(107 days)
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.
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.
The provided text describes a 510(k) premarket notification for the Canady Plasma® SMART XL-1000™ Electrosurgical Generator with Accessories. This is a submission to demonstrate substantial equivalence to a predicate device, rather than a study proving the device meets specific acceptance criteria in a clinical context.
Therefore, many of the requested details, such as sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set information, are not applicable or available in this type of regulatory document.
The document focuses on non-clinical performance data and a comparison to a predicate device to establish substantial equivalence.
Here's the information that can be extracted relevant to acceptance criteria and performance:
1. A table of acceptance criteria and the reported device performance
The document does not present "acceptance criteria" in the typical sense of a clinical performance study with specific endpoints and thresholds. Instead, it demonstrates performance through the comparison of technological characteristics with a predicate device and extensive non-clinical testing.
The acceptance criteria for this submission are implicitly that the modified device should perform as specified, in accordance with the predicate device's specifications, and not raise new questions of safety or effectiveness. The reported "performance" is that it meets these expectations.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Intended Use | Same as predicate device (Cut and/or coagulate tissue). |
| Principles of Operation | Same as predicate device (High Frequency Electrosurgery Unit generating HF voltage and electrically enhanced plasma gas). |
| Technological Characteristics | Same or similar to predicate device (Frequency, Peak to Peak Voltage, CPU Type, Monopolar/Bipolar, Modes, Input Voltage, Safety standards IEC 60601-1, -1-2, -2-2). Minor difference in Display Type (LED with backlight for predicate vs. LCD with backlight for subject device). |
| Physical Performance | Confirmed to meet product specifications and be equivalent to the unmodified predicate device through internal verification and validation testing. |
| Electrical Safety & EMC | Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, demonstrated through extensive testing (Conducted Emissions, Radiated Emissions, Harmonic Current Emission, Voltage Fluctuations/Flicker, various Immunity tests). |
| Functional Performance | Successful testing of: Crest Factor Comparison, Frequency, Peak to Peak Voltage, Monopolar Cut Mode, Maximum Watts, Maximum Voltage, Bipolar Cut Mode, Operation Modes Selection, Power Adjustment, Flow Rate Adjustment, Standby Mode Activation, Gas Tank Pressure Indication, Audio/Visual Warning, User Profile Selection/Editing, Font/Icon Visibility/Color, Power Button Speed, Patient Pad Connectivity, Touchscreen EMF Immunity, LCD Brightness, Audio Volume, Multitouch Prevention, Glove Test, Liquid Spill, Touchscreen LED, Touchscreen Impact, Chemical Resistance. |
| Software Performance | Improved programmable software compared to the predicate, with features like quick start, on-screen tutorial, user manual, and application selection. Design and development quality system procedures established for software. |
| Safety & Effectiveness | Does not raise new questions of safety or effectiveness compared to the predicate device. Performance testing demonstrated it is as safe and effective. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The testing described is non-clinical laboratory testing performed by the manufacturer, not a clinical trial or study with human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable/provided. The testing performed is non-clinical performance and safety testing of an electrosurgical generator, not a diagnostic device requiring expert interpretation for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. Adjudication methods are typically used in clinical studies involving interpretation of data/images, which is not the nature of this submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable/provided. The device is an electrosurgical generator, not an AI-assisted diagnostic or image interpretation tool. Therefore, MRMC studies and AI-related effect sizes are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. The device is a medical instrument (electrosurgical generator), not an algorithm that operates in a standalone capacity without human interaction in a clinical setting.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable/provided in the context of clinical ground truth. For the non-clinical performance testing, the "ground truth" would be the established engineering specifications and compliance standards (e.g., maximum power output, frequency deviation, electrical insulation integrity) which were measured and validated.
8. The sample size for the training set
This information is not applicable/provided. This is a hardware device with "improved programmable software," but the document does not describe it as an AI/ML device that undergoes a "training" process in the sense of predictive modeling.
9. How the ground truth for the training set was established
This information is not applicable/provided for the reasons stated in point 8.
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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
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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
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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)
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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
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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
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| Trade Name | Canady Plasma ElectrosurgeryUnit(Predicate Device) | Canady Plasma SMARTElectrosurgical Generator XL-1000 | SignificantDifference |
|---|---|---|---|
| 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 CoagulatorArgon 4 | CPC is consolidated into theXL-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(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 formonopolar and bipolar | Yes, independent switches formonopolar and bipolar | None |
| Monopolar Modes | Cut (Pure, Blend I,II,III, PureHigh Cut, Blend High Cut I,II), E-CutCoagulation (Spray, FulgurateHigh, Fulgurate Low, Desiccate1,II,III) | Cut (Pure, Blend I,II,III, PureHigh Cut, Blend High Cut I,II), E-CutCoagulation (Spray, FulgurateHigh, Fulgurate Low, DesiccateI,II,III) | None |
| Bipolar Modes | Cut, Coagulate (Micro, Default,Macro) | Cut, Coagulate (Micro, Default,Macro) | None |
| Volume Control | Yes | Yes | None |
| Defeatable-InaudibleVolume 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.
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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 FieldImmunity | Maximum Watts | Gas Tank Pressure Value IndicationTest |
| Immunity to Proximity Fields from RFWireless Communications Equipment | Maximum Voltage | Audio / Visual Warning / NotificationTest |
| 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 andVariations | Icon Size Visibility Test | |
| Button Response Test | ||
| Font / Icon Color Code Test | ||
| Power Button Increment / DecrementSpeed Test | ||
| Power Mode Icon Graphic VisibilityTest | ||
| Patient Pad Connectivity Notification /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-
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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.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
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.(b)
Classification. Class II.