Search Results

The Guidant Microwave Ablation System is indicated for the surgical ablation of soft tissue, and striated, cardiac, and smooth muscles. The System is a device indicated for use, under direct visualization, in surgical procedures, including minimally invasive cardiac surgery procedures. The probes ablate the target tissue by creating an inflammatory response, or thermal necrosis.

The Guidant Microwave Ablation System consists of a microwave generator and handheld ablation probe accessories. The probe is available in two versions: the FLEX 4 and the FLEX 10. The ablation probe contains the microwave antenna that emits the microwave energy.

The microwave generator's output (2450 MHz) is conducted through the output cable, into the cabling of the Probe, and out the antenna at the distal section of the Probe. Energy is expressed in a pattern that is radial to the orientation of the ablating tip. Shielding in the ablating tip inhibits microwave energy expression into non-targeted tissue. The target tissue contains polar molecules (most notably water), which vibrate in response to the induced electromagnetic microwave field. This vibration creates heat through friction, raising the temperature of the tissue throughout the area being ablated. Upon reaching a certain temperature, the tissue becomes necrotic, and thus fully ablated.

FLEX 4 has a flexible antenna fixed at the distal end of the probe. FLEX 10 has a flexible antenna that can be moved along the distal end of the probe.

This document is a 510(k) premarket notification for the Guidant Microwave Ablation System. It primarily addresses a labeling change to refine the indication statement for the device. The document explicitly states that no new testing was performed for this specific 510(k) submission (K041340) because the product's design, technology, materials, manufacturing, performance, specifications, and method of use were unchanged from previous submissions (K003978 and K013946).

Therefore, based on the provided text, it's not possible to provide the detailed information requested regarding new acceptance criteria or a new study proving the device meets those criteria, as no new study was conducted for this submission. The document relies on the substantial equivalence to previously cleared devices and studies.

However, I can extract the information available from the document regarding the device and its regulatory status:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on this 510(k), no new acceptance criteria or specific performance data are reported as this submission is for a labeling change and relies on previous clearances. The document implies that the device's performance, as established in prior 510(k)s (K003978 and K013946), meets the necessary standards, but those specific criteria and performance metrics are not detailed here.

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not applicable as no new testing was performed for this submission. The previous 510(k)s (K003978, K013946) would contain this information.
• Data Provenance: Not applicable for new data in this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable as no new testing was performed for this submission.

4. Adjudication method for the test set:

• Not applicable as no new testing was performed for this submission.

5. 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:

• No MRMC study was done, nor is AI involved. This device is a microwave ablation system, not an AI-powered diagnostic or assistive technology.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Not applicable. This is a medical device for direct surgical use, not a standalone algorithm.

7. The type of ground truth used:

• Not applicable as no new testing was performed for this submission.

8. The sample size for the training set:

• Not applicable.

9. How the ground truth for the training set was established:

• Not applicable.

Summary of Device and Regulatory Context (Based on the document):

• Device Name: The Guidant Microwave Ablation System
• Intended Use: Surgical ablation of soft tissue, and striated, cardiac, and smooth muscles, under direct visualization, including minimally invasive cardiac surgery procedures. The probes ablate target tissue by creating an inflammatory response or thermal necrosis.
• Mechanism of Action: Emits 2450 MHz microwave energy. This energy causes polar molecules (like water) in the tissue to vibrate, creating heat through friction. This raises the tissue temperature to a necrotic level, leading to ablation.
• Regulatory Status: Cleared via 510(k) (K041340) as substantially equivalent to predicate devices (AFx Microwave Ablation System and Accessories K003978, FLEX 10 Accessory K013946, CryoGen Cardiac Cryosurgery System K974320, Heartport™ Maze System: Cryoprobe Set K970496).
• Key Point of K041340: This specific submission is primarily a labeling change to update the product name and make the indication statement more precise and consistent with predicate devices, particularly regarding surgical access. No changes were made to the device's design, technology, materials, manufacturing, performance, or method of use. Therefore, no new testing was deemed necessary.

Ask a specific question about this device

The Epicor Medical UltraCinch is intended for the ablation of cardiac tissue during cardiac surgery.

The items in the UltraCinch Accessory Pack are intended for use in the ablation of cardiac tissue during cardiac surgery.

Epicor Medical UltraCinch Tissue Ablation Device and Accessories

This document is a 510(k) premarket notification for the Epicor Medical UltraCinch Tissue Ablation Device and Accessories. It focuses on demonstrating substantial equivalence to previously marketed devices rather than establishing novel safety and effectiveness criteria through specific performance goals and studies.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth types cannot be fully provided from the given text. This type of submission relies on showing that the new device is as safe and effective as existing legally marketed predicate devices, often by demonstrating similar technological characteristics and performance in standard tests, rather than setting and meeting new, specific quantitative acceptance criteria for a novel clinical outcome.

However, based on the provided text, here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance:

The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., specific percentages, measurements, or clinical outcomes) that the device must meet. Instead, it states that "Results of in vitro testing, in vivo testing, and human clinical studies demonstrate that the Epicor Medical UltraCinch tissue ablation device and accessories are safe and effective for their intended use."

The device performance is generally reported as:

• "safe and effective for their intended use."
• "meet the requirements of ISO 10993-1." (for biocompatibility)

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not specified in the provided text. The document mentions "clinical studies" but does not give details about their size or structure.
• Data Provenance: Not explicitly stated. The document refers to "in vitro testing, in vivo testing, and human clinical studies." These could be retrospective or prospective, and the country of origin is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the text. As this is a 510(k) submission focused on substantial equivalence, the "ground truth" (in the sense of a diagnostic or predictive AI model) is not the primary focus. The "ground truth" for the device's function would be the physical effect of ablation, which is assessed through the "in vivo testing" and "human clinical studies" mentioned in a general sense.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not provided in the text.

5. 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:

This is not applicable to this device. The Epicor Medical UltraCinch is a tissue ablation device, not an AI software or diagnostic imaging system that would involve human readers interpreting cases with or without AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This is not applicable to this device. As explained above, this is a physical medical device for cardiac tissue ablation, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For this type of device, the "ground truth" would likely relate to:

• Successful ablation: Confirmation of tissue destruction/modification.
• Clinical outcomes: Reduction of arrhythmias or other target conditions.
• Safety metrics: Absence of adverse events.

However, the specific methods for establishing this ground truth (e.g., pathology reports from ablated tissue, electrophysiological mapping results, long-term patient follow-up, etc.) are not detailed in the provided text.

8. The sample size for the training set:

This is not applicable as this is a physical medical device, not an AI/ML model that requires a training set. The "studies" mentioned would be for device validation, not model training.

9. How the ground truth for the training set was established:

This is not applicable as this is a physical medical device, not an AI/ML model that requires a training set.

Ask a specific question about this device