RESOLVE BILIARY LOCKING DRAINAGE CATHETER

K141408 · Merit Medical Systems, Inc. · FGE · Nov 26, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K141408
• Device Name: RESOLVE BILIARY LOCKING DRAINAGE CATHETER
• Applicant: Merit Medical Systems, Inc.
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Nov 26, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The ReSolve® Biliary Drainage Catheter with locking pigtail and hydrophilic coating is used for drainage of bile within the biliary system.

Device Story

ReSolve Biliary Locking Drainage Catheter is a single-lumen polyurethane catheter used for biliary drainage. Device features a locking pigtail mechanism, hydrophilic coating to reduce friction, and radiopaque marker band for placement. Includes accessories: metal/flexible stiffening cannulas, pigtail straightener, repositioning tool, and dead-end cap. Used by clinicians in clinical settings for percutaneous biliary drainage via over-the-wire technique. Catheter position established; pigtail formed by retracting internal suture; hub locks suture to maintain shape. Repositioning tool allows unlocking for adjustment or replacement. Printed shaft markings assist depth assessment. Device facilitates bile flow, relieving biliary obstruction. Supplied sterile, single-use.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing included cyclic fatigue, tensile testing, flow testing, kink testing, tip penetration, hub leak/ingress, guide wire passage, and hydrophilic coating adherence. Biocompatibility testing included cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity, genotoxicity, and implantation per USP standards.

Technological Characteristics

Single-lumen polyurethane catheter; 8.5F-14F sizes; 40cm length. Features hydrophilic coating, locking pigtail mechanism, and radiopaque marker band. Includes metal/flexible stiffening cannulas, pigtail straightener, and repositioning tool. Sterilized, single-use. Complies with USP <151> (pyrogen) and USP <661> (plastics).

Indications for Use

Indicated for patients requiring biliary drainage within 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

• ReSolve® Biliary Locking Drainage Catheter (K121832)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 26, 2014

Merit Medical Systems, Inc. Glenn Norton Vice President, Regulatory Affairs 1600 West Merit Parkway South Jordan, UT 84095

Re: K141408

> Trade/Device Name: ReSolve® Biliary Locking Drainage Catheter Regulation Number: 21 CFR 876.5010 Regulation Name: Gastroenterology and Urology Regulatory Class: Class II Product Code: FGE Dated: October 27, 2014 Received: May 28, 2014

Dear Clea Feight:

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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21

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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Herbert P. Lerner -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)

K141408

Device Name ReSolve Biliary Locking Drainage Catheter

Indications for Use (Describe)

The ReSolve Biliary Drainage Catheter with locking pigtail and hydrophilic coating is used for drainage of bile within the biliary system.

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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## 5.0 510(k) Summary

| General Provisions | Submitter Name: | Merit Medical Systems, Inc. |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|
| | Address: | 1600 West Merit Parkway<br>South Jordan, UT 84095 |
| | Telephone Number: | [phone] |
| | Fax Number: | [phone] |
| | Contact Person: | Clea Feight |
| | Date of Preparation: | May 27, 2014 |
| | Registration Number: | 1721504 |
| Subject Device | Trade Name: | ReSolve® Biliary Locking Drainage<br>Catheter |
| | Common/Usual Name: | Biliary Drainage Catheter |
| | Classification Name: | Catheter, Biliary, Diagnostic |
| Predicate Device | Trade Name: | ReSolve® Biliary Locking Drainage<br>Catheter |
| | Classification Name: | Catheter, Biliary, Diagnostic |
| | Premarket Notification: | K121832 |
| | Manufacturer: | Merit Medical Systems, Inc. |
| Classification | Class II<br>21 CFR § 876.5010<br>FDA Product Code: FGE<br>Review Panel: Gastroenterology and Urology | |
| Intended Use | The ReSolve® Biliary Drainage Catheter with locking pigtail and<br>hydrophilic coating is used for drainage of bile within the biliary<br>system. | |

