(29 days)
The Medtronic AVE Bridge™ Stent is intended to maintain patency of a bile 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. 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 120cm. The device is provided in a sterile package.
Here's an analysis of the acceptance criteria and study information for the Medtronic AVE Bridge™ Stent Delivery System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state quantitative acceptance criteria for each test (e.g., "Balloon Burst must be > X psi"). Instead, it focuses on demonstrating substantial equivalence to a predicate device through direct comparison. The "acceptance criteria" can be inferred as achieving comparable performance to the predicate device in the specified tests.
| Test | Acceptance Criteria (Inferred from text) | Reported Device Performance |
|---|---|---|
| Balloon Burst | Performance comparable to the predicate device | "To compare the stent/delivery system of the subject device and the predicate device." (Implies comparable performance was observed or demonstrated) |
| Balloon Deflation Time | Performance comparable to the predicate device | "To compare the stent/delivery system of the subject device and the predicate device." (Implies comparable performance was observed or demonstrated) |
| Crossing Profile | Performance comparable to the predicate device | "To compare the stent/delivery system of the subject device and the predicate device." (Implies comparable performance was observed or demonstrated) |
| Diameter versus Inflation Pressure | Compliance curves comparable to the predicate device | "To create and compare the compliance curves for the subject device and the predicate device." (Implies comparable curves were obtained) |
| Stent Free Area | Dimensional data comparable to the predicate device | "To compare the stent dimensional data for the subject device and the predicate device." (Implies comparable data was obtained) |
| Stent Length | Dimensional data comparable to the predicate device | "To compare the stent dimensional data for the subject device and the predicate device." (Implies comparable data was obtained) |
| Stent Recoil | Dimensional data comparable to the predicate device | "To compare the stent dimensional data for the subject device and the predicate device." (Implies comparable data was obtained) |
Summary of Study Findings: "The performance testing and comparison of the Peripheral AVE Stent Delivery System and the Medtronic AVE Bridge™ Stent prove the two devices are substantially equivalent."
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not specify the sample size for the test set used in the performance testing. It also does not explicitly mention the data provenance (e.g., country of origin, retrospective or prospective). However, the testing conducted appears to be bench testing, which is typically performed in a laboratory setting. This type of testing would not involve human subjects or clinical data in the traditional sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
N/A. This information is not applicable because the testing involved physical device performance comparisons (bench testing) rather than clinical evaluations requiring expert interpretation for ground truth.
4. Adjudication Method for the Test Set
N/A. This information is not applicable as the testing involves objective physical measurements and comparisons, not subjective interpretations requiring adjudication.
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
N/A. This is not an AI-based device. The device is a physical medical implant (stent) and a delivery system. The provided documentation does not include any information about AI or human-in-the-loop performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This is not an AI-based device.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance testing is based on objective physical measurements and established engineering standards/specifications as applied to the predicate device. The performance of the new device is compared directly to the measured performance of the predicate device.
8. The Sample Size for the Training Set
N/A. There is no "training set" in the context of this device's submission, as it is not an AI/machine learning device. The "training" for such a device would refer to manufacturing processes and quality control, not data training.
9. How the Ground Truth for the Training Set Was Established
N/A. As there is no training set as understood in AI/machine learning, this question is not applicable.
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K992569
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 Technologies2330 Circadian WaySanta Rosa, California 95407Contact: Susan L. Walton |
| Phone: (707) 591-7315 FAX: (707) 591-7406e-mail: susan.walton(@medtronic.comDate submitted: July 30, 1999 | |
| Tradename: | Device Name: Medtronic AVE Bridge™ StentModel Numbers: B6028, B6028L, B7028, B7028L, B8028, B8028L, B9028,B9028L, B10028, B10028LClassification 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. |
| Continuad on unaret |
Continued on next page
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510(k) Summary for the Medtronic AVE Stent Delivery
System, Continued
Description of Device
The Bridge™ Stent 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 120cm. The device is provided in a sterile package.
| Size range: | Diameters: 6.0 to 10.0 mmLengths 28 mm |
|---|---|
| ------------- | -------------------------------------------- |
Comparison Table
This device is intended to maintain patency of a bile 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 6 - 10mmLength 28mm | 316L stainless steel balloon expandable premounted stent Diameters 5 - 10mmLengths 17 to 60mm |
| Physical Characteristics (delivery system) | Balloon delivery system PTA catheter (PET)5.3 to 5.8 F shafts75 to 120cm 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 | Bile 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
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 a new stent length.The flexible Medtronic AVE Stent was found to be substantially equivalent inK983008 approved November 25, 1998. Performance testing was conductedon the subject device for the purpose of direct comparison to the predicatedevice. The testing was chosen to highlight any differences between thesubject device and the predicate device. The balloon materials have not beenchanged. The useable catheter length may be either 75 cm (cleared inK983008) or a new length, 120 cm. The manufacturing process is notchanged. | |
|---|---|---|
| Test | Purpose | |
| • Balloon Burst• 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. | |
| • 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• 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. |
Continued on next page
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Kaa 2569
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510(k) Summary for the Medtronic AVE Stent Delivery
System, Continued
(
| Sterilization | The Medtronic AVE Bridge™ Stent is provided sterile.The Medtronic AVE Bridge™ 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 10⁶.The Medtronic AVE Bridge™ Stent is labeled pyrogen free. LAL testing isperformed daily in compliance with FDA guidance on Validation of LimulusAmebocyte Lysate Test as an End Product Endotoxin Test for Human andAnimal Parenteral Drugs, Biological Products and Medical Devices - SectionV - 2 Inhibition and Enhancement Testing as part of Medtronic AVE'sproduct release criteria. |
|---|---|
| --------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized bird or human figures, with three overlapping profiles facing to the right.
Public Health Service
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 31 1999
Ms. Susan L. Walton Regulatory Coordinator Medtronic AVE, Peripheral Technologies 2330A Circadian Way Santa Rosa, CA 95407
Re: K992569
Medtronic AVE Bridge™ Stent System (Hi-Flex) - Biliary Indication Regulatory Class: II 21 CFR 876.5010 Product Code: 78 FGE Dated: July 30, 1999 Received: August 2, 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 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. 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 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 vours.
Jum Cofo
Susan Alpert, Ph D., M.D Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K992569
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.
Tarind A. Styson
(Division Sign-Off) Division of Reproductive, Abdominal, El and Radiological De 510(k) Number
Prescription Use
(Per 21 CFR 801.109) OR
Over-The-Counter Use_
§ 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.