(186 days)
The Bridge Constant Biliary Stent System is indicated for use in the palliation of malignant neoplasm in the biliary tree.
The subject device is a single use only device with a stent mounted on an over-the-wire delivery system. The device is equipped with an A V100 balloon mounted on the distal portion of the catheter to facilitate the percutaneous delivery of the stent.
This is a 510(k) summary for a medical device that does not use AI, therefore, much of the requested information regarding AI-specific studies and performance metrics is not applicable.
Here's the information based on the provided text, with clarifications where direct AI-related data is absent:
Acceptance Criteria and Device Performance for Medtronic AVE Bridge Constant Biliary Stent System
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary focuses on demonstrating substantial equivalence to existing predicate devices (Bridge Extra Support (K991533) and Bridge Assurant (K011817)) rather than specific quantitative acceptance criteria for this device. The core acceptance criterion for this submission is that the device is substantially equivalent to the predicate devices and meets their established performance and safety profiles.
| Acceptance Criterion (Implicit for Substantial Equivalence) | Reported Device Performance (Summary of Equivalence) |
|---|---|
| Intended Use Equivalence: Indicated for the same purpose as predicate devices. | Indicated for use in the palliation of malignant neoplasm in the biliary tree, same as predicate devices. |
| Technological Characteristics Equivalence: Similar materials, design principles, and operational mechanisms to predicate devices, without raising new questions of safety or effectiveness. | Constructed of biocompatible materials; balloon expandable; features stents pre-mounted on a sheathless stent delivery system. Differences between the subject and predicate devices are stated as "not relevant to the ability of the subject device to palliate malignant neoplasms in the biliary tree." |
| Performance (In vitro/Preclinical) Equivalence: Safe and effective performance confirmed through testing. | Preclinical/in-vitro testing was conducted to confirm the safe and effective performance of this device as well as the biocompatibility of the device. |
| Biocompatibility: Device materials are biocompatible. | Device is constructed of biocompatible materials. Preclinical/in-vitro testing confirmed biocompatibility. |
| Sterilization: Provided sterile and not intended for reuse/resterilization. | Device is provided sterile and not intended for reuse or resterilization. |
2. Sample Size for the Test Set and Data Provenance
This 510(k) summary describes preclinical/in-vitro testing. It does not involve a "test set" of patient data or data provenance in the context of an AI study. The testing would have been conducted on the device itself.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This is a medical device submission based on physical device testing and substantial equivalence, not an AI model requiring expert-established ground truth from a test set.
4. Adjudication Method for the Test Set
Not applicable for the reasons stated in point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is not an AI algorithm designed to assist human readers or perform diagnostic tasks. It is a physical medical device (biliary stent system).
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This is not an AI algorithm.
7. Type of Ground Truth Used
For the preclinical/in-vitro testing, the "ground truth" would be established through engineering specifications, material standards, and validated testing protocols. For instance, burst pressure, tensile strength, radial force, and biocompatibility standards would serve as the ground truth against which the device performance is measured. It's not based on expert consensus, pathology, or outcomes data in the human patient context for this specific submission, but rather on physical and chemical performance standards.
8. Sample Size for the Training Set
Not applicable. This is not an AI device trained on a dataset.
9. How the Ground Truth for the Training Set was Established
Not applicable. This is not an AI device.
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510(k) Summary for the Medtronic AVE Bridge Constant Biliary Stent System
. .
| 510(k)Summary | This summary of 510(k) safety and effectiveness information is beingsubmitted in accordance with the requirements of 21 C.F.R. § 807.92. |
|---|---|
| Submitter807.92(a)(1) | Medtronic AVE, Inc.Peripheral Technologies3576 Unocal PlaceSanta Rosa, California 95403 |
| Contact Person807.92(a)(1) | Sarah SheppardAssociate Product Regulation ManagerPhone: (707) 591-7465Fax: (707) 591-7406E-mail: sarah.sheppard@medtronic.com |
| Date Prepared807.92(a)(1) | February 26, 2003 / Name change notification: April 8th, 2003 |
| Trade Name807.92(a)(2) | Medtronic AVE Bridge Constant Biliary Stent System per 807.92 (a) (2) |
| Common Name807.92(a)(2) | Biliary Stent and Delivery System |
| Classification Name807.92(a)(2) | Biliary Catheter and Accessories |
| DeviceClassification807.92(a)(2) | Classification: Class IIClassification Panel: 78FGERegulation Number: 21 C.F.R. §876.5010 |
| Predicate Device807.92(a)(3) | Bridge Extra Support (K991533) cleared July 29th, 1999Bridge Assurant (K011817) cleared August 22nd, 2001 |
| PerformanceStandards | Performance standards have not been established by the FDA undersection 514 of the Federal, Food, Drug and Cosmetic Act |
| Device Description807.92(a)(4) | The subject device is a single use only device with a stent mounted on anover-the-wire delivery system. The device is equipped with an A V100balloon mounted on the distal portion of the catheter to facilitate thepercutaneous delivery of the stent. |
| Indications for Use807.92(a)(5) | The Bridge Constant Biliary Stent System is indicated for use in thepalliation of malignant neoplasm in the biliary tree. |
| TechnologicalCharacteristics807.92(a)(6) | The Bridge Constant is substantially equivalent to the currently marketedBridge Extra Support (K991533) and Bridge Assurant (K011817)devices. The subject and predicate devices are technologically similarand are intended for palliation of malignant neoplasms in the biliary tree.The subject and predicate devices are constructed of biocompatiblematerials. The subject and predicate devices are both balloon expandableand feature stents pre-mounted on a sheathless stent delivery system. Thesubject and predicate devices are comparable and are intended to meetclinical needs. The difference between the subject and predicate devicesare not relevant to the ability of the subject device to palliate malignantneoplasms in the biliary tree. |
| NonclinicalPerformance807.92(b)(1) | Preclinical/in-vitro testing was conducted to confirm the safe andeffective performance of this device as well as the biocompatibility of thedevice. |
| Sterilization807.92(b)(1) | The Bridge Constant Biliary Stent System is provided sterile. The deviceis not intended for reuse or resterilization. |
| Conclusion807.92(b)(3) | The Bridge Constant Biliary Stent System is substantially equivalent tothe currently cleared and marketed devices (Bridge Extra Support –K991533 and Bridge Assurant – K011817) and meets the clinical needsof the physicians. |
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510(k) Summary for the Medtronic AVE Bridge Constant Biliary Stent System
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Image /page/2/Picture/1 description: The image is a black and white seal. The seal is circular and contains an image of a bird with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the edge of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 2 2003
Ms. Sarah Sheppard Associate Product Regulation Manager Medtronic AVE 3576 Unocal Place SANTA ROSA CA 95403
Re: K030633
Trade/Device Name: Medtronic AVE Bridge Constant Biliary Stent System Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: June 3, 2003 Received: June 4, 2003
Dear Ms. Sheppard:
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.
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Page 2 - Ms. Sarah Sheppard
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 (OS) 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/dsmaldsmamain.html.
Sincerely yours,
Daniel G. Schultz, M.D.
Director Office of Device Evaluation Center for Devices and Radiological Health
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510(k) Number (if known): K030633
Device Name: Medtronic AVE Bridge Constant Biliary Stent System
FDA's Statement of the Indications For Use for device:
The Medtronic AVE Bridge Constant Biliary Stent System is indicated for use in the palliation of malignant neoplasms in the biliary tree.
Prescription Use OR (Per 21 CFR 801.109)
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
Nancy C. Brogdon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number_ 0311/2 53
§ 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.