SSN_CDRH-2026-134633.pdf

SSN_CDRH-2026-134633 Pulsed Field Ablation (PFA) System 1

SOURCES SOUGHT NOTICE

Pulsed Field Ablation (PFA) System for Non-Clinical Research Use

Notice ID: SSN_CDRH-2026-134633

Issuing Office: U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS)

NAICS / Size Standard: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing / 1,250 employees

PSC Code: 6515 - Medical and Surgical Equipment, Instruments and Supplies

Place of Delivery: TBD

Response Due: August 10, 2026, 10:30 am ET

Point of Contact: See the point of contact listed in the SAM.gov posting

1.0 PURPOSE AND DISCLAIMER

THIS IS A SOURCES SOUGHT NOTICE ONLY, issued for market research under RFO Part 10. It is not a solicitation and does not commit the Government to issue one. The Government will not pay any costs incurred in responding. Responses will not be returned and respondents will not be notified of results. Not responding does not preclude participation in any future solicitation, which, if issued, will be posted to SAM.gov.

This notice has two purposes: (1) to identify sources of any business size capable of supplying domestic end products meeting this requirement, in support of the Government's obligations under the Buy American statute and RFO Part 25; and (2) to determine whether capable small business concerns, whether as manufacturer, original equipment manufacturer (OEM), authorized distributor, or reseller, exist in sufficient number to support a set-aside under RFO Part 19. Responses will inform the acquisition strategy, including the set-aside decision and any domestic availability determination, and may be summarized in market research documentation posted publicly with a proposed nonavailability waiver, if applicable. Do not submit proprietary pricing; mark any confidential business information clearly.

2.0 DESCRIPTION OF REQUIREMENT

The FDA is conducting market research to identify capable sources for one (1) complete, off-the-shelf Pulsed Field Ablation (PFA) system for FDA non-clinical cardiac ablation research. The contemplated requirement includes the PFA generator, five (5) compatible clinical PFA catheters, accessories, cables, connectors, software, licenses, documentation, training, warranty coverage, and technical support required for a complete and fully functional system.

The proposed system shall meet, at a minimum, the following salient physical, functional, performance, and regulatory characteristics:

• FDA-approved or cleared for clinical use in the United States for the treatment of atrial fibrillation or other cardiac arrhythmias. Respondents shall identify the applicable PMA approval number, 510(k) clearance number, De Novo classification number, or other FDA authorization number.

• New, unused, current-production PFA generator and durable components. The system shall be a commercially available, off-the-shelf product.

• PFA generator capable of producing a bipolar, biphasic pulsed electric field waveform suitable for cardiac ablation research.

• Compatibility with standard building power of 115-120 volts, 60 hertz, single phase. The generator may be cart-mounted or tabletop.

• Five (5) unused clinical PFA catheters compatible with the proposed generator. Expired catheters may be acceptable solely for non-clinical research use if unused, unopened, in intact original packaging, free from recall, and clearly identified as not intended for clinical use.

• All power cables, interface cables, connectors, adapters, software, licenses, and other components needed for operation in a non-clinical research environment.

SSN_CDRH-2026-134633 Pulsed Field Ablation (PFA) System 2

• Identification of any external equipment, third-party hardware, subscriptions, facility requirements, or procedure-specific accessories needed for full operation but not included with the system.

• Suitability for non-clinical research use, including disclosure of any configuration changes, software settings, interfaces, or modifications required for such use.

• Supporting peer-reviewed literature, clinical data, or manufacturer test data addressing hemolysis associated with the proposed system, catheter, and waveform configuration.

• Current Instructions for Use, operator manuals, safety information, component list, software and licensing documentation, and recommended maintenance, cleaning, storage, calibration, and troubleshooting instructions.

• At least one (1) instructor-led user training session, which may be conducted in person or virtually, covering setup, operation, safety, routine troubleshooting, cleaning, storage, and technical-support procedures.

• Manufacturer standard commercial warranty of not less than twelve (12) months after Government acceptance, together with telephone and email technical support during the warranty period.

Delivery timeframe: 60 calendar days after receipt of order.

Delivery location: 10903 New Hampshire Avenue, Silver Spring, MD 20993 Delivery is anticipated to be FOB Destination. On-site installation, manufacturer-standard startup verification, inspection, acceptance, and training will be coordinated with the Government. Respondents shall identify standard commercial lead times, installation requirements, training availability, warranty terms, and any known supply-chain constraints.

