(82 days)
The Boston Scientific Express™ Biliary SD Premounted Stent System is indicated for the palliation of malignant neoplasms in the biliary tree.
The Express Biliary SD Premounted Stent System is available in the models indicated in Table 4.3. A brief description of the device components follows. The Express Biliary SD 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 SD stent is made from 316L surgical grade stainless steel. The stent geometry is a laser-cut pattern consisting of large and small sinusoidal bands connected by axial struts. Additional struts are provided to reinforce the three connector rows of the proximal stent end, resulting in additional scaffolding designed to reduce tumor in-growth at the proximal stent end. The delivery system for the Express Biliary SD Premounted Stent System consists of a Monorail™ catheter with a stent crimped on a balloon near the distal tip. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. The distal segment of the balloon catheter is dual lumen and coaxial. The outer lumen is used for inflation of the balloon. The wire lumen permits the use of guidewires (≤0.018 in / 0,46 mm) to facilitate advancement of the catheter to and through the stricture to be dilated.
This document is a 510(k) Summary for the Boston Scientific Express Biliary SD Premounted Stent System. It primarily focuses on demonstrating substantial equivalence to a predicate device through a comparison of technological characteristics and non-clinical testing.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list "acceptance criteria" in a quantitative way with corresponding numerical performance results for the device. Instead, it outlines a series of non-clinical tests performed to demonstrate that the device functions as intended and is comparable to the predicate device. The implied acceptance criterion for each test is that the device performs acceptably and is substantially equivalent to the predicate.
| Test Category | Specific Test | Implied Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Stent Component Functional Testing | Bile corrosion resistance | Resists corrosion in a bile environment. | Not explicitly stated, but implied to be acceptable for intended use and comparable to predicate. |
| Tensile and elongation | Sufficient strength and flexibility. | Not explicitly stated, but implied to be acceptable for intended use and comparable to predicate. | |
| Foreshortening | Maintains intended length upon deployment. | Not explicitly stated, but implied to be acceptable for intended use and comparable to predicate. | |
| Expanded stent length | Achieves specified length when expanded. | Not explicitly stated, but implied to be acceptable for intended use and comparable to predicate. | |
| Recoil | Minimal recoil after expansion to maintain patency. | Not explicitly stated, but implied to be acceptable for intended use and comparable to predicate. | |
| Expansion uniformity | Expands uniformly to desired diameter. | Not explicitly stated, but implied to be acceptable for intended use and comparable to predicate. | |
| Compression resistance/radial hoop strength | Sufficient radial strength to resist compression and maintain patency. | Not explicitly stated, but implied to be acceptable for intended use and comparable to predicate. | |
| Over-expansion | Tolerates some over-expansion without failure. | Not explicitly stated, but implied to be acceptable for intended use and comparable to predicate. | |
| Deployment pressure, accuracy and diameter | Deploys accurately at specified pressure to achieve desired diameter. | Not explicitly stated, but implied to be acceptable for intended use and comparable to predicate. | |
| Delivery System Functional Testing | Repeat balloon inflation within a stent | Balloon can be inflated multiple times reliably. | Not explicitly stated, but implied to be acceptable for intended use and comparable to predicate. |
| Balloon burst within the stent | Balloon withstands specified pressure without bursting prematurely. | Not explicitly stated, but implied to be acceptable for intended use and comparable to predicate. | |
| Balloon/delivery system distension and compliance | Balloon distends and complies as expected according to labeling. | Not explicitly stated, but implied to be acceptable for intended use and comparable to predicate. | |
| Balloon inflation and deflation time | Inflation and deflation times are within acceptable clinical parameters. | Not explicitly stated, but implied to be acceptable for intended use and comparable to predicate. | |
| Catheter tensile strength | Catheter possesses sufficient tensile strength for manipulation and withdrawal. | Not explicitly stated, but implied to be acceptable for intended use and comparable to predicate. | |
| Stent/balloon crossing profile | Maintains a low profile for navigability through anatomical structures. | Not explicitly stated, but implied to be acceptable for intended use and comparable to predicate. | |
| Stent securement force | Stent remains securely crimped until deployment. | Not explicitly stated, but implied to be acceptable for intended use and comparable to predicate. | |
| Other Testing | Shelf life testing | Demonstrates acceptable results after 3 years of accelerated age testing. | Will be conducted and completed prior to commercialization. Implied to be acceptable to claim a 3-year shelf life. |
| Biocompatibility Assessment | Materials are biocompatible and do not cause adverse reactions. | Not explicitly stated, but implied to be acceptable for intended use and comparable to predicate. |
The Study that Proves the Device Meets Acceptance Criteria:
The "study" described in the document is a non-clinical (in-vitro) testing program designed to demonstrate substantial equivalence to a predicate device. The summary states: "Based on a comparison of intended use, design, and results of in-vitro testing, the Express Biliary SD Premounted Stent System is adequate for the intended use and is considered substantially equivalent to the legally marketed Johnson & Johnson Corinthian IQ Transhepatic Biliary Stent with Delivery Catheter."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a numerical sample size for the "test set" in terms of how many devices or components were used for each non-clinical test. The testing appears to be based on engineering verification and validation of the device's physical and functional characteristics.
