 62 mJ/pin, use of the BTL-785-4 applicator is limited to Skin Types I-IV.

Device Story

BTL-785F is a microprocessor-controlled radiofrequency (RF) system for clinical use. It consists of a console with a 15.6" color touchscreen, an RF generator, and four interchangeable applicators. The device delivers monopolar RF energy to tissue to elevate temperature; specific applicators include massage attachments for cellulite reduction. The user interface guides the clinician through therapy steps; handpieces feature integrated buttons for control. The device monitors treatment parameters and displays them on the screen. The system uses a larger neutral electrode than predicates to enhance safety by preventing overheating. Clinical benefits include pain relief, muscle spasm reduction, improved circulation, and dermatological surgical outcomes. The device is intended for prescription use by healthcare professionals.

Clinical Evidence

Bench testing only. Testing demonstrated the device's ability to achieve and maintain therapeutic temperatures (40-45°C for heating; 60-80°C for fractional) for at least 10 minutes. Bench testing confirmed power output and applicator geometry are equivalent to predicates. Electrical safety and biocompatibility verified per IEC 60601 and ISO 10993 standards.

Technological Characteristics

Monopolar RF system; 3.2 MHz frequency (heating applicators) and 1 MHz (fractional applicator). Includes microprocessor-driven console, RF generator, 15.6" touchscreen, and four applicators with exchangeable tips. Neutral electrode area: 169 cm². Sterilization: Ethylene oxide for tips. Complies with IEC 60601-1, 60601-1-2, 60601-2-2, 60601-2-5, 60601-1-6, IEC 62304, ISO 14971, and ISO 10993 series.

Indications for Use

Indicated for patients requiring tissue heating for pain relief, muscle spasms, or increased local circulation; temporary reduction of cellulite appearance; and dermatological/general surgical procedures for electrocoagulation, hemostasis, or fractional skin treatment. Higher energy fractional treatments (>62 mJ/pin) limited to Skin Types I-IV.

Regulatory Classification

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.

Predicate Devices

• XP3000 (K150720)
• Exilis 5000 (K092191)
• BTL-FR2000 (K180359)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

August 21, 2020

BTL Industries, Inc. David Chmel VP of Operations 362 Elm Street Marlborough, Massachusetts 01752

Re: K193201

Trade/Device Name: BTL-785F Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI, PBX Dated: May 21, 2020 Received: May 26, 2020

Dear David Chmel:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K193201

Device Name BTL-785F

#### Indications for Use (Describe)

The BTL-785F device has the following indications for use:

The BTL-785F with BTL-785-1 applicator is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The BTL-785-1-4 massage device is intended to provide a temporary reduction in the appearance of cellulite. The BTL-785F with BTL-785-2 applicator is indicated to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.

The BTL-785F with BTL-785-3 applicator is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.

The Applicator BTL-785-4 of BTL-785F device used with tips BTL-785-4-1, BTL-785-4-5 and BTL-785-4-6 is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. The Applicator BTL-785-4 of BTL-785F device used with tips BTL-785-4-4, BTL-785-4-7 and BTL-785-4-8 is intended for dermatological procedures requiring fractional treatment of the skin. At higher energy levels greater than 62 mJ/pin, use of the BTL-785-4 applicator is limited to Skin Types I-IV.

| X Prescription Use (Part 21 CFR 801 Subpart D)<br> Over-The-Counter Use (21 CFR 801 Subpart C) | Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------|-------------------------------------------------|--|
| | | |

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Image /page/3/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three interlocking squares in blue, with the letters "BTL" inside the leftmost square. To the right of the squares is the text "BTL Industries" in a dark gray sans-serif font.

