(171 days)
No
The device description and performance studies focus on mechanical delivery of coils and direct visualization via angioscopy, with no mention of AI/ML for image analysis, decision support, or automated functions.
No.
The device facilitates a surgical procedure by delivering occlusion coils and providing visualization, rather than having a direct therapeutic effect itself. The therapeutic action is the occlusion of vessels, which is achieved by the coils, not the delivery system.
No
The device is primarily intended for interventional procedures, specifically for the delivery and placement of occlusion coils during bypass surgery, with the angioscope used for visualization during the intervention, not for diagnosis.
No
The device description explicitly details physical components such as catheters, coils, a guide wire, a plunger mechanism, an angioscope, and an actuator handle. These are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the intravascular delivery and placement of occlusion coils and for vessel visualization during a surgical procedure (in situ saphenous vein bypass graft procedures). This is an interventional surgical device, not a device used to examine specimens in vitro (outside the body).
- Device Description: The description details a system for delivering coils and visualizing vessels within the body. It involves catheters, coils, and an angioscope for direct visualization of the vessel lumen.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, tissue, etc.) or providing diagnostic information based on such analysis. The visualization is for guiding the surgical procedure, not for diagnosing a condition from a sample.
IVD devices are used to examine specimens obtained from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is entirely focused on performing a surgical intervention and providing real-time visualization during that intervention.
N/A
Intended Use / Indications for Use
The Intramed SBO System is intended for the intravascular delivery and placement of occlusion coils into tributaries during in situ saphenous vein bypass graft procedures. The angioscope within the Introducer Catheter is intended to be used for vessel visualization, specifically to visualize the lumen of the saphenous vein during the in situ procedures.
Product codes
Not Found
Device Description
The Intramed SBO System, like the CRI Occlusion System, was developed for the intravascular delivery and placement of occlusion coils into tributaries during in situ saphenous vein bypass graft procedures. The system includes (1) a Coil Delivery Catheter, which is preloaded with an occlusion coil, and (2) an Introducer Catheter, which is used to visualize the side branches and mechanically direct the Coil Delivery Catheter into the side branch for occlusion.
The Coil Delivery Catheter consists of a flexible catheter shaft with an occlusion coil positioned in the distal portion of the catheter lumen. A guide wire is contained within the inner shaft immediately proximal to the occlusion coil. At the proximal end of the catheter, this guide wire connects to a plunger mechanism. When the plunger is depressed. the quide wire pushes the coil out of the catheter and into the side branch for occlusion.
The occlusion coil provided with the Intramed SBO System is purchased from Cook Incorporated. This product is a preamendment device that has been commercially distributed for vessel occlusion/embolizations. The use of this coil in the Intramed SBO System is within the intended use of the occlusion coils as marketed by Cook Incorporated.
The Introducer Catheter has a composite shaft with two lumens. One lumen contains a miniature diameter angioscope with self-contained optics for visualization during the procedure. The other lumen is used to pass the Coil Delivery Catheter to the site of the side branch to be occluded. The catheter has an actuator handle to advance or retract the angioscope by a small amount to provide visualization of the vessel when the angioscope is in the extended position and visualization of the tributary when in the retracted position. The proximal end of the catheter consists of a coil catheter receiver as well as an eyepiece and light source connector for the angioscope.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessel, saphenous vein, peripheral vasculature
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
- Non-Clinical Tests:
- biocompatibility testing: Performed on catheter samples in accordance with ISO 10993 for Transient Contact Duration, Blood Path Direct, Externally Communicating Devices. Results: catheters and materials found biocompatible, nontoxic, and acceptable for intended use.
- functional/bench testing: Performed to evaluate integrity and performance. Results: demonstrated that the product meets its performance requirements.
- cadaver testing: Conducted to verify product performance in saphenous veins. Results: demonstrated that the Intramed SBO System visualizes and identifies side branches and can place coils in appropriate side branches.
- Clinical Testing: Clinical evaluation showed it is as safe and effective as the CRI system for the delivery of occlusion coils during in situ saphenous vein bypass surgery.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5950 Neurovascular embolization device.
(a)
Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 882.1(e).
0
MAR 27 1987
Food and Drug Administration 510(k) Notification for the Intramed Side Branch Occlusion System
K964021
October 4, 1996
Page 37
Appendix I
510(k) Summary
A. Determination of Substantial Equivalence
The Intramed Side Branch Occlusion (SBO) System is substantially equivalent to the CRI Vessel Occlusion System/CRI Occlusion Coil, which was cleared for marketing under premarket notification K914523. The angioscope in the Introducer Catheter is substantially equivalent to the Intramed" .7 mm Passive Angioscope, which was cleared for marketing under K894459.
B. Device Name
Intramed Side Branch Occlusion System, Models 700095 and 700098
C. Predicate Device
The claim of substantial equivalence is based on the following devices:
- CRI Vessel Occlusion System/CRI Occlusion Coil, 510(k) No. K914523 .
- Intramed .7 mm Passive Angioscope, 510(k) No. K894459 .
D. Device Description
The Intramed SBO System, like the CRI Occlusion System, was developed for the intravascular delivery and placement of occlusion coils into tributaries during in situ saphenous vein bypass graft procedures. The system includes (1) a Coil Delivery Catheter, which is preloaded with an occlusion coil, and (2) an Introducer Catheter, which is used to visualize the side branches and mechanically direct the Coil Delivery Catheter into the side branch for occlusion.
