ARSTASIS ONE LATCHWIRE ACCESS SYSTEM

K103143 · Arstasis, Inc. · DYB · Feb 2, 2011 · Cardiovascular

Device Facts

• Record ID: K103143
• Device Name: ARSTASIS ONE LATCHWIRE ACCESS SYSTEM
• Applicant: Arstasis, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Feb 2, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The 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

Arstasisone Latchwire Access System facilitates percutaneous peripheral vascular access and arteriotomy site hemostasis. Device components include latchwire, anchor mechanism, shaft, and handle with control features. Operates by creating shallow access path through arterial wall for guidewire entry into vessel lumen. Used by clinicians during diagnostic femoral artery catheterization. Acts as adjunct to manual compression to promote hemostasis. Benefits include controlled access and improved closure management.

Clinical Evidence

Clinical evidence includes multiple clinical evaluations establishing short-term safety and performance. Long-term safety and re-access capabilities were studied retrospectively in a smaller patient cohort. Preliminary non-GLP animal studies and cadaver assessments were conducted using prototypes of similar design.

Technological Characteristics

Catheter introducer system comprising latchwire, anchor mechanism, shaft, and handle. Materials evaluated for biocompatibility per ISO-10993-1. Tensile testing performed on 19 gauge access needle following gamma radiation sterilization. Mechanical design creates shallow access path for guidewire. No software or electronic components.

Indications for Use

Indicated for patients undergoing diagnostic femoral artery catheterization procedures requiring 5F or 6F introducer sheaths; provides peripheral vascular access and adjunct 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 (K102728)

Submission Summary (Full Text)

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K103143 page 1 of 2

# ત્વદ્યકાર

### Special 510(k): Device Modification

FEB - 2 2011

# APPENDIX A: 510(k) SUMMARY

| Sponsor/Submitter: | Arstasis, Inc.<br>1021 Howard Avenue, Suite C<br>San Carlos, CA 94070 |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Debra Cogan<br>Director, Regulatory & Clinical Affairs<br>Phone: [phone] x273<br>Fax: [phone] |
| Date of Submission: | October 22, 2010 |
| Device Trade Name: | Arstasisone Latchwire 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 (K102728) |
| Device Description: | Arstasisone is a device that is comprised of a latchwire, anchor<br>mechanism, shaft and handle with control features. |
| Indications for Use: | The System is intended to provide access for the percutaneous<br>introduction of devices into the peripheral vasculature and to<br>promote hemostasis at the arteriotomy site as an adjunct to manual<br>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 | Arstasisone Latchwire 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 | Arstasisone met all performance testing acceptance criteria. |
| Summary of<br>Substantial<br>Equivalence: | Bench testing was performed on the Latchwire Device following<br>sterilization of test units. Parameters tested include functionality<br>testing, deployment forces, corrosion resistance, compression and<br>torque loading, flexibility and tensile strength.<br>Tensile testing for the 19 gauge Access Needle was performed<br>following gamma radiation. |

CONFIDENTIAL

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

Additional prior testing included biocompatibility testing pursuant to ISO-10993-1, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing (1995), preliminary animal studies (non-GLP) and cadaver assessments, as well as clinical 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 " Latchwire 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/11 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and features an abstract eagle design in the center. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged around the perimeter of the circle.

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

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

FEB - 2 201

.

#### Re: K103143

Trade/Device Name: Arstasis °°° Latchwire Access System Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II (two) Product Code: DYB Dated: January 25, 2011 Received: January 26, 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.

:

.

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Page 2 – Ms. Debra Cogan

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/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 yours

Bram D. Zuckerman, M.D.

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):

K103143

Trade Name:

Arstasisone Latchwire Access System

Common Name:

Indications For Use:

Arstasis
Latchwire Access Syste

Catheter Introducer

The 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) |
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(Division Sign-Off)

Page of

vision Sign Off) 510(k) Number

(Posted November 13, 2003)

CONFIDENTIAL