BTL-703

K182363 · BTL Industries, Inc. · IMJ · Jan 24, 2019 · Physical Medicine

Device Facts

• Record ID: K182363
• Device Name: BTL-703
• Applicant: BTL Industries, Inc.
• Product Code: IMJ · Physical Medicine
• Decision Date: Jan 24, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5290
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

BTL-703 is indicated to be used for applying therapeutic deep heat in body tissues for the treatment of selected medical conditions such as: 1. Relieving pain; 2. Reducing muscle spasm; 3. Increasing range of motion of contracted joints using heat and stretch techniques; and 4. Increasing blood flow to tissues in the treatment area.

Device Story

BTL-703 is a high-frequency (27.12 MHz) electromagnetic energy device for therapeutic deep tissue heating. System comprises a microprocessor-controlled unit, RF generator, and capacitive applicators. Used in clinical settings by healthcare professionals for hands-free treatment. Applicators are secured to the patient via negative pressure using silicone sleeves, ensuring uniform coupling. Device features a 15.6" HD touch screen for operator control and a mobile cart for office transport. Output power is 200W total, split into two channels for even energy distribution. Thermal stabilization system monitors contact. Clinical benefit includes pain relief, muscle spasm reduction, improved joint mobility, and increased local blood flow.

Clinical Evidence

No human clinical data provided. Safety and performance supported by bench testing (IEC 60601-1, IEC 60601-1-2, ISO 10993 series) and an in vivo porcine study. Porcine study confirmed the device's ability to maintain tissue temperature in the 40-45°C range.

Technological Characteristics

High-frequency (27.12 MHz) electromagnetic energy generator; capacitive applicators with silicone sleeves; negative pressure fixation; 200W continuous output; 15.6" HD touch screen interface; thermal stabilization system; cabinet-mounted with wheels; Class II, BF electrical protection; firmware-controlled.

Indications for Use

Indicated for patients requiring therapeutic deep heat for pain relief, muscle spasm reduction, increased range of motion in contracted joints, or increased blood flow to tissues.

Regulatory Classification

Identification

A nonthermal shortwave therapy is a prescription device that applies to the body pulsed electromagnetic energy in the RF bands of 13.56 MHz or 27.12 MHz and that is intended for adjunctive use in the palliative treatment of postoperative pain and edema of soft tissue by means other than the generation of deep heat within body tissues as described in paragraph (a) of this section.

Special Controls

*Classification: Class II (special controls).* The device is classified as class II. The special controls for this device are:(i) Components of the device that come into human contact must be demonstrated to be biocompatible. (ii) Appropriate analysis/testing must demonstrate that the device is electrically safe and electromagnetically compatible in its intended use environment. (iii) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Non-clinical performance testing must characterize the output waveform of the device and demonstrate that the device meets appropriate output performance specifications. The output characteristics and the methods used to determine these characteristics, including the following, must be determined: (A) Peak output power; (B) Pulse width; (C) Pulse frequency; (D) Duty cycle; (E) Characteristics of other types of modulation that may be used; (F) Average measured output powered into the RF antenna/applicator; (G) Specific absorption rates in saline gel test load or other appropriate model; (H) Characterization of the electrical and magnetic fields in saline gel test load or other appropriate model for each RF antenna and prescribed RF antenna orientation/position; and (I) Characterization of the deposited energy density in saline gel test load or other appropriate model. (iv) A detailed summary of the clinical testing pertinent to use of the device to demonstrate the effectiveness of the device in its intended use. (v) Labeling must include the following: (A) Output characteristics of the device; (B) Recommended treatment regimes, including duration of use; and (C) A detailed summary of the clinical testing pertinent to the use of the device and a summary of the adverse events and complications. (vi) Nonthermal shortwave therapy devices marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with these special controls.

Predicate Devices

• BTL Elite (K120093)

Submission Summary (Full Text)

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January 24, 2019

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

Re: K182363

Trade/Device Name: BTL-703 Regulation Number: 21 CFR 890.5290 Regulation Name: Shortwave Diathermy Regulatory Class: Class II Product Code: IMJ Dated: December 20, 2018 Received: December 26, 2018

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

> Sincerely, VivekJ. Pinto -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K182363

Device Name BTL-703

#### Indications for Use (Describe)

BTL-703 is indicated to be used for applying therapeutic deep heat in body tissues for the treatment of selected medical conditions such as: 1. Relieving pain; 2. Reducing muscle spasm; 3. Increasing range of motion of contracted joints using heat and stretch techniques; and 4. Increasing blood flow to tissues in the treatment area.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| <div> <span> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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Image /page/3/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three interconnected blue squares, each containing the letters B, T, and L respectively. To the right of the square icons, the words "BTL Industries" are written in a gray, sans-serif font.

