Draft SALIENT CHARACTERISTICS.pdf
PDF 86 KB Posted
- Attached to
- IMPELLA PUMPS AND ACCESSORIES OR EQUAL Federal contract opportunity
- Solicitation number
- 36C261-25-AP-1357
About this file
This is a draft salient characteristics document detailing the mandatory specifications for an Impella Pump Set (Model 0048-0003 or equivalent) as part of a Sources Sought notice from the VA San Francisco Health Care System. The document outlines requirements for a minimally invasive ventricular support device that must deliver at least 2.5 L/min blood flow, feature a 9 French catheter diameter, 100cm length, and operate at speeds up to 50,000 RPM. The device must be FDA-cleared and include comprehensive safety features such as automatic speed adjustment and heparin coating.
The associated Sources Sought notice (solicitation 36C261-25-AP-1357) seeks responses from qualified vendors by January 20th, 2025 at 11:00 AM Pacific for an estimated quantity of 9 kits per year under a 5-year IDIQ contract. The NAICS code is 339112 with a size standard of 1,000 employees. Respondents must provide business size classification, capabilities statement, authorized distributorship documentation, and confirmation of compliance with limitations on subcontracting if responding as SDVOSB/VOSB. The VA will use responses to determine appropriate acquisition strategy, with potential use of GSA Schedule holders for final solicitation.
View the file
On GovTribe
Work with this file on GovTribe
- Download the original file
- Contacts named in this file
- Similar government files
- Ask GovTribe AI about this file
Text version
Salient Characteristics
Essential/significant physical, functional, or performance characteristics.
Salient Characteristics for Required Impella Pump Set - Model Number 0048-0003 or Equivalent.
The following salient characteristics define the mandatory features, specifications, and requirements for the procurement of a Pump Set equivalent to Abiomed Impella Model Number 0048-0003. These characteristics are essential to ensure the device meets the intended clinical and operational needs for temporary mechanical circulatory support. Any proposed alternative must meet or exceed these specifications.
1. General Requirements Device Type: Minimally invasive ventricular support device.
Intended Use: The device must provide temporary mechanical circulatory support for patients experiencing acute heart failure or cardiogenic shock. It must be capable of unloading the left ventricle, reducing myocardial workload, and increasing cardiac output.
2. Technical Specifications
2.1 Pump Performance
Flow Rate: Must deliver a minimum of 2.5 liters per minute (L/min) of blood flow.
Pressure Range: Must operate within a range of 50 mmHg to 120 mmHg.
Motor Speed: Must have an adjustable motor speed capable of reaching up to 50,000 RPM.
Power Source: Must operate using an external console with a backup battery system to ensure uninterrupted operation during power outages.
2.2 Catheter Specifications
Catheter Size: Must be 9 French (Fr) in diameter.
Catheter Length: Must be 100 cm in length.
Material: Must be constructed from biocompatible materials, such as polyurethane, and include a heparin coating to minimize thrombogenicity.
Insertion Method: Must be designed for percutaneous insertion via femoral artery access.
2.3 Console Requirements
Display: Must include a high-resolution touchscreen interface for real-time monitoring of hemodynamic parameters.
Alarms: Must feature audible and visual alarms to alert users to system errors, low flow, or pump malfunctions.
Connectivity: Must support data export capabilities for integration with hospital electronic medical records (EMR) systems.
Portability: Must be compact and lightweight for ease of transport within clinical settings.
3. Regulatory and Safety Requirements Regulatory Approval: Must be cleared by the U.S. Food and Drug Administration (FDA) for temporary ventricular support.
Safety Features:
- Must include automatic pump speed adjustment based on real-time hemodynamic data.
- Must have redundant safety systems to prevent overheating or motor failure.
- Must feature heparin-coated surfaces to reduce the risk of thrombosis.
4. Compatibility and Accessories
Compatible Consoles: Must be compatible with an external console capable of controlling and monitoring the pump.
Included Accessories: Must include the following:
- Pump catheter.
- Insertion kit (including guidewire, dilators, and introducer sheath).
- Sterile protective cover for the console.
- Operator’s manual and quick reference guide.
5. Sterilization and Packaging Requirements Sterilization Method: Must be sterilized using Ethylene Oxide (EtO) or an equivalent method approved by the FDA.
Packaging: Must be individually packaged in a sterile, single-use kit.
Shelf Life: Must have a minimum shelf life of 36 months from the date of manufacture.
6. Training and Support Requirements Training: The manufacturer must provide comprehensive training for clinical staff, including:
- Pump insertion and operation.
- Troubleshooting and emergency procedures.
Technical Support: Must offer 24/7 customer support for clinical and technical assistance.
7. Warranty and Service Requirements Warranty: Must include a minimum 12-month warranty from the date of delivery.
Service Agreement: Must offer optional extended service agreements for maintenance and repair.
8. Environmental and Storage Requirements Storage Temperature: Must be stored at a temperature between 15°C and 30°C (59°F to 86°F).
Humidity: Must be stored at a relative humidity of 20% to 80% (non-condensing).
Transport Conditions: Must be transported in a controlled environment to prevent damage or contamination.
9. Compliance with Standards Quality Standards: Must be manufactured in compliance with ISO 13485 (Quality Management System for Medical Devices).
Labeling Requirements: Must comply with 21 CFR Part 801 (FDA labeling requirements for medical devices).
Traceability: Must include a unique device identifier (UDI) for traceability and inventory management.
10. Manufacturer Requirements Manufacturer Qualifications: The manufacturer must be an established provider of medical devices with a proven track record of producing ventricular support systems.
Documentation: The manufacturer must provide all necessary documentation, including FDA clearance, technical specifications, and instructions for use.
11. Equivalent Products
- Any proposed equivalent product must demonstrate compliance with all the above salient characteristics. Deviations must be specified in your response and must clearly demonstrate how the proposed product meets or exceeds these specifications. Failure to meet any of these requirements will result in disqualification from consideration.
File details come from the government source that posted it. Updated .