(111 days)
The 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 vessels and their organization or architecture.
The CranioFlex™ (-,-C) Confocal Miniprobes™ are indicated to provide visualization within central nervous system during cranial diagnostic and therapeutic procedures such as tumor biopsy and resection.
The 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. Confocal Miniprobes™ are intended to be used by qualified physicians to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures, including robot-assisted procedures and during neurosurgical procedures.
CranioFlex™ (-,-C) Confocal Miniprobes™ are used with Cellvizio® 100 Series systems to provide imaging of the brain through contact of their distal tip with the tissue. They are designed to be used and manually handled during neurosurgical procedures.
This document is a 510(k) Premarket Notification for the Cellvizio 100 Series Systems with Confocal Miniprobes, specifically the CranioFlex™ (-,-C) Confocal Miniprobes, for use in neurosurgical procedures.
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It does not present a study with specific acceptance criteria or performance metrics for an AI/algorithm-based device. The device described (Cellvizio with CranioFlex™ Miniprobes) appears to be an optical imaging system that provides direct visualization, not an AI or algorithm that interprets images or assists human readers. Therefore, many of the requested elements for AI acceptance criteria and studies (like MRMC studies, standalone algorithm performance, training set details, ground truth establishment for AI) are not applicable to this type of medical device submission.
The document primarily focuses on comparing the subject device's technological characteristics and intended use to a predicate neuro-endoscope and previously cleared reference devices from the same manufacturer.
Based on the provided text, here's an attempt to address the requested information, highlighting where the information is not applicable (N/A) due to the nature of the device:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or performance metrics in the format typically seen for AI/algorithm-based devices (e.g., sensitivity, specificity, accuracy thresholds). The "acceptance" for this 510(k) relies on demonstrating substantial equivalence to a predicate device. This is achieved through qualitative comparisons of design, materials, indications for use, and technological characteristics, along with verification that risks are acceptable and don't raise new questions of safety or effectiveness.
| Characteristic / "Acceptance Criterion" (Implied from equivalence claim) | Reported Device Performance (from comparison tables) |
|---|---|
| Primary Indication for Use Equivalence | The CranioFlex™ (-,-C) Confocal Miniprobes™ are indicated to provide visualization within the central nervous system during cranial diagnostic and therapeutic procedures such as tumor biopsy and resection. This aligns with the predicate device (KARL STORZ Flexible Video-Neuro-Endoscope System) which also provides visualization during cranial diagnostic and therapeutic procedures such as tumor biopsy and resection, hydrocephalus treatment, etc. The document asserts "equivalent Indications for Use to Karl Storz's Flexible Video-Neuro-Endoscope System." |
| Operating Mechanism for Imaging | Subject Device: Tissue illuminated by laser light transmitted by fibers of the Confocal Miniprobe™ through its distal objective lens. Optical signal collected back by same objective and fibers. Fibers connected to Laser Scanning Unit (LSU) which integrates illumination source and optical detector. Signal digitized and transmitted to Confocal Processor™ for display. |
| Predicate Device: LED in handpiece provides illumination via two glass fiber light bundles. Raw data from distal tip CMOS imaging sensor converted to NTSC video signal by PCB for display. | |
| Comparison/Conclusion: "Equivalent because: Fibers to provide illumination in each case; a source of light and a means to see what is illuminated in each case; a video source processor in each case." | |
| Device Design / Optical Components | Both subject and predicate devices have a rigid section including objective lens and flexible optical fibers to transmit visible light to and from the tissue. Conclusion: "Same as predicate device." |
| Distal Tip Diameter | Subject Device: 2.6 mm |
| Predicate Device: 3.2 mm x 2.4 mm (elliptical shaped distal tip) | |
| Conclusion: "Equivalent." | |
| Distal Tip Cross-Sectional Surface | Subject Device: 5.31 mm2 |
| Predicate Device: 6.03 mm2 | |
| Conclusion: "Equivalent." | |
| Outer Shaft Diameter | Subject Device: 1.4 mm |
| Predicate Device: 2.9 mm | |
| Conclusion: "Equivalent." | |
| Working Channel Diameter | Subject Device: No working channel/lumen |
| Predicate Device: 1.2 mm | |
| Conclusion: "Not having a working channel does not raise different questions of safety or effectiveness." | |
| Distal Tip Type | Both subject and predicate devices have an Atraumatic Tip. Conclusion: "Same as predicate device." |
| Biocompatibility | Both subject and predicate devices use Standard, Proven Inert Materials. Conclusion: "Same as predicate device." |
| Sterilization | Previously cleared reference devices (GastroFlex™) validated for high-level disinfection/sterilization. For neurosurgery, CranioFlex™ will be sterilized similarly to the predicate device (KARL STORZ). The document implies this is sufficient for safety. |
| Risk Analysis | "All risks reviewed during the risk analysis of the subject devices were confirmed to be acceptable. Moreover, they do not change safety, performances nor increase residual risks, compared to the risk level of the reference devices... The global risk is therefore unchanged and remains acceptable and does not change performance, safety and effectiveness." |
2. Sample size used for the test set and the data provenance
The document does not describe a "test set" in the context of an algorithm evaluation with a specific number of cases or data provenance. The assessment for this 510(k) is based on technical comparison and risk analysis, not a prospective clinical study with a defined test set.
- Sample Size for Test Set: N/A (Not an algorithm evaluation study requiring a test set of cases).
- Data Provenance: N/A (The submission primarily relies on design specifications, materials, and comparison to predicate/reference devices, along with in-house testing for sterilization and biocompatibility). There is a mention of a "clinical feasibility study published in a peer reviewed journal" being used to confirm risk assessment, but no details on size, type, or provenance of that dataset are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. As this is not an AI/algorithm-based device being validated against a ground truth dataset, this information is not relevant or provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A. Not applicable to this type of device 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
N/A. This is not an AI-assisted diagnostic device; it's an imaging tool that provides direct visualization. Therefore, an MRMC study assessing AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This is a direct visualization device, not a standalone AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
N/A. The "ground truth" for this submission is implicitly the safety and effectiveness of the legally marketed predicate device (KARL STORZ Flexible Video-Neuro-Endoscope System) and the established safety and performance of the manufacturer's own reference devices (GastroFlex™ Confocal Miniprobes). The CranioFlex™ Miniprobe is asserted to be fundamentally the same device as the GastroFlex™ but with an expanded indication for use into neurosurgery, hence the comparison to a neuro-endoscope predicate.
8. The sample size for the training set
N/A. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
N/A. This is not an AI/machine learning device.
§ 882.1480 Neurological endoscope.
(a)
Identification. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.(b)
Classification. Class II (performance standards).