(155 days)
The Acu-sInQ Complete Endoscope Cleaning Aid System is intended to assist manual flexible endoscope cleaning according to the instructions provided by the endoscope manufacturer, by facilitating performance of a leak test, accurate detergent dosing with water temperature monitoring, channel flushing, rinsing, and process documentation.
The Acu-sInQ Complete Endoscope Cleaning Aid System is used in the reprocessing room of a hospital or endoscopy center, and aids technicians by providing a step-by-step cleaning sequence of flexible endoscopes for process management and reports. The Acu-sInQ Complete Endoscope Cleaning Aid System is a 4-in-1 system with automated scope inflation for performance of a leak test, precision chemical dosing, and automated channel flushing with pulsating fluid technology for main and auxiliary flush ports. The System also provides: Data management via printout with every cycle, USB drive and port output for capture and recording of process data and chemical usage, Software to enable transfer of data between system and Customer's PC, Barcode scanner to input endoscope serial number and technician ID which aids in documentation process, Pre-loading with Customer's endoscope inventory.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Fluid Flushing (open) | Device provides consistent fluid flushing volume when not connected to an endoscope. | PASS |
| Fluid Flushing (Endoscope) | Device provides consistent fluid flushing volume when connected to an endoscope. | PASS |
| Dosing | Accuracy of dose of ± 5% | PASS |
| Temperature Accuracy | Accuracy of temperature of ± 5% | PASS |
| Electrical Safety | Compliant with IEC 61010-1 | PASS |
| Electromagnetic Compatibility | Compliant with IEC 61326-1 | PASS |
2. Sample size used for the test set and the data provenance:
The document does not specify the exact sample sizes used for each individual test. It mentions "non-clinical performance testing" was conducted. The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective, but given it's a pre-market notification for a medical device, the testing would be prospective and conducted by the manufacturer, STERIS Corporation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The tests described are engineering and performance-based (e.g., fluid volume consistency, dosing accuracy, temperature accuracy, electrical safety, EMC) and do not typically involve human expert interpretation for ground truth.
4. Adjudication method for the test set:
Not applicable. The tests are objective and based on measurable engineering parameters, not subjective assessments requiring 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:
Not applicable. This device is an endoscope cleaning aid system, not an AI-powered diagnostic imaging tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device itself is a "Cleaning Aid System" that assists manual cleaning. The performance tests described (fluid flushing, dosing, temperature accuracy, electrical safety, EMC) are inherently standalone device performance evaluations without a human-in-the-loop component for the device's core functions being tested. While the device assists human operators, the tests performed assess the device's technical specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for the tests performed is based on established engineering and metrology standards. For example:
- Fluid Flushing/Dosing/Temperature Accuracy: Likely measured against calibrated instruments to verify accuracy against specified tolerances (e.g., ±5%).
- Electrical Safety/EMC: Compliance with international standards (IEC 61010-1, IEC 61326-1) which define specific test procedures and permissible limits.
8. The sample size for the training set:
Not applicable. This is a physical medical device, an endoscope cleaning aid, not an artificial intelligence algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this 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.