- Data Provenance: The data provenance is non-clinical/in-vitro testing conducted by the manufacturer, Boston Scientific, Inc. No information regarding country of origin of the data or whether it was retrospective or prospective is applicable as it's not a clinical study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not applicable to this type of submission. The "ground truth" for non-clinical engineering tests is based on established engineering standards, specifications, and comparison to the predicate device's known characteristics, rather than expert consensus on diagnostic interpretations.
4. Adjudication Method for the Test Set
- This is not applicable to the non-clinical testing described. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for interpreting medical images or clinical outcomes, which is not the nature of the testing described.
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, an MRMC comparative effectiveness study was not done. This is a 510(k) submission for a medical device (stent and delivery system), not an AI/ CAD (Computer-Aided Detection/Diagnosis) software. Therefore, the concept of human readers improving with or without AI assistance is irrelevant here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, this is not applicable. This device is a physical medical device (stent and delivery system), not an algorithm or software.
7. The Type of Ground Truth Used
- For the non-clinical testing, the "ground truth" is based on engineering specifications, design requirements, and comparison to the characteristics of the legally marketed predicate device.
- For example, for "expanded stent length," the ground truth would be the specified design length. For "compression resistance," it would be the required radial force. For biocompatibility, it would be compliance with ISO standards for medical device materials.
8. The Sample Size for the Training Set
- This is not applicable as this is a physical medical device, not a machine learning or AI model. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set was Established
- This is not applicable for the same reason as above (no training set for a physical medical device).
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| MAR 3 0 2004 |
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KC40027
Page 1 of 4
510(k) Summary
General Provisions 4.1
| Submitter'sName andAddress | Boston Scientific, Inc.One Scimed PlaceMaple Grove MN 55311 | |
|---|---|---|
| ContactPerson | Candice R. BurnsRegulatory Affairs Specialist763-494-2845 | |
| ClassificationName | Biliary Catheter and AccessoriesProduct Code – 78 FGERegulation Number 21 CFR Part 876.5010 | |
| Common orUsual Name | Biliary Stent and Balloon Dilatation Catheter | |
| ProprietaryName | Boston Scientific Corporation Express Biliary SD PremountedStent System | |
| 4.2 | Name of PredicateDevice | Johnson and Johnson Corinthian™ IQ Transhepatic BiliaryStent and Delivery System and Ultra-soft SV BalloonDilatation Catheter |
| 4.3 | DeviceDescription | The Express Biliary SD Premounted Stent System is availablein the models indicated in Table 4.3. A brief description of thedevice components follows. |
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Page 2 of 4
510(k) Summary
Device Description (continued) 4.3
| Table 4.3 Device Description | |||||
|---|---|---|---|---|---|
| BalloonDiametermm | BalloonLengthmm | CrimpedStent Lengthmm | StentDiametermm | Rated BurstPressureatm [kPa] | CatheterLengthcm |
| 4 | 16, 20 | 15, 19 | 4 | 14 [1419] | 90, 150 |
| 5 | 16, 20 | 15, 19 | 5 | 14 [1419] | 90, 150 |
| 6 | 15, 19 | 14, 18 | 6 | 14 [1419] | 90, 150 |
| 7 | 16, 20 | 15, 19 | 7 | 14 [1419] | 90, 150 |
4.3.1 Stent
The Express Biliary SD 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 SD stent is made from 316L surgical grade stainless steel. The stent geometry is a laser-cut pattern consisting of large and small sinusoidal bands connected by axial struts. Additional struts are provided to reinforce the three connector rows of the proximal stent end, resulting in additional scaffolding designed to reduce tumor in-growth at the proximal stent end.
