(28 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.
Percutaneous catheter that 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Pioneer Plus Catheter:
Summary of Acceptance Criteria and Device Performance (Based solely on the provided text):
The provided 510(k) summary primarily focuses on changes to an existing device (Pioneer Plus Catheter, K081804). As such, it relies on demonstrating that the modified device remains substantially equivalent to its predicate, rather than establishing entirely new performance criteria.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety (regarding needle retraction failure) | "A Warning and mitigation steps for managing a needle retraction failure were added to the Instructions for Use. The modifications provide additional safety information to clinicians to facilitate safe use of the Pioneer Plus Catheter." |
| Maintenance of original performance and functional specifications | "Manufacturing process improvements were implemented on the needle subassembly to enhance production consistency and insure the product continues to meet its original specifications. Testing on the needle subassembly was completed and confirmed the process changes did not negatively affect its performance or functionality." |
| No negative impact on performance or functionality due to changes | "Testing on the needle subassembly was completed and confirmed the process changes did not negatively affect its performance or functionality." |
| Equivalence to Predicate Device | "The information above demonstrates equivalence and supports a determination of substantial equivalence between the Subject and Predicate Pioneer Plus Catheters." |
Study Information:
-
Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document mentions "Testing on the needle subassembly," but does not provide details on the number of units tested.
- Data Provenance: Not explicitly stated. The testing appears to be internal to Medtronic Vascular ("Medtronic Vascular Ms. Lucinda Fox Regulatory Affairs Manager"). It is not specified if the data is from a particular country or if it's retrospective or prospective. Given it's for a "Special 510(k) - Changes Being Effected," it's likely a controlled, prospective internal test of the modified components.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This type of information is not applicable to this submission. The submission is not for an AI/machine learning device that requires expert-established ground truth for its performance evaluation. This is a medical device (catheter) where performance is assessed through engineering testing (e.g., mechanical, functional) and comparison to specifications, not diagnostic accuracy against a ground truth.
-
Adjudication method for the test set:
- Not applicable. As the performance is based on engineering testing of the modified needle subassembly, there wouldn't be an adjudication method in the context of diagnostic accuracy.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is not an AI-assisted device, therefore, an MRMC study is not relevant or mentioned.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. For a physical device like this, the "ground truth" for performance is typically engineering specifications, material properties, and functional requirements verified through physical testing, rather than expert consensus on diagnostic interpretations or pathology. The assessment here is about the device's ability to "meet its original specifications" and that process changes "did not negatively affect its performance or functionality."
-
The sample size for the training set:
- Not applicable. This submission is for a physical medical device, not an AI/machine learning model, so there is no concept of a "training set" in this context.
-
How the ground truth for the training set was established:
- Not applicable. As there is no training set for an AI model, this question is irrelevant to this submission.
Conclusion from the Document:
This 510(k) is a "Special 510(k) - Changes Being Effected" for the Pioneer Plus Catheter. The primary purpose of the submission is to demonstrate that minor changes (specifically, manufacturing process improvements to the needle subassembly and additions to the Instructions for Use regarding needle retraction failure) do not negatively impact the device's safety or effectiveness and that the device remains substantially equivalent to its cleared predicate. The "study" mentioned is internal "Testing on the needle subassembly" to confirm its performance after the process changes. No details on this testing (e.g., sample size, specific tests, results) are provided beyond the statement that it "confirmed the process changes did not negatively affect its performance or functionality."
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K101777 C-1
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 |
| Contact Person: | JUL 2 3 2010Lucinda L. FoxRegulatory Affairs ManagerMedtronic Vascular3576 Unocal placeSanta Rosa, CA 95403Phone: 707.591.7028 Fax: 707.591.7138lucinda.l.fox@medtronic.com |
| Date Prepared: | June XX, 2010 |
| Trade Name: | Pioneer Plus Catheter |
| Common Name: | Diagnostic Ultrasound Transducer and Percutaneous Catheter |
| Classification Name: | Diagnostic Ultrasound Transducer and Percutaneous Catheter |
| Predicate Device: | Pioneer Plus Catheter, K081804 (cleared August 5, 2008) |
| Device Description: | Percutaneous catheter that utilizes IVUS imaging and a hollow Nitinolneedle to facilitate redirection and placement of a 0.014° OTWguidewire into peripheral vessels. The guidewire can then facilitateplacement of subsequent devices. The device is a single use, sterilecatheter. |
| Statement of Intended Use: | The Pioneer Plus catheter is intended to facilitate placement andpositioning of catheters within the peripheral vasculature. The PioneerPlus catheter also provides an intraluminal cross-sectional ultrasoundimage of the area of interest to facilitate placement of guidewiresbeyond stenotic lesions (e.g., sub-total, total or chronic totalocclusions) prior to additional intervention (i.e. PTCA, stent, etc.). ThePioneer Plus catheter is not indicated for use in the coronary orcerebral vasculature. |
| Summary of TechnologicalCharacteristics: | The subject and predicate Pioneer Plus Catheters are identical interms of indications for use, intended use, performance specifications,and material specifications. Both devices are designed to facilitateplacement of catheters in the peripheral vasculature and both aresterile, single-use devices with a working length of 120 cm, IVUScapability, and Nitinol needle/guide tip. |
| Summary of Non-clinical Data: | A Warning and mitigation steps for managing a needle retractionfailure were added to the Instructions for Use. The modificationsprovide additional safety information to clinicians to facilitate safe useof the Pioneer Plus Catheter. The changes are being implementedbased on postmarket clinical feedback and are associated with a FieldCorrective Action. No changes were made to the intended use orindications for use, nor were changes made to the product's material |
| Medtronic Vascular Pioneer Plus Catheter | Page 1 of 2 |
Special 510(k) - Changes Being Effected
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510(k) Summary
or performance specifications. Manufacturing process improvements were implemented on the needle subassembly to enhance production consistency and insure the product continues to meet its original specifications. Testing on the needle subassembly was completed and confirmed the process changes did not negatively affect its performance or functionality.
Conclusion from Data: The information above demonstrates equivalence and supports a determination of substantial equivalence between the Subject and Predicate Pioneer Plus Catheters.
Page 2 of 2
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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 & Human Services. The logo features a stylized image of a person with their arms outstretched, surrounded by a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the top of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Medtronic Vascular Ms. Lucinda Fox Regulatory Affairs Manager 3576 Unocal Place Santa Rosa, CA 95043
SEP 18 2013
Re: K101777
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 24, 2010 Received: June 25, 2010
Dear Ms. Fox:
This letter corrects our substantially equivalent letter of July 23, 2010.
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
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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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/Resourcesfor You/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,
Z.M.Z.
for
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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Indications for Use
510(k) Number K101777
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., 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.
AND/OR Prescription Use X (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)
umme R. vi umm
(Division Sian-Off) Division of Cardiovascular Devices
10(k) Number K10-1777
MedIronic Vascular Pioneer Plus Catheler Special 510(k) - Changes Being Effected
§ 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).