ARSTASIS ACCESS SYSTEM

K100615 · Arstasis, Inc. · DYB · Mar 30, 2010 · Cardiovascular

Device Facts

• Record ID: K100615
• Device Name: ARSTASIS ACCESS SYSTEM
• Applicant: Arstasis, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Mar 30, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

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

Device Story

Arstasisone Access System facilitates percutaneous vascular access and hemostasis; device comprises sheath, anchor mechanism, shaft, and handle with control features. Designed to create shallow access path through arterial wall for guidewire entry into vessel lumen. Used in clinical settings by physicians during diagnostic femoral artery catheterization. Device promotes hemostasis at arteriotomy site as adjunct to manual compression. Benefits include controlled access and improved hemostasis management.

Clinical Evidence

Evidence includes preliminary non-GLP animal studies, cadaver assessments, and clinical investigations conducted on earlier device versions of similar design. Retrospective study of a smaller patient cohort evaluated long-term safety and reaccess capability. Short-term safety and clinical performance established.

Technological Characteristics

Catheter introducer system consisting of sheath, anchor mechanism, shaft, and handle. Biocompatibility compliant with ISO-10993-1. Mechanical design creates shallow access path for guidewire. No software or electronic components described.

Indications for Use

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

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

• Arstasis ITG Vascular Access System (K091006)

Submission Summary (Full Text)

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Arstasis

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KOOKIS

# 510(k) SUMMARY

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| Sponsor/Submitter: | Arstasis, Inc.<br>1021 Howard Avenue, Suite C<br>San Carlos, CA 94070 | MAR 3 0 2010 |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact Person: | Su-Mien Chong<br>Acting VP, Regulatory & Clinical Affairs<br>Phone: [phone]<br>Fax: [phone] | |
| Date of Submission: | March 3, 2010 | |
| Device Trade Name: | Arstasisone 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: | Arstasis ITG Vascular Access System (K091006) | |
| Device Description: | Arstasisone is a device that is comprised of a sheath, anchor mechanism, shaft<br>and handle with control features. | |
| Indications for Use: | Arstasisone Access System is intended to provide access for the percutaneous<br>introduction of devices into the peripheral vasculature and to promote<br>hemostasis at the arteriotomy site as an adjunct to manual compression. The<br>Arstasisone Access System is indicated for use in patients undergoing diagnostic<br>femoral artery catheterization procedures using 5F or 6F introducer sheaths. | |
| Technological<br>Characteristics | Arstasisone is designed to create a shallow access path through the arterial wall<br>for the guidewire to enter the vessel lumen. | |
| Summary of<br>Substantial<br>Equivalence: | Bench testing was performed on the subject device as follows: functionality,<br>deployment and release forces, flexibility, torque loading as well as tensile,<br>compressive and torque strengths. Biocompatibility testing was successfully<br>conducted pursuant to ISO-10993-1, Biological Evaluation of Medical Devices<br>Part 1: Evaluation and Testing (1995). | |

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Prior testing included preliminary animal studies (non GLP) and cadaver assessments , as well as clinical investigations.2 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 reaccess, was retrospectively studied in a smaller cohort of patients.

In summary, the cumulative data provided herein demonstrate that the Arstasis 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.

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

² Clinical investigations were conducted on an earlier device version of similar design and configuration.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, with flowing lines suggesting movement or connection.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

# APR 2 9 2010

Ms. Su-Mien Chong Acting Vice President, Research and Development Arstasis, Inc. 1021 Howard Avenue, Suite C San Carlos, CA 94070

Re: K100615 Trade/Device Name: Arstasis000 Access System Regulation Number: 21 CFR §870.1340 Regulation Name: Catheter, Introducer Regulatory Class: Class II (two) Product Code: DYB Dated: March 3, 2010 Received: March 4, 2010

Dear Ms. Chong:

This letter corrects our substantially equivalent letter of March 30, 2010.

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 (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, manier the act include requirements for annual registration, listing of devices, controls provisions or morice, labeling, and prohibitions against misbranding and adulteration.

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 may or subject to additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Su-Mien Chong

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/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,

Bram D. Zuckerman, MD
Director
Division of Cardiovascular Devices

Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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## APPENDIX B: INDICATIONS FOR USE STATEMENT

#### 510(k) Number (if known): K100615

Trade Name: Arstasis 00€ Access System

Common Name: Catheter Introducer

Indications For Use:

The Arstasis 000 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 Arstasis006 Access System is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using 5F or 6F introducer sheaths.

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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### Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

(Posted November 13, 2003)

Dunner 2. be vision Sian-Off Division of Cardiovascular Devices

510(k) Number_K1006 | 5