(212 days)
Not Found
Not Found
No
The summary describes a mechanical stent system and its delivery catheter, with no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is intended for the "palliative treatment of biliary duct strictures caused by malignant tumors," which is a therapeutic purpose.
No
Explanation: The device is a stent system used for palliative treatment of biliary duct strictures caused by malignant tumors. Its purpose is to maintain patency of a body lumen, not to diagnose a condition.
No
The device description clearly outlines physical components including a stent, delivery catheter, balloon, and radiopaque markers, indicating it is a hardware-based medical device.
Based on the provided information, the AVE Bridge™ Stent System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for maintaining patency of a biliary duct occluded by tumor and for palliative treatment of biliary duct strictures. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The description details a physical implantable device (stent) and its delivery system, designed for placement within the biliary ducts.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The AVE Bridge™ Stent System does not perform any such analysis on bodily specimens.
Therefore, the AVE Bridge™ Stent System is a medical device used for treatment within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Arterial Vascular Engineering, Incorporated (AVE) Bridge™ Stent System is intended for use in patients to maintain patency of a biliary duct which is occluded by tumor .
The AVE Bridge™ Stent System is indicated for palliative treatment of biliary duct strictures caused by malignant rumors.
This device is not intended for intravascular use.
Product codes (comma separated list FDA assigned to the subject device)
78 FGE
Device Description
The AVE Bridge™ Stent System consists of a balloon-expandable intraluminal stent premounted onto the balloon of an over-the-wire delivery catherer. The AVE Bridge™ Stent System has two radiopaque platinum markers imbedded in 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 to 90 cm. The AVE Bridge™ Stent System is provided enclosed in a sterile package.
Size Range:
Diameters - 6.0 mm to 10.0 mm Lengths - 16 mm to 40 mm
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Biliary Ducts
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)
-
AVE Bridge™ Stent vs JJIS Palmaz™ Balloon-Expandable Stent - Balloon Performance Study
Purpose: To compare the minimum burst pressure and deflation times of the AVE Bridge™ Stent balloons to the PALMAZ™ Balloon-Expandable Stent balloons. The data gathered will support a premarket notification for the AVE Bridge™ Stent System.
Results: The test proved substantial equivalence. -
AVE Bridge™ Stent vs JJIS Palmaz™ Balloon-Expandable Stent - Two Plane Crush Strength Study
Purpose: To determine and compare the radial strengths of the AVE Bridge™ Stent and the PALMAZ™ Balloon-Expandable Stent by graphically representing the amount of force required to crush a stent to fifty percent (50%) of its deployed diameter. The data gathered will support a premarket notification for the AVE Bridge™ Stent System.
Results: The test proved substantial equivalence. -
AVE Bridge™ Stent Dimensional Verification and Stent Uniformity at Nominal Deployment
Purpose: To verify that processed AVE Bridge™ Stents meet diameter and length specifications after deployment. The data gathered will support a premarket notification for the AVE Bridge™ Stent System.
Results: The results conclude that the stents tested meet the labeled specifications for stent diameter and stent length.
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.
Not Found
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
Image /page/0/Picture/0 description: The image shows the logo for Arterial Vascular Engineering (AVE). The logo features the letters "AVE" in a bold, stylized font, with the "E" having a swooping extension. Below the letters, the full name "Arterial Vascular Engineering" is written in a smaller, sans-serif font.
NOV - 5 1997
AVE Bridge™ Stent System
510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is bcing submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is:
GENERAL INFORMATION
Applicant:
| Date: | 2 April, 1997 |
|---|---|
| Name: | Arterial Vascular Engineering, Incorporated |
| Address: | 3576 Unocal Place |
| Santa Rosa, CA 95403 | |
| Contact: | Joseph Tamayo |
| Phone Number: | (707) 525-0111 |
| FAX Number: | (707) 525-0114 |
Trade Namc:
| Device Name: | AVE Bridge™ Stent System |
|---|---|
| Model Numbers: | TBD |
| Classification Name: | Catheter, Biliary and accessories |
Section 513 Device Classification:
| Classification | Class II |
|---|---|
| Classification Panel: | 78FGE |
Arterial Vascular Engineoring, incorporated
AVC Dridge™- Эtен: Зуэсит - Premarket Notification КУ/1295
Additional Information Requested
3 November, 1997 Page 3 of 7
1
EQUIVALENCE
Arterial Vascular Engineering, Incorporated, claims substantial equivalence to the Johnson & Johnson Interventional Systems' PALMAZ™ Balloon-Expandable Stent.
INTENDED USE
The Arterial Vascular Engineering, Incorporated (AVE) Bridge™ Stent System is intended for use in patients to maintain patency of a biliary duct which is occluded by tumor .
The AVE Bridge™ Stent System is indicated for palliative treatment of biliary duct strictures caused by malignant rumors.
This device is not intended for intravascular use.
DEVICE DESCRIPTION
The AVE Bridge™ Stent System consists of a balloon-expandable intraluminal stent premounted onto the balloon of an over-the-wire delivery catherer. The AVE Bridge™ Stent System has two radiopaque platinum markers imbedded in 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 to 90 cm. The AVE Bridge™ Stent System is provided enclosed in a sterile package.
Size Range:
Diameters - 6.0 mm to 10.0 mm Lengths - 16 mm to 40 mm
2
Comparison to Predicate Device:
Per 807,92(a)(6). the SIU(k) sununary of the technological characteristics of your device compared to the predicate device.
| Characteristic
Compared | AVE Bridge™ Stent System | PALMAZ™ Balloon-Expandable
Stent |
|-----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | The AVE Bridge™ Stent System is
intended for use in patients to maintain
patency of a biliary duct which is
occluded by tumor.
