(121 days)
Not Found
No
The summary describes a mechanical extraction catheter and its accessories, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is indicated for "The removal/aspiration of embolic material (thrombus/debris)" and "To infuse/deliver diagnostic or therapeutic agents," which are therapeutic actions.
No
The device is an extraction catheter for the removal/aspiration of embolic material, and for the infusion/delivery of diagnostic or therapeutic agents. While it can deliver diagnostic agents, its primary function is not to diagnose, but rather to perform an interventional procedure (material removal) or assist in delivering other agents. The device itself does not perform a diagnostic function.
No
The device description clearly outlines a physical catheter with lumens, a tip, a marker band, and a Y-junction, along with related accessories like a syringe, extension line, and stopcock. This is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Pronto .035" extraction catheter is a device used within the body (in the arterial and deep venous systems) to physically remove material (thrombus/debris) or deliver agents. It is an interventional device, not a diagnostic one that analyzes samples.
- Intended Use: The intended uses clearly describe procedures performed directly on the patient's vascular system.
- Device Description: The description details the physical components and how the catheter is used to interact with the blood vessels and remove material.
Therefore, the Pronto .035" extraction catheter is a medical device used for therapeutic and potentially diagnostic (infusion of diagnostic agents) purposes in vivo, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Pronto .035" 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 Pronto .035" extraction catheter is a dual lumen, over-the-wire (OTW) catheter with related accessories. The catheter is designed to be delivered through a 10F or larger introducer sheath over a 0.035" guidewire. The larger lumen allows for the removal of thrombus by use of the included syringe through the extension line and stopcock. The catheter has a rounded distal tip with a protected, extraction lumen to facilitate advancement of the catheter into the blood vessel and maximize extraction of thrombus through the extraction lumen.
The catheter has a radiopaque marker band located approximately 4mm from the distal tip. The proximal end of the catheter incorporates a hemostatic Y-junction that allows for the attachment of the catheter to the included extension line, stopcock and syringe; and can be tightened down on the guidewire to prevent blood leakage.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Arterial system, 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)
Performance Testing: Device Verification Testing was performed to support the equivalency of the Pronto .035" extraction catheter to the predicate devices. Testing included mechanical, functional, shelf life and packaging testing. DVT testing included catheter tortuosity; catheter curve retention; catheter bond strength testing: hub and proximal shaft, proximal to mid-shaft, mid to distal shaft, and distal shaft to distal tip strength; catheter leakage under pressure; extension tubing to male luer strength; extension tubing to female luer strength; thrombus extraction; extraction rate testing; aspiration testing (with extension tube); saline injection test; contrast injection test; silicone visual inspection; packaging stylet removal force; guidewire passage; and introducer passage. The Pronto .035" extraction catheter met all specified design and performance requirements.
Biocompatibility. Biocompatibility testing in accordance with ISO 10993. "Biological Evaluation of Medical Devices" was provided. The material used in the Pronto .035" extraction catheter has been demonstrated to be biocompatible.
The results of the tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its indications for use. The Pronto .035" extraction catheter uses similar technology and has similar intended uses, materials and dimensional characteristics to the predicate devices.
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.
Vascular Solutions Pronto™ Short Extraction Catheter (K051193), Lucas Medical, Inc. Thrombectomy Catheter (K970657), Edwards Lifesciences Fogarty Venous Thrombectomy Catheter (510k unknown), LeMaitre Vascular Inc. (formerly Vascutech, Inc.) LeMaitre Venous . Thrombectomy Catheter (K992934)
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 contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 15, 2021
Vascular Solutions, Inc. Patrice Stromberg Sr. Regulatory Affairs Associate 6464 Sycamore Court Minneapolis, Minnesota 55369
Re: K070403
Trade/Device Name: Pronto .035" Extraction Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ, KRA
Dear Patrice Stromberg:
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 13, 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,
Gregory W. O'connell -S Digitally signed by Gregory W. O'connell -S Date: 2021.09.15 09:26:32 -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
Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features an abstract eagle design with three stylized lines representing the eagle's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
111 3 2017
Vascular Solution, Inc. c/o Ms. Patrice Stromberg Sr. Regulatory Affairs Associate 6464 Sycamore Court Minneapolis, MN 55369
Re: K070403 ProntoTM .035" extraction catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: II (two) Product Code: DXE Dated: May 1, 2007 Received: May 24, 2007
Dear Ms. Stromberg:
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 I 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, TDA max publish further announcements concerning your device in the Federal Register.
