(63 days)
Not Found
No
The summary describes a catheter with ultrasound imaging capabilities for facilitating guidewire placement. There is no mention of AI, ML, or any advanced image processing that would suggest the use of such technologies. The submission focuses on clarifying indications for an existing device.
No
The device is used for guidance and imaging during interventions, specifically to facilitate placement of guidewires and provide ultrasound images, rather than directly treating a disease or condition.
No
The device is intended to facilitate the placement of other catheters and guidewires by providing imaging, not to diagnose a disease or condition. While it provides imaging, the imaging is for procedural guidance rather than diagnosis.
No
The device description explicitly states "The Pioneer Catheter is designed to facilitate the placement and positioning of catheters within peripheral vasculature" and "The Pioneer Catheter also provides an intraluminal cross-sectional ultrasound image". This indicates a physical catheter and an ultrasound imaging component, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Pioneer Catheter is a medical device used within the body (intraluminal) to facilitate the placement of other catheters and provide ultrasound imaging of the peripheral vasculature. It is an interventional device, not a diagnostic test performed on a sample outside the body.
- Intended Use: The intended use clearly describes a procedure performed directly on the patient's vasculature, not a laboratory test on a biological sample.
Therefore, the Pioneer Catheter falls under the category of a medical device used for interventional procedures and imaging, not an in vitro diagnostic.
N/A
Intended Use / Indications for 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."
Product codes (comma separated list FDA assigned to the subject device)
PDU, ITX
Device Description
Not Found
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)
Not Found
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
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 | ||
| catherine.priestley@medtronic.com | Classification Name: | |
| Diagnostic Ultrasound | ||
| Transducer and | ||
| Percutaneous Catheter | ||
| Predicate Device: | Pioneer Catheter (formerly known as CrossPoint TransAccess Catheter) | |
| K013363 (April 2, 2002) and K031920, (July 28, 2003). | ||
| Equivalent Device | Pioneer Catheter, formerly known as the CrossPoint TransAccess Catheter. | |
| The proposed and predicate Pioneer Catheter products are identical in | ||
| terms operation, biocompatibility characteristics, performance | ||
| characteristics, materials, and sterilization process. The purpose of the | ||
| submission is to clarify the indication to include appropriate applications. | ||
| Statement of | ||
| 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. | ||
| Summary of | ||
| Technological | ||
| Characteristics: | No technological changes have been made to the proposed Pioneer | |
| Catheter. This submission covers an update to the indication for use to | ||
| include appropriate applications. Therefore, the predicate and proposed | ||
| products are equivalent in terms of technological characteristics. | ||
| Summary of Non- | ||
| clinical Data: | No technological changes have been made to the proposed Pioneer | |
| Catheter. The purpose of the submission is to clarify the indications to | ||
| include appropriate applications as supported by prior testing and published | ||
| literature. |
1
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.
2
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
3
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 (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/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
4
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