Evaluation Criteria.docx

Lowest Price Technically Acceptable (LPTA) Evaluation Criteria

1. Introduction This document outlines the evaluation criteria for determining the lowest price technically acceptable offer in accordance with Federal Acquisition Regulation (FAR) 15.101-2. The evaluation process will consist of a technical evaluation and a price evaluation. Only offers that meet the minimum technical requirements will be considered for the price evaluation.

2. Evaluation Process Overview

· Step 1: The contracting officer will first evaluate the technical acceptability of each offer based on the specified technical criteria.

· Step 2: Only those offers that are determined technically acceptable will be evaluated for price.

· Step 3: The lowest-priced, technically acceptable offer will be selected for award.

3. Technical Evaluation Criteria The technical evaluation will assess the offeror’s proposal against the following minimum technical requirements (adjust as needed for the specific solicitation):

· Criterion 1:

Endoscope System with the following specification/requirements:

· The Endoscope System shall include the video processor, colonoscope, medical display, and cart that are interoperable with each other.

· The video processor shall satisfy the following requirements:

· The video processor shall be an FDA-cleared 510(k) medical device. The database is publicly available at 510(k) Premarket Notification.

· The light source shall be integrated within the video processor.

· The light source shall use three (3) or more LEDs to synthesize different spectra.

· The video processor shall have the white light mode.

· The video processor shall have two (2) or more narrow-band imaging (NBI) modes that utilize different optical spectra generated by the LED-based light source. The NBI modes shall be FDA-cleared for visualizing biological features such as blood vessels or mucosal surfaces.

· The video processor shall have two (2) or more digital color enhancement modes that utilize different digital image processing techniques. These color enhancement modes shall be FDA-cleared under the FDA product code “PEA”.

· The video processor shall have the following video output ports and video formats:

· 12G-SDI (3840x2160x60p)

· 3G-SDI (1920x1080x60p)

· HD-SDI (1900x1080x60i)

· The video processor shall have the capability of saving still images in a standard image file format such as TIFF or JPEG.

· The video processor shall have the capability of saving video clips in a standard video file format.

· The colonoscope shall satisfy the following requirements:

· The colonoscope shall be an FDA-cleared 510(k) colonoscope device.

· The direction of view shall be forward viewing.

· The field of view shall be 170 ° or wider.

· The depth of field shall cover the range of 5-100 mm or wider.

· The angulation (up/down/right/left) shall be 180°/180°/160°/160° or larger.

· The colonoscope shall have a water nozzle.

· The insertion tube diameter shall be 12.8 mm or smaller.

· The colonoscope shall have an instrument channel with diameter of 3.7 mm or larger.

· The medical display shall satisfy the following requirements:

· The signal input ports shall include:

· 12G-SDI

· 3G-SDI

· Display Port

· HDMI

· DVI

· The pixel count shall be equal to or greater than 3840x2160 pixels (4K).

· The display size (diagonal) shall be equal to or greater than 32 inches.

· All components in the system shall be powered by the standard 120 volts, 60 Hertz alternating current power in the U.S.

· The Endoscope shall include a 1-year system warranty, including parts and labor, travel, and shipping to return the system to operational status.

All bids shall include all shipping and handling cost.

SHIP TO address:

10903 New Hampshire Ave

WO62-3133, US FDA

Silver Spring, MD 20993-0002

4. Price Evaluation

· The price evaluation will assess the total proposed price for the contract.

· The contract award will be made to the lowest-priced offeror whose proposal is determined to be technically acceptable.

· Price Reasonableness: The contracting officer may, at their discretion, review the proposed price for reasonableness based on market research, historical prices, or other available data sources. If the price appears unreasonably low, the contracting officer may request additional information or clarification.

5. Acceptance of Technical Proposal Proposals will be reviewed to ensure they meet all of the following minimum standards. Failure to meet these minimum technical standards will result in the proposal being rated as "Technically Unacceptable," and it will not be considered for price evaluation.

· Acceptance Criterion 1:

Endoscope System with the following specification/requirements:

· The Endoscope System shall include the video processor, colonoscope, medical display, and cart that are interoperable with each other.

· The video processor shall satisfy the following requirements:

· The video processor shall be an FDA-cleared 510(k) medical device. The database is publicly available at 510(k) Premarket Notification.

· The light source shall be integrated within the video processor.

· The light source shall use three (3) or more LEDs to synthesize different spectra.

· The video processor shall have the white light mode.

· The video processor shall have two (2) or more narrow-band imaging (NBI) modes that utilize different optical spectra generated by the LED-based light source. The NBI modes shall be FDA-cleared for visualizing biological features such as blood vessels or mucosal surfaces.

· The video processor shall have two (2) or more digital color enhancement modes that utilize different digital image processing techniques. These color enhancement modes shall be FDA-cleared under the FDA product code “PEA”.

· The video processor shall have the following video output ports and video formats:

· 12G-SDI (3840x2160x60p)

· 3G-SDI (1920x1080x60p)

· HD-SDI (1900x1080x60i)

· The video processor shall have the capability of saving still images in a standard image file format such as TIFF or JPEG.

· The video processor shall have the capability of saving video clips in a standard video file format.

· The colonoscope shall satisfy the following requirements:

· The colonoscope shall be an FDA-cleared 510(k) colonoscope device.

· The direction of view shall be forward viewing.

· The field of view shall be 170 ° or wider.

· The depth of field shall cover the range of 5-100 mm or wider.

· The angulation (up/down/right/left) shall be 180°/180°/160°/160° or larger.

· The colonoscope shall have a water nozzle.

· The insertion tube diameter shall be 12.8 mm or smaller.

· The colonoscope shall have an instrument channel with diameter of 3.7 mm or larger.

· The medical display shall satisfy the following requirements:

· The signal input ports shall include:

· 12G-SDI

· 3G-SDI

· Display Port

· HDMI

· DVI

· The pixel count shall be equal to or greater than 3840x2160 pixels (4K).

· The display size (diagonal) shall be equal to or greater than 32 inches.

· All components in the system shall be powered by the standard 120 volts, 60 Hertz alternating current power in the U.S.

· The Endoscope shall include a 1-year system warranty, including parts and labor, travel, and shipping to return the system to operational status.

All bids shall include all shipping and handling cost.

SHIP TO address:

Attention to: Wei-Chung Cheng 10903 New Hampshire Ave

WO62-3133, US FDA

Silver Spring, MD 20993-0002

6. Unacceptable Proposals A proposal will be deemed "Technically Unacceptable" if it fails to meet the minimum requirements as described in the solicitation. Offers that are deemed technically unacceptable will not be evaluated for price.

7. Final Evaluation The final evaluation will compare the prices of all technically acceptable proposals. The contract will be awarded to the offeror whose price is the lowest among the technically acceptable offers.