(232 days)
The Manzi Mach 1 Instrument Cleaner Processor System is indicated for use with the High Level Disinfectant MS10 concentrate (MEC 0.49% PAA, minimum contact temperature of 120°F for a contact time of 15 minutes) for cleaning and high level disinfecting flexible bronchoscopes used in health care settings by health care workers.
The Manzi Mach 1 Instrument Cleaner-Processor System consists of a Manzi Mach 1 Instrument Cleaner-Processor, a proprietary Manzi germicide, MS10; and a proprietary Manzi Detergent, MD10.
The Manzi Mach 1 Instrument Cleaner-Processor is a self-contained stand-alone system of hardware and software designed to clean and provide high level disinfection of bronchoscopes using the MD10 detergent, the MS10 germicide, and a patented push-pull agitation system. The push-pull agitation system effectively scrubs the interior and exterior surfaces of the bronchoscope 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 followed by two hot water rinses, a push-pull agitation disinfection cycle that provides high level disinfection (spore log reduction of > 10 ° microorganisms with no CFUs) of the device, and a final rinse with an ozonated sanitized water rinse.
The hardware for the Manzi Mach 1 Instrument Cleaner-Processor consists of a stainless steel processing chamber, a push-pull agitation pump, an ozonator, 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 bronchoscope trays, and printer paper.
The Manzi Mach 1 Instrument Cleaner-Processor is designed to: ( ) 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 Manzi Cleaner. MD10 is intended to be used with the Manzi Instrument Cleaner-Processor.
MS10 is a peracetic acid based liquid chemical germicide. MS10 is intended to be used with the Manzi Instrument Cleaner-Processor.
Here's a breakdown of the acceptance criteria and study information for the Manzi Mach 1 Instrument Cleaner-Processor, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document outlines three main sets of qualification testing: FDA Guidance, EU Guidance, and Langford IC Systems (LIC) Requirements.
FDA Guidance (August 1993: "Guidance on Premarket Notification [510(k)] Submissions for Automated Endoscope Washer / Disinfectors, and Disinfectors Intended for Use in Health Care Facilities")
| Requirement | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Process Parameter Tests | Conformity to specified operational parameters | Passed |
| Simulated Use Tests | Effectiveness in a simulated environment | Passed |
| Cleaning Efficacy | Effective removal of contaminants | Passed |
| Disinfection Efficacy | Effective high-level disinfection | Passed |
| Rinsing Efficacy | Effective removal of cleaning and disinfection agents | Passed |
| Other Tests | Not explicitly detailed, but part of overall performance | Passed |
| Combined Process | Effectiveness of the entire cleaning and disinfection process | Passed |
| In – Use Tests | Effectiveness in real-world or near real-world conditions | Passed |
| Software Documentation | Conformance to software documentation requirements | Passed |
| Toxicological Evaluation of Residues | No harmful residues remaining after processing | Passed |
EU Guidance (Draft prEN ISO 15883-1: 2003 and Draft prEN ISO 15883-4: 2001)
| Requirement | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Cleaning Efficacy - Scope Ninhydrin (prEN 15883-4 Annex B.1.1) | Effective removal of protein from scopes | Passed |
| Cleaning Efficacy - Scope Horse serum (prEN 15883-4 Annex B.1.1) | Effective removal of organic load from scopes | Passed |
| Cleaning Efficacy - Surrogate Ninhydrin (prEN 15883-4 Annex B.1.1) | Effective removal of protein from surrogates | Passed |
| Cleaning Efficacy - Surrogate Horse serum (prEN 15883-4 Annex B.1.1) | Effective removal of organic load from surrogates | Passed |
| Disinfection Efficacy - Scope Sheep blood (prEN 15883-4 Annex D) | Effective high-level disinfection of scopes with organic load | Passed |
| Disinfection Efficacy - Surrogate Sheep blood (prEN 15883-4 Annex D) | Effective high-level disinfection of surrogates with organic load | Passed |
Langford IC Systems (LIC) Requirements
| LIC Cleaning Requirement | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Cleaning Efficacy: Reduction of protein loading of scopes contaminated with a Protein Laden Soil to Remaining Protein levels (Ref: AAMI TIR30: 2003, A Compendium of Processes, Materials, Test Methods, and Acceptance Criteria for Cleaning Reusable Medical Devices). | Remaining Protein levels of 10^6 microbial loading; with no CFUs | ≥ 6 spore log reduction; with no CFUs |
