(115 days)
Not Found.
No
The description focuses on microwave ablation technology, real-time image guidance using electromagnetic tracking, and software control for setting parameters and displaying information. There is no mention of AI or ML algorithms for image analysis, prediction, or decision-making.
Yes
The device is intended for coagulation (ablation) of soft tissue, including non-resectable liver tumors, which is a therapeutic intervention.
No
The device is an ablation platform designed to coagulate soft tissue. While it uses image guidance for antenna placement (a form of intraoperative imaging), its primary function is therapeutic (ablation), not diagnostic (identifying or characterizing disease).
No
The device is a microwave-based system that includes a generator, antenna, cooling system, and sensors, in addition to software. While software is a component, it is not the sole component of the medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Intended Use: The Emprint™ SX Ablation Platform is intended for the ablation (destruction) of soft tissue within the body using microwave energy. It is a therapeutic device, not a diagnostic one.
- Mechanism of Action: The device directly interacts with tissue inside the patient's body to achieve a therapeutic effect (ablation). It does not analyze samples taken from the body.
- Navigation Feature: While the navigation feature uses imaging (ultrasound) to guide the procedure, this is for real-time guidance during a therapeutic intervention, not for analyzing a specimen for diagnostic purposes.
Therefore, the Emprint™ SX Ablation Platform is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
NEY
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 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found.
Input Imaging Modality
Ultrasound
Anatomical Site
Soft tissue, including non-resectable liver tumors.
Indicated Patient Age Range
Not Found.
Intended User / Care Setting
Physicians in percutaneous, laparoscopic, and intraoperative procedures.
Description of the training set, sample size, data source, and annotation protocol
Not Found.
Description of the test set, sample size, data source, and annotation protocol
Not Found.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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^-6 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.
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-guided 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Electrical Safety: Both systems comply with the electrical safety requirements described in IEC 60601-1 and IEC 60601-2-6.
- Electromagnetic Compatibility: Both systems comply with the EMC requirements described in IEC 60601-1-2.
- Microwave Generator Output: The output of the microwave generator was compared when controlled manually (as in the predicate system) and using the software-controlled subject device. Measured output levels did not differ across the generator's time and power settings.
- Size and Shape of Thermal Ablation Zones: Ex-vivo tissue testing was conducted using the subject device to verify system-level requirements related to the size and shape of the ablation. A comparison of these values to ex-vivo measurements for the predicate device confirmed equivalent performance across the two ablation systems.
- Safety and Effectiveness: The Emprint™ SX Ablation Platform passed all performance and safety requirements evaluated in an in vivo animal study (porcine model) and no new ablation- or navigation-related risks were identified. The Emprint™ SX Ablation Platform demonstrated a clinically acceptable performance and safety profile compared to Emprint™ Ablation System. When comparing subject device performance to predicate device performance in terms of the number of attempts needed by the physician to place the antenna at the target ablation site, the subject device performed better than the control (predicate). The number of attempts needed to place the navigation antenna was half of what was required for the predicate antenna.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found.
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
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.
1
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 (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" (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 (800) 638-2041 or (301) 796-7100 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
2
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) |
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
510(k) Summary
Page 1/10
510(k) Submitter/Holder
Covidien IIc 15 Hampshire Street Mansfield, MA 02048
Contact
Patti Arndt Principal Regulatory Affairs Specialist Phone: 303-581-6668 Fax: 303-530-6313 Email: patti.l.arndt@medtronic.com
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
4
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).
5
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.
6
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 |
| Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - | |
| Requirements and Tests | |
| 2 | AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 |
| (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements for Basic Safety And | |
| Essential Performance (IEC 60601-1:2005, Mod) | |
| 3 | IEC 60601-2-6:2012 Medical electrical equipment – Part 2-6: Particular requirements for the basic |
| safety and essential performance of microwave therapy equipment | |
| 4 | AAMI / ANSI / IEC 60601-2-2:2009, Medical Electrical Equipment - Part 2-2: Particular Requirements |
| for the Basic Safety and Essential Performance of High Frequency Surgery Equipment and High | |
| 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.
