(162 days)
The Dragonfly Pancreaticobiliary Scope is intended to provide direct visualization and to guide both optical and accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts.
The Dragonfly Digital Controller is intended to provide illumination power and receive, process and output images from the Dragonfly Pancreaticobiliary Scope for diagnostic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts.
The Dragonfly Instrument Channel Caps are used to cover the biopsy/suction channel inlet of an Olympus®, Fujifilm® or Pentax® duodenoscope. The Instrument Channel Caps are intended for exclusive use with the Dragonfly Pancreaticobiliary Scope to provide access for passage, while maintaining leakage of biomaterial from the biopsy port throughout the gastrointestinal endoscopic procedure.
The Dragonfly Pancreaticobiliary Scope is a sterile, single-use endoscope used for singleoperator per-oral 2holoangiopancreatoscopy. The Dragonfly Pancreaticobiliary System is comprised of two components: The Dragonfly Pancreaticobiliary Scope and the Dragonfly Digital Controller.
The Dragonfly Pancreaticobiliary Scope System is intended to provide direct visualization and to guide both optical and accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts. The Dragonfly Pancreaticobiliary Scope is a single-use catheter which provides direct visualization with a camera and illumination, and enables access and delivery of accessories to targeted pancreaticobiliary anatomy. The Dragonfly Pancreaticobiliary Scope comprises of a handle, a catheter, imaging and illumination elements, and a video connection mechanism. The Dragonfly Digital Controller is a reusable accessory which controls illumination and receives, processes, and outputs video signals from the Dragonfly Pancreaticobiliary Scope. The system does not treat or diagnosis conditions.
The Dragonfly Instrument Channel Caps, which are included in package with the Dragonfly Pancreaticobiliary Scope, are used to cover the opening to the biopsy/suction channel inlet of a Olympus®, Fujifilm® or Pentax® duodenoscope. The Instrument Channel Caps are intended for exclusive use with the Dragonfly Pancreaticobiliary Scope to provide access for passage, while maintaining insufflation and minimizing leakage of biomaterial from the biopsy port throughout the gastrointestinal endoscopic procedure.
This document is a 510(k) summary for the Dragonfly™ Pancreaticobiliary Scope, Digital Controller, and Instrument Channel Caps. As such, it focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study report of the new device's performance against specific acceptance criteria. This type of regulatory submission typically does not include the level of detail requested in your prompt regarding specific acceptance criteria, test set characteristics, expert involvement, or training data for AI/ML-based devices.
Based on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document lists performance tests conducted, implying that the device passed these tests. However, it does not explicitly state specific quantitative acceptance criteria for each test. Instead, it broadly states "All testing was performed on test units representative of finished devices. The device passed the following tests."
Here's a table based on the types of tests performed, as specific numerical acceptance criteria are not provided:
| Acceptance Criteria Category | Reported Device Performance (as stated in the document) |
|---|---|
| Biocompatibility | Passed testing per ISO 10993-1. |
| Sterilization | Validated per ANSI/AAMI/ISO 11135. |
| Packaging | Validated per ANSI/AAMI/ISO 11607-1. |
| Electrical Safety & EMC | Complies with applicable requirements of IEC 60601-1, IEC 60601-1-2, & IEC 60601-2-18. |
| Simulated Use | Passed, including use with ancillary devices. |
| Dimensional Verification | Passed (including distal OD, working length, working channel length and ID). |
| Deflection | Verified. |
| Image Testing | Passed (including illumination verification, Field of View and direction measurement, camera function, camera light ingress and glare). |
| HDMI Compatibility | Passed. |
| Image Functionality & Gain | Passed. |
| Sheath Compatibility | Passed. |
| Leak Test | Passed. |
| Tensile Tests | Passed. |
| Optics Testing | Passed (including Resolution, Depth of Field, Field of View, Geometric distortion, Signal-to-Noise Ratio, Dynamic Range, Image intensity uniformity, color performance). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states, "All testing was performed on test units representative of finished devices." However, it does not specify the sample size for any of the tests, nor does it provide information on data provenance (e.g., country of origin, retrospective/prospective nature). These tests are generally laboratory-based device performance tests, not clinical studies involving patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The listed tests are engineering and performance validation tests for a physical medical device, not AI/ML algorithm performance studies that would require expert-established ground truth. Expert involvement in defining test methods or interpreting results would be part of the manufacturer's internal quality system, but is not detailed here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Given the nature of the tests (engineering and device performance), formal adjudication methods like 2+1 or 3+1, which are common in clinical trial or AI model validation, are not typically applicable or detailed in this type of 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
The document does not mention or imply that an MRMC comparative effectiveness study was done. The device is an endoscope system, not an AI-assisted diagnostic tool. Therefore, the question about human reader improvement with AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document does not describe any standalone algorithm performance testing, as the device is a medical imaging and intervention tool, not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the physical device performance tests listed (e.g., dimensional verification, image quality, electrical safety), the "ground truth" is typically defined by engineering specifications, relevant international standards (e.g., ISO, IEC), and internal design requirements. This is not explicitly defined as expert consensus, pathology, or outcomes data in the context of this submission.
8. The sample size for the training set
This information is not provided. There is no indication in the document that the device incorporates an AI/ML component requiring a training set.
9. How the ground truth for the training set was established
This information is not provided, as there is no mention of a training set or AI/ML components for which ground truth would need to be established.
§ 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.