XP300

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines suggesting hair or wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 10, 2015 BTL Industries Incorporated Mr. Jan Zarsky Director 47 Loring Drive Framingham, Massachusetts 01702 Re: K143109 Trade/Device Name: XP300 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical, Cutting & Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: February 4, 2015 Received: February 9, 2015 Dear Mr. Zarsky: This letter corrects our substantially equivalent letter of March 6, 2015. 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 {1}------------------------------------------------ device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 8, please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) Device Name XP300 Indications for Use (Describe) The XP300 device is indicated for the primary treatment of dermatological procedures for non-invasive treatment of periorbital wrinkles and rhytids. 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) #### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 510(k) Summary for ### XP300 #### 1. Submission Sponsor BTL Industries, 47 Loring Drive Framington MA, 01702 USA Phone: 866.285.1656 Fax: 866.499.2502 Contact: Jan Zarsky, Director 2. Submission Correspondent Mr. Jan Zarsky Director BTL Industries 47 Loring Drive Framington, MA 01702 USA Email: zarsky@btlnet.com - 3. Date Prepared January 15, 2015 - 4. Device Identification | Trade/Proprietary Name: | XP300 | |----------------------------|----------------------------------------------------------------| | Common/Usual Name: | Electrosurgical, cutting & coagulation & accessories | | Classification Name: | Electrosurgical cutting and coagulation device and accessories | | Classification Regulation: | 21 CFR 878.4400 | | Product Code: | GEI | | Device Class: | Class II | | Classification Panel: | General & Plastic Surgery | - 5. Legally Marketed Predicate Device(s) | Trade/Proprietary Name: | XP200 | |----------------------------|----------------------------------------------------------------| | Common/Usual Name: | Electrosurgical, cutting & coagulation & accessories | | Classification Name: | Electrosurgical cutting and coagulation device and accessories | | Classification Regulation: | 21 CFR 878.4400 | | Product Code: | GEI | | Device Class: | Class II | | Classification Panel: | General & Plastic Surgery | {4}------------------------------------------------ #### 6. Device Description The XP300 device is indicated for the primary treatment of dermatologic procedures for noninvasive treatment of periorbital wrinkles and rhytids. The XP300 system is a state-of-theart device to apply therapy by a non-invasive method of high-frequency field. The control unit of the device is fitted with a color touch screen, which significantly facilitates the use of the device. The design of the device enables the operator to see the on-screen information from various angles during the procedure. In addition, the brightness of the screen can be set to match the lighting in the room. The on-screen information will guide you through the entire therapy by means of easy setting of parameters using touch-screen buttons and knobs/keys on the device. For easier control, the applicator is equipped with buttons, enabling to operate the device during therapy, and a display, which shows the set and indicated parameters. The XP300 device incorporates the ultrasonic feature for added patient comfort. 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 XP300 consists of the following main components: - . microprocessor-driven control unit - . high-frequency electromagnetic generator and ultrasonic element - . user interface with 8.4" colour touch screen - applicator with colour screen and control buttons . The main change between this device and the predicate is the inclusion of the Ultrasonic convenience function which is intended to improve patient's comfort during the procedure - 7. Indication for Use Statement The XP300 is indicated for the primary treatment of dermatological procedure for noninvasive treatment of periorbital wrinkles and rhytids. - 8. Substantial Equivalence Discussion The following table compares the XP300 to the predicate device, XP200, with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence. {5}------------------------------------------------ | Manufacturer | BTL Industries, Inc. | BLT Industries, Inc. | SIGNIFICANT<br>DIFFERENCES | |-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name | XP300 | XP200 | n/a | | 510(k) Number | Unknown | K122966 | n/a | | Product Code | GEI | GEI | No difference | | Regulation<br>Number | 21 CFR 878.4400 | 21 CFR 878.4400 | No difference | | Regulation Name | Electrosurgical cutting<br>and coagulation device<br>and accessories | Electrosurgical cutting<br>and coagulation device<br>and accessories | No difference | | Intended Use | Application of heat to<br>the tissue w/RF energy | Application of heat to the<br>tissue w/RF energy | No difference | | Indications for Use | The XP300 is indicated<br>for the primary<br>treatment of<br>dermatological<br>procedure for non-<br>invasive treatment of<br>periorbital wrinkles and<br>rhytids. | The XP200 is indicated<br>for the primary<br>treatment of<br>dermatological<br>procedure for non-<br>invasive treatment of<br>periorbital wrinkles and<br>rhytids. | No difference | | Material | The unit is constructed<br>of material that conform<br>with safety standards<br>and requirements. | The unit is constructed of<br>material that conform<br>with safety standards<br>and requirements. | No difference | | Sterile | No | No | No difference | | Single-Use | No | No | No difference | | Interface | Touch-Screen user<br>applied interface to<br>program and set the<br>controls for the patient<br>application; there is a<br>hand-piece utilized to<br>deliver the treatment. | Touch-Screen user<br>applied interface to<br>program and set the<br>controls for the patient<br>application; there is a<br>hand-piece utilized to<br>deliver the treatment. | No difference. | | The ultrasonic<br>convenience<br>Function | Yes | No | No significant<br>difference.