PIONEER PLUS CATHETER

K081804 · Medtronic, Inc. · PDU · Aug 5, 2008 · Cardiovascular

Device Facts

• Record ID: K081804
• Device Name: PIONEER PLUS CATHETER
• Applicant: Medtronic, Inc.
• Product Code: PDU · Cardiovascular
• Decision Date: Aug 5, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Pioneer Plus Catheter is intended to facilitate placement and positioning of catheters within the peripheral vasculature. The Pioneer Plus Catheter also provides an intraluminal cross-sectional ultrasound image of the area of interest to facilitate placement of guidewires beyond stenotic lesions (e.g., sub-total, total or chronic total occlusions) prior to additional intervention (i.e. PTCA, stent, etc.). The Pioneer Plus Catheter is not indicated for use in the coronary or cerebral vasculature.

Device Story

Pioneer Plus Catheter is a single-use, sterile device for peripheral vascular procedures. It integrates IVUS (intravascular ultrasound) imaging with a hollow Nitinol needle. The device provides real-time intraluminal cross-sectional ultrasound images to assist clinicians in navigating and placing a 0.014" over-the-wire (OTW) guidewire across stenotic or occluded peripheral vessels. By visualizing the vessel lumen and lesion, the clinician can steer the needle to redirect the guidewire through the occlusion. Once the guidewire is successfully placed, the catheter is removed, allowing subsequent interventional devices (e.g., stents, balloons) to be advanced over the wire. The device is intended for use by physicians in a clinical or interventional setting. It benefits patients by enabling successful guidewire crossing of complex peripheral lesions that might otherwise be difficult to navigate, facilitating subsequent revascularization.

Clinical Evidence

Bench testing only. In vitro and in vivo testing were conducted to verify performance, function, device characteristics, materials, packaging, biocompatibility, sterilization, and stability compared to the predicate device.

Technological Characteristics

Single-use, sterile catheter featuring an integrated IVUS transducer and a hollow Nitinol needle. Designed for 0.014" OTW guidewire delivery. Operates as a diagnostic ultrasound transducer and percutaneous catheter. Materials, sterilization, and packaging are consistent with the predicate device.

Indications for Use

Indicated for patients requiring catheter placement and positioning within peripheral vasculature. Facilitates guidewire placement beyond stenotic lesions, including sub-total, total, or chronic total occlusions, prior to interventions like PTCA or stenting. Contraindicated for use in coronary or cerebral vasculature.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• Pioneer Catheter (K072155)

Submission Summary (Full Text)

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K081804
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## 510(k) Summary

This 510(k) Summary is being submitted in accordance with the requirements of 21 CFR 807.92.

| Submitter: | Medtronic Vascular<br>3576 Unocal Place<br>Santa Rosa, CA 95403<br>USA | AUG - 5 2008 |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| Contact Person: | Catherine Priestley<br>Regulatory Affairs Specialist<br>Desk: 707.591.7205<br>Fax: [phone]<br>[e-mail] | |
| Date Prepared: | 25 June 2008 | |
| Trade Name: | Pioneer Plus Catheter | |
| Common Name: | Diagnostic Ultrasound Transducer and Percutaneous<br>Catheter | |
| Classification Name: | Diagnostic Ultrasound Transducer and Percutaneous<br>Catheter | |
| Predicate Device: | Pioneer Catheter, K072155 (5 October 2007) | |
| Device<br>Description: | The proposed device is a catheter which utilizes IVUS<br>imaging and a hollow Nitinol needle to facilitate<br>redirection and placement of a 0.014" OTW guidewire<br>into peripheral vessels. The guidewire can then facilitate<br>placement of subsequent devices. The device is a single<br>use, sterile catheter. | |
| Statement of Intended Use: | The Pioneer Plus Catheter is intended to facilitate<br>placement and positioning of catheters within the<br>peripheral vasculature. The Pioneer Plus Catheter also<br>provides an intraluminal cross-sectional ultrasound<br>image of the area of interest to facilitate placement of<br>guidewires beyond stenotic lesions (e.g., sub-total, total<br>or chronic total occlusions) prior to additional<br>intervention (i.e. PTCA, stent, etc.). The Pioneer Plus<br>Catheter is not indicated for use in the coronary or<br>cerebral vasculature. | |
| Summary of Technological<br>Characteristics: | Both products have the same indications and<br>substantially equivalent performance, function, and<br>device characteristics. | |
| Summary of Non-clinical<br>Data: | In vitro and in vivo testing were completed to assess<br>substantial equivalence between the Proposed Pioneer Plus<br>and Predicate Pioneer Catheters in terms of indications,<br>performance, function, device characteristics, materials,<br>packaging, biocompatibility, sterilization, and stability. | |
| Conclusion from Data: | The results of this testing demonstrate equivalence and<br>support a determination of substantial equivalence<br>between the Proposed and Predicate devices. | |

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## 510(k) Summary

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a stylized emblem resembling a caduceus, with three curved lines representing the human services aspect. Encircling the emblem are the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in a simple, sans-serif font and is evenly spaced around the emblem.

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

Medtronic Vascular Inc. Ms. Catherine Priestley, CSSBB, COE, COA Regulatory Affairs Specialist 3576 Unocal Place Santa Rosa, CA 95403

SEP 1 8 2013

Re: K081804

Trade/Device Name: Pioneer Plus Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PDU, ITX Dated: June 25, 2008 Received: June 26, 2008

Dear Ms. Priestly:

This letter corrects our substantially equivalent letter of August 5, 2008.

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

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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" (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.

Zin.Zi

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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Image /page/4/Picture/0 description: The image shows the Medtronic logo. On the left is a circular graphic with a stick figure in the center. To the right of the graphic is the name "Medtronic" in bold, black letters. Below the name is the phrase "Alleviating Pain, Restoring Health".

Alleviating Pain-Restoring Health·Extending Life

Indications for Use

510(k) Number KoBlood

Device Name: Pioneer Plus Catheter

Indications for Use:

"The Pioneer Plus Catheter is intended to facilitate placement and positioning of catheters within the peripheral vasculature. The Pioneer Plus Catheter also provides an intraluminal cross-sectional ultrasound image of the area of interest to facilitate placement of guidewires beyond stenotic lesions (e.g., subtotal, total or chronic total occlusions) prior to additional intervention (i.e. PTCA, stent, etc.). The Pioneer Plus Catheter is not indicated for use in the coronary or cerebral vasculature."

Prescription Use _ X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cardiovascular Devices 1800