(74 days)
The Aurora is indicated for use in the palliation of malignant neoplasm in the biliary tree.
The subject device is a system consisting of a single-lumen, tubular, self-expanding nickel-titanium ("nitinol") stent pre-loaded onto a sheathed delivery catheter. The stent design and catheter incorporate radiopaque markers to aid in stent placement during fluoroscopy. The delivery system is designed to deliver the stent to the stricture site. Once positioned at the stricture site, the sheath is withdrawn and the stent is released. Upon release, the stent's expansion results in the opening of the constructed lumen within the biliary tree.
The provided text is a 510(k) summary for the Medtronic AVE Bridge Aurora Biliary Stent System. It details the device's description, indications for use, and a claim of substantial equivalence to a predicate device. However, it does not contain information about explicit acceptance criteria or a formal study proving the device meets specific performance criteria.
Instead of a study proving performance against acceptance criteria, the document focuses on substantial equivalence (SE) to a previously marketed device. This is a common pathway for medical device clearance in the US, where a new device is shown to be as safe and effective as a legally marketed predicate device.
Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Explicit acceptance criteria are not mentioned in the provided text. | The device is deemed substantially equivalent to the predicate device (Bridge Aurora). |
| The subject and predicate stents are technologically similar and intended for palliation of malignant neoplasms in the biliary tree. | |
| Both are constructed of biocompatible materials. | |
| Both are deployed transhepatically via a sheathed delivery system. | |
| The subject device offers a lower crossing profile. | |
| Preclinical testing was conducted to confirm safe and effective performance and biocompatibility. (Specific results or criteria not provided) |
2. Sample size used for the test set and the data provenance
- No information about a "test set" in the context of a performance study is provided.
- The justification for clearance is based on substantial equivalence and preclinical testing, not a clinical trial or a specific test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable, as no external "test set" and ground truth establishment by experts is described for performance evaluation.
4. Adjudication method for the test set
- Not applicable, as no external "test set" and adjudication by experts is 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
- Not applicable. This device is a physical medical implant (a stent), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI-related effectiveness metrics are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable, as this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The primary "ground truth" or basis for clearance is the performance and safety record of the predicate device.
- For the preclinical testing mentioned, the "ground truth" would be established through engineering specifications, material science standards, and biocompatibility assays, often referencing recognized standards (e.g., ISO for biocompatibility). Specific details are not provided.
8. The sample size for the training set
- Not applicable, as this is a physical medical device, not a machine learning algorithm.
9. How the ground truth for the training set was established
- Not applicable, as this is a physical medical device, not a machine learning algorithm.
Summary of the "Study" that Proves the Device Meets Acceptance Criteria:
The "study" or evidence provided is primarily a demonstration of substantial equivalence to an already legally marketed device – the Medtronic AVE Bridge Aurora. The key elements for this demonstration include:
- Technological Characteristics Comparison: The submission highlights that the "Aurora" (subject device) and "Bridge Aurora" (predicate device) are technologically similar, constructed of biocompatible materials, deployed similarly, and have the same intended use (palliation of malignant neoplasms in the biliary tree). The only noted difference ("lower crossing profile") is deemed minor and not relevant to the ability to palliate malignant neoplasms.
- Nonclinical Performance Testing: The summary states that "Preclinical testing was conducted to confirm the safe and effective performance of this device as well as the biocompatibility of the device." However, no specific details about the nature of these tests, their protocols, sample sizes, or the results are provided in this summary. This preclinical testing, along with the substantial equivalence claim, forms the basis for demonstrating safety and effectiveness.
- Regulatory Conclusion: The FDA's review concludes that the device is "substantially equivalent" to the predicate, permitting its marketing with specific labeling limitations regarding vascular use.
In essence, for this 510(k) clearance, the primary "proof" is the analogy to an existing, cleared device and general statements about preclinical testing, rather than a detailed report of a specific study against predefined quantitative performance criteria.
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510(k) Summary for the Medtronic AVE Bridge Aurora 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. |
|---|---|
| Submitter | Medtronic AVE, Inc.Peripheral Technologies3576 Unocal PlaceSanta Rosa, California 95407 |
| Contact Person | Marlene Cobb-CarlsonAssociate Product Regulation ManagerPhone: (707) 541-3052FAX: (707) 591-7758e-mail: marlene.cobb-carlson@medtronic.com |
| Date Prepared | March 14, 2003 |
| Trade Name | Medtronic AVE Bridge™ Aurora™ Self-Expanding Biliary Stent System( |
| Device Description | The subject device is a system consisting of a single-lumen, tubular, self-expanding nickel-titanium ("nitinol") stent pre-loaded onto a sheatheddelivery catheter. The stent design and catheter incorporate radiopaquemarkers to aid in stent placement during fluoroscopy. The deliverysystem is designed to deliver the stent to the stricture site. Oncepositioned at the stricture site, the sheath is withdrawn and the stent isreleased. Upon release, the stent's expansion results in the opening of theconstructed lumen within the biliary tree. |
| Indications for Use | The Aurora is indicated for use in the palliation of malignant neoplasm inthe biliary tree. |
| TechnologicalCharacteristics | The Aurora is substantially equivalent to the currently marketedBridge Aurora. The subject and predicate stents are technologicallysimilar and are intended for palliation of malignant neoplasms in thebiliary tree. The subject and predicate stents are constructed ofbiocompatible materials. The subject and predicate stents are deployedtranshepatically via a sheathed delivery system. The subject deviceoffers a lower crossing profile. The subject and predicate stents arecomparable and are intended to meet clinical needs. The differencebetween the subject and predicate devices are minor and are notrelevant to the ability of the subject device to palliate malignantneoplasms in the biliary tree. |
| NonclinicalPerformance | Preclinical testing was conducted to confirm the safe and effectiveperformance of this device as well as the biocompatibility of the device. |
| Sterilization | The Aurora is provided sterile. The device is not intended for reuse orresterilization. |
| Conclusion | The Aurora is substantially equivalent to the currently cleared andmarketed device and meets the clinical needs of the physicians. |
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Ko30839
510(k) Summary for the Medtronic AVE Bridge Polaris Biliary Stent System
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a human figure with outstretched arms, resembling a bird in flight. The figure is composed of three curved lines that create the impression of movement and dynamism. Encircling the figure is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
.
MAY 3 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Marlene Cobb-Carlson Associate Product Regulation Manager Medtronic AVE 3576 Unocal Place SANTA ROSA CA 95403
Re: K030839
Trade/Device Name: Medtronic AVE Bridge Aurora Biliary Stent System Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: May 1, 2003 Received: May 2, 2002
Dear Ms. Cobb-Carlson:
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. Cobb-Carlson
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.
Daniel G. Schultz, M.D. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K030839
Device Name: Medtronic AVE Bridge Aurora Biliary Stent System
FDA's Statement of the Indications For Use for device:
The Aurora Biliary Stent System is indicated for use in the palliation of malignant neoplasms in the biliary tree.
Prescription Use V OR (Per 21 CFR 801.109)
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
David A. Liguori
ictive, Abdominal,
§ 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.