SPECIAL NOTICE
66 -- Cosmed K5 wearable metabolic systems
- Notice Date
- 4/10/2020 10:42:53 AM
- Notice Type
- Special Notice
- NAICS
- 334515
— Instrument Manufacturing for Measuring and Testing Electricity and Electrical Signals
- Contracting Office
- W4PZ USA MED RSCH ACQUIS ACT FORT DETRICK MD 21702-5014 USA
- ZIP Code
- 21702-5014
- Solicitation Number
- W81XWH-20-R-0047
- Response Due
- 5/1/2020 11:00:00 AM
- Archive Date
- 05/16/2020
- Point of Contact
- Christopher L. Cook, Phone: 3016192640
- E-Mail Address
-
christopher.l.cook68.civ@mail.mil
(christopher.l.cook68.civ@mail.mil)
- Description
- This notice announces the intent by the U.S. Army Medical Acquisition Activity (USAMRAA), 820 Chandler St, Fort Detrick, Maryland, 21702, to award a sole source contract to Electramed Corporation. under the statutory authority 13.501(a). This contract is for the purchase of 4 new Cosmed K5 wearable metabolic systems for monitoring and data collection of human research subjects for use at the US Army Research Institute of Environmental Medicine (USARIEM). This is an equipment purchase of 4 new Cosmed K5 wearable metabolic system for monitoring and data collection of human research subjects. We require a portable version of this technology for use in field research with dismounted Soldiers, and due to the nature of our research monitoring human subjects in austere conditions and extreme environments we require the device to be designated as substantially equivalent to comparable FDA 510K cleared cart-based systems. Four K5 units will be purchased along with accessories required for operation and on-sight Product Clinical Education training. The devices will be covered by a one year manufacturer warranty, after which they will be serviced by the USARIEM medical maintenance contract. In May 2017 the FDA reviewed and approved premarket notification for the designation of the Cosmed K5 wearable metabolic system as substantially equivalent to FDA 510K cleared Pulmonary-Function devices approved for clinical diagnostic use. The K5 is currently the only wearable device with this designation by the FDA, and Cosmed is the sole source supplier. There are no alternatives to this device available to the government. This device is critical to the timely and accurate monitoring of dismounted Soldiers in extreme environments in order to establish safety guidelines for training and operational planning. An award will be issued on a sole source basis. The North American Industry Classification System (NAICS) for this requirement is 334515 and the size standard is 750.� This announcement fulfills the synopsis requirements under FAR 5.102(a)(6) and 5.203(a). USAMRAA intends to award a contract no sooner than 15 days after publishing this synopsis. This Special Request for Information is not a request for competitive quotes. Information received in response to this notice will be considered solely for the purpose of determining whether a competitive procurement is in the best interest of the Government. If no written responses are received by the expiration date listed in this notice, which reflects at least fifteen (15) days after the publication of this notice, the award will be issued as sole source. All questions and responses concerning this notice shall be emailed to Mr. Christopher L. Cook �at christopher.l.cook68.civ@mail.mil.�
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/a36ea4a978364cae8dc7fe92c4928f16/view)
- Place of Performance
- Address: Natick, MA 01760, USA
- Zip Code: 01760
- Country: USA
- Zip Code: 01760
- Record
- SN05617427-F 20200412/200410230142 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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