PIONEER CATHETER

K072155 · Medtronic, Inc. · PDU · Oct 5, 2007 · Cardiovascular

Device Facts

• Record ID: K072155
• Device Name: PIONEER CATHETER
• Applicant: Medtronic, Inc.
• Product Code: PDU · Cardiovascular
• Decision Date: Oct 5, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Pioneer Catheter is designed to facilitate the placement and positioning of catheters within peripheral vasculature. The Pioneer 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 Catheter is not indicated for use in coronary or cerebral vasculature.

Device Story

Pioneer Catheter facilitates peripheral vascular catheter placement and guidewire navigation through stenotic lesions. Device integrates intraluminal ultrasound imaging to provide cross-sectional visualization of target area. Used by physicians in clinical settings to guide interventions such as PTCA or stenting. Provides real-time visual feedback to assist in navigating complex occlusions; improves procedural success in peripheral vascular interventions. Operates as a percutaneous catheter with diagnostic ultrasound capabilities.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by prior testing and published literature.

Technological Characteristics

Percutaneous catheter with integrated diagnostic ultrasound transducer. Class II device. No technological changes from predicate. Materials, sterilization, and sensing principles remain consistent with previously cleared versions.

Indications for Use

Indicated for patients requiring catheter placement and positioning within peripheral vasculature, specifically to facilitate 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 (formerly CrossPoint TransAccess Catheter) (K013363)
• Pioneer Catheter (formerly CrossPoint TransAccess Catheter) (K031920)

Submission Summary (Full Text)

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## 0CI 5- 2007
- 10(k) Summary

This summary of 510(k) Summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CRF 807.92.

| Date Prepared: 31 July 2007 | | |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| Applicant Information | Contact Person | Device Information |
| Medtronic Vascular | Catherine Priestley | Classification: |
| 3576 Unocal Place | Regulatory Affairs Specialist | Class II |
| Santa Rosa, CA 95403 | 3576 Unocal Place | |
| USA | Santa Rosa, CA 95403 | Trade name: |
| | 707.591.7205 | Pioneer Catheter |
| | 707.591.7138 | |
| | [e-mail] | Classification Name: |
| | | Diagnostic Ultrasound |
| | | Transducer and |
| | | Percutaneous Catheter |
| Predicate Device: | Pioneer Catheter (formerly known as CrossPoint TransAccess Catheter)<br>K013363 (April 2, 2002) and K031920, (July 28, 2003). | |
| | | |
| Equivalent Device | Pioneer Catheter, formerly known as the CrossPoint TransAccess Catheter.<br>The proposed and predicate Pioneer Catheter products are identical in<br>terms operation, biocompatibility characteristics, performance<br>characteristics, materials, and sterilization process. The purpose of the<br>submission is to clarify the indication to include appropriate applications. | |
| Statement of<br>Intended Use: | The Pioneer Catheter is designed to facilitate the placement and positioning<br>of catheters within peripheral vasculature. The Pioneer Catheter also<br>provides an intraluminal cross-sectional ultrasound image of the area of<br>interest to facilitate placement of guidewires beyond stenotic lesions (e.g.,<br>sub-total, total or chronic total occlusions) prior to additional intervention<br>(i.e., PTCA, stent, etc.). The Pioneer Catheter is not indicated for use in<br>coronary or cerebral vasculature. | |
| Summary of<br>Technological<br>Characteristics: | No technological changes have been made to the proposed Pioneer<br>Catheter. This submission covers an update to the indication for use to<br>include appropriate applications. Therefore, the predicate and proposed<br>products are equivalent in terms of technological characteristics. | |
| Summary of Non-<br>clinical Data: | No technological changes have been made to the proposed Pioneer<br>Catheter. The purpose of the submission is to clarify the indications to<br>include appropriate applications as supported by prior testing and published<br>literature. | |

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Data:

Catheter. The purpose of the submission is to clarify the indications to include appropriate applications as supported by prior testing and published literature. Therefore, the proposed and predicate Pioneer Catheter products are substantially equivalent.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

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

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

Re: K072155

Trade/Device Name: Pioneer Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PDU, ITX Dated: July 31, 2007 Received: August 3, 2007

SEP 1 8 2013

Dear Ms. Priestly:

This letter corrects our substantially equivalent letter of October 5, 2007.

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

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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 (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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Zin.Z

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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510(k) Number (if known): ← ○ 7 21 5 5

Device Name: Pioneer Catheter

Proposed Indications For Use (changes in red):

"The Pioneer catheter is intended to facilitate placement and positioning of catheters within the peripheral vasculature. The Pioneer 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 catheter is not indicated for use in the coronary or cerebral vasculature."

| Prescription Use | _X_ |
|-----------------------------|-----|
| Use | |
| (Part 21 CFR 801 Subpart d) | |
| Subpart C) | |

| AND/OR | Over-The-Counter |
|--------|------------------|
| | (21 CFR 807 |

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

Nuna R. Holmes

(Division Sign-Off) Orvision of Cardiovascular Devices

**510(k) Number** k022155