(375 days)
The LIC Instrument Processor when used with the Manzi Detergent MD10, the Manzi Sterilant MS10 concentrate ( MEC 0.49% PAA, minimum contact temperature of 120° F for a contact time of 5 minutes), and filtered and ozonated final rinse water, is indicated for cleaning and high level disinfection of heat sensitive semi-critical endoscopes used in health care settings by health care workers. Manual cleaning of medical devices (endoscopes) is not required prior to placement in the LIC Instrument Processor.
The Manzi Detergent MD10 concentrate when used with the LIC Instrument Processor is indicated for the cleaning of heat sensitive semi-critical endoscopes used in health care settings by health care workers.
The Manzi Sterilant MS10 concentrate when used in the LIC Instrument Processor is indicated for high level disinfection of heat sensitive semi-critical endoscopes used in health care settings by health care workers.
The filtered ozonated final rinse water generated by the LIC Instrument Processor is indicated for the final rinsing in the LIC Instrument Processor of of heat sensitive semi-critical endoscopes used in health care settings by health care workers.
The LIC Instrument Processing System consists of a LIC Instrument Processor, a proprietary Manzi sterilant, MS10; a proprietary enzymatic Manzi Detergent, MD10; and internally generated filtered ozonated final rinse water. The LIC Instrument Processing System requires no connectors to be attached to the endoscope.
The LIC Instrument Processor is a self-contained stand-alone system designed to clean and provide high level disinfection of semi-critical endoscopes using the MD10 detergent, the MS10 sterilant, and a patented push-pull agitation system. The push-pull agitation system effectively scrubs the interior and exterior surfaces of the semi-critical endoscopes without the use of special connectors. The scope is placed in a processing chamber where it is exposed to a push-pull agitation cleaning cycle that provides cleaning to a protein residual level ≤ 6.4 ug / cm², followed by hot water rinses, a push-pull agitation disinfection cycle that provides high level disinfection of the instrument being processed and final rinses with filtered ozonated water.
The hardware for the LIC Instrument Processor consists of a stainless steel processing chamber, a push-pull agitation pump, an ozonator, a neutralization tank, and a variety of components that are mounted in a movable covered frame. The cleaner-processor system utilizes accessories such as disposable water filters, reusable semi-critical endoscopes trays, baffle inserts, and printer paper.
The LIC Instrument Processor is designed to: (1) be used in accordance with the reprocessing instructions provided in the operator's manual of the instruments being processed, and (2) facilitate the health care facility's compliance with reprocessing guidelines published by SGNA, APIC, AORN, ASGE, CDC, and other professional organizations.
MD10 is a low foaming enzyme chemical detergent packaged in single use containers for attachment to the LIC Instrument Processor. MD10 is intended to be used with the LIC Instrument Processor only.
MS10 is a peracetic acid based liquid chemical sterilant packaged in single use containers for attachment to the LIC Instrument Processor. MS10 is intended to be used with the LIC Instrument Processor.
1. Acceptance Criteria and Reported Device Performance:
| Requirement | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Cleaning Efficacy (Protein Laden Soil) | Remaining protein 6 logs spore reduction with no CFUs when challenged with > 10^0 microbial loading | > 6 spore log reduction with no CFUs was achieved when challenged with > 10^0 microbial loading and processed to operational specifications. |
| Toxicological Evaluation of Residues | Detergent and sterilant residuals reduced to non-toxic levels | Detergent and sterilant residuals were reduced to non-toxic levels. |
| Process Parameter Tests | Device performs as intended, achieves/maintains specified parameters, aborts for faults, detects faults, provides alarms/instructions | Device achieved and maintained specified physical process parameters, automatically aborted cycles if parameters not achieved, detected defined fault conditions, and provided designated alarms and instructions in the event of fault condition detection. |
| Manzi MS10 Sterilant Potency | Passed | Passed |
| Manzi MS10 Sterilant Simulated Use Tests | Passed | Passed |
| Manzi MS10 Sterilant In-Use Tests | Passed | Passed |
| Manzi MS10 Sterilant Biocompatibility | Passed | Passed |
| Manzi MS10 Sporicidal Activity | Sporicidal (for Bacillus subtilis and Clostridium sporogenes) | MS10 is sporicidal. |
| Manzi MS10 Fungicidal Activity | Fungicidal (for Trichophyton mentagrophytes) | MS10 is fungicidal. |
| Manzi MS10 Bactericidal Activity | Bactericidal (for Salmonella choleraesuis, Staphylococcus aureus, Pseudomonas aeruginosa) | MS10 is bactericidal. |
| Manzi MS10 Virucidal Testing | Virucidal (for Poliovirus Type I) | MS10 is virucidal. |
| Manzi MS10 Tuberculocidal Testing | Tuberculocidal (for Mycobacterium bovis) | MS10 is tuberculocidal. |
2. Sample Size for Test Set and Data Provenance:
- Sample Size: Not explicitly stated for each test beyond "endoscopes" or "inoculated endoscope" in various simulated use and in-use tests.
- Data Provenance: The document does not specify the country of origin. The study includes both simulated use testing (laboratory-controlled conditions with specific microbial loading) and in-use testing (using endoscopes contaminated by clinical endoscopy with naturally occurring soils). This indicates a mix of prospective (potentially for the simulated use) and retrospective/observational (for in-use samples) approaches.
3. Number of Experts and Qualifications for Ground Truth:
Not applicable as the ground truth for this device (an instrument processing system) is based on quantitative laboratory measurements and microbiological assays, not expert interpretation of images or clinical assessments.
4. Adjudication Method for Test Set:
Not applicable, as ground truth is established through quantitative measurements and laboratory tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC study was not done. This device is an automated instrument processing system, not a diagnostic imaging AI tool that assists human readers. Therefore, the concept of human readers improving with AI vs. without AI assistance does not apply.
6. Standalone Performance:
Yes, a standalone performance evaluation was done. The entire study describes the performance of the LIC Instrument Processing System (the algorithm/device itself) in cleaning and high-level disinfection. All efficacy tests (cleaning, disinfection, rinse water) and residue evaluations directly assess the device's capabilities without human intervention during the processing cycle.
7. Type of Ground Truth Used:
The ground truth used is primarily quantitative laboratory measurements and microbiological assays, including:
- Protein residual levels (µg/cm²)
- Total Organic Carbon (TOC) levels (µg/cm²)
- Microbial loading reduction (log reduction, absence of CFUs)
- Detection of viable organisms
- Chemical residue levels
8. Sample Size for the Training Set:
Not applicable. This document describes the validation of an automated instrument processing system, not a machine learning or AI model that requires a training set. The system operates based on established physical and chemical principles, not learned patterns from data.
9. How Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of 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.