Emprint SX Ablation Platform and Accessories

K171358 · Coviden, LLC · NEY · Sep 1, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K171358
• Device Name: Emprint SX Ablation Platform and Accessories
• Applicant: Coviden, LLC
• Product Code: NEY · General, Plastic Surgery
• Decision Date: Sep 1, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Emprint™ SX Ablation Platform with Thermosphere™ Technology is intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of non-resectable liver tumors. The Emprint™ SX Ablation Platform is not intended for use in cardiac procedures. The system's optional, 3-D navigation feature assists in the placement of the Emprint™ SX Navigation Antenna with Thermosphere™ Technology using real-time image guidance during intraoperative and laparoscopic ablation procedures. The navigation feature enhances the output of a compatible medical ultrasound imaging system and displays an image of the antenna and its predicted trajectory on a computer monitor. The size and shape of the predicted ablation zone relative to the position of the antenna is displayed on the enhanced ultrasound image.

Device Story

Microwave-based ablation system; delivers 2450 MHz energy via antenna to coagulate soft tissue. Employs Thermosphere technology for spherical ablation zones. Features optional 3D navigation: electromagnetic field generator (TTFG) placed under patient; sensors on ultrasound probes and ablation antenna track position. System processes sensor data to overlay antenna trajectory and predicted ablation zone onto real-time ultrasound images on auxiliary monitor. Operated by surgeons in OR/clinic; touchscreen GUI controls power (5-100W) and time (up to 10 min). Closed-loop saline cooling system maintains antenna shaft temperature. Navigation assists precise antenna placement; software-controlled generator ensures consistent energy delivery. Benefits include improved procedural accuracy and reduced antenna placement attempts compared to manual systems.

Clinical Evidence

No clinical data. Evidence based on bench testing (sterility, biocompatibility, shelf life, electrical safety, EMC, ex vivo ablation zone characterization) and two porcine in vivo studies. Animal studies confirmed navigation accuracy, tissue compatibility, and procedural safety equivalent to or better than predicate.

Technological Characteristics

Microwave ablation system (2450 MHz, 100W). Components: generator, peristaltic cooling pump, navigation antenna, TTFG, ultrasound tracking sensors. Materials: biocompatible patient-contacting components. Connectivity: auxiliary monitor for navigation. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-6, IEC 60601-2-2. Sterilization: EO (SAL 10^-6). Software-controlled generator and navigation.

Indications for Use

Indicated for percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of non-resectable liver tumors. Not for cardiac procedures.

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

• Emprint™ Ablation System with Thermosphere™ Technology (K133821, K163105)

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 1, 2017

Covidien LLC Patti Arndt Principal Regulatory Affairs Specialist 5920 Longbow Dr. Boulder, Colorado 80301

Re: K171358

Trade/Device Name: Emprint SX Ablation Platform with Thermosphere Technology Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: NEY Dated: May 5, 2017 Received: May 9, 2017

Dear Patti Arndt:

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 devicerelated 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.

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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" (21 CFR 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,

# David Krause -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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# Indications for Use

510(k) Number (if known) K171358

Device Name

Emprint™ SX Ablation Platform with Thermosphere™ Technology

#### Indications for Use (Describe)

The Emprint™ SX Ablation Platform with Thermosphere™ Technology is intended for use in percutaneous, laparoscopic, and intraoperative coagulation) of soft tissue, including partial or complete ablation of nonresectable liver tumors.

The Emprint SX™ Ablation Platform is not intended for use in cardiac procedures.

The system's optional, 3-D navigation feature assists in the Emprint™ SX Navigation Antenna with Thermosphere™ Technology using real-time image guidance during intraoperative and laparoscopic ablation procedures. The navigation feature enhances the output of a compatible medical ultrasound imaging system and displays an image of the antenna and its predicted trajectory on a computer monitor. The size and shape of the predicted ablation zone relative to the position of the antenna is displayed on the enhanced ultrasound image.

| Type of Use (Select one or both, as applicable) | | | | |
|--------------------------------------------------|---------------------------------------------|--|--|--|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | | | |

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# 510(k) Summary

Page 1/10

K171358

#### 510(k) Submitter/Holder

Covidien IIc 15 Hampshire Street Mansfield, MA 02048

## Contact

Patti Arndt Principal Regulatory Affairs Specialist Phone: [phone] Fax: [phone] Email: [e-mail]

