(28 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 incorporates 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 Once positioned at the stricture site, the sheath is withdrawn and the stent is released.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 expands and conforms to the inner lumen of the biliary duct. Two catheter mounted radiopaque markers aid in visibility during fluoroscopy.
The provided text describes a 510(k) summary for the Medtronic AVE Bridge Aurora Biliary Stent System, focusing on its substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and a study to prove meeting those criteria.
Therefore, many of the requested points cannot be answered directly from the provided text, as it does not contain information about:
- Specific quantitative acceptance criteria for device performance.
- A detailed study protocol (sample sizes for test sets, training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for specific performance metrics).
However, I can extract information related to the overall regulatory approval process and the type of evidence submitted.
Here's what can be inferred or directly stated based on the given documents:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria (Inferred): The primary "acceptance criteria" for 510(k) clearance is demonstrating substantial equivalence to a legally marketed predicate device. This means the new device is as safe and effective as the predicate. The document states: "The Aurora is substantially equivalent to the currently cleared and marketed device and meets the clinical needs of the physicians."
- Reported Device Performance: The document explicitly states: "Preclinical testing was conducted to confirm the safe and effective performance of this device as well as the biocompatibility of the device." However, specific quantitative results of this preclinical testing are not provided in this summary. The device's technological characteristics are mentioned as being similar to the predicate, with the improvement of "increased visibility under fluoroscopy."
| Acceptance Criteria (Inferred from 510(k) Process) | Reported Device Performance (Summary) |
|---|---|
| Substantial equivalence to a predicate device (Bridge SE - K011080, K014205) in terms of safety and effectiveness for the palliation of malignant neoplasms in the biliary tree. | - "The Aurora is substantially equivalent to the currently marketed Bridge SE."- "The subject and predicate stents are technologically similar and are intended for palliation of malignant neoplasms in the biliary tree."- "Constructed of biocompatible materials."- "Delivered via a sheathed delivery system."- "The subject device offers increased visibility under fluoroscopy."- "Preclinical testing was conducted to confirm the safe and effective performance of this device as well as the biocompatibility of the device." |
| Meeting clinical needs of physicians. | - "The Aurora... meets the clinical needs of the physicians." |
| Device safety and effective performance. | - "Preclinical testing was conducted to confirm the safe and effective performance of this device as well as the biocompatibility of the device." (No specific metrics or quantitative data provided in this summary). |
| Biocompatibility. | - "The subject and predicate stents are constructed of biocompatible materials."- "Preclinical testing was conducted to confirm the... biocompatibility of the device." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This information is not provided in the given 510(k) summary. The document mentions "Preclinical testing" but does not detail the nature, size, or provenance of any test sets. This summary focuses on substantial equivalence and device description.
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)
- This information is not provided in the given 510(k) summary. There is no mention of a "test set" in the context of expert review for performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not provided in the given 510(k) summary.
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
- This is not applicable as the device is a Biliary Stent System, not an AI-powered diagnostic device designed to assist human readers. The provided documentation does not suggest any MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable as the device is a Biliary Stent System. It is an implantable medical device, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- This information is not explicitly stated as the details of "preclinical testing" are not elaborated. For an implantable stent, "ground truth" for performance would typically be based on established engineering benchmarks, material science properties, biocompatibility testing (in vitro/in vivo), and potentially animal studies or historical clinical data from predicate devices. It is not framed in terms of expert consensus on diagnostic images.
8. The sample size for the training set
- This information is not provided in the given 510(k) summary. (Moreover, "training set" is typically associated with machine learning or AI models, which is not the nature of this device.)
9. How the ground truth for the training set was established
- This information is not provided in the given 510(k) summary (and again, the concept of a "training set" as commonly understood in AI/ML is not applicable here).
Summary of what is known:
The provided documents are a 510(k) summary for a medical device (a biliary stent), not an AI/ML device. Therefore, the questions related to AI/ML specific rigorous study designs (like MRMC, training/test sets, expert ground truth, adjudication) are not addressed in this type of regulatory submission. The clearance is based on substantial equivalence to existing predicate devices and general "preclinical testing" demonstrating safe and effective performance and biocompatibility, without disclosing specific quantitative results or study methodologies in this public summary.
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K022026 Page lofz
JUL 1 9 2002
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 being submitted in accordance with the requirements of 21 C.F.R. § 807.92. |
|---|---|
| Submitter | Medtronic AVE, Inc. Peripheral Technologies 3576 Unocal Place Santa Rosa, California 95403 |
| 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 |
| Date Prepared | June 20, 2002 |
| Trade Name | Medtronic AVE Bridge Aurora Biliary Stent System ("Aurora") |
| Common Name | Biliary Stent and Delivery System |
| Classification Name | Biliary Catheter and Accessories |
| Device Classification | Classification: Class II Classification Panel: 78FGE Regulation Number: 21 C.F.R. §876.5010 |
| Predicate Device | Bridge SE (K011080, K014205) |
| Performance Standards | Performance standards have not been established by the FDA under section 514 of the Federal, Food, Drug and Cosmetic Act |
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K022026 Page 2 of 2
510(k) Summary for the Medtronic AVE Bridge Aurora 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 incorporates radiopaque markers toaid in stent placement during fluoroscopy. The delivery system isdesigned to deliver the stent to the stricture site. Once positioned at thestricture site, the sheath is withdrawn and the stent is released. Uponrelease, the stent expands and conforms to the inner lumen of the biliaryduct. Two catheter mounted radiopaque markers aid in visibility duringfluoroscopy. |
|---|---|
| -------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
Indications for Use The Aurora is indicated for use in the palliation of malignant neoplasm in the biliary tree.
The Aurora is substantially equivalent to the currently marketed Bridge Technological SE. The subject and predicate stents are technologically similar and are Characteristics intended for palliation of malignant neoplasms in the biliary tree. The subject and predicate stents are constructed of biocompatible materials. The subject and predicate stents are delivered via a sheathed delivery system. The subject device offers increased visibility under fluoroscopy. The subject and predicate stents are comparable and are intended to meet clinical needs. The difference between the subject and predicate devices are minor and are not relevant to the ability of the subject device to palliate malignant neoplasms in the biliary tree.
Preclinical testing was conducted to confirm the safe and effective Nonclinical performance of this device as well as the biocompatibility of the device. Performance
The Aurora is provided sterile. The device is not intended for reuse or Sterilization resterilization.
The Aurora is substantially equivalent to the currently cleared and Conclusion marketed device and meets the clinical needs of the physicians.
Premarket Notification for Aurora Page 2 of 2
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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of three human profiles facing to the right, with a design that resembles a bird in flight above them.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 9 2002
Mr. Kevin Drisko Regulatory Affairs Manager Medtronic AVE, Inc. Medtronic Peripheral Technologies 2170-A Northpoint Parkway SANTA ROSA CA 95407
Re: K022026 Medtronic AVE Bridge Aurora Biliary Stent System Regulatory Class: II 21 CFR §876.5010 Product Code: 78 FGE Dated: June 20, 2002 Received: June 21, 2002
Dear Mr. Drisko:
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 - Mr. Kevin Drisko
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,
Bernard E. Statland, M.D., Ph. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K022026
Device Name: Medtronic AVE Bridge Aurora Biliary Stent System (Aurora)
FDA's Statement of the Indications For Use for device:
The Aurora is indicated for use in the palliation of malignant neoplasms in the biliary tree.
Prescription Use _ OR Over-The-Counter Use _
(Per 21 CFR 801.109)
David A. Leverson
(Division Si Division of and Radi 510(k) Nu
§ 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.