(62 days)
The wavemaX™ Balloon-Expandable Transhepatic Biliary Stent System is intended for use in the palliation of malignant neoplasms in the biliary tree.
The wavemaX™ Balloon-Expandable Transhepatic Biliary Stent System is comprised of a balloon-expandable stent mounted on 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 wavemaX™ Balloon-Expandable Transhepatic Biliary Stent System and an FDA clearance letter. It does not contain information about specific acceptance criteria or a study proving the device meets them in the format requested.
The document primarily focuses on establishing substantial equivalence to predicate devices based on:
- Intended Use: Palliation of malignant neoplasms in the biliary tree.
- Design and Principle of Operation.
- Biocompatibility: Stated that "all materials are biocompatible."
- Performance Characteristics: Stated that "physical properties are appropriate for the intended use."
- Non-clinical testing: "Non-clinical testing was conducted."
Without a detailed study report, I cannot complete the requested information. The document explicitly states: "Abbott Vascular Devices has submitted information on indication for use, design and principle of operation, biocompatibility and performance characteristics to establish that wavemaX™ Balloon-Expandable Transhepatic Biliary Stent System is substantially equivalent to currently marketed predicate device." This indicates that the regulatory clearance was based on equivalence, not necessarily on a novel clinical study with explicit acceptance criteria for performance metrics.
Therefore, I cannot provide the requested table and detailed study information as it is not present in the provided text.
If this were a typical request, and if such a study were present, the information would be structured as follows (and I would fill it in if the data was available):
Acceptance Criteria and Device Performance Study
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| [Example: Primary Patency Rate] | [Example: > 70% at 6 months] | [Example: 78% (95% CI: 72-84%)] |
| [Example: Adverse Event Rate (specific type)] | [Example: < 5%] | [Example: 3.2%] |
| [Example: Technical Success Rate] | [Example: > 95%] | [Example: 98%] |
| (Detailed metrics regarding stent expansion, migration, fracture, etc., would be listed here if available) |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): [Not provided in the document]
- Data Provenance: [Not provided in the document; typically includes country of origin, retrospective/prospective, multicenter/single-center]
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: [Not provided in the document]
- Qualifications of Experts: [Not provided in the document; example: Interventional Radiologists with 10+ years of experience in biliary interventions]
4. Adjudication method for the test set
- Adjudication Method: [Not provided in the document; example: 2+1 (2 reviewers agree, 3rd resolves disagreement) or consensus panel]
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
- MRMC Study: No, this device is a physical medical device (stent), not an AI/software device intended for diagnostic interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No, this is a physical medical device (stent), not an AI/software device.
7. The type of ground truth used
- Type of Ground Truth: [Not explicitly detailed, but for a stent, ground truth typically relates to outcomes data like patency, re-intervention rates, complication rates, and possibly histological confirmation of malignancy for inclusion criteria.]
8. The sample size for the training set
- Sample Size (Training Set): [Not applicable or not provided. For a physical device based on substantial equivalence, there isn't typically a "training set" in the machine learning sense.]
9. How the ground truth for the training set was established
- Ground Truth Establishment (Training Set): [Not applicable for this type of device and submission.]
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APPENDIX A. 510(k) SUMMARY
| A. Sponsor/Submitter: | Abbott Vascular Devices400 Saginaw DriveRedwood City, CA 94063 |
|---|---|
| B. Contact Person: | Joanna KuskowskiRegulatory Affairs CoordinatorPhone:(650) 474-3331Fax:(650) 474-3020 |
| Date of Submission: | December 16, 2003 |
| Device Trade Name: | wavemaX™ 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: | Cordis Palmaz Genesis Transhepatic Biliary Stent (K012590)Abbott Vascular Devices Xpert™ Self-Expanding TranshepaticBiliary Stent System (K033537) |
| Intended Use: | The wavemaX™ Balloon-Expandable Transhepatic Biliary StentSystem is intended for use in the palliation of malignant neoplasms inthe biliary tree. |
| Device Description: | The wavemaX™ Balloon-Expandable Transhepatic Biliary StentSystem is comprised of a balloon-expandable stent mounted on anover the wire (OTW) delivery system designed to deliver the stent tothe biliary tree. |
| Summary of Substantial Equivalence: | Abbott Vascular Devices has submitted information on indication foruse, design and principle of operation, biocompatibility andperformance characteristics to establish that wavemaX™ Balloon-Expandable Transhepatic Biliary Stent System is substantiallyequivalent to currently marketed predicate device.The wavemaX™ Balloon-Expandable Transhepatic Biliary StentSystem has 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 wavemaX™ Balloon-Expandable TranshepaticBiliary Stent System has been shown to be substantially equivalent tothe Class II predicate upon which the device is based. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters. The text is arranged around the top half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 3 2004
Ms. Joanna Kuskowski Regulatory Affairs Coordinator Abbott Vascular Devices 400 Saginaw Drive Redwood City, California 94063
Re: K033909
Trade/Device Name: wavemaX™ 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: December 16, 2003 Received: December 17, 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 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 (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 arc 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, ply see 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: K033909
Device Name: Abbott Vascular Devices wavemaX™ Balloon-Expandable Transhepatic Biliary Stent System
FDA's Statement of the Indications For Use for device:
The Abbott Vascular Devices wavemaX™ Balloon-Expandable Transhepatic Biliary Stent System is intended for use in the palliation of malignant neoplasms in the biliary tree.
Prescription Use V (Per 21 CFR 801.109)
OR
Over-the-Counter Use -------
David le Seggern
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 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.