#### Date of Summary Preparation

August 29, 2017

#### Name of Device

| Device Trade Name: | Emprint™ SX Ablation Platform with Thermosphere™ Technology |
|----------------------|----------------------------------------------------------------|
| Device Common Name: | Microwave Ablation System and Accessories |
| Classification Name: | Electrosurgical Cutting and Coagulation Device and Accessories |
| Regulation: | 21 CFR 878.440 |
| Regulatory Class: | II |
| Product Code: | NEY |

#### Predicate Device

The Emprint™ SX Ablation Platform described in this submission is substantially equivalent to the following, commercially available predicate device:

| Device Trade Name: | Emprint™ Ablation System with Thermosphere™ Technology |
|---------------------|--------------------------------------------------------|
| Device Common Name: | Microwave Ablation System and Accessories |
| 510(k) Numbers: | K133821, K163105 |
| Manufacturer: | Covidien IIc |

#### Device Description

The Emprint™ SX Ablation Platform with Thermosphere™ Technology is microwave-based system intended to deliver energy through an antenna inserted into soft tissue for the purpose of coagulating (ablating) a defined tissue volume. The Emprint™ SX Ablation Platform utilizes a 2450 MHz 100W generator to deliver power to a single microwave ablation antenna. The platform is software-controlled and a touchscreen Graphical User Interface is used to select the desired ablation time (up to 10 minutes) and power (5 to 100W) settings. Using an optional temperature probe, the ablation platform can be set to monitor the temperature of a desired target and to automatically turn the generator off, when the target reaches a pre-set temperature. The ablation platform uses circulating, room-temperature, normal saline to cool the non-radiating portion of the antenna shaft and to provide a consistent ablation zone. The normal

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saline is pumped from an IV bag through the antenna shaft and back to the IV bag in a closed system.

Using an optional/selectable navigation feature, the Emprint™ SX Ablation Platform assists physicians in the accurate placement of the trackable Emprint™ SX Navigation Antenna into a target anatomical structure by overlaying the image of the antenna and its trajectory onto an ultrasound image in real time.

Sensors are attached to platform-compatible, open and laparoscopic ultrasound probes and to the platform's trackable antenna. These sensors detect fluctuations in an electromagnetic field emitted from the system's Table Top Field Generator (TTFG). The TTFG is placed underneath the patient and transmits positional information that is processed by the system's navigation hardware and interpreted by its software. The platform's software allows the surgeon to see a representation of the ablation zone on an auxiliary display and the system's operator to control the ablation system via the touchscreen interface.

The Emprint™ Ablation Platform consists of the following components:

| Emprint™ SX Ablation Platform Component | Catalog No. |
|-------------------------------------------------------------------|-------------|
| Emprint™ SX Ablation Platform | CASYS100 |
| Emprint™ SX Ultrasound Surgical Navigation (software) Application | CAUS1SN |
| Emprint™ Ablation Reusable Cable | CA190RC1 |
| Emprint™ SX Table Top Field Generator | CAFG1 |
| Emprint™ SX Table Top Field Generator Cart | CAFGCART1 |
| Emprint™ SX Field Generator Spacers (Bed Pads) | CAFGSP1 |
| Emprint™ SX Short Navigation Antenna with Thermosphere Technology | CA15L2N |
| Emprint™ Standard Navigation Antenna with Thermosphere Technology | CA20L2N |
| Emprint™ SX Long Navigation Antenna with Thermosphere Technology | CA30L3N |
| Emprint™ SX Open Ultrasound Tracking Sensor | CABK8816 |
| Emprint™ SX Open Ultrasound Tracking Sensor | CAAL9132 |
| Emprint™ SX Laparoscopic Ultrasound Tracking Sensor | CAAL9150L |
| Emprint™ SX Laparoscopic Ultrasound Tracking Sensor | CABK8666L |
| Optional Accessories | |
| Covidien Remote Temperature Probe | RTP20 |
| Covidien Ablation Footswitch | RFASW |

Patient contacting system components include the Short, Standard and Long Emprint™ SX Navigation Antenna (Catalog Nos.: CA15L2N, CA20L2N and CA30L2N), the Emprint™ SX Open Ultrasound Tracking Sensor (Catalog Nos.: CABK8816 and CAAL9132), the Emprint™ SX Laparoscopic Ultrasound Tracking Sensor (Catalog Nos.: CABK8666L and CAAL9150L), and the Covidien Remote Temperature Probe (Catalog No: RTP20).

