Brand_Name_Justification-signed.pdf

CCAP-SCI 12 September 2018

MEMORANDUM FOR RECORD

SUBJECT: Limited Sources (Brand Name) Justification for COSMED K5 Wearable Metabolic

Systems.

1. Requirement: U.S. Army Aberdeen Test Center is requesting a Supply Contract for

COSMED K5 Wearable Metabolic Systems and accessories to be used throughout U.S. Army

Garrison, Aberdeen Proving Ground (USAG-APG). The system will add the ability to conduct breath-by-breath analysis of gas exchange for personnel non-simulated environment (i.e.

running, etc.). A Firm Fixed-Price purchase order contract is contemplated. Research &

Development (R&D) funds, appropriate to the current year of the contract, will be used. The contract will be for an estimated total value of $80,162.00.

2. Description of Action: The Government will limit competition to the brand name of

COSMED K5 Wearable Metabolic Systems.

3. Description of Supplies/Services: Two (2) COSMED K5 units including: Two (2) rechargeable batteries, One (1) dual-bay battery charger, Three (3) face masks with inspiratory valve (small, medium, and large masks), Two (2) headgears (medium and large), One (1) adult harness, Two (2) turbine flowmeters, One (1) turbine reader, Two (2) sampling lines (nafion), One (1) HR monitor and belt, One (1) AC/DC power adapter, headphone, cables and accessories, OMNIA Software, user manual, and rugged carrying case.; Two (2) Mask, V2 w/Headgear &

Turbine Adapter, Turbine 2000 ID28, Adult (Small); Two (2) Mask, V2 w/Headgear & Turbine

Adapter, Turbine 2000 ID28, Adult (Medium); Two (2) Mask, V2 w/Headgear & Turbine

Adapter, Turbine 2000 ID28, Child (X-Small); Two (2) Sampling Line, Permapure KS; Two (2)

Turbine 2000 V02MAX 1D28 (K5-K4b2-CPET); Two (2) Calibration syringe 3 liters; Two (2)

Regulator, KS CAL Gas (x dispos ED cyl.-CGA-973); Two (2) Gas, Cal mix CGA-973 (16%02, 5%C02, N2 bal); Two (2) COSMED Data Collection Terminal; One (1) On-Site Product Clinical

Education (at installation); One (1) Onsite Training with a Clinical Specialist. Interactive session on the proper operation of the instrument.

4. Authority Cited: In accordance with FAR 6.302-1(c), “An acquisition or portion of an acquisition that uses a brand-name description or other purchase description to specify a particular brand-name, product, or feature of a product, peculiar to one manufacturer.”

5. Reason for Authority Cited: Only one brand-name and no other brand-names will satisfy the agency requirements.

a) COSMED is a dual metabolic sampling technology for cardiopulmonary gas exchange analysis researched and approved by Army researchers to maintain the standards of accuracy in a portable design. The K5 wearable system meets FDA standards and is an approved

Class II medical device (510(K) #K162515). This system is the only one approved for use in the Army Test Centers. Many studies and reviews have been conducted to validate the accuracy standards of the K5 in comparison to various simulating systems:

i) Open-Circuit Respirometry: A Historical Review of Portable Gas Analysis Systems

Macfarlane DJ. Eur J Appl Physiol. 2017 Oct 17.

ii) Portable open-circuit spirometry systems: a review. Overstreet BS, Bassett DR Jr, Crouter SE, Rider BC, Parr B.-J Sports Med Phys Fitness. 2016 Feb 10.

iii) Accuracy and reliability of COSMED K5 portable metabolic device versus simulating system C. Baldari, M. Meucci, F. Bolletta, M.C. Gallotta, G.P. Emerenziani, L.

Guidetti - Sport Sciences for Health, September 2015, Volume 11, Supplement 1

b) The COSMED K5 wearable system will enhance mission support by offering additional capability to quantify human performance. The dual chamber feature gives added capability by measuring both gas exchange or breath-by-breath technique while maintaining industry standards for accuracy. The rugged design allows for real world environment testing both inside and outside of the laboratory environment.

c) It is vital to mission success that the test center use equipment and protocols that have been vetted by Army researchers. Using products/protocols that have not been vetted could compromise the quality of test data generated by the test center resulting in inaccurate assessments of Soldier-worn gear and questionable customer reports. Without maintaining the latest performance testing capabilities, the test center risks not providing the highest quality independent tests and reports for the customers.

6. Actions to Increase Competition: A combined synopsis/solicitation was placed on 10

September 2018 to include the specification of the metabolic system to encourage competition.

The internet was used to identify several portable metabolic system; however, the COSMED K5 was identified as the only brand with the same capabilities required to meet the Aberdeen Test

Center’s mission. For future acquisitions, market research will be conducted to review the current available technologies to determine if any new capabilities have been developed that meets the requirements of the test center.

7. Market Research: Internet research of various systems, studies, and product reviews lead to the conclusion that no other manufacturer makes a dual-chamber sampling, wearable metabolic system that meets FDA standards and is an approved Class II medical device while maintaining establish industry standards.

8. Other Facts: Studies and reviews where conducted and available on the internet comparing the features of the K5 with other portable systems and simulating systems comparing the features, accuracy, and reliability of the K5 with other systems and the research validated

COSMED being the only system available that provides the specifications required while maintain the accuracy and reliability established by the FDA.

ATC follows the same testing protocols as NSRDEC and ARL, to include using testing equipment that has been proven successful in supporting the similar missions of providing metabolic testing in both simulated and non-simulated environments while maintaining FDA standards.

9. Technical/Requirements Certification: I certify that the supporting data under my cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief.

Typed Name: John J. Christopher Date: 12 September 2018

Title: Biomechanical Engineer Signature:

10. Contracting Officer Certification: I certify that this justification is accurate and complete to the best of my knowledge and belief.

Typed Name: Barbara D. Cousins Date: 12 September 2018

Title: Contracting Officer Signature: