(95 days)
No
The device description and performance studies focus on the mechanical properties and function of a catheter for thrombus removal. There is no mention of AI, ML, image processing, or any data-driven algorithms.
Yes
The device is designed to remove emboli and thrombi from vessels, which is a therapeutic intervention aimed at treating medical conditions.
No
The device is indicated for the removal of emboli and thrombi, which is a therapeutic function, not a diagnostic one.
No
The device description clearly details a physical catheter, syringe, extension line, and stiffening mandrel, which are all hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The QXT catheter is a physical device designed to be inserted into blood vessels to remove clots. It directly interacts with the patient's anatomy and performs a therapeutic action (removing thrombi).
- Lack of Specimen Analysis: The description does not mention the analysis of any biological specimens. The device's function is mechanical removal, not diagnostic testing of samples.
Therefore, based on the provided information, the QXT catheter is a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The QXT catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.
Product codes
QEZ, DXE
Device Description
The QXT catheter is designed to aspirate or extract soft thrombus from arterial vasculature. It has a dual-lumen design-an extraction lumen that allows for the removal of thrombus by aspiration and a rapid-exchange guidewire lumen that accommodates ≤0.014" diameter guidewires. A Y-adapter is bonded to the catheter's proximal end that facilitates the attachment of syringes and extension lines, and there is a self-sealing straight valve bonded to one port of the Y-adapter. The purpose of the straight valve is to provide a means of inserting and removing a stiffening mandrel, that is supplied with the device, while maintaining hemostasis during use. The catheter's outer diameter is a maximum of approximately 0.063" and its working length is approximately 137cm. The catheter is compatible with ≥6F guide catheters. There is a single radiopaque marker located near the distal tip, and the catheter's shaft has non-radiopaque positioning marks printed at approximately 95cm and 105cm proximal to the distal tip. Each device is supplied with a stiffening mandrel that is placed through the self-sealing straight valve, a 30mL VakLok syringe, and a 6 inch extension line that has a one-way stopcock. The QXT catheter is provided sterile and intended for single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and peripheral vasculature
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
Bench testing was conducted on the QXT catheter and included an assessment of the device's physical properties and its ability to achieve its intended use. Bench tests were conducted as part of design verification activities and after aging the devices in simulated-aging conditions.
The results of the tests confirmed the suitability of the device for its intended use. Each bench test that was conducted is listed, below.
Visual inspection
Tortuosity
Catheter Kink Resistance
Markerband visibility
Thrombus extraction
Blood extraction
Air Leak During Aspiration
Hub-to-proximal-shaft Bond Strength
Extraction Lumen (mid-shaft) Thermal Bond Strength
Extraction Lumen to Distal Tip Bond Strength
Stiffening Wire Bond Strength
Fluid Leak Under Pressure
Guidewire Interface
Guide Catheter Interface
Packaging and product inspections were conducted after the devices were subjected to simulated-distribution conditions, as follows:
Pouch Visual Appearance
Product Containment
Product Visual Appearance
Labeling Legibility
Also, device biocompatibility testing was conducted, as follows:
Cytotoxicity, 929 MEM Elution
Sensitization, Kligman Maximization
Intracutaneous Injection Test
Systemic Toxicity
Material Mediated Pyrogen Test
Prothrombin Time
In Vitro Hemocompatibility
Hemolysis
Lee & White Coagulation Assay
No QXT catheter clinical evaluations were conducted.
Key Metrics
Not Found
Predicate Device(s)
Pronto™ V3 Extraction Catheter (K052232 and K063371), Diver™ C.E. Catheter (K051917 and K050276), Export® XT Extraction Catheter (K040869 and K061059)
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 two logos. On the left is the Department of Health & Human Services logo, which features a stylized human figure. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 15, 2021
Vascular Solutions, Inc. Julie Tapper Sr. Regulatory Affairs Associate 6464 Sycamore Court Minneapolis, Minnesota 55369
Re: K071727
Trade/Device Name: QXT Extraction Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ
Dear Julie Tapper:
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 28, 2007. 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
Gregory O'Connell Assistant Director Plaque Modification Devices Team 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
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 8 2007
Vascular Solution, Inc. c/o Ms. Julie Tapper Senior Regulatory Affairs Associate 6464 Sycamore Court Minneapolis, MN 55369
K071727 Re: QXTTM Extraction Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: August 14, 2007 Received: August 15, 2007
Dear Ms. Tapper:
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. Julie Tapper
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 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 Biometric's (OSB's) 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. lohmer
A 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 Statement
510(k) Number (if known): K071727
Device Name: QXTTM Extraction Catheter
Indications for Use: The QXT catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.
