(80 days)
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.
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: 1. Emprint™ Ablation Generator (2450 MHz), 2. Emprint™ Percutaneous Antenna (sterile, single use), 3. Emprint™ Ablation Reusable Cable, 4. Emprint™ Ablation Pump. The system also includes the following optional equipment/accessories: 5. Emprint™ Ablation Cart, 6. Ablation Footswitch, 7. Isolation Transformer, 8. 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).
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.
The information provided does not describe a study involving a device that uses AI or reports its performance using metrics such as sensitivity, specificity, or AUC. Instead, it describes a medical device (an ablation system) and modifications made to its antenna and instructions for use. The acceptance criteria and performance data discussed are related to the physical and functional characteristics of the ablation antenna, not AI performance. Therefore, I cannot fulfill the request as it pertains to AI-based device performance and study design.
However, I can extract the acceptance criteria and performance data related to the physical modifications of the Emprint Ablation System with Thermosphere Technology and Emprint SX Ablation Platform with Thermosphere Technology antennae based on the provided text, and present it in a modified format relevant to the device's physical changes.
Accepted Criteria and Device Performance (for physical modifications)
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Trocar bond strength greater than the predicate. | Verification testing demonstrated the modified antenna's trocar bond strength was greater than the predicate. |
| No impact on the reliability of the device (thermal ablations in soft tissue during extended use test). | Verification testing confirmed 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 frictional force between modified antenna and adjustable depth guide. | Verification testing quantified and compared the frictional force between the modified antenna and the adjustable depth guide. (Specific quantitative results not provided in this summary, but the test was conducted.) |
| Quantify and compare insertion force (ex-vivo liver tissue) of the modified antenna relative to cleared devices. | Verification testing quantified and compared the insertion force (ex-vivo liver tissue) of the modified antenna relative to the 510(k) cleared devices. (Specific quantitative results not provided in this summary, but the test was conducted.) |
| Quantify and compare extraction force (ex-vivo liver tissue) of the modified antenna relative to cleared devices. | Verification testing quantified and compared the extraction force (ex-vivo liver tissue) of the modified antenna relative to the 510(k) cleared devices. (Specific quantitative results not provided in this summary, but the test was conducted.) |
| The modifications do not affect the system's essential function, performance, or underlying principles of operation. | 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. The antenna changes do not affect the Emprint™ Ablation System with Thermosphere™ Technology and Emprint™ SX Ablation Platform with Thermosphere™ Technology's essential function, performance, or underlying principles of operation. Modifications made to the Antenna's do not alter the Indications for use for the Emprint™ Ablation system and the Emprint™ SX ablation platform. |
Study Details (for physical modifications)
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Sample size used for the test set and the data provenance: Not explicitly stated for specific tests (e.g., how many antennas were tested for bond strength or insertion force). The verification testing included "thermal ablations in soft tissue during the extended use test" and "ex-vivo liver tissue." The data provenance is implied to be from bench testing conducted by Covidien LLC/Medtronic Inc. (the manufacturer). The study is retrospective in the sense that it evaluates modifications to an existing, cleared device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable. The ground truth here is related to physical measurements (bond strength, forces, reliability during ablation) demonstrated through bench and ex-vivo testing, not expert consensus on medical images or diagnoses.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This was bench and ex-vivo testing, not a clinical study requiring adjudication of expert opinions.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document does not describe an AI medical device or a MRMC study.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document does not describe an AI medical device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for the performance claims in this submission is derived from bench verification testing (measuring physical parameters like bond strength, frictional forces, insertion/extraction forces) and ex-vivo testing (thermal ablations in soft tissue, ex-vivo liver tissue).
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The sample size for the training set: Not applicable. This is not an AI/machine learning device.
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How the ground truth for the training set was established: Not applicable. This is not an AI/machine learning device.
§ 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.