ARSTASIS ACCESS SYSTEM

K102728 · Arstasis, Inc. · DYB · Oct 7, 2010 · Cardiovascular

Device Facts

• Record ID: K102728
• Device Name: ARSTASIS ACCESS SYSTEM
• Applicant: Arstasis, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Oct 7, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

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

Device Story

Arstasis Access System is a catheter introducer designed to create a shallow access path through the arterial wall for guidewire entry into the vessel lumen. The device consists of a sheath, anchor mechanism, shaft, and handle with control features. It is used by clinicians in a clinical setting during diagnostic femoral artery catheterization. By facilitating access and promoting hemostasis at the arteriotomy site as an adjunct to manual compression, the device assists in the percutaneous introduction of other medical devices into the peripheral vasculature.

Clinical Evidence

Clinical performance and short-term safety were established through multiple clinical evaluations. Long-term safety and re-access capabilities were evaluated in a retrospective study of a smaller patient cohort. Preliminary animal studies (non-GLP) and cadaver assessments were conducted using prototypes of similar design.

Technological Characteristics

Device comprises a sheath, anchor mechanism, shaft, and handle. Designed to create a shallow access path for guidewire entry. Biocompatibility testing performed pursuant to ISO-10993-1. No electronic or software 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 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

• Arstasisone Access System (K100615)

Submission Summary (Full Text)

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Arstasis

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| | APPENDIX A: 510(k) SUMMARY | |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Sponsor/Submitter: | Arstasis, Inc.<br>1021 Howard Avenue, Suite C<br>San Carlos, CA 94070 | OCT 7 2010 |
| Contact Person: | Debra Cogan<br>Director, Regulatory & Clinical Affairs<br>Phone: [phone] x273<br>Fax: [phone] | |
| Date of Submission: | September 20, 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: | Arstasisone Access System (K100615) | |
| Device Description: | Arstasisone is a device that is comprised of a sheath, anchor<br>mechanism, shaft and handle with control features. | |
| Indications for Use: | Arstasisone 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 Arstasisone Access System is indicated<br>for use in patients undergoing diagnostic femoral artery<br>catheterization procedures using 5F or 6F introducer sheaths. | |
| Technological<br>Characteristics | Arstasisone is designed to create a shallow access path through the<br>arterial wall for the guidewire to enter the vessel lumen. | |
| Summary of<br>Substantial<br>Equivalence: | Selective bench testing was performed on the subject device as<br>follows: functionality, torque loading, flexibility and tensile<br>strength of the core wire assembly and sheath. | |
| | Prior bench testing included deployment forces, flexibility, tensile,<br>compression, and torque loading, were conducted on the predicate<br>device. Additional prior testing included biocompatibility testing<br>pursuant to ISO-10993-1, Biological Evaluation of Medical<br>Devices Part 1: Evaluation and Testing (1995), preliminary animal<br>studies (non-GLP) and cadaver assessments, as well as clinical | |

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investigations.1 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 Arstasis 006 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/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of human figures.

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

OCT 7 2010

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

Re: K102728

Trade/Device Name: Arstasis Access System Regulation Number: 21 CFR §870.1340 Regulation Name: Catheter, Introducer Regulatory Class: Class II (Two) Product Code: DYB Dated: September 20, 2010 Received: September 22, 2010

Dear Ms. Su-Mien Chong:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed your becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations) it itgang actment date of the Medical Device Amendment, or to connineres prior to May 20, 1978, the encordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). and Cosmetic Act (Tier) that to hot required to the general controls provisions of the Act. of the 1 ou may, ulciclore, market the act include requirements for annual registration, listing of general controls provisions of the Provibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability adulteration. Flease note. CDICT does not ovarant must be truthful and not misleading.

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Page 2 - Ms. Su-Mien Chong

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 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,

Duna R. Vuchner

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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Special 510(k): Device Modification

## APPENDIX B: INDICATIONS FOR USE STATEMENT

K102728 510(k) Number (if known):

Trade Name:

Arstasis 90€ Access System

Catheter Introducer

Common Name:

Arstasis

Indications For Use:

The Arstasis®16 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 Arstasis 000 Access 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)

Annual

(Division Sign-Off) (Division Sign-On)
Division of Cardiovascular Devices

Page [ of \

510(k) Number

(Posted November 13, 2003)

Confidential

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