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.

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.

AI/ML Overview

This document describes a 510(k) premarket notification for the Alvision Interventional Cardiology Diagnostic Catheter and Alvicath Endovascular Diagnostic Catheter. The submission aims to demonstrate substantial equivalence to predicate devices, not necessarily to prove a specific level of performance against predefined clinical criteria in a standalone study.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (Implied)	Reported Device Performance
Visual Inspection	Meets established specifications	Passed
Dimensional Verification	Meets established specifications	Passed
Catheter Sheath Introducer Withdrawal Force	Meets established specifications	Passed
Hub Leakage	No leakage beyond acceptable limits	Passed
Kink Diameter and Force	Meets established specifications for resistance to kinking	Passed
Tensile Strength	Meets established specifications for material strength	Passed
Radio-detectability	Sufficiently radiopaque for visualization	Passed
Torque Testing	Meets established specifications for torque response	Passed
Flow Rate	Meets established specifications for fluid delivery	Passed
Power Injection	Withstands power injection forces without failure	Passed
Burst Test	Withstands specified pressure without bursting	Passed
Leakage	No leakage beyond acceptable limits	Passed
Trackability	Meets established specifications for navigating vascular system	Passed
Packaging Integrity (Visual inspection, seal strength test)	Maintained integrity	Passed
Sterilization (EO sterilization evaluation, EO residuals, endotoxin)	Sterilized and within acceptable EO/endotoxin limits	Passed
Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous, Systemic Toxicity, Hemolysis, Complement Activation, Thrombogenicity, Pyrogenicity)	Biocompatible per ISO 10993-1 and relevant standards	Passed
Device-contacting packaging materials (Cytotoxicity, Physicochemical Testing)	Biocompatible per relevant standards	Passed

Note: The document states "The collective results of the nonclinical testing demonstrate that the materials chosen and design of the Alvision and Alvicath Diagnostic Catheters meet the established specifications necessary for consistent performance during its intended use." The specific numerical acceptance criteria are not detailed in this summary, but the successful completion of these tests indicates the device met the pre-defined internal specifications.

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "No clinical testing was performed in support of this premarket notification." Therefore, there is no clinical "test set" in the traditional sense for evaluating device performance against a clinical ground truth. The "test set" here refers to the samples used for the non-clinical, benchtop, and biocompatibility tests. The sample sizes for these individual tests are not specified in the document.

Data Provenance: The testing was non-clinical (benchtop and lab-based biocompatibility). No geographical or retrospective/prospective data provenance applies to these types of tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. As no clinical testing was performed, there was no clinical ground truth established by experts for a test set. The "ground truth" for the non-clinical tests would be the pre-defined engineering specifications and ISO standards.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states "No clinical testing was performed."

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done

Not applicable. This device is a diagnostic catheter, a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" was based on:

Pre-defined engineering specifications for mechanical properties (e.g., tensile strength, flow rate, kink resistance).
International standards for biocompatibility (e.g., ISO 10993-1) and sterilization.
Industry standards for packaging integrity.

8. The Sample Size for the Training Set

Not applicable. As no clinical testing or machine learning model training was involved, there is no "training set." The device's design and materials were developed and refined through engineering processes, not by training against a dataset.

9. How the Ground Truth for the Training Set was Established

Not applicable. There was no training set.

Summary

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Public Health Service

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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.

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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 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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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)]

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.

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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 (<24 hours) to circulating blood, and included:

Device:

Cytotoxicity Study Using the ISO Elution Method IX MEM Extract ●
ISO Guinea Pig Maximization Sensitization Test Extract ●
ISO Intracutaneous Study in Rabbits ●
ISO Systemic Toxicity Study in Mice Extract ●
ASTM Hemolysis Study
Complement Activation Assay Direct Contact ISO ●
Thrombogenicity Study in Dogs ISO ●
. USP Pyrogen Study – Material Mediated

Device-contacting packaging materials:

In Vitro Cytotoxicity Assay on L-929 Mouse Fibroblasts MEM Elution ●
USP Physicochemical Testing (Aqueous Extraction) ●

[807.92(b)(2)]

No clinical testing was performed in support of this premarket notification.

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[807.92(b)(3)]

The collective results of the nonclinical testing demonstrate that the materials chosen and design of the Alvision and Alvicath Diagnostic Catheters meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the Alvision and Alvicath Diagnostic Catheters do not raise new questions of safety or effectiveness when compared to the predicate devices.

VIII. CONCLUSIONS

Based on the similar indication, design and materials, and the results of the bench testing, the Alvision Interventional Cardiology Diagnostic Catheter and Alvicath Endovascular Diagnostic Catheter are considered substantially equivalent to the predicate devices.

The indications for use for the predicate devices are substantially equivalent to the proposed indications for use for the Alvision™ and Alvicath™ Diagnostic Catheters. Any differences in the technological characteristics between the devices do not raise any new issues of safety or effectiveness. Thus, the Alvision Interventional Cardiology Diagnostic Catheter and Alvicath Endovascular Diagnostic Catheter are substantially equivalent to the predicate devices.

Regulation Number and Section

§ 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).