(160 days)
WallFlex® Biliary RX Partially Covered Stent System is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms.
The WallFlex Biliary RX Partially Covered Stent System consists of a self-expanding metal stent and a delivery catheter. The stent is partially covered with Permalume coating and includes a retrieval loop at the proximal end of the stent to aid in removal during the initial stent placement procedure. The stent is mounted onto a sheath delivery system. The delivery system is a coaxial tubing assembly that constrains the stent onto the delivery catheter shaft until the stent is released by retracting the exterior tube.
The provided text is a 510(k) summary for the WallFlex® Biliary RX Partially Covered Stent System. It declares substantial equivalence to previously marketed devices and mentions "In-vitro, in-vivo, and clinical testing have been performed, and all components, subassemblies, and/or full devices met the required specifications for the completed tests." However, it does not provide specific details about the acceptance criteria, reported device performance metrics, sample sizes, ground truth establishment, expert qualifications, or study designs that would allow a comprehensive answer to your request.
Therefore, many of the requested fields cannot be filled from the provided document.
Here's a breakdown of what can and cannot be answered:
1. Table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not specified in the document. The text only states that "all components, subassemblies, and/or full devices met the required specifications for the completed tests." What those specifications were is not detailed.
- Reported Device Performance: Not specified in the document. No numerical performance metrics (e.g., success rates, complication rates, patency rates) are provided.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for any "test set" (clinical, in-vivo, or in-vitro).
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
- Ground Truth Establishment: Not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: 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:
- MRMC Study: Not applicable. This document is for a medical device (stent), not an AI imaging product that would involve human readers interpreting images. Therefore, AI assistance to human readers is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Performance: Not applicable. This is a medical device (stent), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of Ground Truth: Not specified. While "clinical testing" is mentioned, the nature of its ground truth is not detailed.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable/specified. This is a medical device, not an AI model that undergoes "training."
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable.
Summary of available information:
The document states that the WallFlex® Biliary RX Partially Covered Stent System was subjected to "In-vitro, in-vivo, and clinical testing." The primary conclusion drawn from these tests, as presented in this 510(k) summary, is that the device is substantially equivalent to predicate devices (WallFlex Biliary RX Uncovered Stent System and WallStent™ RX Biliary Endoprosthesis). The basis of this substantial equivalence is that the new device shares the "same technological characteristics" and that "all components, subassemblies, and/or full devices met the required specifications for the completed tests."
However, the specific "acceptance criteria" and the "reported device performance" are not detailed in this public summary. The document does not contain the level of detail required to fill out most of the requested fields regarding study design, sample sizes, or ground truth establishment.
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K083374
pg 1 of 2
SECTION 5 510(k) SUMMARY
510(k) SUMMARY
1. Submitter:
Boston Scientific Corporation 100 Boston Scientific Wav Marlborough, MA 01760 Telephone: 508-683-4000 Fax: 508-683-5939
Contact: Marybeth Gamber Manager, Regulatory Affairs Date Prepared: November 12, 2008
2. Device:
Trade Name: WallFlex® Biliary RX Partially Covered Stent System Common Name: Biliary Stent Classification Name: Biliary Catheter and Accessories Regulation Number: 876.5010 Product Code: FGE Classification: Class II
3. Predicate Device:
WallStent™ RX Biliary Endoprosthesis Manufactured by Boston Scientific, Inc. WallFlex® Biliary RX Uncovered Stent System Manufactured by Boston Scientific, Inc.
4. Device Description:
The WallFlex Biliary RX Partially Covered Stent System consists of a self-expanding metal stent and a delivery catheter. The stent is partially covered with Permalume coating and includes a retrieval loop at the proximal end of the stent to aid in removal during the initial stent placement procedure. The stent is mounted onto a sheath delivery system. The delivery system is a coaxial tubing assembly that constrains the stent onto the delivery catheter shaft until the stent is released by retracting the exterior tube.
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K083374
pg 2 of 2
5. Intended Use:
The WallFlex® Biliary RX Partially Covered Stent System is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms.
6. Technological Characteristics:
The WallFlex Biliary RX Partially Covered Stent System has the same technological characteristics as the currently marketed WallFlex Biliary RX Uncovered Stent System (K061231) and the WallStent™ RX Biliary Endoprosthesis (K012752 and K030107).
7. Performance Data:
In-vitro, in-vivo, and clinical testing have been performed, and all components, subassemblies, and/or full devices met the required specifications for the completed tests.
8. Conclusion:
Boston Scientific Corporation has demonstrated that the proposed WallFlex Biliary RX Partially Covered Stent System is substantially equivalent to Boston Scientific Corporation's currently marketed WallFlex Biliary RX Uncovered Stent System (K061231) and WallStent RX Biliary Endoprosthesis (K012752, K030107).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 2 2009
Ms. Marybeth Gamber Manager, Regulatory Affairs Boston Scientific Corporation 100 Boston Scientific Way MARLBORO MA 01752
Re: K083374
Device Name: WallFlex® Biliary RX Partially Covered Stent System Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: April 17, 2009 Received: April 20, 2009
Dear Ms. Gamber:
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. Marybeth Gamber
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.
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.
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.
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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Noth
onna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K083374
Device Name: WallFlex® Biliary RX Partially Covered Stent System
Indications For Use: WallFlex® Biliary RX Partially Covered Stent System is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms.
پ Prescription Use _ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Vortle
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices KO83374 510(k) Number_
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§ 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.