(177 days)
No
The device description and performance studies focus on the physical properties and mechanical performance of a guiding catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is a guiding catheter intended for the introduction of other diagnostic or interventional devices, not for therapeutic action itself.
No
The Alviguide™ Blue+ and Alguide™ Guide Catheters are designed for the "intravascular introduction of interventional/diagnostic devices," meaning they introduce other devices, but are not themselves described as diagnostic.
No
The device description clearly outlines a physical catheter with a tri-layer construction, stainless steel wire braid, and a soft tip. The performance studies also detail bench testing related to physical properties and biocompatibility, indicating a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "intravascular introduction of interventional/diagnostic devices into the coronary vascular system" and "peripheral vascular system." This describes a device used within the body to facilitate other procedures, not a device used to test samples outside the body to diagnose conditions.
- Device Description: The description details a physical catheter designed for insertion into blood vessels. This aligns with an interventional/diagnostic tool used in vivo, not an in vitro diagnostic device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process that would be performed outside of the body to obtain diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is to guide other instruments within the vascular system, which is an in vivo procedure.
N/A
Intended Use / Indications for Use
The Alviguide™ Blue+ Interventional Cardiology Guiding Catheter is intended for use in the intravascular introduction of interventional/diagnostic devices into the coronary vascular system.
The Alguide™ Endovascular Guiding Catheter is intended for use in the introduction of interventional/ diagnostic devices into the peripheral vascular system.
Product codes
DQY
Device Description
The Alviguide™ Blue+ and Alguide™ Guide Catheters are sterile, non-pyrogenic, single lumen catheters with a tri-layer catheter body construction consisting of a polymer inner layer and a radiopaque outer layer surrounding a stainless steel wire braid, and a soft tip at the distal end. The catheters are for single-use only.
The Alviguide™ Blue+ and Alguide™ Guide Catheters are provided in a variety of distal shape configurations and are available in Fr Sizes 5, 6, 7 and 8 and lengths of 45, 60, 65 and 80cm (Alguide™), and 100cm (Alviguide™ Blue+ and Alguide™).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary vascular system, peripheral vascular system
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
Nonclinical, bench testing included:
- Visual Inspection
- Dimensional Verification
- Catheter Sheath Introducer Withdrawal Force
- Hub Leakage
- Kink Diameter and Force
- Tensile Strength
- Radiopacity
- Torque Testing
- Packaging integrity (Visual inspection, seal strength test)
- Sterilization (EO sterilization evaluation, EO residuals, endotoxin)
Biocompatibility testing was conducted in compliance with ISO 10993-1, for externally communicating devices with limited exposure (
§ 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three profiles facing right, suggesting a sense of forward movement and progress. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 3, 2014
Alvimedica c/o Lori Adels Experien Group, LLC 755 N Mathilda Avenue. Suite #100 Sunnyvale, CA 94085
Re: K141529
Trade/Device Name: Alviguide™ Blue+ Interventional Cardiology Guiding Catheter and Alguide™ Endovascular Guiding Catheter Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQY Dated: October 31, 2014 Received: November 3, 2014
Dear Ms. Adels:
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.
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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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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 vours.
Melissa A. Torres -S
For Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Alviguide™ Blue+ Interventional Cardiology Guiding Catheter, Alguide™ Endovascular Guiding Catheter
Indications for Use (Describe)
The Alviguide™ Blue+ Interventional Cardiology Guiding Catheter is intended for use in the intravascular introduction of interventional/diagnostic devices into the coronary vascular system.
The Alguide™ Endovascular Guiding Catheter is intended for use in the introduction of interventional/ diagnostic devices into the peripheral vascular system.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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510(k) Notification K
GENERAL INFORMATION
Applicant:
Alvimedica Tıbbi Ürünler Sanavi ve Dıs Ticaret A.S. İstanbul Trakya Serbest Bölgesi Ferhatpaşa Mahallesi Atatürk Bulvarı Manolya Sokak No:7 34540 Catalca, İstanbul Turkev Phone: +90 212 786 60 80 FAX: +90 212 786 60 90
Contact Person:
Lori E. Adels, Ph.D Regulatory Consultant for Alvimedica Experien Group, LLC 755 N. Mathilda Avenue, Suite 100 Sunnyvale, CA 94085 U.S.A. Phone: (408) 400-0856 ext. 112 FAX: (408) 400-0865
Date Prepared: June 6, 2014
DEVICE INFORMATION
Trade Name:
Alviguide™ Blue+ Interventional Cardiology Guiding Catheter Alguide™ Endovascular Guiding Catheter
Classification Name:
Percutaneous catheter
Generic/Common Name:
Guide catheter
Classification:
Class II per 21 CFR§870.1250
Product Code: DOY
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PREDICATE DEVICES
- Medtronic 5F Sherpa Active NX Guide Catheter (K062420)
- Medtronic 6F Launcher Guide Catheter [Medtronic 6F Z3 Guide Catheter (K021256)]
- Medtronic 7F Launcher Guide Catheter (K022764) ●
- Medtronic 8F Launcher Guide Catheter (K023402) ●
- Merit Medical Systems Concierge Guiding Catheter ● [VasCon LLC Polaris Guiding Catheter (K043387)]
INDICATIONS FOR USE
The Alviguide™ Blue+ Interventional Cardiology Guiding Catheter is intended for use in the intravascular introduction of interventional/diagnostic devices into the coronary vascular system.
The Alguide™ Endovascular Guiding Catheter is intended for use in the intravascular introduction of interventional/diagnostic devices into the peripheral vascular system.
PRODUCT DESCRIPTION
The Alviguide™ Blue+ and Alguide™ Guide Catheters are sterile, non-pyrogenic, single lumen catheters with a tri-layer catheter body construction consisting of a polymer inner layer and a radiopaque outer layer surrounding a stainless steel wire braid, and a soft tip at the distal end. The catheters are for single-use only.
The Alviguide™ Blue+ and Alguide™ Guide Catheters are provided in a variety of distal shape configurations and are available in Fr Sizes 5, 6, 7 and 8 and lengths of 45, 60, 65 and 80cm (Alguide™), and 100cm (Alviguide™ Blue+ and Alguide™).
TECHNOLOGICAL CHARACTERISTICS
The indication for use, design and materials used in the Alviguide Blue+ and Alguide Guide Catheters are similar to those of the predicate guide catheters.
SUBSTANTIAL EQUIVALENCE
The indications for use for the predicate devices are substantially equivalent to the proposed indications for use for the Alviguide Blue+ and Alguide Guide Catheters. Anv differences in the technological characteristics between the devices do not raise any new issues of safety or effectiveness. Thus, the Alviguide Blue+ and Alguide Guide Catheters are substantially equivalent to the predicate devices.
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TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION
All necessary bench and clinical testing was conducted on the Alviguide Blue+ Guide Catheters to support a determination of substantial equivalence to the predicate devices.
Nonclinical Testing Summary:
The nonclinical, bench testing included:
- Visual Inspection
- Dimensional Verification ●
- Catheter Sheath Introducer Withdrawal Force ●
- Hub Leakage
- Kink Diameter and Force ●
- Tensile Strength
- Radiopacity
- Torque Testing
- Packaging integrity (Visual inspection, seal strength test) ●
- Sterilization (EO sterilization evaluation, EO residuals, endotoxin)
Biocompatibility Testing Summary:
Biocompatibility testing was conducted in compliance with ISO 10993-1, for externally communicating devices with limited exposure (