(23 days)
The Cellvizio® I.V.E. system with Confocal Miniprobes™ is a confocal laser system 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 vessels and their organization or architecture.
The Cellvizio® I.V.E. system is indicated for imaging blood flow in vascular areas, including microvasculature and capillaries.
The GastroFlex™ N and ColoFlex™ N Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., gastrointestinal systems, accessed by an endoscope or endoscopic accessories.
The AlveoFlex™ N Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., respiratory systems, accessed by an endoscope or endoscopic accessories.
The CholangioFlex™ N Confocal Miniprobes™ are intended to allow imaging of the upper gastrointestinal tract including biliary and pancreatic ducts, accessed by an endoscope or endoscopic accessories.
The AQ-Flex™ 19 N Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., gastrointestinal and respiratory tracts, accessed by an endoscopic accessories (e.g. aspiration needles used during procedures including but not limited to EUS-FNA, EBUS-TBNA and TBNA).
The CystoFlex™F N, CystoFlex™ R N and UroFlex™ N Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., urinary, including, but not limited to, urethra, bladder, and ureter, accessed through an endoscope or endoscopic accessories.
The CelioFlex™ 5 N Confocal Miniprobes™ are intended to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures, including robot-assisted procedures.
Confocal Miniprobes™ are used with Cellyizio® I.V.E. system. which is a confocal imaging system with fiber optic probes which allows visualization of internal microstructure of tissues and blood flow including, but not limited to, the identification of cells, vessels and their organization or architecture, during endoscopic and laparoscopic surgical procedures, including robot-assisted procedures.
Fluorescein Sodium is used as a fluorescence contrast agent to allow imaging of microvasculature and visualization of blood flow in vascular areas, including microvasculature and capillaries. Fluorescein Sodium can be used as a contrast agent with Cellvizio® I.V.E. system with Confocal Miniprobes™ without change of formulation, mode of action, approved dose or route of administration: it is delivered independent of Cellyizio® I.V.E. system in accordance with Fluorescein Sodium instruction for use.
The provided text is a 510(k) Premarket Notification summary for the Cellvizio® I.V.E. system with Confocal Miniprobes™. This submission is primarily to extend the device's Indications for Use to include imaging blood flow in vascular areas when used with Fluorescein Sodium as a contrast agent.
Based on the document, here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for performance metrics in a quantitative manner (e.g., sensitivity, specificity, accuracy thresholds). Instead, the submission relies on demonstrating substantial equivalence to previously cleared devices. The "performance" assessment is based on the device having the "same intended use," "same operating principle," "same technological characteristics," "same design," and "same biocompatible materials" as predicate and reference devices, especially in the context of the new expanded indication.
Therefore, the "acceptance criteria" are implied to be equivalence to the performance of the predicate and reference devices under the expanded use case (imaging blood flow with Fluorescein Sodium), as the core technology and hardware are unchanged.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance and Justification |
|---|---|
| Similar Intended Use and Indications for Use (especially with Fluorescein Sodium) | Subject Device: The Cellvizio® I.V.E. system with Confocal Miniprobes™ is indicated for imaging blood flow in vascular areas, including microvasculature and capillaries when used with Fluorescein Sodium. |
| Predicate Device (K191144): The Cellvizio® 100 Series system with Confocal Miniprobes™ with Fluorescein also has identical Indications for Use including blood flow visualization in vascular areas, including microvasculature and capillaries with Fluorescein Sodium. | |
| Justification: "Identical Indications for Use... including blood flow visualization in vascular areas, including microvasculature and capillaries with Fluorescein Sodium." | |
| Similar Operating Principle & Technological Characteristics | Subject Device: Confocal laser scanning system with fiber optic probe. |
| Predicate and Reference Devices: Also confocal laser scanning system with fiber optic probe. | |
| Justification: "has the same operating principle, the same technological characteristics, and the same design." | |
| Similar Hardware Design (Laser, Detection, Scanning, Display, etc.) | All key hardware attributes (Laser source, Physical Method of Illumination, Physical Method of Imaging, Laser classification, Scanning system technology, Illumination output, Detection Bandwidth, Location of Signal Detection/Conversion/Processing, Fluorescence Excitation) are stated to be "Same" or "Same technology" as the predicate and reference devices. |
