(177 days)
Not Found
No
The summary describes a mechanical stent and delivery system with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a stent used to maintain patency in the biliary tree, specifically for the palliation of malignant strictures, which aligns with the definition of a therapeutic intervention.
No
The device is described as a "self-expanding polygon mesh surface, tubular prosthesis designed to maintain patency of bile duct strictures," which is a therapeutic function, not a diagnostic one. Its indicated use is for "palliation of malignant strictures," further supporting its role as a treatment device.
No
The device description clearly states it is a physical stent made of Nitinol wire, provided preloaded on a delivery device, and available in different diameters and lengths. This indicates a hardware medical device, not a software-only one.
Based on the provided information, the BONASTENT® Biliary Stent is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. They are used outside of the body.
- BONASTENT® Function: The BONASTENT® is a medical device that is implanted into the biliary tree to physically maintain patency of strictures. It is a therapeutic device, not a diagnostic test performed on a sample.
The description clearly indicates it's a self-expanding prosthesis designed to be placed within the body to treat a condition. This aligns with the definition of a medical device used for treatment, not an IVD used for diagnosis.
N/A
Intended Use / Indications for Use
The Bonastent® Biliary is indicated for the palliation of malignant strictures in the biliary tree.
Product codes (comma separated list FDA assigned to the subject device)
FGE
Device Description
The Bonastent® Biliary stent is a self-expanding polygon mesh surface, tubular prosthesis designed to maintain patency of bile duct strictures caused by malignant tumors. The stent is made of Nitinol wire and is designed in such a way as to prevent migration and tumor in-growth. The stent is provided preloaded on a delivery device and is available in 2 different diameters (8mm and 10mm) in various lengths.
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)
Not Found
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.
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MAR 2 4 ZOLO
510(K) Summary
[as required by section 807.92(c)]
Bonastent® Biliary
510(k) Number K_ 09 3003
Applicant's Name:
==============================================================================================================================================================================
EndoChoice Inc. 11800 Wills Rd. Suite 100Alpharetta, GA 30009 Telephone: 770-682-8700 Fax: 770-962-6981
Contact Person:
Name: Shoshana (Shosh) Friedman Telephone: 704-899-0092 Fax: 704-899-0098 Email: shosh@pushmed.com
Trade Name:
Bonastent® Biliary
Classification Name: Regulation Number: Product Code: FGE Classification: Review Panel:
Biliary catheter and accessories 876.5010 Class II Gastroenterology/Urology
Predicate Devices:
- Niti-S Biliary Stent by Taewoong Medical Co., Ltd, K073667 ●
- WallFlex™ Biliary RX Stent System by Boston Scientific Corporation . K081733
Device Description:
The Bonastent® Biliary stent is a self-expanding polygon mesh surface, tubular prosthesis designed to maintain patency of bile duct strictures caused by malignant tumors. The stent is made of Nitinol wire and is designed in such a way as to prevent migration and tumor in-growth. The stent is provided preloaded on a delivery device and is available in 2 different diameters (8mm and 10mm) in various lengths.
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Intended Use:
The Bonastent® Biliary is indicated for the palliation of malignant strictures in the biliary tree.
Technological Characteristics:
The Bonastent® Biliary is weaved using hook & cross wire construction which reduces the delivery device diameter. The stent includes 3 groups of 4 radiopaque markers located at the center of the stent as well as at both ends of the stent.
Conclusion:
EndoChoice believes that, based on the information provided in this submission, the Bonastent® Biliary stent system is substantially equivalent to its predicate devices without raising any new safety and/or effectiveness issue.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the 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 symbol of a human figure with outstretched arms, representing health and well-being. The symbol is black and white.
Public Health Service
MAR 2 4 2010
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Ms. Shoshana Friedman, RAC Regulatory Consultant EndoChoice, Inc. 11800 Wills road. Suite 100 ALPHARETTA GA 30009
Re: K093003
Trade/Device Name: BONASTENT® Biliary Stent Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: March 16, 2010 Received: March 18, 2010
Dear Ms. Friedman:
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.
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Page 2 - Ms. Shoshana Friedman, RAC
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.
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.
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.
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) 796-5484. 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) 796-5857 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
B/Yemmer for
Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K093003
Device Name: BONASTENT® Biliary Stent
Indications For Use: The BONASTENT® Biliary Stent is indicated for 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)
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number __K 09 30 30 3
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