(24 days)
EX Embolic Protection System, GuardWire Temporary Occlusion and Aspiration System
Not Found
No
The device description and performance studies focus on mechanical components and clinical outcomes, with no mention of AI/ML, image processing, or data training/testing.
Yes
Explanation: The device is indicated for use to "contain and remove embolic material (thrombus/debris) while performing carotid artery angioplasty and stenting procedures" and functions as a protection system. This direct medical intervention to protect against complications qualifies it as a therapeutic device.
No
Explanation: The device is an embolic protection system designed to capture and remove embolic material during carotid artery angioplasty and stenting procedures. It is an interventional device, not one that is used for diagnosing a condition or disease.
No
The device description clearly states that the ANGIOGUARD XP and ANGIOGUARD RX devices consist of a guidewire with an integrated emboli filter, which are physical hardware components. The performance studies also describe in-vitro testing, animal models, and clinical evaluations of these physical devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "contain and remove embolic material (thrombus/debris) while performing carotid artery angioplasty and stenting procedures in carotid arteries." This is a therapeutic and procedural use, not a diagnostic one.
- Device Description: The device is described as a "guidewire with an integrated emboli filter" that functions as an "interventional guidewire and distal protection device." It physically captures emboli during a procedure. This is a mechanical intervention, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, tissue, etc.)
- Detecting or measuring substances in a sample
- Providing information for diagnosis, monitoring, or screening
The device is a medical device used during a surgical procedure to protect the patient from complications. It does not perform any diagnostic testing.
N/A
Intended Use / Indications for Use
The ANGIOGUARD XP Emboli Capture Guidewire and the ANGIOGUARD RX Emboli Capture Guidewire are indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing carotid artery angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of filter basket placement should be from 3mm to 7.5 mm.
Product codes
NTE
Device Description
ANGIOGUARD XP and ANGIOGUARD RX devices consist of a guidewire with an integrated emboli filter at the distal end. The devices function as an interventional guidewire and distal protection device during delivery and placement of the stents and interventional devices during carotid procedures. The devices are delivered via a deployment sheath and captured via a capture sheath. The ANGIOGUARD devices have a filter basket at the distal end that is deployed prior to the stenting procedure. When deployed, the filter basket opens in an umbrella-like fashion, allowing passive hemo-filtration with subsequent emboli capture. At the end of the procedure, the filter is collapsed and retrieved. The device is available with filter basket diameters of 4, 5, 6, 7 and 8mm. The ANGIOGUARD devices are intended to capture emboli during carotid stenting procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
carotid arteries
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
In-vitro testing consisted of dimensional, tensile/torque testing and functional testing. Biocompatibility, sterilization qualification and residual analysis, packaging testing, product shelf-life testing and functional testing in animal models have also been successfully conducted.
Cordis conducted emboli capture and vessel damage studies utilizing an earlier version ANGIOGUARD device; which demonstrated satisfactory results with no significant luminal disruption or hemolysis. Results are applicable to ANGIOGUARD XP and ANGIOGUARD RX, as the basket components of the devices are identical.
Acute studies were conducted on the ANGIOGUARD XP and RX devices to evaluate device performance. Porcine models were used to simulate the anatomy of tortuous human arteries because of the similarity in arterial diameter to human vessels. Results demonstrated satisfactory device performance characteristics.
Clinical evaluation: The SAPPHIRE study was a multi-center, randomized study conducted at 29 investigative sites in the United States. It assessed carotid artery stenting with distal protection (using Cordis PRECISE® Nitinol Stent System and ANGIOGUARD XP Emboli Capture Guidewire) compared to carotid endarterectomy in high-risk surgical patients. It also included non-randomized stent and surgical arms. A total of 747 patients were enrolled (334 in randomized arm: 167 stent, 167 CEA; 406 in non-randomized stent arm; 7 in non-randomized surgical arm).
Clinical evaluation of ANGIOGUARD XP, together with the preclinical data supporting both ANGIOGUARD XP and RX, was used to provide reasonable assurance of the safety and effectiveness of both devices for the intended clinical indication.
Key Metrics
Randomized Study Arm: The incidence of death, stroke, or MI at 30 days plus death or ipsilateral stroke at 360 days (MAE) in the carotid stent group was 12.0% (20/167) compared with 19.2% (32/167) in the surgical group. In comparing treatment arms for MAE at 360 days, the stent arm was noninferior to the CEA arm within the designated 3% delta (-7.2% {14.9%, 0.6)}). The difference represented a trend for superiority of the stent arm (p=0.067).
Registry Study Arm: The incidence of death, stroke and MI at 30 days plus death or ipsilateral stroke at 360 days (MAE) was 15.8% (64/406). In a test of the primary endpoint against the OPC, despite the fact that the rate was numerically less than the OPC plus the delta, the p-value was found to be 0.2899. In a test of the MAE rate when post 30-day non-neurological deaths are not included, the p-value was
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
.
