(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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 2, 2024
CenterPoint Systems LLC Conner Johnson Regulatory/Ouality Associate 3338 Parkway Blvd West Valley City, Utah 84119
Re: K233752
Trade/Device Name: Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; DragonflyTM Instrument Channel Caps Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FBN, NTN, FET, ODC Dated: April 2, 2024 Received: April 2, 2024
Dear Conner Johnson:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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Sincerely,
Shanil P. Haugen -S
Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K233752
Device Name
Dragonfly™ pancreaticobiliary scope; Dragonfly™ digital controller; Dragonfly™ instrument channel caps
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) SUMMARY
| 1 | SUBMITTER | |
|---|---|---|
| Name: | CenterPoint Systems LLC | |
| Address: | 3338 Parkway BlvdWest Valley City, UT | |
| Phone: | 877-848-0828 | |
| Contact Person: | Conner Johnson | |
| Date Prepared: | December 21, 2023 |
2 DEVICE
| Name of Device: | Dragonfly Pancreaticobiliary Scope System |
|---|---|
| Common or Usual Name: | Pancreaticobiliary Scope |
| Classification Name: | Endoscope and accessories |
| Regulatory Class: | Class II per 21 CFR 876.1500 |
| Product Code: | FBN, NTN, FET |
| Name of Device: | Dragonfly Instrument Channel Caps |
|---|---|
| Common or Usual Name: | Instrument Caps |
| Classification Name: | Endoscope and accessories |
| Regulatory Class: | Class II per 21 CFR 876.1500 |
| Product Code: | ODC |
3 PREDICATE DEVICES Predicate Name and 510(k) Number: SpyGlass Visualization System, K181439
This predicate has not been subject to a design-related recall.
No reference predicates were used in this submission.
Predicate Name and 510(k) Number: BioShield biopsy valve EUS – Linear, K202583
This predicate has not been subject to a design-related recall.
No reference predicates were used in this submission.
CONFIDENTIAL
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510(k) Summary - Pancreaticobiliary Scope: Traditional 510(k) Premarket Notification Submission DragonflyTM Pancreaticobiliary Scope System with Instrument Channel Caps
4 DEVICE DESCRIPTION
Dragonfly Pancreaticobiliary Scope and Digital Controller
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.
Dragonfly Instrument Channel Caps
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.
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510(k) Summary - Pancreaticobiliary Scope: Traditional 510(k) Premarket Notification Submission DragonflyTM Pancreaticobiliary Scope System with Instrument Channel Caps
5 INDICATIONS FOR USE
Dragonfly Pancreaticobiliary Scope and Digital Controller
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 and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts.
Dragonfly Instrument Channel Caps
The Dragonfly Instrument Channel Caps 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.
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510(k) Summary - Pancreaticobiliary Scope: Traditional 510(k) Premarket Notification Submission DragonflyTM Pancreaticobiliary Scope System with Instrument Channel Caps
6 COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE -DRAGONFLY PANCREATICOBILIARY SCOPE AND DIGITAL CONTROLER
The proposed Dragonfly Pancreaticobiliary Scope System and the predicate SpyGlass Visualization System (K181439) are similar in indications for use, intended use, and technological characteristics, and principles of operation.
The differences between the Proposed Device and the Predicate Device are minor and raise no different questions of safety and effectiveness, thus it was concluded that the Proposed Device is substantially equivalent to the Predicate Device. In accordance with 21CFR807.92(a)(6) a summary of how the technological characteristics of the Proposed Device compares to the Predicate Device is provided below.
