(25 days)
The Boston Scientific Express™ Biliary LD Unmounted Stent is indicated for use in the palliation of malignant neoplasms in the biliary tree.
The Express Biliary LD Unmounted Stent will be the identical stent that is currently marketed as the Express Biliary LD Premounted Stent System (K021630 and K024048). The stent will be hand mounted by the user upon its recommended balloon delivery catheter.
The Express Biliary LD Stent is a balloon expandable metallic 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 Express Biliary LD Stent is made from 316L surgical grade stainless steel tubing. The seamless tubing is initially extruded to a cylindrical shape, and is then drawn down in a series of steps to the final tubing dimension. The stent is formed by laser cutting the pattern from the tube, then it is cleaned and electropolished to obtain smooth rounded struts.
The geometry is a continuous pattern consisting of large and small sinusoidal bands connected by axial struts. The deployed stent provides radial strength while conforming to the natural curvature of the anatomy.
The Express Biliary LD Stent will be offered in Small Lumen (SL) and Large Lumen (LL) models. The SL model will be offered in lengths of 17 mm, 27 mm, 37 mm, and 57 mm and is designed to expand from 6 mm to 8 mm in diameter. The LL model will be offered in lengths of 25 mm, 37 mm, and 57 mm and is designed to expand from 9 mm to 10 mm in diameter. They are the identical stent sizes in which the Express Biliary LD Premounted Stent System is offered.
The provided text describes the Boston Scientific Express Biliary LD Unmounted Stent. However, it does not contain specific acceptance criteria, reported device performance metrics (e.g., sensitivity, specificity, accuracy), or details of a study involving human readers or AI assistance. The document focuses on establishing substantial equivalence to a predicate device through non-clinical testing.
Therefore, many of the requested sections cannot be filled from the provided text.
Here's a breakdown of what can be extracted and what is missing:
The device described is the Boston Scientific Express Biliary LD Unmounted Stent, indicated for the palliation of malignant neoplasms in the biliary tree.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided in the document. The document states that "safety and effectiveness... have been demonstrated via data collected from non-clinical design verification tests and analyses." However, specific numerical acceptance criteria or performance metrics (like accuracy, sensitivity, or specificity) are not detailed. | Not provided in the document. The document states "Test results verified that the Express Biliary LD Unmounted Stent is adequate for its intended use." No specific performance data is presented. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable. The document describes non-clinical design verification tests and analyses, not a clinical study involving human or AI interpretation of a test set.
- Data Provenance: Not applicable. The tests are non-clinical (biocompatibility, product and packaging shelf life testing).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. No experts were used for ground truth establishment as it was a non-clinical evaluation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. There was no test set requiring adjudication in the context of human or AI performance.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done, and therefore, no effect size for human readers with and without AI assistance is reported. This submission is for a medical device (a stent), not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical stent, not an algorithm, so standalone algorithm performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of diagnostic accuracy. The ground truth for the non-clinical tests would be based on engineering specifications, material standards, and validated laboratory methodologies for biocompatibility and shelf-life testing.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI model, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI model.
Summary of the study that proves the device meets the acceptance criteria (based on the provided text):
The device (Express Biliary LD Unmounted Stent) received clearance based on non-clinical design verification tests and comparative analysis to a predicate device. The key arguments for demonstrating safety and effectiveness were:
- Identical Stent: The Express Biliary LD Unmounted Stent is stated to be the "identical stent that is currently marketed as the Express Biliary LD Premounted Stent System (K021630 and K024048)."
- Identical Design and Technology: It incorporates the "identical design, method of deployment, fundamental technology, manufacturing, sterilization, and intended use" as the predicate device.
- Identical Sizes: The available stent sizes (SL and LL models with various lengths and diameters) are identical to those offered in the premounted system.
- Non-Clinical Testing: "Biocompatibility, product and packaging shelf life testing have also been conducted." The results "verified that the Express Biliary LD Unmounted Stent is adequate for its intended use."
The entire submission is essentially a declaration of substantial equivalence to existing, legally marketed predicate devices, supported by non-clinical testing demonstrating that the unmounted version performs equivalently to the premounted version, with the primary difference being user-mounting onto a recommended, existing delivery catheter. There is no mention of clinical trials or performance evaluations involving human readers or AI.
