(161 days)
The Boston Scientific Express™ Biliary LD Premounted Stent System is intended for the palliation of malignant neoplasms in the biliary tree.
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, after which 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 excellent 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 Vessel (SV) and Large Vessel (LV) models. The SV model will be used for vessel diameters ranging from 6 mm through 8 mm, with lengths of 17 mm, 37 mm, and 57 mm. The LV model will be used for vessel diameters of 9 mm and 10 mm with lengths of 25 mm, 37 mm, and 57 mm.
The Express Biliary LD balloon delivery catheter will be substantially equivalent to the legally marketed Boston Scientific Ultra-thin SDS Balloon Dilatation Catheter (K011889 and K011909). The delivery catheter is identical to the predicate catheter with the exception of one minor component and material change and one design change associated with the number of balloon folds. The hub utilized for the delivery catheter will be the hub design currently used on the Boston Scientific Synergy Balloon Dilatation Catheter (submitted under the name SC 35 Balloon Dilatation Catheter), cleared to market under K993303 and K993305. The Balloon Delivery 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 proposed device is designed to be placed over guidewires which have outer diameters of 0.035" or smaller. This lumen can also be used for infusion of contrast medium. The second lumen communicates with the balloon and is used to inflate and deflate the balloon during the stenting 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.
The provided document does not contain acceptance criteria for device performance in the traditional sense of a study with quantitative metrics and statistical analysis. Instead, it describes a 510(k) premarket notification for a medical device (Boston Scientific Express Biliary LD Premounted Stent System), which focuses on demonstrating substantial equivalence to a predicate device already on the market.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth are not applicable to this type of regulatory submission.
However, I can extract information related to the non-clinical testing performed to establish this substantial equivalence.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of specific numerical acceptance criteria alongside quantifiable reported device performance in the typical scientific study format. Instead, it lists various functional tests and concludes that the test results "verified that the Express Biliary LD Premounted Stent System is adequate for its intended use and is considered substantially equivalent to the legally marketed Johnson & Johnson Corinthian IQ Transhepatic Biliary Stent with Delivery Catheter." Essentially, the "acceptance criteria" here implicitly mean passing these functional tests to demonstrate similar performance to the predicate device.
| Functional Component | Functional Tests Performed | Stated Performance (Implicit Acceptance) |
|---|---|---|
| Stent | Tensile and elongation | "Test results verified that the Express Biliary LD Premounted Stent System is adequate for its intended use and is considered substantially equivalent to the legally marketed Johnson & Johnson Corinthian IQ Transhepatic Biliary Stent with Delivery Catheter based on a comparison of intended use, the design, and the results of in-vitro testing and evaluation." This statement applies to all functional tests. For the shelf life testing, "the data must show acceptable results after 2 years accelerated aging in order to claim the labeled shelf life of two years." |
| Bile corrosion resistance | ||
| Dimensional verification (strut widths, stent lengths) | ||
| Foreshortening | ||
| Recoil | ||
| Expansion uniformity | ||
| Compression resistance | ||
| Over expansion | ||
| Deployment accuracy | ||
| Balloon Delivery | Multiple balloon inflation within a stent | |
| Catheter | Balloon burst within a stent | |
| Balloon inflation and deflation time | ||
| Balloon proximal bond tensile | ||
| Stent / balloon crossing profile | ||
| Sheath insertion / withdrawal force | ||
| Stent securement force | ||
| Tracking | ||
| Hub to shaft tensile | ||
| Biocompatibility | Biocompatibility testing | "Biocompatibility has also been conducted. Test results verified that the Express Biliary LD Premounted Stent System is adequate for its intended use..." |
| Shelf Life | Accelerated aging (for 2 years shelf life claim) | "Product shelf life testing will be conducted and the data must show acceptable results after 2 years accelerated aging in order to claim the labeled shelf life of two years." (This is a forward-looking statement, indicating future compliance). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the sample sizes (e.g., number of stents or catheters tested) for any of the functional or biocompatibility tests.
- Data Provenance: The tests are described as "Non-clinical Test Summary" and "in-vitro testing and evaluation." This indicates that the tests were conducted in a laboratory setting, likely by the manufacturer (Boston Scientific Corporation, One Scimed Place, Maple Grove, Minnesota), rather than involving human clinical data. Therefore, country of origin related to patient data, retrospective/prospective, are not applicable.
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)
- This information is not applicable as the tests described are functional and biocompatibility bench/in-vitro tests, not clinical evaluations requiring expert interpretation of patient data or images to establish a "ground truth" for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable for the same reasons as point 3. These are non-clinical engineering and biological tests, not clinical studies with subjective evaluation that would require adjudication.
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
- An MRMC comparative effectiveness study was not done. This document describes a 510(k) submission for a physical medical device (stent system), not an AI/software device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable, as the device is a physical medical stent system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical tests, the "ground truth" would be established by objective, verifiable engineering and scientific standards (e.g., direct measurements of dimensions, standardized material property tests, established biocompatibility protocols). There's no "expert consensus" or "pathology" in the human diagnostic sense involved.
