CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODCER 65CM CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER 80CM

K120086 · Cardiosolutions · DRA · Apr 24, 2012 · Cardiovascular

Device Facts

• Record ID: K120086
• Device Name: CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODCER 65CM CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER 80CM
• Applicant: Cardiosolutions
• Product Code: DRA · Cardiovascular
• Decision Date: Apr 24, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1280
• Device Class: Class 2

Intended Use

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

Device Story

14Fr steerable introducer set including dilator, stylet, and tear-away sheath; provides flexible catheter positioning in cardiac anatomy via proximal and distal tip steering. Features hemostasis valve to minimize blood loss; sideport with stopcock for aspiration, fluid infusion, blood sampling, and pressure monitoring. Used in clinical settings by physicians for cardiovascular catheterization. Sheath reinforced with Pebax; distal tip includes radiopaque marker for fluoroscopic visualization. Available in 65 cm or 80 cm lengths. Single-use, sterile device.

Clinical Evidence

Bench testing only. Biocompatibility and hemocompatibility testing per ISO 10993 (cytotoxicity, sensitization, pyrogenicity, hemolysis, complement activation, and in vivo thromboresistance). Mechanical testing per ISO 10555 and FDA guidance for intravascular catheters (tensile force, tip separation, leakage, flexural fatigue, and simulated use).

Technological Characteristics

14Fr steerable introducer; reinforced Pebax sheath; radiopaque distal marker. Includes hemostasis valve and sideport with stopcock. Mechanical design; no electronic or software components. Sterilized for single use. Testing conducted per ISO 10993 and ISO 10555.

Indications for Use

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

Regulatory Classification

Identification

A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.

Predicate Devices

• Agilis™ Steerable Catheter Introducer (K042623)
• Steerable Guide Catheter (K100789)

Submission Summary (Full Text)

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#### APR 2 4 2012 11-120084

P. 1 of 2

# 510(k) Summary

# As required by section 807.92(c) _____________________________________________________________________________________________________________________________________________

| As required by section 807.92(c) | |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Name | Cardiosolutions Inc. |
| Address | 375 West St.<br>West Bridgewater MA 02379<br>Phone: [phone]<br>Fax: [phone] |
| Contact Person | Michele Lucey |
| Date Prepared | April 24, 2012 |
| Trade Name | Percu-Pro™ Steerable Introducer |
| Common Name | Steerable Introducer |
| Classification<br>Name | Steerable Guide Catheter |
| Product Code | DRA, DYB |
| Regulation # | 21 CFR 870.1280 |
| Class | 2 |
| Panel | Cardiovascular |
| Predicate<br>Devices | St. Jude Medical, Diag Division, Inc., Agilis™ Steerable Catheter Introducer, K042623<br>Evalve Inc., Steerable Guide Catheter, K100789 |
| Device<br>Description | The Cardiosolutions Percu-Pro™ Steerable Introducer is a 14Fr Introducer. The set also consists of a dilator, stylet, and tear-away introducer sheath. The steerable introducer is designed to provide flexible catheter positioning in the cardiac anatomy. The steerable introducer provides both proximal tip and distal tip steering and is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with stopcock is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The introducer sheath is reinforced Pebax and the distal tip has a radiopaque marker to improve fluoroscopic visualization. The device is provided in 65 cm or 80 cm working lengths. The device is provided sterile and is intended for single use only. |
| Intended Use | The Percu-Pro™ Steerable Introducer is intended to be used for the introduction of various cardiovascular catheters into the heart, including the left side of 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 and Cosmetic Act for these devices, However, testing was conducted in accordance with protocols based on the requirements of industry standards and guidance |

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documents.

Safety and performance testing included:

Biocompatibilty and Hemocompatibility testing in accordance with ISO 10993 were conducted. Results demonstrate that the device is suitable for its intended use. The assessments performed include:

Cytotoxicity

- Systemic Injection O
- No intracutaneous reaction observed Intracutaneous Injection 0
- Sensitization Maximization O
- Material Mediated Pyrogenicity 0
- Direct Hemolysis O
- Partial Thromboplastin Time 0
- In Vivo Thromboresistance Study in Dog* O
- ASTM Hemolysis- Direct Contact O
- SC5b-9 Complement Activation Assay O
- C3a Complement Activation Assay O

Mechanical testing was conducted in accordance with the ISO 10555 Sterile, single-use intravascular catheters Part 1: General requirements (as amended, 1999, 2004) and in consideration of FDA Guidance on Premarket Notification 510(k) Submission for Short Term and Long Term Intravascular Catheters. The following tests were completed:

- Visual Surface Inspection 0
- Dimensional Verification o
- Corrosion Resistance O
- Tensile Break Force O
- Tip Separation Force O
- Freedom from Leakage Under Pressure O
- Air Leakage During Aspiration 0
- O Luer Hub Compliance
- Flexural Fatigue Tolerance 0
- In Vitro Simulated Use Studies ্
- O Functional Performance Testing
- Radiopacity O

All test results demonstrate that the properties and performance of the device are suitable for its intended use.

The Percu-Pro™ Steerable Introducer is substantially equivalent to the predicate Substantial Equivalence devices in terms of intended use, design, materials, technology, and function. There are no differences between devices which would raise new issues of safety or effectiveness.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the eagle.

#### Public Health Service

APR 2 4 2012

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

Cardiosolutions. Inc. c/o Ms. Michele Lucey Vice President, Regulatory Affairs & Quality Assurance 375 West Street West Bridgewater, MA 02379

Re: K120086

Trade/Device Name: Percu Pro Steerable Introducer Regulation Number: 21 CFR 870.1280 Regulation Name: Steerable Guide Catheter Regulatory Class: Class II Product Code: DRA. DYB Dated: March 9, 2012 Received: March 12, 2012

## Dear Ms. Lucey:

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

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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 (OS) 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,

M.A. Killen

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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### K120086

## INDICATIONS FOR USE

# 510(k) Number (if known): K120086

Device Name: Percu-Pro™ Steerable Introducer

Indications for Use:

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

Prescription Use __ X__

Over-The_Counter Use

(PLEASE DO NOTR WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

AND/OR

M. J. Hillen

n Sian-Off n of Cardiovascular Devices

510(k) Number K120086