(31 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a stent and its delivery system, with no mention of AI or ML.
Yes
The device is a stent intended to maintain the patency of a bile duct occluded by a malignant tumor, which is a direct therapeutic intervention to address a medical condition.
No
The device is a stent intended to maintain the patency of a bile duct occluded by a malignant tumor. Its function is interventional, not diagnostic.
No
The device description clearly outlines a physical stent and delivery catheter, which are hardware components. The intended use also describes a physical intervention (maintaining patency of a bile duct).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Medtronic AVE Bridge™ Stent is a physical device that is implanted inside the body to maintain the patency of a bile or biliary duct. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for maintaining patency of a duct occluded by a tumor, which is a therapeutic intervention, not a diagnostic test.
- Device Description: The description details a physical stent and delivery system, not a test kit or analytical instrument.
- Input Imaging Modality: Fluoroscopy is an imaging technique used to guide the placement of the device in vivo, not to analyze samples in vitro.
Therefore, the Medtronic AVE Bridge™ Stent is a medical device used for treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Medtronic AVE Bridge™ Stent is intended to maintain patency of a bile duct which is occluded by a malignant tumor.
Product codes (comma separated list FDA assigned to the subject device)
78 FGE
Device Description
The Bridge™ Stent consists of a balloon expandable intralumenal stent premounted onto the balloon of an over-the-wire delivery catheter. Radiopaque 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 or 120cm. The device is provided in a sterile package. Diameters: 6.0 to 10.0 mm. Lengths: 20mm, 40mm, 60mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Bile duct
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was conducted on the subject device for the purpose of direct comparison to the predicate device.
Tests conducted:
- Balloon Deflation Time
- Crossing Profile
- Stent Free Area
- Stent Length
- Stent Recoil
Purpose of tests: To compare the stent/delivery system of the subject device and the predicate device. To compare the stent dimensional data for the subject device and the predicate device.
Conclusions: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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 being
submitted in accordance with the requirements of SMDA 1990 and 21 CFR
807.92. |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Identification | The assigned 510(k) number is |
| Applicant: | Medtronic AVE, Inc.
Peripheral Technologies
2330 Circadian Way
Santa Rosa, California 95407
Contact: Susan L. Walton |
| | Phone: (707) 591-7315 FAX: (707) 591-7406
e-mail: susan.walton@medtronic.com
Date submitted: September 18, 1999 |
| Tradename: | Device Name: Medtronic AVE Bridge™ Stent
Model 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,
B10060L
Classification Name: Catheter, Biliary and accessories |
| Section 513
Device
Classification | Classification: Class II
Classification Panel: 78FGE |
| Equivalence | Medtronic AVE claims substantial equivalence to the Peripheral AVE Stent
Delivery System - For Use In Biliary Indication. |
| Intended Use | The Medtronic AVE Bridge™ Stent is intended to maintain patency of a bile
duct 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
| Performance
Testing | The subject device for this 510(k) is identical to the predicate device with the
exception of an alternate stent segment (component). The flexible Bridge™
Stent was found to be substantially equivalent in K983008 approved
November 25, 1998. Performance testing was conducted on the subject
device for the purpose of direct comparison to the predicate device. The
testing was chosen to highlight any differences between the subject device
and the predicate device. The balloon materials have not been changed. The
useable catheter length may be either 75 cm (cleared in K983008) or a new
length, 120 cm. The manufacturing process is not changed. | |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Test | Purpose |
| | • Balloon Deflation Time
• Crossing Profile | 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. |
| | • Stent Free Area
• Stent Length
• Stent Recoil | To compare the stent dimensional data for 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. |
| Conclusions | 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. | |
| Additional
Information | The summary includes any other information reasonably deemed necessary
by FDA. | |
| Biocompatibility | The materials used in the Medtronic AVE Bridge™ Stent passed all
biocompatibility tests. | |
| Sterilization | The Medtronic AVE Bridge™ Stent is provided sterile and is not intended for
sterilization or reuse/resterilization by the user.
Medtronic AVE validates the sterilization method for its stent delivery
systems to a Sterility Assurance Level (SAL) of 10-6.
The Medtronic AVE Bridge™ Stent is labeled pyrogen free. LAL testing is
performed 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 _