CORDIA PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, MODEL PC125BPS, PC126BPS, PC127BPS,PC128BPS, PC

K990631 · Cordis Corp. · FGE · Apr 30, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K990631
• Device Name: CORDIA PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, MODEL PC125BPS, PC126BPS, PC127BPS,PC128BPS, PC
• Applicant: Cordis Corp.
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Apr 30, 1999
• Decision: SESU
• Submission Type: Traditional
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent and Delivery System is intended for use in the palliation of malignant neoplasms in the biliary tree.

Device Story

The Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent and Delivery System is a balloon-expandable, stainless steel stent mounted on a balloon catheter delivery device. The system is advanced over a guidewire through a sheath lumen to an obstruction site within the biliary tree. Once positioned, the balloon is inflated to expand the stent, then deflated and removed, leaving the stent in place to maintain patency. The device is intended for single use and is provided sterile. It is operated by clinicians in a clinical setting to provide palliative treatment for malignant biliary neoplasms. The device benefits patients by relieving biliary obstructions caused by malignancies.

Clinical Evidence

No clinical data. Safety and effectiveness were demonstrated via nonclinical design verification tests and analyses.

Technological Characteristics

Balloon-expandable stainless steel stent; mounted on balloon catheter delivery system. Stent lengths: 12-18 mm; expanded diameters: 5-8 mm. Sterile, single-use. Mechanical deployment via balloon inflation.

Indications for Use

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

• Cordis PALMAZ Balloon-Expandable Stents (K905720)
• Cordis PALMAZ Balloon-Expandable Stents (K911581)
• Cordis PALMAZ Balloon-Expandable Stents (K964688)

Submission Summary (Full Text)

{0}------------------------------------------------

K990631

4/30/99

510(K) Summary of Safety and Effectiveness

Vage 1/3

| Submitter: | Cordis Corporation, a Johnson & Johnson Company<br>40 Technology Drive<br>Warren, New Jersey 07059 | |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|
| | Telephone:<br>Fax: | [phone]<br>[phone] |
| Contact Person: | Charles J. Ryan<br>Manager, Regulatory Affairs<br>Cordis Corporation, a Johnson & Johnson Company<br>40 Technology Drive<br>Warren, New Jersey 07059 | |
| | Telephone:<br>Fax: | [phone]<br>[phone] |
| Date Prepared: | April 28, 1999 | |
| Trade Name: | Cordis PALMAZ CORINTHIAN Transhepatic Biliary<br>Stent and Delivery System | |
| Common Name: | Biliary Stent and Delivery Catheter | |
| Classification Name: | Biliary Catheter and Accessories (per 21 CFR 876.5010) | |
| Device Classification: | Class II | |

# Summary of Substantial Equivalence:

The design, matcrial, components, method of delivery, fundamental technology and I ne design, matchar, ochiponialer, ins PALMAZ CORINTHIAN Transhepatic Biliary Stent and Delivery System are substantially equivalent to those featured among Occh and Dollvory Bytiell are accosses 110(k) #K905720, #K911581, and #K964688).

In short, the Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent and Delivery In short, the Cordis I Hillian Ocean the predicate Cordis PALMAZ Balloon-Expandable Stents (510(k) #K911581).

{1}------------------------------------------------

## Device Description:

The Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent and Delivery System is a balloon-expandable, stainless steel stent that is provided mounted upon its balloon catheter delivery device. The Cordis PowerFlex Plus Balloon Catheters are used for the delivery of the Cordis PALMAZ CORINTHIAN Transhepatic Billiary Stant as to balloon catheters are substantially equivalent to the balloon catheter delivery devices used with the aforementioned predicate Cordis metal biliary stents.

The Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent and Delivery System is advanced over a guidewire through a sheath lumen to an obstruction site in the biliary tree where the balloon is then inflated to expand the stent. After full expansion of the stent, the balloon is then deflated and removed

The Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent and Delivery System is provided sterile and is intended for single use only.

#### Intended Use:

The Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent and Delivery System is intended for use in the palliation of malignant neoplasms in the biliary tree.

## Technological Characteristics:

The Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent and Delivery System incorporates the same method of deployment, materials, fundamental technology and intended use as those found among predicate Cordis metal billiary stent products (see 510(k) #K905720, #K911581 and #K964688). The Cordis PALMAZ CORINTHIAN Transhepatic Billiary Stent and Delivery System incorporates a modified stent design that is substantially equivalent to that found with predicate Cordis metal biliary stents.

