(201 days)
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.
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.
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 |
§ 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.