The Government has not identified a brand name or part number for this market research. Respondents may identify any commercially available system that meets the stated minimum characteristics.

3.0 INSTRUCTIONS TO RESPONDENTS

Responses shall be submitted by email to the point of contact identified in the SAM.gov posting no later than the response due date, with the subject line “Sources Sought Response – SSN_CDRH-2026-134633 - [COMPANY NAME].” A complete response consists of:

1. The Vendor Response Form (Attachment 1), completed and returned in its NATIVE MICROSOFT EXCEL

(.xlsx) FORMAT. Do not convert the form to PDF, scan it, or alter its structure. Name the file: CDRH-2026- 134633_CompanyName.xlsx; and

2. A capability statement not exceeding ten (10) pages in PDF format providing narrative elaboration and supporting documentation, as applicable, including product literature, specification sheets, FDA authorization documentation, warranty information, and letters of supply or authorized distribution.

The Company Information fields in Section 4.0 and the questions in Sections 5.0 and 6.0 below are reproduced in the Vendor Response Form. The Government intends to consolidate and analyze market data directly from the returned forms; responses submitted without the completed form in native Excel format may not be fully considered in the Government’s analysis. Telephone inquiries will not be accepted.

4.0 COMPANY INFORMATION

Company Name / Address:

UEI / CAGE Code:

Point of Contact (Name, Phone, Email):

Active SAM.gov Registration (Yes/No):

Business Size under the stated NAICS (Small / Other than Small):

Socioeconomic Categories (all that apply): 8(a); HUBZone; SDVOSB;

VOSB; WOSB; EDWOSB; SDB; None

SSN_CDRH-2026-134633 Pulsed Field Ablation (PFA) System 3

Existing Contract Vehicles

(FSS/MAS, GWAC, IDIQ/BPA):

5.0 SMALL BUSINESS CAPABILITY QUESTIONS

5.1. Identify your role for the required items: OEM, manufacturer, authorized distributor or dealer, reseller, or other

(describe). If a distributor or reseller, identify the manufacturer(s) of the end items you would supply and provide evidence of authorized distribution, if available.

5.2. If you are a small business that is not the manufacturer of the end item, state whether you can supply end items manufactured by a small business concern in the United States, consistent with the nonmanufacturer rule (13 CFR 121.406), and identify that manufacturer if known. If you would supply the product of an other than small or foreign manufacturer, state this clearly.

5.3. Describe your capability and capacity to fulfill the full scope of this requirement, including the quantities and delivery timeframes in Section 2.0, and identify any portion you could not fulfill. Include relevant experience (up to three recent contracts or commercial sales) and any applicable quality or regulatory certifications. Federal experience is not required.

5.4. Describe any teaming, joint venture, or subcontracting arrangements you anticipate.

5.5. Identify the proposed manufacturer, system name, model number, configuration, and all included components.

State whether the system is currently available for commercial sale and provide the standard lead time.

5.6. State whether the proposed system meets each minimum characteristic in Section 2.0. Clearly identify and explain any exception, deviation, dependency, required third-party component, or limitation.

6.0 DOMESTIC MANUFACTURE AND AVAILABILITY QUESTIONS

All respondents shall answer, regardless of business size.

6.1. Identify the country (or countries) in which the offered end item is manufactured and the operations performed at each location.

6.2. If manufactured in the United States, state whether the item meets the domestic content threshold in effect under RFO 25.101 as of the anticipated award date, or the approximate domestic content percentage you can certify to. State whether the item is a commercially available off-the-shelf (COTS) item and whether it consists wholly or predominantly of iron or steel.

6.3. Identify the country of origin of any critical components or components for which no domestic source is known to you.

6.4. If you can supply a domestic end product, describe production capacity against the Section 2.0 quantities, including sustainable output, available inventory, and lead times. If you can satisfy the requirement only in part or with deviations from the salient characteristics, describe the shortfall specifically.

6.5. If you do not currently manufacture a domestic end product meeting this requirement, state whether and under what conditions you could establish or expand domestic production, including estimated timeline, minimum quantities, or other commitments required.

6.6. Identify any alternative or substitute items manufactured in the United States that could satisfy the Section 2.0 characteristics, including items made by other firms, and any other known domestic manufacturers or supply-chain constraints relevant to domestic availability.

6.7. If the offered item is not a domestic end product, identify its country of origin and, if known, whether it is a designated country end product under the Trade Agreements Act.