| Justification: "The subject device... is exactly the same device in terms of design and performance as the previously cleared device (K193416)." | |
| Similar Software/Firmware (Image Processing, Control) | Firmware algorithm and Image processing algorithm are stated to be "Same functions with equivalent algorithm" or "Same algorithm with addition of automatic adjustment of laser focus in the fiber bundle" (which is a refinement, not a fundamental change). |
| Justification: Found substantially equivalent (cleared via K193416). | |
| Safety Data (Biocompatibility, Laser Safety) | Justification: "constructed with the same biocompatible materials and meets the same biocompatibility tests requirements"; "Same maximum laser output and therefore no additional testing was performed to ensure safety." |
| Co-packaging (with Fluorescein Sodium) | Justification: "Confocal Miniprobes™ model will be delivered co-packaged with Sodium Fluorescein vials in an identical way as the one described and cleared in K191144." "No additional testing was performed for the co-packaging of Sodium Fluorescein with Cellvizio® I.V.E the Confocal Miniprobes™." |
2. Sample sizes used for the test set and the data provenance
The document explicitly states: "As no technical change is being made to the subject/reference device, all testing required has been provided in the previous submission (K193416)." And further, regarding co-packaging: "Therefore, no additional testing was performed for the co-packaging of Sodium Fluorescein with Cellvizio® I.V.E the Confocal Miniprobes™."
This indicates that no new clinical study or test set data was generated for this specific 510(k) submission (K212322). The basis for substantial equivalence is the prior clearance of the Cellvizio® I.V.E. system (K193416 as a reference device) and the Cellvizio® 100 Series system with Fluorescein (K191144 as a predicate device). The document does not provide details about the sample sizes or data provenance (e.g., country of origin, retrospective/prospective) of the studies that supported those previous clearances.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Since no new human reading study or clinical test set was conducted for this submission (K212322), this information is not provided. The substantial equivalence argument relies on the inherent capabilities of the device, which were previously established and deemed safe and effective in earlier clearances.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no new clinical study or human reading test set was conducted for this submission.
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 imaging system, not an AI-assisted diagnostic tool for human readers, and no MRMC study was performed for this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This refers to the performance of the device itself as an imaging system. The "performance" is demonstrated through its physical and optical characteristics (e.g., field of view, depth of observation, lateral resolution, real-time image visualization frequency), which are stated to be "Same" as previously cleared devices. The document essentially argues that the device's technical specifications and resulting image quality are equivalent to the predicate and reference devices, implying equivalent "standalone" performance. No new quantitative performance metrics (like accuracy against a ground truth for a specific disease) are presented as part of this submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this specific 510(k), since the submission is based on substantial equivalence to existing devices and expanding an indication for an existing capability (blood flow imaging with a contrast agent), no new ground truth establishment is detailed. The performance of confocal endomicroscopy in general (the technology this device uses) is inherently about visualizing microstructures and blood flow. The "truth" would logically be the real-time images themselves, and in a clinical context, a physician's interpretation of those images in conjunction with other diagnostic information. For the original clearances of the predicate and reference devices, ground truth for imaging capabilities would typically involve:
- Physical/Optical Measurements: Demonstrating adherence to specifications for resolution, field of view, depth of observation.
- Bench Testing/Phantom Studies: Using known physical models to assess image quality.
- Pre-clinical (animal) and Clinical Studies: Demonstrating the ability to visualize the intended structures (cells, vessels, blood flow) in vivo, often compared to histological confirmation or other established imaging modalities if applicable to the initial clearances.
8. The sample size for the training set
Not applicable. This submission is for an imaging device, not an AI/machine learning algorithm requiring a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no AI algorithm being trained for this submission.
§ 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.