(98 days)
Medivators Advantage Plus Endoscope Reprocessing System tests, cleans, disinfects and rinses 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 and related accessories. Manual cleaning of endoscopes is not required prior to placement in the Advantage Plus system. The scopes must be precleaned immediatelv after use.
The Advantage Plus Endoscope Reprocessing System uses Rapicide PA High Level Disinfectant to provide high level disinfection of endoscopes when used according to the directions for use. The system uses Intercept Detergent in its cleaning cycle at a concentration of 0.5%.
Rapicide PA Test Strips are used after the disinfection cycle to ensure that the used disinfectant is above the minimum recommended concentration (MRC) of 850ppm peracetic acid; this ensures that the disinfectant was above MRC during the entire disinfection cycle. Rapicide PA should be used in the Advantage Plus System under the following contact conditions:
Contact Time: 5 minutes
Temperature: 30℃
MRC: 850ppm
The Advantage AER is an electro-mechanical system intended to test, clean, and high level disinfect fiberoptic and video endoscopes and their related accessories between uses.
The Advantage system uses the peracetic acid based Rapicide PA High Level Disinfectant.
The AER machine has the capability of cleaning endoscopes as part of the overall cleaning/disinfection cycle of the machine. The users may use the cleaning cycle to replace manual cleaning of the endoscope, however, the users are instructed that they need to preclean the endoscope immediately after use to the SGNA and facility guidelines.
Here's an analysis of the provided text regarding the Medivators Advantage Plus Endoscope Reprocessing System, structured to address your specific questions.
Device Name: Medivators Advantage Plus Endoscope Reprocessing System
510(k) Number: K102996
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Cleaning Efficacy | The device's cleaning cycle is stated as "efficacious" for its intended use, allowing endoscopes to be placed into the machine without prior manual cleaning (though precleaning after use is still required). |
| High-Level Disinfection (HLD) Efficacy | The device provides "high level disinfection of heat sensitive semi-critical endoscopes and related accessories" using Rapicide PA High Level Disinfectant. Specific contact conditions for HLD are: |
- Contact Time: 5 minutes
- Temperature: 30°C
- Minimum Recommended Concentration (MRC) of Peracetic Acid: 850ppm |
| Disinfectant Concentration Maintenance | Rapicide PA Test Strips are used after the disinfection cycle to ensure the used disinfectant is above the MRC of 850ppm peracetic acid, guaranteeing it was above MRC throughout the entire cycle. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "simulated use testing with the major brands of endoscopes and testing of used clinical scopes." However, specific sample sizes for either the simulated use testing or the used clinical scopes are NOT provided.
The data provenance is not explicitly stated (e.g., country of origin). Since this is a U.S. FDA 510(k) submission, it is highly likely the testing was conducted to meet U.S. regulatory standards, but the physical location of the testing is not described. The document does not specify if the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The evaluation seems to rely on the results of the cleaning and disinfection tests themselves, rather than expert interpretation of images or other data.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method as it relates to expert review of test results. The testing appears to follow standardized protocols for evaluating cleaning and disinfection efficacy.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted for this device. This type of study is typically relevant for interpretative devices (e.g., imaging AI) where human readers are involved in diagnosis. This device is an endoscope reprocessor.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)
This question is not directly applicable in the context of an endoscope reprocessor. The device itself is an automated system for cleaning and disinfection, so its "performance" is inherently "standalone" in executing its programmed cycles. There isn't a human-in-the-loop component in the reprocessing itself that would then have its performance compared to an algorithm-only scenario. The machine's performance is its standalone function.
7. Type of Ground Truth Used
The ground truth for the efficacy claims (cleaning and disinfection) is based on measurable outcomes of biological and chemical testing. This would typically involve:
- Microbiological assays: To confirm the reduction/elimination of microorganisms (for disinfection and cleaning).
- Chemical residue detection: To confirm the removal of organic and inorganic soils (for cleaning).
- Visual inspection (under magnification): To assess the cleanliness of lumina and exterior surfaces.
- Disinfectant concentration measurements: To confirm the maintenance of the active disinfectant's concentration.
8. Sample Size for the Training Set
The document does not mention a "training set" in the context of an AI/machine learning algorithm. This device is a physical electro-mechanical system, not an AI or diagnostic software.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set for an AI/ML algorithm, this question is not applicable.
§ 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.