(60 days)
Not Found
No
The device description and performance studies focus on mechanical components and basic functional testing, with no mention of AI, ML, or image processing.
No
Explanation: This device is used for the endoscopic removal of stones and foreign bodies, which is an interventional procedure rather than a therapeutic treatment in itself. Its function is to extract obstructions, not to treat a disease or condition therapeutically.
No
The device is used for endoscopic removal of stones and foreign bodies, indicating a therapeutic or interventional purpose rather than a diagnostic one. Its description focuses on extraction mechanisms (basket, catheter), not on identifying or assessing medical conditions.
No
The device description explicitly details physical components (basket, catheter, handle) made of materials like metal wires, PTFE, and polycarbonate, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the physical removal of stones and foreign bodies from the biliary and pancreatic ducts using an endoscopic basket. This is a therapeutic procedure performed in vivo (within the body).
- Device Description: The description details a mechanical device (basket, catheter, handle) designed for physical manipulation and extraction.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, tissue, or other bodily fluids) to provide diagnostic information about a patient's condition. IVDs are used to perform tests in vitro (outside the body) to diagnose diseases or conditions.
Therefore, this device falls under the category of a therapeutic medical device used for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Used for endoscopic removal of biliary stones, pancreatic stones, and foreign bodies.
Product codes
LQR
Device Description
The Wilson-Cook Mini Basket Extraction Basket is a sterile, single use device used through the accessory channel of endoscopes. The device consists of basket, catheter, and handle components. The basket component is constructed of monofilament metal wires and a helical design. The catheter is 200 cm in total length with a working length of 182 cm and 5 Fr diameter. The catheter is composed of Polytetrafluoroethylene (PTFE). The handle is a pin-vice design composed of polycarbonate with an acetal side arm fitting. The device is not compatible with any mechanical lithotripter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary, pancreatic
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
The following performance testing was conducted to demonstrate the basic performance of the subject device and confirmed that the subject device performs as intended.
- Stone and Foreign Body Capture Testing .
- Tensile Testing .
- . Functional Testing
- Shelf Life Testing .
Biocompatibility testing was performed in accordance with the FDA Guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process" and per ISO 10993-1:2009, Biological evaluation of medical devices- Evaluation and testing within 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
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.
October 30, 2018
Wilson-Cook Medical, Inc. Tiffanny A. Thomas Global Regulatory Affairs Specialist 4900 Bethania Station Road Winston-Salem, NC 27105
Re: K182381
Trade/Device Name: Wilson-Cook Mini Basket Regulation Number: 21 CFR§ 876.5010 Regulation Name: Biliary Catheter and Accessories Regulatory Class: II Product Code: LQR Dated: August 30, 2018 Received: August 31, 2018
Dear Tiffanny A. Thomas:
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 mav, 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 avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located 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.
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.
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 4, Subpart A) for combination products; 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 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,
Image /page/1/Picture/7 description: The image shows the FDA logo on the left side. On the right side, the text "Jeffrey W. Cooper -S 2018.10.30 15:35:40 -04"" is displayed. The text appears to be a signature or timestamp associated with the FDA logo.
for 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) K182381
Device Name Wilson-Cook Mini Basket
Indications for Use (Describe)
Used for endoscopic removal of biliary stones, pancreatic stones, and foreign bodies.
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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3
Submitted By:
Submission: Applicant: Contact: Applicant Address:
Traditional 510(k) Premarket Notification Wilson-Cook Medical, Inc. / Cook Endoscopy Tiffanny A. Thomas Wilson-Cook Medical, Inc. / Cook Endoscopy 4900 Bethania Station Road Winston-Salem, North Carolina 27105
Contact Phone Number: (336) 744-0157 ext.396680 Contact Fax Number: (336) 201-5994
Device Information
| Trade Name: | Wilson-Cook Mini Basket |
|---|---|
| Common Name: | Dislodger, Stone, Biliary |
| Classification Name: | Biliary Catheter and Accessories |
| Regulation Number: | 21 CFR 876.5010, |
| Product Code: | LQR |
| Device Class: | Class II |
| Review Panel: | Gastroenterology-Urology |
Predicate Device
| Name: | Non-Lithotripsy Extraction Basket |
|---|---|
| 510(k) Number: | K171969 |
| Date: | Cleared March 28, 2018 |
Device Description
The Wilson-Cook Mini Basket Extraction Basket is a sterile, single use device used through the accessory channel of endoscopes. The device consists of basket, catheter, and handle components. The basket component is constructed of monofilament metal wires and a helical design. The catheter is 200 cm in total length with a working length of 182 cm and 5 Fr diameter. The catheter is composed of Polytetrafluoroethylene (PTFE). The handle is a pin-vice design composed of polycarbonate with an acetal side arm fitting. The device is not compatible with any mechanical lithotripter.
Intended Use
Used for endoscopic removal of biliary stones, pancreatic stones, and foreign bodies.
4
Comparison to Predicate Device
The Wilson-Cook Mini Basket Extraction Basket has the same principles of operation, direct patient contacting materials and fundamental technology as the predicate device. The modifications to the subject device include a more specific intended use, a smaller catheter diameter, dimensional changes to the basket and material change on the injection hub/side arm fitting. These changes do not raise new questions of safety or effectiveness.
Summary of Non-Clinical Testing
The following performance testing was conducted to demonstrate the basic performance of the subject device and confirmed that the subject device performs as intended.
- Stone and Foreign Body Capture Testing .
- Tensile Testing .
- . Functional Testing
- Shelf Life Testing .
Biocompatibility testing was performed in accordance with the FDA Guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process" and per ISO 10993-1:2009, Biological evaluation of medical devices- Evaluation and testing within risk management process.
Conclusion
We believe the risks associated with the modifications to the subject device were adequately addressed through our Design Control Processes and do not affect safety or effectiveness of the device. The information and data contained in this notification supports a determination of substantial equivalence.