AXERA RX ACCESS SYSTEM

K140287 · Arstasis, Inc. · DYB · May 16, 2014 · Cardiovascular

Device Facts

• Record ID: K140287
• Device Name: AXERA RX ACCESS SYSTEM
• Applicant: Arstasis, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: May 16, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The AXERA Access System is intended to provide access for the percutaneous introduction of devices into the peripheral vasculature and to promote hemostasis at the arteriotomy site as an adjunct to manual compression. AXERA is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using 5F or 6F introducer sheaths.

Device Story

AXERA RX Access System; catheter introducer for peripheral vasculature. Device components: flexible tip, anchor mechanism, shaft, handle with control features. Operation: creates shallow access path through arterial wall for guidewire entry; promotes hemostasis at arteriotomy site as adjunct to manual compression. Used by physicians in clinical settings during diagnostic femoral artery catheterization. Modifications from predicate: permanently attached flexible tip, added guidewire exit port, 20 gauge needle (vs 19 gauge), added lock symbol. Output: vascular access path; facilitates device introduction. Benefits: provides access and assists in hemostasis.

Clinical Evidence

Bench testing performed on modified components (functionality, tip flexibility, tensile/compressive/torque strength, corrosion resistance). Simulated use testing conducted on cadaveric models. Unmodified design features supported by previous bench testing, biocompatibility, non-GLP animal studies, cadaver assessments, and clinical evaluations. Short-term safety and performance established; long-term safety and re-access studied retrospectively in a small patient cohort.

Technological Characteristics

Catheter introducer system. Components: flexible tip, anchor mechanism, shaft, handle. Materials: metallic needle, polymer components. Connectivity: none. Energy source: manual/mechanical. Sterilization: not specified. Software: none.

Indications for Use

Indicated for patients undergoing diagnostic femoral artery catheterization procedures using 5F or 6F introducer sheaths requiring peripheral vascular access and hemostasis adjunct.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• AXERA 2 Access System (K132263)

Submission Summary (Full Text)

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## SECTION 2. 510(k) SUMMARY

| Sponsor/Submitter: | Arstasis, Inc. |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 740 Bay Road |
| Contact Person: | Grace Li<br>Director of Quality<br>Phone: [phone] |
| Date of Submission: | February 4, 2014 |
| Device Trade Name: | AXERA RX Access System |
| Common Name: | Catheter Introducer |
| Device Classification: | Class II |
| Regulation Number: | 21 CFR 870.1340 |
| Classification Name: | Catheter Introducer |
| Product Code: | DYB |
| Predicate Device: | AXERA 2 Access System (K132263) |
| Device Description: | The AXERA RX is a device that is comprised of a flexible tip,<br>anchor mechanism, shaft and handle with control features. |
| Indications for Use: | The AXERA Access System is intended to provide access for the<br>percutaneous introduction of devices into the peripheral vasculature<br>and to promote hemostasis at the arteriotomy site as an adjunct to<br>manual compression. AXERA is indicated for use in patients<br>undergoing diagnostic femoral artery catheterization procedures<br>using 5F or 6F introducer sheaths. |
| Technological<br>Characteristics | The AXERA RX Access Device is designed to create a shallow<br>access path through the arterial wall for the guidewire to enter the<br>vessel lumen. |
| Performance Data | The AXERA RX Access Device met all performance testing<br>acceptance criteria. |

・

Redwood City, CA 94063

www.arstasis.com

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K140287

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Arstasis

MAY 1 6 2014

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Summary of Substantial Equivalence: Modifications to the AXERA 2 Access System consist of replacing the user-attached Latchwire with a permanently attached flexible tip, adding a guidewire exit port in the needle-lumen-anchor assembly, replacing the 19 gauge access needle with a 20 gauge access needle, and adding a lock symbol to the device handle. The modified device is known as the AXERA RX Access System.

There are no changes to the Indications for Use resulting from the changes described within this submission. The procedural steps have been updated accordingly for the subject device.

Bench testing of the AXERA RX Access System was performed for device specifications affected by the modifications described above, following sterilization of test units. The following tests were performed: device functionality, tip flexibility, flex conditioning (flexible tip), tensile strength of flexible tip to anchor, compressive strength (handle/anchor), torque loading (handle/anchor), and corrosion resistance (needle lumen anchor). Simulated use testing was performed on a cadaveric model.

Additional bench testing of the unmodified AXERA RX design features included accessory functionality, deployment forces (heel, needle, plunger), release forces (heel), tensile strength of multiple . joints (needle lumen anchor, heel, plunger, plunger tube, access needle, guidewire, dilator adapter), access needle integrity, compressive strength (plunger lockout), corrosion resistance testing (guidewire), guidewire resistance to fracture, guidewire resistance to flexing, biocompatibility testing, preliminary animal studies (non-GLP) and cadaver assessments, as well as clinical investigations. '

Simulated use testing of the unmodified AXERA RX design features was performed previously on a cadaveric model and in multiple clinical evaluations. The short term safety and clinical performance of the device were established. The long term safety, as well as the ability to access and re-access, was retrospectively studied in a smaller cohort of patients.

In summary, the data provided herein demonstrate that the AXERA RX Access System is substantially equivalent to its predicate in providing access to the arterial lumen and facilitating the introduction and placement of devices into the peripheral vasculature and promoting hemostasis as an adjunct to manual compression.

I The preliminary Animal Studies and Cadaver Assessments were conducted using prototypes of a similar design and configuration.

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## Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 16, 2014

Arstasis, Inc. Ms. Grace Li Director of Quality 740 Bay Road Redwood City, CA 94063

K140287 Re:

> Trade/Device Name: AXERA RX Access System Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: April 15, 2014 Received: April 16, 2014

Dear Ms. Li,

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 10 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.

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

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Page 2 - Ms. Grace Li

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (2) 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

for

Sincerely yours.

**Kenneth J. Cavanaugh -S**

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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বাহাট্যবাদ

## SECTION 1. INDICATIONS FOR USE STATEMENT

| 510(k) Number (if known): | K140287 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | AXERA RX Access System |
| Common Name: | Catheter Introducer |
| Indications For Use: | The AXERA Access System is intended to provide access for the percutaneous introduction of devices into the peripheral vasculature and to promote hemostasis at the arteriotomy site as an adjunct to manual compression. AXERA is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using 5F or 6F introducer sheaths. |

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 OF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

Image /page/4/Picture/10 description: The image shows the name "Kenneth" in a bold, sans-serif font. The letters are black, and the name is followed by what appears to be the letters "J.Cavanaugh -S", but the letters are stylized and difficult to read. The text is horizontally oriented and appears to be part of a larger document or sign.

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