(260 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a catheter, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is used for endoscopic cannulation and injection of contrast for visualization, not for treating any condition or disease.
No
The device is used for endoscopic cannulation and allows for fluoroscopic visualization by injecting contrast, which are interventional procedures rather than diagnostic ones. The key metrics section is not applicable (Not Found), and the performance studies focus on physical performance rather than diagnostic accuracy.
No
The device description clearly outlines physical components such as catheters, fittings, connectors, hubs, luer locks, tips (stainless steel, tapered, dome, angled), lumens, injection ports, wire guide ports, and stylet wires. The performance studies also focus on physical characteristics and testing (e.g., force to remove, tensile strength, radiopaque band detachment). This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for endoscopic cannulation of the ductal system." This describes a procedure performed within the body to access a specific anatomical structure.
- Device Description: The description details a catheter designed for insertion into the body through an endoscope, with features for injecting contrast and guiding wires. These are all characteristics of devices used for interventional procedures.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) in vitro (outside the body) to provide diagnostic information. The fluoroscopic visualization is used to guide the procedure, not to analyze a sample for diagnostic purposes.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is procedural and interventional, not diagnostic in the IVD sense.
N/A
Intended Use / Indications for Use
This device is used for endoscopic cannulation of the ductal system. This device is indicated for adult use only.
Product codes
ODD
Device Description
The subject devices consist of a catheter with a T-fitting, a Y-body connector, a hub, or a female luer lock on the proximal handle and 3 MM markings at the distal radiopaque tip.
The device distal tip configurations include stainless steel metal, tapered, dome and/or angled tips. ERCP catheters are available in single, double, or triple lumen configurations. All devices have an injection port/wire guide port. Some catheters include a stylet wire to facilitate advancement of the catheter, which is removed prior to wire guide insertion or contrast injection. ERCP catheters are used by passing the device through an endoscope. The injection port/wire guide port is then used to allow fluoroscopic visualization by injecting contrast and/or wire guide access to the desired duct.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ductal system
Indicated Patient Age Range
adult use only
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
Performance testing consisting of non-clinical bench testing demonstrates that the subject devices met the performance requirements to fulfill their intended uses. The results of this testing provide reasonable assurance that the subject devices will function as intended. The subject devices do not raise new questions of safety or effectiveness as compared to their respective predicate devices.
Summary of non-clinical testing:
The following non-clinical testing was conducted to demonstrate the performance of the subject device and confirmed that the subject device performs as intended.
- Functional Age Testing
- Design Validation of Fluoroscopic Visibility
- Force to Remove ERCP w/ Metal Tips from Ductal System
- Radiopaque Band Detachment
- Verification Testing Force to Peel Through
- Tensile Strength of Metal Tip to Catheter Joint
- Package Integrity
- EO Residual Testing
Biocompatibility testing was performed in accordance with the FDA Guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices-Part I: Evaluation and testing within a risk management process."
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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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.
March 20, 2018
Wilson-Cook Medical Inc. Ashley Howard Specialist I - Regulatory Affairs 4900 Bethania Station Road Winston-Salem, North Carolina 27105
Re: K171989
Trade/Device Name: Classic ERCP Catheter (ERCP), Huibregtse-Katon® ERCP Catheter (ERCP), Huibregtse-Katon® Angled ERCP Catheter (ERCP), Glo-Tip® ERCP Catheter (GT), Glo-Tip® ERCP Catheter with Radiopaque Bands (GT), Fusion® ERCP Catheter with DomeTip® (FS-GT) Fusion® OMNI ERCP Catheter with DomeTip®(FS-GT), Glo-Tip II® Double Lumen ERCP Catheter (GT) Glo-Tip II® Double Lumen ERCP Catheter with Radiopaque Bands (GT), Haber RAMPTM Catheter (HRC), Soehendra Universal Catheter (SUC) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: ODD Dated: February 8, 2018 Received: February 9, 2018
Dear Ashley Howard:
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 (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. 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
1
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K171989
Device Name ERCP Catheters (ERCP, GT, FS-GT, HRC and SUC)
Indications for Use (Describe)
This device is used for endoscopic cannulation of the ductal system. This device is indicated for adult use only.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is in white, and the word "MEDICAL" is in white and set against a darker red background.
