Purchase Description_SAM.gov.pdf

Version 11-30-2016-1 FAR Part 11—Describing Agency Needs

PURCHASE DESCRIPTION

1. Statement of Need and Purpose: This request covers the purchase of an FDA-approved instrument for the measurement of oxygen concentration in human tissues using pre-sterilized, disposable oxygen sensors. This equipment will be used to assess the effects of aging and sarcopenia on human skeletal muscle oxygenation, particularly in the lower extremities.

2. Background Information and Objective: The age-associated loss of muscle strength and mass (sarcopenia) is a well-documented phenomenon and is closely associated with frailty and morbidity in the elderly. Current research is focused on comparing the degree to which age-related changes in blood perfusion, neuromuscular control, mitochondrial function, tissue oxygenation and other anatomical and physiological factors contribute to a decline in muscle strength and endurance. While various methods exist to indirectly assess muscle oxygen concentration or to detect relative changes in muscle oxygenation with age or exercise, invasive polarographic sensors (Clark-type electrodes) represent the gold standard for absolute oxygen concentration measurements in human tissue. Because measurements must be performed in human subjects, purchasing a FDA-cleared instrument is greatly preferred for human subject research protection considerations. Literature research indicated the the LICOX tissue oxygen monitor, while marketed for brain tissue oxygenation measurements in neurosurgery, is a reliable, established means of obtaining absolute oxygen concentration data in human muscle tissue. This monitor utilizes pre-sterilized, pre-calibrated, disposable electrodes, which promotes safety while avoiding measurement errors due to incorrect sensor calibration.

3. Generic Name of Product: Human in vivo tissue oxygen concentration monitor

4. Purchase Description: LICOX Brain Tissue Oxygen Monitor; Integra Life Sciences;

Model LCX02 (monitor)

5. Salient characteristics

a. Instrument must measure tissue oxygen partial pressure in units of mmHg across a range of at least 0 to 50 mmHg with a precision of ±1 mmHg (±0.1% oxygen saturation) or better and an accuracy of ±10% of better. – This corresponds to the range of oxygen concentration in skeletal muscle tissue at rest and during vigorous exercise and recovery.

b. Instrument shall employ polarographic sensors to measure absolute oxygen concentration in human tissue. – This technique is considered to be the gold standard for tissue oxygen measurements in vivo.

Version 11-30-2016-1 FAR Part 11—Describing Agency Needs

c. Instrument shall simultaneously measure tissue temperature at the site of oxygen concentration measurement with a precision of ±0.2°C or better and accuracy of ±1°C or better and automatically correct oxygen readings for temperature dependence using the measured temperature. – This is necessary for obtaining accurate oxygen concentration data using polarographic techniques.

d. Instrument shall be FDA-cleared for use in measuring tissue oxygen partial pressure in human subjects. – This is needed for approval of the proposed study by the NIH Intramural Research Board (IRB).

e. Instrument shall employ pre-calibrated, pre-sterilized oxygen/temperature sensors. – This is needed for accurate, consistent measurements and for safety from infection of the measured tissue.

f. Each oxygen and temperature sensor pair shall be combined into a single probe which may be inserted within a single catheter.- This is preferred over separate needles to minimize microtrauma and to ensure that oxygen concentration and temperature are being measured in the same tissue volume.

g. Each oxygen/temperature probe must fit within a single catheter no larger than 16 gauge. – This is needed to minimize microtrauma to the test site and to facilitate combining oxygen and temperature measurements with intracompartmental pressure measurements at the same site.

h. Instrument shall measure and report tissue oxygen concentration and temperature at a minimum rate of one sample per minute. – Faster time resolution is desirable to follow the decrease in tissue oxygenation with exercise and its recovery. This exercise intervention can reveal differences between subjects that would be undetectable at rest.

i. Instrument shall record trend data at a rate of at least one sample per minute for a duration of at least 1 day and export these data to an ASCII text file for analysis and storage on a Windows PC. – This is necessary to archive and analyze data from numerous subjects participating in a given clinical study.

j. Preferably, the instrument shall have a real-time analog and/or digital outputs corresponding to the currently-displayed tissue oxygen concentration and temperature. – This facilitates the synchronous measurement and display of these parameters with additional physiological parameters such as compartment pressure or blood perfusion.

k. Preferably, the instrument shall have been demonstrated to measure tissue oxygen in human skeletal muscle, either as its primary or an off-label application.

6. Quantity: 1

7. Delivery Date: 4-6 weeks ARO

8. Period of Performance: One year warranty following delivery

9. Option(s): None