| Feature | Dragonfly PancreaticobiliaryScope (proposed device) | Primary Predicate: SpyScopeDS Access & DeliveryCatheter(K181439) | Same/Different betweenProposed &Predicate |
|---|---|---|---|
| IntendedUse/Indications forUse (Scope) | The Dragonfly PancreaticobiliaryScope System is intended toprovide direct visualization and toguide both optical and accessorydevices for diagnostic andtherapeutic applications duringendoscopic procedures in thepancreaticobiliary system includingthe hepatic ducts. | The SpyGlass VisualizationSystem is intended to providedirect visualization and to guideboth optical and accessory devicesfor diagnostic and therapeuticapplications during endoscopicprocedures in thepancreaticobiliary systemincluding the hepatic ducts. | Same |
| Device Class | II | II | Same |
| Product Code | FBN, NTN, FET | FBN, NTN, KQM | Same |
| Regulation number | 21 CFR 876.1500 | 21 CFR 876.1500 | Same |
| Duration of use | Single-use, Transient | Single-use, Transient | Same |
| Insertion Method | Through a duodenoscope | Through a duodenoscope | Same |
| Sterilization | Ethylene Oxide | Ethylene Oxide | Same |
| PrescriptionDevice | Yes | Yes | Same |
| Working ChannelInner Diameter | 5.1F | 3.6F | Different(SubstantiallyEquivalent) |
| Working Length | 139cm | 214cm | Different(SubstantiallyEquivalent) |
| Type of imagesensor | CMOS | CMOS | Same |
| Illumination Type | LED | LED | Same |
| Field of View | 120 degrees | 120 degrees | Same |
| Outer ShaftDiameter(Proximal) | 3.6mm | 3.6mm | Same |
Table 1: Dragonfly Pancreaticobiliary Scope Comparison to Predicate Device
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510(k) Summary – Pancreaticobiliary Scope: Traditional 510(k) Premarket Notification Submission Dragonfly™ Pancreaticobiliary Scope System with Instrument Channel Caps
| Feature | Dragonfly PancreaticobiliaryScope (proposed device) | Primary Predicate: SpyScopeDS Access & DeliveryCatheter(K181439) | Same/Different betweenProposed &Predicate |
|---|---|---|---|
| Outer ShaftDiameter (Distal) | 3.6mm | 3.5mm | Different(SubstantiallyEquivalent) |
| Articulation | Yes, using deflection knobs onhandle | Yes, using deflection knobs onhandle | Same |
| Materials/Biocompatibility | Standard medical device materials,including PEBAX, PTFE, StainlessSteelAs described in the 510(k) thematerials above were tested duringbiocompatibility testing. Thebiocompatibility tests demonstratesthat there are no adversebiocompatibility risks associatedwith use of this material. All testresults met the requirements of ISO10993-1. | Standard medical device materials.The biocompatibility testsdemonstrates that there are noadverse biocompatibility risksassociated with use of thismaterial. All test results met therequirements of ISO 10993-1. | Same |
| Features | Handle, Deflection knobs,Umbilical Cable, AccessoryWorking Channel, Irrigation Ports, | Handle, Articulation Lever,Umbilical Cable, AccessoryAccess Port, Irrigation Port | Same |
| Video ProcessingUnit | Separate VPU which connects to anexisting monitor. | Separate VPU which connects toan existing monitor | Same |
| Direction of View | 0 degrees | 0 degrees | Same |
| MinimumDuodenoscopeWorking Channel | 4.2mm | 4.2mm | Same |
| EMC SafetyTesting | Complies with applicable clauses ofIEC 60601 | Complies with applicable clausesof IEC 60601 | Same |
| Table 2: Dragonfly Digital Controller Comparison to Predicate Device |
|---|
| Feature | Dragonfly Digital Controller | Primary Predicate: SpyGlass DS Digital Controller (K181439) | Same/Different between Proposed & Predicate |
|---|---|---|---|
| Intended Use/Indications for Use (Controller) | The Dragonfly Digital Controller is intended to provide illumination power and receive, process and output images from the Dragonfly Pancreaticobiliary Scope for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts. | The SpyGlass DS Digital Controller is intended to provide illumination and receive, process, and output images from the SpyScope DS Access and Delivery Catheter or SpyScope DS II Access and Delivery Catheter for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts. | Different (Substantially Equivalent) |
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510(k) Summary – Pancreaticobiliary Scope: Traditional 510(k) Premarket Notification Submission Dragonfly™ Pancreaticobiliary Scope System with Instrument Channel Caps
| Feature | Dragonfly Digital Controller | Primary Predicate: SpyGlass DSDigital Controller (K181439) | Same/Different betweenProposed &Predicate |
|---|---|---|---|
| Device Class | II | II | Same |
| Product Code | FBN | FBN | Same |
| Regulation number | 21 CFR 876.1500 | 21 CFR 876.1500 | Same |
| Video Outputs | DVI | S-video, VGA or DVI | Same |
| White Balancing | Automatic | Automatic | Same |
| Brightness Control | Yes | Yes | Same |
| Separate Monitor | Yes | Yes | Same |
| Energyused/Power source | Yes | Yes | Same |
| Reusability | Yes | Yes | Same |
| EMC SafetyTesting | Complies with applicable clauses ofIEC-60601 | Complies with applicable clausesof IEC-60601 | Same |
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7 COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE -DRAGONFLY INSTRUMENT CHANNEL CAPS
The proposed Dragonfly Instrument Channel Caps and the predicate BioShield biopsy valve EUS - Linear (K202583) are similar in indications for use, intended use, and technological characteristics, and principles of operation.
