MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT
Device Facts
| Record ID | K020809 |
|---|---|
| Device Name | MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT |
| Applicant | Cordis Corp. |
| Product Code | FGE · Gastroenterology, Urology |
| Decision Date | Apr 12, 2002 |
| Decision | SESU |
| Submission Type | Special |
| Regulation | 21 CFR 876.5010 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent is indicated for the palliation of malignant neoplasms in the biliary tree.
Device Story
The Cordis PALMAZ GENESIS Transhepatic Biliary Stent is a balloon-expandable, stainless steel stent designed for the biliary tree. It is provided unmounted and is intended for single use. The device is hand-crimped onto a recommended balloon catheter delivery system (e.g., Cordis OPTA PRO). The assembly is advanced over a guidewire through a sheath lumen using a metal introducer tube to the biliary obstruction site. The balloon is inflated to expand the stent, then deflated and removed. The procedure is performed by a clinician. The stent provides mechanical support to maintain biliary patency in patients with malignant neoplasms, facilitating bile flow and palliating symptoms. The device is sterilized via gamma irradiation.
Clinical Evidence
Bench testing only. Safety and effectiveness were demonstrated via non-clinical design verification tests and analyses.
Technological Characteristics
Balloon-expandable stainless steel stent. Nominal unexpanded lengths: 19-59 mm; expanded diameters: 10-12 mm. Delivered via balloon catheter and metal introducer tube. Sterilized via gamma irradiation. Single-use.
Indications for Use
Indicated for the palliation of malignant neoplasms in the biliary tree. No specific age or gender restrictions provided.
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 GENESIS Transhepatic Biliary Stent (K012090)
- Cordis PALMAZ GENESIS Transhepatic Biliary Stent on .035 OPTA PRO Delivery System (K012590)
- Cordis PALMAZ Balloon-Expandable Stent (K905720)
- Cordis PALMAZ Balloon-Expandable Stent (K911581)
Submission Summary (Full Text)
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K020809
Page 1 of 3
# 510(k) Summary of Safety and Effectiveness
#### Submitter:
Cordis Corporation, a Johnson & Johnson Company 40 Technology Drive Warren, New Jersey 07059
(908) 755-8300 Telephone: (908) 412-3915 Fax:
Contact Person:
Donna Marshall Regulatory Affairs Associate II Cordis Corporation, a Johnson & Johnson Company 7 Powder Horn Drive Warren, New Jersey 07059
(908) 412-3844 Telephone: (908) 412-3915 Fax:
Date Prepared:
March 12, 2002
Cordis PALMAZ® GENESIS™ Transhepatic Biliary Trade Name: Stent Biliary Stent and Accessories Common Name: Biliary Catheter and Accessories (per 21 CFR 876.5010) Classification Name: Class II Device Classification:
#### Summary of Substantial Equivalence:
The design, material, components, accessories, method of delivery, fundamental technology and intended use featured with the Cordis PALMAZ GENESIS Transhepatic Biliary Stent are substantially equivalent to those featured with the predecessor Cordis PALMAZ GENESIS Transhepatic Biliary Stent (see 510(k) #K012090). In short, the subject Cordis PALMAZ GENESIS Transhepatic Biliary Stent represents additional stent lengths and diameters for the dimensional ranges featured with the predicate device.
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## Device Description:
The Cordis PALMAZ GENESIS Transhepatic Biliary Stent is a balloon-expandable, stainless steel stent that is provided unmounted (without its recommended balloon catheter delivery device). The Cordis OPTA® PRO Balloon Catheter is recommended for the delivery of the Cordis PALMAZ GENESIS Transhepatic Biliary Stent.
The Cordis PALMAZ GENESIS Transhepatic Biliary Stent is hand crimped upon its recommended balloon catheter delivery device. The stent / balloon catheter assembly is then advanced over a guidewire through a sheath lumen, via the use of a metal introducer tube accessory, which is also provided separately, 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 GENESIS Transhepatic Biliary Stent is provided sterile (via gamma irradiation) and is intended for single use only.
#### Intended Use:
The Cordis PALMAZ GENESIS Transhepatic Biliary Stent is intended for use in the palliation of malignant neoplasms in the biliary tree.
#### Technological Characteristics:
The Cordis PALMAZ GENESIS Transhepatic Biliary Stent incorporates a design, size range, method of deployment, device and packaging materials, fundamental technology, delivery devices, intended use, and manufacturing and sterilization processes substantially equivalent to those featured with the following predicate Cordis devices:
- Cordis PALMAZ GENESIS Transhepatic Biliary Stent (see 510(k) #K012090); .
- Cordis PALMAZ GENESIS Transhepatic Biliary Stent on .035 OPTA PRO . Delivery System (see 510(k) #K012590); and,
- Cordis PALMAZ Balloon-Expandable Stent for use in the biliary system (see 510(k) . #K905720 and K911581).
The subject PALMAZ GENESIS Transhepatic Biliary Stent is provided in nominal unexpanded lengths of 19-59 mm and is designed for expanded diameters of 10-12 mm.
#### Performance Data:
The safety and effectiveness of the Cordis PALMAZ GENESIS Transhepatic Biliary Stent have been demonstrated via data collected from non-clinical design verification tests and analyses.
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A statement of substantial equivalence to another product is required by 21 CFR 807.87 and relates only to whether the present product can be marketed without prior reclassification or clinical approval. The present 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 premarket approval or reclassification. This determination is not intended to have any bearing whatsoever on the resolution of patent infringement suits." 42 Federal Register 42, 50 et seq. (1977).
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 2 2002
Ms. Donna Marshall Regulatory Affairs Associate II Cordis Corporation 7 Powder Horn Drive WARREN NJ 07059
Re: K020809
Trade/Device Name: Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: March 12, 2002 Received: March 13, 2002
Dear Ms. Marshall:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.
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 could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of 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, including pouch, 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. Donna Marshall
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.
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 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. Therefore, a new 510(k) is required before 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 device (21 CFR Part 801 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Bernard E. Statland, M.D., Ph.D. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K020809
Device Name: Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent
FDA's Statement of the Indications For Use for device:
The Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent is indicated for the palliation of malignant neoplasms in the biliary tree.
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
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Nancy C Hodgson
Division of Reproductive, Abdominal,
and Radiological Devices K020809
510(k) Number,
