(162 days)
No reference predicates were used in this submission.
No
The document describes image processing and output, but there is no mention of AI, ML, or any advanced analytical capabilities beyond basic signal processing for visualization.
Yes
The device is described as guiding "both optical and accessory devices for diagnostic and therapeutic applications."
Yes
The "Intended Use / Indications for Use" section explicitly states that the Dragonfly Pancreaticobiliary Scope and the Dragonfly Digital Controller are intended for "diagnostic applications." The "Device Description" also notes that the system is intended to "provide direct visualization" for diagnostic applications, and the "Mentions image processing" section further clarifies that the Digital Controller outputs images "for diagnostic applications."
No
The device description clearly outlines hardware components including a scope (catheter, handle, imaging/illumination elements, video connection) and a digital controller, and performance testing includes hardware-specific tests like electrical safety, dimensional verification, and tensile tests.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Dragonfly Pancreaticobiliary Scope System is an endoscopic device used for direct visualization and guiding instruments within the body (specifically the pancreaticobiliary system). It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states "to provide direct visualization and to guide both optical and accessory devices for diagnostic and therapeutic applications during endoscopic procedures". This describes an in-vivo procedure, not an in-vitro analysis of specimens.
- Device Description: The description reinforces that it's an endoscope used for "single-operator per-oral cholangiopancreatoscopy" and provides "direct visualization with a camera and illumination".
While the device is used for "diagnostic applications" and processes images, this is related to visualizing internal anatomy directly, not analyzing biological samples in a lab setting.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FBN, NTN, FET, ODC
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical
Anatomical Site
pancreaticobiliary system including the hepatic ducts.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
SpyGlass Visualization System, K181439, BioShield biopsy valve EUS – Linear, K202583
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
No reference predicates were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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"
1
(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).
2
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
3
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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4
510(K) SUMMARY
| 1 | SUBMITTER | |
|---|---|---|
| Name: | CenterPoint Systems LLC | |
| Address: | 3338 Parkway Blvd | |
| West 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
5
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.
6
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.
7
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 Pancreaticobiliary
Scope (proposed device) | Primary Predicate: SpyScope
DS Access & Delivery
Catheter(K181439) | Same/Differe
nt between
Proposed &
Predicate |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| Intended
Use/Indications for
Use (Scope) | 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 SpyGlass Visualization
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. | 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 |
| Prescription
Device | Yes | Yes | Same |
| Working Channel
Inner Diameter | 5.1F | 3.6F | Different
(Substantially
Equivalent) |
| Working Length | 139cm | 214cm | Different
(Substantially
Equivalent) |
| Type of image
sensor | CMOS | CMOS | Same |
| Illumination Type | LED | LED | Same |
| Field of View | 120 degrees | 120 degrees | Same |
| Outer Shaft
Diameter
(Proximal) | 3.6mm | 3.6mm | Same |
Table 1: Dragonfly Pancreaticobiliary Scope Comparison to Predicate Device
8
510(k) Summary – Pancreaticobiliary Scope: Traditional 510(k) Premarket Notification Submission Dragonfly™ Pancreaticobiliary Scope System with Instrument Channel Caps
| Feature | Dragonfly Pancreaticobiliary
Scope (proposed device) | Primary Predicate: SpyScope
DS Access & Delivery
Catheter(K181439) | Same/Differe
nt between
Proposed &
Predicate |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| Outer Shaft
Diameter (Distal) | 3.6mm | 3.5mm | Different
(Substantially
Equivalent) |
| Articulation | Yes, using deflection knobs on
handle | Yes, using deflection knobs on
handle | Same |
| Materials/
Biocompatibility | Standard medical device materials,
including PEBAX, PTFE, Stainless
Steel
As described in the 510(k) the
materials above were tested during
biocompatibility testing. The
biocompatibility tests demonstrates
that there are no adverse
biocompatibility risks associated
with use of this material. All test
results met the requirements of ISO
10993-1. | Standard medical device materials.
The biocompatibility tests
demonstrates that there are no
adverse biocompatibility risks
associated with use of this
material. All test results met the
requirements of ISO 10993-1. | Same |
| Features | Handle, Deflection knobs,
Umbilical Cable, Accessory
Working Channel, Irrigation Ports, | Handle, Articulation Lever,
Umbilical Cable, Accessory
Access Port, Irrigation Port | Same |
| Video Processing
Unit | Separate VPU which connects to an
existing monitor. | Separate VPU which connects to
an existing monitor | Same |
| Direction of View | 0 degrees | 0 degrees | Same |
| Minimum
Duodenoscope
Working Channel | 4.2mm | 4.2mm | Same |
| EMC Safety
Testing | Complies with applicable clauses of
IEC 60601 | Complies with applicable clauses
of 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) |
9
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 DS
Digital Controller (K181439) | Same/Differe
nt between
Proposed &
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 |
| Energy
used/Power source | Yes | Yes | Same |
| Reusability | Yes | Yes | Same |
| EMC Safety
Testing | Complies with applicable clauses of
IEC-60601 | Complies with applicable clauses
of IEC-60601 | Same |
10
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: BioShield
biopsy valve EUS - Linear
(K202583) | Same/Different
between
Proposed &
Predicate |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| Intended Use | The Dragonfly Instrument Channel
Caps are intended to cover the
opening to the biopsy/suction
channel of flexible
echoendoscopes. It provides access
for endoscopic device passage and
exchange, helps maintain
insufflation, minimizes leakage of
biomaterial from the biopsy port
throughout the endoscopic
procedure. | The BioShield biopsy valve EUS
– Linear (K202583) is intended to
cover the opening to the
biopsy/suction channel of flexible
echoendoscopes. It provides
access for endoscopic device
passage and exchange, helps
maintain insufflation, minimizes
leakage of biomaterial from the
biopsy port throughout the
endoscopic procedure. | Same |
| Indications for
Use | 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. | The single use BioShield(@ biopsy
valve EUS is used to cover the
opening to the biopsy/suction
channel of flexible
echoendoscopes. It provides
access for endoscopic device
passage and exchange, helps
maintain insufflation, minimizes
leakage of biomaterial from the
biopsy port throughout the
endoscopic procedure and
provides access for irrigation. | Different
(Substantially
Equivalent) |
| Device Class | II | II | Same |
11
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: BioShield
biopsy valve EUS – Linear
(K202583) | Same/Different
between
Proposed &
Predicate |
|----------------------------------|---------------------------------------------------|------------------------------------------------------------------------|------------------------------------------------------|
| Regulation
number | 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
(Substantially
Equivalent) |
| Sterilization
Method | Ethylene Oxide | Ethylene Oxide | Same |
| Sterilization
Assurance Level | 10-6 | 10-6 | Same |
| Prescription
Device | Yes | Yes | Same |
| Device
Dimensions | Length: 0.615"
Width: 0.615"
Height: 0.480" | Length: 0.52"
Width: 0.52"
Height: 0.77" | Different
(Substantially
Equivalent) |
| Target Population | GI Endoscopic procedures | GI Endoscopic procedures | Same |
| Energy
used/delivered | None | None | Same |
| Method of
application | Manual application | Manual application | Same |
| Compatible
endoscopes | Olympus, Pentax, FujiFlim
duodenoscopes | Linear echoendoscopes | Different
(Substantially
equivalent) |
| Materials/
Biocompatibility | Silicone | Thermoplastic elastomer | Same |
12
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.