(40 days)
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.
The proposed device is a catheter which utilizes IVUS imaging and a hollow Nitinol needle to facilitate redirection and placement of a 0.014" OTW guidewire into peripheral vessels. The guidewire can then facilitate placement of subsequent devices. The device is a single use, sterile catheter.
The provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria. Instead, it is a 510(k) summary and FDA clearance letter for a medical device called the "Pioneer Plus Catheter."
The summary primarily focuses on establishing "substantial equivalence" to a predicate device (Pioneer Catheter, K072155) based on:
- Same indications for use: Facilitate placement and positioning of catheters and provide an intraluminal cross-sectional ultrasound image to facilitate guidewire placement beyond stenotic lesions in peripheral vasculature (not coronary or cerebral).
- Substantially equivalent performance, function, and device characteristics.
- Non-clinical data: In vitro and in vivo testing were completed to assess substantial equivalence in terms of indications, performance, function, device characteristics, materials, packaging, biocompatibility, sterilization, and stability.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study details as this type of information is not present in the provided document.
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K081804
p. 1 of 2
510(k) Summary
This 510(k) Summary is being submitted in accordance with the requirements of 21 CFR 807.92.
| Submitter: | Medtronic Vascular3576 Unocal PlaceSanta Rosa, CA 95403USA | AUG - 5 2008 |
|---|---|---|
| Contact Person: | Catherine PriestleyRegulatory Affairs SpecialistDesk: 707.591.7205Fax: 707.591.7138catherine.priestley@medtronic.com | |
| Date Prepared: | 25 June 2008 | |
| Trade Name: | Pioneer Plus Catheter | |
| Common Name: | Diagnostic Ultrasound Transducer and PercutaneousCatheter | |
| Classification Name: | Diagnostic Ultrasound Transducer and PercutaneousCatheter | |
| Predicate Device: | Pioneer Catheter, K072155 (5 October 2007) | |
| DeviceDescription: | The proposed device is a catheter which utilizes IVUSimaging and a hollow Nitinol needle to facilitateredirection and placement of a 0.014" OTW guidewireinto peripheral vessels. The guidewire can then facilitateplacement of subsequent devices. The device is a singleuse, sterile catheter. | |
| Statement of Intended Use: | The Pioneer Plus Catheter is intended to facilitateplacement and positioning of catheters within theperipheral vasculature. The Pioneer Plus Catheter alsoprovides an intraluminal cross-sectional ultrasoundimage of the area of interest to facilitate placement ofguidewires beyond stenotic lesions (e.g., sub-total, totalor chronic total occlusions) prior to additionalintervention (i.e. PTCA, stent, etc.). The Pioneer PlusCatheter is not indicated for use in the coronary orcerebral vasculature. | |
| Summary of TechnologicalCharacteristics: | Both products have the same indications andsubstantially equivalent performance, function, anddevice characteristics. | |
| Summary of Non-clinicalData: | In vitro and in vivo testing were completed to assesssubstantial equivalence between the Proposed Pioneer Plusand Predicate Pioneer Catheters in terms of indications,performance, function, device characteristics, materials,packaging, biocompatibility, sterilization, and stability. | |
| Conclusion from Data: | The results of this testing demonstrate equivalence andsupport a determination of substantial equivalencebetween 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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
§ 870.1250 Percutaneous catheter.
(a)
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.(b)
Classification. Class II (performance standards).