The differences between the Proposed Device and the Predicate Device are minor and raise no different questions of safety and effectiveness, thus it was concluded that the Proposed Device is substantially equivalent to the Predicate Device. In accordance with 21CFR807.92(a)(6) a summary of how the technological characteristics of the Proposed Device compares to the Predicate Device is provided below.
| Feature | Dragonfly Instrument Caps(proposed device) | Primary Predicate: BioShieldbiopsy valve EUS - Linear(K202583) | Same/DifferentbetweenProposed &Predicate |
|---|---|---|---|
| Intended Use | The Dragonfly Instrument ChannelCaps are intended to cover theopening to the biopsy/suctionchannel of flexibleechoendoscopes. It provides accessfor endoscopic device passage andexchange, helps maintaininsufflation, minimizes leakage ofbiomaterial from the biopsy portthroughout the endoscopicprocedure. | The BioShield biopsy valve EUS– Linear (K202583) is intended tocover the opening to thebiopsy/suction channel of flexibleechoendoscopes. It providesaccess for endoscopic devicepassage and exchange, helpsmaintain insufflation, minimizesleakage of biomaterial from thebiopsy port throughout theendoscopic procedure. | Same |
| Indications forUse | The Dragonfly Instrument ChannelCaps are used to cover the openingto the biopsy/suction channel inletof a Olympus®, Fujifilm® orPentax® duodenoscope. TheInstrument Channel Caps areintended for exclusive use with theDragonfly Pancreaticobiliary Scopeto provide access for passage,while maintaining insufflation andminimizing leakage of biomaterialfrom the biopsy port throughout thegastrointestinal endoscopicprocedure. | The single use BioShield(@ biopsyvalve EUS is used to cover theopening to the biopsy/suctionchannel of flexibleechoendoscopes. It providesaccess for endoscopic devicepassage and exchange, helpsmaintain insufflation, minimizesleakage of biomaterial from thebiopsy port throughout theendoscopic procedure andprovides access for irrigation. | Different(SubstantiallyEquivalent) |
| Device Class | II | II | Same |
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510(k) Summary – Pancreaticobiliary Scope: Traditional 510(k) Premarket Notification Submission Dragonfly™ Pancreaticobiliary Scope System with Instrument Channel Caps
| Feature | Dragonfly Instrument Caps(proposed device) | Primary Predicate: BioShieldbiopsy valve EUS – Linear(K202583) | Same/DifferentbetweenProposed &Predicate |
|---|---|---|---|
| Regulationnumber | 21 CFR 876.1500 | 21 CFR 876.1500 | Same |
| Duration of use | Single-use, Transient | Single-use, Transient | Same |
| Construction | Cap | Valve Body, Valve Cap | Different(SubstantiallyEquivalent) |
| SterilizationMethod | Ethylene Oxide | Ethylene Oxide | Same |
| SterilizationAssurance Level | 10-6 | 10-6 | Same |
| PrescriptionDevice | Yes | Yes | Same |
| DeviceDimensions | Length: 0.615"Width: 0.615"Height: 0.480" | Length: 0.52"Width: 0.52"Height: 0.77" | Different(SubstantiallyEquivalent) |
| Target Population | GI Endoscopic procedures | GI Endoscopic procedures | Same |
| Energyused/delivered | None | None | Same |
| Method ofapplication | Manual application | Manual application | Same |
| Compatibleendoscopes | Olympus, Pentax, FujiFlimduodenoscopes | Linear echoendoscopes | Different(Substantiallyequivalent) |
| Materials/Biocompatibility | Silicone | Thermoplastic elastomer | Same |
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510(k) Summary - Pancreaticobiliary Scope: Traditional 510(k) Premarket Notification Submission DragonflyTM Pancreaticobiliary Scope System with Instrument Channel Caps
8 PERFORMANCE DATA
All necessary performance testing has been conducted on the Dragonfly Pancreaticobiliary Scope System and Instrument Channel Caps to assure substantial equivalence to the predicate devices and to demonstrate the device performs as intended. All testing was performed on test units representative of finished devices. The device passed the following tests:
- . Biocompatibility testing per FDA Final Guidance Document, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" (2023)
- . Sterilization validation per ANSI/AAMI/ISO 11135
- Packaging validation per ● ANSI/AAMI/ISO 11607-1
- Electrical Safety and electromagnetic (EMC) Testing per applicable requirements of IEC 60601-1, IEC 60601-1-2, & IEC 60601-2-18.
- Simulated use testing, including use with ancillary devices
- . Scope and controller Dimensional verification, including distal OD, working length, working channel length and ID
- . Deflection verifications
- . Image testing, including illumination verification, Field of View and direction measurement, camera function, camera light ingress and glare
- HDMI compatibility ●
- Image functionality and gain function ●
- Sheath compatibility ●
- Leak test
- . Tensile tests
- Optics testing, including Resolution, . Depth of Field, Field of View, Geometric distortion, Signal-to-Noise Ratio, Dynamic Range, Image intensity uniformity, color performance
9 CONCLUSION
Upon reviewing the information provided in this submission and comparing the intended use, principle of operation and overall technological characteristics, the is substantially equivalent to existing legally marketed devices.
§ 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.