(350 days)
The EVOTECH® ECR Endoscope Cleaner and Reprocessor, a washer/disinfector, is indicated for use with high-level disinfectant CIDEX® OPA Concentrate Solution and an enzymatic detergent (CIDEZYME XTRA) to achieve cleaning and high level disinfection of heat sensitive (>60°C) semi-critical endoscopes. Manual cleaning of medical devices (endoscopes) is not required prior to placement in the EVOTECH® ECR Endoscope Cleaner and Reprocessor System when selecting those cycles that contain a wash stage. (Manual cleaning of medical devices (endoscopes) is required when selecting the Disinfect only or Disinfect/Alcohol Flush Cycle.)
The EVOTECH® ECR Endoscope Cleaner and Reprocessor is a two-basin The washer/disinfector utilizing an enzymatic detergent and a concentrated high level disinfectant, CIDEX® OPA Concentrate Solution. Both the detergent and high level disinfectant are diluted in the system to in-use concentrations. The EVOTECH® ECR Endoscope Cleaner and Reprocessor is capable of cleaning endoscopes that have not been manually cleaned prior to placing in the system.
Here's a breakdown of the acceptance criteria and study information for the EVOTECH® ECR Endoscope Cleaner and Reprocessor, based on the provided text:
Important Note: This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. Therefore, the "acceptance criteria" discussed are largely in reference to meeting established standards and demonstrating performance comparable to previously cleared devices, rather than a novel, bespoke set of criteria for this specific submission's unique functionality. The "study" largely refers to a compilation of previous testing and new verification for the minor modification.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) submission for a device with minor modifications (specifically, DCHP network capability), much of the performance data refers to studies conducted for previous iterations of the device (K040883, K061889, K140977). The "acceptance criteria" are derived from relevant FDA guidance and established standards for endoscope reprocessors.
| Acceptance Criteria Category | Specific Acceptance Criteria (Derived/Implied) | Reported Device Performance |
|---|---|---|
| Software Verification & Validation | Compliance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Moderate Level of Concern) | Software verification and validation conducted, showing no significant effect on safety or effectiveness due to software changes (for DHCP network connectivity). |
| Electrical Safety & Electromagnetic Compatibility (EMC) | Compliance with EN 60601-1-2:2007 Class A, IEC 60601-1-2:2014 Class A, CISPR 11:2009 (Amended by A1: 2010) Class A, CAN/CSA-C22.2 No.: 61010-1 2004, UL 61010-1/R: 2008-10, EN 61010-1:2001 | All test results met the requirements of the standards for radiated/conducted emissions and safety. |
| High-Level Disinfection Efficacy (Simulated Use) | ≥ 6 Log10 reduction of Mycobacterium terrae when exposed to CIDEX® OPA Concentrate in use solution (0.055% OPA at 50°C) with artificial soil. | Achieved and demonstrated a 6 Log10 reduction of Mycobacterium terrae within 5 minutes at 50-52°C using CIDEX® OPA Concentrate (0.042% concentration with 5% fetal bovine serum organic soil load). (Referenced from K040883 and K140977 studies) |
| High-Level Disinfection Efficacy (Clinical/In-Use) | Sterility testing demonstrates no growth after reprocessing clinically used endoscopes without manual cleaning. | Sterility testing demonstrated no growth. (Referenced from K040883 study) |
| Cleaning Efficacy (Residual Soil) | Residual protein and Total Organic Carbon (TOC) below predefined limit (e.g., |
§ 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.