RESOLVE BILIARY DRAINAGE CATHETER

K063733 · Merit Medical Systems, Inc. · FGE · Nov 14, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K063733
• Device Name: RESOLVE BILIARY DRAINAGE CATHETER
• Applicant: Merit Medical Systems, Inc.
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Nov 14, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 Drainage Catheter is a single-lumen, biocompatible thermoplastic catheter designed for biliary drainage. Features include a distal pigtail tip with 17-18 drainage holes, a hydrophilic coating to reduce friction during placement, and a suture-based locking mechanism at the hub to maintain pigtail shape. Includes accessories for over-the-wire placement: metal stiffener, flexible plastic stiffener, straightener, and repositioning tool. A radiopaque marker band assists in positioning. Used by clinicians in a clinical setting to facilitate bile drainage; the locking mechanism allows for secure placement and subsequent repositioning or replacement via the repositioning tool.

Clinical Evidence

Bench testing only. Performance testing compared the ReSolve Biliary Drainage Catheter to the predicate device to establish substantial equivalence.

Technological Characteristics

Biocompatible thermoplastic catheter; single-lumen; 17-18 drainage holes; hydrophilic coating; suture-based pigtail locking mechanism; radiopaque marker band; over-the-wire placement accessories (metal/plastic stiffeners, straightener, repositioning tool).

Indications for Use

Indicated for drainage of bile 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

• UreSil Hydrophilic-coated Chole-Cath® Biliary Drainage Catheter (K981344)

Submission Summary (Full Text)

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# Merit Medical Systems, Inc. ReSolve® Biliary Drainage Catheter PREMARKET NOTIFICATION [510(k)] CONFIDENTIAL 510(k) Summary

Submitter

#### Establishment Registration Number

Contact Person(s) Primary Contact Person Title

> Phone Fax e-mail

Alternate Contact Person Title

Phone Fax e-mail

Date Prepared

Name of Medical Device

Classification Name: Common/Usual Name: Trade/Proprietary Name:

Device Classification

Panel: Device Class: Product Code: Regulation Number:

Predicate Device Identification

Device Brand Name

- Classification Name Device Class Classification Panel Number Product Code Clearance Status Manufacturer Registration Number ·
Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, Utah 84095-2416 USA

1721504

Amy McKinney Amy Mercimey
Merit Medical Systems, Inc. [e-mail]

William D. Jordan Senior Regulatory Affairs Specialist Merit Medical Systems, Inc. [phone] [phone] [e-mail]

December 15, 2006

Catheter, Biliary, Diagnostic (21 CFR 876.5010) Biliary Drainage Catheter ReSolve® Biliary Drainage Catheter

Gastroenterology - Urology Devices Class II FGE 21 CFR 876.5010

UreSil Hydrophilic-coated Chole-Cath® Biliary Drainage Catheter Catheter, Biliary, Diagnostic (21 CFR 876.5010) Class II 876 FGE K981344 Uresil L.P. 1450395

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# Merit Medical Systems, Inc. ReSolve® Biliary Drainage Catheter PREMARKET NOTIFICATION [510(k)] CONFIDENTIAL 510(k) Summary

## Device Description

The Resolve® Biliary Drainage Catheter consists of single lumen tubing with two suture holes and 17 to 18 drainage holes in the distal curve region. It is made from a biocompatible thermo-plastic. A hydrophilic coating reduces entry site/catheter friction during placement. The components of the catheter allow initial placement using an over-the-wire technique. These include a metal stiffener, flexible plastic stiffener, straightener and repositioning tool. The pigtail straightener is provided to assist in feeding the guide wire through the catheter. Once the catheter position is established in the area to be drained, the pigtail is formed by retracting a suture which is looped from the hib, to the catheter tip and 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 cather. A single reditorsale marker band is located proximal to the most proximal drainage hole to assist in accurate placement of the drainage holes in the biliary duct.

## Intended Use

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

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# Merit Medical Systems, Inc. ReSolve® Biliary Drainage Catheter PREMARKET NOTIFICATION [510(k)] CONFIDENTIAL 510(k) Summary

## Summary of Characteristics in Relation to the Predicate Device

## Does the new device have the same indication statement as the predicate device?

Yes.

Although there are minor differences, the intended use is the same.

#### Does the new device have the same technological characteristics, e.g., design, materials, etc. as the predicate device?

Yes.

The Resolve® Biliary Drainage Catheter employs a similar method of operation and design as compared to the predicate device. Both the new and predicate devices consist of a hub, shaft with pigtail tip, drainage holes on the distal end and a pigtail locking mechanism. Both the new and predicate devices are comprised of similar materials and are the same sizes.

## Are the descriptive characteristics precise enough to ensure equivalence to the predicate device?

No.

Bench testing was conducted on the Resolve® Biliary Drainage Catheter in order to establish substantial equivalence.

## Are performance data available to assess effects of the new device as compared to the predicate device?

Yes.

Performance testing was conducted according to international standards as well as Merit's in-house protocols. Where performance could affect the safety or effectiveness of the Resolve® Biliary Drainage Catheter, comparison tests with the predicate device was conducted.

#### Does performance data demonstrate equivalence?

Yes.

Performance data demonstrates that the Resolve® Biliary Drainage Catheter is substantially equivalent to the predicate device.

Conclusion: "Substantial Equivalence" Determination

Based on CDRH's substantial equivalence decision tree, the Resolve® Biliary Drainage Catheter is substantially equivalent to the predicate device.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized eagle symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The eagle symbol is composed of three curved lines that suggest the shape of an eagle's head and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# NOV 1 4 2007

Ms. Amy E. McKinney Regulatory Affairs Consultant Merit Medical Systems, Inc. 1111 South Velasco ANGLETON TX 77515

Re: K063733

Trade/Device Name: ReSolve Biliary Drainage Catheter Regulation Number; 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: October 31, 2007 Received: November 1, 2007

Dear Ms. McKinney:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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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 CFR Part 807); labeling (21 CFR Part 801); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Nancy Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Merit Medical Systems, Inc. ReSolve® Biliary Drainage Catheter PREMARKET NOTIFICATION [510(k)] CONFIDENTIAL

# INDICATION(S) FOR USE STATEMENT *

510(k) Number (if known):

Device Name:

ReSolve® Biliary Drainage Catheter

Indications for Use:

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

Prescription Use X (Part 21 CFR 901 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart O)

(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Helmut Rempel

(Division Sign-Off) (Division Sign-Olf)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number