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K040027
Page 3 of 4
510(k) Summary
| 4.3.2 | DeliverySystem | The delivery system for the Express Biliary SD PremountedStent System consists of a Monorail™ catheter with a stentcrimped on a balloon near the distal tip. The balloon isdesigned to provide an inflatable segment of known diameterand length at recommended pressures. The distal segment ofthe balloon catheter is dual lumen and coaxial. The outerlumen is used for inflation of the balloon. The wire lumenpermits the use of guidewires (≤0.018 in / 0,46 mm) tofacilitate advancement of the catheter to and through thestricture to be dilated. |
|---|---|---|
| 4.4 | Intended Use | The Express Biliary SD Premounted Stent System is indicatedfor palliation of malignant neoplasms in the biliary tree. |
| 4.5 | Summary ofTechnologicalCharacteristics | The Express Biliary SD Premounted Stent System willincorporate a substantially equivalent design, method ofdeployment, packaging, fundamental technology,manufacturing, sterilization and intended use as those featuredin the predicate Johnson and Johnson Legally marketedCorinthian IQ Biliary Stent and Delivery System. |
| 4.6 | Non-clinical TestSummary | Functional testing for the stent component includes:• Bile corrosion resistance• Tensile and elongation• Foreshortening• Expanded stent length• Recoil• Expansion uniformity• Compression resistance/radial hoop strength• Over-expansion• Deployment pressure, accuracy and diameter |
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K040027
Page 4 of 4
510(k) Summary
4.6 Non-clinical Test Summary
(continued)
- Functional testing for the delivery system includes:
- Repeat balloon inflation within a stent .
- Balloon burst within the stent .
- Balloon/delivery system distension and compliance . labeling
- Balloon inflation and deflation time .
- Catheter tensile strength .
- . Stent/balloon crossing profile
- Stent securement force .
- . Shelf life testing
- Biocompatibility Assessment .
Product shelf life testing will be conducted and completed prior to the commercialization of this device. The shelf-life data must show acceptable results after 3 years of accelerated age testing in order to claim the labeled shelf life of 3 years.
Based on a comparison of intended use, design, and results of in-vitro testing, the Express Biliary SD Premounted Stent System is adequate for the intended use and is considered substantially equivalent to the legally marketed Johnson & Johnson Corinthian IQ Transhepatic Biliary Stent with Delivery Catheter.
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Image /page/4/Picture/13 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three curved lines, resembling a person embracing another person.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 3 0 2004
Ms. Candice Burns Regulatory Affairs Specialist Boston Scientific Corporation One Scimed Place MAPLE GROVE MN 55311-1566
Re: K040027
Trade/Device Name: Boston Scientific Express™ Biliary SD Premounted Stent System Regulation Number: 21 CFR $876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: January 7, 2004 Received: January 8, 2004
Dear Ms. Burns:
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. Candice Burns
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,
Dániel 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: K040027
Device Name: Boston Scientific Express™ Biliary SD Premounted Stent System
FDA's Statement of the Indications For Use for device:
The Boston Scientific Express™ Biliary SD Premounted Stent System is indicated for the palliation of malignant neoplasms in the biliary tree.
Prescription Use V (Per 21 CFR 801.109)
OR
Over-the-Counter Use
. . . . . . . . .
Nancy C. Brogdon
Division Sign-Off
(Division Sign-Off) Division of Reproductive, Abdon 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.