SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER

K092014 · Onset Medical Corporation · DYB · Oct 8, 2009 · Cardiovascular

Device Facts

• Record ID: K092014
• Device Name: SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER
• Applicant: Onset Medical Corporation
• Product Code: DYB · Cardiovascular
• Decision Date: Oct 8, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The SoloPath™ Balloon Expandable TransFemoral Introducer is intended to be inserted percutaneously into the femoral artery, over a guidewire, and once expanded, to provide a guide for catheters and /or devices introduced into the femoral iliac arteries.

Device Story

SoloPath™ Balloon Expandable TransFemoral Introducer; percutaneous femoral artery access device. Input: guidewire placement. Operation: balloon expansion to create conduit for secondary catheters/devices in femoral iliac arteries. Used in clinical settings by physicians. Benefits: facilitates delivery of interventional devices through femoral access.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Balloon expandable catheter introducer; percutaneous design; femoral artery access; mechanical expansion mechanism.

Indications for Use

Indicated for percutaneous insertion into the femoral artery over a guidewire to provide a conduit for catheters and devices into the femoral iliac arteries.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Submission Summary (Full Text)

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

Onset Medical Corporation c/o Mr. Mark Job 1394 25th St. NW Buffalo, MN 55313

OCT - 8 2009

Re: K092014

SoloPath™ Balloon Expandable TransFemoral Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: September 22, 2009 Received: September 23, 2009

Dear Mr. Job:

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 for association 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, de noos that have been require approval of a premarket approval application (PMA). and Costhede Fror (110) the device, subject to the general controls provisions of the Act. The I ou may, diorolore, mains of the Act include requirements for annual registration, listing of general controls proficturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (so acols, 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 I lease be advisou that I Dr over intimation that your device complies with other requirements of the Act that I DIT has made a cond regulations administered by other Federal agencies. You must of uny I occurrents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical CITY at 007), laborning (21 CFR 803); good manufacturing practice requirements as set de rice-related adverse overlis) (2) Canadon (21 CFR Part 820); and if applicable, the electronic forth in the quality of every of ections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2 - Mr. Mark Job

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.html 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,

R. bohner

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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## 4. Indications for Use

510(k) Number (if known):_ ko 9 ZO | 4

Device Name: SoloPath™ Balloon Expandable TransFemoral Introducer

Indications for Use:

The SoloPath™ Balloon Expandable TransFemoral Introducer is intended to be inserted percutaneously into the femoral artery, over a guidewire, and once expanded, to provide a guide for catheters and /or devices introduced into the femoral iliac arteries.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

suma R. Vahnes

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number_ 109 201