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The Cellvizio 100 Series System with Confocal Miniprobes is a confocal laser system with fiber optic probes that is intended to allow imaging of the internal microstructure of tissues in anatomical tracts, i.e., gastrointestinal.

The AQ-Flex 19TM member of the GastroFlex M series.of Confocal Miniprobes can be used within anatomical tracts, i.e., gastrointestinal. accessed by an endoscope or endoscopic accessories, including through EUS-FNA needles.

The subject device, "AQ-Flex 19" is a member of the GastroFlex M family of devices cleared via K122042 and K120208. It is identical in design to the GastroFlex M devices described in K120208. There are no differences in design, materials, or function between the subject AQ-Flex 19 device and the recently cleared GastroFlex M devices. A locking accessory is being added to the package as an aid to secure placement inside a EUS-FNA needle in place of a Stylet. Instructions for Sterilization have also been added.

This document is a 510(k) premarket notification for the "AQ-Flex 19" Confocal Miniprobe, a component of the Cellvizio family of devices. The filing asserts substantial equivalence to previously cleared devices. Therefore, the information provided does not describe a clinical study with acceptance criteria and a detailed performance evaluation of a new or significantly modified device. Instead, it focuses on demonstrating that the new device is functionally identical to existing, cleared devices.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:
   Since this is a 510(k) for a device stated to be identical to a previously cleared one, direct acceptance criteria and specific performance metrics for this particular device are not explicitly stated in the provided text. The submission focuses on demonstrating sameness rather than new performance. The text states:

   • "The subject device, "AQ-Flex 19" is a member of the GastroFlex M family of devices cleared via K122042 and K120208. It is identical in design to the GastroFlex M devices described in K120208. There are no differences in design, materials, or function between the subject AQ-Flex 19 device and the recently cleared GastroFlex M devices."
   • "No change is being made to the subject/predicate device. The subject device is identical to the previously cleared device (K120208)."
   • "Verification and validation testing has shown that the AQ-Flex 19 Confocal Miniprobes are compatible with endoscopes or endoscopic accessories designed and commonly used in these procedures (such as endoscopic needles)."

   Therefore, the "acceptance criteria" implicitly are that the device performs identically to the predicate device, K120208, and remains compatible with intended endoscopic accessories. No specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy) are provided for this filing.

2. Sample size used for the test set and the data provenance:
   The document does not describe a specific clinical test set for evaluating a new performance claim. The "verification and validation testing" mentioned is likely engineering and bench testing to demonstrate physical and functional equivalence and compatibility, rather than a clinical study with a patient test set. No information is given regarding data provenance (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable, as no clinical test set for establishing ground truth is described.

4. Adjudication method for the test set:
   Not applicable, as no clinical test set requiring adjudication is described.

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 a confocallaser system and miniprobe for imaging, not an AI or diagnostic software tool that would typically involve human reader performance evaluation.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   Not applicable. The device is a physical imaging system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   Not applicable, as no clinical ground truth assessment is described for the new device's performance. The "ground truth" for the submission is the demonstrated functional equivalence to its predicate.

8. The sample size for the training set:
   Not applicable, as this is not an AI/machine learning device requiring a training set.

9. How the ground truth for the training set was established:
   Not applicable.

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The GastroFlex M™ series of Confocal Miniprobes™ are intended to allow imaging of the internal microstructure of tissues in the upper gastrointestinal tract including biliary and pancreatic ducts, accessed by an endoscope or endoscopic accessories.

The GastroFlex™ M series of Confocal Miniprobes are used as part of the Cellvizio® 100 Series system and the Cellvizio" system, to allow imaging of the internal microstructure of tissues in the gastrointestinal system accessed by an endoscope or endoscopic accessories.

The provided text is a 510(k) Premarket Notification summary for the Cellvizio® 100 Series System and Cellvizio® System with Confocal Miniprobes™. It primarily focuses on demonstrating substantial equivalence to a predicate device and modifying the "Indications for Use."

Crucially, the provided document does NOT contain a study with acceptance criteria and reported device performance as requested. The document states that "Verification and validation testing has shown that the GastroFlex M™ Confocal Miniprobes are compatible with endoscopes and endoscopic accessories designed and commonly used for biliary and pancreatic imaging," but it does not present the details of such testing, acceptance criteria, or performance outcomes.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor can I describe a study that proves the device meets those criteria, as this information is not present in the provided text.

The document mainly focuses on:

• Device Description: The GastroFlex M™ Confocal Miniprobes are used with the Cellvizio system for imaging internal tissue microstructures in the gastrointestinal system, including biliary and pancreatic ducts. The current submission is for revisions to the Indication for Use, specifically verifying compatibility with specialized endoscopes.
• Comparison to Predicate Device: The subject device is stated to be identical to the previously cleared GastroFlex M™ Confocal Miniprobes (K120208). The change is to the Indications for Use to be consistent with the cleared device and the Boston Scientific SpyGlass Direct Visualization Probe.
• Indications for Use: The GastroFlex M™ series is intended to allow imaging of internal microstructures in the upper gastrointestinal tract, including biliary and pancreatic ducts, accessed by an endoscope or endoscopic accessories.

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