# 510(k) Summary

# General Information

| Sponsor: | BTL Industries, Inc.<br>362 Elm Street<br>Marlborough, MA 01752<br>Tel: [phone]<br>Fax: [phone] |
|---------------------------|-----------------------------------------------------------------------------------------------------------------|
| Applicant: | BTL Industries, Inc.<br>362 Elm Street<br>Marlborough, MA 01752<br>Tel: [phone]<br>Fax: [phone] |
| Contact Person: | David Chmel<br>BTL Industries, Inc.<br>[e-mail] |
| Summary Preparation Date: | August 21, 2020 |

# Device

| Trade/Proprietary Name: | BTL-785F |
|------------------------------|-------------------------------------------------------------------|
| Primary Classification Name: | Electrosurgical cutting and coagulation device and<br>accessories |
| Classification Regulation: | 21 CFR 878.4400, Class II |
| Classification Product Code: | GEI, PBX |

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Image /page/4/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three blue squares, each rotated 45 degrees, with the letters "BTL" inside the leftmost square. To the right of the squares is the text "BTL Industries" in a gray, sans-serif font.

# Legally Marketed Predicate Devices

The BTL-785F is a state-of-the-art radiofrequency device with accessories, and is substantially equivalent to the three current products that are already cleared for distribution in the USA under the following 510(k) Premarket Notification numbers:

- XP3000 (K150720) .
- Exilis 5000 (K092191) ●
- BTL-FR2000 (K180359) .

## Product Description

The BTL-785F is a state-of-the-art radiofrequency device that enables the application of therapy by a high-frequency field.

The control unit of the system is equipped with a large color touch screen that significantly facilitates the use of the device. The on-screen information quides the user step by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen of the device. During the therapy the device displays information about the applied therapy type, remaining therapy time and main therapy parameters on the screen. For easier control, the hand-pieces are equipped with buttons, enabling operation of the device during therapy. The energy flow's quality is indicated by the illuminated treatment tip. The BTL-785F device comes with four different types of applicators.

The BTL-785F device consists of the following main components:

- . microprocessor-driven control unit
- . radiofrequency generator
- user interface with 15.6" color touch screen .
- . applicators for an application of radiofrequency
- . exchangeable applicator tips

#### Indications for Use

The BTL-785F device has the following indications for use:

The BTL-785F with BTL-785-1 applicator is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The BTL-785-1-4 massage device is intended to provide a temporary reduction in the appearance of cellulite.

The BTL-785F with BTL-785-2 applicator is indicated to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.

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Image /page/5/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three blue squares nested inside each other, with the letters "BTL" in white inside the innermost square. To the right of the square logo is the text "BTL Industries" in a dark gray sans-serif font. The logo is simple and modern, and the colors are clean and professional.

The BTL-785F with BTL-785-3 applicator is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.

The Applicator BTL-785-4 of BTL-785F device used with tips BTL-785-4-1, BTL-785-4-2, BTL-785-4-5 and BTL-785-4-6 is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.

The Applicator BTL-785-4 of BTL-785F device used with tips BTL-785-4-3. BTL-785-4-4. BTL-785-4-7 and BTL-785-4-8 is intended for dermatological procedures requiring fractional treatment of the skin. At higher energy levels greater than 62 mJ/pin, use of the BTL-785-4 applicator is limited to Skin Types I-IV.

## Performance Data

The BTL-785F device has been thoroughly evaluated for electrical safety. The device has been found to comply with applicable medical device safety standards:

| IEC 60601-1 | Medical electrical equipment – Part 1: General requirements for basic<br>safety and essential performance |
|---------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1-2 | Medical electrical equipment - Part 1-2: General requirements for basic<br>safety and essential performance - Collateral standard:<br>Electromagnetic disturbances - Requirements and tests |
| IEC 60601-2-2 | Medical electrical equipment - Part 2-2: Particular requirements for the<br>basic safety and essential performance of high frequency surgery<br>equipment and high frequency surgical accessories |
| IEC 60601-2-5 | Medical electrical equipment - Part 2-5: Particular requirements for the<br>basic safety and essential performance of ultrasonic physiotherapy<br>equipment |
| IEC 60601-1-6 | Medical electrical equipment - Part 1-6: General requirements for basic<br>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<br>within a risk management process |
| ISO 10993-5 | Biological evaluation of medical devices - Part 5: Tests for in vitro<br>cytotoxicity |
| ISO 10993-7 | Biological evaluation of medical devices - Part 7: Ethylene oxide<br>sterilization residuals |
| ISO 10993-10 | Biological evaluation of medical devices – Part 10: Tests for irritation<br>and skin sensitization |