8. The sample size for the training set
- This is not applicable. There is no "training set" as this is not a machine learning or AI-based device. The device itself is what was tested.
9. How the ground truth for the training set was established
- This is not applicable for the same reason as point 8.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows a handwritten text that appears to be a combination of alphanumeric characters and words. The top line consists of the characters "K021630", while the bottom line reads "Page 1 of 3". The text is written in a casual, handwritten style, and the image seems to be a scan or photograph of a document.
Section 5
Summary of Safety and Effectiveness
(Pursuant To Section 12 of the SAFE MEDICAL DEVICES ACT of 1990)
General Provisions 5.1
| 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 System |
| Name of Predicate Devices | Boston Scientific Ultra-thin™ SDS BalloonDilatation Catheter and Johnson & JohnsonCorinthian™ IQ Transhepatic Biliary Stent |
5.3 Device Description
Stent
5.2
The Express Biliary LD stent will be substantially equivalent to the legally marketed Johnson & Johnson Corinthian IQ Transhepatic Biliary Stent (K992755).
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
{1}------------------------------------------------
pattern from the tube, after which 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 excellent 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 Vessel (SV) and Large Vessel (LV) models. The SV model will be used for vessel diameters ranging from 6 mm through 8 mm, with lengths of 17 mm, 37 mm, and 57 mm. The LV model will be used for vessel diameters of 9 mm and 10 mm with lengths of 25 mm, 37 mm, and 57 mm.
Delivery Catheter
The Express Biliary LD balloon delivery catheter will be substantially equivalent to the legally marketed Boston Scientific Ultra-thin SDS Balloon Dilatation Catheter (K011889 and K011909). The delivery catheter is identical to the predicate catheter with the exception of one minor component and material change and one design change associated with the number of balloon folds. The hub utilized for the delivery catheter will be the hub design currently used on the Boston Scientific Synergy Balloon Dilatation Catheter (submitted under the name SC 35 Balloon Dilatation Catheter), cleared to market under K993303 and K993305.
The Balloon Delivery 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 proposed device is designed to be placed over guidewires which have outer diameters of 0.035" or smaller. This lumen can also be used for infusion of contrast medium.
The second lumen communicates with the balloon and is used to inflate and deflate the balloon during the stenting 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.
5.4 Intended Use
The Express™ Biliary LD Premounted Stent System is indicated for the treatment of biliary strictures produced by malignant neoplasms.
ર્સ્ડ Summary of Technological Characteristics
The Boston Scientific Express Biliary LD Premounted Stent System will incorporate a substantially equivalent design, method of deployment, packaging, fundamental technology, manufacturing, sterilization and intended use as those featured in the
{2}------------------------------------------------
K021630
Page 3 of 3
predicate Johnson and Johnson legally marketed Corinthian IQ Biliary Stent and Delivery System.
5.6 Non-clinical Test Summary
Functional testing for the stent component consisted of tensile and elongation, bile corrosion resistance, dimensional verification (strut widths, stent lengths), foreshortening, recoil, expansion uniformity, compression resistance, over expansion, and deployment accuracy.
Functional testing for the balloon delivery catheter consisted of multiple balloon inflation within a stent, balloon burst within a stent, balloon inflation and deflation time, balloon proximal bond tensile, stent / balloon crossing profile, sheath insertion / withdrawal force, stent securement force, tracking, and hub to shaft tensile.
Biocompatibility has also been conducted. Test results verified that the Express Biliary LD Premounted Stent System is adequate for its intended use and is considered substantially equivalent to the legally marketed Johnson & Johnson Corinthian IQ Transhepatic Biliary Stent with Delivery Catheter based on a comparison of intended use, the design, and the results of in-vitro testing and evaluation.
Product shelf life testing will be conducted and the data must show acceptable results after 2 years accelerated aging in order to claim the labeled shelf life of two years.
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
OCT 2 5 2002
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Todd Kornmann Senior Regulatory Affairs Specialist Boston Scientific Scimed, Inc. One Scimed Place Maple Grove, Minnesota 55311-1566
Re: K021630
Trade/Device Name: Boston Scientific Express™ Biliary LD Premounted Stent System Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: August 19, 2002 Received: August 22, 2002
Dear Mr. Kornmann:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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.
{4}------------------------------------------------
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 above is added to your labeling, as described.
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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.
Daniel G. Schultz, M.D. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Page 1 of 1
510(k) Number (if known): K021630
Device Name: Boston Scientific Express™ Biliary LD Premounted Stent System
FDA's Statement of the Indications For Use for device:
The Boston Scientific Express™ Biliary LD Premounted Stent System is intended for the palliation of malignant neoplasms in the biliary tree.
Prescription Use V OR (Per 21 CFR 801.109)
Over-The-Counter Use
Daniel A. Seymour
(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.