(29 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.
The provided document is a 510(k) summary for the Xceed Nitinol Self-Expanding Transhepatic Biliary Stent System. It details the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically associated with AI/software devices (e.g., performance metrics, ground truth, expert adjudication).
This document is for a physical medical device (a stent and delivery system), and the concept of "acceptance criteria" for its performance is addressed through different types of testing, primarily non-clinical (mechanical, materials, functional) testing, rather than studies involving performance metrics like sensitivity, specificity, or reader improvement.
Therefore, I cannot fulfill most of your request as the information is not present in the provided text. I can, however, extract the information that is available:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the document. The document states:
- "Substantial equivalence was confirmed through non-clinical testing." This implies that the device met certain internal or regulatory criteria for physical and functional performance, but the specific metrics, acceptance thresholds, and measured results are not detailed.
2. Sample size used for the test set and the data provenance:
This information is not applicable/provided in the context of this 510(k) summary for a physical stent system. There is no "test set" of data in the sense of images or cases. "Non-clinical testing" typically involves bench testing, material characterization, and perhaps animal models, not human data sets.
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/provided. As noted above, there isn't a "test set" requiring expert ground truth in the context of this submission.
4. Adjudication method for the test set:
This information is not applicable/provided.
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:
This information is not applicable/provided. MRMC studies are relevant for software/AI devices where human reader performance is being evaluated, often with and without AI assistance. This document is for a physical stent.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable/provided. This is a physical device, not an algorithm.
7. The type of ground truth used:
This information is not applicable/provided. For a physical device like a stent, "ground truth" would relate to its physical properties meeting specifications, achieved through engineering and quality control, rather than expert consensus on diagnostic imaging.
8. The sample size for the training set:
This information is not applicable/provided. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
This information is not applicable/provided.
Summary of available information from the document (relevant to the device itself):
- Device Trade Name: Xceed Nitinol Self-Expanding Transhepatic Biliary Stent System
- Intended Use: The Xceed Nitinol Self-Expanding Transhepatic Biliary Stent System is intended for use in the palliation of malignant neoplasms in the biliary tree.
- Predicate Device: Xceed Nitinol Self-Expanding Transhepatic Biliary Stent System (K032929)
- Proof of Substantial Equivalence: "Substantial equivalence was confirmed through non-clinical testing."
- FDA Labeling Limitation: "The safety and effectiveness of this device for use in the vascular system have not been established." And the biliary use indication must be prominently displayed.
In essence, the document serves as a regulatory submission for a physical medical device, not an AI or software-based diagnostic tool, which is why the specific metrics and study designs you've asked for are not present.
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KOSO103 ***. 1~
FED 1 A 2005
Special 510(k): Device Modification ('ONFIDENTIAL ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
APPENDIX A. 510(k) SUMMARY
| Sponsor/Submitter: | Abbott LaboratoriesAbbott Vascular Devices400 Saginaw DriveRedwood City, CA 94063 |
|---|---|
| Contact Person: | Ann E. LeonardRegulatory Affairs CoordinatorPhone:(650) 474-3477Fax:(650) 474-3041 |
| Date of Submission: | January 17, 2005 |
| Device Trade Name: | Xceed Nitinol Self-Expanding Transhepatic Biliary Stent System |
| 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: | Xceed Nitinol Self-Expanding Transhepatic Biliary Stent System(K032929) |
| Intended Use: | The Xceed Nitinol Self-Expanding Transhepatic Biliary StentSystem is intended for use in the palliation of malignant neoplasmsin the biliary trec. |
| Device Description: | The Abbott Vascular Devices Xceed Nitinol Self-ExpandingTranshepatic Biliary Stent System is comprised of a delivery systemand a self-expanding stent. The delivery system is an over the wire(OTW) system designed to deliver the self-expanding stent to thebiliary tree. |
| Summary of SubstantialEquivalence: | The Xceed Nitinol Self-Expanding Transhepatic Biliary StentSystem is substantially equivalent to the predicate device.Substantial equivalence was confirmed through non-clinical testing. |
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 6 2005
Ann E. Leonard, Ph.D. Regulatory Affairs Coordinator Abbott Vascular Devices 400 Saginaw Drive REDWOOD CITY CA 94063
Re: K050103
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: January 17, 2005 Received: January 18, 2005
Dear Dr. Lconard:
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. Thereforc, 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 - Dr. Ann Leonard
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,
Qaritu
Donna-Bea Tillman, Ph.D. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number: K050103
Device Name: Abbott Vascular Devices™ Xceed™ Nitinol Self-F.xpanding Transhepatic Biliary Stent System
FDA's Statement of the Indications For Use for device:
The Abbott Vascular Devices 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)
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Over-the-Counter Use --------
Javici burdon
(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devi
510(k) Number K050102
§ 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.