(38 days)
Not Found
No
The description focuses on real-time image guidance and overlay based on electromagnetic tracking, not AI/ML image processing or predictive modeling.
Yes
The device is intended for the "coagulation (ablation) of soft tissue, including partial or complete ablation of nonresectable liver tumors," which directly treats a medical condition.
No
The device is an ablation platform designed for the coagulation of soft tissue, specifically nonresectable liver tumors. While it has a navigation feature that uses real-time image guidance for placement, its primary function is therapeutic (ablation) rather than diagnostic (identifying or characterizing disease). The navigation feature enhances placement but does not diagnose.
No
The device description clearly outlines multiple hardware components including a generator, antenna, temperature probe, pump, sensors, and a Table Top Field Generator (TTFG). While it is software-controlled and has a software-based navigation feature, it is fundamentally a hardware system with integrated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Emprint™ SX Ablation Platform is a therapeutic device that uses microwave energy to ablate (destroy) soft tissue, specifically nonresectable liver tumors. It is used in vivo (within the body) during surgical procedures.
- Intended Use: The intended use clearly states "coagulation of soft tissue" and "ablation of nonresectable liver tumors," which are therapeutic actions, not diagnostic tests performed on samples outside the body.
- Device Description: The description details a system that delivers energy into the body via an antenna, not a system that analyzes biological samples.
The device utilizes imaging (ultrasound) for guidance during the therapeutic procedure, but the primary function is treatment, not diagnosis based on analyzing biological samples.
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) 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 3D 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 zone relative to the position of the antenna are 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, nonresectable liver tumors
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians / percutaneous, laparoscopic, and intraoperative ablation 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)
Comprehensive SW Verification testing was performed by Medtronic in support of the proposed change. No additional pre-clinical or clinical data is required to support the substantial equivalence determination for this software update.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
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December 17, 2020
Medtronic Inc. Liron Bar-Yaakov Senior Manager of Regulatory Affairs 5920 Longbow Dr. Boulder, Colorado 80301
Re: K203303
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: November 4, 2020 Received: November 9, 2020
Dear Liron Bar-Yaakov:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm_identifies_combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/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 (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 Ouality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K203303
Device Name
The 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 3D 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 zone relative to the position of the antenna are displayed on the enhanced ultrasound image.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
K203303
Covidien LLC Special 510(k) Submission Emprint™ SX Ablation Platform with Thermosphere™ Technology Emprint™ SX 1.1.1 Software Update
510(k) Summary
l. Submitter
Medtronic Inc 5920 Longbow Dr. Boulder, CO 80301
Contact: Liron Bar-Yaakov Senior Manager of Regulatory Affairs 5920 Longbow Dr Boulder, CO 80301 Telephone: (508) 261-8000 Email: Liron.Baryaakov@medtronic.com
Date of Summary Preparation: November 05, 2020
ll. Devices
Table 5.1 Devices:
| Device Trade Name | Emprint™ SX Ablation Platform with Thermosphere™ Technology |
|---|---|
| Device Common Name | Microwave Ablation System |
| Classification Name | System, Ablation, Microwave and Accessories |
| Regulatory Class | II |
| Product Code | NEY |
III. Predicate Devices
This Special 510(k) submission describes enhancements to the software of the previously cleared Emprint™ SX Ablation Platform with Thermosphere™ Technology.
Table 5.2 Predicate Devices
| Device Name | Classification Name and Class | 510(k) Clearance No |
|---|---|---|
| Emprint™ SX Ablation Platform with | ||
| Thermosphere™ | System, Ablation, Microwave | |
| and Accessories; Class II | K171358 |
IV. 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.
4
Covidien LLC Special 510(k) Submission
Emprint™ SX Ablation Platform with Thermosphere™ Technology
Emprint™ SX 1.1.1 Software Update
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.
| Table 5.3 EmprintTM SX Ablation Platform components: | |
|---|---|
| Component Name | Catalog No. |
| EmprintTM SX Ablation Platform with ThermosphereTM Technology | CASYS100 |
| EmprintTM SX Ultrasound Surgical Navigation (software) Application | CAUS1SN |
| EmprintTM Ablation Reusable Cable | CA190RC1 |
| EmprintTM SX Table Top Field Generator | CAFG1 |
| EmprintTM SX Table Top Field Generator Cart | CAFGCART1 |
| EmprintTM SX Field Generator Spacers (Bed Pads) | CAFGSP1 |
| EmprintTM SX Short Navigation Antenna with ThermosphereTM Technology, 15cm | CA15L2N |
| EmprintTM SX Standard Navigation Antenna with ThermosphereTM Technology, 20cm | CA20L2N |
| EmprintTM SX Long Navigation Antenna with ThermosphereTM Technology, 30cm | CA30L3N |
| EmprintTM SX Open Ultrasound Tracking Sensor | CABK8816 |
| EmprintTM SX Open Ultrasound Tracking Sensor | CAAL9132 |
| EmprintTM SX Laparoscopic Ultrasound Tracking Sensor | CAAL9150L |
| EmprintTM SX Laparoscopic Ultrasound Tracking Sensor | CABK8666L |
| Remote Temperature Probe | RTP20 |
| Ablation Footswitch | RFASW |
Table 5.3 Emprint™ SX Ablation Platform components:
V. Description of Changes
Modifications have been made only to the software of the Emprint™ SX Ablation Platform with Thermosphere™ Technology. Enhancements were made to the Software to allow the user to clear a general system error without power-cycling the system in order to deliver ablation therapy, mitigating any risk of delay in procedure.
These software changes, do not affect the Emprint™ SX Ablation Platform with Thermosphere™ Technology indication for use, essential function, performance, or underlying principles of operation.
5
Covidien LLC Special 510(k) Submission Emprint™ SX Ablation Platform with Thermosphere™ Technology Emprint™ SX 1.1.1 Software Update
VI. Indications for use
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 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.
VII. Comparison of technological characteristics with the predicate device
Emprint™ SX Ablation Platform with Thermosphere™ Technology current software (predicate device) and the updated software update share the same underlying technology. Both devices are used to deliver microwave energy to soft tissue in a highly controlled way. Signal frequency, power and exposure time are controlled by the system's 2450 MHz generator. The design of the radiating portion of the accessory and continuous cooling of the accessory during the ablation procedure determines the shape (near spherical) and size of the resulting ablations.
The enhancement to CAUS1SN software allows the user to avoid power cycling the system removing a delay to the procedure due to the receipt of a general system error. This is completed through a feature update to the Emprint API code, responsible for processing messages from the generator. There are no effects on any other portion of the software architecture, or on the systems underlying technological characteristics.
VIII. Performance Data
Comprehensive SW Verification testing was performed by Medtronic in support of the proposed change. No additional pre-clinical or clinical data is required to support the substantial equivalence determination for this software update.
IX. Conclusions
The Modified Emprint™ SX Ablation Platform with Thermosphere™ Technology software (CAUS1SN) update is nearly identical to the predicate Emprint™ SX Ablation Platform with Thermosphere™ Technology software. The subject and predicate devices share intended use, technological characteristics, and meet identical performance requirements. The results of comprehensive verification testing raised no new questions of safety or effectiveness. The current Emprint™ SX Ablation Platform with Thermosphere™ Technology software version, and the Emprint™ SX Ablation Platform with Thermosphere™ Technology new software version are substantially equivalent.