Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories

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November 21, 2019 US Medical Innovations, LLC % Timothy Joiner, Senior Consultant Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, Texas 78746 Re: K192124 Trade/Device Name: Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: October 22, 2019 Received: October 28, 2019 Dear Timothy Joiner: 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. 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 {1}------------------------------------------------ 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 medical devices and radiation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K192124 Device Name Canady Plasma® SMART XL-1000™ Electrosurgical Generator with Accessories #### Indications for Use (Describe) The Canady Plasma® SMART XL-1000™ Electrosurgical Generator with Accessories is intended to provide gasenhanced coagulation during general surgery procedures. The Cana® SMART XL-1000™ Electrosurgical Generator with Accessories is designed for gas enhanced coagulation when used only with the Canady Plasma Electrosurgery Unit and compatible monopolar and/or bipolar handpieces. The Canady Electrosurgery Unit Generators are intended to cut and/or coagulate tissue when used with compatible monopolar and/or bipolar RF handpieces. The Canady Electrosurgery Unit Generators are capable of monopolar argon gas enhanced coagulation when used with Canady Plasma Coagulator and probes X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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}------------------------------------------------ # Special 510(k) Summary Canady Plasma® SMART XL-1000™ Electrosurgical Generator with Accessories ## 1. Submission Sponsor US Medical Innovations, LLC 6930 Carroll Ave Suite 1000 Takoma Park MD, 20912 USA Contact: Jerome Canady Title: CEO # 2. Submission Correspondent Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Office Phone: (512) 327-9997 Contact: Timothy Joiner Title: Senior Consultant ### 3. Date Prepared August 5, 2019 # 4. Device Identification Trade/Proprietary Name: Canady Plasma® SMART XL-1000™ Electrosurgical Generator with Accessories Common/Usual Name: Electrosurgical Generator Classification Name: Electrosurgical cutting and coagulation device and accessories Regulation Number: 878.4400 Product Code: GEI Class: 2 Classification Panel: General and Plastic Surgery ### 5. Legally Marketed Predicate Device Canady Plasma® Electrosurgical Unit SS Series with Accessories (K100669) ### 6. Indication for Use Statement {4}------------------------------------------------ The Canady Plasma® SMART XL-1000™ Electrosurgical Generator with Accessories is intended to provide gas-enhanced coagulation during general surgery procedures. The Canady Plasma® SMART XL-1000™ Electrosurgical Generator with Accessories is designed for gas enhanced coagulation when used only with the Canady Plasma Electrosurgery Unit and compatible monopolar and/or bipolar handpieces. The Canady Electrosurgery Unit Generators are intended to cut and/or coagulate tissue when used with compatible monopolar and/or bipolar RF handpieces. The Canady Electrosurgery Unit Generators are capable of monopolar argon gas enhanced coagulation when used with Canady Plasma Coagulator and probes. # 7. Device Description The Canady Plasma® SMART XL-1000™ Electrosurgical Generator (CPSXEG) with Accessories is a High Frequency (HF) Electrosurgery Unit (ESU) used in combination with electrosurgical probes. The CPSXEG combines (HF) voltage to electrically enhanced plasma gas (i.e. Argon) to produce a plasma gas stream. Current density upon arrival at the tissue surface from Canady Plasma Probes causes coagulation of the tissue. The CPSXEG is also a monopolar and bipolar RF surgical device for cutting and coagulation. It is used for tissue removal and coagulation in accordance with the operative procedure performed by the physician. The unit provides various cutting, coagulation, hybrid plasma, and argon plasma modes to meet the physician's flexibility performing the specific procedure with the device The modified Canady Plasma Smart XL-1000™ ESU has the same intended use as the predicate SS-601/Argon 4 Canady Plasma® Electrosurgical Unit as well as the same performance specifications. The modified device has the same protective circuits as the predicate ESU which displays the equipment output error on the monitor screen with a graphic symbol so that the user can determine the cause of the error. The packaging, labeling (i.e. user manual) are the same. The Canady Plasma® SMART XL-1000™ Electrosurgical Generator has a touch screen color monitor that provides the user with quick start, on screen tutorial and user manual as well as operational and settings. Various cutting, coagulation, bipolar, and plasma modes are the predicate unit, but the modified device has improved programmable software. When turned on, an APPS screen is displayed on the monitor screen. The user can decide which medical application is started by touching the particular application (i.e Pediatrics, orthopedics, endoscopy, gynecology). Upon activation of the device audio and visual error system malfunctions or user errors can be observed by the user. Once the device is activated, power in watts, gas flow rate, gas volume, PPM, and energy mode are displayed on the monitor screen. # 8. Substantial Equivalence Discussion The following table compares the Canady Plasma® SMART XL-1000™ Electrosurgical Generator with Accessories to the predicate device with respect to intended use, principles of operation, technological characteristics, and performance, and forms the basis for the determination of substantial equivalence. The subject device does not raise any new questions of safety or effectiveness as compared to the predicate device. # Table 5A – Comparison of Characteristics {5}------------------------------------------------ | Trade Name | Canady Plasma Electrosurgery<br>Unit<br>(Predicate Device) | Canady Plasma SMART<br>Electrosurgical Generator XL-<br>1000 | Significant<br>Difference | |----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------| | Manufacturer | USMI | USMI | N/A | | 510(k) Number | K100669 | N/A | N/A | | Model | SS-601MCa | XL-1000 | N/A | | CPC Used With | Canady Plasma Coagulator<br>Argon 4 | CPC is consolidated into the<br>XL-1000 | N/A | | Intended Use | Cut and/or coagulate tissue | Cut and/or coagulate tissue | None | | Generator Type | High Frequency | High Frequency | None | | Frequency | 390 kHz | 390 kHz | None | | Peak to Peak Voltage<br>(rated Ω) | 4kV (1000 Ω) | 4kV (1000 Ω) | None | | Main CPU Type | FPGA | FPGA | None | | Display Type | LED with backlight | LCD with backlight | Minor | | Monopolar | Yes, insulated | Yes, insulated | None | | Bipolar | Yes | Yes | None | | Handswitch | Yes | Yes | None | | Footswitch | Yes, independent switches for<br>monopolar and bipolar | Yes, independent switches for<br>monopolar and bipolar | None | | Monopolar Modes | Cut (Pure, Blend I,II,III, Pure<br>High Cut, Blend High Cut I,II), E-<br>Cut<br>Coagulation (Spray, Fulgurate<br>High, Fulgurate Low, Desiccate<br>1,II,III) | Cut (Pure, Blend I,II,III, Pure<br>High Cut, Blend High Cut I,II), E-<br>Cut<br>Coagulation (Spray, Fulgurate<br>High, Fulgurate Low, Desiccate<br>I,II,III) | None | | Bipolar Modes | Cut, Coagulate (Micro, Default,<br>Macro) | Cut, Coagulate (Micro, Default,<br>Macro) | None | | Volume Control | Yes | Yes | None | | Defeatable-Inaudible<br>Volume Control | No | No | None | | Power Setting Shown | Yes | Yes | None | | Cooling Type | Convection | Convection | None | | Input Voltage, VAC | 100 – 240 | 100 - 240 | None | | Meets IEC 60601-1 | Yes | Yes | None | | Meets IEC 60601-1-2 | Yes | Yes | None | | Meets IEC 60601-2-2 | Yes | Yes | None | # 9. Non-Clinical Performance Data Internal verification and validation testing confirm that product specifications of the Canady Plasma® SMART XL-1000™ Electrosurgical Generator with Accessories are met. These are equivalent to those of the unmodified predicate device. The testing/measurement of the output parameters of the Canady Plasma® SMART XL-1000™ Electrosurgical Generator (CPSEG-XL-1000) was performed to demonstrate that the CPSEG-XL-1000 performed as specified and in accordance with the specifications of the predicate device USMI SS-601/Argon 4. The results support that the device's design changes do not affect the safe and effective use of the device as compared to the unmodified predicate device. {6}------------------------------------------------ US Medical Innovations, LLC established design and development quality system procedures to direct and control hardware and software design and development activities. The following procedures are: Development plan, design, Design input / Software (as applicable) Risk Management/ Risk Analysis, Design Review, Validation Master Sheet, Verification Master Sheet, Design Change Master Sheet, Design Transfer Checklist and Release Documentation. The activities provide a framework for final project and management approval for the necessary controls on the design and development of new products. The Canady Plasma® SMART XL-1000™ Electrosurgical Generator with Accessories has the same principles of operation and technological characteristics as the predicate device in the previous 510k (K100669). Electromagnetic Compatibility, Electrical Safety, and Performance Testing of the Canady Plasma® SMART XL-1000™ Electrosurgical Generator with Accessories included the following testing: | EM / ES | Performance | Usability | |---------------------------------------------------------------------------|-------------------------|-------------------------------------------------------| | Conducted Emissions - Voltage | Crest Factor Comparison | Operation Modes Selection Test | | Radiated Emissions | Frequency | Power Adjustment Test | | Harmonic Current Emission | Peak to Peak Voltage | Flow Rate Adjustment Test | | Voltage Fluctuations / Flicker | Monopolar Cut Mode | Standby Mode System Activation Test | | Radiated Electromagnetic Field<br>Immunity | Maximum Watts | Gas Tank Pressure Value Indication<br>Test | | Immunity to Proximity Fields from RF<br>Wireless Communications Equipment | Maximum Voltage | Audio / Visual Warning / Notification<br>Test | | Surge Immunity | Bipolar Cut Mode | User Profile Selection Test | | Conducted RF Immunity | Maximum Watts | User Profile Editing Test | | Magnetic Immunity | Maximum Voltage | Font Size Visibility Test | | Voltage Dips Interruption and<br>Variations | | Icon Size Visibility Test | | | | Button Response Test | | | | Font / Icon Color Code Test | | | | Power Button Increment / Decrement<br>Speed Test | | | | Power Mode Icon Graphic Visibility<br>Test | | | | Patient Pad Connectivity Notification /<br>Alarm Test | | | | Touchscreen EMF Immunity Test | | | | LCD Brightness Visibility Test | | | | Audio Volume Adjustment Test | | | | Multitouch Prevention Test | | | | Glove Test | | | | Liquid Spill Test | | | | Touchscreen LED Test | | | | Touchscreen Impact Test | | | | Chemical Resistance Test | ### 10. Statement of Substantial Equivalence The Canady Plasma® SMART XL-1000™ Electrosurgical Generator with Accessories has the same intended use as the predicate device, and the same or similar technological characteristics. The modifications in technological characteristics do not raise new or different questions of safety and effectiveness. Performance testing in accordance with standards has demonstrated the Canady Plasma® SMART XL- {7}------------------------------------------------ 1000™ Electrosurgical Generator with Accessories is as safe and effective as the predicate device. Therefore, the Canady Plasma® SMART XL-1000™ Electrosurgical Generator with Accessories is substantially equivalent to the Canady Plasma® Electrosurgical Unit SS Series with Accessories.