XP1000 RF

K143559 · BTL Industries, Inc. · GEI · Jun 11, 2015 · General, Plastic Surgery

Device Facts

• Record ID: K143559
• Device Name: XP1000 RF
• Applicant: BTL Industries, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jun 11, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The XP1000 RF device is indicated for temporary reduction in circumference of the abdomen.

Device Story

XP1000 RF is a high-frequency electromagnetic field device for temporary reduction of abdominal circumference. System comprises a microprocessor-controlled unit, RF generator, 8.4" touch screen, and applicator on a multi-jointed arm. Operated by clinicians in office settings; device positioned via cart. Operator uses touch screen and control knob to set output power; applicator delivers RF energy to target tissue. Device disrupts adipocyte cells via deep tissue heating (40°C–45°C). Clinical benefit includes measurable waist circumference reduction. Safety features include patch electrode contact quality monitoring. Patient feedback and external IR thermometer used for temperature monitoring.

Clinical Evidence

Double-blinded study of 60 subjects (19-53 years old) randomized to treatment (n=40) or sham (n=20). Primary endpoint: ≥3 cm waist circumference reduction in >80% of treatment subjects. Treatment group achieved statistically significant reduction compared to placebo at 30-day follow-up. No adverse events reported. Efficacy established at maximum power (200 points).

Technological Characteristics

Bipolar RF energy generator (27.12 MHz ±400kHz). Max power 200W. Class II, BF electrical protection. Multi-jointed arm applicator. 8.4" color touch screen interface. Materials conform to ISO 10993-1, -5, -10. Complies with IEC 60601-1, 60601-1-2, 60601-1-6, 60601-2-2, and ISO 14971. Includes patch electrode contact quality monitoring. Sterilization not specified; device is for external use.

Indications for Use

Indicated for temporary reduction in abdominal circumference in patients 22 years or older.

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

• Transcend System (K120510)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 11, 2015

BTL Industries Incorporated % Dr. Michail Pankratov MMP Medical Associates, LLC 16 Appleton Street Waltham, Massachusetts 02453

Re: K143559

Trade/Device Name: XP1000 RF Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: May 6, 2015 Received: May 7, 2015

Dear Dr. Pankratov:

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. 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Jennifer R. Stevenson -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
F

#### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K143559

Device Name XP1000 RF

Indications for Use (Describe)

The XP1000 RF device is indicated for temporary reduction in circumference of the abdomen.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| <span> ☒ Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
|-------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
|-------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|

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Image /page/3/Picture/0 description: The image shows a logo for BTL, which is a telecommunications company in Belize. The logo consists of three interconnected blue diamonds. The letters "B", "T", and "L" are placed inside the diamonds, with each letter in a separate diamond.

#### K143559 Page 1 of 6

## Section 5 – 510(k) Summary

#### General Information

| Sponsor: | BTL Industries, Inc.<br>47 Loring Drive<br>Framingham, MA 01702<br>Tel: [phone]<br>Fax: [phone] |
|------------|-----------------------------------------------------------------------------------------------------------------|
| Applicant: | BTL Industries, Inc.<br>47 Loring Drive |

Framingham, MA 01702 Tel: [phone] Fax: [phone]

- Contact Person: Michail Pankratov MMP Medical Associates, LLC 16 Appleton Street Waltham, MA 02453 Tel: [phone] Fax: [phone]

| Summary Preparation | |
|---------------------|--------------|
| Date: | June 3, 2015 |

#### Device Names

| Trade/Proprietary Name: | XP1000 RF |
|------------------------------|--------------------------------------------------------------|
| Primary Classification Name: | Electrosurgical Cutting and Coagulation Device & Accessories |
| Classification Regulation: | 878.4400 |
| Product Code: | GEI |

#### Legally Marketed Predicate Devices

The XP1000 RF system 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:

- Transcend System (K120510)

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Image /page/4/Picture/0 description: The image shows a logo with the letters BTL in a stylized font. The letters are arranged within three interconnected diamond shapes. The logo is a solid blue color and is set against a white background.

### Product Description

The XP1000 RF system is designed for temporary reduction in circumference of the abdomen by means of high-frequency electromagnetic field.