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)
Duana R. Vahner
. Ision Sign-Off) nsion of Cardiovascular Devices
510(k) Number_K 071727
4
510(k) Summary As required by 21 CFR 807.92(c)
SEP 2 8 2007
510(k) Number: Ko71727
Date Prepared June 22, 2007
Submitter Information
Submitter's Name: Address:
Vascular Solutions, Inc. 6464 Sycamore Court Minneapolis, MN 55369
Contact Person:
Julie Tapper Senior Regulatory Affairs Associate
Device Information
Trade Name: QXTTM Extraction Catheter Common Name: Embolectomy catheter Class: II Classification Name: Embolectomy catheter (21CFR 870.5150, Product Code DXE)
Predicate Device(s)
Pronto™ V3 Extraction Catheter (K052232 and K063371) manufactured by Vascular Solutions, Inc.
Diver™ C.E. Catheter (K051917 and K050276) submitted by ev3.
Export® XT Extraction Catheter (K040869 and K061059) manufactured by Medtronic Vascular, Inc.
Device Description
The QXT catheter is designed to aspirate or extract soft thrombus from arterial vasculature. It has a dual-lumen design-an extraction lumen that allows for the removal of thrombus by aspiration and a rapid-exchange guidewire lumen that accommodates ≤0.014" diameter guidewires. A Y-adapter is bonded to the catheter's proximal end that facilitates the attachment of syringes and extension lines, and there is a self-sealing straight valve bonded to one port of the Y-adapter. The purpose of the straight valve is to provide a means of inserting and removing a stiffening mandrel, that is supplied with the device, while maintaining hemostasis during use. The catheter's outer diameter is a maximum of approximately 0.063" and its working
5
length is approximately 137cm. The catheter is compatible with ≥6F guide catheters. There is a single radiopaque marker located near the distal tip, and the catheter's shaft has non-radiopaque positioning marks printed at approximately 95cm and 105cm proximal to the distal tip. Each device is supplied with a stiffening mandrel that is placed through the self-sealing straight valve, a 30mL VakLok syringe, and a 6 inch extension line that has a one-way stopcock. The QXT catheter is provided sterile and intended for single use.
Intended Use/Indications for Use
The QXT catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.
Summary of Testing
Bench testing was conducted on the QXT catheter and included an assessment of the device's physical properties and its ability to achieve its intended use. Bench tests were conducted as part of design verification activities and after aging the devices in simulated-aging conditions.
The results of the tests confirmed the suitability of the device for its intended use. Each bench test that was conducted is listed, below.
| Visual inspection | Hub-to-proximal-shaft Bond Strength |
|---|---|
| Tortuosity | Extraction Lumen (mid-shaft) Thermal Bond |
| Strength | |
| Catheter Kink Resistance | Extraction Lumen to Distal Tip Bond Strength |
| Markerband visibility | Stiffening Wire Bond Strength |
| Thrombus extraction | Fluid Leak Under Pressure |
| Blood extraction | Guidewire Interface |
| Air Leak During Aspiration | Guide Catheter Interface |
Packaging and product inspections were conducted after the devices were subjected to simulated-distribution conditions, as follows:
| Pouch Visual Appearance | Product Visual Appearance |
|---|---|
| Product Containment | Labeling Legibility |
Also, device biocompatibility testing was conducted, as follows:
| Cytotoxicity, 929 MEM Elution | Prothrombin Time |
|---|---|
| Sensitization, Kligman Maximization | In Vitro Hemocompatibility |
| Intracutaneous Injection Test | Hemolysis |
| Systemic Toxicity | Lee & White Coagulation Assay |
| Material Mediated Pyrogen Test |
No QXT catheter clinical evaluations were conducted.
6
Statement of Equivalence
The QXT catheter is substantially equivalent to the currently marketed Pronto V3, Diver CE, and Export catheters, based on comparisons of the device classifications, indications for use, technological characteristics, and sterilization methods.
Conclusions
The QXT catheter is substantially equivalent to the currently marketed Pronto V3, Diver CE, and Export catheters, based on comparisons of the device classifications, indications for use, technological characteristics, and sterilization methods. Bench tests confirmed the suitability of the device for its intended use.