GUIDEWIRE, PURSUER SERIES

K130104 · Oscor, Inc. · DQX · Jun 13, 2013 · Cardiovascular

Device Facts

• Record ID: K130104
• Device Name: GUIDEWIRE, PURSUER SERIES
• Applicant: Oscor, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Jun 13, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The guidewire is intended to facilitate the introduction of intravascular devices for use in the coronary and/or peripheral vasculature during diagnostic and interventional procedures.

Device Story

The Pursuer Series Guidewire is a medical device designed to facilitate the placement of intravascular devices within the coronary and peripheral vasculature. It is used by physicians during diagnostic and interventional procedures to navigate the vascular system. The device acts as a track for other interventional tools, aiding in their delivery to target sites. It is a mechanical device without electronic components or software.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Class II catheter guide wire (21 CFR 870.1330, Product Code DOX). Mechanical device; no electronic, software, or energy-based components.

Indications for Use

Indicated for patients undergoing diagnostic and interventional procedures in the coronary and/or peripheral vasculature requiring the introduction of intravascular devices.

Regulatory Classification

Identification

A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.

Special Controls

*Classification.* Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

June 13, 2013

Oscor Inc. C/O Mila Doskocil 3816 De Soto Blvd. Palm Harbor, FL 34683 US

Re: K130104

> Trade/Device Name: Guidewire, Pursuer Series Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DOX Dated: April 30, 2013 Received: May 6, 2013

Dear Ms. Doskocil:

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.off 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 (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,

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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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 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 vours.

M& Hillelien

for Bram D. Zuckerman, Ph.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

510k Number (if known) – K130104

## Device Name: Guidewire, Pursuer Series

The guidewire is intended to facilitate the introduction of intravascular devices for use in the coronary and/or peripheral vasculature during diagnostic and interventional procedures.

Prescription Use X (Per 21 CFR 801.109) (Optional Format 1-2-96) OR

Over-The-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF

NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

MZ. Hillebrand