COOK ENDOSCOPY 4900 BETHANIA STATION ROAD WINSTON-SALEM, NC 27105 U.S.A. PHONE: 336.744.0157 TOLL FREE: 800.245.4707 WWW.COOKMEDICAL.COM
510(k) Summary
| Name: | Wilson-Cook Medical, Inc./ Cook Endoscopy |
|---|---|
| Address: | 4900 Bethania Station Road |
| Winston-Salem, North Carolina 27105 | |
| Phone: | 765.436.7537 ext. 6174 |
| Fax: | 336.201.5994 |
| Contact: | Ashley Howard, Specialist I - Regulatory Affairs |
| Date: | March 20, 2018 |
| Subject Device | |
| Trade Names: | Classic ERCP Catheter (ERCP) |
| Huibregtse-Katon® ERCP Catheter (ERCP) | |
| Huibregtse-Katon® Angled ERCP Catheter (ERCP) | |
| Glo-Tip® ERCP Catheter (GT) | |
| Glo-Tip® ERCP Catheter with Radiopaque Bands (GT) | |
| Fusion® ERCP Catheter with DomeTip® (FS-GT) | |
| Fusion® OMNI ERCP Catheter with DomeTip® (FS-GT) | |
| Glo-Tip II® Double Lumen ERCP Catheter (GT) | |
| Glo-Tip II® Double Lumen ERCP Catheter with | |
| Radiopaque Bands (GT) | |
| Haber RAMPTM Catheter (HRC) | |
| Soehendra® Universal Catheter (SUC) | |
| Common Name: | ERCP Catheters |
| Classification Name: | Endoscopic Retrograde Cholangiography (ERCP) Cannula; |
| ODD; Class II | |
| Regulation Number: | 21 CFR 876.1500 |
| Regulation Name: | Endoscope and accessories |
| Predicate Device: | Endoscopic Retrograde Cholangiography Catheter |
| (E.R.C.P): K851964, cleared June 13, 1985 |
Intended Use
This device is used for endoscopic cannulation of the ductal system. This device is indicated for adult use only.
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Image /page/4/Picture/0 description: The image shows the logo for Cook Medical. The word "COOK" is in large, white, sans-serif font on a red background. Below "COOK" is the word "MEDICAL" in a smaller, white, sans-serif font, also on a red background, but the background is shaped like a banner.
Device Description:
The subject devices consist of a catheter with a T-fitting, a Y-body connector, a hub, or a female luer lock on the proximal handle and 3 MM markings at the distal radiopaque tip.
The device distal tip configurations include stainless steel metal, tapered, dome and/or angled tips. ERCP catheters are available in single, double, or triple lumen configurations. All devices have an injection port/wire guide port. Some catheters include a stylet wire to facilitate advancement of the catheter, which is removed prior to wire guide insertion or contrast injection. ERCP catheters are used by passing the device through an endoscope. The injection port/wire guide port is then used to allow fluoroscopic visualization by injecting contrast and/or wire guide access to the desired duct.
Substantial Equivalence:
Minor changes were made to the predicate catheter cleared to market via K851964. Changes to the subject devices include: labeling to incorporate the addition of Instructions for Use with contraindications, catheter length, diameter, stylet wire material and size, type and number of radiopaque and ink markings, handle design, and number of lumens. The device is also now disposable, single use.
Performance Data:
Performance testing consisting of non-clinical bench testing demonstrates that the subject devices met the performance requirements to fulfill their intended uses. The results of this testing provide reasonable assurance that the subject devices will function as intended. The subject devices do not raise new questions of safety or effectiveness as compared to their respective predicate devices.
Summary of non-clinical testing:
The following non-clinical testing was conducted to demonstrate the performance of the subject device and confirmed that the subject device performs as intended.
- . Functional Age Testing
- Design Validation of Fluoroscopic Visibility ●
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Image /page/5/Picture/0 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is in large, white, sans-serif font, and the word "MEDICAL" is in a smaller, white, sans-serif font below the word "COOK".
- Force to Remove ERCP w/ Metal Tips from Ductal System
- . Radiopaque Band Detachment
- . Verification Testing Force to Peel Through
- Tensile Strength of Metal Tip to Catheter Joint ●
- Package Integrity
- EO Residual Testing .
Biocompatibility testing was performed in accordance with the FDA Guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices-Part I: Evaluation and testing within a risk management process."
Conclusion:
We believe that the subject ERCP catheters (ERCP, GT, FS-GT, HRC and SUC) are substantially equivalent to the predicate devices in terms of intended use, key operating principles, materials and technological characteristics. We consider the risks associated with the modifications to the subject devices to have been adequately addressed through our Design Control Processes and do not affect safety or effectiveness of the devices.