# K182363

# 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<br>Date: | January 21, 2019 |

## Device Names

| Trade/Proprietary Name: | BTL-703 |
|------------------------------|--------------------------------------------------------------------|
| Primary Classification Name: | Diathermy, Shortwave, For Use In Applying<br>Therapeutic Deep Heat |
| Classification Regulation: | 890.5290 |
| Product Code: | IMJ |

## Predicate Device

The BTL-703 is a state-of-the-art high-frequency energy device with accessory, and is substantially equivalent to the current product that is already cleared for USA distribution under the following 510(k) Premarket Notification number:

- K120093, BTL Elite .

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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 that are nested inside of each other. The letters "BTL" are written in white inside of the innermost square. To the right of the squares, the words "BTL Industries" are written in gray.

## Product Description

The BTL-703 is comprised of a device unit and applicator that deliver radiofrequency energy to the targeted tissue. The device is designed to enable hands-free treatment. Easyto-use color touch screen allows for maximum operator comfort. The main unit is placed in a specially designed cart, the shape of which provides maximum operator comfort and easy movement of the device in the office.

The BTL-703 consists of the following main components:

- microprocessor-driven control unit .
- . high-frequency energy generator
- user interface with 15,6" HD touch screen
- . four-point applicator

#### Indications for Use

BTL-703 is indicated to be used for applying therapeutic deep heat in body tissues for the treatment of selected medical conditions such as: 1. Relieving pain; 2. Reducing muscle spasm; 3. Increasing range of motion of contracted joints using heat and stretch techniques; and 4. Increasing blood flow to tissues in the treatment area.

### Non-clinical Testing

The BTL-703 device has been thoroughly evaluated for its safety and performance. The device has been found to comply with applicable medical device safety standards:

| IEC 60601-1 | Medical electrical equipment – Part 1: General requirements for<br>basic safety and essential performance |
|---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1-2 | Medical electrical equipment – Part 1-2: General requirements for<br>basic safety and essential performance - Collateral standard:<br>Electromagnetic Disturbance – Requirements and tests |
| IEC 62304 | Medical device software – Software life cycle processes |
| ISO 14971 | Medical devices - Application of risk management to medical<br>devices |
| ISO 10993-1 | Biological evaluation of medical devices – Part 1: Evaluation and<br>testing within a risk management process |
| ISO 10993-5 | Biological evaluation of medical devices – Part 5: Tests for in vitro<br>cytotoxicity |
| ISO 10993-10 | Biological evaluation of medical devices – Part 10: Tests for irritation<br>and skin sensitization |

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Image /page/5/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three interconnected blue squares, each containing the letters "B", "T", and "L" respectively. To the right of the square logo is the text "BTL Industries" in a dark gray sans-serif font.

## Animal Testing

In order to demonstrate the device is able to maintain temperature in the range of approx. 40-45°C in vivo, study in porcine model has been conducted. The results of this evaluation confirmed the ability of the BTL 703 device to maintain the temperature in the range of approx. 40-45°C in vivo.

### Technological Characteristics

The BTL-703 device has similar technological characteristics compared to its predicate. Both devices comprised of a system console and applicator(s). The system console consists of the RF generator, computer, and the touch-screen control panel.

Both devices use high-frequency electromagnetic current for a purpose of deep heating of tissue. The BTL-703, compared to the predicate device, does not included pulsed mode of operation and inductive type of applicator. Output power of BTL-703 is divided into two outputs for more even energy distribution. Nevertheless, total maximum power output stays the same (200W) as by the predicted device. The working frequency is identical for both devices.

The BTL 703 is using neqative pressure for applicator fixation compared to the predicate device using mechanical arm. Negative pressure under silicone applicator sleeves ensures uniform coupling between the capacitive electrodes and patient. The BTL-703 device also differs in the shape and dimensions when compared to its predicate. Nevertheless, these differences does not rise any new safety or effectiveness questions compared to the predicate.

