6515--MEDTRONIC DBS IMPLANTS (VA-23-00007287)

This Notice of Intent is provided to advise that the Government intends to solicit and negotiate a Sole Source, Firm-Fixed-Priced Purchase Order with only one source Medtronic, Inc. The procurement is for the Deep Brain Stimulator (DBS) Sensing Leads. This contract action is for supplies for which the Government intends to solicit and negotiate with only one source under the authority of FAR 13.501(a)(1)(ii) and 41 USC §1901, only one will meet the Government s needs. Only one source is capable of responding due to the unique or specialized nature of the supplies and/or services. Interested persons may identify their interest and capability to respond to the requirement. The applicable NAICS Code is 339113 and the size standard is 750 employees. SCHEDULE OF PROPOSED CLIN ITEM INFORMATION ITEM NUMBER DESCRIPTION OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT 0001 2.00 EA __________________ __________________ MEDTRONIC NEURO SENSIGHT DBS LEAD .5MM 42CM DBS PN: B3300542 0002 4.00 EA __________________ __________________ MEDTRONIC NEURO SENSIGHT DBS LEAD 1.5MM 42CM DBS PN: B3301542 0003 2.00 EA __________________ __________________ MEDTRONIC SENSIGHT DBS LEAD .5MM 42CM MARKER DBS PN: B3300542M 0004 4.00 EA __________________ __________________ MEDTRONIC NEURO SENSIGHT DBS LEAD 1.5MM 42CM MARKER DBS PN: B2201542M 0005 8.00 EA __________________ __________________ MEDTRONIC NEURO SENSIGHT DBS EXTENSION 60CM DBS PN: B3400060 0006 8.00 EA __________________ __________________ MEDTRONIC NEURO SENSIGHT DBS EXTENSION 60CM MARKER DBS PN: B3400060M 0007 8.00 EA __________________ __________________ MEDTRONIC NEURO SENSIGHT DBS BURR HOLE DEVICE KIT PN: B32000 0008 4.00 EA __________________ __________________ MEDTRONIC NEURO SENSIGHT DBS BURR HOLE DEVICE ADDTNL PARTS PN: B31000 0009 2.00 EA __________________ __________________ MEDTRONIC NEURO SENSIGHT DBS DEPTH STOP AND CRANIAL TUNNELER PN: B31010 0010 2.00 EA __________________ __________________ MEDTRONIC NEURO SENSIGHT DBS LEAD CAP KIT W/ TORQUE WRENCH PN: B31020 0011 4.00 EA __________________ __________________ MEDTRONIC NEURO SENSIGHT DBS LEAD TEST CABLE PN: B31040 GRAND TOTAL __________________ Attachment 1 Salient Characteristics Salient Characteristics General: Please reference the parts and salient characteristics related for each item below. The salient characteristics are essential, significant and functional to the requirement Essential/significant physical, functional, or performance characteristics. DBS system must have: Neurostimulator operating values Amplitude of 0 to 25.5 mA Pulse Width of 20 to 450 us Rate of 2 to 250 Hz Cycling off, on: 0.1s to 24hr Sensing noise floor <300nV/rtHz Input sensing range 0.55 to 500uVrms Features Connector type with 8 contacts inline, dual channel Volume 33cm Mass 61 g HxWxD 68mmx51mmx11mm (case), 68mmx51mmx13mm (connector block) Surface area 79cm 2) Complete generic identification Deep brain stimulation leads Applicable model/make/catalog number B3300542 B3301542 B3300542M B3301542M B3400060 B3400060M B32000 B31000 B31010 B31020 B31040 Manufacturer name Medtronic Compatibility Devices - B35200 Percept PC 37601 Activa PC 37612 Activa RC Extensions - B34000 SenSight Extension Kit Implant Tools - B31010 SenSight Depth Stop and Cranial Tunneler Kit B31040 SenSight Lead Test Cable Kit B31020 SenSight Lead Cap Kit Burr Hole Device - B31000 SenSight Burr Hole Device B32000 SenSight Burr Hole Device Kit Clinician Programmer - CT900D 8880T2 Communicator A610 3.0 Software Application Per VAAR 811.104 and 811.105, I certify the following regarding the above information: The salient characteristics listed above are essential to the Government s requirements. To my knowledge, the restrictions listed above will not limit the acquisition to an item peculiar to one manufacture. Purpose How will this item be utilized? These new Medtronic DBS leads have current steering ability to direct stimulation to effective areas of the brain that will improve symptoms in patients with movement disorders and avoid stimulation of areas that can lead to side effects, which can greatly improve therapy for all patients getting deep brain stimulation (DBS) implants. Characteristics: These leads have the additional sensing ability, allowing clinicians to track brain states overtime and provide personalized stimulation setting with the ability to perform closed-loop (adaptive) DBS in the future, which is one of the greatest technological advancements in the field of DBS since its inception 25 years ago. The new DBS leads, lead extenders, and burr hole covers are much more durable, flexible, and are therefore much less prone to lead fracture/lead pull out/other lead-related hardware complications, which are costly to repair and require reoperations. DELIVERY OF ITEMS The address is with FOB Destination shipping: VA San Francisco Healthcare System 4150 Clement St. San Francisco, CA 94121 This notice of intent is not a request for competitive quotes and no solicitation will be made available. Any responses received will only be considered for the purposes of determining whether to conduct a competitive procurement in lieu of sole source contract described in this notice, and such determination shall be made at the sole discretion of the Government. Supporting evidence must be furnished in sufficient detail to demonstrate the ability to comply with the requirement. If no responses are received, the government will proceed with the Sole Source acquisition. Your response should include a STATEMENT OF CAPABLILITY, GSA SCHEDULE INFORMATION, DUNS#, BUSINESS SIZE, AND SOCIO-ECONOMIC STATUS. The Government will not pay for information submitted any quotation/response should be emailed to Carlos M. Exconde at contact@example.gov by 3:00 P.M. PST. Tuesday September 13, 2022. No telephone requests will be accepted.