XP3000

K150720 · BTL Industries, Inc. · PBX · Sep 16, 2015 · General, Plastic Surgery

Device Facts

• Record ID: K150720
• Device Name: XP3000
• Applicant: BTL Industries, Inc.
• Product Code: PBX · General, Plastic Surgery
• Decision Date: Sep 16, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The XP3000 RF device 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 XP3000 massage device is intended to provide a temporary reduction in the appearance of cellulite.

Device Story

XP3000 is a radiofrequency (RF) device with massage attachments; delivers non-invasive, high-frequency electromagnetic energy to tissue. System comprises a microprocessor-driven control unit, RF generator, 8.4" color touch screen, and multiple handpieces (XP 215/3 and large 215/1). Operator uses touch screen to select parameters; handpiece buttons allow control during therapy. Illuminated treatment tip indicates energy flow; contact quality monitoring system monitors patch electrode. Device used in clinical settings by trained operators. Output is controlled thermal energy (40-45 °C) to elevate tissue temperature. Benefits include temporary pain relief, muscle spasm reduction, improved local circulation, and temporary reduction in cellulite appearance.

Clinical Evidence

Performance testing was conducted to verify that the XP3000 reaches and maintains effective treatment temperatures (40-45 °C). No clinical human trials were required; substantial equivalence is supported by bench testing and comparison of technical specifications to the predicate device.

Technological Characteristics

Monopolar RF energy generator; 3.25 MHz ± 50 kHz output frequency. Class II, BF electrical protection. 8.4" color touch screen interface. Handpieces include integrated massage attachments (grey plastic). Contact quality monitoring system. Power input 100-240 VAC. Complies with ISO 14971, IEC 62304, ISO 60601-1, ISO 60601-1-2, ISO 60601-2-2, ISO 60601-1-6, and ISO 10993 series.

Indications for Use

Indicated for patients requiring tissue heating for temporary pain relief, muscle spasms, and increased local circulation, or for the temporary reduction in the appearance of cellulite.

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

• Exilis XP (K143040)

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

September 16, 2015

BTL Industries Incorporated Ms. Jan Zarsky Executive Vice President 47 Loring Drive Framingham, Massachusetts 01702

Re: K150720

Trade/Device Name: XP3000 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: PBX Dated: August 18, 2015 Received: August 20, 2015

Dear Mr. Zarsky:

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.

Sincerelv vours.

Joshua C. Nipper -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. For 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 Food and Drug Administration

#### Indications for Use

510(k) Number (if known)

#### K150720

Device Name XP3000

#### Indications for Use (Describe)

The XP3000 RF device 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 XP3000 massage device is intended to provide a temporary reduction in the appearance of cellulite.

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

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# 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<br>Framingham, MA 01702<br>Tel: [phone]<br>Fax: [phone] |
| Contact Person: | Jan Zarsky<br>BTL Industries, Inc.<br>Executive VP |

[e-mail]

Summary Preparation 12 February 2015 Date:

#### Device Names

| Trade/Proprietary Name: | XP3000 |
|------------------------------|------------------------------------------------|
| Primary Classification Name: | Massager, Vacuum, Radio Frequency Induced Heat |
| Classification Regulation: | 878.4400 |
| Product Code: | PBX |

### Legally Marketed Predicate Devices

The XP3000 system is a state-of-the-art high-frequency energy device with accessories, and is substantially equivalent to the current product that is already cleared for USA distribution under the following 510(k) Premarket Notification number:

- . Exilis XP (K143040)
### Product Description

The XP3000 is a state-of-the-art radiofrequency device with massage attachments that enables the application of therapy by a non-invasive, high-frequency field.

The control unit of the system is fitted with a color touch screen, to facilitate use of the device. The on-screen information guides the operator through the entire therapy. For

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easier control, the handpieces are equipped with buttons, enabling operation of the device during therapy. Quality of the energy flow is indicated by the illuminated treatment tip.

Contact quality monitoring system is present for monitoring of the contact quality under the patch electrode. An easy-to-read handpiece displays show the selected treatment parameters.

Any therapeutic parameter can be set easily by simple use of the touch-screen buttons. During the entire therapy time the device informs you about the therapeutic method, the type of the therapy applied, the set power, and other necessary data.

The XP3000 consists of the following main components:

- microprocessor-driven control unit .
- . high-frequency electromagnetic energy generator
- . user interface with 8.4" color touch screen
- . handpiece XP (215/3)
- . two massage attachments for the XP handpiece
- . large handpiece (215/1) with integrated massage part
- . large handpiece (215/1)

### Indications for Use

The XP3000 RF device 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 XP3000 massage device is intended to provide a temporary reduction in the appearance of cellulite.

#### Non-clinical Testing

The XP3000 device has been thoroughly evaluated for electrical safety. The XP3000 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

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

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Image /page/5/Picture/0 description: The image shows a logo with three interconnected squares in blue. Inside the squares are the letters 'B', 'T', and 'L', respectively. Below the logo, the text 'ISO 1099' is displayed, indicating a reference to the ISO 1099 standard.

