(221 days)
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:
| Acceptance Criteria Category | Reported Device Performance (Implied) |
|---|---|
| Manual Cleaning Validation | Met all acceptance criteria. |
| Steam Sterilization Validation | Met all acceptance criteria. |
| Functionality Post-Cleaning | Cleaning process does not impact the functionality of the device. |
| Safety and Effectiveness | Device found to be safe and effective (after cleaning and sterilization). |
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.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.