The multi-jointed arm firmly supports the applicator during treatment. Large knobs lock and unlock the joints to make positioning the applicators to the patient quick, easy and secure.

The control unit consists of the control system and the electronic system. The control system contains the main microcomputer and software for control of the entire equipment; the electronic system contains the complete electromagnetic field generation. Easy-to-use color touch screen allows for maximum operator comfort. A large control knob is provided to increase and decrease output power.

The XP1000 RF system 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 XP1000 RF consists of the following main components:

- . microprocessor-driven control unit
- . high-frequency electromagnetic energy generator
- . user interface with 8.4" color touch screen
- . applicator on a multi-jointed arm

#### Indications for Use

The XP1000 RF is indicated for temporary reduction in circumference of the abdomen.

#### Non-clinical Testing

The XP1000 RF device has been thoroughly evaluated for electrical safety and performance. The XP1000 RF has been found to conform with applicable medical device safety standards. The system complies with the following standards:

ISO 14971 – Medical devices – Application of risk management to medical devices IEC 62304 - Medical Device Software - Software Life Cycle Processes

Medical Electrical Equipment

IEC 60601-1 General requirements for safety IEC 60601-1-2 Electromagnetic compatibility-Requirements and Tests IEC 60601-1-6 Usability IEC 60601-2-2 Particular requirements for basic safety and performance of high frequency surqical equipment ISO 10993-1 Evaluation and testing within a risk management process ISO 10993-5 Biological Evaluation of Medical Devices-Tests for In Vitro toxicity

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Image /page/5/Picture/1 description: The image shows a logo with three blue diamond shapes interlocked. The letters "BTL" are arranged inside the diamond shapes. The logo is simple and modern, with a clean design.

ISO 10993-10 Biological Evaluation of Medical Devices-Test for Irritation and Skin Sensitization

### Clinical testing

The device was clinically tested for reduction of abdominal circumference by disruption of adipocvte cells.

Sixty subjects, ranging from 19 to 53 years of age, were enrolled in the double blinded study and divided into 2 groups: 40 to the XP1000 RF Treatment Group and 20 to the Sham (Placebo) Group. All subiects but one finished the study.

The Treatment Group subjects have met the primary efficacy outcome measure by achieving ≥3 cm waist circumferential reduction in more than 80% of subjects. The mean circumferential reduction was ≥1 cm than the mean circumferential reduction of the Placebo Group at the 30-day Follow Up evaluation point.

Waist circumference changes (Baseline data vs the 30-day and 90-day Follow Up data) between the XP1000 RF Treatment subjects and the Placebo Group were statistically highly significant.

The secondary objective was absence of adverse events (AE) associated with the treatment procedure. The secondary objective was met with no adverse events recorded.

The clinical study supports the effectiveness of the device for temporary reduction of abdominal circumference.

The efficacy of XP1000 RF was not established at power level settings below maximum power of 200 points. The device is indicated for patients 22 years or older because its safety and effectiveness have not been established in pediatric patients younger than 22 years.

