(91 days)
Not Found
No
The summary describes a mechanical stent and delivery system with no mention of AI or ML capabilities.
Yes
The device is a stent used to maintain the patency of biliary ducts obstructed by malignant neoplasms, which directly treats a medical condition.
No
The device is a stent used to treat biliary strictures by maintaining the patency of biliary ducts. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is a "stenting device" and includes a "self-expanding Bard® LUMINEXX™ 3 biliary stent pre-loaded on a flexible delivery system," indicating it is a physical medical device with hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The Bard® LUMINEXX™ 3 Biliary Stent and Delivery System is a therapeutic device. It is implanted into the body to treat a condition (biliary strictures) by maintaining the patency of the biliary ducts.
The description clearly states its purpose is to "maintain the patency of biliary ducts obstructed by malignant neoplasms," which is a direct intervention within the body, not an analysis of a sample taken from the body.
N/A
Intended Use / Indications for Use
The Bard® LUMINEXX™ 3 Biliary Stent and Delivery System is indicated for use in the treatment of biliary strictures resulting from malignant neoplasms.
Product codes
78 FGL
Device Description
The Bard® LUMINEXX™ 3 Biliary Stent and Delivery System is a stenting device, designed to maintain the patency of biliary ducts obstructed by malignant neoplasms. The device includes a self-expanding Bard® LUMINEXX™ 3 biliary stent pre-loaded on a flexible delivery system. Highly radiopaque markers on the ends of the stent facilitate stent placement. The Bard® LUMINEXX™ 3 Biliary Stent and Delivery System is available in several diameters and lengths.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary ducts
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5010 Biliary catheter and accessories.
(a)
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.(b)
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.
0
FEB - 4 2004
K033497
Page 1 of 1
Bard® LUMINEXX™ 3 Billary Stent and Delivery System Snacial 510/k Bard Peripheral Vascular, Inc.
SUMMARY OF SAFETY AND EFFECTIVENESS
As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part (I)(3)(A) of the Food, Drug and Cosmetic Act, a summary of the safety and effectiveness information upon which substantial equivalence determination is based as follows:
- A. Submitter Information:
| | Applicant: | Bard Peripheral Vascular, Inc.
1625 West 3rd Street
Tempe, Arizona 85280 |
|----|----------------------------|---------------------------------------------------------------------------------------|
| | Phone:
Fax:
Contact: | 480-303-2752
480-449-2546
Aymee R. Berry, Associate Manager, Regulatory Affairs |
| B. | Device Name: | Bard® LUMINEXX™ 3 Biliary Stent and Delivery System |
| | Common or
Usual Name: | Catheter, Biliary |
Classification: Class II
- C. Predicate Bard® LUMINEXX™ 6F Biliary Stent and Delivery System Device Name(s): (K020682)
- D. Device Description:
The Bard® LUMINEXX™ 3 Biliary Stent and Delivery System is a stenting device, designed to maintain the patency of biliary ducts obstructed by malignant neoplasms. The device includes a self-expanding Bard® LUMINEXX™ 3 biliary stent pre-loaded on a flexible delivery system. Highly radiopaque markers on the ends of the stent facilitate stent placement. The Bard® LUMINEXX™ 3 Biliary Stent and Delivery System is available in several diameters and lengths.
-
E. Statement of Intended Use:
The Bard® LUMINEXX™ 3 Biliary Stent and Delivery System is indicated for use in the treatment of biliary strictures resulting from malignant neoplasms. -
F. Substantial Equivalence:
A variety of tests, assessments, and comparisons demonstrate that the Bard® LUMINEXX™ 3 Biliary Stent and Delivery System is substantially equivalent to the above-referenced predicate in terms of composition, design, intended use, and performance attributes.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Aymee Berry Associate Manager, Regulatory Affairs Bard Peripheral Vascular, Inc. 1625 West 3td Street TEMPE, A7.85280
FEB 4 - 2004
Re: K033497
Trade/Device Name: Bard® LUMINEXX"M 3 Biliary Stent and Delivery System Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGL Dated: January 21, 2004 Received: January 22, 2004
Dear Ms. Berry:
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). 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 Scction 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.
2
Page 2 -- Ms. Aymec Berry
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 vou to begin marketing your device as described in your Section 510(k) prematict notification if the limitation statement described above is added to your labeling.
Please note that the above labeling limitations are required by Section 513(i)(1)(1)(1)(1)(1)(1) 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), please contact the Office of Compliance at (301) 594-4616. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
th.
Daniel G. Schultz, M.D. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page__________________________________________________________________________________________________________________________________________________________________________
510(k) Number: K033497
Device Name: Bard® LUMINEXX™ 3 Biliary Stent and Delivery System
FDA's Statement of the Indications For Use for device:
The Bard® LUMINEXX™ 3 Biliary Stent and Delivery System is indicated for use in the treatment of biliary strictures resulting from malignant neoplasms.
Prescription Use (Per 21 CFR 801.109) OR
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
David G. Seymour
(Division Sign-Off) (Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number