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The Manzi Cleaner, when used in accordance with its labeling and the Manzi Detergent MD10, is for the cleaning of bronchoscopes in a health care setting by health care workers.

Device Description

The Manzi Cleaner System consists of a Manzi Cleaner and a proprietary Manzi Detergent, MD10. The Manzi Cleaner is a self-contained stand-alone system of hardware and software designed to clean bronchoscopes using the MD10 detergent 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. The hardware for the Manzi Cleaner consists of a stainless steel processing chamber, a push-pull agitation pump, and a variety of components that are mounted in a movable covered frame. The cleaner system utilizes accessories such as disposable water filters. reusable bronchoscope trays, and printer paper. MD10 is a low foaming anionic chemical detergent packaged in custom containers for attachment to the Manzi Cleaner. The detergent is automatically diluted to a use dilution of 2.0% detergent concentration. MD10 is intended to be used exclusively with the Manzi Cleaner.

AI/ML Overview

The provided text describes the Manzi Cleaner System, a device for cleaning bronchoscopes, and details the nonclinical tests conducted to demonstrate its performance and substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study information based on the provided text:

Acceptance Criteria and Reported Device Performance

Requirement	Acceptance Criteria	Reported Device Performance
FDA Guidance (Class II Special Controls Guidance Document: Medical Washers and Medical Washer - Disinfectors; Guidance for the Medical Device Industry and FDA Review Staff, issued on February 7, 2002)	Conformance with the requirements of the guidance document	Passed
Process Parameter Physical Tests	Not explicitly stated, implied to meet guidance requirements	Passed
Simulated Use Tests	Not explicitly stated, implied to meet guidance requirements	Passed
Cleaning Efficacy	Not explicitly stated, implied to meet guidance requirements	Passed
Disinfection Efficacy	Not applicable for this device as it is a cleaner, not a disinfector	Not Applicable
Rinsing Efficacy	Not explicitly stated, implied to meet guidance requirements	Passed
Self Disinfection Efficacy	Not applicable for this device as it is a cleaner, not a disinfector	Not Applicable
Other Tests	Not explicitly stated, implied to meet guidance requirements	Passed
In-Use Tests	Not explicitly stated, implied to meet guidance requirements	Passed
Toxicological Evaluation of Residues	Not explicitly stated, implied to meet guidance requirements	Passed
Software Documentation	Not explicitly stated, implied to meet guidance requirements	Passed
Electrical Safety Documentation	Not explicitly stated, implied to meet guidance requirements	Passed
Electromagnetic Compatibility	Not explicitly stated, implied to meet guidance requirements	Passed
EU Guidance (Draft prEN ISO 15883-1: 2003 and Draft prEN ISO 15883-4: 2001)	Conformance with the requirements of the guidance documents	Passed
Cleaning Efficacy - Scope Ninhydrin	Not explicitly stated, implied to meet prEN 15883-4 Annex B.1.1	Passed
Cleaning Efficacy – Surrogate Ninhydrin	Not explicitly stated, implied to meet prEN 15883-4 Annex B.1.1 and Surrogate - prEN 15883-4	Passed
Langford IC Systems (LIC) Requirements
Microbial Load Reduction	A four spore log reduction of microbial load on scopes contaminated with Birmingham soil mixture inoculated with Bacillus subtilis spores at a concentration of > 10^7 spores/ml	Passed (> 4 spore log reduction)
Protein Loading Reduction	Reduction of protein loading of scopes contaminated with a Protein Laden Soil to Remaining Protein levels of

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