(60 days)
Not Found
No
The device description and intended use focus on the mechanical function of a catheter for aspiration and infusion. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities.
Yes
The intended use statement explicitly indicates that the device can be used "to subselectively infuse/deliver diagnostic or therapeutic agents."
Yes
The "Intended Use / Indications for Use" section states: "To subselectively infuse/deliver diagnostic or therapeutic agents". This indicates that the device can be used to deliver diagnostic agents, implying a diagnostic function.
No
The device description clearly outlines a physical catheter with lumens, a guidewire lumen, an aspiration lumen, an aspiration syringe, and an aspiration line. These are all hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the removal/aspiration of material from blood vessels and the infusion/delivery of agents. This is a therapeutic or interventional procedure performed directly on the patient's body.
- Device Description: The description details a catheter designed for physical manipulation within the arterial system (aspiration, infusion, running over a guidewire). This is consistent with a medical device used for treatment or diagnosis in vivo.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body, not to directly interact with the body's internal structures for treatment or diagnosis in vivo.
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
Device Description
The Export Catheter is a dual lumen catheter for use as a general embolectomy catheter. 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 0.14-inch guidewire 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 7-French 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 (K040869)
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: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized representation of a human figure, while the FDA name on the right is written in blue, with "FDA" in a square and "U.S. FOOD & DRUG ADMINISTRATION" written in two lines.
October 8, 2021
Medtronic Vascular Fred Boucher Director, RA 37a Cherry Hill Dr. Danvers, Massachusetts 01923
Re: K050139
Trade/Device Name: Export Aspiration 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 March 22, 2005. 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(a)FDA.HHS.gov.
Sincerely,
Digitally signed by Gregory W. Gregory W. O'connell -S O'connell -S Date: 2021.10.08 10:32:56 -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/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a circular design with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized eagle or bird-like symbol, which is a common element in government seals. The overall design is simple and conveys the official nature of the department.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 2 2005
Medtronic Vascular c/o Mr. Fred L. Boucher Director, Regulatory Affairs 37A Cherry Hill Drive Danvers, MA 01923
K050139 Re: Export Aspiration Catheter Regulation Number: 21 CFR 870.5051 Regulation Name: Embolectomy Catheter Regulatory Class: Class II (two) Product Code: 74 DXE Dated: February 23, 2005 Received: February 25, 2005
Dear Mr. Boucher:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 310(x) premained instantially equivalent (for the indications referenced above and nave decemined the are are and the Madical Devices marketed in interstate for use stated in the enclosure) to regally manced promotion Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1970, the chacinone with the provisions of the Federal Food, Drug.
devices that have been reclassified in accordance with the provel annlication (PM devices that have been recuire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval or answere arcasions of the Act. The and Cosmetic Act (Act) that do not require approvate controls provisions of the Act. The Y ou may, therefore, market the device, becjoc, be use of the manual registration, listing of
general controls provisions of the Act include requirements michrending and general controls provisions of the Fect merides sand prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) mls. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation EDA may be subject to such additional controlis. Extronize - Parts 800 to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 agai be found in the Code of Pederal Regaring 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 issualice of a substantal oquirements of the Act
that FDA has made a determination that your device complies . You must that FDA has made a determination that your areas by other Federal agencies. You must or any Federal statutes and regulations administers, but not lited to: registration and listing (21 comply with all the Act s requirements, including, our not and if englise requirements as set
CFR Part 807); labeling (21 CFR Part 801); go a manufacturing practice the elect CFR Part 807); labeling (21 CFR Part 800); good manata 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Party); 11 CFR 1000 1050 forth in the quality systems (Q5) regulation (Sections 531-542 of the Act); 21 CFF 1000-1050.
product radiation control provisions (Sections 531-542 of the Action Section 5 product radiation control provisions (Sections 991 - 12 - 12 - 12 - 12 - 10 -This letter will allow you to begil marketing your artial equivalence of your device to a legally premarket notification. The PDA miding of substantial equive and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (1 CFR Part 801), please If you desire specific advice for your de not on on on one note the regulation entitled, which and contact the Office of Complance at (210 m/16cation" (21CFR Part 807.97). You may obtain " Misoranding by relected to premation in the Act from the Division of Small other general Informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International Consanhibition www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Xuna R. Winer
Image /page/2/Picture/5 description: The image contains a handwritten symbol that appears to be a combination of a circle and a stylized letter 'B'. The symbol is accompanied by the words 'Branch' and 'Directly' stacked vertically to the right of the symbol. The handwriting is simple and clear, suggesting a note or label.
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):
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) の 2007年の1000年の1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には1000年に10000000000000000000000000000000000000000
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duina R. Vachner
· )ivision Sign-Off) Avision of Cardiovascular Devices
10(k) Number K050139
Page 1 of 1_
4
MAR 2 2 2005
Section 7 Summary of Safety and Effectiveness
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS 510(R) SOMINARY - 12, Safe Medical Devices Act of 1990)
Identifying Information: 1.
| 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 (K040869) |
Description: 5.
The Export Catheter is a dual lumen catheter for use as a general embolectomy The main (continuous) lumen of the catheter is the aspiration/infusion catheter. 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 0.14-inch guidewire 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.
Intended-Use: 6.
The Export Catheter is designed as an aspiration catheter. The 7-French Export Catheter has identical indications for use as the 6-French Export Catheter, the legally marketed predicate device.
The indication for use of the Export catheter is presented here.
5
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.
Technology: 7.
The 7-French Export Catheter is manufactured in the same manner, using the same processes and materials, as the 6-French Export Catheter, a legally marketed predicate device. In addition to being technologically equivalent to the predicate devices, the 7-French Export Catheter has been subjected to performance testing and it has been determined that the Export Catheter is suitable for its intended use.