MicroTract Access System

K151877 · Arstasis, Inc. · DRE · Aug 7, 2015 · Cardiovascular

Device Facts

• Record ID: K151877
• Device Name: MicroTract Access System
• Applicant: Arstasis, Inc.
• Product Code: DRE · Cardiovascular
• Decision Date: Aug 7, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1310
• Device Class: Class 2

Intended Use

The MicroTract Access System is intended to allow the use of a .018" guidewire with a .035" or .038" guidewire compatible dilator up to 23cm in overall length.

Device Story

MicroTract Access System facilitates percutaneous catheterization by bridging size mismatch between guidewires and dilators. Components include 20-gauge stainless steel access needle, 0.018" Nitinol/Tungsten guidewire, and polyethylene dilator adapter. Adapter fills excess space between 0.018" guidewire and larger inner diameter dilators (0.035"-0.038"). Used in clinical settings by physicians; device is sterile, single-use. System ensures compatibility during vascular access, allowing clinicians to utilize smaller guidewires with standard larger-diameter dilators, potentially simplifying access procedures.

Clinical Evidence

Bench testing only. Testing included tensile testing per ISO 11070-1998, dimensional specification verification, and design validation including insertion forces and usability assessed on a simulated clinical bench model.

Technological Characteristics

Components: 20-gauge stainless steel access needle; 0.018" Nitinol guidewire with Tungsten coil; polyethylene bump extrusion dilator adapter. Designed for compatibility with 0.035"-0.038" vessel dilators. Sterile, single-use. Mechanical device; no software or energy source.

Indications for Use

Indicated for patients requiring percutaneous catheterization procedures where a .018" guidewire is used in conjunction with a .035" or .038" compatible vessel dilator.

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

• Arstasis Dilator Adapter (K103421)
• AXERA RX Access System (K140287)

Submission Summary (Full Text)

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Public Health Service

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

August 7, 2015

Arstasis, Inc. Debra Cogan Regulatory Consultant 6500 Kaiser Drive Suite 120 Fremont, CA, 94555

Re: K151877

Trade/Device Name: MicroTract Access System Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel dilator for percutaneous catheterization Regulatory Class: II Product Code: DRE Dated: July 7, 2015 Received: July 9, 2015

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 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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 -S

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

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## SECTION 1. INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

| Trade Name: | MicroTract Access System |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | dilator, vessel, for percutaneous catheterization |
| Indications For Use: | The MicroTract Access System is intended to allow the use of a<br>.018" guidewire with a .035" or .038" guidewire compatible dilator<br>up to 23cm in overall length. |

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

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## SECTION 2. 510(k) SUMMARY

| Sponsor/Submitter: | Arstasis, Inc.<br>650 Kaiser Rd<br>Fremont, CA 94555 |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Debra Cogan<br>Regulatory Consultant<br>Phone: [phone] |
| Date of Submission: | Fax: [phone]<br>July 7, 2015 |
| Device Trade Name: | MicroTract Access System |
| Common Name: | Dilator Adapter |
| Device Classification: | Class II |
| Regulation Number: | 21 CFR 870.1310 |
| Classification Name: | dilator, vessel, for percutaneous catheterization |
| Product Code: | DRE |
| Primary Predicate<br>Device: | Arstasis Dilator Adapter (K103421) |
| Secondary Predicate<br>Device: | AXERA RX Access System (K140287) |
| Device Description: | The MicroTract Access System contains a 20 gauge Access Needle, a<br>0.018" Guidewire, and a Dilator Adapter. The Dilator Adapter is a sterile,<br>single use device that is hollow and has a tapered increase in outer<br>diameter on one end. This shape allows the Adapter to fill the excess<br>space between .018" guidewires and dilators with larger inner diameters. |
| Indications for Use: | The MicroTract Access System is intended to allow the use of a .018"<br>guidewire with a .035" or .038" guidewire compatible dilator up to 23cm<br>in overall length. |
| Technological<br>Characteristics | The MicroTract Dilator Adapter is a polyethylene bump extrusion that fits<br>into a .035"-.038" compatible vessel dilator with an internal diameter<br>sized to 0.018" guidewire. The Access Needle is a 20 gauge diameter<br>needle made of stainless steel. The guidewire is 0.018" diameter made of<br>Nitinol with a Tungsten coil. |
| Performance Data | The MicroTract Access System was subjected to tensile testing to<br>demonstrate that it met ISO11070-1998 specifications for dilators. The<br>System 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 MicroTract Access System is substantially equivalent to the predicate<br>device as confirmed through performance testing. |