(30 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of the catheter for thrombus extraction, with no mention of AI or ML.
Yes
The device is used to remove embolic material (thrombus/debris) from vessels and to infuse/deliver therapeutic agents, both of which are therapeutic interventions.
No
The device is primarily intended for the mechanical removal/aspiration of material and for infusion/delivery of diagnostic or therapeutic agents, not for providing diagnostic information itself. While it can collect material for "laboratory analysis," the device itself does not perform the diagnosis.
No
The device description clearly details a physical catheter with various material components, dimensions, and mechanical properties, indicating it is a hardware device, not software only.
Based on the provided information, the XL extraction catheter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The primary intended use is the removal/aspiration of embolic material from blood vessels and the infusion/delivery of agents. These are direct interventions within the body (in vivo).
- Device Description: The description details a catheter designed for physical manipulation within blood vessels.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, tissue, etc.) in vitro (outside the body) to provide information for diagnostic purposes. This device's function is not to analyze a sample in vitro. While the supplied filter baskets can be used to filter blood for laboratory analysis, the catheter itself is not performing the diagnostic test.
Therefore, the XL extraction catheter is a medical device used for therapeutic and potentially diagnostic delivery purposes within the body, not an IVD device used for in vitro analysis of specimens.
N/A
Intended Use / Indications for Use
The XL extraction catheter is indicated for:
- the removal/aspiration of embolic material (thrombus/debris) from vessels of the arterial . system
- the removal/aspiration of embolic material (thrombus/debris) from vessels of the deep . venous system
- to infuse/deliver diagnostic or therapeutic agents .
Product codes (comma separated list FDA assigned to the subject device)
QEZ, KRA, DXE
Device Description
The XL extraction catheter is an over-the-wire embolectomy catheter that has a working length of 120 cm (straight tip model 5090) or 122.5 cm (pigtail tip model 5091 when tip is straightened). The device is delivered over a 0.035 inch guidewire and through a 14F or larger introducer sheath. Proximal to the tip, the catheter has an extraction lumen opening supported by nitinol and has radiopaque marker bands on each side of the opening. The catheter lumen is constructed with a PTFE liner, stainless steel braid, and various durometers of Pebax® (polyether block amide) resin loaded with barium sulfate. This construction creates a radiopaque shaft transitioning from a stiff proximal region to a more-flexible distal region. A silicone oil wipe is applied to the distal end of the catheter as a lubricant to enhance deliverability.
The proximal end of the catheter has a strain relief and hemostatic Y-junction hub. One branch of the hub is for the guidewire and the other for the attached extension line with roller clamp. The proximal end of the extension line has a custom luer fitting designed to be compatible with the custom luer tip of the supplied 60 mL vacuum-locking syringes. The supplied filter baskets can be used to filter blood aspirated during the procedure for laboratory analysis of any thrombus.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels of the arterial system, vessels of the deep venous 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 device design was qualified through the following verification/validation and biomaterial tests:
- Dimensional verifications
- Visual inspections
- Simulated anatomy/concomitant device use
- Thrombus aspiration
- Extraction rate
- Kink testing
- Torque testing
- Air aspiration
- Liquid leak and flush
- Tensile
- Radiopacity
- Biocompatibility
- Cytotoxicity
- Sensitization
- Irritation/intracutaneous reactivity
- Acute systemic toxicity
- Material-mediated pyrogens
- Hemocompatibility
- Hemolysis
- Coagulation
- Prothrombin time
- Hemotological parameters
- Complement activation
- Thrombogenicity
Results of non-clinical testing met the specified acceptance criteria, did not raise new questions of safety or effectiveness, and demonstrate that the XL extraction catheter is substantially equivalent to the predicate device.
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.
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 logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 8, 2021
Vascular Solutions, Inc. Matt Nienstedt Regulatory Product Specialist 6464 Sycamore Court North Minneapolis, Minnesota 55369
Re: K112571
Trade/Device Name: XL Extraction Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ, KRA
Dear Matt Nienstedt:
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 October 6, 2011. 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 ○'connell -S Date: 2021.02.08
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. The logo is a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of a stylized human figure with three lines extending from the head. The figure is facing to the right.
- 6 2311
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Vascular Solutions, Inc c/o Matt Nienstedt 6464 Sycamore Court Minneapolis, MN 55369
Re: KI12571
Trade/Device Name: XL Extraction Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II (two) Product Code: DXE Dated: September 2, 2011 Received: September 6, 2011
Dear Mr. Nienstedt:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
lf your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 or any Federal statutes and regulations administered by other Federal agencies. You must
2
Page 2 - Mr. Matt Nienstedt
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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 331-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/Reportal?roblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
LL
Image /page/2/Picture/7 description: The image contains a handwritten symbol on the left side, resembling a slanted 'K' or a stylized checkmark. To the right of this symbol, there are three lines of text, although the text is not clear enough to be read. The text appears to be vertically stacked, with each line possibly representing a word or a short phrase.
