(105 days)
Not Found
No
The device description focuses on mechanical components and functionality for thrombus extraction, with no mention of AI or ML.
Yes
The device is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system, which is a therapeutic intervention.
No
The device is indicated for the "removal of fresh, soft emboli and thrombi," which is a treatment action, not a diagnostic one. While it does mention a filter for "visual or laboratory analysis," this is a secondary function related to the removed material, not the primary intended use of diagnosing a condition.
No
The device description clearly outlines a physical catheter with associated hardware components (syringe, tubing, filter basket) and mentions physical characteristics like working length, diameter, and coating. It is a hardware device used for physical extraction.
Based on the provided information, the QuickCat™ Extraction Catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the removal of emboli and thrombi from vessels in the arterial system. This is a therapeutic procedure performed in vivo (within the body).
- Device Description: The description details a catheter designed for physical extraction of material from the body. While a filter basket is supplied for potential analysis, the primary function of the device itself is not to perform a diagnostic test on a sample in vitro (outside the body).
- Lack of Diagnostic Function: There is no mention of the device performing any kind of test, analysis, or measurement on a biological sample to provide diagnostic information.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic purposes. The QuickCat™ Extraction Catheter's function is to physically remove material from the body, not to diagnose a condition based on analyzing a sample.
N/A
Intended Use / Indications for Use
The QuickCat™ Extraction Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.
Product codes
QEZ, DXE
Device Description
The QuickCat™ Extraction Catheter is a single use, disposable, dual lumen catheter with associated accessories consisting of a 30 ml. vacuum syringe, extension tubing with stopcock, and an independent 40-micron filter basket. The 145 cm working length and is compatible with 6F guiding catheters with an inner diameter (I.D.) > 0.068" (1.73 mm) and 0.014" (0.36 mm) diameter guidewires. The extraction lumen of the catheter facilitates removal of emboli and thrombi via the attached tubing assembly, stopcock and vacuum syringe. The atraumatic distal tip, which incorporates a radiopaque marker for visibility under fluoroscopy, provides for smooth passage in the arterial system. The catheter consists of three segments. The stiffer proximal segment and more flexible distal segments provide the required structural integrity and flexibility to navigate tortuous vasculature. The distal segment consists of a dual lumen to allow for "rapid exchange" attachment to the guidewire. The catheter's distal portion has a hydrophilic coating to enhance deliverability. A 40-micron pore filter basket is supplied to assist in filtering of blood and thrombotic material for visual or laboratory analysis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels in the arterial system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
Non-clinical verification has been verified through in-vitro bench testing and biocompatibility testing. Results of this testing indicate that the QuickCat design meets all specifications and intended use.
Key Metrics
Not Found
Predicate Device(s)
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 20, 2021
Kensey Nash Corp. Robin M. Fatzinger Regulatory Affairs Specialist 735 Pennsylvania Drive Exton, Pennsylvania 19341
Re: K073519
Trade/Device Name: QuickCat Extraction Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ
Dear Robin M. Fatzinger:
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 28, 2008. Specifically, FDA is updating this SE Letter as an administrative correction 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 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
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a bird or a human figure with outstretched arms, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 8 2008
Kensey Nash Corp. c/o Ms. Robin M. Fatzinger, RAC Vice President of Clinical and Regulatory Affairs 735 Pennsylvania Drive Exton, PA 19341
Re: K073519
Quickcat Extraction Catheter, Model 60090-01 Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II (two) Product Code: DXE Dated: March 3, 2008 Received: March 4, 2008
Dear Ms. Fatzinger:
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. Robin M. Fatzinger, RAC
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
R. Zukerman, M
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
K 073519
510(k) Number (if known):
Device Name:
QuickCat™ Extraction Catheter
Indications for Use:
The OuickCat™ Extraction Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.
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)
Ochmbe
510(k) Numbe
4
510(k) Summary
MAR 2 8 2008
510(k) Number: K073519
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR $807.92.
| Submitted By: | Kensey Nash Corporation
735 Pennsylvania Drive
Exton, PA 19341 USA |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Cindy R. Varughese, RAC
Regulatory Affairs Specialist
Tel: (484) 713-2100
Fax: (484) 713-2903
E-mail: Cindy.Varughese@kenseynash.com |
| Trade Name: | QuickCat™ Extraction Catheter |
| Common Name: | Embolectomy Catheter |
| Classification Name: | Embolectomy Catheter (21 CFR Section 870.5150) |
| Regulatory Class: | Class II |
| Device Product Code: | DXE |
| Predicate Device: | Kensey Nash Corporation's QuickCat™ Extraction Catheter
(K060092) |
| Date Prepared: | December 12, 2007 |
Description of Device:
The QuickCat™ Extraction Catheter is a single use, disposable, dual lumen catheter with associated accessories consisting of a 30 ml. vacuum syringe, extension tubing with stopcock, and an independent 40-micron filter basket. The 145 cm working length and is compatible with 6F guiding catheters with an inner diameter (I.D.) > 0.068" (1.73 mm) and 0.014" (0.36 mm) diameter guidewires. The extraction lumen of the catheter facilitates removal of emboli and thrombi via the attached tubing assembly, stopcock and vacuum syringe. The atraumatic distal tip, which incorporates a radiopaque marker for visibility under fluoroscopy, provides for smooth passage in the arterial system. The catheter consists of three segments. The stiffer proximal segment and more flexible distal segments provide the required structural integrity and flexibility to navigate tortuous vasculature. The distal segment consists of a dual lumen to allow for "rapid exchange" attachment to the guidewire. The catheter's distal portion has a hydrophilic coating to enhance deliverability. A 40-micron pore filter basket is supplied to assist in filtering of blood and thrombotic material for visual or laboratory analysis.
Intended Use:
The QuickCat™ Extraction Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.
Substantial Equivalence:
QuickCat is substantially equivalent to the predicate device with regard to intended use, principles of operation, and technological characteristics.
5
Non-Clinical Summary:
Non-clinical verification has been verified through in-vitro bench testing and biocompatibility testing. Results of this testing indicate that the QuickCat design meets all specifications and intended use.