(58 days)
Cellvizio® 100 Series Systems with Confocal Miniprobes™ are confocal laser systems with fiber optic probes that are intended to allow imaging of the internal microstructure of tissues, including, but not limited to, the identification of cells and their organization or architecture.
The AQ-Flex™ 19 Confocal Miniprobe™ is intended to allow imaging of anatomical tracts, i.e., gastrointestinal and respiratory tracts, accessed by an endoscope, or endoscopic accessories (e.g. aspiration needles used during procedures including EUS-FNA, EBUS-TBNA and TBNA needles).
AQ-Flex™ 19 Confocal Miniprobes™ is used with Cellvizio® 100 Series system to provide imaging of anatomical tracts, i.e., gastrointestinal and respiratory tracts, accessed by an endoscope, or endoscopic accessories. It is designed to be used during transbronchial needle aspiration (TBNA), endoscopic ultrasound transbronchial needle aspiration (EBUS-TBNA) and endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) procedures.
There are no changes in design, materials, or function between the subject AQ-Flex™ 19 device and the cleared AQ-Flex™ 19 Confocal Miniprobe™ (K123676, K150831, and K172844), except for the length of the AQ-Flex 19 which has been reduced from 4 to 3 meters (AQ-Flex™ 19 Confocal Miniprobe™ has previously been cleared with a length of 4 meters).
A locking accessory already available in the package of the predicate device is used as an aid to secure placement inside the needle used during EUS-FNA procedures and can also be used during TBNA, and EBUS-TBNA procedures.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Cellvizio® 100 Series Confocal laser imaging systems and their Confocal Miniprobe™ AQ-Flex™ 19:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility (Cytotoxicity, Sensitization, Irritation or Intracutaneous reactivity & Systemic toxicity) | All requirements met | Pass |
| Resistance to reprocessing methods: mechanical resistance, tensile strength assessment, functional testing, image quality etc. | All requirements met | Pass |
| Efficacy of reprocessing methods | All requirements met | Pass |
| Laser safety | All requirements met | Pass |
| Imaging quality | All requirements met | Pass |
| Compatibility of the AQ-Flex™ 19 Confocal Miniprobe™ with endoscopic accessories used during EUS-FNA procedures. | All requirements met | Pass |
| Compatibility of the AQ-Flex™ 19 Confocal Miniprobe™ with endoscopic accessories used during (EBUS)-TBNA procedures: Mechanical tests to verify no creation of sharp edges on distal head. | Verification of smooth distal surface and absence of spikes and edges on distal tip according to ISO 8600-1 standard | Pass (25/25) |
| Compatibility of the AQ-Flex™ 19 Confocal Miniprobe™ with endoscopic accessories used during (EBUS)-TBNA procedures: Confocal Miniprobe™ strength test by insertion/extraction and bending in (EBUS)-TBNA needles. | Verification of mechanical resistance of the probe after extraction of AQ-Flex™ 19 from needle in EUS-TBNA and TBNA retroflex position | Pass (25/25) |
| Protrusion test of the of the AQ-Flex™ 19 Confocal Miniprobe™ length when used with (This row is incomplete in the provided text, but the intention is clear from the acceptance criteria and result for securing position.) | Securing position of AQ-Flex™ 19 distal tip with (The specific conditions for securing are not fully detailed in the provided text, but the general concept is present.) | Pass (5/5) |
2. Sample Sizes Used for the Test Set and Data Provenance
The document primarily focuses on bench testing and compatibility assessments, not clinical performance studies with human data in the test set.
- Mechanical tests for sharp edges: 25 samples ("Pass (25/25)")
- Mechanical strength test (insertion/extraction and bending): 25 samples ("Pass (25/25)")
- Protrusion test: 5 samples ("Pass (5/5)")
The provenance of this data is not explicitly stated as country of origin, retrospective, or prospective. Given that these are primarily compatibility and mechanical tests, they are likely prospective bench tests conducted by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not mention human experts being used to establish ground truth for the "test set" in the context of clinical performance. The "ground truth" for the mechanical and compatibility tests would primarily be adherence to engineering specifications and international standards (like ISO 8600-1), which are verified by testers, not expert clinicians establishing a diagnostic truth.
4. Adjudication Method for the Test Set
Not applicable as the reported tests are primarily objective mechanical and compatibility tests against predefined criteria and standards, 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
There is no mention of an MRMC comparative effectiveness study in this document. The device is a confocal laser imaging system for visualizing tissue microstructure, and the submission is for an expanded indication of use for an existing component (AQ-Flex™ 19 Confocal Miniprobe™) in specific endoscopic procedures. There is no AI component or human-in-the-loop performance evaluation described.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an imaging tool that provides visual information to a human operator, not an AI algorithm performing a diagnostic task independently.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the tests reported is primarily:
- Adherence to engineering specifications and standards (e.g., ISO 8600-1 for smooth distal surface, absence of spikes/edges).
- Verification of mechanical integrity and functionality after stress tests.
- Compliance with safety standards (e.g., laser safety).
- Internal validation of performance characteristics (e.g., image quality, resistance to reprocessing).
There is no mention of clinical ground truth such as pathology or outcomes data in this submission for the expanded indication.
8. The Sample Size for the Training Set
Not applicable. This document describes the testing and validation for a hardware device and its accessories, not the development or training of an algorithm or AI system.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for an algorithm described in this document.
§ 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.