The AVE Bridge™ Stent System is
indicated for palliative treatment of
biliary duct strictures caused by
malignant tumors. | The device is a permanent implant
intended to maintain patency of a bile duct
which is obstructed by scar tissue or tumor. |
| Physical
Characteristics
(Stent): | 316L stainless steel balloon
expandable stent - premounted Diameters - 6 mm to 10 mm Lengths - 16 mm to 40 mm | 316L stainless steel balloon expandable
stent - premounted or unmounted Diameters - 4 mm to 12 mm Lengths - 9 mm to 40 mm |
| Physical
Characteristics
(Delivery catheter): | balloon delivery system - PTA catheter 5.3 F shaft size 75 cm to 90 cm length 0.035 in. Guidewire diameter | balloon delivery system - PTA catheter 5 F to 7 F shaft size 75 cm length 0.035 in. Guidewire diameter for unmounted stents - Medi-tech PE-MT™
PTA balloon catheters 5 F to 9 F shaft size 60 cm to 120 cm length 0.035 in. Guidewire diameter |
| Anatomical Sites: | Biliary Ducts | Biliary Ducts |
| Target Population: | Patients with biliary duct obstruction
caused by malignant tumor | Patients with biliary duct obstruction
caused by tumor or scar tissue |
3/5
3
Performance Testing:
Per 807.92(b)(1) If the determination of substuntial equivalence is also based on un assessment of performance data, the summary includes a brief discussion of the non clinical less and how their results support a decemination of substantial cquivalence
1. AVE Bridge™ Stent vs JJIS Palmaz™ Balloon-Expandable Stent - Balloon Performance Study
Purpose:
To compare the minimum burst pressure and deflation times of the AVE Bridge™ Stent balloons to the PALMAZ™ Balloon-Expandable Stent balloons. The data gathered will support a premarket notification for the AVE Bridge™ Stent System.
Results:
The test proved substantial equivalence.
2. AVE Bridge™ Stent vs JJIS Palmaz™ Balloon-Expandable Stent - Two Plane Crush Strength Study
Purpose:
To determine and compare the radial strengths of the AVE Bridge™ Stent and the PALMAZ™ Balloon-Expandable Stent by graphically representing the amount of force required to crush a stent to fifty percent (50%) of its deployed diameter. The data gathered will support a premarket notification for the AVE Bridge™ Stent System.
Results:
The test proved substantial equivalence.
3. AVE Bridge™ Stent Dimensional Verification and Stent Uniformity at Nominal Deployment
Purpose:
To verify that processed AVE Bridge™ Stents meet diameter and length specifications after deployment. The data gathered will support a premarket notification for the AVE Bridge™ Stent System.
Results:
The results conclude that the stents tested meet the labeled specifications for stent diameter and stent length.
Page 415
4
CONCLUSIONS:
The AVE Bridge™ Steut vs the JJIS Palmaz™ Balloon-Fxpandable Stent performance testing results prove that the Bridge™ Stent is substantially equivalent to the JJS Palmaz™ Balloon-Expandable Stent
Additional Information:
Per 807.92(d), the summary includes any other information reasonably decreed neicasaly by FDA.
BIOCOMPATIBILITY
The materials cmployed in the AVE Bridge™ Stent Delivery System passed all biocompatibility tests.
STERILIZATION INFORMATION
The AVE Bridge 2M Stent System is provided sterile.
The AVE Bridge™ Stem is not intended for sterilization or reuse/ resterilization by the user.
Validation
Arterial Vascular Engineering, Incorporated validates the sterilization method, for its stent delivery system products, quarterly each year according to the ANSI/ AAMI/ ISO 11137 - 1994, Method I. Sterilization of Healthcare Products - Requirements for Validation and Routine Control - Radiation Sterilization.
Sterility Assurance Lovel (SAL)
The Sterility Assurance Level or SAL for the validated AVE stent systems is 10 .
Pyrogen Testing
The AVE Bridge™ Stent System is labeled "pyrogen free". LAL testing is performed datty, in compliance with FDA guidcline on Validation of Limulus Amebocyte I yeate Test as an End Product Endotoxin Test for IIuman and Animal Parenteral Drugs, Biological Products, and Medical Devices - Section V - 2 Inlibition and Enhancement Testing, as part of AVE's product release critcria.
5 November, 1997
Page 7 of 7
Arterial Vascular Engineering, Incorporatod AVF Bridge™ Stent Syctom - Promarket Notification K971295 Additional Information Requested
5
Image /page/5/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. In the center is a stylized caduceus, a symbol often associated with healthcare. The text "AN SERVICES - USA" is also included in the seal.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 5 1997
Mr. Joseph.Tamayo Regulatory Affairs Specialist Arterial Vascular Engineering, Inc. 3576 Unocal Place Santa Rosa, California 95403
Re: K971295
AVE Bridge™ Stent System Dated: August 12, 1997 Received: August 13, 1997 Regulatory class: II 21 CFR §876.5010/Product code: 78 FGE
Dear Mr. Tamayo:
We have reviewed your Section 510(k) notification of intent to market the device and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, subject to the general controls provisions of the Act. 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.
If your device is classified (see above) into either class III (Premarket Aproval), 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 requirement, 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 Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation wititled, "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/dsmamain.html".
Sincerely vours
William Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
510 (k) Number: K971295 AVE Bridge™ Stent System Device Name:
Indications For Use:
The AVE Bridge™ Stent System is indicated for palliative treatment of biliary duct strictures caused by malignant tumors.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Robert
Sign-Oling /
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K971295