The system's antennas and ultrasound tracking sensors are provided sterile and are intended for single use. The system must be used with a standard IV bag of sterile normal saline (not provided with the system). A compatible, auxiliary monitor is required to view the information provided by the optional navigation feature (not provided with system).

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Covidien IIc Traditional 510(k) Submission Emprint™ SX Ablation Platform

#### Indications for Use

The Emprint™ SX Ablation Platform with Thermosphere™ Technology is intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of non-resectable liver tumors.

The Emprint™ SX Ablation Platform is not intended for use in cardiac procedures.

The system's optional, 3-D* navigation feature assists in the placement of the Emprint™ SX Navigation Antenna with Thermosphere™ Technology using real-time image guidance during intraoperative and laparoscopic ablation procedures. The navigation feature enhances the output of a compatible medical ultrasound imaging system and displays an image of the antenna and its predicted traiectory on a computer monitor. The size and shape of the predicted ablation zone relative to the position of the antenna are displayed on the enhanced ultrasound image.

* Three-dimensional spatial relationships displayed as a perspective image on a twodimensional monoscopic monitor

## Technological Characteristics

The Emprint SX™ Ablation Platform with Thermosphere Technology is a microwave ablation system. As shown in the following Comparison Table, it relies on the same principles of operation and fundamental technology, and has the same performance characteristics as the predicate device – with respect to its intended use of soft tissue ablation in open, laparoscopic and percutaneous procedures. The platform's optional navigation feature does not raise new questions of safety or effectiveness and performance testing was conducted to evaluate the added functionality/technological differences.

#### Performance Testing

The performance of the ablation platform was verified through subsystem and system-level testing. For the platform's sterile disposables, verification testing included evaluations of the products' sterility (10° SAL), residual EO/ECH levels, biocompatibility, shelf life (2 years) and packaging. Additionally, the disposable devices underwent functional testing, following exposure to mechanical and electrical stressors.

At the system level, electrical safety and electromagnetic compatibility were evaluated to establish conformity to applicable IEC 60601 safety standards. Ex vivo tissue testing was conducted to further characterize the platform's performance. Ablation zone size and shape were measured at selected generator time and power settings and were equivalent to the predicate system. The accuracy of the platform's navigation feature was evaluated and is specified in the product's labeling. Packaging for the platform's cart and navigation equipment also was validated. The system's ability to function as designed across a wide range of operating conditions (altitude, temperature and humidity) was verified in an environmentally controlled chamber. Human factors evaluations and a design validation demonstrated that the ablation platform's navigation feature met user needs and expectations.

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Performance testing demonstrated the Emprint™ SX Ablation Platform's compliance with the following international, safety standards.

| International Standard | |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | IEC 60601-1-2 Edition 3: 2007-03, Medical Electrical Equipment - Part 1-2: General Requirements for<br>Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility -<br>Requirements and Tests |
| 2 | AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012<br>(Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements for Basic Safety And<br>Essential Performance (IEC 60601-1:2005, Mod) |
| 3 | IEC 60601-2-6:2012 Medical electrical equipment – Part 2-6: Particular requirements for the basic<br>safety and essential performance of microwave therapy equipment |
| 4 | AAMI / ANSI / IEC 60601-2-2:2009, Medical Electrical Equipment - Part 2-2: Particular Requirements<br>for the Basic Safety and Essential Performance of High Frequency Surgery Equipment and High<br>Frequency Surgical Accessories |

## Animal Testing

Two animal studies were conducted to further evaluate the safety and performance of the Emprint™ SX Ablation Platform.

The objective of the first study was to evaluate the performance of the platform's disposable accessories (navigation antenna, open ultrasound tracking sensor and laparoscopic ultrasound tracking sensor). The performance evaluation was conducted in a porcine model and included the measurement of maximum insertion and extraction forces for the Emprint™ SX Navigation Antenna and confirmation of the ultrasound tracking sensors' soft tissue compatibility. The average maximum forces required to insert the navigation antenna through the body wall and into a soft tissue target and to extract the navigation antenna from an ablated soft tissue target were equivalent to previously reported measurements for the predicate device. Tissue compatibility testing conducted with each of the different ultrasound tracking sensors resulted in no visible tissue trauma or damage and confirmed their suitability and safety for clinical use.

