(130 days)
The WallFlex" Biliary RX Stent System is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms.
The proposed 10mm X 40mm Uncovered WallFlex™ Biliary RX Stent System consists of a self-expanding 10mm outer diameter by 40mm length metal stent and a delivery catheter. The proposed stent features Platinum cored Nitinol wires wound together to form a cylinder with proximal and distal flares. The stent is mounted onto a sheath delivery system which is a coaxial tubing assembly. This tubing assembly constrains the stent onto the delivery catheter shaft until the stent is released by retracting the exterior tube.
The manufacturer did not provide specific acceptance criteria with numerical targets. Instead, the performance data focused on demonstrating substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical Performance | |
| Dimensional Evaluation | Performed similarly to predicate device |
| Radial Expansion Force | Performed similarly to predicate device |
| Radial Compression Force | Performed similarly to predicate device |
| Trackability | Performed similarly to predicate device |
| Deployment Force | Performed similarly to predicate device |
| Reconstrainment Force | Performed similarly to predicate device |
2. Sample Size and Data Provenance for Test Set:
The document does not specify exact sample sizes for each performance test. It states that "Performance testing was completed to establish substantial equivalence." The tests were presumably conducted on the proposed 10mm X 40mm Uncovered WallFlex™ Biliary RX Stent System.
The provenance of the data is not explicitly stated (e.g., country of origin, retrospective or prospective). However, it is an in-house performance test conducted by Boston Scientific Corporation.
3. Number of Experts and Qualifications for Ground Truth:
Not applicable. This study focuses on engineering performance data of a medical device, not on diagnostic accuracy requiring expert interpretation for ground truth.
4. Adjudication Method:
Not applicable. Adjudication methods are typically relevant for studies involving human interpretation or clinical endpoints.
5. Multi-Reader-Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not conducted. This device is a medical stent, and the study presented here focuses on its physical and mechanical performance compared to a predicate device, not on diagnostic accuracy or reader improvement with AI assistance.
6. Standalone Performance Study:
Yes, a standalone performance study was conducted in the sense that the device's engineering characteristics were tested independently. The performance tests (dimensional evaluation, radial expansion/compression force, trackability, deployment force, reconstrainment force) were conducted on the proposed device. The results were then compared to the predicate device to establish substantial equivalence.
7. Type of Ground Truth Used:
The "ground truth" in this context refers to the established functional and mechanical properties expected of a biliary stent and, more specifically, the performance characteristics of the legally marketed predicate device (uncovered WallFlex Biliary RX Stent System, K061231). The goal was to show that the new size configuration performed "similarly" to the predicate.
8. Sample Size for Training Set:
Not applicable. This is not a machine learning or AI-based study that would require a "training set."
9. How Ground Truth for Training Set Was Established:
Not applicable. This is not a machine learning or AI-based study.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows a sequence of handwritten characters and numbers. The sequence starts with the letter 'K', followed by the number '0', then '81733'. The characters are written in a dark ink, and the image has a simple, unadorned style.
510(K) SUMMARY
1. 510(k) Owner:
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: (508) 683 - 4141 (508) 683 - 5939 Fax:
Contact: Mr. Wing Ng Title: Regulatory Specialist Date Prepared: June 17, 2008
2. Device:
Trade Name: WallFlex™ Biliary RX Stent System Common Name: Biliary Stent System Classification Name: Biliary Catheter and Accessories Regulation Number: 21 CFR 876.5010 Product Code: FGE Classification: Class II
3. Predicate Device:
Boston Scientific Corporation's currently marketed uncovered WallFlex Biliary RX Stent System (K061231).
4, Device Description:
The proposed 10mm X 40mm Uncovered WallFlex Biliary RX Stent System consists of a self-expanding 10mm outer diameter by 40mm length metal stent and a delivery catheter. The proposed stent features Platinum cored Nitinol wires wound together to form a cylinder with proximal and distal flares. The stent is mounted onto a sheath delivery system which is a coaxial tubing assembly. This tubing assembly constrains the stent onto the delivery catheter shaft until the stent is released by retracting the exterior tube.
5. Intended Use:
The WallFlex Biliary RX Stent System is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms.
Page 1 of 2
000015
Endoscopy
100 Boston Scientific Way Marlborough, MA 01752-1234 508-683-4000 Tel www.bostonscientific.com
OCT 2 7 2008
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image shows a sequence of handwritten characters, which appear to be a combination of letters and numbers. The sequence reads 'K081733'. The characters are written in a simple, slightly irregular style, giving them a casual, handwritten appearance. The image is a close-up, focusing solely on the characters without any background context.
6. Technological Characteristics:
The proposed 10mm X 40mm Uncovered WallFlex™ Biliary RX Stent System has identical technological characteristics to the currently marketed uncovered WallFlex Biliary RX Stent System (K061231) with the exception of the stent outer diameter and the stent length dimensions. The purpose of this premarket notification is to add a new stent configuration of 10mm outer diameter by 40mm length that was previously not included in the matrix of cleared uncovered WallFlex Biliary RX Stent System (K061231) sizes.
7. Performance Data:
Performance testing was completed to establish substantial equivalence between the proposed device and the predicate device. This testing included dimensional evaluation, radial expansion force, radial compression force, trackability, deployment force, and reconstrainment force. The results of the performance testing show that the proposed device performed similarly to the predicate device which supports the determination of substantial equivalence.
8. Conclusion:
Based on performance testing results, Boston Scientific Corporation has concluded that the proposed 10mm X 40mm Uncovered WallFlex Biliary RX Stent System is substantially equivalent to the currently marketed uncovered WallFlex Biliary RX Stent System (K061231).
page 2 of 2
000016
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Wing Ng Regulatory Affairs Specialist Boston Scientific Corporation Endoscopy Division 100 Boston Scientific Way MARLBOROUGH MA 01752-1234
OCT 2 7 2008
Re: K081733
Trade/Device Name: 10mm X 40mm Uncovered WallFlex™ Biliary RX Stent System Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: October 17, 2008 Received: October 20, 2008
Dear Mr. Ng:
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 interstance 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 cold de ause harm. Therefore, in accordance with Section 513(i)(i)(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.
{3}------------------------------------------------
Page 2 - Mr. Wing Ng
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 (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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
510(k) Number: K081733
Device Name: 10mm X 40mm Uncovered WallFlex™ Biliary RX Stent System
FDA's Statement of the Indications for Use for device:
The WallFlex" Biliary RX Stent System is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms.
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)
Helena Romer
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Page 1 of 1
§ 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.