(30 days)
Not Found
No
The summary describes a mechanical device (stent and delivery system) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
Yes
The device is described as a stent system intended for the palliation of malignant strictures or neoplasms in the biliary tree, which is a therapeutic intervention.
No
Explanation: The device is a stent system intended for the palliation of malignant strictures in the biliary tree, which is a treatment function, not a diagnostic one.
No
The device description explicitly states it is comprised of a delivery system and a self-expanding stent, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "palliation of malignant strictures in the biliary tree" and "palliation of malignant neoplasms in the biliary tree." This describes a therapeutic intervention performed within the body to treat a condition.
- Device Description: The device is a "Self-Expanding Transhepatic Biliary Stent System" comprised of a "delivery system and a self-expanding stent." This is a physical implantable device used to open up blocked passages.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
The device described is a therapeutic medical device, specifically a stent system used for interventional procedures.
N/A
Intended Use / Indications for Use
The Xpert Self-Expanding Transhepatic Biliary Stent System is intended for use in the palliation of malignant strictures in the biliary tree.
The Abbott Vascular Devices Xpert™ Self-Expanding Transhepatic Biliary Stent System is intended for use in the palliation of malignant neoplasms in the biliary tree.
Product codes (comma separated list FDA assigned to the subject device)
78 FGE
Device Description
The Xpert Self-Expanding Transhepatic Biliary Stent System is comprised of a delivery system and a self-expanding stent. The delivery system is an over the wire (OTW) system designed to deliver the self-expanding Xpert Biliary Stent to the biliary tree.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary tree
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Substantial equivalence was confirmed through non-clinical testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
SelfX Biliary Stent (K030053)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
DEC 1 0 2003
APPENDIX A. 510(k) SUMMARY
| Sponsor/Submitter: | Abbott Laboratories (Perclose, Inc.)
Abbott Vascular Devices
400 Saginaw Drive
Redwood City, CA 94063 |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Joanna Kuskowski
Regulatory Affairs Coordinator
Phone:(650) 474-3331
Fax:(650) 474-3020 |
| Date of Submission: | November 7, 2003 |
| Device Trade Name: | Xpert Self-Expanding Transhepatic Biliary Stent System
(Xpert Biliary Stent) |
| Device Common Name: | Biliary Stent and Delivery System |
| Device Classification: | Class II |
| Regulation Number: | 21 CFR 876.5010 |
| Classification Name: | Biliary Catheter and Accessories |
| Product Code: | 78 FGE |
| Predicate Device: | SelfX Biliary Stent (K030053) |
| Intended Use: | The Xpert Self-Expanding Transhepatic Biliary Stent System is intended
for use in the palliation of malignant strictures in the biliary tree. |
| Device Description: | The Xpert Self-Expanding Transhepatic Biliary Stent System is comprised
of a delivery system and a self-expanding stent. The delivery system is an
over the wire (OTW) system designed to deliver the self-expanding Xpert
Biliary Stent to the biliary tree. |
| Summary of Substantial
Equivalence: | The Xpert Self-Expanding Transhepatic Biliary Stent System is
substantially equivalent to the predicate device. Substantial equivalence
was confirmed through non-clinical testing. |
:
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an emblem that resembles a stylized caduceus, which is a symbol often associated with healthcare. The emblem features a staff with two snakes coiled around it, topped with a pair of wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 0 2003
Ms. Joanna Kuskowski Regulatory Affairs Coordinator Abbott Laboratories (Perclose, Inc.) Abbott Vascular Devices 400 Saginaw Drive Redwood City, California 94063
Re: K033537
Trade/Device Name: Xpert™ Self-Expanding Transhepatic Biliary Stent System Regulation Number: 21 CFR $876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: November 7, 2003 Received: November 10, 2003
Dear Ms. Kuskowski:
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 labcling 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.
2
Page 2 - Ms. Joanna Kuskowski
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 described above is added to your labeling.
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), 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
Daniel C. Schultz, M.D.
Daniel G. Schultz, M.D. Director Office of Device Evaluation Center for Devices and Radiological Health
3
Page_1 of 1
510(k) Number: K033537
Device Name: Abbott Vascular Devices Xpert™ Self-Expanding Transhepatic Biliary Stent System
FDA's Statement of the Indications For Use for device:
The Abbott Vascular Devices Xpert™ Self-Expanding Transhepatic Biliary Stent System is intended for use in the palliation of malignant neoplasms in the biliary tree.
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-Counter Use _____________
David A. Layson
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devi 510(k) Number