(139 days)
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:
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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.
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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). -
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. -
Adjudication method for the test set:
Not applicable, as no clinical test set requiring adjudication is described. -
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. -
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. -
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. -
The sample size for the training set:
Not applicable, as this is not an AI/machine learning device requiring a training set. -
How the ground truth for the training set was established:
Not applicable.
§ 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.