(188 days)
The Colibri Endoscopy System is intended to visualize the internal cavities of the ear, airways, nose and sinus cavities during diagnostic and therapeutic endoscope procedures.
The Colibri Endoscopy System is a single-use ENT (ear, nose & throat) endoscope (provided sterile under EtO sterilization) which allows the user to steer through the anatomy and visualize it. The device is used in patients in whom endoscopic evaluation of, or intervention in, the ear, airways, nose, and sinus cavities is indicated. The Colibri endoscopy system consists of: A Single-use Endoscope includes a distal CMOS imager, an LED for illumination, and an add-on working channel which enables suction. The endoscope is provided sterile. The multi-use handle and the endoscope attachment cable, which were separate components in the cleared 3NT Endoscopy System, are now an integral part of the single-use endoscope, thus eliminating all multi-use components from the system. A Video Console (formerly named Camera Control Unit, or CCU) which includes a video board and a tablet-based display, connects to the endoscope through the endoscope cable to receive video images from the endoscope and display them.
This document describes the premarket notification (510(k)) for the Colibri Endoscopy System. The information provided outlines the system's performance data, but it does not contain the details typically found in a study proving a device meets acceptance criteria for an AI/ML algorithm, as none are mentioned. Instead, it focuses on the substantial equivalence of the Colibri Endoscopy System to a predicate device based on common medical device performance benchmarks.
Therefore, many of the requested items related to AI/ML acceptance criteria, ground truth establishment, expert adjudication, and MRMC studies cannot be answered from the provided text.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document provides the following performance data and verification of compliance, rather than specific numerical acceptance criteria linked to AI/ML performance. The "acceptance criteria" here refer to successful completion of standard medical device tests.
| Test | Description | Reported Device Performance (Results and Substantial Equivalence Discussion) |
|---|---|---|
| Biocompatibility testing | Conducted in accordance with ISO 10993-1:2018 and FDA guidance. Battery of tests included Cytotoxicity, Sensitization, Irritation, Acute systemic toxicity. Categorized as contact with intact mucosal membranes, Limited Exposure A (up to 24 hours). | Test results verify that the Colibri Endoscopy System complies with the same biocompatibility requirements as the predicate device and hence substantial equivalence is determined. |
| Electrical safety and electromagnetic compatibility (EMC) | Electrical safety tests: IEC 60601-1:2005/A1:2012 and IEC 60601-2-18:2009. EMC tests: IEC60601-1-2:2014. | Test results verify that the Colibri Endoscopy System complies with the same electrical safety and EMC requirements as the predicate device and hence substantial equivalence is determined. |
| Software Verification and Validation testing | Conducted in accordance with IEC 62304:20006 and FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Level of Concern defined as Moderate. | Colibri Endoscopy System has the same level of concern as the predicate device and the software was validated following the same standard requirements and FDA guidelines, hence substantial equivalence is demonstrated. |
| Bench testing: Colibri Scope Functionality and Simulated use, 3NT Console Functionality and dimensions verification | To ensure Colibri Endoscopy System functionality in simulated use is according to the indications for use. | The Colibri Endoscopy System passed all the functionality and simulated use tests. The tests passed and all acceptance criteria were met. The Colibri Endoscopy System and the predicate device have the same indications for use, which were verified by the described test. Substantial equivalence is demonstrated. |
| Bench testing: Colibri Scope Visual and Dimensions | To verify that the critical dimensions and surface quality of Colibri Scope comply with the predefined specification as part of the system requirements. | The Colibri Endoscopy System passed all the visual and dimensions inspections. The test passed and all acceptance criteria were met. |
| Bench testing: Colibri Scope Mechanical Properties Verification | To verify that the physical and mechanical properties of the Colibri Scope (tube flexibility Suction module disconnection mechanism, bond strength). | The tests passed and all acceptance criteria were met. |
| Bench testing: Colibri Scope System Image Quality Performance | Side by side comparison of image quality of Colibri Endoscopy System and predicate device based on 'CIE pub.116-1995 industrial color difference evaluation' and 'Sharma Gaurav 2003 - Digital Color Imaging Hand Book'. | The Colibri Endoscopy System image is accurate and well reflects the observed items in terms of color accuracy. The tests passed and all acceptance criteria were met. The Colibri Endoscopy System image quality was found to be superior to that of the predicate device. |
| Bench testing: Colibri Scope Optical performance and MTF | Side by side comparison of Colibri and predicate device optical attributes according to ISO 8600 series and ISO 12233:2017. | The tests passed and all acceptance criteria were met. The Colibri Endoscopy System optical performance was found to be equal or better than these of the predicate device. |
| Bench testing: Colibri Scope Labeling Verification and 3NT Console label verification | To verify Colibri Endoscopy System IFU and labels contain all required symbols, warnings, information, instructions for use and product specifications. | Colibri Labels and IFU found to include all information required by regulatory requirements and risks mitigations. |
| Bench testing: Transportation and Shelf life | Transportation simulation according to ASTM D4169-16. Accelerated aging simulation according to ASTM F1980-16. | The test passed and all acceptance criteria were met. |
| Bench testing: Joint connection test | To verify working channel tensile strength and no leakage under use conditions. | The tests passed and all acceptance criteria were met. Colibri Endoscopy System suction / irrigation channel was found to comply with no leakage and separation force requirements. This test verifies that no new risks of leakage or disconnection are introduced. |
2. Sample sized used for the test set and the data provenance
- Sample Size for Test Set: Not specified for any of the performance tests. For bench testing, it refers to the number of devices or components tested, which is not provided.
- Data Provenance: Not specified.
- Retrospective or Prospective: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable as this is not an AI/ML algorithm study involving expert review for ground truth. Image quality and optical performance comparisons were based on consensus international standards and published scientific literature by unspecified personnel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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
No MRMC study was reported. This device is an endoscope, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The performance data relates to the physical and functional characteristics of the endoscope itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For image quality, ground truth appears to be based on adherence to international standards and published literature for color and optical performance evaluation. For other physical/functional tests, the "ground truth" is compliance with predefined specifications and standards.
8. The sample size for the training set
Not applicable. This is not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.