(70 days)
The Schoelly CMOS Video Nasopharyngoscope System may only be used by persons with an appropriate medical qualification and who are acquainted with the rhino/laryngoscopic technique. The endoscopic diagnosis within the nasal lumens and airway and is intended to provide visualization via a video monitor.
The Schoelly CMOS Video Nasopharyngoscope System consists of a flexible and steerable endoscope and a camera control unit (CCU) for regulation of light intensity and connection to a monitor, PC, medical video recorder or printer for image display or image documentation.
The endoscope has outer surfaces mainly made from plastic. The endoscope handle incorporates a control lever to bend the distal tip and an integrated LED light source. Light is transmitted through fiberoptic bundles illuminating the anatomy under investigation. The video signal is captured by a CMOS imaging sensor located at the tip of the endoscope shaft and transferred to the CCU.
The endoscope further incorporates a ventilation system to protect the shaust valve at the endoscope handle can further be used for leakage testing. For this purpose the system is accompanied by a leakage tester and accessories.
The Schoelly CMOS Video Nasopharyngoscope System is delivered in a non-sterile condition.
This document is a 510(k) summary for a Special 510(k) submission, meaning the changes described are limited to a modification of an already cleared device. In this specific case, the only change is an update to the Instructions for Use to add a validated method for high-level disinfection.
Therefore, the "device performance" described is specifically the performance of the High-Level Disinfection (HLD) process, not the overall performance of the nasopharyngoscope system for its intended diagnostic use. The study proves the HLD process meets the acceptance criteria for disinfection efficacy.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (HLD Efficacy) |
|---|---|
| Minimum 6-log reduction of an appropriate indicator organism (Mycobacterium terrae) | Successfully achieved a 7.5-log reduction. |
| No significant adverse effects on the endoscope from HLD process | No damage or material degradation observed after multiple, extended HLD cycles. |
| No residual disinfectant material that could adversely affect test results by obscuring residual indicator organisms. | Cytotoxicity testing confirmed no such residual material. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for HLD Efficacy Test: "In total, five results for microbial reduction by HLD and three inoculation control results were obtained as part of the efficacy study." This refers to the number of test devices and control devices used in the disinfection validation.
- Data Provenance: The devices used for validation had "previously been in clinical use to ensure 'real life' conditions." This suggests the data provenance is retrospective clinical use, but the validation itself was a prospective laboratory study performed on these used devices. The country of origin for the data is not explicitly stated, but the manufacturer is based in Germany.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable to this specific study. The "ground truth" for the HLD efficacy study was established through laboratory methods (culturing viable indicator organisms to determine log reduction), not through expert clinical consensus or interpretation of images.
4. Adjudication Method for the Test Set
This is not applicable. The HLD efficacy test involved quantitative microbiological culturing and functional/material testing, not human interpretation that would require adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study involves human readers evaluating cases with and without AI assistance and is relevant for evaluating diagnostic accuracy, which is not the focus of this specific 510(k) submission (which only concerns HLD validation).
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not applicable. There is no "algorithm" or AI in the context of high-level disinfection validation. The study evaluated the mechanical and chemical process of disinfection.
7. The type of ground truth used
The ground truth used for the HLD efficacy study was laboratory-derived quantitative microbiological counts. Specifically, the number of viable indicator organisms (Mycobacterium terrae) remaining after disinfection, determined by culturing.
8. The sample size for the training set
This is not applicable. There is no "training set" in the context of validating a high-level disinfection process. This is a laboratory validation, not a machine learning model.
9. How the ground truth for the training set was established
This is not applicable for the reasons stated above.
§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.