(40 days)
Not Found
No
The summary describes a catheter with IVUS imaging and a needle for guidewire placement. There is no mention of AI, ML, image processing beyond basic IVUS, or any performance metrics typically associated with AI/ML algorithms. The performance studies focus on equivalence to a predicate device based on device characteristics and function, not algorithmic performance.
No
The device is used to facilitate placement and positioning of other catheters and guidewires, and to provide imaging, which are diagnostic and guidance functions, not therapeutic ones.
Yes
The device provides an intraluminal cross-sectional ultrasound image, which is used for visualizing the area of interest to facilitate placement of guidewires. This imaging function serves a diagnostic purpose by providing visual information about the internal structures.
No
The device description explicitly states it is a catheter, which is a physical hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Pioneer Plus Catheter is a medical device used within the body (in the peripheral vasculature) to facilitate the placement of other devices (catheters and guidewires) and provide imaging in situ (using IVUS). It does not analyze specimens taken from the body.
The information provided clearly describes a device used for interventional procedures within the patient's body, not for laboratory testing of samples.
N/A
Intended Use / 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."
Product codes (comma separated list FDA assigned to the subject device)
PDU, ITX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
In vitro and in vivo testing were completed to assess substantial equivalence between the Proposed Pioneer Plus and Predicate Pioneer Catheters in terms of indications, performance, function, device characteristics, materials, packaging, biocompatibility, sterilization, and stability.
The results of this testing demonstrate equivalence and support a determination of substantial equivalence between the Proposed and Predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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 Vascular
3576 Unocal Place
Santa Rosa, CA 95403
USA | AUG - 5 2008 |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| Contact Person: | Catherine Priestley
Regulatory Affairs Specialist
Desk: 707.591.7205
Fax: 707.591.7138
catherine.priestley@medtronic.com | |
| Date Prepared: | 25 June 2008 | |
| Trade Name: | Pioneer Plus Catheter | |
| Common Name: | Diagnostic Ultrasound Transducer and Percutaneous
Catheter | |
| Classification Name: | Diagnostic Ultrasound Transducer and Percutaneous
Catheter | |
| Predicate Device: | Pioneer Catheter, K072155 (5 October 2007) | |
| Device
Description: | 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. | |
| Statement of 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. | |
| Summary of Technological
Characteristics: | Both products have the same indications and
substantially equivalent performance, function, and
device characteristics. | |
| Summary of Non-clinical
Data: | In vitro and in vivo testing were completed to assess
substantial equivalence between the Proposed Pioneer Plus
and 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 and
support a determination of substantial equivalence
between the Proposed and Predicate devices. | |
1
510(k) Summary
2
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
3
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
4
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