(129 days)
Medivators Advantage Plus Endoscope Reprocessing System tests, washes, disinfects and rinses flexible endoscopes, such as fiberoptic and video endoscopes between patient uses. The Advantage Plus system is indicated to provide high level disinfection of heat sensitive semi-critical endoscopes. Manual cleaning of endoscopes is required prior to placement in the Advantage Plus system.
Rapicide PA High Level Disinfectant is intended for use with the Advantage Plus Endoscope Reprocessing System to provide high level disinfection of endoscopes when used according to the directions for use. Rapicide PA Test Strips are used after the disinfection cycle to ensure that the used disinfectant is above the minimum recommended concentration (850ppm peracetic acid); this ensures that the disinfectant was above MRC during the entire disinfection cycle. Rapicide PA should be used under the following contact conditions:
Claim: High Level Disinfection
Time: 5 minutes
Temperature: 30(°C)
Minimum Recommended Concentration of Peracetic Acid (MRC): 850ppm
The Advantage Plus AER is an electro-mechanical system intended to test, wash, and high level disinfect flexible fiberoptic and video endoscopes between uses. It is not intended for reprocessing rigid endoscopes. The Advantage is capable of asynchronously reprocessing two scopes at a time.
The Advantage Plus system uses the peracetic acid based Rapicide PA High Level Disinfectant. The Advantage Plus is a single use system in that it mixes the Part A and Part B of the 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 placing in the system for reprocessing.
After the scopes are connected to the AER, the system tests the endoscopes for blockages in the channels and leaks in the outer skin, and then proceeds to the washing step. The system also includes an optional channel connectivity test to verify proper connection of the fluid channels for reprocessing. If the endoscopes pass the blockage and leak tests and the washing cycle has been completed, the system proceeds to rinse the instruments and begins the disinfection cycle.
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 water temperature is within the operating constraints (30℃) required for disinfection after the water and germicide are mixed together. Following the 5 minute disinfectant contact time, the user takes a sample to test for MRC and then the disinfectant is emptied from the basin into the drain from the machine. 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 many 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 machine also prints records by endoscope serial number indicating the results of testing, disinfection, number of disinfections, etc. which are required for permanent records.
Rapicide PA High Level Disinfectant is a peracetic acid based, two part disinfectant. Part A contains the active ingredients and Part B contains anticorrosive agents and surfactants. Part A and Part B are mixed in the machine and diluted with water. The Minimum Recommended Concentration (MRC) of Rapicide PA is 850 ppm of peracetic acid. A test strip is used to ensure that the use solution is above the MRC.
The provided document describes a 510(k) premarket notification for the Medivators Advantage Plus Endoscope Reprocessing System and Rapicide PA High Level Disinfectant. It focuses on demonstrating the device's substantial equivalence to existing devices and its safety and effectiveness.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Specific Criterion | Reported Device Performance |
|---|---|---|
| High-Level Disinfection (HLD) Efficacy (for Rapicide PA) | ||
| Sporicidal | Total kill of Clostridium sporogenes and Bacillus subtilis spores | Total Kill |
| Confirmatory Sporicidal | Total kill of Clostridium sporogenes and Bacillus subtilis spores | Total Kill |
| Tuberculocidal | Total kill of Mycobacterium bovis (BCG) | Total Kill |
| Virucidal (Polio) | Complete inactivation of Polio virus type 2 | Complete Inactivation |
| Virucidal (Herpes) | Complete inactivation of Herpes simplex virus type 1 | Complete Inactivation |
| Virucidal (HIV) | Complete inactivation of Human Immunodeficiency Virus type 1 | Complete Inactivation |
| Fungicidal | Total kill of Trichophyton mentagrophytes | Total Kill |
| Use-Dilution | Total kill of Pseudomonas aeruginosa, Staphylococcus aureus, Salmonella choleraesuis | Total Kill |
| Simulated-Use | >6 log Reduction of Mycobacterium terrae | >6 log Reduction |
| In-Use | Total kill on Clinically Used Scopes (microorganisms) | Total Kill |
| Disinfectant Parameters (for Rapicide PA) | ||
| Contact Time | 5 minutes | Used as prescribed in conditions for HLD |
| Temperature | 30°C | Used as prescribed in conditions for HLD; machine maintained required temperature |
| Minimum Recommended Concentration (MRC) | 850ppm peracetic acid | Used as prescribed in conditions for HLD; test strips ensure MRC is above 850ppm |