Therefore, the BTL-703 has similar technological characteristics compared to its predicate device. A device comparison table comparing characteristics of the BTL-703 with the BTL Elite including the indications for use, is provided below.

| 510(k) number | K182363 | K120093 |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device name | BTL-703 | BTL Elite |
| Company name | BTL Industries, Inc. | BTL Industries, Inc. |
| Product Code<br>and Regulation | Physical Medicine<br>21 CFR 890.5290<br>IMJ – Diathermy, Shortwave,<br>For Use In Applying Therapeutic<br>Deep Heat | Physical Medicine<br>21 CFR 890.5290<br>IMJ – Diathermy, Shortwave,<br>For Use In Applying Therapeutic<br>Deep Heat |
| 510(k) number | K182363 | K120093 |
| Device name | BTL-703 | BTL Elite |
| Company name | BTL Industries, Inc. | BTL Industries, Inc. |
| Indications for Use | BTL-703 is indicated to be used<br>for applying therapeutic deep<br>heat in body tissues for the<br>treatment of selected medical<br>conditions such as: 1. Relieving<br>pain; 2. Reducing muscle<br>spasm; 3. Increasing range of<br>motion of contracted joints using<br>heat and stretch techniques; and<br>4. Increasing blood flow to<br>tissues in the treatment area. | Indications for Use: Indications<br>for use in applying therapeutic<br>deep heat in body tissues for<br>the treatment of selected<br>medical conditions such as:<br>1. Relieving pain; 2. Reducing<br>muscle spasm; 3. Increasing<br>range of motion of contracted<br>joints using heat and stretch<br>techniques; and 4. Increasing<br>blood flow to tissues in the<br>treatment area. |
| Principle of Action | Deep heating of tissue by<br>therapeutic application of radio<br>frequency electrical currents | Deep heating of tissue by<br>therapeutic application of radio<br>frequency electrical currents |
| Clinical Use | Prescription use | Prescription use |
| Electrical Protection | Class II, BF | Class I, BF |
| User Interface | Touch screen | Touch screen |
| Firmware Controlled | Yes | Yes |
| Type of Energy | High-frequency electromagnetic<br>current | High-frequency electromagnetic<br>current |
| Working frequency | 27.12 MHz | 27.12 MHz |
| Modes of operation | Continuous | Continuous<br>Pulsed |
| Max Power Output | 2 x 100 W (continuous) | 200 W (continuous) |
| 510(k) number | K182363 | K120093 |
| Device name | BTL-703 | BTL Elite |
| Company name | BTL Industries, Inc. | BTL Industries, Inc. |
| | N/A | 400 W (pulsed) |
| Therapy Time | 1 – 30 min | 1 – 30 min |
| Applicators type | Capacitive | Capacitive<br>Inductive |
| Capacitive<br>Applicators<br>Size | 100 mm | 42 mm<br>85 mm<br>130 mm |
| Inductive<br>Applicators<br>Size | N/A | 80 mm<br>140 mm |
| Way of Applicator<br>Attachment | Negative pressure | Mechanical arm lock |
| Applicator Sleeves | Yes | No |
| Thermal<br>Stabilization System | Yes | No |
| Arm control | Electrical / Mechanical | Mechanical |
| Hands-free<br>Application | Yes | Yes |
| Stop Remote<br>Control | Yes | Yes |
| Applicator<br>Contact<br>Monitor | Yes | Yes |
| System Dimensions<br>(W×H×D) | 627x985x674 mm<br>(24.7x38.8x26.5 in) | 560×980×560 mm<br>(22.5×38.6×22.5 in) |
| Configuration | Cabinet-mounted with wheels | Cabinet-mounted with wheels |
| 510(k) number | K182363 | K120093 |
| Device name | BTL-703 | BTL Elite |
| Company name | BTL Industries, Inc. | BTL Industries, Inc. |
| Environmental<br>Specifications | For indoor use only | For indoor use only |

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Image /page/6/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" inside the innermost square. To the right of the squares is the text "BTL Industries" in a gray sans-serif font.

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Image /page/7/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 logo is the text "BTL Industries" in a dark gray sans-serif font. The logo is simple and modern, and the text is clear and easy to read.

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Image /page/8/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three nested squares on the left side of the image. The letters "BTL" are inside the squares. To the right of the squares, the words "BTL Industries" are written in a sans-serif font.

## Substantial Equivalence

Based upon the indications for use and technical information provided in this pre-market notification, the BTL-703 device has been shown to be substantially equivalent to currently marketed predicate device.

### Conclusions

Performance data demonstrate that the differences between the BTL-703 and the predicate do not raise any new question regarding the safety or effectiveness.

Based on the aforementioned information, the BTL-703 is substantially equivalent to the identified predicate device.