<br><br>The change is being<br>introduced to improve<br>patient's comfort<br>during the application.<br><br>There is no change to<br>the principle of<br>operation. | | Table 5A – Comparison of Characteristics | | |---------------------------------------------|--| | | | {6}------------------------------------------------ | Manufacturer | BTL Industries, Inc. | BLT Industries, Inc. | SIGNIFICANT<br>DIFFERENCES | |--------------------------------------------|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|----------------------------| | Trade Name | XP300 | XP200 | n/a | | Color Touch Screen | 8.4" (2.15 cm)/640x480 pixels | 8.4" (2.15 cm)/640x480 pixels | No difference | | Energy Type | Radiofrequency | Radiofrequency | No difference | | Modes of Operation | Monopolar | Monopolar | No difference | | Nominal Operating power | 120 W | 120 W | No difference | | Operating temperature | 18°C to 30°C | 18°C to 30°C | No difference | | Operating Humidity | 60%-75% | 60%-75% | No difference | | Temperature Treatment Range | 39°C to 42°C | 39°C to 42°C | No difference | | Power Level Adjustable via Applicator | Yes | Yes | No difference | | Patch Electrode Contact Quality Monitoring | Yes | Yes | No difference | | RF Energy Emission Indicator | Yes; Information displayed on the screen of the applicator and on the main screen of the unit. | Yes; Information displayed on the screen of the applicator and on the main screen of the unit. | No difference | | Applicator Dimensions | 4.25" x 2.6" x 7"<br>(11cm x 7cm x18cm) | 4.25" x 2.6" x 7"<br>(11cm x 7cm x18cm) | No difference | | Complies with ISO 10993-1 | Yes | Yes | No difference | | Electrical Safety Testing Passed | Class II, BF | Class II, BF | No difference | | Energy Source | 100-240 VAC, max 4A,<br>50-60 Hz | 100-240 VAC, max 4A,<br>50-60 Hz | No difference | | System Dimensions | 16" X 10.6" x 11.9"<br>(41cm x 22cm x 18cm) | 16" X 10.6" x 11.9"<br>(41cm x 22cm x 18cm) | No difference | | System Weight | 16lb (7.3kg) | 16lb (7.3kg) | No difference | {7}------------------------------------------------ #### Non-Clinical Performance Data 9. This Special 510(k) proposes a modification to the applicator by incorporating an ultrasonic element to improve patient's comfort during the application. This proposed change does not impact the indications for use, technology, principle of operation, patient contact materials, or packaging of the device. Testing has been performed on the modified applicator to demonstrate that treatment heads applied to the patient shall have a convenient patient contact surface temperature. The change only applies to the applicator therefore XP300 continues to conform to the medical device safety standards applicable to both XP300 and XP200. The device has been evaluated to demonstrate electrical, electromagnetic and mechanical safety. Medical device software life cycle processes have been verified and validated as well as output and biocompatibility. 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 #### MedicalElectricalEquipment: IEC 60601-1 General requirements for safety IEC 60601-1-2 Collateral Standard: Electromagnetic compatibility – Requirements and Tests IEC 60601-2-2 Particular requirements for the safety of high frequency surgical equipment IEC 60601-1-6 General requirements for basic safety and essential performance Collateral standard: Usability EMCRequirements for Medical Equipment: IEC 61000-4-2; IEC 61000-4-3; IEC 61000-4-4; IEC 61000-4-5 BiologicalEvaluationforMedicalDevices: ISO 10993-1; ISO 10993-5; ISO 10993-10 #### PerformanceTesting: - Frequency Accuracy and Carrier Wave Form . - . Carrier Wave Nominal Output Power - Power Fluency - Tissue Heating: The performance testing confirmed safety of simultaneous application of radiofrequency and ultrasound energy. The XP300 meets all the requirements for overall design, biocompatibility, and electrical safety confirms that the output meets the design inputs and specifications. The XP300 complies with the applicable voluntary standards for biocompatibility. {8}------------------------------------------------ #### 10. Clinical Performance Data There was no clinical testing required to support the XP 300 medical device as the indications for use are equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with a proven safety and efficacy for the use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device. #### 11. Biocompatibility and Sterilization/Shelf-life The change does not impact the biological safety of the device. The XP200 device biocompatibility was tested according to the ISO 10993-1; ISO 10993-5; ISO 10993-10. There are no changes in the product life and shelf life compared to that of XP200 device. The device shelf life is 5 years. The product life is 5 years. The device is not intended to be sterile and is not intended to be sterilized by the user. #### 12. Statement of Substantial Equivalence It has been shown in this 510(k) submission that the differences between the XP300 and the predicate device do not raise any questions regarding its safety and effectiveness. The XP300, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate device; XP200.