(72 days)
The Xpand™ Balloon-Expandable Transhepatic Biliary Stent System is intended for use in the palliation of malignant neoplasms in the biliary tree.
The Xpand™ Balloon-Expandable Transhepatic Biliary Stent System is comprised of a balloon-expandable stent mounted on the balloon of an over the wire (OTW) delivery system designed to deliver the stent to the biliary tree.
The provided text is a 510(k) summary for the Xpand™ Balloon-Expandable Transhepatic Biliary Stent System. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and device performance metrics in the way one would see for a novel AI/software device.
Therefore, the requested information elements related to AI/software performance studies (such as specific performance metrics, sample sizes for test/training sets, expert ground truth, adjudication methods, and MRMC studies) are not present in this document.
However, I can extract the available information regarding the device and its demonstrated equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" or provide "reported device performance" in numerical metrics for the Xpand™ Stent System. Instead, the submission focuses on establishing substantial equivalence to a predicate device (wavemaX™ Transhepatic Biliary Stent, K033909) based on qualitative and certain non-clinical tests.
The criteria for substantial equivalence, which can be interpreted as the "acceptance criteria" in this context, are:
| Acceptance Criteria (based on Substantial Equivalence Claim) | Reported Device "Performance" (demonstration of equivalence) |
|---|---|
| Same intended use as predicate device | The Xpand™ Stent System has the same intended use: palliation of malignant neoplasms in the biliary tree. |
| Materials are biocompatible | Results of scientific testing ensured all materials are biocompatible. |
| No new adverse effects introduced | Scientific testing ensured no new adverse effects were introduced. |
| Physical properties appropriate for intended use | Scientific testing ensured physical properties are appropriate for the intended use. |
| Design and principle of operation are similar | Information on design and principle of operation was submitted to establish equivalence. |
| Performance characteristics are similar | Performance characteristics were submitted to establish equivalence (likely referring to non-clinical tests). |
2. Sample size used for the test set and the data provenance
Not applicable. This is a medical device (stent) submission, not an AI/software device that would typically have a "test set" in the context of diagnostic performance evaluation. The data provenance would be related to the non-clinical testing performed on the device itself. The document mentions "non-clinical testing was conducted" but does not specify the sample size or further details.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This information is typically relevant for diagnostic AI/software devices. The "ground truth" for a stent would be established through clinical outcomes, device integrity testing, and biocompatibility testing, not through expert consensus on a test set of images.
4. Adjudication method for the test set
Not applicable for a medical device's non-clinical testing.
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
Not applicable. This is a medical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device, not an algorithm.
7. The type of ground truth used
For this type of device, the "ground truth" for demonstrating safety and effectiveness for substantial equivalence would generally derive from:
- Biocompatibility testing: Compliance with ISO standards for materials.
- Mechanical/Physical testing: Bench testing to evaluate stent expansion, radial strength, flexibility, fatigue resistance, and crimp integrity, compared to the predicate device.
- Sterilization validation: Ensuring the device can be sterilized effectively.
- Clinical experience/performance of the predicate device: The basis for establishing the safety and effectiveness of the equivalent device.
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. Non-clinical testing was conducted." This implies that the ground truth was established through laboratory-based scientific testing and comparisons to established standards and the known performance of the predicate device.
8. The sample size for the training set
Not applicable. This is a medical device, not an AI/software device.
9. How the ground truth for the training set was established
Not applicable. This is a medical device, not an AI/software device.
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1 2004 ОСТ
APPENDIX A. 510(k) SUMMARY
| APPENDIX A. 510(k) SUMMARY | K041962 | |
|---|---|---|
| Page 1 of 1 | ||
| Sponsor/Submitter: | Abbott Vascular Devices400 Saginaw DriveRedwood City, CA 94063 | |
| Contact Person: | Joanna KuskowskiRegulatory Affairs CoordinatorPhone:(650) 474-3331Fax:(650) 474-3020 | |
| Date of Submission: | July 20, 2004 | |
| Device Trade Name: | Xpand™ Balloon-Expandable 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: | wavemaX™ Transhepatic Biliary Stent (K033909) | |
| Intended Use: | The Xpand™ Balloon-Expandable Transhepatic Biliary Stent Systemis intended for use in the palliation of malignant neoplasms in thebiliary tree. | |
| Device Description: | The Xpand™ Balloon-Expandable Transhepatic Biliary Stent Systemis comprised of a balloon-expandable stent mounted on the balloon ofan over the wire (OTW) delivery system designed to deliver the stentto the biliary tree. | |
| Summary of SubstantialEquivalence: | Abbott Vascular Devices has submitted information on indication foruse, design and principle of operation, biocompatibility andperformance characteristics to establish that Xpand™ Balloon-Expandable Transhepatic Biliary Stent System is substantiallyequivalent to currently marketed predicate device.The Xpand™ Balloon-Expandable Transhepatic Biliary Stent Systemhas the same intended use as the predicate device. Results ofscientific testing have ensured that all materials are biocompatible, nonew adverse effects were introduced and physical properties areappropriate for the intended use. Non-clinical testing was conducted.In conclusion, the Xpand™ Balloon-Expandable Transhepatic BiliaryStent System has been shown to be substantially equivalent to theClass II predicate upon which the device is based. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. 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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1 2004 OCT
Ms. Joanna Kuskowski Regulatory Affairs Coordinator Abbott Vascular Devices 400 Saginaw Drive REDWOOD CITY CA 94063
Re: K041962
Trade/Device Name: Xpand™ Balloon-Expandable Transhepatic Biliary Stent System Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: July 20, 2004 Received: July 22, 2004
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 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. 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 (OS) 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,
Sincerely yours,
nna-Bea Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number: K041962
Device Name: Abbott Vascular Devices Xpand™ Balloon-Expandable Transhepatic Biliary Stent System
FDA's Statement of the Indications For Use for device:
The Abbott Vascular Devices Xpand™ Balloon-Expandable 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. Seymann
(Division Sign-Off) Division of Reproductive, A 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.