(73 days)
Advanix™ Biliary Stent with NaviFlex™ RX Delivery System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.
The proposed Advanix™ Biliary Stent with NaviFlex™ RX Delivery System consists of biliary plastic stents and delivery system catheters. They are sold separately or in a pre-loaded configuration, in which a stent comes attached to the catheter via a suture. The system is comprised of two (2) primary components: stent and delivery catheter with a locking mechanism. The Advanix Biliary Stent allows for drainage of the biliary duct and gall bladder by preventing closure and maintaining the patency of the biliary duct. These biliary stents are provided in center bend and duodenal bend shapes and have leading and trailing bars, a tapered leading end tip to facilitate access through the papilla, and a rounded tailing end to match the profile of the push catheter portion of the delivery system.
The Advanix Biliary Stent will be offered in 7Fr. 8.5Fr, and 10Fr diameters. The stent leneths for each diameter vary from 5cm-18cm stent lengths. The Advanix biliary stents are constructed of a Polyethylene material.
The NaviFlex RX Delivery System will be offered in 202.5cm working length. The delivery system consists of a guide catheter and outer push catheter. The guide catheter is constructed of Polyvinylidene fluoride material. The guide catheter also includes a radiopaque marker. The push catheter is composed of polyether block amide material and also has a Nylon repositioning suture.
The provided text describes the regulatory clearance for a medical device, specifically the Advanix™ Biliary Stent with NaviFlex™ RX Delivery System. It functions as a 510(k) Summary, outlining the device, its intended use, technological characteristics, and performance data to demonstrate substantial equivalence to a predicate device.
However, the information provided does not contain the details typically found in a study report designed to "prove the device meets acceptance criteria" in terms of clinical performance or a detailed analytical study with statistical analysis. Instead, it focuses on bench testing and biocompatibility to demonstrate safety and performance similar to an already cleared device.
Therefore, for many of the requested categories, the answer will be "Not Applicable" or "Not specified in this document" because the document is a 510(k) summary, not a clinical study report.
Here's the breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes a series of tests performed, implying that for each test, there were "required specifications" that were met. However, the specific numerical acceptance criteria and the quantitative reported performance for each criterion are not detailed in this summary.
| Acceptance Criteria Category | Specific Criteria (Implicitly Met) | Reported Device Performance (General Statement) |
|---|---|---|
| Biocompatibility | Cytotoxicity (EN ISO 10993-1:2009) | Passed |
| Sensitization (EN ISO 10993-1:2009) | Passed | |
| Intracutaneous Reactivity (EN ISO 10993-1:2009) | Passed | |
| Systemic Toxicity - Acute (EN ISO 10993-1:2009) | Passed | |
| Subacute Toxicity (Intravenous/Intraperitoneal) | Passed | |
| Genotoxicity (Ames Assay & Mouse Lymphoma) | Passed | |
| Implantation (EN ISO 10993-1:2009) | Passed | |
| USP Physicochemical (Stent) | Passed | |
| USP Physicochemical (Delivery System) | Passed | |
| Device Bench Testing | Drainage Lumen ID (Required Specifications) | Acceptable (Met design specifications) |
| Stent Length (Required Specifications) | Acceptable (Met design specifications) | |
| Stent OD (Required Specifications) | Acceptable (Met design specifications) | |
| Stent Shape (Required Specifications) | Acceptable (Met design specifications) | |
| Repositionability (Required Specifications) | Acceptable (Met design specifications) | |
| Deployment Force (Required Specifications) | Acceptable (Met design specifications) | |
| Trackability Force (Required Specifications) | Acceptable (Met design specifications) | |
| Guidewire Compatibility (Required Specifications) | Acceptable (Met design specifications) | |
| Duodenoscope Compatibility (Required Specifications) | Acceptable (Met design specifications) | |
| Barb Flap Cover Compatibility (Required Specifications) | Acceptable (Met design specifications) | |
| Biopsy Cap Compatibility (Required Specifications) | Acceptable (Met design specifications) | |
| Delivery System Working Length (Required Specifications) | Acceptable (Met design specifications) | |
| Delivery System OD (Required Specifications) | Acceptable (Met design specifications) | |
| Guide Catheter Pushability (Required Specifications) | Acceptable (Met design specifications) | |
| RX Port Buckling Resistance (Required Specifications) | Acceptable (Met design specifications) | |
| Locking Mechanism Retention Ability (Required Specifications) | Acceptable (Met design specifications) | |
| Locking Mechanism to Dual Lumen Catheter Tensile Strength | Acceptable (Met design specifications) | |
| Dual Lumen Catheter to Single Lumen Catheter Tensile Strength | Acceptable (Met design specifications) | |
| Pullwire Assembly to Guide Catheter Tensile Strength | Acceptable (Met design specifications) | |
| Pullwire Tensile Strength (Required Specifications) | Acceptable (Met design specifications) | |
| Guide Catheter RO Marker Band Strength (Required Specifications) | Acceptable (Met design specifications) | |
| Push Catheter RO Marker Band Strength (Required Specifications) | Acceptable (Met design specifications) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in this 510(k) summary. The document mentions "in-vitro testing" and "all components, subassemblies, and/or full devices" but does not give a specific number of units tested for each criterion.
