(14 days)
Not Found
No
The summary describes a physical medical device (stent and delivery system) and does not mention any software, algorithms, or data processing that would indicate the use of AI or 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 used for the palliation of malignant neoplasms in the biliary tree, which is a treatment for a medical condition.
No
The device is a stent system intended for palliation of malignant neoplasms in the biliary tree, which is a treatment rather than a diagnostic function.
No
The device description explicitly states it is comprised of a delivery system and a self-expanding stent, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "palliation of malignant neoplasms in the biliary tree." This describes a therapeutic intervention performed directly on a patient's anatomy.
- Device Description: The device is a "Self-Expanding Transhepatic Biliary Stent System" comprised of a delivery system and a stent. This is a physical implant designed to be placed within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) for treatment.
N/A
Intended Use / Indications for Use
The Xceed Nitinol Self-Expanding Transhepatic Biliary Stent System is intended for use in the palliation of malignant neoplasms in the biliary tree.
Product codes
78 FGE
Device Description
The Abbott Vascular Devices Xceed Nitinol 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 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
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 (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)
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.
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APPENDIX A. 510(k) SUMMARY
| Sponsor/Submitter: | Abbott Laboratories
Abbott Vascular Devices
400 Saginaw Drive
Redwood City, CA 94063 |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ann E. Leonard
Regulatory Affairs Coordinator
Phone:(650) 474-3477
Fax:(650) 474-3041 |
| Date of Submission: | February 25, 2005
MAR 1 4 2005 |
| Device Trade Name: | Xceed Nitinol Self-Expanding Transhepatic Biliary Stent System |
| 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: | Xceed Nitinol Self-Expanding Transhepatic Biliary Stent System
(K050103) |
| Intended Use: | The Xceed Nitinol Self-Expanding Transhepatic Biliary Stent
System is intended for use in the palliation of malignant neoplasms
in the biliary tree. |
| Device Description: | The Abbott Vascular Devices Xceed Nitinol 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 stent to the
biliary tree. |
| Summary of Substantial
Equivalence: | The Xceed Nitinol 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 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 an eagle with three curved lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 4 2005
Ann E. Leonard, Ph.D. Regulatory Affairs Coordinator Abbott Vascular Devices 400 Saginaw Drive REDWOOD CITY CA 94063
Re: K050501
KU50301
Trade/Device Name: Xceed™ Nitinol 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: February 25, 2005 Reccived: February 28, 2005
Dear Dr. Leonard:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave revewed your section 510(x) premained is substantially equivalent (for the indications for referenced above and nave actemined and as a so a set a sevices marketed in interstate commerce use stated in the encrosure/ to regally manythe Medical Device Amendments, or to devices that prior to May 26, 1770, the ondemont adts the provisions of the Federal Food, Drug, and Cosmetic nave been reclassified in accordants that e device, subject to the general controls provisions of the Act (Act). Tou may, mercerors, markew. The general controls provisions of the Act include Act and the infridations desorroed betwn - 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 I fie Office of De vice Evaranton has deterfied in the proposed labeling and that such use could cause will be used for an intended ass not resmaion 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 runnermore, the marculen for of estructions 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 - Dr. Ann Leonard
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to additional controls. Existing major regulations affecting your device can be found may be subject to additions. Exismigations Existing major organism FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination doest not mean that Please be advised that IDA's Issualled of a sace annolies with other requirements of the Act of any FDA has made a determination that your der Federal agencies. You must comply with all
Federal statutes and regulations administered by other Federal (21 GED B. 4807) Federal statutes and regulations dammisted to: registration and listing (21 CFR Part 807); the Act s requirements, mending, but not mined to: 10 reguirements as set forth in the quality labeling (21 CFR Part 801), good manataling problicable, the electronic product radiation
systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product Systems (QD) regulation (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 The FDA Inding Of substantar equivalence or your device to proceed to the market. This results in a classification for your device and permise 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. Please note that the above labeling immations 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 If you desire specific information association as appliance at (301) 594-4616. Also, please note (21 CFR Fart 6017), prease contact ins Officence to premarket notification'' (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division I ou may obtain other general ational, 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,
jQeGTn
Jonna-Bea Tillman, Ph.D. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page_1_of 1
510(k) Number: K050501
Device Name: Abbott Vascular Devices™ Xceed™ Nitinol Self-Expanding Transhepatic Biliary Stent System
FDA's Statement of the Indications For Use for device:
The Abbott Vascular Devices™ Xceed™ Nitinol Self-Expanding Transhepatic Biliary Stent System I he Abbott vascular Doviees
is intended for use in the palliation of malignant neoplasms in the biliary tree.
Prescription Use (Pcr 21 CFR 801.109) OR
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
) Nancy Hogdon
(Division Sign-Off)
Oivision of Reproductive, Abdom ind Radiological Devices 10(k) Number_ 05091