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Image /page/6/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of a geometric design on the left and the text "BTL Industries" on the right. The geometric design is made up of three nested squares, with the letters "B", "T", and "L" inside the innermost square. The text "BTL Industries" is written in a sans-serif font and is gray in color.

| ISO 10993-11 | Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity |
|--------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 11135 | Sterilization of health-care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ISO 11607-1 | Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| ISO 11607-2 | Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes |

Bench testing has been performed in order to demonstrate that the device is able to achieve and maintain therapeutic temperature on different treated areas for at least 10min. Bench testing has been performed in order to demonstrate that the power output of the

generator and geometry of the 785-4 applicator is identical to the same of the predicate.

## Technoloqical Characteristics

The BTL-785F device has similar technological characteristics compared to its predicate devices. The BTL-785F device and the predicates are comprised of a system console and applicator(s). The system console consists of the RF generator, computer, and the touchscreen control panel. The device is accompanied by four applicators enabling connection to exchangeable tips.

The compared devices' applicators use the RF signal of the same monopolar mode of operation, waveform and frequency. The maximum power intensity level of BTL-785F device in some cases differs to the predicates; nevertheless, based on the performance tests, the current device is able to reach the required treatment temperature and maintain it throughout the recommended treatment time. Therefore the current device is able to achieve substantial equivalent intended use based on identical mechanism of action.

The compared devices have similar properties regarding their RF tips, including material, size, biocompatibility properties and sterilization method where applicable.

The BTL-785F device is used with a larger neutral electrode compared to the predicate device. This approach prevents overheating and assures higher level of safety compared to the predicate device.

The differences do not raise any new questions of safety nor effectiveness.

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# Comparison with the Predicate Device

