(328 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and delivery system of a stent, with no mention of AI or ML.
Yes
The device is intended for "palliation of malignant strictures in the biliary tree," which is a therapeutic purpose. It is designed to treat a medical condition by providing symptomatic relief.
No.
The device is a self-expanding stent system intended for palliation of malignant strictures in the biliary tree, which is a therapeutic function, not a diagnostic one.
No
The device description clearly details a physical stent and a delivery system, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes. This typically involves tests performed on blood, urine, tissue samples, etc., outside of the body.
- Device Description and Intended Use: The provided information clearly describes a stent system that is implanted into the biliary tree to palliate malignant strictures. This is an invasive procedure performed within the body.
The device's function is to physically open a blocked passage within the biliary tree, not to analyze biological samples for diagnostic information.
N/A
Intended Use / Indications for Use
The Absolute® Pro .035 Biliary Self-Expanding Stent System is intended for palliation of malignant strictures in the biliary tree.
Product codes (comma separated list FDA assigned to the subject device)
FGE
Device Description
The Absolute® Pro .035 Biliary Self-Expanding Stent System includes a selfexpanding nickel titanium stent that is pre-mounted on an over-the-wire Delivery System. A total of 12 (6 at each end) radiopaque markers made of a radiopaque nickel titanium alloy are located at the ends of the stent. The Absolute Pro .035 Biliary Self-Expanding Stent System utilizes a 0.035" (0.89 mm) guide wire. The system includes radiopaque markers that identify the stent location.
The catheter comprises a retractable sheath that covers the stent during delivery. a radiopaque tip, an I-Beam to support the stent during deployment with an internal guide wire lumen, a detachable outer jacket, and a handle assembly with a safety lock and retraction features. With the handle in the unlocked position, rolling back the thumbwheel deploys the stent.
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)
The results of the in vitro bench tests and analyses demonstrates that the Absolute® Pro .035 Biliary Self-Expanding Stent System is substantially equivalent in performance to the Absolute® .035 Biliary Self-Expanding Stent System.
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.
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
RC72768 PAGE 1 CF 2
(Posted November 13, 2003)
510(k) Summary
AUG 1 8 2008
The 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92
| Submitter's Name: | Abbott Vascular |
|---|---|
| Submitter's Address: | 3200 Lakeside Drive |
| Santa Clara, CA 95054 | |
| Telephone: | |
| Fax: | 408-845-0613 |
| 408-845-0921 | |
| Contact Person: | |
| Date Prepared: | Michelle Grossman, Senior Regulatory Affairs Associate |
| September 24, 2007 | |
| Device Trade Name: | Absolute® Pro .035 Biliary Self-Expanding Stent System |
| Device Common Name: | |
| Device Classification Name: | Biliary Stent |
| Biliary Catheter | |
| Device Classification: | Class II |
Summary of Substantial Equivalence:
The Absolute® Pro .035 Biliary Self-Expanding Stent System is substantially equivalent to the Absolute® 035 Biliary Self-Expanding Stent System (K033393, cleared 11/10/03); and Xceed Nitinol Self Expanding Transhepatic Biliary Stent System (K050501, cleared 3/14/05).
Device Description:
The Absolute® Pro .035 Biliary Self-Expanding Stent System includes a selfexpanding nickel titanium stent that is pre-mounted on an over-the-wire Delivery System. A total of 12 (6 at each end) radiopaque markers made of a radiopaque nickel titanium alloy are located at the ends of the stent. The Absolute Pro .035 Biliary Self-Expanding Stent System utilizes a 0.035" (0.89 mm) guide wire. The system includes radiopaque markers that identify the stent location.
The catheter comprises a retractable sheath that covers the stent during delivery. a radiopaque tip, an I-Beam to support the stent during deployment with an internal guide wire lumen, a detachable outer jacket, and a handle assembly with a safety lock and retraction features. With the handle in the unlocked position, rolling back the thumbwheel deploys the stent.
1
XC727C8 PAGE 2 OF 2
Intended Use:
The Absolute® Pro .035 Biliary Self-Expanding Stent System is intended for palliation of malignant strictures in the biliary tree.
Technological Characteristics Compared to Predicate:
A comparison of the technological characteristics of the Absolute® Pro .035 Biliary Self-Expanding Stent System and the predicate devices have been performed. The results of this comparison demonstrate that the Absolute® Pro .035 Biliary Self-Expanding Stent System is equivalent to the predicate devices.
Performance Data:
The results of the in vitro bench tests and analyses demonstrates that the Absolute® Pro .035 Biliary Self-Expanding Stent System is substantially equivalent in performance to the Absolute® .035 Biliary Self-Expanding Stent System.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and three horizontal bars below the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Michelle Grossman AUG 1 8 2008 Regulatory Affairs Abbott Vascular - Vascular Solutions 3200 Lakeside Drive SANTA CLARA CA 95054
Re: K072708
Trade/Device Name: Absolute® Pro .035 Biliary Self-Expanding Stent System Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: July 15, 2008 Received: July 16, 2008
Dear Ms. Grossman:
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 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.
3
Page 2 – Ms. Michelle Grossman
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 (240) 276-0115. 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.
Christy Foreman for
Donna-Bea Tillman, Ph.D., M.P.H. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K072708
Absolute® Pro .035 Biliary Self-Expanding Stent System Device Name: The Absolute® Pro .035 Biliary Self-Expanding Stent Indications for Use: System is intended for palliation of malignant strictures
in the billiary tree.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, and | Page |
| Radiological Devices |
(017)
510(k) Number