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FBO DAILY - FEDBIZOPPS ISSUE OF AUGUST 31, 2017 FBO #5760
DOCUMENT

65 -- Barrx Flex RFA Energy Generator - Attachment

Notice Date

8/29/2017
 

Notice Type

Attachment
 

NAICS

334510 — Electromedical and Electrotherapeutic Apparatus Manufacturing
 

Contracting Office

Department of Veterans Affairs;Network Contracting Office 20;5115 NE 82nd Ave, Suite 102;Vancouver WA 98662
 

ZIP Code

98662
 

Solicitation Number

VA26017N0675
 

Response Due

9/4/2017
 

Archive Date

9/19/2017
 

Point of Contact

Robert Hamilton
 

E-Mail Address

robert.hamilton8@va.gov
(robert.hamilton8@va.gov)
 

Small Business Set-Aside

N/A
 

Description

Sources Sought The purpose of this Sources Sought Announcement is for market research to make appropriate acquisition decisions and to gain knowledge of potential qualified sources for the equipment listed below. This is not a request for quotations. The Department of Veterans Affairs, NCO20 is looking for sources of the following: MFG Part Number / Item 1. 1190A-115A / Barrx Flex Energy Generator 2. CART-100 / Barrx RFA Cart 3. XWAR5-FL / 5-Year Service Plan This an Unrestricted, Brand Name or Equal notice and the brand manufacturer is Covidien - Medtronic. The VA Medical Center seeks to acquire a device to treat dysplasia in Barrett s esophagus. Barrett s esophagus develops from chronic acid reflux and injury to the lower lining of the esophagus. This injury can stimulate the conversion of normal squamous tissue into more acid resistant tissue such as stomach or intestinal tissue; this process is called metaplasia. Intestinal metaplasia of squamous mucosa in the esophagus can further transform into precancerous tissue called dysplasia. There is widespread concurrence in the medical community that dysplasia significantly increases the risk of developing esophageal cancer. Dysplasia should at a minimum be monitored with serial biopsy for low grade dysplasia and should be definitively managed for persistent low grade dysplasia refractory to medical management or progression to high grade dysplasia. Treatments for dysplasia include surgery, ablation, or mucosal resection. Current guidelines recommend the least invasive approach to treatment, determined by the grade of dysplasia and extent of disease. Mucosal resection is indicated for small areas of dysplasia, while ablation or surgery is indicated for large areas of disease. Any equal item must meet or exceed the following salient characteristics RFA Unit 1) Must provide American Society of Gastrointestinal Endoscopy (ASGE) guidelines for use to treat Barrett s esophagus. Additionally, the equipment must be FDA approved for radiofrequency ablation of esophageal tissue with intestinal metaplasia (Barrett s esophagus). 2) Must have robust data on efficacy and have a clear safety profile, e.g. Complication rates from the device, Rates of successful ablation of tissue and recurrence, etc. 3) Must be compatible with facilities exiting endoscopes (Olympus 190 System). 4) RFA must offer a seamless transition between circumferential and spot treatment cases. 5) Must allow for rapid firing (<5 sec) for reduced procedure time. 6) Unit must automatically recommend ablation catheter sizing. 7) Unit must tract and display total number of ablations. 8) Unit must automatically adjust power density settings to match catheter. 9) Unit must be footswitch controlled. 9) Power: 115VAC. Cart 1) Overall dimensions, must be within 3 inches of the following: H - 42.5 X W 22.5 up to 34 if trays are included X D 23 2) Cart must be able to store all catheters and accessories to make the system completely portable. 3) Must have 4 casters that are approved for medical facilities. Service Plan 1) Minimum 5-year Service plan to include the following: if equipment fails to perform to specifications, due to defects in materials or workmanship, within the term of this Service Plan: a. Repair or replace (with functionally equivalent equipment) all covered equipment at no charge, including shipping, parts and labor. b. Vendor will provide functionally equivalent equipment (loaner) while covered equipment is being serviced or replaced. c. Software revisions offered for commercial sale will be offered at no charge for the term of this Service Plan. Potential sources shall provide, at a minimum, the following information to Point of Contact listed below: 1) Company name, address, and point of contact, phone number, e-mail address, and DUNS. 2) Please identify your company s size in comparison to the anticipated North American Industry Classification System (NAICS) code 334510 Electromedical and Electrotherapeutic Apparatus Manufacturing. To be considered a small business your company must have fewer than 1,250 employees. 3) Any Service Disabled Veteran Owned Small Businesses or Veteran Owned Small Businesses who responds to a solicitation on this project must be registered with the Department of Veterans Affairs Center for Veterans Enterprise VetBiz Registry located at http://vip.vetbiz.gov. 4) The Non-Manufacturer Rule (NMR) will apply if there is a decision to set-aside the procurement. 5) Potential sources shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor or authorized reseller for the proposed equipment/system such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty, and service associated with the equipment/system shall be in accordance with the OEM terms and conditions. This procurement is for new Equipment ONLY; no remanufactured or "gray market" items. All Equipment must be covered by the manufacturer's warranty. Responses are due by 09/04/2017 12:00 PM EST, to the Point of Contact. The Government is not obligated to nor will it pay for or reimburse any costs associated with responding to this sources sought notice. This notice shall not be construed as a commitment by the Government to issue a solicitation or ultimately award a contract, nor does it restrict the Government to a particular acquisition approach. The Government will in no way be bound to this information if any solicitation is issued. Notice to Potential Offerors: All Offerors who provide goods or services to the United States Federal Government must be registered in the System Award Management (SAM located on the web at www.sam.gov). It is desirable that any Offeror to have completed their business Online Representations and Certifications Application in the System for Award Management (SAM). Point of Contact: Robert Hamilton, Contracting Officer robert.hamilton8@va.gov, 360-852-9880
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/notices/759faa8e51667ca6c6a012c70ecce928)
 

Document(s)

Attachment
 

File Name: VA260-17-N-0675 VA260-17-N-0675_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3764283&FileName=VA260-17-N-0675-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3764283&FileName=VA260-17-N-0675-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Place of Performance

Address: Department of Veterans Affairs;VA Portland Health Care System;Vancouver Warehouse;1601 E. Fourth Plain Blvd;Vancouver

Zip Code: WA
 

Record

SN04652078-W 20170831/170829233636-759faa8e51667ca6c6a012c70ecce928 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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