(60 days)
Not Found
No
The device description and intended use focus on the mechanical function of a catheter for aspiration and infusion, with no mention of AI or ML capabilities.
Yes
The device is indicated for the removal/aspiration of embolic material, which is a therapeutic intervention, and also for subselective infusion/delivery of therapeutic agents.
No
The intended use of the Export Aspiration Catheter is for removal/aspiration of embolic material and to infuse/deliver diagnostic or therapeutic agents. While it can deliver diagnostic agents, its primary function is not to diagnose. It does not perform any diagnostic measurements or analysis.
No
The device description clearly describes a physical catheter, syringe, and aspiration line, which are hardware components.
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. They are used outside of the body (in vitro) to provide information about a person's health.
- Device Function: The Export Aspiration Catheter is a device used within the body (in vivo) to physically remove material from blood vessels or deliver substances directly into them. It is an interventional device, not a diagnostic test performed on a sample.
- Intended Use: The intended use clearly describes procedures performed directly on the patient's arterial system.
- Device Description: The description details the physical components of a catheter designed for insertion into the body.
Therefore, the Export Aspiration Catheter falls under the category of a medical device used for treatment and intervention within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Export Aspiration Catheter is indicated for:
- Removal/aspiration of embolic material (thrombus/debris) from vessels of the arterial system, and
- To subselectively infuse/deliver diagnostic or therapeutic agents with or without vessel occlusion.
Product codes
QEZ, KRA, DXE
Device Description
The Export Catheter is a dual lumen catheter for use with the GuardWire Temporary Occlusion and Aspiration System. The main (continuous) lumen of the catheter is the aspiration/infusion lumen while the smaller of the lumens is the guidewire lumen. The size of the wire lumen is sized so that the Export catheter may run over a 0.14inch wire smoothly. Also, the wire lumen is designed as a single operator lumen, as such it is only present on a small section of the distal end of the catheter. The larger sized lumen is the aspiration lumen. An aspiration syringe is provided, as is an aspiration line. These are attached to the proximal end of the Export to facilitate blood and debris being evacuated from the site into the syringe.
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 Export Catheter has been subjected to performance testing and it has been determined that the Export Catheter is suitable for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Medtronic Export Catheter (K030201), Vascular Solutions Pronto Extraction Catheter (K032763)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 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 acronym followed by the full name of the agency, "U.S. Food & Drug Administration," on the right. The FDA part of the logo is in blue, with the acronym in a solid blue square and the agency's name in a lighter shade of blue.
October 8, 2021
Medtronic Vascular Fred Boucher Director, Regulatory Affairs 37a Cherry Hill Dr. Danvers, Massachusetts 01923
Re: K040869
Trade/Device Name: Export Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ, KRA
Dear Fred Boucher:
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 1, 2004. 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 -O'connell -S Date: 2021.10.08 10:25:04 -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/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three wing-like shapes forming a profile of a human face. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 1 2004
Medtronic, Inc. c/o Mr. Fred L. Boucher Director, Regulatory Affairs 37A Cherry Hill Drive Danvers, MA 01923
K040869 Re: Export Aspiration Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: DXE Dated: April 1, 2004 Received: April 2, 2004
Dear Mr. Boucher:
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 - Mr. Fred L. Boucher
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualles or a substite complies with other requirements of the Act
that FDA has made a determination that your device complies - You must that FDA has made a decemmation and regulations administered by other Federal statusion and light or any Federal statutes and regulations daminities, but not limited to: registration and listing (21 comply with all the Act s requirements, more and manufacturing practice requirements as set CFR Part 807); labeling (21 CFR Part 800); good manat 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Sections of I device as described in your Section 510(k)
This letter will allow you to begin marketing your device as described in Jega I his letter will anow you to begin maneting of substantial equivalence of your device to a legally premarket notification. The PDA iniding of substantalized one 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 If you desire specific advice for your ac (301) 594-4648. Also, please note the regulation entitled, Contact the Office of Comphance at (501) 317 - 121 807.97). You may obtain "Misbranding by reference to premantonibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
(501)445-05W.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Dana D. Lechner
J Bram D. Zuckerman, M.D.
Director
Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
3
Indications for Use
510(k) Number (if known): K040869
Device Name: Export Aspiration Catheter
Indications For Use:
The Export Aspiration Catheter is indicated for:
- Removal/aspiration of embolic material (thrombus/debris) from vessels of � the arterial system, and
- To subselectively infuse/deliver diagnostic 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. Sohner
Division Sign-Off) vision of Cardiovascular Devices
× Number K 04 086 9
Page 1 of __ 1 __
4
JUN - 1 2004
Section 7 Summary of Safety and Effectiveness
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Pursuant to Section 12, Safe Medical Devices Act of 1990)
| 1. Identifying Information: | |
|---|---|
| 1.1. Submitters Name: | Medtronic Vascular, Inc. 37A Cherry Hill Drive Danvers, MA 01923 |
| 1.2. Contact Person: | Fred L. Boucher R.A.C. (978) 777-0042 |
| 2. Classification Name: | Embolectomy Catheter (21 CFR Part 870.5150) |
| 3. Proprietary Name: | Export Catheter |
| 4. Name of Predicate Devices: | Medtronic Export Catheter (K030201) Vascular Solutions Pronto Extraction Catheter (K032763) |
ഗ് Description:
The Export Catheter is a dual lumen catheter for use with the GuardWire Temporary Occlusion and Aspiration System. The main (continuous) lumen of the catheter is the aspiration/infusion lumen while the smaller of the lumens is the guidewire lumen. The size of the wire lumen is sized so that the Export catheter may run over a 0.14inch wire smoothly. Also, the wire lumen is designed as a single operator lumen, as such it is only present on a small section of the distal end of the catheter. The larger sized lumen is the aspiration lumen. An aspiration syringe is provided, as is an aspiration line. These are attached to the proximal end of the Export to facilitate blood and debris being evacuated from the site into the syringe.
5
Intended-Use: 6.
The Export Catheter is designed as an aspiration catheter. The Export Catheter has substantially equivalent indications for use as the legally marketed predicate devices. The indication for use of the Export catheter are presented here.
The Export Aspiration Catheter is indicated for:
- · Removal/aspiration of embolic material (thrombus/debris) from vessels of the arterial system, and
- · To subselectively infuse/deliver diagnostic or therapeutic agents with or without vessel occlusion.
7. Technology:
The Export Catheter is manufactured in the same manner, using the same processes and materials, as the Export Catheter, a legally marketed predicate device. In addition to being technologically equivalent to the predicate devices, the Export Catheter has been subjected to performance testing and it has been determined that the Export Catheter is suitable for its intended use.