Wilson-Cook Mini Basket

K182381 · Wilson-Cook Medical, Inc. · LQR · Oct 30, 2018 · Gastroenterology, Urology

Device Facts

• Record ID: K182381
• Device Name: Wilson-Cook Mini Basket
• Applicant: Wilson-Cook Medical, Inc.
• Product Code: LQR · Gastroenterology, Urology
• Decision Date: Oct 30, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Used for endoscopic removal of biliary stones, pancreatic stones, and foreign bodies.

Device Story

Wilson-Cook Mini Basket is a sterile, single-use endoscopic accessory; used for stone and foreign body retrieval in biliary and pancreatic ducts. Device comprises a helical monofilament metal wire basket, a 5 Fr PTFE catheter (200 cm total length), and a polycarbonate pin-vice handle. Operated by a physician through an endoscope accessory channel; basket is deployed to capture stones/foreign bodies for removal. Device is not compatible with mechanical lithotripters. Benefits include minimally invasive removal of obstructions, reducing need for more invasive surgical interventions.

Clinical Evidence

Bench testing only. Testing included stone and foreign body capture, tensile testing, functional testing, and shelf-life testing. Biocompatibility testing performed per ISO 10993-1:2009.

Technological Characteristics

Materials: Monofilament metal wire (basket), PTFE (catheter), polycarbonate/acetal (handle). Dimensions: 5 Fr diameter, 200 cm total length, 182 cm working length. Design: Helical basket, pin-vice handle. Energy: Manual mechanical actuation. Sterilization: Sterile, single-use. Connectivity: None.

Indications for Use

Indicated for patients requiring endoscopic removal of biliary stones, pancreatic stones, and foreign bodies.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Non-Lithotripsy Extraction Basket (K171969)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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

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# 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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#### 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: [phone] ext.396680 Contact Fax Number: [phone]

# 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.

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# 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.