AXERA 2 ACCESS SYSTEM MODEL AXE200

K123135 · Arstasis, Inc. · DYB · Jan 28, 2013 · Cardiovascular

Device Facts

• Record ID: K123135
• Device Name: AXERA 2 ACCESS SYSTEM MODEL AXE200
• Applicant: Arstasis, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Jan 28, 2013
• 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 2 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. Designed to create shallow access path through arterial wall for guidewire entry into vessel lumen. Used by clinicians during diagnostic femoral artery catheterization. Output is physical access to arterial lumen; clinical benefit includes facilitated device introduction and improved hemostasis management. Device is unchanged from predicate; performance established via bench testing (functionality, deployment/release forces, tensile/compressive strength, torque, corrosion resistance), biocompatibility, animal studies, cadaver assessments, and clinical investigations (including RECITAL study).

Clinical Evidence

Clinical performance established via multiple evaluations, including the RECITAL study. Data includes patient safety, device performance, and efficacy metrics: time to hemostasis, time to ambulation, time to sit up 45 degrees, time to discharge eligibility, and actual discharge. Long-term safety and re-access capability studied retrospectively in a smaller patient cohort. Preliminary animal studies and cadaver assessments conducted on similar prototypes.

Technological Characteristics

Catheter introducer system consisting of latchwire, anchor mechanism, shaft, and handle. Mechanical design creates shallow access path through arterial wall. Biocompatible materials. No electronic components or software algorithms.

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 (K121521)

Submission Summary (Full Text)

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K123135
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## JAN 2 8 2013

Arstasis

## SECTION 2. 510(k) SUMMARY

| Sponsor/Submitter: | Arstasis, Inc. |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 740 Bay Road |
| Contact Person: | Debra Cogan |
| | Director, Quality Assurance, Regulatory & Clinical Affairs |
| | Phone: [phone] |
| Date of Submission: | October 4, 2012 |
| 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 Access System (K121521) |
| Device Description: | The AXERA 2 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 2 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 | Device is unchanged for the predicate device. The predicate device<br>met all performance testing acceptance criteria. |

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K123135
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Summary of Substantial Equivalence:

There are no changes to the Indications for Use. The clinical section of the Instructions for Use was amended to include a summary of the RECITAL study results. The clinical summary includes data related to patient safety, device performance and efficacy, including time to hemostasis, time to ambulation, time to sit up 45 degrees, time to discharge eligibility and actual discharge.

Device is unchanged for the AXERA 2 Access System. Bench Testing performed for the predicate device is applicable and was not repeated for the subject AXERA 2 Access Device. All acceptance criteria for bench testing performed for the predicate device were met and test results demonstrated that the predicate device met performance requirements for its intended use. No new issues of safety or effectiveness have been raised when compared to the predicate device.

Prior bench testing of the AXERA 2 device included 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, plunger tube, needle), compressive strength (handle/anchor, plunger lockout), and torque loading (handle/anchor), corrosion resistance testing, 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 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 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

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

Re: K123135

Trade Name: AXERA 2 Access System Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: December 19, 2012 Received: December 20, 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 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

JAN 2 8 2013

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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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Matthew G. Hillebrenner

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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19 21 27

Traditional 510(k)

## SECTION 1. INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Trade Name:

AXERA 2 Access System

Common Name:

Catheter Introducer

K123135

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)

.g.killelea

(Division Sign-Off) Division of Cardiovascular Devices

123135 510(k) Number

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