(90 days)
No
The summary does not mention AI, ML, image processing, or any data-driven performance metrics typically associated with AI/ML devices. The description focuses on the physical device and its intended use for vascular occlusion.
Yes
The device is used for the "interventional radiologic management of arteriovenous malformations and other vascular lesions" to reduce or block blood flow, indicating a therapeutic purpose.
No
Explanation: The device is described as an "Occlusion Device" used to "reduce or block the rate of blood flow" and for "interventional radiologic management of arteriovenous malformations and other vascular lesions." This indicates a therapeutic or interventional function, not a diagnostic one.
No
The device description explicitly mentions "occlusion device and coil pusher," which are physical hardware components used in interventional radiology procedures.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The description and intended use of the CES Occlusion Devices clearly indicate they are used within the body to physically block blood flow in vessels. This is an interventional procedure, not a diagnostic test performed on a specimen.
The information provided describes a device used for therapeutic intervention, not for diagnosing a condition by analyzing samples.
N/A
Intended Use / Indications for Use
CES Occlusion Devices may be used to reduce or block the rate of blood flow in small or tapering vessels. They are indicated for use in the interventional radiologic management of arteriovenous malformations and other vascular lesions of the brain, spinal cord and spine when devascularization prior to definitive surgical resection is desired.
Product codes
Not Found
Device Description
The CES Vascular Occlusion System (occlusion device and coil pusher) are similar in their basic design, construction, indication for use and performance characteristics to other commercially available coil occlusion systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
brain, spinal cord and spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
interventional radiologic management
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)
Not Found
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.
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
§ 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
ભારતનાં
PREMARKET NOTIFICATION 510(k) Cordis Corporation CES Vascular Occlusion System
JAN 30 1997
SUMMARY OF SAFETY AND EFFECTIVENESS
General Provisions l.
Common or Usual Name: Occlusion Device or Occlusion Coils or Fibered Microcoils Coil pusher or Embolic Coil Pusher
CES Vascular Occlusion System Proprietary Name:
Name of Predicate Devices ll.
Target Therapeutics Fibered Helical Coils (K901721- concurred 07/03/90)
Cook. Inc. Hilal Embolization Microcoil (K901337 - concurred 11/09/90)
Target Therapeutics Helical Coils and Coil Pusher (K891688 - concurred 09/15/89)
Cordis Endovascular Systems (CES), Inc. Instinct® Steerable Guidewire (K930982 concurred 02/24/94)
Classification 비.
Class III
Performance Standards IV.
Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act.
Intended Use and Device Description V.
CES Occlusion Devices may be used to reduce or block the rate of blood flow in small or tapering vessels. They are indicated for use in the interventional radiologic management of arteriovenous malformations and other vascular lesions of the brain, spinal cord and spine when devascularization prior to definitive surgical resection is desired.
Biocompatibility VI.
All appropriate biocompatibility tests were successfully performed on the CES Occlusion System (occlusion device and coil pusher).
Summary of Substantial Equivalence VII.
The CES Vascular Occlusion System (occlusion device and coil pusher) are similar in their basic design, construction, indication for use and performance characteristics to other commercially available coil occlusion systems.