(21 days)
The Medtronic AVE Stent Delivery System - For Use In Biliary Indication device is intended to maintain patency of a bile duct which is occluded by a malignant tumor.
The device consists of a balloon expandable intralumenal stent premounted onto the balloon of an over-the-wire delivery catheter. The device has two radiopaque platinum markers 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 75cm to 90cm. The device is provided in a sterile package.
The Medtronic AVE Stent Delivery System did not provide acceptance criteria in a quantitative format with reported performance. Instead, the submission relies on demonstrating substantial equivalence to a predicate device through performance testing. The study focuses on direct comparisons between the subject device and the predicate device for various physical and mechanical properties.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The submission does not present acceptance criteria in a quantitative table format. Instead, it describes performance testing conducted to demonstrate substantial equivalence to a predicate device. The general acceptance criterion seems to be that the subject device performs comparably to the predicate device for the listed tests.
| Test | Purpose | Reported Performance |
|---|---|---|
| Balloon Burst | To compare the stent/delivery system of the subject device and the predicate device. | Not explicitly stated, but the conclusion is that the two devices are substantially equivalent. |
| Bond Strength | To compare the stent/delivery system of the subject device and the predicate device. | Not explicitly stated, but the conclusion is that the two devices are substantially equivalent. |
| Balloon Deflation Time | To compare the stent/delivery system of the subject device and the predicate device. | Not explicitly stated, but the conclusion is that the two devices are substantially equivalent. |
| Crossing Profile | To compare the stent/delivery system of the subject device and the predicate device. | Not explicitly stated, but the conclusion is that the two devices are substantially equivalent. |
| Diameter versus Inflation Pressure | To create and compare the compliance curves for the subject device and the predicate device. | Not explicitly stated, but the conclusion is that the two devices are substantially equivalent. |
| Stent Free Area | To compare the stent dimensional data for the subject device and the predicate device. | Not explicitly stated, but the conclusion is that the two devices are substantially equivalent. |
| Stent Length | To compare the stent dimensional data for the subject device and the predicate device. | Not explicitly stated, but the conclusion is that the two devices are substantially equivalent. |
| Crush Strength | To compare the stent dimensional data for the subject device and the predicate device. | Not explicitly stated, but the conclusion is that the two devices are substantially equivalent. |
| Stent Recoil | To compare the stent dimensional data for the subject device and the predicate device. | Not explicitly stated, but the conclusion is that the two devices are substantially equivalent. |
| Stent Expansion | To compare the stent dimensional data for the subject device and the predicate device. | Not explicitly stated, but the conclusion is that the two devices are substantially equivalent. |
| Biocompatibility | To ensure the material used in the stent is safe for biological contact. | "The material used in the Medtronic AVE Stent passed all biocompatibility tests." |
| Sterilization | To ensure the sterilization method is effective. | "The Medtronic AVE Stent is provided sterile." and validated according to ANSI/AAMI/ISO 11137 - 1994, Method I, with a SAL of 10-6. "Labeled pyrogen free." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for each of the performance tests conducted. It refers to "performance testing" being conducted but provides no details on the number of units tested for each parameter. The data provenance is also not mentioned; it's a submission for a medical device by Medtronic AVE, Inc. in Santa Rosa, California, but details on where the tests were conducted or the origin of any 'data' beyond the tests are absent. These appear to be bench tests, not clinical studies involving patients.
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 section is not applicable. The study involves demonstrating the physical and mechanical performance of a medical device against a predicate device, not establishing a ground truth for a diagnostic algorithm or interpretation. There are no "experts" involved in judging test results in the clinical sense mentioned here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable for the same reasons as point 3. There is no adjudication method described as this is not a study requiring human interpretation or consensus.
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
There was no MRMC comparative effectiveness study done. This submission is for a medical device (stent delivery system), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable as this is a medical device (stent delivery system), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is the performance and characteristics of the predicate device (Peripheral AVE Stent Delivery System - For Use In Biliary Indication) and established engineering/performance standards for medical devices, coupled with the results from the specific performance tests conducted on the subject device. The goal is to show the subject device performs equivalently.
8. The sample size for the training set
This section is not applicable as the submission describes a physical medical device, not a machine learning model. There is no concept of a "training set" here.
9. How the ground truth for the training set was established
This section is not applicable for the same reasons as point 8.