APPENDIX A
SEP 2 2 2006
510(K) SUMMARY OF SAFETY AND EFFECTIVINESS
| Submitter: | Joan Martin
Manager, Regulatory Affairs
Cordis Corporation
7 Powderhorn Drive
Warren, NJ 07059 |
|----------------|------------------------------------------------------------------------------------------------------------|
| Telephone: | 908-412-7250 |
| Fax | 908-412-3008 |
| e-mail address | jmartin@crdus.jnj.com |
Date Prepared: August 23, 2006
| General
Provisions: | Trade Name | ANGIOGUARD™ XP Emboli Capture Guidewire System
ANGIOGUARD™ RX Emboli Capture Guidewire System |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Common Name | Embolic Protection Guidewire |
| | Classification Name | Cardiovascular Percutaneous Catheter (per 21 CFR 870.1250) & Catheter Guidewire (per 21 CFR 870.1330) |
| | Device-classification | Class II |
| Predicate
Devices: | | The subject Cordis ANGIOGUARD™ RX Emboli Capture Guidewire System and
ANGIOGUARD™ XP Emboli Capture Guidewire System are substantially
equivalent to:
• FilterWire ™ EX Embolic Protection System, Boston Scientific Corp.
• PercuSurge GuardWire Temporary Occlusion and Aspiration System,
PercuSurge, Inc. |
| Device
Description | ANGIOGUARD XP and ANGIOGUARD RX devices consist of a guidewire with an
integrated emboli filter at the distal end. The devices function as an interventional
guidewire and distal protection device during delivery and placement of the stents
and interventional devices during carotid procedures. The devices are delivered via a
deployment sheath and captured via a capture sheath. The ANGIOGUARD devices
have a filter basket at the distal end that is deployed prior to the stenting procedure.
When deployed, the filter basket opens in an umbrella-like fashion, allowing passive
hemo-filtration with subsequent emboli capture. At the end of the procedure, the
filter is collapsed and retrieved. The device is available with filter basket diameters
of 4, 5, 6, 7 and 8mm.
The ANGIOGUARD devices are intended to capture emboli during carotid stenting | |
procedures.
1
Indications for ANGIOGUARD XP " Emboli Capture Guidewire and ANGIOGUARD RX Emboli Capture Guidewire Use
The ANGIOGUARD XP Emboli Capture Guidewire and the ANGIOGUARD RX Emboli Capture Guidewire are indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing carotid artery angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of filter basket placement should be from 3mm to 7.5 mm.
Performance In-vitro testing consisted of dimensional, tensile/torque testing and functional Data: testing. Biocompatibility, sterilization qualification and residual analysis, packaging testing, product shelf-life testing and functional testing in animal models have also been successfully conducted.
Cordis conducted emboli capture and vessel damage studies utilizing an earlier version ANGIOGUARD device; which demonstrated satisfactory results with no significant luminal disruption or hemolysis. Results are applicable to ANGIOGUARD XP and ANGIOGUARD RX, as the basket components of the devices are identical.
Acute studies were conducted on the ANGIOGUARD XP and RX devices to evaluate device performance. Porcine models were used to simulate the anatomy of tortuous human arteries because of the similarity in arterial diameter to human vessels. Results demonstrated satisfactory device performance characteristics.
2
Clinical A clinical evaluation in a multi-center, randomized study (SAPPHIRE) was Summary conducted at 29 investigative sites in the United States. The study assessed carotid artery stenting with distal protection, utilizing the Cordis PRECISE® Nitinol Stent System and the ANGIOGUARD XP Emboli Capture Guidewire, as compared to carotid endarterectomy in patients at high-risk for surgery. A separate stent arm was included for patients meeting the entry criteria, but who were determined by the vascular surgeon to be at too high a risk for surgery. Also included was a surgical arm for patients meeting the entry criteria, who the interventionalist determined to be unacceptable candidates for stenting. A total of 334 subjects were entered into the randomized arm of the study (167 stent and 167 CEA patients). A total of 406 subjects were entered into the non-randomized stent arm and 7 subjects were entered into the non-randomized surgical arm. Hence, an overall total of 747 patients were entered into Cordis' pivotal SAPPHIRE study.
Clinical evaluation of ANGIOGUARD XP, together with the preclinical data supporting both ANGIOGUARD XP and RX, was used to provide reasonable assurance of the safety and effectiveness of both devices for the intended clinical indication.
Multicenter clinical data reached the following conclusions:
Randomized Study Arm: The incidence of death, stroke, or MI at 30 days plus death or ipsilateral stroke at 360 days (MAE) in the carotid stent group was 12.0% (20/167) compared with 19.2% (32/167) in the surgical group. In comparing treatment arms for MAE at 360 days, the stent arm was noninferior to the CEA arm within the designated 3% delta (-7.2% {14.9%, 0.6)}). The difference represented a trend for superiority of the stent arm (p=0.067).
Registry Study Arm: The incidence of death, stroke and MI at 30 days plus death or ipsilateral stroke at 360 days (MAE) was 15.8% (64/406). In a test of the primary endpoint against the OPC, despite the fact that the rate was numerically less than the OPC plus the delta, the p-value was found to be 0.2899. In a test of the MAE rate when post 30-day non-neurological deaths are not included, the p-value was