Fusion Quattro Extraction Balloon

K200247 · Wilson-Cook Medical, Inc. · GCA · Feb 27, 2020 · Gastroenterology, Urology

Device Facts

• Record ID: K200247
• Device Name: Fusion Quattro Extraction Balloon
• Applicant: Wilson-Cook Medical, Inc.
• Product Code: GCA · Gastroenterology, Urology
• Decision Date: Feb 27, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is used for endoscopic removal of stones in the biliary system and for contrast injection.

Device Story

Fusion Quattro Extraction Balloon is a biliary catheter used for stone removal and contrast injection. Device consists of a latex balloon mounted on a 200 cm, 6.6 Fr nylon triple-lumen catheter. Features include radiopaque bands for fluoroscopic visualization and black ink markings for direct visualization. Injection port located above or below the balloon depending on model. Operated by clinicians during endoscopic procedures. Balloon inflates to four diameters: 8.5 mm, 10 mm, 12 mm, and 15 mm. Device facilitates stone extraction and contrast delivery to the biliary system, aiding in therapeutic biliary interventions.

Clinical Evidence

Bench testing only. Testing included design verification, dimensional verification, functional testing, and fluoroscopic visibility assessment to confirm performance requirements were met.

Technological Characteristics

Latex balloon; nylon triple-lumen catheter (6.6 Fr, 200 cm length). Features radiopaque bands for fluoroscopic visualization and black ink markings. Multi-diameter inflation capability (8.5 mm, 10 mm, 12 mm, 15 mm).

Indications for Use

Indicated for patients requiring endoscopic removal of biliary stones and contrast injection in the biliary system.

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

• Fusion Quattro Extraction Balloons XL (K063677)

Submission Summary (Full Text)

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February 27, 2020

Wilson-Cook Medical, Inc Tiffanny Thomas Global Regulatory Affairs Specialist 4900 Bethania Station Road Winston-Salem, NC 27105

Re: K200247

Trade/Device Name: Fusion Quattro Extraction Balloon Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary Catheter and Accessories Regulatory Class: II Product Code: GCA Dated: January 30, 2020 Received: January 31, 2020

Dear Tiffanny 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 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 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

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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) for devices or postmarketing safety reporting (21 CFR 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 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Daniel G. Walter, Jr. 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

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# Indications for Use

510(k) Number (if known) K200247

Device Name Fusion Quattro Extraction Balloon

Indications for Use (Describe)

This device is used for endoscopic removal of stones in the biliary system and for contrast injection.

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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#### 510(k) Summary

| Name:<br>Address: | Wilson-Cook Medical, Inc. /Cook Endoscopy<br>4900 Bethania Station Road<br>Winston-Salem, North Carolina 27105 |
|----------------------|----------------------------------------------------------------------------------------------------------------|
| Phone:<br>Fax: | [phone]<br>[phone] |
| Contact: | Tiffanny A. Thomas, Global Regulatory Affairs Specialist<br>Theresa de Prat, Regulatory Affairs Specialist II |
| Date: | January 30, 2020 |
| Trade Names: | Fusion Quattro Extraction Balloon |
| Common Name: | Extraction Balloon |
| Classification Name: | Biliary Catheter and Accessories |
| | 21 CFR §876.5010, GCA, Class II |
| Predicate Devices: | Fusion Quattro Extraction Balloons XL K063677, cleared January 5, 2007 |

Intended Use: This device is used for endoscopic removal of stones in the biliary system and for contrast injection.

## Device Description:

The subject device is composed of a latex balloon mounted at the distal end of a nylon triple lumen catheter. The balloon can be inflated to four sizes: 8.5 mm, 10 mm, and 15 mm diameters. Radiopaque bands are placed on the catheter to provide fluoroscopic visualization of the catheter and balloon location. The nylon catheter length is 200 cm with a diameter of 6.6 Fr. There is an injection port on the catheter either above the balloon or below the balloon depending on the device model. The catheter also has black ink markings for direct visualization.

#### Substantial Equivalence:

A minor design change was made to the predicate Fusion Quattro Extraction Balloon XL cleared to market via K063677. The modification is a design change to include a balloon with inflation diameters of 8.5 mm, 10 mm, 12 mm, and 15 mm. The modification does not result in a change of intended use. Both the subject device and the predicate device are used for endoscopic removal of stones in the biliary system and for contrast injection.

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## Performance Data:

Performance testing consisting of non-clinical bench testing demonstrates the subject device met the performance requirements to fulfill the intended use. This testing provides reasonable assurance that the subject device will function as intended. The subject device does not raise new questions of safety or effectiveness as compared to the predicate device.

### Summary of non-clinical testing:

The following non-clinical testing was conducted to demonstrate the performance of the subject device and confirms that the subject device performs as intended.

- . Design Verification Testing
- . Dimensional Verification
- Functional Testing ●
- Fluoroscopic Visibility .

## Conclusion:

We believe that the subject device is substantially equivalent to the predicate device with respect to intended use, key operating principles, materials of construction, and technological characteristics. We consider the risks associated with the modifications to the subject device to have been adequately addressed through our Design Control Processes, evaluated through a well-established method, and do not affect the safety or effectiveness of the device.