| 510(k) number | K143559 | K120510 |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device name | XP1000 RF | Transcend System |
| Company name | BTL Industries, Inc. | Syneron Medical Ltd. |
| Product Code<br>Regulation | General & Plastic<br>Surgery<br>21 CFR 878.4400<br>-GEI, Electrosurgical<br>Cutting and<br>Coagulation<br>Device & | General & Plastic<br>Surgery<br>21 CFR 878.4400<br>-GEI, Electrosurgical<br>Cutting and<br>Coagulation<br>Device & |
| 510(k) number | K143559 | K120510 |
| Device name | XP1000 RF | Transcend System |
| Company name | BTL Industries, Inc. | Syneron Medical<br>Ltd. |
| | Accessories. | Accessories. |
| Indications for<br>Use | The XP1000 RF is<br>indicated for<br>temporary reduction<br>in circumference of<br>the abdomen. | The Transcend is<br>indicated for<br>temporary reduction<br>in circumference of<br>the abdomen. |
| Deep tissue<br>Heating<br>Electromagnetic<br>Energy | Radiofrequency | Radiofrequency +<br>InfraRed |
| Vacuum | No | Yes |
| Electrical<br>Protection | Class II, BF | Class I, BF |
| Unit<br>Construction | Constructed of<br>materials that<br>conform with safety<br>standards and<br>requirements. | Constructed of<br>materials that<br>conform with safety<br>standards and<br>requirements. |
| Interface | Touch-screen user<br>applied interface to<br>program and set the<br>controls for the<br>patient application;<br>there is an applicator<br>utilized to deliver the<br>treatment. | Touch-screen user<br>applied interface to<br>program and set the<br>controls for the<br>patient application;<br>there is a hand-<br>piece utilized to<br>deliver the<br>treatment. |
| Color Touch<br>Screen | 8.4"<br>(21.5cm)/640x480<br>pixel | 10.1" (25.7 cm) |
| Modes Of<br>Operation | Bipolar | Bipolar |
| 510(k) number | K143559 | K120510 |
| Device name | XP1000 RF | Transcend System |
| Company name | BTL Industries, Inc. | Syneron<br>Medical<br>Ltd. |
| Nominal<br>Operating<br>Power | Max: 200W RF | Max: 151.7W (150W<br>RF, 1.7 or 3.3W IR) |
| RF Carrier<br>Frequency | 27.12<br>(±400kHz) MHz | 1 MHz |
| Operating<br>Temperature | 10°C to 30°C | 15°C to 30°C |
| Operating<br>Humidity | 30% - 75% | Up to 80% |
| Skin<br>Temperature<br>Monitoring | Based on patient's<br>feedback. External<br>IR thermometer. | Based on patient's<br>feedback. Built-in IR<br>thermometer. |
| Treatment<br>Temperature<br>Range | 40°C - 45°C | 40°C - 45°C |
| Cooling | Not Available | Not Available |
| Cooling<br>Mechanism | Not Available | Not Available |
| Applicator<br>Holder | YES | YES |
| Availability<br>Waveform | Sinusoid | Sinusoid |
| Applicator<br>Effective<br>Area | 20,106 mm² | 1,250 mm²<br>750 mm²<br>130 mm² |
| Treatment Time | Up to 45 min. per<br>treated area (waist) | Up to 45 min. per<br>treated area (waist) |
| Total Energy<br>Density<br>(fluence) | 3.6 - 27 J/mm² | 3.6 J/mm²<br>6.0 J/mm²<br>34.6 J/mm² |
| Material of the<br>Generator Case | Plastic/metal | Plastic/metal |
| Dual Dispersive<br>Patch Electrode<br>Grounding | NO | NO |
| Patch Electrode<br>Contact Quality<br>Monitoring | YES | N/A |
| 510(k) number | K143559 | K120510 |
| Device name | XP1000 RF | Transcend System |
| Company name | BTL Industries, Inc. | Syneron Medical Ltd. |
| RF Energy Emission Indicator | YES; Information displayed on the screen of the unit | YES |
| Applicator Weight | 3.9 lbs (1760 g) | 2.2 lbs (1 kg) |
| Energy Source | 100 – 240 VAC, max 5A, 50 – 60Hz | 110 – 230 VAC, max 5A, 50Hz |
| External Exchangeable Fuse | 2 × T4A / 250V, tube fuse 5 × 20 mm | Available |
| System Dimensions | 22" × 39" × 22"<br>(56 cm x 98 cm x 56 cm) | 15" × 19" × 51.8"<br>(132 cm × 49 cm × 38 cm) |
| System Weight | 83 lbs (38 kg) | 44.1 lbs (20 kg) |

#### Comparison with the Predicate Device

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Image /page/6/Picture/1 description: The image shows a logo with the letters B, T, and L. The letters are in blue and are inside of three diamond shapes that are linked together. The letter B is in the left diamond, the letter T is in the center diamond, and the letter L is in the right diamond. The logo is simple and modern.

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Image /page/8/Picture/1 description: The image shows a blue logo with the letters BTL. The letters are inside of three diamond shapes that are connected to each other. The logo is simple and modern.

### Substantial Equivalence

Based upon the intended use and technical information provided in this pre-market notification, the XP1000 RF device has been shown to be substantially equivalent to currently marketed predicate device.

#### Conclusion

Based on the aforementioned information, the XP1000 RF is safe and effective and substantially equivalent to the identified predicate device.