AXERA ACCESS SYSTEM

K121521 · Arstasis, Inc. · DYB · Jun 21, 2012 · Cardiovascular

Device Facts

• Record ID: K121521
• Device Name: AXERA ACCESS SYSTEM
• Applicant: Arstasis, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Jun 21, 2012
• 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 Access System facilitates percutaneous peripheral vascular access and promotes hemostasis at arteriotomy sites as an adjunct to manual compression. Device comprises latchwire, anchor mechanism, shaft, and handle with control features. Operator (physician) uses device to create shallow access path through arterial wall for guidewire entry. Modifications include adjusted Needle Lumen Anchor (NLA) assembly for improved needle centering/contact, shortened integrated needle, and modified latchwire dimensions/shape for manufacturability. Device used in clinical settings during diagnostic femoral artery catheterization. Output is a prepared access site for introducer sheaths. Benefits include efficient vascular access and adjunctive hemostasis support.

Clinical Evidence

Clinical evidence includes prior clinical investigations establishing short-term safety and performance. Long-term safety and re-access capabilities were retrospectively studied in a smaller patient cohort. Bench testing confirmed device functionality and mechanical integrity post-modification.

Technological Characteristics

Catheter introducer system consisting of latchwire, anchor mechanism, shaft, and handle. Mechanical design creates shallow arterial access path. Modifications involve NLA assembly, integrated needle, and latchwire geometry. Sterilization performed on test units. No software or electronic components described.

Indications for Use

Indicated for patients undergoing diagnostic femoral artery catheterization procedures using 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 Access System (K113110)

Submission Summary (Full Text)

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K12)521

## Special 510(k): Device Modification

:

# APPENDIX A: 510(k) SUMMARY

# JUN 2 1 2012

ﺳﮯ

| Sponsor/Submitter: | Arstasis, Inc.<br>740 Bay Road<br>Redwood City, CA 94063 |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Debra Cogan<br>Director, Quality Assurance, Regulatory & Clinical Affairs<br>Phone: [phone]<br>Fax: [phone] |
| Date of Submission: | May 22, 2012 |
| Device Trade Name: | AXERA 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 Access System (K113110) |
| Device Description: | The AXERA is a device that is comprised of a latchwire, anchor<br>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 Access Device is designed to create a shallow access<br>path through the arterial wall for the guidewire to enter the vessel<br>lumen. |
| Performance Data | The AXERA Access Device met all performance testing<br>acceptance criteria. |
| Summary of<br>Substantial<br>Equivalence: | Modifications to the AXERA Access System include changes to the<br>Needle Lumen Anchor (NLA) assembly to allow the Integrated<br>Needle to remain centered and in contact with the anchor when<br>deployed. Additionally, the length of the Integrated Needle is<br>shortened and the diameter of the Latchwire and shape of the<br>Latchwire latch sub-component has also been adjusted to |

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accommodate the change to the distal end of the NLA and to improve manufacturability.

Bench testing of the modified AXERA device was performed for device specifications affected by the modifications described above, following sterilization of test units. All acceptance criteria were met and test results demonstrated that the modified AXERA met performance requirements for its intended use. No new issues of safety or effectiveness were raised. The following tests were performed: device functionality, deployment forces (heel, needle, plunger), release forces (heel), flex conditioning (latchwire), resistance of latchwire to damage by flexing, tensile strength of multiple joints (latchwire, anchor, heel, plunger, needle), compressive strength (handle/anchor), and torque loading (handle/anchor), and corrosion resistance testing.

Additional prior testing included tensile testing of multiple joints (plunger, plunger tube), compressive strength testing (plunger lockout), biocompatibility testing, preliminary animal studies (non-GLP) and cadaver assessments, as well as clinical investigations. 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 cumulative data provided herein demonstrates that the AXERA 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 achievement of hemostasis.

### CONFIDENTIAL

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

#### Public Health Service

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

JUN 2 1 2012

Arstasis. Inc. c/o Ms. Debra Cogan Director, Quality Assurance, Regulatory & Clinical Affairs 740 Bay Road Redwood City, CA 94063

Re: K121521

Trade/Device Name: AXERA Access Systerm Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: May 22, 2012 Received: May 23, 2012

Dear Ms. Cogan:

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

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Page 2 - Ms. Debra Cogan

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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 vours.

Bram D. Zuckerman, MD Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Arstasis

#### Special 510(k): Device Modification

## APPENDIX B: INDICATIONS FOR USE STATEMENT

K121521 510(k) Number (if known):

Trade Name:

AXERA Access System

Catheter Introducer

Common Name:

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 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Page | of |
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(Posted November 13, 2003)

| (Division Sign-Off) | |
|-----------------------------------|---------|
| Division: Cardiovascular Division | |
| 510(k) Number | K121541 |

(Posted Novem

CONFIDENTIAL

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