ALVIGUIDE BLUE+ INTERVENTIONAL CARDIOLOGY GUIDING CATHETER

K141529 · Alvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S · DQY · Dec 3, 2014 · Cardiovascular

Device Facts

• Record ID: K141529
• Device Name: ALVIGUIDE BLUE+ INTERVENTIONAL CARDIOLOGY GUIDING CATHETER
• Applicant: Alvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S
• Product Code: DQY · Cardiovascular
• Decision Date: Dec 3, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended 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.

Device Story

Alviguide™ Blue+ and Alguide™ are sterile, single-lumen, single-use guide catheters. They facilitate the delivery of interventional or diagnostic devices into the coronary or peripheral vascular systems. Operated by physicians in clinical settings, these catheters provide a pathway for secondary devices. They feature a tri-layer construction (polymer inner layer, stainless steel wire braid, radiopaque outer layer) and a soft distal tip. Available in various French sizes (5-8F) and lengths (45-100cm) with multiple distal shape configurations. The device is inserted into the vasculature to guide other instruments to target sites, aiding in diagnostic or interventional procedures.

Clinical Evidence

Bench testing only. Testing included visual inspection, dimensional verification, withdrawal force, hub leakage, kink resistance, tensile strength, radiopacity, torque testing, packaging integrity, and EO sterilization validation. Biocompatibility testing per ISO 10993-1 for limited exposure (<24 hours) included cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemocompatibility, and material-mediated pyrogenicity. Results demonstrate performance consistent with predicate devices.

Technological Characteristics

Tri-layer construction: polymer inner layer, stainless steel wire braid, radiopaque outer layer. Soft distal tip. Single-lumen. Sizes: 5F, 6F, 7F, 8F. Lengths: 45cm, 60cm, 65cm, 80cm, 100cm. Sterilization: Ethylene Oxide (EO). Biocompatibility: ISO 10993-1 compliant.

Indications for Use

Indicated for patients requiring intravascular introduction of interventional or diagnostic devices into the coronary vascular system (Alviguide™ Blue+) or peripheral vascular system (Alguide™).

Regulatory Classification

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.

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)]

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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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:

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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: [phone] FAX: [phone]

#### 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: [phone] ext. 112 FAX: [phone]

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

- Cytotoxicity ●
- Sensitization ●
- Intracutaneous Reactivity ●
- Acute Systemic Toxicity
- Hemocompatibility
- . Material Mediated Pyrogen

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

## CONCLUSION

Based on the similar indication, design and materials, and the results of the bench testing, the Alviguide Blue+ Interventional Cardiology Guiding Catheter and Alguide Endovascular Guiding Catheter are considered substantially equivalent to the predicate devices listed above.

## SUMMARY

The Alviguide Blue+ Interventional Cardiology Guiding Catheter and the Alguide Endovascular Guiding Catheter are substantially equivalent to the predicate devices.