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The CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SET is intended to connect a CO2 source (insufflator), and a sterile water source (water bottle), to an endoscope to supply CO2 during gastrointestinal endoscopic procedures.

Device Description

The Bracco Diagnostics Inc. (BDI) CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SET (ILTS) is intended for use with BDI CO2 Endoscopic Insufflators and OEM endoscope systems, in this specific case the Olympus® 140, 160, 180, and 190 series endoscopes. The ILTS is supplied sterilized using Gamma radiation to a Sterility Assurance Level (SAL) of 10-6. The ILTS is individually packaged At the time of this submission, accelerated aging tests confirmed a one (1) year shelf life.

AI/ML Overview

The provided text describes the acceptance criteria and the studies conducted for the "Bracco Diagnostics, Inc. CO2 Endoscopic Insufflator In Line Tubing Set (ILTS)."

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Sterilization	Sterility Assurance Level (SAL) of 10^-6 in accordance with ISO 11137-1:2006 and ISO 11137-2:2006.	Verified to a sterility assurance level of 10^-6. Complies with ISO 11137-1:2006 and ISO 11137-2:2006.
Packaging	Packaging validated in accordance with ISO 11607-1:2006 (requirements for materials, sterile barrier systems, and packaging systems) and ISO 11607-2:2006 (validation requirements for forming, sealing, and assembly processes).	Verification results indicate that the ILTS packaging complies with the standards.
Shelf-Life	Initially, a shelf life of at least one (1) year. (Based on accelerated aging tests).	Accelerated aging tests confirmed a one (1) year shelf life.
Biocompatibility	Patient contact materials verified in accordance with ISO 10993-1:2009 (Biological evaluation of medical devices - Part I: Evaluation and testing within a risk management process).	Verification results indicated that the ILTS patient contact materials comply with the standard.
Performance Testing	Predetermined specifications for:

Device compatibility
Usability
Environmental
Delivery flow rate
Delivery pressure
Leakage
Mechanical integrity
Shipping and transportation
Labeling | Test results indicate that the ILTS complies with its predetermined specification for all listed performance parameters (device compatibility, usability, environmental, delivery flow rate, delivery pressure, leakage, mechanical integrity, shipping and transportation, and labeling). |

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for each specific test (e.g., sterilization validation, biocompatibility, performance testing). Instead, it refers to "verification results" and "test results" indicating compliance with standards.

The data provenance is not specified regarding country of origin or whether studies were retrospective or prospective. Given the nature of a 510(k) submission for a medical device accessory, these would typically be internal laboratory tests and validations rather than clinical studies with patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable to this type of device and study. The "ground truth" for a medical tubing set's performance is established by objective engineering and scientific standards (e.g., sterility, biocompatibility, flow rates) rather than expert clinical consensus or interpretation of subjective data.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in studies involving expert interpretation, such as image reading or clinical assessments, to resolve discrepancies. This is not relevant for the objective performance testing described for this device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret output (e.g., medical images) with and without AI assistance. The "LINE TUBING SET" is a hardware accessory, not a diagnostic AI tool.

6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) was Done

This question is not applicable. The device is a physical tubing set, not an algorithm. The performance testing described (sterilization, shelf-life, biocompatibility, device compatibility, flow rate, etc.) constitutes its standalone performance assessment.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

International Standards: e.g., ISO 11137 for sterilization, ISO 11607 for packaging, ISO 10993-1 for biocompatibility.
Predetermined Specifications: Internal engineering specifications for performance parameters like delivery flow rate, delivery pressure, leakage, and mechanical integrity.

8. The Sample Size for the Training Set

This is not applicable. The ILTS is a passive medical device accessory, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

This is not applicable as there is no training set for this device.

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