(243 days)
Medivators DSD Edge Endoscope Reprocessing System tests, washes, disinfects and rinses flexible endoscopes, such as fiberoptic and video endoscopes between patient uses. The DSD Edge system is indicated to provide high level disinfection, using Rapicide PA High Level Disinfectant, of heat sensitive semi-critical endoscopes. Manual cleaning of endoscopes is required prior to placement in the DSD Edge system.
Rapicide PA contact conditions in the DSD Edge
- 5 Minutes 30℃ 850 ppm peracetic acid .
The DSD Edge system is an electro-mechanical system intended to test, wash and high level disinfect flexible fiberoptic and video endoscopes between uses. The DSD Edge is capable of asynchronously reprocessing two scopes at a time.
The DSD Edge system uses the peracetic acid based Rapicide PA High Level Disinfectant (K082988). The DSD Edge is a single use system in that it mixes Part A and Part B of Rapicide PA with water immediately prior to reprocessing and the disinfectant is not reused.
Endoscopes must be pre-cleaned and manually cleaned to SGNA and facility guidelines prior to being placed in the system for reprocessing.
After the endoscopes are connected to the DSD Edge the system tests the scopes for leaks in the outer skin. If the endoscopes pass the leak test the system will proceeds to a scope flush or an optional wash cycle followed by a flush.
For the disinfection cycle, the incoming water is mixed with the two part germicide in the basin. The temperature of the incoming water is monitored to ensure that the water temperature is within the operating constraints (30℃) required for disinfection after the water and germicide are mixed together. A sample of the germicide is retained to test for MRC. Following disinfection, the endoscopes are rinsed and dried by the machine, either by filtered air or an optional alcohol rinse, and are then removed from the machine for the next use.
The machine has built in safety features which stop the cycle and alarm when certain conditions exist which could indicate that disinfection might be compromised. These alarms and causes are defined in the directions for use for the product.
The DSD Edge also prints records indicating the results of testing, disinfection, etc. which are required for permanent records.
The document describes the Medivators DSD Edge Endoscope Reprocessing System, an electro-mechanical system designed to test, wash, and high-level disinfect flexible endoscopes. The system uses Rapicide PA High Level Disinfectant. The following information details the acceptance criteria and the study that proves the device meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria for performance; instead, it indicates that the device must "perform as required" for various functions. The reported device performance is based on successful completion of these tests.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Material compatibility with disinfectant | System materials showed no significant deterioration over time; filters were compatible with disinfectant. |
| Biocompatibility (disinfectant residue) | Any remaining disinfectant residues would not have an effect on patients or users. |
| Proper functioning of leak check | Device performs leak checks correctly. |
| Proper functioning of washing cycle | Device performs washing cycles correctly. |
| Proper functioning of disinfection cycle | Device performs disinfection cycles correctly. |
| Proper functioning of rinse cycles | Device performs rinse cycles correctly. |
| Proper functioning of drying cycles | Device performs drying cycles correctly. |
| Proper functioning of error messages/alarms | Error messages were tested and function properly to notify users of failure modes. |
| Disinfectant temperature maintenance | Disinfectant remained at its required temperature (30℃) for the required length of time (5 minutes). |
| Proper functioning of self-disinfection cycle | Self-disinfection cycle works properly, disinfecting all areas including the water filtration system. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a quantitative sample size for the test set (e.g., number of endoscopes, number of cycles). The testing appears to be conducted by the manufacturer, Medivators, and the data provenance is not explicitly stated as retrospective or prospective, nor does it specify country of origin beyond "Medivators has provided testing." Typically, such premarket submissions involve prospective testing conducted at the manufacturer's facilities or a designated testing laboratory.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This type of device (endoscope reprocessor) does not typically involve human expert assessment for establishing "ground truth" in the same way an AI diagnostic tool would. Instead, performance is validated against established engineering and biological standards (e.g., microbial reduction, temperature control, leak detection accuracy). Therefore, the concept of "experts establishing ground truth" in the context of radiologists or similar medical professionals does not apply here. The "experts" would be the engineers and microbiologists conducting the tests and verifying the device's functionality against pre-defined specifications. The document does not specify the number or qualifications of these internal experts.
4. Adjudication Method for the Test Set
Adjudication methods like 2+1 or 3+1 consensus are not applicable for the type of testing described (material compatibility, functional performance, residue levels). The validation relies on objective measurements and compliance with technical specifications and safety standards defined in FDA guidance documents (e.g., FDA's Guidance on Premarket [510(k)] Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care Facilities).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC comparative effectiveness study is not relevant for this device. This study type is typically used for diagnostic or screening tools where a human reader's interpretation is central to the outcome and performance needs to be measured with and without AI assistance across multiple cases and readers. The Medivators DSD Edge is an automated reprocessing system, not a diagnostic tool requiring human interpretation of medical images or data.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device itself is a standalone automated system. Its performance metrics (e.g., effective disinfection, leak detection, proper rinsing) are evaluated independently of a human operator making real-time decisions that affect the disinfection process. While manual pre-cleaning is required, the "reprocessing" cycle within the DSD Edge is fully automated. Therefore, the performance described reflects the standalone capabilities of the device in performing its indicated functions.
7. The Type of Ground Truth Used
The "ground truth" for verifying the performance of the DSD Edge Reprocessing System is based on:
- Engineering Specifications: Ensuring mechanical and electrical components (e.g., pumps, sensors, heating elements) function as designed.
- Chemical/Physical Measurements: Verifying parameters like disinfectant concentration (850 ppm peracetic acid), temperature (30℃), contact time (5 minutes), and residue levels.
- Microbiological Standards: Although not explicitly detailed in this summary, the "high-level disinfection" claim inherently relies on demonstrating the device's ability to achieve a specified reduction in microbial load (e.g., vegetative bacteria, mycobacteria, fungi, viruses) under the specified contact conditions. This is typically proven through standardized inactivation studies.
- Material Science: Verifying material compatibility to ensure integrity and longevity of the device and associated filters.
8. The Sample Size for the Training Set
This document describes a medical device (an endoscope reprocessor), not an AI/machine learning algorithm. Therefore, the concept of a "training set" for an algorithm to learn from does not apply. The device's operation is based on pre-programmed logic, physical and chemical principles, and validated engineering design, not on a machine learning model trained on a large dataset.
9. How the Ground Truth for the Training Set Was Established
As noted above, there is no "training set" in the context of machine learning for this device. The 'ground truth' for the design and validation of this electro-mechanical system is established through engineering design principles, recognized industry standards, scientific understanding of disinfection processes, and regulatory guidance documents.
§ 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.