7
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 | ||||
| Platform | Emprint™ Ablation System | |||
| (K133821, K163105) | (Same, Similar, | |||
| Different) | ||||
| Labeling | ||||
| 1 | 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 | ||||
| trajectory 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. | The Emprint™ Ablation | |||
| System 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™ Ablation | ||||
| System is not intended for use | ||||
| in cardiac procedures. | Similar | |||
| For the subject | ||||
| device, an | ||||
| indication has | ||||
| been added that | ||||
| describes the | ||||
| platform's | ||||
| optional, | ||||
| navigation | ||||
| feature. The new | ||||
| indication does | ||||
| not change the | ||||
| intended use of | ||||
| the device (soft | ||||
| tissue ablation), | ||||
| relative to the | ||||
| 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: |
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
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
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
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
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
Platform | Emprint™ Ablation System
(K133821, K163105) | (Same, Similar,
Different) |
| | | | | improve tube
retention. |
| 3 | Reusable Ablation
Cable (connects
the ablation
antenna to the
microwave
generator) | The same reusable cable is used with both systems. | | Same |
| 4 | System Cart | Components of the new
ablation platform are
permanently installed and
connected within a
mobile/transportable cart.
Catalog No. CASYS100C | A mobile, transportable cart is
provided for optional use.
System components are not
permanently installed on the
cart. | Different
Compared to the
predicate device,
the usability/
transportability of
the subject device
is enhanced by the
use of a permanent
cart. |
| 5 | Field Generator
and Supporting
Hardware;
Spacers (Bed
Pads); External
(Surgeon's)
Display | The new ablation platform
includes hardware components
and accessories that, with the
platform's software, implement
the optional navigation feature.
Emprint™ SX Table Top Field
Generator, Catalog No.
CATTFG1
Emprint™ SX Table Top Field
Generator Spacers, Catalog No.
CAFGSP1
External (Surgeon's) Display
(Not provided with the platform) | NA | Different
The predicate
device does not
include an optional
ultrasound-guided
navigation feature.
Performance
testing was
conducted to
demonstrate the
functional
equivalency of the
two ablation
systems. |
| | Software | | | |
| 1 | Software | Software is used in the subject
device to control the microwave
generator, to interpret and
display information received
from the platform's navigation
hardware and to interface with
the user (GUI). | NA. The Emprint™ Ablation
System does not include
firmware or software. | Different
Compared to the
predicate device,
the usability of the
subject device is
enhanced by the
software control of
its primary ablation
function and its
optional navigation
feature.
Performance
testing was
conducted to
demonstrate the
functional |
| Attribute | Subject Device
Emprint™ SX Ablation
Platform | Predicate Device
Emprint™ Ablation System
(K133821, K163105) | Comparison
(Same, Similar, Different) | |
| | | | equivalency of the
two devices. | |
| Disposable Accessories - Ablation Antennas | | | | |
| 1 | Catalog Nos. | Emprint™ Short Navigation
Antenna, 15cm (CA15L2N)
Emprint™ Standard Navigation
Antenna, 20cm (CA20L2N)
Emprint™ Long Navigation
Antenna, 30cm (CA30L2N) | Emprint™ Short Percutaneous
Antenna, 15cm (CA15L2)
Emprint™ Standard
Percutaneous Antenna, 20cm
(CA20L2)
Emprint™ Long Percutaneous
Antenna, 30cm (CA30L2) | Similar
A navigation sensor
has been added to
the ablation
antennas used with
the subject device;
otherwise, the
devices are
identical. |
| 2 | Disposable/Single-
use Device | The antennas are disposable and are to be used within a single
patient procedure only. | The antennas are disposable and are to be used within a single
patient procedure only. | Same |
| 3 | Sterility | The accessories are sterilized with EO (SAL: 10 $^{-6}$ ) | The accessories are sterilized with EO (SAL: 10 $^{-6}$ ) | Same |
