(181 days)
The DuraMax™.018 Biliary Stent System is indicated for palliation of malignant neoplasms in the biliary tree
The DuraMax™.018 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 ≤0.018" and the attachment of a balloon inflation device via a standard luer connector. Stents sizes include diameters of 5, 6 & 7 mm in lengths of 13, and 18 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.
The DuraMax™ .018 Biliary Stent System has achieved substantial equivalence based on a comparison to a predicate device and extensive non-clinical testing. Here's a breakdown of the acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance | Study Proving Acceptance |
|---|---|---|
| Biocompatibility | Device passed all biocompatibility testing. | Biocompatibility testing |
| Material Composition | Constructed of similar materials to predicate device. | Non-clinical design verification tests and analyses |
| Sizes (Diameter & Length) | Available in similar diameters and lengths (5, 6, 7 mm diameters; 13, 18 mm lengths) to predicate and other marketed biliary stents. | Non-clinical design verification tests and analyses |
| Design | Similar design to predicate device (balloon-expandable 316L stainless steel stent pre-mounted on an OTW delivery catheter with distal balloon and two radiopaque markers). | Non-clinical design verification tests and analyses |
| Indications for Use | Same indications as predicate device: palliation of malignant neoplasms in the biliary tree. | Comparison to predicate device's indications |
| Safety and Effectiveness | Demonstrated through non-clinical design verification tests and analyses. | Bench and Biocompatibility testing |
2. Sample Sized Used for the Test Set and the Data Provenance
The provided document does not mention any human clinical study or "test set" in the context of a comparative effectiveness study with human subjects. The safety and effectiveness were demonstrated using "non-clinical design verification tests and analyses" and "bench and Biocompatibility testing." Therefore, information on sample size for a test set and data provenance (country of origin, retrospective/prospective) is not applicable in this case.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable as the document does not describe a study involving human experts establishing ground truth for a test set. The evaluation was based on non-clinical testing and comparison to a predicate device.
4. Adjudication Method for the Test Set
This information is not applicable as the document does not describe a study involving human experts and adjudication for a test set.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no mention of an MRMC comparative effectiveness study, AI assistance, or human readers improving with AI in the provided documents. The DuraMax™ .018 Biliary Stent System appears to be a medical device (stent and delivery system), not an AI-powered diagnostic or assistive tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable as the DuraMax™ .018 Biliary Stent System is a physical medical device, not an algorithm, and its performance would not be evaluated in a "standalone" algorithmic context.
7. The Type of Ground Truth Used
The ground truth for the device's performance was established through:
- Non-clinical design verification tests and analyses (Bench testing): This refers to laboratory testing to evaluate the device's physical properties, mechanical performance, and functional characteristics against predetermined specifications.
- Biocompatibility testing: This confirms that the materials used in the device are safe for contact with the human body and do not elicit adverse biological responses.
- Comparison to a predicate device: The device's characteristics and intended use were deemed "substantially equivalent" to the Cordis® PALMAZ® GENESIS™ Transhepatic Biliary Stent on SLALOM .018" Delivery System, implying that the predicate's established safe and effective performance serves as a benchmark for the DuraMax system.
8. The Sample Size for the Training Set
This information is not applicable. The DuraMax™ .018 Biliary Stent System is a physical medical device, not a machine learning model, and therefore did not undergo "training" with a dataset in that sense. The "training" in this context would likely refer to the design, engineering, and manufacturing processes that led to the device's creation.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as #8. The "ground truth" for the device's design and manufacturing would be established through engineering principles, material science, and quality control processes to ensure it meets its specifications.
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DuraMax™ .018 Biliary Stent System
XIII. 510(k) Summary
FEB - 4 2004
K-032436
| 510(k) Summary - DuraMax™.018 Biliary Stent System | |
|---|---|
| Submitter | Avantec Vascular Corporation1049 Kiel CourtSunnyvale, CA 04089 |
| Date Prepared | August 4, 2003 |
| Contact Person | James M. ShyPhone: (408) 743-3125FAX: (408) 548-0088e-mail: jshy@avantecvascular.com |
| Classification Name | 21 CFR 876.5010 Biliary Catheter and accessories |
| Device Common Name | Biliary Stent System |
| Device Trade Name | DuraMax™.018 Biliary Stent System |
| Intended Use | The DuraMax™.018 Biliary Stent System is indicated for palliation ofmalignant neoplasms in the biliary tree |
| Device Classification | Regulatory Class: Class II (two)Product Code: FGE |
| Predicate Device | Cordis® PALMAZ® GENESIS™ Transhepatic Biliary Stent onSLALOM .018" Delivery System. |
| Performance Standards | Have not been established for this device. |
| Device Description | The DuraMax™.018 Biliary Stent Delivery System is a balloon-expandable 316L stainless steel stent pre-mounted on a deliverycatheter. The delivery catheter is an Over-the-Wire (OTW) design with adistal balloon and two radiopaque markers to aid in the placement of thestent. The proximal end of the catheter has a Y-connector that allowsfor the use of a guidewire ≤0.018" and the attachment of a ballooninflation device via a standard luer connector. Stents sizes includediameters of5, 6 & 7 mm in lengths of 13, and 18 mm. The catheter is available intwo working lengths, 80 cm and 135 cm. Shaft markers at 93 and 103cm are provided on the 135 cm catheter. The catheter system isprovided sterile and is intended for one use only. |
| Biocompatibility | The DuraMax™.018 Biliary Stent System has passed allBiocompatibility testing. |
| Performance Data | The safety and effectiveness of the DuraMax™.018 Biliary StentDelivery System have been demonstrated with data collected from non-clinical design verification tests and analyses. |
| Summary | The DuraMax™.018 Biliary Stent System is constructed of similarmaterials, is available in similar diameters and lengths, has a similardesign and the same indications as the Predicate Device and othercurrently marketed Biliary Stent Systems. Bench and Biocompatibilitytesting has demonstrated the safety and effectiveness of the device. |
| Conclusion | The DuraMax™.018 Biliary Stent System is substantially equivalent tothe predicate device and other currently marketed Biliary Stent Systems. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The logo is black and white and appears to be a simple, vectorized design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. James M. Shy Vice President, Regulatory Affairs Avantec Vascular Corporation 1049 Kiel Court SUNNYVALE CA 94089
FEB 4 - 2004
Re: K032436
Trade/Device Name: DuraMax™ .018 Biliary Stent System Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: November 21, 2003 Received: November 24, 2003
Dear Mr. Shy:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 rcclassified 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 - Mr. James M. Shy
If your device is classified (see above) into cither 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) press rket notification if the limitation statement above is added to your labeling, as described.
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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification''(21 CFR Part 807.97). Other general information on your responsibilitics under the Act may be obtained 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.D.
Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): K032436
Device Name:_DuraMax™ .018 Biliary Stent System
FDA's Statement of the Indications For Use for device:
The DuraMax™ .018 Biliary Stent System is indicated for palliation of malignant neoplasms in the biliary tree.
Prescription Use V Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ OR (Per 21 CFR 801.109)
David L. Larson
(Division Sign-Off) (Division Sign-On)
Division of Reproductive, Abdominal, and Radiological Device 510(k) Number
§ 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.