Attachment 1 Requirements_Document_ESU_CDRH-2026-134011_jwg.docx

U.S. Food and Drug Administration Attachment 1 Requirements Document, Electrosurgical Unit and Accessories

CDRH-2026-134011

U.S. Food and Drug Administration Requirements Document Electrosurgical Unit (ESU) and Required Accessories Center for Devices and Radiological Health, Office of Science and Engineering Laboratories

1. Purpose This document states the technical requirements for the acquisition of one (1) commercial electrosurgical unit (ESU) and all accessories required to operate it in every supported operating mode, together with the manufacturer's warranty and technical documentation.

2. Background The Office of Science and Engineering Laboratories within the U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), requires an electrosurgical unit to generate electromagnetic disturbance signals that emulate real-world exposure conditions, in support of laboratory experiments, test method development, and verification activities.

3. Scope This acquisition includes:

1. Delivery of the electrosurgical unit and all required accessories

1. The manufacturer's warranty

1. User manuals and technical documentation

1. Warranty documentation and service contact information

4. Equipment Requirements All equipment shall be newly manufactured. It shall not be used, refurbished, reconditioned, remanufactured, or previously used for demonstration. The equipment and all included accessories shall be new, unused, and in full working condition at the time of delivery.

Salient characteristics and any single-source need The salient physical, functional, and performance characteristics the equipment must meet are stated under Minimum technical requirements below.

Minimum technical requirements The equipment shall meet the following minimum requirements.

Display and user interface

1. A touchscreen display for user interaction and parameter control Tissue impedance monitoring

1. Monitoring of tissue impedance at a minimum rate of 434,000 times per second, providing real-time feedback and energy delivery adjustment Output frequency

1. Output frequency within the range of 400 kHz to 500 kHz Operating modes The equipment shall support the following operating modes.

1. Monopolar CUT (Pure)

1. Monopolar CUT (Blend)

1. Monopolar COAG (Fulgurate)

1. Monopolar COAG (Spray)

1. Monopolar COAG (Soft)

1. Bipolar coagulation

1. Vessel sealing Electrical and safety

1. Compliance with all applicable Federal, state, and local safety standards Required accessories The contractor shall provide all accessories necessary to fully operate the equipment in every operating mode listed above. At minimum the following shall be included.

1. Monopolar electrode and holster with switch, compatible with all monopolar modes.

1. Patient return electrode for monopolar operation.

1. Bipolar forceps, cord, and footswitch for bipolar coagulation.

1. Vessel sealer with switch for vessel sealing mode.

All accessories shall be compatible with the delivered equipment and ready for use upon delivery.

Trade-in Not applicable. No trade-in is offered under this acquisition.

5. Information Technology and Accessibility Not applicable.

6. Warranty Requirements Consistent with RFO 12.105(b), the Government will accept the contractor's standard commercial warranty to the maximum extent practicable and use that warranty for the repair and replacement of the equipment. The warranty shall provide, at a minimum:

1. A full manufacturer's warranty of twelve (12) months from the date of final acceptance

1. Warranty coverage of parts, labor, and service for the equipment and all included accessories

1. Technical support by phone or email during standard business hours

7. Ancillary Maintenance Requirements Not applicable.

8. Training and Documentation The contractor shall provide:

1. User manuals and technical documentation

1. Warranty documentation and service contact information

1. Safety data sheets (SDS), if applicable

9. Delivery

1. Packaging and marking: No special requirements

1. Installation: Required

1. Delivery 30 days after award

10. Acceptance Criteria The Government will inspect and accept the equipment at destination.

The warranty period begins at final acceptance.

11. Holidays and Government Closures The contractor is not required to perform on-site services on the following Federal holidays, or on any other day designated as a holiday for the Washington, DC area:

1. New Year's Day

1. Martin Luther King Jr. Day

1. Presidents' Day

1. Memorial Day

1. Juneteenth National Independence Day

1. Independence Day

1. Labor Day

1. Columbus Day

1. Veterans Day

1. Thanksgiving Day

1. Christmas Day

1. Inauguration Day (every four years, for performance sites in the DC area)

12. Points of Contact See contract for points of contact.