Occlusion Perfusion Catheter

K151554 · Advanced Catheter Therapies, Inc. · QEY · Sep 15, 2015 · Cardiovascular

Device Facts

• Record ID: K151554
• Device Name: Occlusion Perfusion Catheter
• Applicant: Advanced Catheter Therapies, Inc.
• Product Code: QEY · Cardiovascular
• Decision Date: Sep 15, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Occlusion Perfusion Catheter™ is indicated for localized infusion of various diagnostic and therapeutic agents into the peripheral vasculature. It is not indicated for use in the neurovasculature.

Device Story

Occlusion Perfusion Catheter is a percutaneous catheter designed for localized delivery of diagnostic or therapeutic agents into peripheral vasculature; device enables targeted infusion by isolating specific vessel segments; used by physicians in clinical settings; provides localized drug/agent delivery to improve therapeutic efficacy or diagnostic accuracy while minimizing systemic exposure; device operation involves standard catheterization techniques.

Clinical Evidence

No clinical data provided; substantial equivalence established via bench testing and design comparison.

Technological Characteristics

Percutaneous catheter; Class II device (21 CFR 870.1250); product code DOY. Design facilitates localized infusion in peripheral vasculature. No software or electronic components described.

Indications for Use

Indicated for localized infusion of diagnostic and therapeutic agents into peripheral vasculature. Contraindicated for use in neurovasculature.

Regulatory Classification

Identification

An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

September 15, 2015

Advanced Catheter Therapies, Inc. % Mr. Chris Henza Director, Regulatory and Operations Regulatory Compliance Associates, Inc. 10411 Corporate Drive, Suite 102 Pleasant Prairie, WI 53158

Re: K151554

Trade/Device Name: Occlusion Perfusion Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: July 15, 2015 Received: July 17, 2015

Dear Mr. Henza:

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

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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 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. 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,

Mitchell Stein

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

510(k) Number (if known) K151554

Device Name Occlusion Perfusion Catheter™

Indications for Use (Describe)

The Occlusion Perfusion Catheter™ is indicated for localized infusion of various diagnostic and therapeutic agents into the peripheral vasculature. It is not indicated for use in the neurovasculature.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|----------------------------------------------|---------------------------------------------|
|----------------------------------------------|---------------------------------------------|

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