(106 days)
The Xceed Nitinol Self-Expanding Transhepatic Biliary Stent System is intended for use in the palliation of malignant neoplasms in the biliary tree.
The Abbott Vascular Devices Xceed Nitinol Self-Expanding Transhepatic Biliary Stent System is comprised of a delivery system and a self-expanding stent. The delivery system is an over the wire (OTW) system designed to deliver the self-expanding stent to the biliary tree.
This document is a 510(k) summary for the Xceed Nitinol Self-Expanding Transhepatic Biliary Stent System. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance metrics typically found for AI/imaging devices.
Therefore, many of the requested details, such as specific acceptance criteria for a device's performance, sample sizes for test sets (especially with AI/imaging context), number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment are not present in this document. This is a medical device approval summary, not a clinical trial report for an AI or diagnostic imaging device.
However, based on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
This document does not specify quantitative acceptance criteria for device performance in the manner requested (e.g., sensitivity, specificity thresholds). Instead, it relies on demonstrating substantial equivalence to an existing predicate device (Cordis Nitinol Stent and Delivery System (K980823)).
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|
| Same intended use | "Xceed Nitinol Self-Expanding Transhepatic Biliary Stent System has the same intended use as the predicate device." |
| Biocompatibility | "Results of scientific testing have ensured that all materials are biocompatible..." |
| No new adverse effects | "...no new adverse effects were introduced..." |
| Appropriate physical properties for intended use | "...and physical properties are appropriate for the intended use." |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified. The document mentions "Nonclinical testing was conducted" but does not provide details on the sample size or type of tests in a way that aligns with an AI/imaging device performance study.
- Data Provenance: Not applicable in the context of an AI/imaging study. The testing referenced is likely bench testing and potentially animal studies for device mechanics and biocompatibility, not clinical data from specific countries.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. This is a medical device (stent) approval document, not a diagnostic imaging or AI study where experts would establish ground truth for a test set of images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not specified.
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:
- No. This is a physical medical device (stent), not an AI or imaging diagnostic tool. An MRMC study is not relevant to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the context of diagnostic AI/imaging. The "ground truth" for a device like a stent would be its physical properties, biocompatibility, and functional performance in in-vitro or animal models, not a diagnostic outcome from a patient. The document states "Results of scientific testing have ensured that all materials are biocompatible, no new adverse effects were introduced and physical properties are appropriate for the intended use."
8. The sample size for the training set:
- Not applicable. This is not an AI device, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. There is no training set.
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APPENDIX A. 510(k) SUMMARY
| Sponsor/Submitter: | Abbott Vascular Devices |
|---|---|
| 400 Saginaw DriveRedwood City, CA 94063 | |
| Contact Person: | Joanna KuskowskiRegulatory Affairs CoordinatorPhone:(650) 474-3331Fax:(650) 474-3020 |
| Date of Submission: | April 24, 2003 |
| Device Trade Name: | Xceed Nitinol Self-Expanding Transhepatic Biliary StentSystem |
| Device Common Name: | Biliary Stent and Delivery System |
| Device Classification: | Class II |
| Regulation Number: | 21 CFR 876.5010 |
| Classification Name: | Biliary Catheter and Accessories |
| Product Code: | 78 FGE |
| Predicate Device: | Cordis Nitinol Stent and Delivery System (K980823) |
| Intended Use: | The Xceed Nitinol Self-Expanding Transhepatic Biliary StentSystem is intended for use in the palliation of malignantneoplasms in the biliary tree. |
| Device Description: | The Abbott Vascular Devices Xceed Nitinol Self-ExpandingTranshepatic Biliary Stent System is comprised of a deliverysystem and a self-expanding stent. The delivery system is anover the wire (OTW) system designed to deliver the self- |
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expanding stent to the biliary tree.
Summary of Substantial Abbott Vascular Devices has submitted information on Equivalence: indication for use, design and principle of operation, biocompatibility and performance characteristics to establish that Xceed Nitinol Self-Expanding Transhepatic Biliary Stent System is substantially equivalent to currently marketed predicate device. Xceed Nitinol Self-Expanding Transhepatic Biliary Stent System has the same intended use as the predicate device. Results of scientific testing have ensured that all materials are biocompatible, no new adverse effects were introduced and physical properties are appropriate for the intended use. Nonclinical testing was conducted. In conclusion, Xceed Nitinol Self-Expanding Transhepatic Biliary Stent System has been shown to be substantially equivalent to the Class II predicate upon which the device is based.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 2 2003
Ms. Joanna Kuskowski Regulatory Affairs Coordinator Abbott Vascular Devices 400 Saginaw Drive Redwood City, California 94063
Re: K031331
Trade/Device Name: Xceed™ Nitinol Self-Expanding Transhepatic Biliary Stent System Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: August 1, 2003 Received: August 4, 2003
Dear Ms. Kuskowski:
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 A'ct 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. Joanna Kuskowski
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.D. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number: K031331
Device Name: Abbott Vascular Devices Xceed™ Nitinol Self-Expanding Transhepatic Biliary Stent System
FDA's Statement of the Indications For Use for device:
The Abbott Vascular Devices Xceed™ Nitinol Self-Expanding Transhepatic Biliary Stent System is intended for use in the palliation of malignant neoplasms in the biliary tree.
Prescription Use (Per 21 CFR 801.109)
OR
Over-the-Counter Use
David A. Ligman
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.