(27 days)
The Boston Scientific Express™ Biliary LD Stent is indicated for the palliation of malignant neoplasms in the biliary tree.
The 5 mm Express Biliary LD Stent (Premounted Stent System and Unmounted Stent) are identical to the currently marketed Express Biliary LD Premounted Stent Systems (K021630 and K024048) and to the currently marketed Express Biliary LD Unmounted Stents (K030645), with the exception of size. The Express Biliary LD Stent is a balloon expandable 316L surgical grade stainless steel stent intended to maintain patency of biliary strictures produced by malignant neoplasms. The stent will be available in a variety of sizes to address clinician needs.
The provided text describes a 510(k) summary for the Boston Scientific Express Biliary LD Stent and explicitly states the device's substantial equivalence to predicate devices based on non-clinical testing. It does not contain information about acceptance criteria, device performance via a clinical study, sample sizes, expert involvement, adjudication methods, MRMC studies, or standalone algorithm performance. The information focuses on design, manufacturing, and intended use equivalence, referencing existing 510(k) applications for a detailed device description.
Therefore, I cannot fulfill your request for information regarding clinical study setup and results from the provided text. The document is a regulatory submission focused on demonstrating substantial equivalence through non-clinical means.
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AUG 2 7 2003
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Section 6
510(k) Summary
(Pursuant To 21 CFR 807.92)
General Provisions 6.1
| Submitter's Name andAddress | Boston Scientific CorporationOne Scimed PlaceMaple Grove, Minnesota 55311 |
|---|---|
| Contact Person | Todd Kornmann(763) 494-2467 |
| Classification Name | Biliary Catheter and AccessoriesProduct Code - 78 FGERegulation Number 21 CFR Part 876.5010 |
| Common or Usual Name | Biliary Stent and Balloon DilatationCatheter |
| Proprietary Name | Boston Scientific CorporationExpress Biliary LD Premounted Stent Systemand Express Biliary LD Unmounted Stent. |
| Name of Predicate Device | Boston Scientific Express Biliary LDPremounted Stent System and ExpressBiliary LD Unmounted Stent |
6.3 Device Description
Stent Description
6.2
The 5 mm Express Biliary LD Stent (Premounted Stent System and Unmounted Stent) are identical to the currently marketed Express Biliary LD Premounted Stent Systems (K021630 and K024048) and to the currently marketed Express Biliary LD Unmounted Stents (K030645), with the exception of size.
The Express Biliary LD Stent is a balloon expandable 316L surgical grade stainless steel stent intended to maintain patency of biliary strictures produced by malignant neoplasms. The stent will be available in a variety of sizes to address clinician needs.
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510(k) Summary
The currently marketed Express Biliary LD Premounted Stent System and Express Biliary LD Unmounted Stent are offered with stent diameters of 6 - 10 mm, in one mm increments. The 6 - 8 mm diameter stents have lengths of 17 mm, 27 mm, and 57 mm. These are considered to be the Small Lumen (SL) models. The 5 mm diameter is proposed for these stent lengths and is the subject of this submission.
The 9 mm and 10 mm diameter stents have lengths of 25 mm, 37 mm, and 57 mm. These are considered to be the Large Lumen (LL) models.
Express Biliary LD Premounted Balloon Delivery Catheter
The balloon delivery catheter for the 5 mm Express Biliary LD Premounted Stent System is identical to the balloon delivery catheter utilized on the currently marketed Express Biliary LD Premounted Stent Systems (K021630 and K024048). The balloon delivery catheter is an over-the-wire catheter offered in a two lumen catheter shaft design.
Express Biliary LD Unmounted Stent Recommended Delivery Catheter
The delivery catheter recommended for use with the 5 mm Express Biliary LD Unmounted Stent is the currently marketed Boston Scientific Ultra-thin SDS Balloon Dilatation catheter (K011889 and K011909). The Ultra-thin SDS catheter was determined substantially equivalent for PTA indications under K011889, and for the indication of stent deployment / optimization of a Biliary Stent under K011909.
The recommended delivery catheter, the Ultra-thin SDS Balloon Dilatation Catheter, is the identical catheter that is utlized for the Express Biliary LD Unmounted Stents cleared to market under K030645. The Ultra-thin SDS Balloon Dilatation Catheter is an overthe-wire catheter offered in a two lumen catheter shaft design.
A more detailed device description is provided in the original 510(k) applications (K011909 or K011889, Attachment A, Device Description) and is also provided in Section 8 of this submission.
6.4 Intended Use
The Express Biliary LD Stent is indicated for the treatment of biliary strictures produced by malignant neoplasms.
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Section 6
510(k) Summary
Comparison of Required Technological Characteristics ર્ભ.સ
The Boston Scientific 5 mm Express Biliary LD Stent will incorporate the identical design, method of deployment, fundamental technology, manufacturing, packaging, labeling, sterilization, and intended use as those in the currently marketed the Express Biliary LD Premounted Stent System (K021630 and K024048) and Express Biliary LD Unmounted Stents (K030645).
Summary of Non-clinical Test Summary 6.6
The safety and effectiveness of the the 5 mm Express Biliary LD Stent in both the Premounted an Unmounted models have been demonstrated via data collected from nonclincal design verification tests and analyses.
Sterilization, biocompatibility, product and packaging shelf life testing have also been evaluated. Test results verified that the 5 mm Express Biliary LD Stent is adequate for its intended use.
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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three birds in flight, represented by curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 7 2003
Mr. Todd Kornmann Sr. Regulatory Affairs Specialist Boston Scientific Corporation One Scimed Place Maple Grove, Minnesota 55311-1566
Re: K032360
Trade/Device Name: Boston Scientific Express™ Biliary LD Premounted Stent System and Express™ Biliary LD Unmounted Stent Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: August 1, 2003 Received: July 31, 2003
Dear Mr. Kornmann:
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 -- Mr. Todd Kornmann
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,
Daniel C. Schultz, M.D.
Daniel G. Schultz, M.D. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page_1 of 1
510(k) Number: K032360
Device Name: Boston Scientific Express™ Biliary LD Premounted Stent System and Express™ Biliary LD Unmounted Stent
FDA's Statement of the Indications For Use for device:
The Boston Scientific Express™ Biliary LD Stent is indicated for the palliation of malignant neoplasms in the biliary tree.
1 Prescription Use (Per 21 CFR 801.109)
OR
Over-the-Counter Use
David A. Segner
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Dev. 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.