A second in vivo study was conducted to demonstrate that the platform performed as expected when used, first, to navigate to previously placed fiducial targets in a porcine model and, secondly, to ablate the targeted soft tissue. The comparative study was designed to demonstrate the equivalence of the Emprint™ SX Ablation Platform and predicate Emprint™ Ablation System, with respect to safety and performance, when used in an animal model and surgical environment that closely simulated human clinical use. In vivo testing of the Emprint™ SX and predicate systems demonstrated that the performance and procedural safety of the new device was equivalent to or better than its predicate. The incidence/severity of intra-operative bleeding after antenna placement was similar with both systems and there were no macroscopic differences between ablation zones created with the two systems. Finally, the number of attempts needed by participating physicians to place the antenna was fewer when using the navigation-quided ablation platform compared to the previous-generator Emprint™ Ablation System, suggesting that the navigation feature enhances the platform's overall usability.

#### Clinical Testing

Clinical studies were not required to demonstrate the substantial equivalence of the new ablation platform and its predicate.

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Covidien IIc Traditional 510(k) Submission Emprint™ SX Ablation Platform

# Comparison to Predicate Device - Key Differences and Similarities

Essential differences between the Emprint™ SX Ablation Platform and the predicate device include (1) software (vs. manual) control of the microwave generator and pump and, (2) the addition of the optional navigation feature (comprised of hardware and software components). Both systems incorporate a 2.45 GHz microwave generator, a cooling pump, and are compatible with the same accessories.

The Emprint™ SX Ablation Platform's electromagnetic navigation feature uses the previously cleared Emprint Percutaneous Antenna – modified to include an embedded, navigation sensor. For procedures where the navigation feature is not used, the unmodified Emprint Percutaneous Antenna (K163105) can be used with the software-controlled ablation platform in percutaneous, laparoscopic, and intraoperative procedures.

A detailed comparison of the subject and predicate devices is provided in the following table.

