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The Saneso Lens Wash Bottle Assembly (SAN-LWB-A) is intended to be used with FDA-cleared Saneso endoscopes. It facilitates the following: 1. Sterile water for lens wash function 2. Air / CO2 for luminal insufflation function

The Saneso Lens Wash Bottle Assembly is intended to be used with Saneso endoscopes. It facilitates the following: - Sterile water for lens wash function 1. - 2. Air / CO2 for luminal insufflation function Saneso lens wash & insufflation system is divided into proximal and distal sections: Proximal Section: It comprises the Lens Wash Bottle Assembly and terminates at its connection with the air/water port on the endoscope. It consists of the lens wash bottle, lens wash bottle cap, airline, water line, CO2 line, and air/water connector. This section is the non-patient contacting portion of the system and is covered in this submission. Distal Section: It starts at the air/water port and terminates at the air/water nozzles on the distal end of the endoscope. It consists of the air/water valve, air/water valve, air/water channel, and the lens wash nozzles, which are all located in the endoscope. This section is the patient contacting portion of the system and is part of the Saneso endoscopes, which is FDA 510k approved (K210052).

This document describes a 510(k) premarket notification for the Saneso Lens Wash Bottle Assembly (SAN-LWB-A). The key information provided focuses on demonstrating substantial equivalence to a previously cleared device (Saneso Lens Wash Bottle, K210052), particularly addressing a change from single-use to multi-use.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a direct table of specific acceptance criteria values with corresponding measured device performance for parameters like residual protein levels, microbial load post-cleaning, or sterilization efficacy metrics. Instead, it states that the device "met all the acceptance criteria" for the validation tests.

However, based on the narrative, we can infer the categories of acceptance criteria and the positive outcome of the performance for these categories:

The document does not detail the specific quantitative thresholds for these acceptance criteria.

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

The document does not specify the exact sample size (number of devices) used for the Manual Cleaning Validation and Steam Sterilization Validation tests. It refers to these as "performance testing" and "reprocessing validation results."

The data provenance is not explicitly stated in terms of country of origin, but it is implied to be from Saneso, Inc.'s internal testing, as they are the submitter. The studies are retrospective in the sense that they are laboratory-based validation studies conducted to support the engineering change, rather than prospective clinical trials.

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

This section is not applicable in the traditional sense of AI/medical image analysis studies. The document describes non-clinical performance testing (cleaning and sterilization validation) of a medical accessory, not an AI or diagnostic device that requires expert ground truth labeling. The "ground truth" here is established by validated laboratory methods and industry standards for reprocessing.

4. Adjudication Method for the Test Set

This section is not applicable for the type of testing described (cleaning and sterilization validation). Adjudication methods are typically used in clinical or image analysis studies to resolve discrepancies in expert interpretations.

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 evaluating the impact of AI on human reader performance, which is not the subject of this 510(k) submission.

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

No, a standalone algorithm performance study was not done. The device is a physical accessory (lens wash bottle assembly) and does not involve an algorithm or AI.

7. The type of ground truth used

For the non-clinical performance testing, the "ground truth" is established by adherence to validated laboratory methods and industry standards for cleaning and sterilization, such as residual soil detection methods and microbial inactivation assays. This implicitly substitutes for "expert consensus, pathology, or outcomes data" in a typical diagnostic study context.

8. The Sample Size for the Training Set

This section is not applicable as the device is not an AI/machine learning product and does not involve a training set.

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

This section is not applicable as the device is not an AI/machine learning product and does not involve a training set.

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