(121 days)
Not Found
No
The provided text does not contain any mention of AI, ML, image processing, or any other indicators of AI/ML technology. The description focuses solely on the intended use and anatomical site of a stent system.
Yes
The device is described as being used for "palliation of malignant strictures in the biliary tree," which is a form of treatment or therapy.
No
The device is a self-expanding stent system indicated for the palliation of malignant strictures, which is a treatment (therapeutic) function rather than a diagnostic one.
No
The device is described as a "Stent System," which inherently implies a physical, implantable device, not software.
Based on the provided information, the FlexStent® Biliary Self Expanding Stent System 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." This describes a device used within the body to treat a condition, not a test performed outside the body on samples to diagnose or monitor a condition.
- Device Description (Not Found): While the description is missing, the intended use strongly suggests an implantable or interventional device.
- No mention of IVD characteristics: There is no mention of analyzing samples (blood, tissue, etc.), diagnostic testing, or any of the typical characteristics of an IVD.
Therefore, the FlexStent® Biliary Self Expanding Stent System is a medical device used for treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The FlexStent® Biliary Self Expanding Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
Product codes
FGE
Device Description
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
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
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around a stylized emblem. The emblem is a stylized representation of a human figure with outstretched arms, symbolizing care and protection. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Joseph C. Griffin, III Vice President, RA/QA Flexible Stenting Solutions 23 Christopher Way, Suite 103 EATONTOWN NJ 07724
DEC 30 2011
Re: K112522
Trade/Device Name: FlexStent® Biliary Self Expanding Stent System Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: December 21, 2011 Received: December 22, 2011
Dear Mr. Griffin:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enorosary is regar.) is tegar.
commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to Continered proc to May 20, 1978, the occordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls and Cosment Act (7tel). "Tod imay, and see, the below. The general controls provisions of the provisions of the Act and the minutes stration, 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 I he Office of Doriet Erailation of the not identified in the proposed labeling and that such use de vice will be used for an mosicordance 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, i unnermore, the menouncile instructions for use, and other promotional materials, in merading pouch, othe trade name, of a similar point size, and in bold print.
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. I herefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
1
Page 2 – Mr. Joseph C. Griffin, III
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) ictter will anow you to begin manteming your above is added to your labeling.
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 that I Dr mas made a and regulations administered by other Federal agencies. You must or any I cathar sthates uncluding, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical CI K F art 007), laboring (21 CFR 803); good manufacturing practice requirements as set de rice-related adverse overse (21 CFR Part 820); and if applicable, the electronic form in the quand of of ovisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you desire specific ad : AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for go to map. Www.radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part note the regulations regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Tou may of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark A. Milkerson
Christy Foreman Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K112522
Device Name: FlexStent® Biliary Self Expanding Stent System
Indications For Use: The FlexStent® Biliary Self Expanding Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Colin m. Pollard
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K112522
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