(80 days)
Not Found
No
The summary describes a microwave ablation system with an optional navigation feature that enhances ultrasound images. There is no mention of AI or ML in the intended use, device description, or performance studies. The navigation feature appears to be based on image guidance and predicted trajectory/ablation zone display, not AI/ML-driven analysis or decision-making.
Yes
The device is intended for coagulation (ablation) of soft tissue, including nonresectable liver tumors, which directly treats a medical condition.
No
Explanation: The device is described as an "ablation system" and is intended for "coagulation (ablation) of soft tissue." Its function is to destroy tissue, not diagnose conditions. While it uses image guidance for placement, this is for therapeutic delivery, not diagnostic interpretation.
No
The device description clearly lists multiple hardware components including a generator, antenna, cable, pump, and optional accessories like a cart and footswitch. While software is mentioned for control and navigation, it is part of a larger hardware system.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue samples) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Emprint™ Ablation System is used for the direct treatment of soft tissue and tumors within the body through coagulation (ablation) using microwave energy. It is an interventional device used during surgical procedures.
- Intended Use: The intended use clearly states "coagulation (ablation) of soft tissue, including partial or complete ablation of nonresectable liver tumors." This is a therapeutic action, not a diagnostic test performed on a sample outside the body.
- Device Description: The description details a microwave generator, antenna, pump, and accessories used to deliver energy to the patient's tissue. This aligns with a therapeutic device, not an IVD.
The device utilizes imaging (ultrasound) for guidance, but this is for placement of the therapeutic device, not for analyzing a biological sample.
N/A
Intended Use / Indications for Use
The Emprint™ Ablation System 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™ Ablation System is not intended for use in cardiac procedures.
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 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 is displayed on the enhanced ultrasound image.
Product codes (comma separated list FDA assigned to the subject device)
NEY
Device Description
The Emprint™ Ablation System with Thermosphere™ Technology, Covidien's microwave ablation platform, was released for commercial distribution in the United States in April 2014.
The 510(k) Cleared Emprint™ Ablation System consists of the following components:
-
- Emprint™ Ablation Generator (2450 MHz)
-
- Emprint™ Percutaneous Antenna (sterile, single use)
-
- Emprint™ Ablation Reusable Cable
-
- Emprint™ Ablation Pump
The system also includes the following optional equipment/accessories:
- 5. Emprint™ Ablation Cart
-
- Ablation Footswitch
-
- Isolation Transformer
-
- Remote Temperature Probe (sterile, single use)
The ablation platform must be used with a standard IV bag of sterile, normal saline (not provided with the device).
In 2016 Covidien LLC made changes to improve the usability of the Emprint™ Ablation System's percutaneous antenna, by increasing the stiffness of the antenna's shaft. Like the predicate antenna approved via traditional 510(k) (K133821), the modified antenna is manufactured in 3 lengths (15, 20 and 30 cm) and is uniquely identified by catalog numbers (CA15L2, CA20L2 and CA30L2).
The Emprint™ SX Ablation Platform with Thermosphere™ Technology is a microwave ablation system with an optional navigation feature. It relies on the same principles of operation, fundamental technology, and performance characteristics as its predicate, the Emprint™ Ablation System with Thermosphere™ Technology (K133821, K163105).
The main differences between the Emprint™ SX Ablation Platform with Thermosphere™ Technology and the predicate device include software (vs. manual) control of the generator and pump, as well as the addition of an optional navigation feature. Both systems include a 2.45 GHz microwave generator, a cooling pump, and accessories. A bag/bottle of sterile fluid that connects to the antenna's tubing and to the peristaltic pump is required for proper system operation. The 510(k) Cleared Emprint™ Percutaneous Antenna (K163105) can be used with either system to create predictable, spherical ablation zones in soft tissue in percutaneous, laparoscopic, and intraoperative procedures.