The Coil Delivery Catheter consists of a flexible catheter shaft with an occlusion coil positioned in the distal portion of the catheter lumen. A guide wire is contained within the inner shaft immediately proximal to the occlusion coil. At the proximal end of the catheter, this guide wire connects to a plunger mechanism. When the plunger is depressed. the quide wire pushes the coil out of the catheter and into the side branch for occlusion.
The occlusion coil provided with the Intramed SBO System is purchased from Cook Incorporated. This product is a preamendment device that has been commercially distributed for vessel occlusion/embolizations. The use of this coil in the Intramed SBO System is within the intended use of the occlusion coils as marketed by Cook Incorporated.
1
The Introducer Catheter has a composite shaft with two lumens. One lumen contains a miniature diameter angioscope with self-contained optics for visualization during the procedure. The other lumen is used to pass the Coil Delivery Catheter to the site of the side branch to be occluded. The catheter has an actuator handle to advance or retract the angioscope by a small amount to provide visualization of the vessel when the angioscope is in the extended position and visualization of the tributary when in the retracted position. The proximal end of the catheter consists of a coil catheter receiver as well as an eyepiece and light source connector for the angioscope.
E. Intended Use of Device
The Intramed SBO System is intended for the intravascular delivery and placement of occlusion coils into tributaries during in situ saphenous vein bypass graft procedures. The angioscope within the Introducer Catheter is intended to be used for vessel visualization, specifically to visualize the lumen of the saphenous vein during the in situ procedures.
F. Intended Use of Predicate Device
The CRI Vessel Occlusion System is intended for the intravascular delivery and placement of occlusion coils into tributaries during in situ saphenous vein bypass graft procedures. The Intramed . 7 mm Passive Angioscope is intended to be used for visualization of peripheral vasculature.
G. Technological Comparison of the Intramed SBO System and the Predicate Device
The Intramed SBO System is similar to the CRI System in the type of system components and mode of operation. Both systems include (1) a coil, (2) a delivery catheter through which the coil is inserted into the tributary and (3) a catheter through which the coil delivery catheter and coil are directed/steered into the tributary. The systems are both used intraoperatively and the use of both systems entails locating the tributary, directing the coil delivery catheter into the tributary and injecting the coil into the tributary. The coils in both systems are intended to cause a thrombus to form in the tributary, thereby occluding the tributary and preventing formation of an arteriovenous fistula in the graffed vessel. Overall, the mode of operation is the same for the two products.
The Intramed® SBO and CRI systems have some differences in materials and The Intrained SDO and Cril systems nave some and of metal brithed fands and
mechanics. The coils used with both systems are made of metal but the SBO only of the SBO only mechaniss. The colled with both synthetic have be necessor and and the south and only Art All (A)
also contains attactions attactions . Both collections in which (V) (All (V also contains attached synthetic fibers. Both coils have been demonstrated to tributary are also somewhat different. The Intramed" SBO System mechanically directs the coil; that is, the tip of the Introducer Catheter is angioscopically aimed at the tributary so that the path of the Coil Delivery Catheter is directed into the tributary. The CRI system utilizes a steerable catheter whose tip is manipulated via
ta
ignature
2
October 4, 1996 Page 39
a control system, thereby aiming or steering the delivery catheter into the tributary. In addition, the CRI coils are ejected hydraulically, while the Intramed SBO System catheter injects the coil mechanically via a guide wire/plunger. Finally, as indicated previously, the Intramed SBO System contains an integral angioscope that aids in both locating the side branch and in directing the delivery catheter and coil into the side branch. The CRI system requires the use of an external angioscopic device or fluoroscopy in locating the side branches and aiming the delivery catheter. These differences in design of the systems do not affect the intended use or indication for use of the product, nor do they affect the similarities in the general operation of the systems. As indicated previously, both systems function similarly; the introducer catheter passes down the saphenous vein, directs the coil delivery catheter into the side branches of the vein and occlusion coils are deployed through the delivery catheters into the side branches.
The angioscope used in the Intramed SBO System and the Intramed® .7 mm Passive Angioscope both consist of light and image transmitting borosilicate fiber bundles contained within the angioscope body. The image is transmitted through the fibers to an eyepiece or focusing coupler and a camera system. The technology of the two products is equivalent as are the materials, device characteristics and intended use.
H. Discussion of Non-Clinical Tests and Conclusions
The following non-clinical testing was performed on the Intramed SBO System:
- . biocompatibility testing
- functional/bench testing, and .
- cadaver testing. .
Biocompatibility testing was performed on the catheter samples in accordance with the requirements specified in ISO 10993 standard for Transient Contact Duration, Blood Path Direct, Externally Communicating Devices. The catheters and their materials were found to be biocompatible and nontoxic and acceptable for their intended use.
Functional testing was performed on the Intramed SBO System to evaluate the integrity and performance of the device. The testing demonstrated that the product meets its performance requirements.
Evaluation of the product in cadavers was conducted to verify the product's performance in saphenous veins. The studies demonstrated that the Intramed SBO System visualizes and identifies side branches and can place coils in appropriate side branches
etachment-
?
3
Summary of Clinical Testing l.
Clinical evaluation of the Intramed SBO System showed that it is as safe and effective as the CRI system for the delivery of occlusion coils during in situ saphenous vein bypass surgery.
J. Summary of Safety and Effectiveness
The above testing demonstrates that the Intramed® Side Branch Occlusion System is safe and effective for its intended use.
Irene Loza Parker
Irene Ponzoa Parker, R.N., M.B.A. Manager, Regulatory Affairs and Clinical Programs Edwards Critical-Care and Vascular Systems Divisions