| 510(k) number | K193201 | K150720 | K092191 | K180359 | 1 MHz ± 5%<br>(BTL-785-4) | | | | |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|---------------------------------------|-----------------------------------------|
| Device name | BTL-785F | XP3000 | Exilis 5000 | BTL-FR2000 | Mode of<br>Operation | Monopolar | Monopolar | Monopolar | Monopolar |
| Company name | BTL Industries, Inc. | BTL Industries, Inc. | BTL Industries, Inc. | BTL Industries, Inc. | User Interface | Color Touch-screen<br>15.6" 1920x1080 px | Color Touch-screen<br>8.4" 640x480 px | Color Touch-screen<br>8.4" 640x480 px | Color Touch-screen<br>8.4" 640x480 px |
| | General & Plastic<br>Surgery<br>21 CFR 878.4400 | General & Plastic<br>Surgery<br>21 CFR 878.4400 | General & Plastic<br>Surgery<br>21 CFR 878.4400 | General & Plastic<br>Surgery<br>21 CFR 878.4400 | Maximum<br>Output Power | 125 W (BTL-785-1-2)<br>140 W (BTL-785-1-1)<br>62 W (BTL-785-2-1)<br>53 W (BTL-785-2-2)<br>62 W (BTL-785-2-3)<br>48 W (BTL-785-3-1)<br>30 W (BTL-785-4-1, 2,<br>5, 6)<br>25 W (BTL-785-5-4, 8)<br>20 W (BTL-785-4-3, 7) | 120 W (215/3)<br>170 W (215/1) | 170W | 30 W (N1, N2)<br>25 W (P2)<br>20 W (P1) |
| Product Code<br>and Regulation | GEI - Electrosurgical,<br>Cutting & Coagulation<br>& Accessories<br>PBX - Massager,<br>Vacuum,<br>Radiofrequency<br>Induced Heat | PBX - Massager,<br>Vacuum,<br>Radiofrequency<br>Induced Heat | GEI -<br>Electrosurgical,<br>Cutting &<br>Coagulation &<br>Accessories | GEI - Electrosurgical,<br>Cutting &<br>Coagulation &<br>Accessories | Effective<br>Treatment<br>Temperature | 40 - 45°C<br>(104 - 113°F) | 40 - 45°C<br>(104 - 113°F) | 39 - 42°C<br>(102 - 108°F) | 60 - 80°C<br>(140°F-176°F) |
| | Skin<br>Temperature<br>Monitoring | Integrated<br>thermometer +<br>patient's feedback<br>(BTL-785-1, 2, 3) | Integrated<br>thermometer +<br>patient's feedback<br>(Handpiece 215/1)<br>Based on patient's<br>feedback<br>(Handpiece 215/3) | Skin temperature<br>measurement | N/A | | | | |
| Indications for<br>Use | The BTL-785F device<br>has the following<br>indications for use:<br>The BTL-785F with<br>BTL-785-1 applicator<br>is intended to provide<br>heating for the<br>purpose of elevating<br>tissue temperature for<br>selected medical<br>conditions such as<br>temporary relief of<br>pain, muscle spasms,<br>and increase in local<br>circulation. The BTL-<br>785-1-4 massage<br>device is intended to<br>provide a temporary<br>reduction in the<br>appearance of<br>cellulite.<br>The BTL-785F with<br>BTL-785-2 applicator<br>is indicated to provide<br>heating for the<br>purpose of elevating<br>tissue temperature for<br>selected medical<br>conditions such as<br>temporary relief of<br>pain, muscle spasms,<br>and increase in local<br>circulation.<br>The BTL-785F with<br>BTL-785-3 applicator<br>is intended to provide<br>heating for the<br>purpose of elevating | The XP3000 device<br>is intended to<br>provide heating for<br>the purpose of<br>elevating tissue<br>temperature for<br>selected medical<br>conditions such as<br>temporary relief of<br>pain, muscle<br>spasms, and<br>increase in local<br>circulation. The<br>XP3000 massage<br>device is intended to<br>provide a temporary<br>reduction in the<br>appearance of<br>cellulite. | The EXILIS device is<br>indicated for the<br>primary treatment of<br>dermatologic and<br>general surgical<br>procedures for non-<br>invasive treatment of<br>wrinkles and rhytids. | The Applicator 786-1<br>of BTL-FR2000<br>device is indicated for<br>use in dermatological<br>and general surgical<br>procedures for<br>electrocoagulation<br>and hemostasis.<br>The Applicator 786-2<br>of BTL-FR2000<br>device is intended for<br>dermatological<br>procedures requiring<br>fractional treatment of<br>the skin. | The Ultrasonic<br>Tip Pre-heating<br>Function | Yes (BTL-785-1, 2) | No | No | No |
| | | | | | Massage<br>Attachment | Yes (BTL-785-1) | Yes | Yes | No |
| | tissue temperature for<br>selected medical<br>conditions such as<br>temporary relief of<br>pain, muscle spasms,<br>and increase in local<br>circulation.<br><br>The Applicator BTL-<br>785-4 of BTL-785F<br>device used with tips<br>BTL-785-4-1, BTL-<br>785-4-2, BTL-785-4-5<br>and BTL-785-4-6 is<br>indicated for use in<br>dermatological and<br>general surgical<br>procedures for<br>electrocoagulation<br>and hemostasis.<br><br>The Applicator BTL-<br>785-4 of BTL-785F<br>device used with tips<br>BTL-785-4-3, BTL-<br>785-4-4, BTL-785-4-7<br>and BTL-785-4-8 is<br>intended for<br>dermatological<br>procedures requiring<br>fractional treatment of<br>the skin. At higher<br>energy levels greater<br>than 62 mJ/pin, use of<br>the BTL-785-4<br>applicator is limited to<br>Skin Types I-IV. | | | | Number of<br>Microneedles | 6 x 6 | N/A | N/A | 6 x 6 |
| Principle of<br>Action | Application of the heat<br>to the tissue via RF<br>energy.<br>Massaging of body<br>parts with massage<br>attachment. (785-1<br>applicator only) | Application of the<br>heat to the tissue<br>via RF energy.<br>Massaging of body<br>parts with massage<br>attachment. | Application of the<br>heat to the tissue via<br>RF energy.<br>Massaging of body<br>parts with massage<br>attachment. | Delivering the RF<br>energy through the<br>skin results in an<br>electro-thermal<br>reaction. The heating<br>effect causes<br>collagen coagulation<br>and encourages<br>skin's natural healing<br>process. | Depth of<br>Microneedle<br>Electrodes | 0.5 - 4 mm | N/A | N/A | 0.5 – 3.5 mm |
| Clinical Use | Prescription use | Prescription use | Prescription use | Prescription use | Number of Pins<br>of Superficial<br>Tips | 32 | N/A | N/A | 32 |
| Energy Source | 100 - 120 V AC,<br>50/60 Hz<br>200 - 240 V AC,<br>50/60 Hz | 100 - 240 V AC,<br>50 – 60 Hz | 100-120 V AC, 5 A,<br>50/60 Hz<br>208-240 V AC, 2.5 A,<br>50 Hz | 100 - 240 V AC,<br>50 – 60 Hz | | 64 | N/A | N/A | 64 |
| Type of Energy<br>Applied | Electromagnetic<br>Energy -<br>Radiofrequency | Electromagnetic<br>Energy -<br>Radiofrequency | Electromagnetic<br>Energy -<br>Radiofrequency | Electromagnetic<br>Energy -<br>Radiofrequency | Sterilization<br>Method | Ethylene oxide | N/A | N/A | Ethylene oxide |
| Frequency | 3.2 MHz ± 5%<br>(BTL-785-1, BTL-785-<br>2, and BTL-785-3) | 3.25 MHz ± 50 kHz | 3.25 MHz ± 50 kHz | 1 MHz ± 5% | | | | | |

