AXERA ACCESS SYSTEM

K113110 · Arstasis, Inc. · DYB · Nov 9, 2011 · Cardiovascular

Device Facts

• Record ID: K113110
• Device Name: AXERA ACCESS SYSTEM
• Applicant: Arstasis, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Nov 9, 2011
• 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. The System 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 arteriotomy site hemostasis. Device comprises latchwire, anchor mechanism, shaft, and handle with control features. Operator creates shallow access path through arterial wall for guidewire entry. Used in clinical settings by physicians during diagnostic femoral artery catheterization. Modifications include stainless steel needle (replacing nitinol), adjusted Needle Lumen Anchor (NLA) geometry, and added marking holes for improved blood feedback. Device functions as adjunct to manual compression to promote hemostasis. Benefits include controlled access and facilitated device placement.

Clinical Evidence

Bench testing only for modified components (functionality, mechanical strength, deployment forces). Previous clinical evaluations, animal studies, and cadaver assessments supported the original design, which remains substantially equivalent.

Technological Characteristics

Catheter introducer; stainless steel needle; latchwire and anchor mechanism; handle with control features. Modifications include stainless steel needle material, adjusted NLA geometry, and marking holes for blood feedback. Mechanical operation; no energy source. Sterilized.

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

• Latchwire Access Device/AXERA (K103143)

Submission Summary (Full Text)

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Arstasis

NOV - 9, 2011 K113110 page 1 of 2

Special 510(k): Device Modification

## APPENDIX A: 510(k) SUMMARY

| Sponsor/Submitter: | Arstasis, Inc.<br>740 Bay St<br>Redwood City, CA 94063 |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Debra Cogan<br>Director, Regulatory & Clinical Affairs<br>Phone: [phone]<br>Fax: [phone] |
| Date of Submission: | October 19, 2011 |
| 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: | Latchwire Access Device/AXERA (K103143) |
| 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. The System 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 device is designed to create a shallow access path<br>through the arterial wall for the guidewire to enter the vessel lumen.<br>The modified device continues to have the same technological<br>characteristics as that of the predicate. Modifications include<br>changing the needle material from nitinol to stainless steel, a minor<br>change in the Needle Lumen Anchor (NLA) geometry and<br>manufacturing process to accommodate the stiffer stainless steel<br>material, and the addition of marking holes enhance user feedback<br>of blood mark. |
| Performance Data | The AXERA device met all performance testing acceptance<br>criteria. |

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K113110 page 2 of 2

## Arstasis

Summary of

Equivalence:

Substantial

## Special 510(k): Device Modification

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), tensile strength of multiple joints (latchwire, anchor, heel, plunger, needle), compressive strength (handle/anchor), and torque loading (handle/anchor).

Additional prior testing included corrosion resistance testing. flex conditioning, tensile testing of multiple joints, compressive strength testing, biocompatibility testing, preliminary animal studies (non-GLP) and cadaver assessments, as well as clinical investigations.1 Multiple clinical evaluations were conducted.

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.

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

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name, "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA," arranged in a circular pattern around a stylized eagle-like emblem. The emblem is a simple, abstract design of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans and provide essential human services.

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

NOV - 9 2011

Arstasis. Inc. c/o Debra Cogan 740 Bay Rd. Redwood City, CA 94063

Re: K113110

Trade/Device Name: AXERA Access System Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II (two) Product Code: DYB Dated: October 19, 2011 Received: October 20, 2011

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 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

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Page 2 - Ms. Debra Cogan

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/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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Br
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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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## APPENDIX B: INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Trade Name:

AYERA Access System

Common Name:

Indications For Use:

AXERA Access System

K113110

Catheter Introducer

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. The System is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using 5F or-6F introducer sheaths. - - - - - ---------------------------------

Prescription Use (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)

| (Division Sign-Off) | |
|------------------------------------|---------|
| Division of Cardiovascular Devices | |
| 510(k) Number | K113112 |

Page 1 of 1(Posted November 13, 2003)

CONFIDENTIAL

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