CARDIOSOLUTIONS DEXTERITY STEERABLE INTRODUCER

K140015 · Cardiosolutions, Inc. · DYB · Feb 5, 2014 · Cardiovascular

Device Facts

• Record ID: K140015
• Device Name: CARDIOSOLUTIONS DEXTERITY STEERABLE INTRODUCER
• Applicant: Cardiosolutions, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Feb 5, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Dexterity™ Steerable Introducer is intended to be used for the percutaneous introduction of various cardiovascular catheters into the heart, including the left side of the heart through the inter-atrial septum.

Device Story

Dexterity™ Steerable Introducer facilitates flexible catheter positioning within cardiac anatomy. Device features proximal and distal tip steering; includes hemostasis valve to minimize blood loss during catheter exchange; sideport with stopcock allows for aspiration, fluid infusion, blood sampling, and pressure monitoring. Sheath constructed of reinforced Pebax; distal tip contains radiopaque marker for fluoroscopic visualization. Used by clinicians in cardiovascular procedures to introduce catheters into the heart. Provides stable access for diagnostic or therapeutic catheter placement; benefits patient by enabling precise navigation to target cardiac sites.

Clinical Evidence

Bench testing only. Testing performed per ISO 10555 and FDA guidance for intravascular catheters. Evaluated visual surface, dimensions, corrosion resistance, tensile break force, tip separation force, leakage under pressure, air aspiration, luer hub compliance, flexural fatigue, in vitro simulated use, functional performance, and radiopacity.

Technological Characteristics

Reinforced Pebax sheath; radiopaque distal marker. Available in 9Fr and 14Fr diameters with various working lengths (up to 105 cm). Includes dilator, stylet, and tear-away sheath depending on model. Sterile, single-use. Mechanical steering mechanism. No software or electronic components.

Indications for Use

Indicated for percutaneous introduction of cardiovascular catheters into the heart, including the left side via the inter-atrial septum.

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

• Percu-Pro™ Steerable Introducer (K120086, 131332)

Submission Summary (Full Text)

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K140015
FEB - 5 2014

## SECTION 7.0

·

### SPECIAL 510(K) SUMMARY

:

Premarket Notification for the Cardiosolutions Dexterity™ Steerable Introducer

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### 510(k) Summary

## Special 510(k)

As required by section 807.92(c)

| Company<br>Name | Cardiosolutions Inc. | | | |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|---------------|--------------------------------|
| Address | 375 West St.<br>West Bridgewater MA 02379<br>Phone: [phone]<br>Fax: [phone] | | | |
| Contact Person | Christine Santagate | | | |
| Date Prepared | December 17, 2013 | | | |
| Trade Name | Dexterity™ Steerable Introducer | | | |
| Common Name | Steerable Introducer | | | |
| Classification<br>Name | Catheter Introducer | | | |
| Product Code | DYB, DRA | | | |
| Regulation # | 21 CFR 870.1340 | | | |
| Class | 2 | | | |
| Panel | Cardiovascular | | | |
| Predicate<br>Devices | Percu-Pro™ Steerable Introducer K120086, 131332 | | | |
| Device<br>Description | The Cardiosolutions Dexterity™ Steerable Introducer is provided as a 9Fr and 14Fr<br>Introducer. The set also consists of the following components based on the model#: | | | |
| | Size and Working<br>Length | Included Accessories | | |
| | 14FR 65 and 85<br>CM | Dilator | Stylet | Tear-away<br>introducer sheath |
| | 14Fr 105 CM | Dilator | NA | Tear-away<br>introducer sheath |
| | 9Fr 65CM | NA | Curved Stylet | NA |
| | The Dexterity steerable introducer is designed to provide flexible catheter positioning in<br>the cardiac anatomy. The steerable introducer provides both proximal tip and distal tip<br>steering and is fitted with a hemostasis valve to minimize blood loss during catheter<br>introduction and/or exchange. A sideport with stopcock is provided for air or blood<br>aspiration, fluid infusion, blood sampling, and pressure monitoring. The introducer<br>sheath is reinforced Pebax and the distal tip has a radiopaque marker to improve<br>fluoroscopic visualization. The device is provided in various diameters and working<br>lengths. The device is provided sterile and is intended for single use only. | | | |
| | The purpose of this submission is to add an additional device working length, 105 CM,<br>to the 14Fr Introducer product offering. In addition the intended use statement is<br>modified to include the term percutaneous for clarification only. This change is not a<br>change to the intended use of the device. | | | |
| Intended Use | The Dexterity™ Steerable Introducer is intended to be used for the percutaneous<br>introduction of various cardiovascular catheters into the heart, including the left side of<br>the heart through the inter-atrial septum. | | | |
| Safety and<br>Performance<br>Testing | No performance standards have been established under Section 514 of the Food, Drug<br>and Cosmetic Act for these devices. | | | |
| | The materials used in the 14 Fr 105 CM Dexterity™ Steerable Introducer are identical to<br>the Dexterity™ Steerable Introducer predicate device. No additional biocompatibility is<br>required. | | | |
| | Design verification testing performed on the modified device consisted of mechanical<br>testing conducted in accordance with the ISO 10555 Sterile, single-use intravascular<br>catheters Part 1: General requirements (as amended, 1999, 2004) and in consideration of<br>FDA Guidance on Premarket Notification 510(k) Submission for Short Term and Long<br>Term Intravascular Catheters. The following tests were completed: | | | |
| | o | Visual Surface Inspection | | |
| | o | Dimensional Verification | | |
| | o | Corrosion Resistance | | |
| | o | Tensile Break Force | | |
| | o | Tip Separation Force | | |
| | o | Freedom from Leakage Under Pressure | | |
| | o | Air Leakage During Aspiration | | |
| | o | Luer Hub Compliance | | |
| | o | Flexural Fatigue Tolerance | | |
| | o | <i>In Vitro</i> Simulated Use Studies | | |
| | o | Functional Performance Testing | | |
| | o | Radiopacity | | |

Premarket Notification for the Cardiosolutions Dexterity™ Steerable Introducer

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Premarket Notification for the Cardiosolutions Dexterity™ Steerable Introducer

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| | o | Shelf Life |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | All test results demonstrate that the properties and performance of the device are<br>substantially equivalent to the predicate device and suitable for its intended use. | |
| Substantial<br>Equivalence | The 14Fr 105 CM Dexterity™ Steerable Introducer is substantially equivalent to the<br>predicate devices in terms of intended use, design, materials, technology, and function.<br>There are no differences between devices which would raise new issues of safety or<br>effectiveness. | |

Premarket Notification for the Cardiosolutions Dexterity™ Steerable Introducer

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Image /page/4/Picture/1 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 image of an eagle with its wings spread.

Public Health Service

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

February 5, 2014

Cardiosolutions Inc. Christine Santagate Manager of Regulatory Consulting Services 375 West St. West Bridgewater, MA 02379

Re: K140015

Trade/Device Name: Cardiosolutions Dexterity Steerable Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter, Introducer Regulatory Class: Class II Product Code: DYB Dated: January 7, 2014 Received: January 8, 2014

Dear Ms. Santagate,

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

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Page 2 - Christine Santagate

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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,

M. Ar. Heele

for 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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### Indications for Use Statement

K140015 510(k) Number:

Device Name: Dexterity™ Steerable Introducer

Indications for Use:

The Dexterity™ Steerable Introducer is intended to be used for the percutaneous introduction of various cardiovascular catheters into the heart, including the left side of the heart through the inter-atrial septum.

Prescription Use X (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

M. L. Hillman