(31 days)
The Medtronic AVE Bridge™ Stent is intended to maintain patency of a bile duct which is occluded by a malignant tumor.
The Medtronic AVE Bridge™ Stent System (Hi-Flex) -- Biliary Indication is intended to maintain patency of a biliary duct which is occluded by a malignant tumor.
The Bridge™ Stent consists of a balloon expandable intralumenal stent premounted onto the balloon of an over-the-wire delivery catheter. Radiopaque markers are imbedded on the inner shaft (at each end of the stent) to aid in the placement of the stent during fluoroscopy. The delivery system is compatible with 0.035" guidewires and has a useable length of 75 cm or 120 cm. The device is provided in a sterile package. Size range: 6.0 to 10.0 mm Diameters; 20mm, 40mm, 60mm Lengths.
Based on the provided text, the Medtronic AVE Stent Delivery System is a medical device, and the document describes its 510(k) submission. However, the text does not contain a study that proves the device meets specific acceptance criteria in the format typically used for AI/software devices.
This document is a 510(k) summary for a physical medical device (a stent delivery system), not a software or AI-based device. The "performance testing" described is for comparing physical characteristics of the stent and its delivery system to a predicate device, focusing on substantial equivalence.
Therefore, I cannot provide the requested information in the format of AI-related acceptance criteria and study details because the document does not describe such a study for an AI/software device.
Instead, I can extract the information relevant to this physical medical device's performance testing and conclusions regarding substantial equivalence:
Acceptance Criteria and Device Performance (for a physical medical device, not AI/software):
| Performance Measure/Characteristic | Purpose of Testing | Reported Device Performance/Conclusion |
|---|---|---|
| (Not explicitly stated as "acceptance criteria") | To compare the stent/delivery system of the subject device and the predicate device. The data will support a premarket notification for the Medtronic AVE Stent Delivery System - For Use In Biliary Indication. | Subject Device (Medtronic AVE Bridge™ Stent) was found to be substantially equivalent to the predicate device (Peripheral AVE Stent Delivery System). The flexible Bridge™ Stent was previously found substantially equivalent in K983008 (approved Nov 25, 1998). Performance testing specifically aimed to highlight any differences and confirm this equivalence. |
| Specific Tests Conducted: | ||
| • Balloon Deflation Time | To compare the stent/delivery system of the subject device and the predicate device. | (Implicitly found comparable/equivalent to predicate, as overall conclusion is substantial equivalence) |
| • Crossing Profile | To compare the stent/delivery system of the subject device and the predicate device. | (Implicitly found comparable/equivalent to predicate, as overall conclusion is substantial equivalence) |
| • Stent Free Area | To compare the stent dimensional data for the subject device and the predicate device. | (Implicitly found comparable/equivalent to predicate, as overall conclusion is substantial equivalence) |
| • Stent Length | To compare the stent dimensional data for the subject device and the predicate device. | (Implicitly found comparable/equivalent to predicate, as overall conclusion is substantial equivalence) |
| • Stent Recoil | To compare the stent dimensional data for the subject device and the predicate device. | (Implicitly found comparable/equivalent to predicate, as overall conclusion is substantial equivalence) |
| Biocompatibility | To ensure the materials used are safe for human contact. | Passed all biocompatibility tests. |
| Sterilization | To ensure the device is sterile when provided. | Validated to a Sterility Assurance Level (SAL) of 10-6. Labeled pyrogen free; LAL testing performed daily as product release criteria. (Note: not "performance" in the same sense as stent function, but a critical quality characteristic) |
Explanation for AI/Software-Specific Questions (Not Applicable to this Document):
The following points refer to information typically found in submissions for AI/software devices. Since this document is for a physical medical device, these details are not present in the provided text.
- Sample sized used for the test set and the data provenance: Not applicable. The document describes physical testing, not a dataset for an AI model.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI model is not relevant here. The ground truth for the physical tests would be measured physical properties.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This refers to expert consensus in AI model validation.
- 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 is for AI-assisted diagnostic tools.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI algorithm performance.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the physical tests, the "ground truth" is typically the measured physical properties of the device components and comparisons against engineering specifications or predicate device performance.
- The sample size for the training set: Not applicable. No AI model is described.
- How the ground truth for the training set was established: Not applicable. No AI model is described.
In summary, the provided document describes a 510(k) submission for a physical stent delivery system, where "performance testing" focuses on establishing substantial equivalence to a predicate device based on physical and material characteristics, biocompatibility, and sterility, rather than the validation of an AI or software algorithm.
{0}------------------------------------------------
OCT 21 1999
Image /page/0/Picture/1 description: The image shows handwritten text. The text at the top reads "K993145". Below that, the text reads "fig 1 of 3". The handwriting is somewhat cursive and slightly difficult to read.
510(k) Summary for the Medtronic AVE Stent Delivery System
.
| 510(k)Summary | This summary of 510(k) safety and effectiveness information is beingsubmitted in accordance with the requirements of SMDA 1990 and 21 CFR807.92. |
|---|---|
| Identification | The assigned 510(k) number is |
| Applicant: | Medtronic AVE, Inc.Peripheral Technologies2330 Circadian WaySanta Rosa, California 95407Contact: Susan L. Walton |
| Phone: (707) 591-7315 FAX: (707) 591-7406e-mail: susan.walton@medtronic.comDate submitted: September 18, 1999 | |
| Tradename: | Device Name: Medtronic AVE Bridge™ StentModel Numbers: B6020, B7020, B8020, B6020L, B7020L, B8020L, B6040,B7040, B8040, B9040, B10040, B6040L, B7040L,B8040L, B9040L, B10040L, B6060, B7060, B8060,B9060, B10060, B6060L, B7060L, B8060L, B9060L,B10060LClassification Name: Catheter, Biliary and accessories |
| Section 513DeviceClassification | Classification: Class IIClassification Panel: 78FGE |
| Equivalence | Medtronic AVE claims substantial equivalence to the Peripheral AVE StentDelivery System - For Use In Biliary Indication. |
| Intended Use | The Medtronic AVE Bridge™ Stent is intended to maintain patency of a bileduct which is occluded by a malignant tumor. |
| Continued on next page |
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image shows handwritten text on a white background. The text includes the identifier "K993145" on the top line. Below that, the text "Pg 2 of 2" is written in a cursive style.