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The ReSolve® Biliary Locking Drainage Catheter consists of single lumen tubing with 17 to 18 drainage holes (depending on the French size of the catheter) and a single dedicated suture hole. One of the drainage holes doubles as a suture hole. The tubing is made from a polyurethane material. A hydrophilic coating reduces entry site/catheter friction during placement. The catheter is offered in two drainage hole configurations. The RBC (long) configuration has a lesion gap (distance between the proximal pigtail and the distal shaft drainage hole) of 5 cm. The RBDC (standard) has a lesion gap of 2 cm. The components of the catheter allow initial placement using an over-the-wire technique. These include a metal stiffening cannula, flexible stiffening cannula, pigtail straightener and repositioning tool. The hubs of the flexible and metal stiffening cannula are color coded for catheter French size identification. The pigtail straightener is provided to assist in feeding the guide wire through the catheter. A dead end cap is included to prevent fluid from exiting the catheter after placement. Once the catheter position is established in the area to be drained, the Device Description pigtail is formed by retracting a suture which is looped from the hub to catheter tip then back to the hub. The hub incorporates a suture locking mechanism to retain the distal pigtail shape. It may be unlocked using the repositioning tool to allow repositioning or replacement of the catheter. A single radiopaque marker band is located proximal to the most proximal drainage hole to assist in accurate placement of the drainage holes in the biliary duct. In addition, the shaft of the catheter is printed with markings for the clinician to determine how deep the catheter is in the patient. The catheter is available in the same sizes 8.5F, 10F, 12F, and 14F with the same useable length, 40 cm, as the predicate device. The ReSolve® Biliary Locking Drainage Catheter is a single use device that is supplied sterile and non-pyrogenic. The device is marketed with the following components, depending on the product configuration: StayFIX® or Revolution™ catheter securement device.

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| | The technological characteristics of the subject ReSolve® Biliary<br>Locking Drainage Catheter are substantially equivalent to those<br>of the predicate device. The subject device has the same basic<br>design as the predicate device in that it consists of single lumen<br>tubing with drainage holes, hub, and suture locking mechanism<br>and is provided with a metal stiffening cannula, flexible stiffening<br>cannula, pigtail straightener, repositioning tool and dead end<br>cap. The ReSolve® Biliary Locking Drainage Catheter is similar<br>in clinical use and function to the predicate ReSolve® Biliary<br>Locking Drainage Catheter. |
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| Comparison to<br>Predicate Device | The main difference is in the catheter shaft material and that the<br>subject device is coated with a different hydrophilic coating on<br>the outer surface of the catheter tubing. In addition, printed<br>depth markings have been added to the catheter shaft and the<br>location of the drainage holes has been modified to standardize<br>the gap between the pigtail and the shaft holes (RBC versus<br>RBDC) across all French sizes with adjustment of the marker<br>band location to account for this change. The geometry of the<br>tip has been modified slightly to have a longer taper. |
| | Minor changes have also been made to the colorant formulation<br>(color additives) used in molding three of the accessory<br>components of the device due to discontinuation notices from<br>suppliers. |

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- United States Pharmacopeia Section <151>, USP 36 . Pyrogen Testing, 2013-12-01
- o United States Pharmacopeia Section <661>, USP 36 Physiochemical Tests for Plastics

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| Safety &<br>Performance Tests<br>cont.<br>Performance Testing-Bench Cyclic Fatigue Testing Material Improvement Chemical Testing Optical Density/Radio-detectability Curve Shape Visual Product Dimensions – Useable Length Product Dimensions – Marker Band to Pigtail Distance Product Dimensions – Distal Shaft Hole to Pigtail Distance Marker Band/Proximal Hole Location Punched Holes Orientation and Number of Holes Hydrophilic Coating Coverage/Adherence and Length Guide Wire Passage Test Flow Testing Pigtail Pull Test Tip Penetration Test Cannula and Stiffener Insertion Test Tip Geometry Drainage Hole Tensile Test Catheter Collapse Tubing Kink Testing Hub Leak/Liquid Ingress Test Hub Tensile Test Marker Band Transition Ink Adherence 14F Metal and Plastic Stiffening Cannula Hub Tensile Test and Visual Inspection Pigtail Straightener Test<br>Biocompatibility Cytotoxicity Sensitization Irritation Acute Systemic Toxicity Pyrogenicity Genotoxicity Implantation Chemical Characterization | Summary of<br>Substantial<br>Equivalence<br>Based on the indications for use, design, safety and<br>performance testing, the subject ReSolve® Biliary Locking<br>Drainage Catheter meets the requirements that are considered<br>essential for its intended use and is substantially equivalent to<br>the predicate device, the ReSolve® Biliary Locking Drainage<br>Catheter, K131832. |
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