(131 days)
Not Found
Not Found
No
The device description focuses on the mechanical components of a stent and delivery system, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is indicated for "palliation of malignant neoplasms in the biliary tree," which describes a direct therapeutic intervention to alleviate symptoms or treat a disease.
No
The device is a biliary stent system, which is used for palliation of malignant neoplasms (treatment), not for identifying or diagnosing a condition.
No
The device description clearly details a physical medical device (stent and delivery catheter) made of materials like 316L stainless steel and including components like a balloon, radiopaque markers, and a Y-connector. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "palliation of malignant neoplasms in the biliary tree." This describes a therapeutic intervention performed within the body, not a test performed on samples taken from the body.
- Device Description: The description details a physical implant (stent) and a delivery system used to place it within the biliary tree. This is consistent with an interventional medical device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
This device is clearly an implantable medical device used for a therapeutic purpose.
N/A
Intended Use / Indications for Use
The DuraMax™ .035 Biliary Stent System is indicated for palliation of malignant neoplasms in the biliary tree.
Product codes (comma separated list FDA assigned to the subject device)
FGE
Device Description
The DuraMax™ .035 Biliary Stent Delivery System is a balloon-expandable 316L stainless steel stent pre-mounted on a delivery catheter. The delivery catheter is an Over-the-Wire (OTW) design with a distal balloon and two radiopaque markers to aid in the placement of the stent. The proximal end of the catheter has a Y-connector that allows for the use of a guidewire
§ 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
Avantec Vascular Corporation .
XIII. 510(k) Summary
9 2003 JUL
510(k) Summary - DuraMax™.035 Biliary Stent System
| Submitter | Avantec Vascular Corporation
1049 Kiel Court
Sunnyvale, CA 04089 |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | January 6, 2003 |
| Contact Person | James M. Shy
Phone: (408) 743-3125
FAX: (408) 548-0088
e-mail: jshy@avantecvascular.com |
| Classification Name | 21 CFR 876.5010 Biliary Catheter and accessories |
| Device Common Name | Biliary Stent System |
| Device Trade Name | DuraMax™ .035 Biliary Stent System |
| Intended Use | The DuraMax™ .035 Biliary Stent System is indicated for palliation of
malignant neoplasms in the biliary tree |
| Device Classification | Regulatory Class: Class II (two)
Product Code: FGE |
| Predicate Device | Cordis® PALMAZ® GENESIS™ Transhepatic Biliary Stent on
OPTA PRO .035" Delivery System. |
| Performance Standards | Have not been established for this device. |
| Device Description | The DuraMax™ .035 Biliary Stent Delivery System is a balloon-
expandable 316L stainless steel stent pre-mounted on a delivery
catheter. The delivery catheter is an Over-the-Wire (OTW) design with a
distal balloon and two radiopaque markers to aid in the placement of the
stent. The proximal end of the catheter has a Y-connector that allows for
the use of a guidewire ≤ 0.035" and the attachment of a balloon inflation
device via a standard luer connector. Stents sizes include diameters of 7,
8, 9 & 10 mm in lengths of 18, 28 and 28 mm. The catheter is available
in two working lengths, 80 cm and 135 cm. Shaft markers at 93 and 103
cm are provided on the 135 cm catheter. The catheter system is
provided sterile and is intended for one use only. |
| Biocompatibility | The DuraMax™ .035 Biliary Stent System has passed all Biocompatibility
testing. |
| Performance Data | The safety and effectiveness of the DuraMax™ .035 Biliary Stent Delivery
System have been demonstrated with data collected form non-clinical
design verification tests and analyses. |
| Summary | The DuraMax™ .035 Biliary Stent System is constructed of similar
materials, is available in similar diameters and lengths, has a similar
design and the same indications as the Predicate Device and other
currently marketed Biliary Stent Systems. Bench and Biocompatibility
testing has demonstrated the safety and effectiveness of the device. |
| Conclusion | The DuraMax™ .035 Biliary Stent System is substantially equivalent to
the predicate device and other currently marketed Biliary Stent Systems. |
1
Image /page/1/Picture/1 description: The image shows the seal of 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 a stylized image of a caduceus, a symbol of medicine and health.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
9 2003 JUL
Mr. James M. Shy V. P. Regulatory Affairs Avantec Vascular Corporation 1049 Kiel Court Sunnyvale, California 94089
Re: K030638
Trade/Device Name: DuraMax™ .035 Biliary Stent System, Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: June 19, 2003 Received: June 20, 2003
Dear Mr. Shy:
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.
2
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 G. Schultz. M.J.
Daniel G. Schultz, M.D. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
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510(k) Number (if known): K030638
Device Name: DuraMax™ .035 Biliary Stent System
FDA's Statement of the Indications For Use for device:
The DuraMax™ .035 Biliary Stent System is indicated for palliation of malignant neoplasms in the biliary tree.
く Prescription Use (Per 21 CFR 801.109)
OR
Over-the-Counter Use _
David A. Sezman
(Division Sign-Off) Division of Reproductive. Abdominal, and Radiological Devices 510(k) Number __