2
Page 2 - Ms. Patrice Stromberg
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 not 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, theres as sor 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 Ivqally marketed predicate device results in a classification for your device and thus, percoits 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 (21 cr re arr an oor), pica "Misbranding by reference to premarket notification" (210) 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) 633-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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): _ K070403
Device Name: Pronto™ .035" Extraction Catheter
Indications for Use:
The Pronto .035" 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 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)
(Division Sign-Off)
Division of Cardiovascula
610(k) Number 4070403
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Pg. 1 of 3
Image /page/4/Picture/1 description: The image shows a logo for a company called "Vascula Solution". The logo features the company name in a bold, sans-serif font, with "Vascula" in a larger size than "Solution". Above the name is an abstract design composed of small squares that transition from solid black to a gradient of gray, creating a visual effect of movement or dispersion. The overall design is clean and modern, suggesting a focus on technology or innovation.
JUN 1 3 2007
510(k) SUMMARY 510(k) Number: Ko70403
Date Prepared
February 9, 2007
Submitter Information
Submitter's Name/ Address:
Vascular Solutions, Inc. 6464 Sycamore Court Minneapolis, MN 55369
Establishment Registration 2134812
Contact Person:
Patrice Stromberg Sr. Regulatory Affairs Associate (763) 656-4243 telephone (763) 656-4200 fax pstromberg@vascularsolutions.com
Device Information
Trade Name: Common Name: Classification Name: Product Code: Regulation:
Pronto™ .035" extraction catheter Embolectomy Catheter Embolectomy Catheter DXE Class II, 21 CFR 870.5150
Predicate Device(s)
- Vascular Solutions Pronto™ Short Extraction Catheter (K051193)
- Lucas Medical, Inc. Thrombectomy Catheter (K970657) ●
- Edwards Lifesciences Fogarty Venous Thrombectomy Catheter (510k unknown) ●
- LeMaitre Vascular Inc. (formerly Vascutech, Inc.) LeMaitre Venous . Thrombectomy Catheter (K992934)
5
Device Description
The Pronto .035" extraction catheter is a dual lumen, over-the-wire (OTW) catheter with related accessories. The catheter is designed to be delivered through a 10F or larger introducer sheath over a 0.035" guidewire. The larger lumen allows for the removal of thrombus by use of the included syringe through the extension line and stopcock. The catheter has a rounded distal tip with a protected, extraction lumen to facilitate advancement of the catheter into the blood vessel and maximize extraction of thrombus through the extraction lumen.
The catheter has a radiopaque marker band located approximately 4mm from the distal tip. The proximal end of the catheter incorporates a hemostatic Y-junction that allows for the attachment of the catheter to the included extension line, stopcock and syringe; and can be tightened down on the guidewire to prevent blood leakage.
Intended Use/Indications for Use
The Pronto .035" extraction catheter is indicated for:
- The removal/aspiration of embolic material (thrombus/debris) from yessels 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. .
Summary of Non-Clinical Testing
Performance Testing: Device Verification Testing was performed to support the equivalency of the Pronto .035" extraction catheter to the predicate devices. Testing included mechanical, functional, shelf life and packaging testing. DVT testing included catheter tortuosity; catheter curve retention; catheter bond strength testing: hub and proximal shaft, proximal to mid-shaft, mid to distal shaft, and distal shaft to distal tip strength; catheter leakage under pressure; extension tubing to male luer strength; extension tubing to female luer strength; thrombus extraction; extraction rate testing; aspiration testing (with extension tube); saline injection test; contrast injection test; silicone visual inspection; packaging stylet removal force; guidewire passage; and introducer passage. The Pronto .035" extraction catheter met all specified design and performance requirements.
Biocompatibility. Biocompatibility testing in accordance with ISO 10993. "Biological Evaluation of Medical Devices" was provided. The material used in the Pronto .035" extraction catheter has been demonstrated to be biocompatible.
The results of the tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its indications for use. The Pronto .035" extraction catheter uses similar technology and has
6
similar intended uses, materials and dimensional characteristics to the predicate devices.
343
Summary of Clinical Testing
No clinical evaluations of this product have been conducted.
Statement of Equivalence
Through the data and information presented, Vascular Solutions considers the Pronto .035" extraction catheter to be substantially equivalent to the Vascular Solutions Pronto™ Short Extraction Catheter, Lucas Medical. Inc. Thrombectomy Catheter, Edwards Lifesciences Fogarty Venous Thrombectorny Catheter, and LeMaitre Vascular Inc. Venous Thrombectomy Catheter. The testing performed confirms that the Pronto .035" extraction catheter will perform as intended.