(28 days)
Not Found
No
The device description and performance studies focus on mechanical function and material properties, with no mention of AI/ML terms or data analysis.
Yes
The device is described as an "emboli capture guidewire" and "embolic protection system" used to "contain and remove embolic material (thrombus/debris)" during medical procedures, which aligns with the definition of a therapeutic device designed to treat a medical condition or prevent its progression.
No.
The device is an embolic protection system designed to capture and remove embolic material during carotid artery procedures, not to diagnose a condition.
No
The device description clearly outlines a physical guidewire with an integrated filter basket, which is a hardware component. The performance studies also focus on physical characteristics and testing, not software validation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Device Description: The ANGIOGUARD™ XP and RX Emboli Capture Guidewires are described as physical devices used inside the body during a medical procedure (carotid artery angioplasty and stenting). They function as a guidewire and a filter to capture debris during the procedure.
- Intended Use: The intended use is to contain and remove embolic material during a surgical procedure, not to perform a diagnostic test on a sample.
The device is an interventional medical device used in vivo (inside the body).
N/A
Intended Use / Indications for Use
The ANGIOGUARD™ XP Emboli Capture Guidewire is 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 (comma separated list FDA assigned to the subject device)
NTE
Device Description
Both subject and predicate ANGIOGUARD XP and RX devices consist of a guidewire with integrated emboli filter basket at the distal end. The devices function as an interventional guidewire and distal protection device during delivery and placement of stents and interventional devices in carotid procedures. The guidewire is delivered via an OTW (over-the-wire) or RX (rapid-exchange) deployment sheath and is captured via an OTW or RX capture sheath. ANGIOGUARD devices have a fitter 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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Design verification activities (Deployment and Capture Testing, Visual Inspections, Bioburden, Endotoxin, EtO residual testing and biocompatibility testing per ISO 10993-1) were conducted to confirm that the modified devices meet the same requirements as the current, legally marketed predicate devices. Results demonstrated that design outputs continue to meet device inputs. Hence, the subject ANGIOGUARD XP and RX Emboli Capture Guidewire devices are substantially equivalent to the current, legally marketed ANGIOGUARD XP and RX Emboli Capture Guidewire predicate devices.
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.
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
§ 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
KU1651
Special 510(k) Notification
Cordis Corporation ANGIOGUARD XP & RX Emboli Capture Guidewires
510(k) Summary
| Applicant | Cordis Corporation, a Johnson & Johnson Company
430 Rt. 22 East
Bridgewater, New Jersey 08807
Telephone: 908-541-4888
Fax: 908-541-4559 | | JUL - 9 2010 | | | | | | | | |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--------------|--|--|--|--|--|--|--|--|
| Contact
Person | Joan Martin
Manager
Regulatory Affairs | | | | | | | | | | |
| Date | June 10, 2009 | | | | | | | | | | |
| Device Name | Trade Name: ANGIOGUARD™ XP Emboli Capture Guidewire
ANGIOGUARD™ RX Emboli Capture Guidewire Common or Usual
Name: Common Name: Embolic Protection Guidewire
Cardiovascular Percutaneous Catheter per 21 CFR
870.1250 and Catheter Guidewire per 21 CFR
870.1330 Classification: Class II Classification Panel Cardiovascular | | | | | | | | | | |
| Predicate
Devices | The device is substantially equivalent to Cordis' current, legally-marketed
ANGIOGUARD™ XP Emboli Capture Guidewire and ANGIOGUARD™ | | | | | | | | | | |
RX Emboli Capture Guidewire which were found to be substantially equivalent to Boston Scientific's FilterWire EX Embolic Protection System (K023691) and PercuSurge, Inc.'s Percusurge Guardwire Temporary Occlusion and Aspiration System (K013913) via 510(k) K062531 on September 22, 2006.
1
Cordis Corporation ANGIOGUARD XP & RX Emboli Capture Guidewires Special 510(k) Notification
Both subject and predicate ANGIOGUARD XP and RX devices consist of a Device guidewire with integrated emboli filter basket at the distal end. The devices Description function as an interventional guidewire and distal protection device during delivery and placement of stents and interventional devices in carotid procedures. The guidewire is delivered via an OTW (over-the-wire) or RX (rapid-exchange) deployment sheath and is captured via an OTW or RX capture sheath. ANGIOGUARD devices have a fitter 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 subject and predicate ANGIOGUARD XP and ANGIOGUARD RX Intended Use Emboli Capture Guidewire devicves 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.
Summary of Substantial Equivalence
With the exception of a change to the adhesive material used to adhere radiopaque markers to the filter basket struts, the subject and predicate devices share the same:
- Intended use .
- Indication for use
- Design & Dimensions .
- Size Range .
- Materials (with exception of adhesive material change described herein) .
- Fundamental technology and operating principle .
- Manufacturing site and methods .
- Sterilization site, method, parameters, and sterility assurance level .
- Packaging .
- Labeling / Instructions for use .
- . Shelf Life
subject ANGIOGUARD XP Emboli Capture Guidewire and The ANGIOGUARD RX Emboli Capture Guidewire devices are substantially equivalent to the predicate ANGIOGUARD XP Emboli Capture Guidewire and ANGIOGUARD RX Emboli Capture Guidewire devices.
2
Cordis Corporation ANGIOGUARD XP & RX Emboli Capture Guidewires Special 510(k) Notification
Design verification activities (Deployment and Capture Testing, Visual Summary of Inspections, Bioburden, Endotoxin, EtO residual testing and biocompatibility & Conclusions testing per ISO 10993-1) were conducted to confirm that the modified devices Drawn from meet the same requirements as the current, legally marketed predicate Design devices. Verification Activities
Results demonstrated that design outputs continue to meet device inputs. Hence, the subject ANGIOGUARD XP and RX Emboli Capture Guidewire devices are substantially equivalent to the current, legally marketed ANGIOGUARD XP and RX Emboli Capture Guidewire predicate devices.
3
Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a bird, possibly an eagle, with its wings spread. The bird is stylized with thick, curved lines, giving it a modern and symbolic appearance.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
JUL - 9 2010
Cordis Corporation c/o Joan Martin Manager, Regulatory Affairs 430 Route 22 East Bridgewater, NJ 08807
Re: K101651
Trade/Device Name: Angioguard XP and RX Emboli Capture Guidewires Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: NTE Dated: June 10, 2010 Received: June 11, 2010
Dear Ms. Martin:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
Page 2 - Ms. Joan Martin
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
R. Vilmer
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Special 510(k) Notification
Cordis Corporation ANGIOGUARD XP & RX Emboli Capture Guidewires
Indication for Use
K10165 510(k) Number: ___
Device Name: ANGIOGUARD™ XP Emboli Capture Guidewire System
Indications For Use: The ANGIOGUARD™ XP Emboli Capture Guidewire is 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.
Prescription Use: X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use: (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duna D. Valuer
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_K101651
6
Special 510(k) Notification
Cordis Corporation ANGIOGUARD XP & RX Emboli Capture Guidewires
Indication for Use
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Device Name: ANGIOGUARD™ RX Emboli Capture Guidewire System
Indications For Use: The ANGIOGUARD™ RX Emboli Capture Guidewire is 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.
Prescription Use: X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use: (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
brmea D. McAlusen
Division Sian-Off) Division of Čardiovascular Devices
510(k) Number