(69 days)
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.
§ 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.