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K992318
Page 1 of 4
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 AMDA 1990 and 21 CFR807.92. |
|---|---|
| Identification | The assigned 510(k) number is |
| Applicant: | Medtronic AVE, Inc.Peripheral Technologies2330A Circadian WaySanta Rosa, California 95407Contact: Susan L. Walton |
| Phone: (707) 591-7315 FAX: (707) 591-7406e-mail: susan.walton@medtronic.comDate submitted: July 9, 1999 | |
| Tradename: | Device Name: Medtronic AVE StentModel Numbers: B7080, B8080, B70100, B80100Classification 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 Stent Delivery System - For Use In Biliary Indicationdevice is intended to maintain patency of a bile duct which is occluded by amalignant tumor. |
Continued on next page
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510(k) Summary for the Medtronic AVE Stent Delivery
System, Continued
Description of Device The device consists of a balloon expandable intralumenal stent premounted onto the balloon of an over-the-wire delivery catheter. The device has two radiopaque platinum markers 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 75cm to 90cm. The device is provided in a sterile package.
| Size range: | Diameters: 7.0 to 8.0 mmLengths 80 to 100 mm |
|---|---|
| ------------- | -------------------------------------------------- |
Comparison Table This device is intended to maintain patency of a biliary duct which is occluded by a malignant tumor.
| Characteristic | Subject Device | Predicate Device | |
|---|---|---|---|
| Intended Use | This device is intended to maintain patency of a bile duct which is occluded by tumor. | This device is intended to maintain patency of a biliary duct which is occluded by tumor. | |
| Physical Characteristics (stent) | 316L stainless steel balloon expandable premounted stent Diameters 7 - 8mmLengths 80 to 100mm | 316L stainless steel balloon expandable premounted stent Diameters 6 - 10mmLengths 17 to 60mm | |
| Physical Characteristics (delivery system) | Balloon delivery system PTA catheter (PET)5.3 to 5.8 F shafts75 to 90cm lengths0.035" guidewire Ø | Balloon delivery system PTA catheter (PET)5.3 to 5.8 F shafts75 to 90cm lengths0.035" guidewire Ø | |
| Anatomical site | Biliary duct | Biliary duct | |
| Target population | Patients with bile duct obstruction caused by malignant tumor. | Patients with biliary duct obstruction caused by malignant tumor. |
Continued on next page
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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) and extended stentlengths. The flexible Medtronic AVE Stent was found to be substantiallyequivalent in K983008 approved November 25, 1998. Performance testingwas conducted on the subject device for the purpose of direct comparison tothe predicate device. The testing was chosen to highlight any differencesbetween the subject device and the predicate device. The balloon materialshave not been changed. The useable catheter length is not changed. Themanufacturing process is not changed. | |
|---|---|---|
| Test | Purpose | |
| • Balloon Burst | To compare the stent/delivery system of thesubject device and the predicate device. The | |
| • Bond Strength | subject device and the predicate device. The | |
| • Balloon Deflation Time | data will support a premarket notification for | |
| • Crossing Profile | the Medtronic AVE Stent Delivery System -For Use In Biliary Indication. | |
| • Diameter versusInflation Pressure | To create and compare the compliance curvesfor the subject device and the predicate device.The data will support a premarket notificationfor the Medtronic AVE Stent Delivery System -For Use In Biliary Indication. | |
| • Stent Free Area | To compare the stent dimensional data for thesubject device and the predicate device. The | |
| • Stent Length | subject device and the predicate device. The | |
| • Crush Strength• Stent Recoil• Stent Expansion | data 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 - For Use In Biliary Indication and the Medtronic AVE StentDiameter versus Inflation Pressure prove the two devices are substantiallyequivalent. | |
| AdditionalInformation | The summary includes any other information reasonably deemed necessaryby FDA. | |
| Biocompatibility | The material used in the Medtronic AVE Stent passed all biocompatibilitytests. |
Continued on next page
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K992318
Page 4 of 4
510(k) Summary for the Medtronic AVE Stent Delivery System, Continued
| Sterilization | The Medtronic AVE Stent is provided sterile. |
|---|---|
| The Medtronic AVE Stent is not intended for sterilization orreuse/resterilization by the user. | |
| Medtronic AVE validates the sterilization method for its stent deliverysystems according to the ANSI/AAMI/ISO 11137 - 1994, Method I:Sterilization of Healthcare Products - Requirements for Validation andRoutine Control - Radiation Sterilization. The Sterility Assurance Level(SAL) is 10-6. | |
| The Medtronic AVE Stent is labeled pyrogen free. LAL testing is performeddaily in compliance with FDA guidance on Validation of Limulus AmebocyteLysate Test as an End Product Endotoxin Test for Human and AnimalParenteral Drugs, Biological Products and Medical Devices - Section V - 2Inhibition and Enhancement Testing as part of Medtronic AVE's productrelease criteria. |
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2 1999 Alle
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Susan L. Walton Regulatory Coordinator Medtronic AVE, Peripheral Technologies 2330A Circadian Way Santa Rosa, CA 95407
K992318 Re:
Medtronic AVE Bridge™ Stent System (Hi-Flex) - Biliary Indication Regulatory Class: II 21 CFR 876.5010 Product Code: 78 FGE Dated: July 10, 1999 Received: July 12, 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 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 scction 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. Susan L. Walton
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 renamed 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 mspotions) the Food and Diam 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 The I Dri mainig of sacctantial equice 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,
Sincerely yours,
Susan Alpert, Ph.D., M.D.
Susan Alpert, Ph.D., M.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): K992318
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 bile duct which is occluded by a malignant tumor.
Prescription Use」 OR (Per 21 CFR 801.109)
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
Girard W. Seaymore
Division Sign Off
eproductive, Abdominal, E 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.