- Data Provenance: The tests are described as "in-vitro testing" and "bench tests," implying laboratory-based testing, not human patient data. There is no mention of country of origin for data or whether it was retrospective or prospective, as these are typically clinical study terms.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This document describes engineering and biocompatibility testing, not a study where human experts would establish a "ground truth" for a test set (e.g., image interpretation). The "ground truth" for these tests would be the established engineering specifications and recognized biocompatibility standards.
4. Adjudication method for the test set
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used in clinical or image-based studies where expert consensus is needed to resolve discrepancies. This document describes laboratory testing against predetermined specifications.
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
- Not Applicable. This document does not describe a multi-reader multi-case study, clinical trial, or any assessment of AI assistance. The device is a physical medical implant (stent) and a delivery system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a physical stent and delivery system, not an algorithm or AI.
7. The type of ground truth used
- The "ground truth" for the tests described would be based on engineering specifications (for device bench testing) and established international standards (EN ISO 10993-1:2009 for biocompatibility). There is no "expert consensus," "pathology," or "outcomes data" explicitly mentioned as ground truth for the evaluations detailed in this summary.
8. The sample size for the training set
- Not Applicable. This document does not describe a machine learning algorithm or AI model that would require a "training set." The performance assessments are for a physical medical device.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for an AI/ML model, this question does not apply.
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K 101314
Page 1 of 2
SECTION 5 510(k) SUMMARY
510(k) SUMMARY
1. Submitter:
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939
Contact: Elena Nieves Senior Regulatory Affairs Specialist Date Prepared: May 10, 2010
2. Proposed Device:
Trade Name: Advanix™ Biliary Stent with NaviFlex™ RX Delivery System Classification Name: Biliary Catheters and Accessories Regulation Number: 876.5010 Product Code: FGE Classification: Class II
3. Predicate Device:
Trade Name: Microvasive® Biliary Stent and Delivery System Manufacturer and Clearance Number: Boston Scientific Corporation, K965147 Classification Name: Biliary Catheters and Accessories Regulation Number: 876.5010 Product Code: FGE Classification: Class II
4. Proposed Device Description:
The proposed Advanix™ Biliary Stent with NaviFlex™ RX Delivery System consists of biliary plastic stents and delivery system catheters. They are sold separately or in a pre-loaded configuration, in which a stent comes attached to the catheter via a suture. The system is comprised of two (2) primary components: stent and delivery catheter with a locking mechanism. The Advanix Biliary Stent allows for drainage of the biliary duct and gall bladder by preventing closure and maintaining the patency of the biliary duct. These biliary stents are provided in center bend and duodenal bend shapes and have leading and trailing bars, a tapered leading end tip to facilitate access through the papilla, and a rounded tailing end to match the profile of the push catheter portion of the delivery system.
The Advanix Biliary Stent will be offered in 7Fr. 8.5Fr, and 10Fr diameters. The stent leneths for each diameter vary from 5cm-18cm stent lengths. The Advanix biliary stents are constructed of a Polyethylene material.
The NaviFlex RX Delivery System will be offered in 202.5cm working length. The delivery system consists of a guide catheter and outer push catheter. The guide catheter is constructed of Polyvinylidene fluoride material. The guide catheter also includes a radiopaque marker. The push catheter is composed of polyether block amide material and also has a Nylon repositioning suture.