| Material Compatibility | No significant deterioration of endoscopes and AER materials over time | Showed no significant deterioration |
| Biocompatibility | Disinfectant residue left on endoscopes within determined safe levels | Any remaining residues would not have an effect on patients or users |
| Machine Performance (Advantage Plus AER) | ||
| Leak Check | Performs correctly | Performed correctly |
| Blockage Check | Performs correctly | Performed correctly |
| Connectivity Checks | Performs correctly | Performed correctly |
| Washing Cycle | Performs correctly | Performed correctly |
| Disinfection Cycle | Performs correctly | Performed correctly |
| Rinse Cycles | Performs correctly | Performed correctly |
| Drying Cycles | Performs correctly | Performed correctly |
| Error Messages | Function properly to notify users of failure modes | Functioned properly |
| Critical Parameters | Function correctly | Functioned correctly |
| Self-Disinfection Cycle | Disinfects all areas of the machine, including water filtration system | Works properly, disinfecting all areas |
| Water Filtration System | Functions appropriately over time; alarms if filters plugged | Functions appropriately; alarms when plugged |
| Water Filters (when plugged) | Remain bacterial retentive | Remained bacterial retentive |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not explicitly state the sample sizes for most of the efficacy tests (e.g., number of replicates for sporicidal, virucidal, etc., or number of endoscopes/tests for simulated-use and in-use).
- In-Use Study: "Clinically Used Scopes" were used. The number is not specified.
- Country of Origin: Not specified, but the manufacturer is "Medivators Reprocessing Systems, a Division of Minntech Corporation" with an address in Minneapolis, MN, USA. This suggests the testing was likely conducted in the USA or under US regulations.
- Retrospective or Prospective: The nature of the efficacy and performance testing implies prospective studies designed to meet regulatory requirements, as they are "provided to the FDA to show" these aspects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not provided in the document. The efficacy tests are primarily microbiological and engineering in nature, relying on laboratory methods and established quantitative measures (e.g., cell/spore counts, log reduction, temperature, concentration). "Experts" in this context would likely be microbiologists, chemists, and engineers, but their number and specific qualifications are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This concept of "adjudication method" (typically used for expert consensus on image interpretation) is not applicable to the type of testing described (microbiological efficacy, material compatibility, machine performance). The results are based on objective measurements and established laboratory protocols.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. An MRMC study is relevant for diagnostic imaging interpretation with AI assistance. The Medivators device is an endoscope reprocessor and high-level disinfectant, not an AI-powered diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This is not applicable in the context of an AI algorithm. However, if interpreted as "device function without human intervention during the critical phases," the document describes the Advantage Plus AER as an automated system that performs cycles (washing, disinfection, rinsing, drying) with built-in safety features and alarms. The disinfection cycle itself is automated after manual pre-cleaning and loading. A human user takes a sample for MRC testing after the disinfection cycle, indicating a human "check" but not necessarily "in-the-loop" performance during the automated disinfection process itself. The efficacy tests for Rapicide PA are a standalone assessment of the disinfectant's capability.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The ground truth for most of the efficacy claims is established by:
- Microbiological assays: Quantitative laboratory methods to determine the reduction or "kill" of specific microorganisms (bacteria, spores, viruses, fungi) under controlled conditions. This involves standard protocols for culture, inoculation, exposure, and enumeration.
- Chemical analysis: To confirm concentration (e.g., ppm peracetic acid).
- Physical measurements: Temperature, time.
- Engineering validation: Testing of machine functions (leak check, blockage check, washing, rinsing, drying, error messages) against design specifications and operational requirements.
8. The sample size for the training set:
This is not applicable. This device is not an AI/machine learning model that requires a training set. The term "training set" is relevant for AI systems, not for a physical reprocessing system and disinfectant.
9. How the ground truth for the training set was established:
This is not applicable as there is no "training set" for this device.
§ 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.