(72 days)
The Medtronic AVE Bridge™ FX Biliary Stent Delivery System is intended to maintain patency of a bile duct, which is occluded by a malignant tumor.
The Bridge FX Stent Delivery System consists of a balloon-expandable intralumenal, 316L stainless steel stent pre-mounted onto the balloon of an over-the-wire delivery catheter. The device is available in diameters ranging from 6-10 mm and in several lengths including 20, 30, 40, and 60 mm. The delivery system has two radiopaque marker bands to aid in the placement of the stent during fluoroscopy. The delivery system is compatible with 0.035" guidewires and has useable lengths of 80 and 130 cm. The device is provided in a sterile package.
The provided text is a 510(k) summary for the Medtronic AVE Bridge FX Stent Delivery System. It describes the device, its intended use, and states that preclinical testing was conducted to confirm its safe and effective performance. However, this document does not contain information about acceptance criteria or a detailed study proving the device meets specific performance criteria in the way typically expected for an AI/CADe device.
The 510(k) process for a device like this stent typically relies on demonstrating "substantial equivalence" to a legally marketed predicate device rather than presenting extensive clinical performance studies with acceptance criteria in the format requested. The "performance" section mentions "Preclinical testing was conducted to confirm the safe and effective performance of the Bridge FX. The device passed biocompatibility testing." This is a high-level summary and doesn't provide the granular detail needed for the requested table and study information.
Therefore, many sections of your request cannot be fulfilled based on the provided text. I will indicate where information is "Not provided in the text."
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided in the text. (Typically for a stent, this would involve criteria related to deployment success, patency rates, complication rates, etc., which are often derived from clinical studies or meta-analyses of related devices). | "Preclinical testing was conducted to confirm the safe and effective performance of the Bridge FX.""The device passed biocompatibility testing." |
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 provided in the text. The term "preclinical testing" suggests laboratory or animal studies, not human clinical trials with a test set in the traditional sense for evaluating diagnostic performance.
- Data provenance: Not provided in the text.
- Retrospective or prospective: Not provided in the text.
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 as the text describes preclinical testing of a physical medical device (stent), not an AI/CADe system requiring expert-established ground truth for image interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for the type of preclinical 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. This is a physical medical device (stent), not an AI/CADe system, so an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For "preclinical testing," ground truth would be established through laboratory measurements, engineering specifications, and potentially animal model outcomes (e.g., successful stent deployment, patency in a simulated vessel, biocompatibility assessment using standard assays). The specific details are not provided in the summary.
8. The sample size for the training set
- Not applicable for the type of preclinical testing described. The device is a physical stent, not an AI model requiring a training set of data.
9. How the ground truth for the training set was established
- Not applicable for the type of preclinical testing described.
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This summary of 510(k) safety and effectiveness information is being 210(k) submitted in accordance with the requirements of 21 C.F.R. § 807.92. Summary Submitter Medtronic AVE, Inc. Peripheral Technologies 2170-A Northpoint Parkway Santa Rosa, California 95407 Contact Person John Riolo Vice President, Regulatory Affairs and Quality Assurance Phone: (707) 541-3271 FAX: (707) 566-1159 e-mail: john.riolo@medtronic.com June 11, 2001 Date Prepared Bridge FX Stent Delivery System Trade Name Biliary Stent and Delivery System Common Name Biliary Catheter and Accessories Classification Name Classification: Class II Device Classification Classification Panel: 78FGE Regulation Number: 21 C.F.R. §876.5010 Predicate Bridge X3 (K000744, 6/5/00) . Devices Bridge Flexible/Hi-Flex (K992569, 8/31/99; K993145, 10/21/99) ● Performance standards have not been established by the FDA under section Performance 514 of the Federal, Food, Drug and Cosmetic Act Standards
510(k) Summary for the Bridge FX Stent Delivery System
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510(k) Summary for the Bridge FX Stent Delivery System
| Device Description | The Bridge FX Stent Delivery System consists of a balloon-expandable intralumenal, 316L stainless steel stent pre-mountedonto the balloon of an over-the-wire delivery catheter. Thedevice is available in diameters ranging from 6-10 mm and inseveral lengths including 20, 30, 40, and 60 mm. The deliverysystem has two radiopaque marker bands to aid in the placementof the stent during fluoroscopy. The delivery system iscompatible with 0.035" guidewires and has useable lengths of 80and 130 cm. The device is provided in a sterile package. |
|---|---|
| Indications for Use | The Medtronic AVE Bridge FX Stent Delivery System is intended tomaintain patency of a bile duct, which is occluded by a malignant tumor. |
| TechnologicalCharacteristics | The Medtronic AVE Bridge FX Stent Delivery System is substantiallyequivalent to Medtronic AVE's previously-cleared Bridge products. Thedevices have the same indications for use, intended use, and the samefundamental scientific technology. Difference between the subject andpredicate devices are minor and are not relevant to its ability to maintainpatency of a bile duct. |
| NonclinicalPerformance | Preclinical testing was conducted to confirm the safe and effectiveperformance of the Bridge FX. The device passed biocompatibilitytesting. |
| Sterilization | The Bridge FX is provided sterile. The device is not intended for reuseor resterilization. |
| Conclusion | The Medtronic AVE Bridge FX Stent Delivery System is substantiallyequivalent to Medtronic AVE's currently cleared and marketed Bridgeproducts. |
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Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol of medicine and healing. The caduceus is depicted as a staff with two snakes coiled around it and wings at the top.
AUG 2 2 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Kevin Drisko Senior Regulatory Affairs Specialist Medtronic AVE, Inc. 2170 A Northpoint Parkway SANTA ROSA CA 95407
Re: K011817
Medtronic AVE Bridge™ FX Biliary Stent Delivery System Regulatory Class: II 21 CFR 876.5010 Product Code: 78 FGE Dated: July 20, 2001 Received: July 23, 2001
Dear Mr. Drisko:
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 - Mr. Kevin Drisko
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations (1 remarket in pp. o taly was found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to mspoculish the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 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 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 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,
Bernard E. Statland, M.D., Ph.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): K011817
Device Name: Medtronic AVE Bridge™ FX Biliary Stent Delivery System
FDA's Statement of the Indications For Use for device:
The Medtronic AVE Bridge™ FX Biliary Stent Delivery System is intended to maintain patency of a bile duct, which is occluded by a malignant tumor.
Prescription Use OR (Per 21 CFR 801.109)
Over-The-Counter Use
Nancy C. Bergdon
Division Sign-Off Division of Reproductive, Abd dominal. and Radiological Deyice 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.