| 4 | Biocompatibility | Patient-contacting materials are biocompatible. | Patient-contacting materials are biocompatible. | Same |
| 6 | Device
Temperature
Monitoring | Temperate monitoring features used to ensure system safety are
the same for the subject and predicate devices. | Temperate monitoring features used to ensure system safety are
the same for the subject and predicate devices. | Same |
| 7 | Device Cooling | Pumped, normal saline is used to cool the Emprint™ SX
Navigation Antenna and its predicate. | Pumped, normal saline is used to cool the Emprint™ SX
Navigation Antenna and its predicate. | Same |
| 8 | Maximum Power
Delivered to
Tissue | The maximum power delivered by both devices is the same. | The maximum power delivered by both devices is the same. | Same |
| 9 | Number of Active
Antennas that can
be Connected to
the Microwave
Generator
(simultaneously) | One | One | Same |
| Disposable Accessories - Ultrasound Probe Tracking Sensors | | | | |
| 1 | Tracking devices
designed for use
with system-
compatible
ultrasound probes | Emprint™ SX Open Ultrasound
Tracking Sensor, CAAL9132
Emprint™ SX Open Ultrasound
Tracking Sensor, CABK8816
Emprint™ SX Laparoscopic
Ultrasound Tracking Sensor,
CAAL9150L
Emprint™ SX Laparoscopic
Ultrasound Tracking Sensor, | NA | Different
The predicate
device does not
include an ultra-
sound guided
navigation feature.
Performance
testing was
conducted to
demonstrate the
functional |
| Attribute | Subject Device | Predicate Device | Comparison | |
| | Emprint™ SX Ablation
Platform | Emprint™ Ablation System
(K133821, K163105) | (Same, Similar, Different) | |
| | CABK8666L | | equivalency of the
two devices. | |
| | Performance - Key Metrics | | | |
| 1 | Electrical Safety | Both systems comply with the electrical safety requirements
described in IEC 60601-1 and IEC 60601-2-6. | | Same |
| 2 | Electromagnetic
Compatibility | Both systems comply with the EMC requirements described in
IEC 60601-1-2. | | Same |
| 3 | Microwave
Generator Output | The output of the microwave generator was compared when
controlled manually (as in the predicate system) and using the
software-controlled subject device. Measured output levels did
not differ across the generator's time and power settings. | | Same |
| 4 | Size and Shape of
Thermal Ablation
Zones | Ex-vivo tissue testing was conducted using the subject device to
verify system-level requirements related to the size and shape of
the ablation. A comparison of these values to ex-vivo
measurements for the predicate device confirmed equivalent
performance across the two ablation systems. | | Same |
| 5 | Safety and
Effectiveness | The Emprint™ SX Ablation Platform passed all performance and
safety requirements evaluated in an in vivo animal study (porcine
model) and no new ablation- or navigation-related risks were
identified. The Emprint™ SX Ablation Platform demonstrated a
clinically acceptable performance and safety profile compared to
Emprint™ Ablation System. When comparing subject device
performance to predicate device performance in terms of the
number of attempts needed by the physician to place the antenna
at the target ablation site, the subject device performed better
than the control (predicate). The number of attempts needed to
place the navigation antenna was half of what was required for
the predicate antenna. | | Same or Better |
Comparison Table
8
K171358
9
K171358
10
11
12
Covidien IIc Traditional 510(k) Submission Emprint™ SX Ablation Platform
Conclusions
The Emprint™ SX Ablation Platform is used to coagulate (ablate) soft tissue in the same way, incorporating many of the same components, as the predicate Emprint Ablation System. Although the Emprint™ SX Ablation Platform differs from the predicate device with respect to its technological characteristics (computer control of the microwave generator and an optional navigation feature), performance data demonstrate that these differences do not impact the safety and effectiveness of the device and confirm its substantial equivalence to the Emprint™ Ablation System.