ARSTASIS DILATOR ADAPTER

K103421 · Arstasis, Inc. · DRE · May 24, 2011 · Cardiovascular

Device Facts

• Record ID: K103421
• Device Name: ARSTASIS DILATOR ADAPTER
• Applicant: Arstasis, Inc.
• Product Code: DRE · Cardiovascular
• Decision Date: May 24, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1310
• Device Class: Class 2

Intended Use

The Adapter is intended to allow the use of a .018" guidewire with a .035" or .038" guidewire compatible dilator up to 23 cm in overall length and to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.

Device Story

The Arstasis Dilator Adapter is a sterile, single-use, hollow polyethylene bump extrusion. It functions as an adapter to fill the gap between .018" guidewires and larger .035" or .038" compatible vessel dilators (up to 23cm length). Used by clinicians during percutaneous catheterization procedures to facilitate device introduction into veins or arteries while maintaining hemostasis. The device is a mechanical accessory; it does not involve electronic processing, software, or AI. It benefits the patient by enabling the use of smaller guidewires within standard larger-diameter dilators during vascular access.

Clinical Evidence

Bench testing only. Testing included tensile strength (ISO 11070-1998), dimensional specifications, and design verification/validation using a simulated clinical bench model to assess insertion forces and usability.

Technological Characteristics

Polyethylene bump extrusion; hollow, tapered outer diameter; single-use; sterile. Dimensions sized to interface .018" guidewires with .035"-.038" compatible vessel dilators. Mechanical device; no energy source, software, or connectivity.

Indications for Use

Indicated for patients requiring percutaneous vascular access for diagnostic or therapeutic procedures, allowing use of .018" guidewires with .035"/.038" compatible dilators.

Regulatory Classification

Identification

A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.

Predicate Devices

• Prelude Sheath Introducer (K070159)

Submission Summary (Full Text)

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| | SECTION 4: 510(K) SUMMARY | MAY 24 2011 |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| 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: | November 19, 2010 | |
| Device Trade Name: | Arstasis Dilator Adapter | |
| Common Name: | Dilator Adapter | |
| Device Classification: | Class II | |
| Regulation Number: | 21 CFR 870.1310 | |
| Classification Name: | dilator, vessel, for percutaneous catheterization | |
| Product Code: | DRE | |
| Predicate Device: | Prelude Sheath Introducer (K070159) | |
| Device Description: | The Adapter is a sterile, single use device that is hollow and has a<br>tapered increase in outer diameter on one end. This shape allows the<br>Adapter to fill the excess space between .018" guidewires and<br>dilators with larger inner diameters. | |
| Indications for Use: | The Adapter is intended to allow the use of a .018" guidewire with a<br>.035" or .038" guidewire compatible dilator up to 23cm in overall<br>length. | |
| Technological<br>Characteristics | The Dilator Adapter is a polyethylene bump extrusion that fits into a<br>.035"-.038" compatible vessel dilator with an internal diameter-sized--<br>to an .018" guidewire. | |
| Performance Data | The Dilator Adapter was subjected to tensile testing to demonstrate<br>that it met ISO11070-1998 specifications for dilators. The Adapter<br>also underwent testing for dimensional specifications, design<br>verification and validation including insertion forces and useability as<br>assessed on a simulated clinical bench model. | |
| Summary of<br>Substantial<br>Equivalence: | The Arstasis Dilator Adapter is substantially equivalent to the<br>predicate device as confirmed through performance testing. | |

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## SECTION 3: INDICATIONS FOR USE STATEMENT

| 510(k) Number (if known): | K103421 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | Arstasis Dilator Adapter |
| Common Name: | dilator, vessel, for percutaneous catheterization |
| Indications For Use: | The Adapter is intended to allow the use of a .018" guidewire with a<br>.035" or .038" guidewire compatible dilator up to 23cm in overall length. |

Prescription Use Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (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) Page of of __ of _

(Posted November 13, 2003)

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(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number_ 165992

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

JUN 2882011

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

Re: K103421

> Trade Name: Arstasis Dilator Adapter Regulation Number: 21 CFR 870.1310 Regulation Name: Dilator, Vessel, for Percutaneous Catheterization Regulatory Class: II (two) Product Code: DRE Dated: May 12, 2011 Received: May 13, 2011

Dear Ms. Cogan:

This letter corrects our substantially equivalent letter of May 24, 2011.

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.

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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 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,

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure Indications for Use Statement

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Arstasis Dilator Adaptor K103421/A001 Attachment A

## INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Trade Name: Arstasis Dilator Adapter

dilator, vessel, for percutaneous catheterization Common Name:

- "The Adapter is intended to allow the use of a .018" guidewire with a Indications For Use: 0.035" or .038" guidewire compatible dilator up to 23 cm in overall length and to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures."

| Prescription Use (Part 21 CFR 801 Subpart D) | X |
|----------------------------------------------|---|
| 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) | |
|--------------------------------------------------------|--|
| Page ___ of ___ | |
| (Posted November 13, 2003) | |

Division Sign-Off

Division of Cardiovascular Devices

| 510(k) Number | K103421 |
|---------------|---------|
|---------------|---------|