510(k) Summary for the Medtronic AVE Stent Delivery
System, Continued
The Bridge™ Stent consists of a balloon expandable intralumenal stent Description of The Bridge - Ston over-the-wire delivery catheter. The Device premounted onto the banoon of an o rarrers imbedded on the inner shaft (at each end of the stent) to aid in the placement of the stent during fluoroscopy. each end of the stem') to are in the prith 0.035" guidewires and has a useable I ne denvery system is comple is provided in a sterile package. 6.0 to 10.0 mm Diameters: Size range: 20mm, 40mm, 60mm Lengths This device is intended to maintain patency of a bile duct which is occluded Comparison by a malignant tumor. Table Predicate Device Subject Device Characteristic This device is intended This device is intended Intended Use to maintain patency of a to maintain patency of a biliary duct which is bile duct which is occluded by tumor. occluded by tumor. • Diameters 6 - 10mm • Diameters 5 - 10mm Physical · Lengths 17 - 60mm · Lengths 20, 40 and Characteristics (316L stainless steel balloon 60mm expandable premounted stent) · PTA catheter (PET) · PTA catheter (PET) Physical • 5.3 - 5.8 F shafts Characteristics · 5.3 - 5.8 F shafts · 75 - 90cm lengths (Balloon delivery · 75 - 120cm lengths system) · 0.035" guidewire Ø · 0.035" guidewire Ø Biliary duct Bile duct Anatomical site Patients with biliary duct Patients with bile duct
Continued on next page
obstruction caused by
malignant tumor.
obstruction caused by
malignant tumor.
Target population
{2}------------------------------------------------
Pg 2 of 3
510(k) Summary for the Medtronic AVE Stent Delivery
System, Continued
| PerformanceTesting | The subject device for this 510(k) is identical to the predicate device with theexception of an alternate stent segment (component). The flexible Bridge™Stent was found to be substantially equivalent in K983008 approvedNovember 25, 1998. Performance testing was conducted on the subjectdevice for the purpose of direct comparison to the predicate device. Thetesting was chosen to highlight any differences between the subject deviceand the predicate device. The balloon materials have not been changed. Theuseable catheter length may be either 75 cm (cleared in K983008) or a newlength, 120 cm. The manufacturing process is not changed. | |
|---|---|---|
| Test | Purpose | |
| • Balloon Deflation Time• Crossing Profile | To compare the stent/delivery system of thesubject device and the predicate device. Thedata will support a premarket notification forthe Medtronic AVE Stent Delivery System -For Use In Biliary Indication. | |
| • Stent Free Area• Stent Length• Stent Recoil | To compare the stent dimensional data for thesubject device and the predicate device. Thedata will support a premarket notification forthe Medtronic AVE Stent Delivery System -For Use In Biliary Indication. | |
| Conclusions | The performance testing and comparison of the Peripheral AVE StentDelivery System and the Medtronic AVE Bridge™ Stent prove the twodevices are substantially equivalent. | |
| AdditionalInformation | The summary includes any other information reasonably deemed necessaryby FDA. | |
| Biocompatibility | The materials used in the Medtronic AVE Bridge™ Stent passed allbiocompatibility tests. | |
| Sterilization | The Medtronic AVE Bridge™ Stent is provided sterile and is not intended forsterilization or reuse/resterilization by the user.Medtronic AVE validates the sterilization method for its stent deliverysystems to a Sterility Assurance Level (SAL) of 10-6.The Medtronic AVE Bridge™ Stent is labeled pyrogen free. LAL testing isperformed daily as part of Medtronic AVE's product release criteria. |
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 1 1999
Ms. Susan L. Walton Regulatory Coordinator Medtronic AVE / Peripheral Technologies 2330A Circadian Way Santa Rosa, CA 95407
Rc: K993145
Medtronic AVE Bridge™ Stent System (Hi-Flcx) - Biliary Indication Regulatory Class: II 21 CFR 876.5010 Product Code: 78 FGE Dated: September 17, 1999 Received: September 20, 1999
Dear Ms. Walton:
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 prodicatc 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.
{4}------------------------------------------------
Page 2 - Ms. Susan L. Walton
If your device is classified (scc above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be 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 comply with 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 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,
Sur Africt
Susan Alpert, Ph.D., M Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Page __ l of 1
510(k) Number (if known): K993145
Device Name: Medtronic AVE Bridge™ Stent System (Hi-Flex) - Biliary Indication
FDA's Statement of the Indications For Use for device
The Medtronic AVE Bridge™ Stent System (Hi-Flex) -- Biliary Indication is intended to maintain patency of a biliary duct which is occluded by a malignant tumor.
Prescription Use_V OR (Per 21 CFR 801.109)
Over-The-Counter Use_
David C. Ingram
(Division Sign-Off)
Division of Reproductive, Abdominal, EN 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.