(22 days)
Not Found
No
The summary describes a mechanical aspiration catheter and does not mention any AI or ML components or functionalities.
Yes
The device is indicated for the "delivery of therapeutic agents," which is a therapeutic function.
No
The device is described as an aspiration catheter for removing material or for infusing agents. While it mentions the delivery of "diagnostics," it does not perform any diagnostic analysis itself; rather, it delivers substances that may be used for diagnostic purposes by other means.
No
The device description clearly states it is a "dual lumen catheter," which is a physical hardware component, not software.
Based on the provided information, the Medtronic Export® AP 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, 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 collecting, preparing, or analyzing blood, tissue, or other bodily fluids for diagnostic purposes.
Therefore, the Medtronic Export® AP Catheter is a medical device used for therapeutic and diagnostic delivery/removal within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Medtronic Export® AP Catheter is indicated for: - Removal/aspiration of embolic material (thrombus/debris) from vessels of the arterial system, and - To subselectively infuse/deliver diagnostics or therapeutic agents with or without vessel occlusion.
Product codes (comma separated list FDA assigned to the subject device)
QEZ, KRA, DXE
Device Description
The Medtronic Export® AP Aspiration Catheter is a dual lumen catheter used for aspiration of thrombus and/or debris from a vascular site. The Medtronic Export® AP 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® AP Aspiration 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.
Medtronic Export® XT Aspiration Catheter K061958
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" stacked on top of the words "U.S. FOOD & DRUG ADMINISTRATION".
May 20, 2021
Medtronic Vascular Tara Turney Regulatory Affairs Specialist 37a Cherry Hill Drive Danvers, Massachusetts 01923
Re: K081573
Trade/Device Name: Medtronic Export AP Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ, KRA
Dear Tara Turney:
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 June 27, 2008. 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,
Gregory W. Digitally signed by
Gregory W. Gregory W. O'connell -S O'connell -S Date: 2021.05.20
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
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 7 2008
Medtronic Vascular c/o Ms. Tara N. Turney Regulatory Affairs Specialist 37A Cherry Hill Drive Danvers, MA 01923-5186
Re: K081573
Trade Name: Medtronic Export® AP Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II (two) Product Code: DXE Dated: June 4, 2008 Received: June 5, 2008
Dear Ms. Turney:
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.
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
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Page 2 - Ms. Tara N. Turney
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
R. Vachner
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
K68573 510(k) Number (if known):
Device Name: Medtronic Export® AP Catheter -
Indications for Use:
The Medtronic Export® AP Catheter is indicated for:
- Removal/aspiration of embolic material (thrombus/debris) from vessels of 0 the arterial system, and
- To subselectively infuse/deliver diagnostics or therapeutic agents with or � without vessel occlusion
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
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)
Duna R. Sochmer
(Division Sign-Off) Division of Cardiovascular Devices Page 1 of
510(k) Number_K081593
Page 88
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081573
JUN 27 2008 510(k) Summary Submitter: Medtronic Vascular 37A Cherry Hill Drive Danvers, MA 01923-5186 Contact Person: Tara N. Turney Regulatory Affairs Specialist Phone: 978-739-6654 Fax: 978-777-0390 tara.n.turney@medtronic.com June 4th, 2008 Date Prepared: Trade Name: Medtronic Export® AP Aspiration Catheter Common Name: Aspiration Catheter Classification Embolectomy Catheter Name: Predicate Device: Medtronic Export® XT Aspiration Catheter K061958 Device The Medtronic Export® AP Aspiration Catheter is a dual Description: lumen catheter used for aspiration of thrombus and/or debris from a vascular site. The Medtronic Export® AP may also be used for the infusion of diagnostic or therapeutic agents to a desired vascular site. Statement of The Medtronic Export® AP Aspiration Catheter is indicated Intended Use: for: Removal/aspiration of embolic material . (thrombus/debris) from vessels of the arterial system, and . To subselectively infuse/deliver diagnostics or therapeutic agents with or without vessel occlusion. Summary of . Distal Dual Lumen: The smaller of the two lumens Technological provides a conduit for delivery over a 0.014" Characteristics: guidewire, or equivalent, and the larger lumen provides conduit for aspiration of embolic material. . Radiopaque Markerband: Embedded in the distal tip to facilitate placement by fluoroscopy.
5
- External Coating: Provides lubricious external surface . for ease of delivery. Wire Braided Shaft: Provides a balance of stiffness . and compliance for delivery of the catheter to the intended therapy site. Luer Hub: Provides a connection fitting to mate the . shaft with the aspiration line. The proposed Medtronic Export® AP Aspiration Catheter has Summary of Nonsuccessfully passed all design verification and validation clinical Data: testing. Conclusion from Medtronic has demonstrated that the Export® AP Aspiration Data: Catheter is substantially equivalent to the predicate device based upon indications for use, design, test results and fundamental scientific technology.