The Emprint™ antenna, the applied part of the Emprint™ ablation system with Thermosphere™ Technology and Emprint™ SX ablation platform with Thermosphere™ Technology that delivers microwave energy to the patient, has a sharp, engineered ceramic tip (called "trocar") at the distal end of the device that allows a user to puncture tissue. The shaft of the disposable antenna is inserted directly into the tissue intended to be ablated. The radiating tip of the antenna shaft delivers microwave energy to the target tissue.
Modifications have been made to the Emprint™ Ablation System and Emprint™ SX Ablation Platform's IFU's and Antenna's. Updates were made to the IFU to reduce the possible trocar detachment post ablation resulting from atypical use.
Changes made to the bond curing schedule is to enhance the bond strength between the trocar and the fiberglass shaft.
Additionally, the clear non-stick heat shrink was extended further on the antennae to reduce tissue adherence post ablation.
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
Not Found
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)
Bench Verification Testing:
Testing was conducted to:
- demonstrate the modified antenna's trocar bond strength was greater than the predicate.
- confirm that the change did not impact the reliability of the device by performing thermal ablations in soft tissue during the extended use test.
- quantify and compare the frictional force between the modified antenna and the adjustable depth quide. insertion force and extraction force (ex-vivo liver tissue) of the modified antenna relative to the 510(k) cleared devices.
Key results: The modification to the antennae trocar bonding and clear non-stick heat shrink extension have improved parameters such as tensile bond strength, antenna insertion force and antenna extraction force compared to the current device (predicate) without affecting the design requirements and the essential performance of the antenna and the system as a whole.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 13, 2020
Covidien LLC Medtronic Inc. Hilla Debby Director Regulatory Affairs 6135 Gunbarrel Ave Boulder, CO 80301
Re: K193232
Trade/Device Name: Emprint Ablation System with Thermosphere Technology, 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: January 22, 2020 Received: January 23, 2020
Dear Hilla Debby:
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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Covidien LLC
Special 510(k) Submission Emprint™ Ablation System with Thermosphere™ Technology and Emprint™ SX Ablation Platform with Thermosphere™ Technology IFU Updates and Antenna Modifications
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|---|---|
| Food and Drug Administration | Expiration Date: 06/30/2020 |
| Indications for Use | See PRA Statement below. |
| 510(k) Number (if known) |
5
Device Name
Emprint™ Ablation System with Thermosphere™ Technology Emprint™ SX Ablation Platform with Thermosphere™ Technology
Indications for Use (Describe)
The Emprint™ Ablation System with Thermosphere™ Technology:
The Emprint™ Ablation System is intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of nonresectable liver tumors.
The EmprintTM Ablation System is not intended for use in cardiac procedures.
The Emprint™ SX Ablation Platform with Thermosphere™M Technology:
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 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 is 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
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3
510(k) Summary
Submitter -
Medtronic Inc 5920 Longbow Dr. Boulder, CO 80301
| Contact Person: | Hilla Debby |
|---|---|
| Director of Regulatory Affairs | |
| Phone: | 97-204-909-7774 |
| Email: | Hilla.Debby@medtronic.com |
| Address: | 2 Hacarmet St. New Industrial Park POB 258 Yoqneam, IL 20692 |
| Date of Summary Preparation: | November 22, 2019 |
II. Devices
Table 5.1 Devices:
| Device Trade Names | Emprint™ Ablation System with Thermosphere™
Technology
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 changes to the Instructions for Use (IFU) and modifications to the Antenna's previously cleared for the Emprint™ Ablation System with Thermosphere™ Technology and Emprint™ SX Ablation Platform with Thermosphere™ Technology. The modified Emprint™ Ablation System with Thermosphere™ Technology and the modified Emprint™ SX Ablation Platform with Thermosphere™ Technology are substantially equivalent to the predicate devices outlined in Table 5.2.
