Statement of Work.docx

STATEMENT OF WORK (SOW)

Contract Title

Piranha Morcellator

Background The Salt Lake City VA HCS requires the purchase and installation of a Richard Wolf Piranha Laser Enucleation System with morcellator to allow for laser enucleation of the prostate (LEP) to treat benign prostatic hyperplasia (BPH). The Contractor shall provide the Richard Wolf Piranha Laser Enucleation System, a complete and integrated system designed for laser enucleation of the prostate (LEP) in the treatment of benign prostatic hyperplasia (BPH). The system features a laser resectoscope, an offset PIRANHA scope, and a tissue morcellator, and is the only integrated laser enucleation system of its kind available for sale in the United States. The Piranha Laser Enucleation System gives urologists a cutting-edge, versatile solution capable of treating any size prostate quickly and effectively. The modular design is compatible with existing Richard Wolf equipment and works with any type of laser, accommodating laser fibers up to 1000 µm. The system's powerful turbine suction rapidly draws in tissue for morcellation while dynamic suction maintains a clear field of view, allowing surgeons to maintain orientation throughout the procedure. The PIRANHA scope and laser resectoscope share the same outer sheath, enabling both enucleation and morcellation to be performed without changing sheaths during a case.

Compliance The Contractor shall ensure that all delivered equipment consists of FDA-cleared medical devices appropriate for use in urological surgical procedures within the United States, and that all components conform to applicable federal, state, and local regulations governing medical devices. The morcellator handpiece and cable shall be fully autoclavable and meet all applicable sterilization and infection control standards. All disposable components, including rotation morcellators, pump tubing, tissue containers, and bacteria filters, shall be single-use products and appropriately labeled as such. The system shall incorporate an atraumatic distal morcellator tip engineered for patient safety, with a single suction opening designed to prevent inadvertent suctioning of the bladder mucosal membrane. All capital equipment shall be delivered in new condition with applicable manufacturer warranties, and the Contractor shall provide operator training and clinical in-service support upon delivery and installation to ensure safe and effective use of the system.

Characteristics The Richard Wolf Piranha Laser Enucleation System with Morcellator is a modular system designed for efficient tissue removal during endoscopic urologic surgery. The core of the system is a high-powered Holmium: YAG laser, capable of delivering variable wattage (typically up to 100W) via a flexible laser fiber. The system allows precise tissue cutting using adjustable pulse energy and frequency settings, and the laser is administered through a compatible endoscope sheath. Once tissue is separated, the Piranha Morcellator component is introduced through a 26 Fr or larger continuous flow resectoscope. The morcellator features a high-speed, reciprocating inner blade (~1,100–1,700 cycles/minute), powered by an integrated electric drive unit. This blade shreds tissue fragments within a rigid outer sheath while simultaneously applying continuous suction. The system’s motor speed, suction, and irrigation can be controlled via a foot pedal interface, optimizing ergonomics and workflow during the procedure. Visualization is maintained by integrated endoscopic optics, and real-time tissue evacuation is enabled through the system’s high-capacity suction. The morcellator is designed for rapid throughput with minimal blockages, and all major components—including the drive shaft, cutting blade, and outer sheath—are autoclavable for sterilization.

The Piranha system is compatible with standard urologic towers and irrigation systems, and its modular design allows it to integrate seamlessly into most operating room environments. All switches and connection ports are color-coded for intuitive rapid assembly and breakdown.

Scope The Contractor shall supply, deliver, and support the complete Richard Wolf Piranha Laser Enucleation System at the designated facility, encompassing all capital equipment, instrumentation, disposables, and accessories necessary for a fully operational laser enucleation setup at the VHA Salt Lake City Health Care System, 500 Foothill Drive, Salt Lake City, UT 84148. Installation will be in the operating room of bldg.. 4, 3rd floor. The Contractor shall be responsible for coordinating delivery, installation, and verification that all system components are functioning properly prior to clinical use. The scope of work includes the morcellator system with pump kit, handpiece, and power control unit; all laser enucleation components including the PIRANHA scope, endoscopes, sheaths, obturators, laser bridge, laser working element, and guide tubes; all required disposables such as rotation morcellators, pump tubing, tissue containers, bacteria filters, and o-rings; and all supporting accessories including suction canister bundles, light cables, and sterilization trays. The Contractor shall additionally provide comprehensive operator in-service training covering system assembly and setup, use of PIRANHA mode for suctioning and morcellation, use of Suction mode for coagulated blood and small tissue chips, foot pedal operation, and proper sterilization and maintenance procedures. All delivered components shall be available and ready for clinical use upon completion of installation and training.

Specific Tasks Task 1 – Installation. The contractor will be responsible to ensure delivery and installation of the system and all peripheral equipment and consumables to the facility.

Task 2 – Verification of Product. Contractor will ensure that installed device is verified as complete and operational prior to it being used in any medical procedure.

Task 3 – Training. Contractor will provide comprehensive operator in-service training covering system assembly and setup, use of PIRANHA mode for suctioning and morcellation, use of Suction mode for coagulated blood and small tissue chips, foot pedal operation, and proper sterilization and maintenance procedures. All delivered components shall be available and ready for clinical use upon completion of installation and training.

Task 4 - Support.

No services or service contracts will be awarded or included for post-installation support. All support needs beyond the manufacturer's warranty will be handled by internal VA personnel. Standard support requirements, such as troubleshooting, configuration assistance, and maintenance, will not be outsourced and do not require an ad hoc or dedicated support/maintenance service component within the contract. Should issues arise outside the scope of the manufacturer’s warranty, the VA will rely on its own IT/help desk resources to resolve them.

Deliverables When this project wraps up, the vendor will have delivered a complete set of new medical equipment, exactly as detailed in the attached quote. This includes a suction pump, a motor control unit, a metal Endocam tray, two 8-foot power cords, a 3-liter suction canister bundle, a 3-liter polysulfone suction jar, a large patient lid with overflow protection, a single-pedal footswitch, a recto pump connection tube, a motor handpiece (with a max speed of 6,000 RPM), and a 3-meter connection cable. All items will be brand new, and the total cost for everything comes to $29,156.60 (not including shipping or handling).

Once everything arrives, the vendor will check to make sure all equipment is accounted for and in good working order. Beyond delivery, though, the vendor’s role is complete—installation, setup, and any necessary training will be handled by the Government’s own staff. No additional support or service contracts are part of this purchase.

To help the process go smoothly, the Government will make sure the delivery site is ready and that staff are available to receive the shipment. All installation and staff training will be done in-house.

The goal is to have everything delivered no later than 90 days after the contract is awarded, unless we all agree on a different timeframe.

Government Furnished Property/Equipment None.

Performance Reporting The completion of the initial installation, operational verification, and training will be documented by the Government. Receipt of invoice from the contractor does not constitute completion of performance. If the contractor documents completion at each step by securing a Government signature, a copy of that documentation may be used as the performance report.

END OF STATEMENT OF WORK