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510(k) Data Aggregation
(132 days)
THE ABLATION SYSTEM
The Acessa System is indicated for use in percutaneous, laparoscopic coagulation and ablation of soft tissue, including treatment of symptomatic uterine fibroids under laparoscopic ultrasound guidance.
The Acessa System includes the following system components: Generator (Model Number 1000): Provides RF energy to the Handpiece through the Handpiece Cable. Handpiece (Model Number 2000): Consisting of a disposable handle with a trocar-pointed shaft and 7 deployable needle electrodes. For use only disposable electrosurgical devices provided by Halt Medical, Inc. Handpiece Cable (Model Number 4200): Connects Handpiece to the Generator. This extension cable is provided with the Generator. Pads (Model Number 3000): A disposable set of 2 units, providing the return path for the RF energy applied by the Handpiece. Use only the Pads provided by Halt Medical, Inc. Pad Cable (Model Number 4300): Connects the Pads to the Generator. This extension cable is provided with the RF Generator. Power Cord (Model Number 4110): A medical grade power cord that provides AC power to the Generator. The Power cord is provided with the Generator. Foot Pedal (Model Number 4100): Pneumatic foot pedal with tubing used to turn RF energy on and off. The Foot Pedal with tubing is provided with the Generator. The Acessa System is designed to deliver up to 200 W of RF power at 460 kHz in three operational modes: Temperature Control, Manual Control and Coagulation Mode. A touch screen with a graphical user interface (GUI) enables selection of operational parameters such as the mode of operation, the ablation time, the target temperature, and the power delivery level. With the Handpiece placed in the tissue to be ablated and its electrodes deployed, RF power can be turned on. The system parameters are continuously monitored and displayed on the Generator. If the measured parameters are outside the acceptable limits, the RF energy delivery automatically stops and a message appears on the graphical user interface. RF energy during an ablation or coagulation can also be stopped at any time by the user by pressing the foot pedal. NOTE: The Acessa System must be used under laparoscopic ultrasound guidance. Laparoscopic ultrasound equipment is not included with the Acessa System.
The provided document describes the Acessa System, a device for laparoscopic coagulation and ablation of soft tissue, specifically for symptomatic uterine fibroids. Here's a breakdown of the acceptance criteria and the studies conducted:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a tabulated format with specific thresholds. Instead, it describes various performance testing and clinical study outcomes that demonstrate the device's safety and effectiveness. Based on the provided information, the closest approximation of acceptance criteria and reported performance is:
| Acceptance Criteria (Inferred) | Reported Device Performance (as demonstrated by studies) |
|---|---|
| Safety - Electrical, Mechanical, Software, and Biocompatibility | The Acessa System passed all electrical, mechanical, and software validation testing, as well as applicable safety requirements (EN/IEC 60601-1, EN/IEC 60601-1-2, EN/IEC 60601-2-2). EMC and safety testing were completed on the entire device and per component. Biocompatibility testing demonstrated materials are safe and in compliance with ISO 10993-1, ISO 10993-5, and ISO 10993-10. Device-related adverse events were less than 4% in the pivotal study, with only 2 serious adverse events (a pelvic abscess and a serosal colon injury) considered related to the device among 10 reported serious events. Only one (1.4%) serious adverse event (abdominal wall hematoma) was considered procedure-related in the Phase II studies. |
| Functional Performance - Ablation Capability & Control | Animal and bench ablation testing successfully demonstrated the Acessa System performs as intended and per specifications. Ablation capability was confirmed, providing a reproducible, discretely demarcated zone of tissue necrosis. The peri-hysterectomy feasibility study showed that ex vivo bench testing ablation results are predictive of ablations in fibroid tissue in vivo, with no device-related adverse events. The system continuously monitors parameters, automatically stops RF energy if outside acceptable limits, and allows user-initiated stops. |
| Effectiveness - Reduction in Menstrual Blood Loss (for symptomatic uterine fibroids) | Phase II Studies: At 12 months post-treatment, 3.5% (p |
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