No reference devices were used in this submission
4
Table 5.2 Predicate Devices:
| Device Name | Classification Name and Class | 510(k) Clearance No. |
|---|---|---|
| Emprint™ Ablation System with | ||
| Thermosphere™ Technology | System, Ablation, Microwave and | |
| Accessories; Class II | K133821 | |
| Emprint™ Ablation System with | ||
| Thermosphere™ Technology | System, Ablation, Microwave and | |
| Accessories; Class II | K163105 | |
| Emprint™ SX Ablation Platform | ||
| with Thermosphere™ Technology | System, Ablation, Microwave and | |
| Accessories; Class II | K171358 |
IV. Device description
The Emprint™ Ablation System with Thermosphere™ Technology, Covidien's microwave ablation platform, was released for commercial distribution in the United States in April 2014.
The 510(k) Cleared Emprint™ Ablation System consists of the following components:
-
- Emprint™ Ablation Generator (2450 MHz)
-
- Emprint™ Percutaneous Antenna (sterile, single use)
-
- Emprint™ Ablation Reusable Cable
-
- Emprint™ Ablation Pump
The system also includes the following optional equipment/accessories:
-
- Emprint™ Ablation Cart
-
- Ablation Footswitch
-
- Isolation Transformer
-
- Remote Temperature Probe (sterile, single use)
The ablation platform must be used with a standard IV bag of sterile, normal saline (not provided with the device).
In 2016 Covidien LLC made changes to improve the usability of the Emprint™ Ablation System's percutaneous antenna, by increasing the stiffness of the antenna's shaft. Like the predicate antenna approved via traditional 510(k) (K133821), the modified antenna is manufactured in 3 lengths (15, 20 and 30 cm) and is uniquely identified by catalog numbers (CA15L2, CA20L2 and CA30L2).
Covidien made the change to accommodate a usability-related preference, expressed by physicians. The modification was not in response to reported device malfunctions or adverse events associated with the current, more-flexible ablation antenna.
This change in stiffness enhances the antenna's usability; and has no effect on the system's essential function, performance or underlying principles of operation.
The Emprint™ SX Ablation Platform with Thermosphere™ Technology is a microwave ablation system with an optional navigation feature. It relies on the same principles of operation, fundamental technology, and performance characteristics as its predicate, the Emprint™ Ablation
5
System with Thermosphere™ Technology (K133821, K163105).
The main differences between the Emprint™ SX Ablation Platform with Thermosphere™ Technology and the predicate device include software (vs. manual) control of the generator and pump, as well as the addition of an optional navigation feature. Both systems include a 2.45 GHz microwave generator, a cooling pump, and accessories. A bag/bottle of sterile fluid that connects to the antenna's tubing and to the peristaltic pump is required for proper system operation. The 510(k) Cleared Emprint™ Percutaneous Antenna (K163105) can be used with either system to create predictable, spherical ablation zones in soft tissue in percutaneous, laparoscopic, and intraoperative procedures.
The Emprint™ antenna, the applied part of the Emprint™ ablation system with Thermosphere™ Technology and Emprint™ SX ablation platform with Thermosphere™ Technology that delivers microwave energy to the patient, has a sharp, engineered ceramic tip (called "trocar") at the distal end of the device that allows a user to puncture tissue. The shaft of the disposable antenna is inserted directly into the tissue intended to be ablated. The radiating tip of the antenna shaft delivers microwave energy to the target tissue.
Modifications have been made to the Emprint™ Ablation System and Emprint™ SX Ablation Platform's IFU's and Antenna's. Updates were made to the IFU to reduce the possible trocar detachment post ablation resulting from atypical use.
Changes made to the bond curing schedule is to enhance the bond strength between the trocar and the fiberglass shaft.
Additionally, the clear non-stick heat shrink was extended further on the antennae to reduce tissue adherence post ablation.
The Antenna changes mentioned above do not affect the Emprint™ Ablation System with Thermosphere™ Technology and Emprint™ SX Ablation Platform with Thermosphere™ Technology essential function, performance or underlying principles of operation.
Extensive bench verification testing was conducted to ensure the modified Emprint™ Percutaneous Antenna performs as designed and meets essential requirements. The device modification was implemented in compliance with FDA's quality system and design control requirements.