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

# Clinical testing

The substantial equivalence determination for the XP3000 is based on clinical performance testing. The aim of the performance test was to prove that XP3000 device reaches the effective treatment temperature and maintain it for required time.

| Comparison with the Predicate Device | |
|--------------------------------------|--|
|--------------------------------------|--|

| Device Name | XP3000 | Exilis XP |
|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | BTL Industries, Inc. | BTL Industries, Inc. |
| 510(k) Number | Current Submission | K143040 |
| Product Code | General & Plastic Surgery<br>21 CFR 878.4400 | General & Plastic Surgery<br>21 CFR 878.4400 |
| Regulation | · PBX, Massager, Vacuum, Radio<br>Frequency Induced Heat | · PBX, Massager, Vacuum, Radio<br>Frequency Induced Heat |
| Indications for<br>Use | The XP3000 RF device is<br>intended to provide heating for the<br>purpose of elevating tissue<br>temperature for selected medical<br>conditions such as temporary<br>relief of pain, muscle spasms, and<br>increase in local circulation. The<br>XP3000 massage device is<br>intended to provide a temporary<br>reduction in the appearance of<br>cellulite. | The Exilis XP RF device is<br>intended to provide heating for the<br>purpose of elevating tissue<br>temperature for selected medical<br>conditions such as temporary relief<br>of pain, muscle spasms, and<br>increase in local circulation. The<br>Exilis XP massage device is<br>intended to provide a temporary<br>reduction in the appearance of<br>cellulite. |
| Device<br>Technologies | Application of the heat to the<br>tissue via RF energy. Massaging<br>of body parts with massage<br>attachment. | Application of the heat to the<br>tissue via RF energy. Massaging<br>of body parts with massage<br>attachment. |
| Electrical<br>Protection | Class II, BF | Class II, BF |
| Color Touch<br>Screen | 8.4" (215mm)/640×480 pixel | 8.4" (215mm)/640×480 pixel |
| RF Tip<br>Diameter XP<br>Handpiece<br>(215/3) | 18mm | 18mm |
| RF Tip<br>Diameter<br>Large | 21.4mm | N/A |
| Device Name | XP3000 | Exilis XP |
| Manufacturer | BTL Industries, Inc. | BTL Industries, Inc. |
| 510(k) Number | Current Submission | K143040 |
| Handpiece | | |
| with Integrated | | |
| Massage Part | | |
| (215/1) | | |
| RF Tip | 21.4mm | N/A |
| Diameter | | |
| Large<br>Handpiece | | |
| without | | |
| Integrated | | |
| Massage Part | | |
| (215/1) | | |
| Maximum | Handpiece 215/3 - 120W | Handpiece 215/3 - 120W |
| Output | Handpiece 215/1 - 170W | Handpiece 215/1 - N/A |
| Power | | |
| Energy | 0.473 W/mm² | 0.472 W/mm² |
| Density | | |
| Effective | 40 - 45 °C | 40 - 45 °C |
| Treatment | | |
| Temperature | | |
| Large | YES | N/A |
| Handpiece | | |
| (215/1) Cooling | | |
| Modes of | Monopolar | Monopolar |
| Operation | | |
| Output | 3.25MHz ± 50kHz | 3.25MHz ± 50kHz |
| Frequency | | |
| Massage | Grey Plastic material | Grey Plastic material |
| Attachment | | |
| Material | | |
| Massage | Diameter 80 mm, | Diameter 80 mm, |
| Attachment 1 | Massage ball diameter 19mm, | Massage ball diameter 19mm, |
| (XP | Massage ball number: 5 | Massage ball number: 5 |
| Handpiece)<br>Massage | Diameter 52mm, | Diameter 52mm, |
| Attachment 2 | Massage ball diameter 12mm | Massage ball diameter 12mm |
| (XP | Massage ball number: 5 | Massage ball number: 5 |
| Handpiece) | | |
| Massage Part | Diameter 80mm, | N/A |
| (Large | Massage ball diameter 19mm, | |
| Handpiece) | Massage ball number: 5 | |
| Device Name | XP3000 | Exilis XP |
| Manufacturer | BTL Industries, Inc. | BTL Industries, Inc. |
| | 510(k) Number Current Submission | K143040 |
| | Energy Source 100 - 240 VAC, max 4A, 50-60 Hz 110 - 240 V, max 4A, 50-60 Hz | |
| Dimensions<br>(W x H x D) | 600 × 1000 × 600mm<br>(24" × 39" × 24") | 406 × 270 × 302mm<br>(15.98" × 10.63" × 11.87") |
| Weight | 66 lb (30 kg) | 16 lb (7.3 kg) |

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## Substantial Equivalence

Based upon the intended use and technical information provided in this pre-market notification, the XP3000 device has been shown to be substantially equivalent to currently marketed predicate device.

### Conclusion

Based on the aforementioned information, the XP3000 is safe and effective and substantially equivalent to the identified predicate device.