Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Memory 5 Fr. Soft Wire Baskets or Memory Helical Stone Extractor, Memory Eight Wire Baskets or Memory Hard Wire Baskets, Fusion Wire Guided Extraction Basket, Non-Lithotripsy Extraction Basket

K171969 · Wilson-Cook Medical, Inc. · LQR · Mar 28, 2018 · Gastroenterology, Urology

Device Facts

• Record ID: K171969
• Device Name: Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Memory 5 Fr. Soft Wire Baskets or Memory Helical Stone Extractor, Memory Eight Wire Baskets or Memory Hard Wire Baskets, Fusion Wire Guided Extraction Basket, Non-Lithotripsy Extraction Basket
• Applicant: Wilson-Cook Medical, Inc.
• Product Code: LQR · Gastroenterology, Urology
• Decision Date: Mar 28, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Endoscopic removal of stones in the biliary system and foreign bodies.

Device Story

Non-Lithotripsy Extraction Basket is a sterile, single-use device for endoscopic removal of biliary stones and foreign bodies. Device comprises a basket, catheter, and handle. Basket, made of monofilament or multifilament metal wires, is advanced from and retracted into a polytetrafluoroethylene (PTFE) catheter sheath via a handle-mounted actuator. Used in clinical settings by physicians during endoscopic procedures. Device is inserted through the accessory channel of an endoscope. Physician manipulates the handle to deploy the basket, capture the stone or foreign body, and withdraw it. Benefits include minimally invasive retrieval of biliary obstructions. Device is not compatible with mechanical lithotripters.

Clinical Evidence

Bench testing only. Testing included stone and foreign body capture, tensile testing, flexibility testing, and post-aging functional testing. Biocompatibility, sterilization, and shelf-life validation were also performed.

Technological Characteristics

Sterile, single-use biliary catheter. Components: metal wire basket (monofilament/multifilament), PTFE catheter sheath, handle actuator. Mechanical operation via manual handle manipulation. Dimensions and materials vary by model. Not compatible with mechanical lithotripsy. No software or electronic components.

Indications for Use

Indicated for endoscopic removal of stones in the biliary system and foreign bodies in patients requiring such procedures.

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

• Wilson-Cook Stone Extractor (K851965)

Submission Summary (Full Text)

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March 28, 2018

Wilson-Cook Medical, Inc. Ashley Howard Specialist I - Regulatory Affairs 4900 Bethania Station Road Winston-Salem, NC 27105

Re: K171969

Trade/Device Name: Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Memory 5 Fr. Soft Wire Baskets or Memory Helical Stone Extractor, Memory Eight Wire Baskets or Memory Hard Wire Baskets, Fusion Wire Guided Extraction Basket. Non-Lithotripsy Extraction Basket Regulation Number: 21 CFR§ 876.5010 Regulation Name: Biliary Catheter and Accessories

Regulatory Class: II Product Code: LOR Dated: February 13, 2018 Received: February 14, 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) 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 mediation-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,

Joyce M. Whang -S

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)

K171969

#### Device Name

Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Memory 5 Fr. Soft Wire Baskets or Memory Helical Stone Extractor, Memory Eight Wire Baskets or Memory Hard Wire Guided Extraction Basket, Non-Lithotripsy Extraction Basket

#### Indications for Use (Describe)

Endoscopic removal of stones in the biliary system 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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# Non-Lithotripsy Extraction Basket

510(k) Premarket Notification June 30, 2017

# Applicant Information

| Applicant: | Wilson-Cook Medical, Inc. / Cook Endoscopy<br>4900 Bethania Station Road<br>Winston-Salem, North Carolina 27105 |
|------------|-----------------------------------------------------------------------------------------------------------------|
| Contact: | Ashley Howard, Specialist I – Regulatory Affairs |
| Phone: | [phone] ext. 6174 |
| Fax: | [phone] |

### Device Information

| Trade Name: | Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Memory 5 Fr. Soft Wire Baskets or Memory Helical Stone Extractor, Memory Eight Wire Baskets or Memory Hard Wire Baskets, Fusion Wire Guided Extraction Basket, Non-Lithotripsy Extraction 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: | Wilson-Cook Stone Extractor |
|----------------|-----------------------------|
| 510(k) Number: | K851965 |
| Date: | Cleared July 29, 1985 |

### Device Description

The Non-Lithotripsy Extraction Basket is a sterile, single use device compatible with the accessory channel of endoscopes. The device consists of basket, catheter, and handle components. The basket component is constructed of monofilament or multifilament metal wires joined at the distal and proximal ends, and is advanced out of and retracted into the single or double lumen polytetrafluoroethylene catheter sheath using the handle component's actuator. The device is not compatible with any mechanical lithotripter.

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Image /page/4/Picture/0 description: The image shows the Cook Medical logo. The logo is set against a red background. The word "COOK" is in large, white, sans-serif font, with the registered trademark symbol to the right. Below "COOK" is a smaller red rectangle with the word "MEDICAL" in white, sans-serif font.

K171969

### Intended Use

Endoscopic removal of stones in the biliary system and foreign bodies.

# Comparison to Predicate Device

The Non-Lithotripsy Extraction Basket has the same principles of operation and fundamental technologies as the predicate device. Changes to the subject device include labeling to incorporate the addition of Instructions for Use with contraindications, dimensions, materials, handle configuration, and an expanded indication for use. These changes do not raise new questions of safety or effectiveness.

# Performance Data and Non-Clinical Testing

Performance testing consisting of sterilization, shelf life, biocompatibility, and nonclinical bench testing demonstrate that the Non-Lithotripsy Extraction Basket meets the performance criteria required to fulfill the intended use of the device. The following summarizes the non-clinical bench testing conducted:

- Stone and Foreign Body Capture Testing ●
- . Tensile Testing
- Flexibility Testing
- Post-Aging Functional Testing ●

### 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.