The Cordis PALMAZ CORINTHIAN Stent is provided in a range of nominal, unexpanded lengths from 12 to 18 mm and in a range of expanded diameters from 5 to 8 mm.

#### Performance Data:

The safety and effectiveness of the Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent and Delivery System have been demonstrated via data collected from nonclinical design verification tests and analyses.

{2}------------------------------------------------

A statement of substantial equivalence to another product is required by 21 CFR 807.87 and relates only to whether the product can be marketed without Prior reclassification or clinical approval. The proceet submission is therefore not related to the coverage of any patent and is not to be interpreted as an admission or used as evidence in a patent infringement lawsuit. As the commissioner of the stated, "A determination of substantial equivalence under the Federal Food, Drug and Cosmetic Act related to the fact that the product can be lawfully marketed without pre-market approval or reclassification. This determination is not intended to have any bearing whistsoever on the resolution of patent infringement suits." 42 Federal Register 42, 5

tage 3/3

1990631

{3}------------------------------------------------

Public Health Service

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features an abstract image of an eagle. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the top half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 3 0 1999

Mr. Chuck Ryan Manager, Regulatory Affairs Cordis, a Johnson & Johnson Company 40 Technology Drive Warren, New Jersey 07059

K990631 Re:

K990631
Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent and Delivery System Regulatory Class: II 21 CFR 876.5010 Product Code: 78 FGE Dated: March 31, 1999 Received: April 1, 1999

Dear Mr. Ryan:

We have reviewed your Section 510(k) notification of intent to market the device referenced We have reviewed your Secuon > IV(K) notincation of the indications for use indications for use above and we have determined the uevice is subsited in interstate commence
stated in the enclosure) to legally marketed prodical Parise Amendments, or to devices th stated in the enclosure) to legally marketed predical Device Amendments, or to devices that
prior to May 28, 1976, the enactment and wiss a stre Federal Hood Drug, and prior to May 28, 1976, the enactment use or the Provisions of the Federal Food, Drug, and have been reclassified in accordance with the provisions, subject to the general controls provisions Cosmetic Act (Act). You may, deletote, marked below. The general colorols provisions of the provisions of the Act and the inmultions described of devices, good manufacturing practice,
Act include requirements for annual registration, listing of devices, Act merude requirements against misbranding and adulteration.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this The Office of Device Evanuation has decemined the proposed labeling and that such use device will be used for an intended use hot tacititive in as p(i)(1)(E) of the Act, the following
could cause harm. Therefore, in accordance with Section in the Act, the fol Could Cause marm: " earlings 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, Furthermore, the indication for othary use must be provincies and other promotional materials, in
including pouch, box, and carton labels, instructions for use, and other pro meluding pouch, 00%, and carton itsels, interest, and in bold print.

{4}------------------------------------------------

Page 2 - Mr. Chuck Ryan

If your device is classified (see above) into cither class II (Special Controls) or class III If your device is classified (Scc above) into onthols. Existing major regulations (Premarket Apploval), it may of subject to aden frontal Regulations, Title 21, Parts 800 to 895. affecting your device can or round intinues compliance with the Current Good A substantially Equivalent mintenents, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to mspections, the rood and Drug Trainmesult in regulatory action. In addition, FDA may publish comply with the GMT regulation may result in the Federal Register. Please note: this response to your premarks octification submission does not affect any obligation you might response to your promations and of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device The FDA Inding Of Substantial equivalence or your device to proceed to the market. This results in a classified.com for your device as described in your 510(k) premarket notification if the limitation statement above is added to your labeling, as described.

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. I teast note that the above racomig manuse these limitations are modified in any way or removed from the device's labeling.

If you desire specific information about the application of other labeling requirements to your If you desire specific information as our of on in vitro diagnostic devices), please contact device (21 OF R Part 001 and 2011) 594-4616. Additionally, for questions on the promotion and the Office of Comphance at (201) 57 + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + please note the regulation entitled, "Misbranding by reference to premarket notification" prease note the regalation on your responsibilities under the Act may be (21 Cr K 60). The Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Susan Abert, Ph.D., M.D.

. Ph.D., M.D. Susan A Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

510(k) Number (if known): K990631

Device Name: _Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent and Delivery System

FDA's Statement of the Indications For Use for device:

The Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent and Delivery System is indicated for the palliation of malignant neoplasms in the biliary tree.

Prescription Use V_ OR (Per 21 CFR 801.109)

Over-The-Counter Use_

David M. Heggem

Abdominal. 510(k) Number