V. Description of Changes
A. INSTRUCTIONS FOR USE (IFU) UPDATE
The following language (see table 5.3 below) was added to the Instructions for Use (IFU) for both the Emprint™ Ablation System with Thermosphere™ Technology and Emprint™ SX Ablation Platform with Thermosphere™ Technology:
"5. When energy delivery to the antenna stops, allow the pump to continue running for five seconds to cool the antenna. Then rotate the antenna shaft to release any adhered tissue. Then reposition or remove the antenna."
6
Additionally, several minor edits, unrelated to trocar detachment from atypical use, were included in the instructions for use.
| Product
Code | Description | Change Description | Name of the
Devices | 510 (k)
Clearance
No. |
|-------------------------|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|-----------------------------|
| PT00101561
(English) | Instruction
for Use
(IFU) | Added "When energy delivery to the antenna stops, allow the pump to continue running for five seconds to cool the antenna. Then rotate the antenna shaft to release any adhered tissue. Then reposition or remove the antenna." Additionally, several clarifications were included in the instructions for use updates. | Emprint™
Ablation System
with
Thermosphere™
Technology | K133821
and
K163105 |
| PT00102817
(English) | Instruction
for Use
(IFU) | Added "When energy delivery to the antenna stops, allow the pump to continue running for five seconds to cool the antenna. Then rotate the antenna shaft to release any adhered tissue. Then reposition or remove the antenna." Additionally, several clarifications were included in the instructions for use updates. | Emprint™ SX
Ablation Platform
with
Thermosphere™
Technology | K171358 |
| Table 5.3 Lanquage Change Summary for IFU: | |||
|---|---|---|---|
B. Bond Cure Schedule Change
Changes have been made to the bond cure schedule in order to increase the bond strength between the trocar and the fiberglass shaft.
7
ﻥ CLEAR NON-STICK HEAT SHRINK DESIGN CHANGE
The clear non-stick heat shrink was extended further on the antennae to reduce tissue adherence.
VI. Indications for use
Modifications made to the Antenna's do not alter the Indications for use (shown below) for the Emprint™ Ablation system and the Emprint™ SX ablation platform.
The Emprint™ Ablation System with Thermosphere™ Technology:
The Emprint™ Ablation System is intended for use in percutaneous, laparoscopic, endoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of nonresectable liver tumors.
The Emprint™ Ablation System is not intended for use in cardiac procedures.
The Emprint™ SX Ablation Platform with Thermosphere™ Technology:
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
The Emprint™ Ablation System with Thermosphere™ Technology and Emprint™ SX Ablation Platform with Thermosphere™ Technology current antennae (predicate device's) and the modified ablation antenna 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 modification to the antennae trocar bonding and clear non-stick heat shrink extension have improved parameters such as tensile bond strength, antenna insertion force and antenna extraction force compared to the current device (predicate) without affecting the design requirements and the essential performance of the antenna and the system as a whole.
8
VIII. Performance data
Non-clinical performance data was provided in support of the substantial equivalence determination.
Bench Verification Testing a)
Verification testing was conducted to:(1) demonstrate the modified antenna's trocar bond strength was greater than the predicate, (2) confirm that the change did not impact the reliability of the device by performing thermal ablations in soft tissue during the extended use test. (3) quantify and compare the frictional force between the modified antenna and the adjustable depth quide. insertion force and extraction force (ex-vivo liver tissue) of the modified antenna relative to the 510(k) cleared devices.
IX. Conclusions
The modified Emprint™ Ablation System with Thermosphere™ Technology and Emprint™ SX Ablation Platform with Thermosphere™ Technology antennae are identical to the predicate device's, except for bond cure schedule change and clear non-stick heat shrink design change. 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 Emprint™ Ablation System with Thermosphere™ Technology and Emprint™ SX Ablation Platform with Thermosphere™ Technology Antennae (subject device) and the modified antennae are substantially equivalent.