AXERA 2 ACCESS SYSTEM

K140871 · Arstasis, Inc. · DYB · Jun 6, 2014 · Cardiovascular

Device Facts

• Record ID: K140871
• Device Name: AXERA 2 ACCESS SYSTEM
• Applicant: Arstasis, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Jun 6, 2014
• Decision: SESE
• Submission Type: Special
• 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 2 Access System facilitates percutaneous peripheral vascular access and arteriotomy site hemostasis; adjunct to manual compression. Device components include Latchwire, anchor mechanism, shaft, and handle. Operation involves creating a shallow access path through the arterial wall for guidewire entry into the vessel lumen. Used in clinical settings by physicians during diagnostic femoral artery catheterization. Output is a secured access path for 5F or 6F introducer sheaths. Benefits include controlled access and promoted hemostasis. Modifications in this submission include reshaped Needle Lumen Anchor (NLA), lengthened Integrated Needle, and an alternate Access Needle accessory.

Clinical Evidence

Clinical evidence includes prior clinical investigations and simulated use testing on cadaveric models for the unmodified AXERA 2 design. Short-term safety and performance were established. Long-term safety and re-access capability were retrospectively studied in a smaller patient cohort. Current submission relies on bench testing for modified components (NLA, needle).

Technological Characteristics

Device comprises Latchwire, anchor mechanism, shaft, and handle. Designed to create shallow access path through arterial wall. Mechanical operation; no energy source. Sterilized. No software or electronic components.

Indications for Use

Indicated for patients undergoing diagnostic femoral artery catheterization procedures requiring 5F or 6F introducer sheaths.

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 (K140201)

Submission Summary (Full Text)

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## SECTION 2. 510(k) SUMMARY

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| Sponsor/Submitter: | Arstasis, Inc. |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 740 Bay Road |
| Contact Person: | Grace Li |
| | Director of Quality |
| | Phone: [phone] |
| Date of Submission: | April 3, 2014 |
| Device Trade Name: | AXERA 2 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 (K140201) |
| Device Description: | The AXERA 2 is a device that is comprised of a Latchwire, anchor mechanism, shaft and handle with control features. |
| 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. |
| Technological<br>Characteristics | The AXERA 2 Access Device is designed to create a shallow access path through the arterial wall for the guidewire to enter the vessel lumen. |
| Performance Data | The AXERA 2 Access Device met all performance testing acceptance criteria. |

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www.arstasis.com

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## Summary of Substantial Equivalence:

Modifications to the AXERA 2 Access System consist of reshaping the Needle Lumen Anchor (NLA) component and lengthening the Integrated Needle. An alternate Access Needle accessory device manufactured by another supplier is also added.

There are no changes to the Indications for Use or procedural steps resulting from the changes described within this submission.

Bench testing of the AXERA 2 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, deployment forces (needle, plunger), tensile strength of Latchwire to Anchor (parallel and nonparallel), compressive strength (handle/anchor), torque loading (handle/anchor), access needle functionality, access needle integrity, and tensile strength of access needle.

Additional prior bench testing of the unmodified AXERA 2 design features included accessory functionality, deployment forces (heel), 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 (Latchwire/guidewire), guidewire resistance to fracture, Latchwire/guidewire resistance to flexing, tensile strength of Latchwire distal coil to core wire, tensile strength of Latchwire proximal coil, latch, and core wire, biocompatibility testing, preliminary animal studies (non-GLP) and cadaver assessments, as well as clinical investigations. T

Prior simulated use testing of the unmodified AXERA 2 design features was performed on a cadaveric model and multiple clinical evaluations were conducted. 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 2 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.

¹ The preliminary Animal Studies and Cadaver Assessments were conducted using prototypes of a similar design and configuration.

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

June 6, 2014

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

Re: K140871

> 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: May 6, 2014 Received: May 7, 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 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.

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" (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 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.

Sincerely yours,

**Kenneth J. Cavanaugh -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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## SECTION 1. INDICATIONS FOR USE STATEMENT

K140871 510(k) Number (if known): Trade Name: AXERA 2 Access System Common Name: Catheter Introducer The AXERA Access System is intended to provide access for the Indications For Use: 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)

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