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Image /page/8/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three overlapping squares with the letters "BTL" inside. To the right of the squares is the text "BTL Industries" in a sans-serif font. The logo is simple and modern.

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Image /page/9/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three blue squares, each containing a letter of the company's name. The letters are white and are stacked on top of each other. To the right of the squares is the company's name in gray text.

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Image /page/10/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three interlocking squares in blue, with the letters "BTL" inside the squares. To the right of the squares is the text "BTL Industries" in a dark gray sans-serif font. The logo is simple and modern, and the colors are clean and professional.

| Neutral<br>Electrode Area | 169 cm² | 118 cm² | 118 cm² | 118 cm² |
|--------------------------------|------------------------------------------------------|---------------------------------------------------------|----------------------------------------------------|------------------------------------------------------|
| System Weight | 60 kg<br>(132 lb) | 30 kg<br>(66 lb) | 15.3 kg<br>(33.7 lb) | 7.3 kg<br>(16 lb) |
| System<br>Dimension<br>(WxHxD) | 1370 mm x 670 x 670<br>(53.94" x 26.38"<br>x 26.38") | 1000 x 600 x 600<br>mm<br>(39.37" x 23.62"<br>x 23.62") | 230 x 390 x 260 mm<br>(9.06" x 15.35" x<br>10.24") | 1000 x 600 x 600 mm<br>(39.37" x 23.62"<br>x 23.62") |

# Substantial Equivalence

The BTL-785F device has similar technological characteristics and intended use compared to the predicate devices. Any differences between the predicate devices and BTL-785F device have no significant influence on safety or effectiveness of the BTL-785F device. Therefore, the BTL-785F device is substantially equivalent to the predicate devices.

# Conclusion

Based upon the intended use, comparison of technical characteristics and performance testing provided in this pre-market notification, the BTL-785F device has been shown to be substantially equivalent to currently marketed predicate devices for requested intended use.