| LIC Microbiological Efficacy Tests | ||
| Simulated Use Test (15 min.) - ISO 15883-4 Surrogates, Sheep's blood soil (Test Organisms: Bacillus subtilis, Mycobacterium terrae, Candida albicans, Enterococcus faecium, Staphylococcus aureus) | > 6 spore log reduction; no Colony Forming Units (CFU) | > 6 spore log reduction; no CFU |
| Simulated Use Test (15 min.) - Olympus Bronchoscopes, Sheep's blood soil (Test Organism: Bacillus subtilis) | > 6 spore log reduction; no CFU | > 6 spore log reduction; no CFU |
| Simulated Use Test - Ozonated Water System (Test Organisms: Candida albicans, Staphylococcus aureus, Bacillus subtilis) | > 6 spore log reduction; no CFU | > 6 spore log reduction; no CFU |
| LIC Sanitized Ozonated Water System Requirement | ||
| Final Rinse System Efficacy: Reduction of microbial loading of scopes with no colony forming units (CFUs) | Reduction of ≥ 10^6 microbial loading; with no colony forming units (CFUs) | ≥ 6 spore log reduction; with no CFUs |
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not explicitly state the numerical sample size for the test set (number of scopes, surrogates, or runs). Instead, it refers to broad categories of tests such as "Simulated Use Tests," "In-Use Tests," and testing on "Olympus Bronchoscopes" and "Surrogates".
The data provenance is not specified in terms of country of origin. The study appears to be retrospective in the sense that the test results are reported after the completion of the tests rather than being part of an ongoing prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The ground truth for effectiveness (cleaning, disinfection, organism reduction) is established by laboratory-based microbiological and chemical testing, not expert consensus in the diagnostic sense.
4. Adjudication Method for the Test Set:
This is not applicable to this type of device evaluation. Adjudication methods like 2+1 or 3+1 are typically used for interpreting diagnostic outputs where human readers might disagree. For device performance in cleaning and disinfection, the results are quantitative (e.g., protein levels, log reduction of microorganisms) and therefore do not require such adjudication.
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. The Manzi Mach 1 is an automated instrument cleaner-processor, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study and the concept of human reader improvement with AI are not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, the studies describe the standalone performance of the Manzi Mach 1 Instrument Cleaner-Processor combined with its proprietary chemicals (MS10 germicide and MD10 detergent). The device operates automatically to clean and disinfect the instruments, without human intervention in the core cleaning/disinfection process itself. The "Results" section in the tables reflects the performance of the automated system.
7. The Type of Ground Truth Used:
The ground truth used in these studies is primarily laboratory-based microbiological and chemical testing against established standards and validated methods. Examples include:
- Microbiological assays: To determine log reduction of specific test organisms (e.g., Bacillus subtilis, Mycobacterium terrae, Candida albicans) to assess disinfection efficacy.
- Chemical assays: To measure remaining protein levels (e.g., Ninhydrin test) to assess cleaning efficacy.
- Biological indicator assessment: Counting Colony Forming Units (CFUs) to confirm complete elimination or reduction of microorganisms.
- Adherence to recognized standards: FDA Guidance, EU ISO standards (prEN ISO 15883-1 and 15883-4), and AAMI TIR30: 2003.
8. The Sample Size for the Training Set:
The document does not mention a "training set" in the context of machine learning or AI. This is a traditional medical device pre-market notification (510(k)) for a physical cleaning and disinfection system. Therefore, the concept of a training set as used in AI development is not applicable here. The device itself is "trained" during its engineering and design phase, and validated through the qualification testing described.
9. How the Ground Truth for the Training Set Was Established:
As there is no "training set" in the AI sense, this question is not applicable. The device's performance parameters were likely established through iterative design, engineering, and testing phases to meet the specified performance metrics, but this is not analogous to establishing ground truth for an AI training dataset.
§ 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.