(189 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a diagnostic catheter, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is described as a "Diagnostic Catheter" intended for the delivery of radio-opaque media, which is a diagnostic function, not a therapeutic one.
Yes
The name of the device, "Alvision™ Interventional Cardiology Diagnostic Catheters," includes "Diagnostic." The "Intended Use" states they are for "delivery of radio-opaque media to selected sites in the coronary vascular system," which is a diagnostic procedure (angiography).
No
The device description clearly details a physical catheter with specific material construction, dimensions, and physical performance testing, indicating it is 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 is to deliver radio-opaque media to specific sites within the vascular system. This is a procedure performed within the body for imaging purposes, not a test performed on a sample taken from the body.
- Device Description: The description details a catheter, which is a physical instrument used for insertion into the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.
IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a tool used in a medical procedure for imaging, not for analyzing a sample.
N/A
Intended Use / Indications for Use
Alvision™ Interventional Cardiology Diagnostic Catheters are intended for use in the delivery of radio-opaque media to selected sites in the coronary vascular system.
Alvicath™ Endovascular Diagnostic Catheters are intended for use in the delivery of radio-opaque media to selected sites in the peripheral vascular system.
Product codes (comma separated list FDA assigned to the subject device)
DQO
Device Description
The Alvision™ Interventional Cardiology Diagnostic Catheter ("Alvision™") and the Alvicath™ Endovascular Diagnostic Catheter ("Alvicath™") are sterile, nonpyrogenic, single lumen catheters with a soft distal tip and a proximal strain relief and luer hub. The tri-layer catheter body construction is constructed of a first extrusion layer, a stainless steel wire braid middle layer, and a radiopaque outer layer of Nylon 12. The catheters are for single-use only.
The Alvision™ and Alvicath™ Diagnostic Catheters are provided in a variety of distal shape configurations and are available in Fr Sizes 4, 5, 6 and 7. Alvision Diagnostic Catheters are provided in useable lengths of 80, 100 and 110cm. Alvicath Endovascular Diagnostic Catheters are provided in useable lengths of 45, 60, 65, 80 and 100cm.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 ●
- Radio-detectability ●
- Torque Testing
- Flow Rate
- Power Injection
- Burst Test
- Leakage ●
- Trackability
- 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 (
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).
0
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three human profiles facing right, stacked on top of each other, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 25, 2015
Alvimedica Tibbi Urunler Sanayi Ve Dis Ticaret A.s % Ronald Warren Regulatory Consultant Experien Group, LLC 755 N Mathilda Avenue Suite 100 Sunnyvale, California 94085
Re: K143604
Trade/Device Name: Alvision Interventional Cardiology Diagnostic Catheter, Alvicath Endovascular Diagnostic Catheters Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DQO Dated: May 11, 2015 Received: May 12, 2015
Dear Ronald Warren,
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.
1
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 devicerelated 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" (21 CFR 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 yours.
M. A. Hillebrand
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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Indications for Use
510(k) Number (if known) K143604
Device Name
Alvision™ Interventional Cardiology Diagnostic Catheter
Alvicath™ Endovascular Diagnostic Catheter
Indications for Use (Describe)
Alvision™ Interventional Cardiology Diagnostic Catheters are intended for use in the delivery of radio-opaque media to selected sites in the coronary vascular system.
Alvicath™ Endovascular Diagnostic Catheters are intended for use in the delivery of radio-opaque media to selected sites in the peripheral vascular system.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Notification K
I. GENERAL INFORMATION [807.92(a)(1)]
Applicant:
Alvimedica Tıbbi Ürünler Sanayi ve Dıs Ticaret A.S. İstanbul Trakya Serbest Bölgesi Ferhatpaşa Mahallesi Atatürk Bulvarı Manolya Sokak No:7 34540 Çatalca, İstanbul Turkey Phone: +90 212 786 60 80 FAX: +90 212 786 60 90
Contact Person:
Ronald S. Warren Regulatory Consultant for Alvimedica Experien Group, LLC 755 N. Mathilda Avenue, Suite 100 Sunnyvale, CA 94085 U.S.A. Phone: (408) 505-3926 FAX: (408) 400-0865
Date Prepared: December 17, 2014
II. DEVICE INFORMATION [807.92(a)(2)]
Trade/Proprietary Name:
Alvision™ Interventional Cardiology Diagnostic Catheter Alvicath™ Endovascular Diagnostic Catheter
Classification Name:
Diagnostic intravascular catheter
Generic/Common Name:
Diagnostic catheter
Regulatory Classification:
Class II per 21 CFR§870.1200
Product Code:
DQO
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III. PREDICATE DEVICES [807.92(a)(3)]
- . Merit Medical Performa (Softouch) Angiography Catheters (K943739; K000659)
No reference devices were used in this submission.
IV. DEVICE DESCRIPTION [807.92(a)(4)]
The Alvision™ Interventional Cardiology Diagnostic Catheter ("Alvision™") and the Alvicath™ Endovascular Diagnostic Catheter ("Alvicath™") are sterile, nonpyrogenic, single lumen catheters with a soft distal tip and a proximal strain relief and luer hub. The tri-layer catheter body construction is constructed of a first extrusion layer, a stainless steel wire braid middle layer, and a radiopaque outer layer of Nylon 12. The catheters are for single-use only.
The Alvision™ and Alvicath™ Diagnostic Catheters are provided in a variety of distal shape configurations and are available in Fr Sizes 4, 5, 6 and 7. Alvision Diagnostic Catheters are provided in useable lengths of 80, 100 and 110cm. Alvicath Endovascular Diagnostic Catheters are provided in useable lengths of 45, 60, 65, 80 and 100cm.
V. INDICATIONS FOR USE [807.92(a)(5)]
The Indication for Use statements for the Alvision™ and the Alvicath™ Diagnostic Catheters are provided below:
Alvision™ Interventional Cardiology Diagnostic Catheters are intended for use in the delivery of radio-opaque media to selected sites in the coronary vascular system.
Alvicath™ Endovascular Diagnostic Catheters are intended for use in the delivery of radio-opaque media to selected sites in the peripheral vascular svstem.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES [807.92(a)(6)]
The indication for use, design and materials used in the Alvision™ and Alvicath™ Diagnostic Catheters are similar to those of the predicate diagnostic catheters. The Alvision™ and Alvicath™ Diagnostic Catheters are substantially equivalent to the predicate catheters, as they have the same intended use in the same anatomical types, utilize similar performance specifications and have comparable technological features to achieve the same mechanism of action.
5
VII. PERFORMANCE DATA [807.92(b)]
All necessary bench and clinical testing was conducted on the Alvision Diagnostic Catheters to support a determination of substantial equivalence to the predicate devices.
[807.92(b)(1)]
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 ●
- Radio-detectability ●
- Torque Testing
- Flow Rate
- Power Injection
- Burst Test
- Leakage ●
- Trackability
- 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 (