Attachment B Salient Characteristics.docx

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6515--Equipment: Pulsed Electric Field Ablation System
Solicitation number
36C24825Q0455
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This is a salient characteristics document (Attachment B) detailing the technical requirements for a Pulsed Electric Field (PEF) Ablation System for the VA North Florida/South Georgia Veterans Health System in Gainesville, FL. The document specifies requirements for a non-thermal pulmonary soft tissue ablation system for use in bronchoscopy procedures.

The system must be FDA approved for endoscopic lung nodule/cancer treatment and include a generator, cardiac monitor with synchronization capabilities, user manual, and specific electrodes (5-pack), flex needles (5-pack), and 19G needles (5-pack). Key technical requirements include high-voltage short-duration electrical energy delivery, preservation of surrounding tissue, constant ablation size, 4-lead cardiac synchronization, LCD touchscreen display, and various connection ports for power, foot switch, and electrodes. The system requires a minimum 1-year manufacturer warranty and includes on-site staff education for clinical personnel.

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File Type Posted
Attachment D VA Limitations on Subcontracting.pdf PDF
36C24825Q0455.docx DOCX document
Attachment A Combined Synopsis Solicitation.docx DOCX document
Attachment C Price Delivery Schedule.docx DOCX document

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36C24825Q0455 Attachment B – Salient Characteristics

The Pulsed Electric Field (PEF) Ablation System shall meet or exceed the following characteristics:

· Shall be able to provide one (1) PEF Ablation System with consumables that supports non-thermal pulmonary soft tissue ablation procedures in the Bronchoscopy suite setting.

· Shall be FDA approved for endoscopic treatment of lung nodules / cancer intervention.

· Deliver high voltage in short duration electrical energy locally that alters the transmembrane potential of a cell by disrupting cellular homeostasis and inducing non-thermal programmed cell death.

· Able to preserve surrounding tissue.

· Provide potential immune activation.

· Provides a constant ablation size for a predictable ablation zone.

· Shall provide a compatible cardiac monitor for synchronization of the delivery of energy with the patient’s cardiac cycle.

· 4-lead configuration that detects the R-wave of the EKG/ECG signal, then sends a trigger signal to the generator for exact synchronization of energy output.

· Generator includes software with algorithm that detects trigger signals from cardiac monitor.

· PEF system shall include:

· Generator

· Cardiac Monitor with Synchronization

· User manual

· Electrodes (system specific, 5 pack)

· Flex Needles (system specific, 5 pack)

· 19G Needles (system specific, 5 pack)

· Display: LCD front panel display with touch screen capable of displaying graphics, messages, activation information, and receiving touch screen input from operator.

· Provide displays of power output and current output.

· Provide connections for:

· AC line power

· Foot switch

· Synchronization input

· Ablation device connector

· Dispersive electrode connections

· Manufacturer warranty: minimum 1 year.

· Provide staff education on-site to all clinical staff utilizing equipment.

File details come from the government source that posted it. Updated .