Special 510(k) Premarket Notification, Advanix™ Biliary Stent with NaviFlex™ RX Delivery System Proprietary and Confidential Information of Boston Scientific Corporation
JUL 2 3 2010
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5. Intended Use:
Advanix™ Biliary Stent with NaviFlex™ RX Delivery System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.
6. Technological Characteristics:
The proposed Advanix™ Biliary Stent with NaviFlex™ RX Delivery System has the same technological characteristics as the predicate Microvasive® Biliary Stent and Delivery System (K965147).
The proposed device has the same intended use and is placed using the same methodology as the predicate device. Both the proposed and predicate device function in the same manner allowing for biliary drainage through the lumen.
The shape of the proposed Advanix Biliary Stent is the same as the predicate Microvasive Biliary Stent and Delivery System and also includes an additional center bend stent shape.
The materials of the proposed Advanix Biliary Stent have been modified to the polymer materials mentioned above in part 4 of this 510(k) Summary.
7. Performance Data:
In-vitro testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests.
The proposed Advanix™ Biliary Stent was evaluated in accordance with EN ISO 10993-1:2009. The following tests were performed on the stent: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Systemic Toxicity -Acute Systemic Toxicity, Subacute Toxicity - Intravenous and Intraperitoneal, Genotoxicity - Ames Assay and Mouse Lymphoma, Implantation, and USP Physicochemical.
The NaviFlex™ RX Delivery System was evaluated in accordance with EN ISO 10993-1:2009. The following tests were performed on the delivery system: Cytotoxicity, Sensitization, Intracutaneous Reactivity, and USP Physicochemical.
The following tests were conducted on the Advanix™ Biliary Stent with NaviFlex™ RX Delivery System: Drainage Lumen ID, Stent Length, Stent OD, Stent Shape, Repositionability, Deployment Force, Trackability Force, Guidewire Compatibility, Duodenoscope Compatibility, Barb Flap Cover Compatibility, Biopsy Cap Compatibility, Delivery System Working Length, Delivery System OD, Guide Catheter Pushability, RX Port Buckling Resistance, Locking Mechanism Retention Ability, Locking Mechanism to Dual Lumen Catheter Tensile Strength, Dual Lumen Catheter to Single Lumen Catheter Tensile Strength, Pullwire Assembly to Guide Catheter Tensile Strength, Pullwire Tensile Strength, Guide Catheter RO Marker Band Strength, and Push Catheter RO Marker Band Strength.
8. Conclusion:
All biocompatibility tests conducted on the Advanix™ Biliary Stent with NaviFlex™ RX Delivery System passed. Therefore, the Advanix Biliary Stent with NaviFlex RX Delivery System is considered biocompatible for its intended use.
All device bench test results were acceptable. The data demonstrate that the Advanix™ Biliary Stent with NaviFlex™ RX Delivery System sufficiently meets the design specifications and is suitable for the intended use.
Boston Scientific Corporation has demonstrated that the proposed Advanix™ Biliary Stent with NaviFlex™ RX Delivery System is substantially equivalent to Boston Scientific Corporation's currently marketed Microvasive® Biliary Stent and Delivery System (K965147).
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Image /page/2/Picture/0 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUM. S." written around the edge. Inside the circle is a stylized image of an eagle with its wings spread. The image is black and white and appears to be a scan of a document.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Ms. Elena Nieves Sr. Regulatory Affairs Specialist Boston Scientific Corporation 100 Boston Scientific Way MARLBOROUGH MA 01752
JUL 2 3 2010
Re: K101314
Trade/Device Name: Advanix™ Biliary Stent with NaviFlex™ RX Delivery System Regulation Number: 21 CFR& 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: May 10, 2010 Received: May 11, 2010
Dear Ms. Nieves:
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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); medical device reporting of medical device-related
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adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the aurerse overns (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please rryou desire specific da 100 too too too too too fices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please the Concer 101 Donece and the beginne by reference to premarket notification" (21CFR Part note the regalation regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Tou may other of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name:
Indications for Use:
AdvanixTM Biliary Stent with NaviFlex™ RX Delivery System
Advanix™ Biliary Stent with NaviFlex™ RX Delivery System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.
Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hebert Demir
(Division Sign-Off) (Division Sign-Ont)
Division of Reproductive, Abdominal, and Radiological Device 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.