(56 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The device description is purely mechanical.
No
The device is described as a catheter for aspiration of material and infusion of agents, rather than directly providing therapy itself. While it can deliver therapeutic agents, it is a delivery mechanism, not the therapeutic device.
No
The device is used for removal/aspiration of embolic material and infusion of diagnostic or therapeutic agents, which are interventional or treatment purposes, not diagnostic. While it can deliver diagnostic agents, the device itself doesn't perform diagnosis.
No
The device description clearly states it is a "dual lumen catheter," which is a physical hardware component.
Based on the provided information, the Medtronic Export® XT Catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that this catheter is used for procedures within the arterial system (removal of material, infusion of agents). It is a medical device used for intervention and treatment, not for testing samples outside the body.
- The description focuses on mechanical action and delivery. The primary functions are aspiration and infusion, which are physical actions performed on the patient's vascular system.
- There is no mention of analyzing biological samples. The text does not describe any process of examining blood, tissue, or other bodily fluids to diagnose a condition.
Therefore, the Medtronic Export® XT Catheter falls under the category of a medical device used for therapeutic and diagnostic delivery purposes within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Medtronic Export® XT Catheter is indicated for: - Removal/aspiration of embolic material (thrombus/debris) from vessels . of the arterial system, and - To subselectively infuse/deliver diagnostics or therapeutics agents with . or without vessel occlusion.
Product codes (comma separated list FDA assigned to the subject device)
QEZ, KRA (Initially DXE)
Device Description
The Medtronic Export XT Catheter is a dual lumen catheter used for the aspiration of thrombus and/or debris from a vascular site. The Medtronic Export XT Catheter may also be used for the infusion of diagnostic or therapeutic agents to a desired vascular site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels of the arterial system
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)
The proposed Medtronic Export® XT Catheter has successfully passed all design verification and validation testing.
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.
Export Aspiration Catheter (K040869)
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
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 15, 2021
Medtronic Vascular Karen Brozowski RA Manager 37a Cherry Hill Dr. Danvers, Massachusetts 01923
Re: K061958
Trade/Device Name: Medtronic Export XT Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ, KRA
Dear Karen Brozowski:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated September 5. 2006. Specifically, FDA is updating this SE Letter because FDA has created a new product code to better categorize your device technology.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Gregory O'Connell, OHT2: Office of Cardiovascular Devices, (301) 796-6075, Gregory.Oconnell@FDA.HHS.gov.
Sincerely,
Digitally signed by Gregory W. Gregory W. O'connell -S O'connell -S Date: 2021.09.15
O'connell -S 09:18:24 -04'00'
Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three stripes forming its wings, symbolizing the department's mission to protect and promote the health and well-being of all Americans. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's official name and national scope. The logo is simple, clean, and easily recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 5 2006
Medtronic, Inc. c/o Ms. Karen A. Brozowski Regulatory Affairs Specialist 37A Cherry Hill Drive Danvers, MA 01923
Re: K061958 Medtronic® Export® XT Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II (two) Product Code: DXE Dated: August 15, 2006 Received: August 16, 2006
Dear Ms. Brozowski:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
2
Page 2 - Ms. Karen A. Brozowski
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): KDG / 958
Device Name: Medtronic Export® XT Catheter
Indications for Use:
::
The Medtronic Export® XT Catheter is indicated for:
- Removal/aspiration of embolic material (thrombus/debris) from vessels . of the arterial system, and
- To subselectively infuse/deliver diagnostics or therapeutics agents with . or without vessel occlusion.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| (Division Sign-Off) |
| Division of Cardiovascular Devices |
| age 1 of | 1 |
|---|---|
| 510(k) Number | K061958 |
Page 1 of_____________________________________________________________________________________________________________________________________________________________________
4
1061958
510(k) Summary
| Submitter: | Medtronic Vascular
37A Cherry Hill Drive
Danvers, MA 01923
USA | SEP - 5 2006 |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact Person: | Karen A. Brozowski
Regulatory Affairs Manager
978.739.4143
978.777.0390
Karen.a.brozowski@medtronic.com | |
| Date Prepared: | July 7, 2006 | |
| Trade Name: | Medtronic® Export® XT Catheter | |
| Common Name: | Percutaneous Catheter | |
| Classification
Name: | Percutaneous Catheter | |
| Predicate Device: | Export Aspiration Catheter (K040869) | |
| Device
Description: | The Medtronic Export XT Catheter is a dual lumen catheter
used for the aspiration of thrombus and/or debris from a
vascular site. The Medtronic Export XT Catheter may also be
used for the infusion of diagnostic or therapeutic agents to a
desired vascular site. | |
| Statement of
Intended Use: | The Medtronic Export XT Catheter is indicated for:
Removal/aspiration of embolic material thrombus/debris)
from vessels of the arterial system, and to subselectively
infuse/deliver diagnostics or therapeutics agents with or
without vessel occlusion. | |
| Summary of
Technological
Characteristics: | • Distal Dual Lumen: Small lumen provides conduit for
delivery over a 0.014" guidewire, or equivalent, and large
lumen provides conduit for aspiration of embolic material.
• Radiopaque Markerband: Embedded in the distal tip to
facilitate placement by fluoroscopy
• External Coating: Provides lubricious external surface for
ease of delivery through the vasculature.
• Wire Braided Shaft: Provides a balance of stiffness and
compliance for delivery of the catheter to the intended | |
5
therapy site.
- Luer Hub: Provides a connection fitting to mate the shaft with the aspiration line.
- · Strain Relief: Provides a stiffness transition between the shaft and the rigid hub to reduce likelihood of shaft kink.
Technological Characteristics (continued):
Summary of
Summary of Nonclinical Data:
The proposed Medtronic Export® XT Catheter has successfully passed all design verification and validation testing.