| Attribute | | Subject Device | Predicate Device | Comparison |
|------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Emprint™ SX Ablation<br>Platform | Emprint™ Ablation System<br>(K133821, K163105) | (Same, Similar,<br>Different) |
| | Labeling | | | |
| 1 | Indications for Use | The Emprint™ SX Ablation<br>Platform with Thermosphere™<br>Technology is intended for use<br>in percutaneous, laparoscopic,<br>and intraoperative coagulation<br>(ablation) of soft tissue,<br>including partial or complete<br>ablation of non-resectable liver<br>tumors.<br>The Emprint™ SX Ablation<br>Platform is not intended for use<br>in cardiac procedures.<br>The system's optional, 3-D*<br>navigation feature assists in the<br>placement of the Emprint™ SX<br>Navigation Antenna with<br>Thermosphere™ Technology<br>using real-time image guidance<br>during intraoperative and<br>laparoscopic ablation<br>procedures. The navigation<br>feature enhances the output of<br>a compatible medical<br>ultrasound imaging system and<br>displays an image of the<br>antenna and its predicted<br>trajectory on a computer<br>monitor. The size and shape of<br>the predicted ablation zone<br>relative to the position of the<br>antenna are displayed on the<br>enhanced ultrasound image. | The Emprint™ Ablation<br>System is intended for use in<br>percutaneous, laparoscopic,<br>and intraoperative coagulation<br>(ablation) of soft tissue,<br>including partial or complete<br>ablation of non-resectable liver<br>tumors.<br>The Emprint™ Ablation<br>System is not intended for use<br>in cardiac procedures. | Similar<br>For the subject<br>device, an<br>indication has<br>been added that<br>describes the<br>platform's<br>optional,<br>navigation<br>feature. The new<br>indication does<br>not change the<br>intended use of<br>the device (soft<br>tissue ablation),<br>relative to the<br>predicate. |
| Attribute | | Subject Device | Predicate Device | Comparison |
| | | Emprint™ SX Ablation Platform | Emprint™ Ablation System (K133821, K163105) | (Same, Similar, Different) |
| | | * Three-dimensional spatial relationships displayed as a perspective image on a two-dimensional monoscopic monitor | | |
| Conditions of Use / Compatibility | | | | |
| 1 | Intended Use | Soft tissue ablation, including partial or complete ablation of non-resectable liver tumors. | Soft tissue ablation, including partial or complete ablation of non-resectable liver tumors. | Same |
| 2 | Surgical Approach | Both systems may be used in percutaneous, laparoscopic, and intraoperative procedures. | | Same |
| 3 | Compatibility of Accessories | The subject and predicate devices are compatible with the following, 510(k)-cleared Emprint™ Ablation System accessories/components:<br><br>Emprint™ Short Percutaneous Antenna with Thermosphere™ Technology, Catalog Nos. CA15L2, CA20L2 and CA30L2 Covidien Remote Temperature Probe, Catalog No. RTP20 Covidien Ablation Footswitch, Catalog No. RFASW | | Same |
| Principles of Operation | | | | |
| 1 | Use of Microwave Energy to Ablate Soft Tissue | Using both systems, soft tissue is ablated using a 2450 MHz microwave signal of up to 100 watts. | | Same |
| 2 | Thermosphere™ Technology | The predicate and subject devices use Covidien's patented Thermosphere Technology to achieve repeatable and near-spherical ablations. | | Same |
| 3 | Control of Microwave Generator Power and Time Settings | Computer/software control | Manual control | Different<br>The same microwave generator is controlled differently across the two systems. Verification testing demonstrated that the generator's output was equivalent for the subject and predicate devices at all selectable time and power settings. |
| | Attribute | Subject Device | Predicate Device | Comparison |
| | | Emprint™ SX Ablation Platform | Emprint™ Ablation System (K133821, K163105) | (Same, Similar, Different) |
| 4 | Ultrasound-guided Navigation | Electromagnetic | NA | Different<br>The predicate device does not include an ultrasound guided navigation feature. Performance testing was conducted to demonstrate the functional equivalency of the two devices. |
| | Key Feature/Component | | | |
| | Hardware | | | |
| 1 | Microwave Generator | Ablation antennas used with the subject and predicate devices are powered using the same microwave generator. | | Similar<br>Ablation antennas used with the subject and predicate devices are powered using the same microwave generator. In order to use the generator in the Emprint™ SX Ablation Platform, its front panel control knobs (time and power settings) were removed, the generator was set to "remote mode", its speaker was disabled, and an internal 5 volt source to the rear panel was removed. |
| 2 | Peristaltic Pump | Similar pumps are used in the subject and predicate devices. | | Similar<br>The pumps are made using the same motor, electronics, and pump head. The pump used in the subject device has a slightly different |
| Attribute | | Subject Device | Predicate Device | Comparison |
| | | Emprint™ SX Ablation<br>Platform | Emprint™ Ablation System<br>(K133821, K163105) | (Same, Similar,<br>Different) |
| | | | | improve tube<br>retention. |
| 3 | Reusable Ablation<br>Cable (connects<br>the ablation<br>antenna to the<br>microwave<br>generator) | The same reusable cable is used with both systems. | | Same |
| 4 | System Cart | Components of the new<br>ablation platform are<br>permanently installed and<br>connected within a<br>mobile/transportable cart.<br>Catalog No. CASYS100C | A mobile, transportable cart is<br>provided for optional use.<br>System components are not<br>permanently installed on the<br>cart. | Different<br>Compared to the<br>predicate device,<br>the usability/<br>transportability of<br>the subject device<br>is enhanced by the<br>use of a permanent<br>cart. |
| 5 | Field Generator<br>and Supporting<br>Hardware;<br>Spacers (Bed<br>Pads); External<br>(Surgeon's)<br>Display | The new ablation platform<br>includes hardware components<br>and accessories that, with the<br>platform's software, implement<br>the optional navigation feature.<br>Emprint™ SX Table Top Field<br>Generator, Catalog No.<br>CATTFG1<br>Emprint™ SX Table Top Field<br>Generator Spacers, Catalog No.<br>CAFGSP1<br>External (Surgeon's) Display<br>(Not provided with the platform) | NA | Different<br>The predicate<br>device does not<br>include an optional<br>ultrasound-guided<br>navigation feature.<br>Performance<br>testing was<br>conducted to<br>demonstrate the<br>functional<br>equivalency of the<br>two ablation<br>systems. |
| | Software | | | |
| 1 | Software | Software is used in the subject<br>device to control the microwave<br>generator, to interpret and<br>display information received<br>from the platform's navigation<br>hardware and to interface with<br>the user (GUI). | NA. The Emprint™ Ablation<br>System does not include<br>firmware or software. | Different<br>Compared to the<br>predicate device,<br>the usability of the<br>subject device is<br>enhanced by the<br>software control of<br>its primary ablation<br>function and its<br>optional navigation<br>feature.<br>Performance<br>testing was<br>conducted to<br>demonstrate the<br>functional |
| Attribute | Subject Device<br>Emprint™ SX Ablation<br>Platform | Predicate Device<br>Emprint™ Ablation System<br>(K133821, K163105) | Comparison<br>(Same, Similar, Different) |…