COOK FORMULA 418 BILIARY STENT SYSTEM

K052539 · Cook, Inc. · FGE · Dec 9, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K052539
• Device Name: COOK FORMULA 418 BILIARY STENT SYSTEM
• Applicant: Cook, Inc.
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Dec 9, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cook® Formula 418™ Biliary Stent System is indicated for use in palliation of malignant neoplasms in the biliary tree.

Device Story

Balloon-expandable, stainless steel biliary stent premounted on delivery system. Used for palliation of malignant neoplasms in biliary tree. Available in 5-6 mm diameters and 12-30 mm lengths. Supplied sterile for single-use. Operated by clinicians in clinical settings. Stent provides mechanical support to maintain biliary patency. Clinical benefit includes symptom relief from malignant biliary obstruction. Labeling requires warning that safety/effectiveness for vascular use is not established.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included expansion force, compression force, dimensional, balloon burst, and deployment testing to ensure design and performance reliability.

Technological Characteristics

Balloon-expandable stainless steel stent. Premounted on delivery system. Diameters: 5-6 mm; Lengths: 12-30 mm. Sterile, single-use. Mechanical device.

Indications for Use

Indicated for palliation of malignant neoplasms in the biliary tree.

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

• Bridge FX (Bridge Assurant) Stent Delivery System (K011817)
• Palmaz Genesis Transhepatic Biliary Stent (K021345)
• Lifestent LP SDS Biliary Endoprosthesis (K023248)

Submission Summary (Full Text)

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Cook® Formula 418™ Biliary Stent System D.C. #K051785 Request for Additional Information

> DEC 9 2005

## 510(k) Summary

## Submitted By:

Karen Bradburn, RAC Senior Regulatory Affairs Specialist Cook Incorporated 750 Daniels Way, PO Box 489 Bloomington, IN 47402 812-339-2235 November 9, 2005

#### Device:

| Trade Name: | Cook® Formula 418™ Biliary Stent System |
|--------------------------|-----------------------------------------|
| Proposed Classification: | Catheter, Biliary Diagnostic |
| | FGE (21 CFR§876.5010) |

## Indications for Use

Indicated for use in palliation of malignant neoplasms in the biliary tree.

## Predicate Devices:

The Formula 418 Biliary Stent is similar in terms of intended use, principles of operation, materials of construction and technological characteristics to predicate devices reviewed as devices for palliation of malignant neoplasms in the biliary tree.

#### Device Description:

The Formula 418 Biliary Stent is a balloon-expandable, stainless steel stent which is premounted on the delivery system. The stent will be available in diameters of 5 and 6 mm and lengths of 12, 16, 20, 24 and 30 mm. This device will be supplied sterile and is intended for one-time use.

#### Substantial Equivalence:

The Formula 418 Biliary Stent is similar to many devices in commercial distribution for palliation of malignant neoplasms in the Biliary tree. These devices include the Formula 418™ Biliary Stent System (D.C. #K051785), Bridge FX (Bridge Assurant) Stent Delivery System (D.C. #K011817) stent, the Palmaz Genesis Transhepatic Biliary Stent (D.C. #K021345) and the Lifestent LP SDS Biliary Endoprosthesis (D.C. #K023248).

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Cook® Formula 418™ Biliary Stent System D.C. #K051785 Request for Additional Information

The similar indications for use, principles of operation, technological characteristics and performance testing results of the Formula 418 Biliary Stent as compared to the predicate devices support a determination of substantial equivalency.

## Test Data:

The Formula 418 Biliary Stent was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of:

- Expansion Force Testing 1.
- Compression Force Testing 2.
- Dimensional Testing 3.
- Balloon Burst Testing র্ধা
- Deployment Testing 5.

The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a biliary stent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

DEC - 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Karen Bradburn, RAC Senior Regulatory Affairs Specialist Cook Incorporated 750 Daniels Way P.O. Box 489 BLOOMINGTON IN 47402-0489

Re: K052539

Trade/Device Name: Cook® Formula 418™ Biliary Stent System Regulation Number: 21 CFR \$876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: November 9, 2005 Received: November 10, 2005

Dear Ms. Bradburn:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conninered pror to may 20, 1978, ac excordance with the provisions of the Federal Food, Drug, devices that have been roof our any, therefore, market the device, subject to the general controls and Cosment Friel (110). " Le limitations described below. The general controls provisions of the provisions of the for and the and al registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use doneo win be about to wor with Section 513(i)(1)(E) of the Act, the Act, the following limitation must appear in the Warnings section of the device's labeling:

The safety and effectiveness of this device for use in the vascular system have not been established.

Furthermore, the indication for biliary use must be prominently displayed in all labeling, i attremore), box, and carton labels, instructions for use, and other promotional materials, in close proximity to the trade name, of a similar point size, and in bold print.

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#### Page 2 – Ms. Karen Bradburn

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

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

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 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.

If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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/dsma/dsmamain.html.

Sincerely yours,

Wustam MD for

Dorma-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K052539

Device Name: Cook® Formula 418™ Biliary Stent System

FDA's Indications For Use:

The Cook® Formula 418™ Biliary Stent System is indicated for use in palliation of malignant neoplasms in the biliary tree.

Prescription Use X

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel la Logeman
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number_

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