RFI Attachment 1_ Critical Operational Device Specification CODS _Fiber Bronchoscope.pdf
PDF 151 KB Posted
- Attached to
- Request for Information Fiber Bronchoscope
- Solicitation number
- W81K0425Q1935
- Issued by
-
Department of the Army Medical Command
About this file
This is a Critical Operational Device Specification (CODS) attachment to an RFI for a Fiber Bronchoscope issued by the Department of the Army Medical Command. The document outlines minimum and desired specifications for the medical device, which must be FDA-cleared (510(k) approval for Class II devices or FDA registration for Class I devices). The system requires a Closed Suction Valve, compatibility with battery-powered or conventional light sources (110/120 VAC, 60Hz), minimum 2.0mm working channels, 180-degree tip deflection capability, and full immersibility for sterilization.
The logistical requirements include providing repair parts documentation with country of origin information, minimum one-year warranty (three years desired), physical and digital user/operator manuals, Trade Agreements Act compliance, and hardened reusable transport cases meeting specific MIL-STD testing requirements (including temperature, humidity, vibration, shock, and shipboard equipment standards). The system must weigh no more than 12 pounds (10 pounds desired) and should include an extra battery as an additional desired performance parameter.
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Other files
| File | Type | Posted |
|---|---|---|
| RFI Attachment 2_ Company and Product Information.pdf | ||
| RFI Fiber Bronchoscope.pdf | ||
| RFI Attachment 3_Flexible Bronchoscopes Device Specification.xlsx | XLSX spreadsheet |
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Text version
Attachment 1
Critical Operational Device Specification (CODS)
Critical Specifications: The below are critical specifications and the minimum must be met in order for the device to be considered acceptable by the government. They are separated by “minimum” and “desired” columns.
Instructions: Indicate “yes” or “no” under both minimum and desired columns below.
Additional comments may be added.
1. Critical Operational Device Specifications
Number
Operational
Characteristic Minimum Required Desired
Characteristics
Meets Minimum
Y/N?
Meets Desired
Y/N? Comments
Food and Drug Administration (FDA) Regulatory Oversight
The system shall be cleared by the FDA with a 510(k) approval if it is a Class II medical device.
If the system is a Class I medical device, it shall be registered with the FDA for human use.
Minimum Requirement
N/A
2 Therapeutic Ability
The system shall have Closed Suction Valve (CSV), a unique mechanism for improved suction
Minimum Requirement
N/A
3 Power
The system shall be compatible with a battery-powered light source (BS portable series only) or connected to a conventional light source supported by 110 or 120 Volts Alternating Current (VAC) and 60 Hertz (Hz)
Desired characteristic is for the system to be compatible with a battery-powered light source (BS portable series only) or connected to a conventional light source supported by 110 or 120 VAC, 60Hz, and/ or 220-240 VAC, 50Hz, with the ability to auto- detect and auto-switch between the two
4 Channel Size The system shall contain large working
Minimum Requirement channels with a minimum size of 2.0mm to accommodate a wide range of instruments and high suction capacity.
5 Tip Control/ Maneuverability
The system shall reprocess up to 180°tip deflection, a tight bending radius, and wide angle of view for easy maneuverability.
Minimum Requirement
6 Sterilization
The system shall be able to be fully immersible and re-processible allowing the instruments to be completely and effectively high- level disinfected or sterilization.
7 Operational Cube and Weight
The system shall weigh no more than 12lbs.
Desired characteristic of the system is that it weighs less than 10lbs.
2. Critical Logistic Specifications
Operational
Characteristic Minimum Required Desired
Characteristics
Meets Minimum
Y/N?
Meets Desired
Y/N? Comments
1 Repair Parts Support
Contractor shall provide a full listing of repair parts and distinguish the items to be considered high-failure repair parts (identified by OEM and Government Subject Matter Experts). The country of origin, availability, proprietary parts, and procurement accessibility of each item shall be provided on the list.
2 Warranty
The contractor shall provide a warranty for at least (1) year.
This warranty shall include all parts, In- House labor, and technical support during the warranty period
Desired the contractor provides a warranty for at least 3 years.
This warranty shall include all parts, In-house labor, and technical support during the warranty period.
3 Manuals
The vendor shall provide 1 physical and 1 digital User and Operator Service Manuals with each system
Minimum Requirement
N/A
4 Trade Agreements Act (TAA) Compliance
The system shall be compliant with TAA regulations.
5 Harden Reusable Transport Case
A.) The system and all accessories should be contained in harden reusable transport cases (e.g. Hardigg, Pelican, ECS Case or Equivalent).
B.) The system should be designed to withstand MILSTD testing in accordance with (IAW) the following paragraphs:
501.7 High Temperature
502.7 Low Temperature
507.6 Humidity
511.7 Explosive Atmosphere
514.8 Vibration
516.8 Shock
517.3 Pyro-shock
528.1 Mechanical Vibrations
of Shipboard Equipment (Type I- Environmental and Type II- Internally Excited)
3. ADDITIONAL PERFORMANCE PARAMETERS
These are desired Additional Performance Parameters (APPs) but are not essential.
Additional Performance Parameters Minimum Requirement
Meets Minium
(APPs) Requirements
1 Additional Battery The system will come with an extra battery.
(End of CODS)
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