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Special 510(k) Notification Boston Scientific Corporation Express Biliary LD Unmounted Stent
MAR 2 5 2003
KO30645 l of 3
Section 6
Summary of Safety and Effectiveness
(Pursuant To Section 12 of the SAFE MEDICAL DEVICES ACT of 1990)
6.1 General Provisions
| Submitter's Name and Address | 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 |
| Proprietary Name | Boston Scientific CorporationExpress Biliary LD Unmounted Stent |
| Name of Predicate Device | Boston Scientific Express Biliary LDPremounted Stent System |
| Device Descriptions |
Stent Description
6.2
6.3
The Express Biliary LD Unmounted Stent will be the identical stent that is currently marketed as the Express Biliary LD Premounted Stent System (K021630 and K024048). The stent will be hand mounted by the user upon its recommended balloon delivery catheter.
The Express Biliary LD Stent is a balloon expandable metallic 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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K030645
page 2 of 3
Section 6
Summary of Safety and Effectiveness
The Express Biliary LD Stent is made from 316L surgical grade stainless steel tubing. The seamless tubing is initially extruded to a cylindrical shape, and is then drawn down in a series of steps to the final tubing dimension. The stent is formed by laser cutting the pattern from the tube, then it is cleaned and electropolished to obtain smooth rounded struts.
The geometry is a continuous pattern consisting of large and small sinusoidal bands connected by axial struts. The deployed stent provides radial strength while conforming to the natural curvature of the anatomy. The stent provides a ghost like image using conventional radiographic imaging equipment.
The Express Biliary LD Stent will be offered in Small Lumen (SL) and Large Lumen (LL) models. The SL model will be offered in lengths of 17 mm, 27 mm, 37 mm, and 57 mm and is designed to expand from 6 mm to 8 mm in diameter. The LL model will be offered in lengths of 25 mm, 37 mm, and 57 mm and is designed to expand from 9 mm to 10 mm in diameter. They are the identical stent sizes in which the Express Biliary LD Premounted Stent System is offered.
Recommended Delivery Catheter
The delivery catheter recommended for use with the proposed Express Biliary LD Stent will be 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 Premounted Stent System, with the exception of a slighty different hub design.
The Ultra-thin SDS Balloon Dilatation Catheter is an over-the-wire catheter offered in a two lumen catheter shaft design. One lumen is used to pass the catheter over a guidewire. The Ultra-thin SDS catheter is designed to be placed over guidewires which have outer diameters of 0.035" or smaller. The second lumen communicates with the balloon and is used to inflate and deflate the balloon during the procedure. The guidewire lumen and the balloon lumen terminate at the proximal end of the catheter by means of a bifurcated hub with luer lock fittings.
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Section 6
Summary of Safety and Effectiveness
A more detailed device description is provided in the original 510(k) applications (K011909 or K011889, Attachment A, Device Description) and is provided in Section 8 of this submission.
6.4 Intended Use
The Express™ Biliary LD Stent is indicated for the palliation of malignant neoplasms in the biliary tree.
Summary of Technological Characteristics 6.5
The Boston Scientific Express Biliary LD Unmounted Stent will incorporate the identical design, method of deployment, fundamental technology, manufacturing, sterilization, and intended use as those featured in the currently marketed Express Biliary LD Premounted Stent System (K021630 and K024048).
6.6 Non-clinical Test Summary
The safety and effectiveness of the Express Biliary LD Unmounted Stent have been demonstrated via data collected from non-clincal design verification tests and analyses.
Biocompatibility, product and packaging shelf life testing have also been conducted. Test results verified that the Express Biliary LD Unmounted Stent is adequate for its intended use.
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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's emblem in the center. The emblem is a stylized caduceus, featuring a staff with a serpent entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 5 2003
Mr. Todd Kornmann Sr. Regulatory Affairs Specialist Boston Scientific Scimed, Inc. One Scimed Place MAPLE GROVE MN 55311-1566
Re: K030645
Trade/Device Name: 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: February 27, 2003 Received: February 28, 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.
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
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Page 2 -- Mr. Todd Kornmann
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,
Damel 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 (if known): K030645
Device Name: Boston Scientific Express™ Biliary LD Unmounted Stent
FDA's Statement of the Indications For Use for device:
The Boston Scientific Express™ Biliary LD Unmounted Stent is indicated for use in the palliation of malignant neoplasms in the biliary tree.
| Prescription Use | √ |
|---|---|
| (Per 21 CFR 801.109) |
OR
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
Nancy Chrigdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K030645
§ 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.