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: K11257 |
Device Name: XL extraction catheter
Indications for Use:
The XL extraction catheter is indicated for:
- the removal/aspiration of embolic material (thrombus/debris) from vessels of the arterial . system
- the removal/aspiration of embolic material (thrombus/debris) from vessels of the deep . venous system
- to infuse/deliver diagnostic or therapeutic agents .
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) |
|---|
| Division of Cardiovascular Devices |
| 510(k) Number | K112571 |
|---|---|
| --------------- | --------- |
XL Extraction Catheter Special 510(k) - Page 5 of 163
4
Page 1 of 3
510(k) Summarv 2
OCT - 6 2011
[As required by 21 CFR 807.92]
510(k) Number: K112571
Date Prepared: September 27, 2011
Submitter's Information / Contact Person
Manufacturer
Vascular Solutions, Inc. 6464 Sycamore Court Minneapolis, MN 55369 USA Establishment Registration # 2134812
Contact Person
Matt Nienstedt Regulatory Product Specialist Tel: 763.656.4317 (direct) Fax: 763.656.4253 Email: mnienstedt@vasc.com
Alternate Contact Person Stacy Ouellette Senior Regulatory Operations Associate Tel: 763.656.4217 (direct) Fax: 763.656.4253 Email: souellette@vasc.com
General Information
| Trade Name | XL™ extraction catheter |
|---|---|
| Common / Usual Name | extraction catheter |
| Classification Name | 21 CFR 870.5150, embolectomy catheter |
| Predicate Device | Pronto .035" extraction catheter (K070403 - Vascular Solutions, Inc.) |
Device Description
The XL extraction catheter is an over-the-wire embolectomy catheter that has a working length of 120 cm (straight tip model 5090) or 122.5 cm (pigtail tip model 5091 when tip is straightened). The device is delivered over a 0.035 inch guidewire and through a 14F or larger introducer sheath. Proximal to the tip, the catheter has an extraction lumen opening supported by nitinol and has radiopaque marker bands on each side of the opening. The catheter lumen is constructed with a PTFE liner, stainless steel braid, and various durometers of Pebax® (polyether block amide) resin loaded with barium sulfate. This construction creates a radiopaque shaft transitioning from a stiff proximal region to a more-flexible distal region. A silicone oil wipe is applied to the distal end of the catheter as a lubricant to enhance deliverability.
5
K112571 page 2 of 3
The proximal end of the catheter has a strain relief and hemostatic Y-junction hub. One branch of the hub is for the guidewire and the other for the attached extension line with roller clamp. The proximal end of the extension line has a custom luer fitting designed to be compatible with the custom luer tip of the supplied 60 mL vacuum-locking syringes. The supplied filter baskets can be used to filter blood aspirated during the procedure for laboratory analysis of any thrombus.
Intended Use / Indications
The XL extraction catheter is indicated for:
- . the removal/aspiration of embolic material (thrombus/debris) from vessels of the arterial system
- . the removal/aspiration of embolic material (thrombus/debris) from vessels of the deep venous system
- . to infuse/deliver diagnostic or therapeutic agents
Technological Characteristics
The XL extraction catheter and predicate Pronto .035" devices have the following characteristics in common:
- Catheter shaft consists of various durometers of Pebax resin reflowed together over a . stainless steel braid
- . Radiopaque marker bands
- . Lubricious silicone wipe
- . Extraction rate ≥1 mL/second
- . Sterilized by ethylene oxide
The XL extraction catheter and predicate Pronto .035" devices differ in the following:
- . Some shaft materials and construction
- . Tip configuration
- Dimensional differences .
6
K112571 page 3 of 3
Substantial Equivalence and Summary of Studies
XL extraction catheters are substantially equivalent to the predicate device based on comparisons of the device functionality, technological characteristics, and indications for use. The device design was qualified through the following verification/validation and biomaterial tests:
- Dimensional verifications .
- Visual inspections .
- Simulated anatomy/concomitant device use �
- . Thrombus aspiration
- . Extraction rate
- Kink testing .
- . Torque testing
- . Air aspiration
- . Liquid leak and flush
- Tensile .
- Radiopacity
- Biocompatibility ●
- Cytotoxicity o
- o Sensitization
- Irritation/intracutaneous reactivity 0
- Acute systemic toxicity 0
- Material-mediated pyrogens 0
- Hemocompatibility O
- Hemolysis
- Coagulation
- 트 Prothrombin time
- 트 Hemotological parameters
- D Complement activation
- 트 Thrombogenicity
Results of non-clinical testing met the specified acceptance criteria, did not raise new questions of safety or effectiveness, and demonstrate that the XL extraction catheter is substantially equivalent to the predicate device.