(79 days)
Not Found
No
The device description and performance testing focus solely on the mechanical and physical properties of the catheter for thrombus extraction. There is no mention of any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is indicated for the removal of emboli and thrombi from vessels, which is a therapeutic intervention aimed at treating medical conditions.
No
The device description and intended use clearly state that the Pronto LP extraction catheter is designed for the "removal of fresh, soft emboli and thrombi," which is a therapeutic function, not a diagnostic one.
No
The device description clearly details a physical catheter and related accessories, including materials, dimensions, and mechanical properties, indicating it 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 Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. These tests are performed outside the body.
- Device Function: The Pronto LP extraction catheter is a device used inside the body to physically remove blood clots (emboli and thrombi) from blood vessels. It is an interventional device, not a diagnostic one.
- Intended Use: The intended use clearly states "removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral system." This is a therapeutic/interventional action, not a diagnostic test.
- Device Description: The description details a catheter designed for insertion into blood vessels and aspiration of material. This aligns with an interventional device.
- Performance Studies: The performance studies focus on the physical properties and functionality of the catheter itself (tortuosity, bond strength, extraction rate, etc.), not on the accuracy or reliability of a diagnostic test.
Therefore, the Pronto LP extraction catheter is an interventional medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Pronto LP extraction catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral system.
Product codes (comma separated list FDA assigned to the subject device)
QEZ, DXE
Device Description
The Vascular Solutions Pronto™ Low Profile (LP) extraction catheter is a dual lumen catheter with related accessories. The Pronto LP will has a lower crossing profile to provide compatibility with small vessels and deliverability through a standard 0.066" (6F) guide catheter alongside an additional 0.014" guidewire.
The catheter has a rounded distal tip with a protected, sloped opening of the extraction lumen to facilitate advancement of the catheter into the blood vessel and maximize extraction of thrombus through the extraction lumen. Incorporated within the catheter distal tip is a non-blood contacting radiopaque marker for fluoroscopic visualization. The catheter has a rapid exchange design with a distal flexible region with stiffness along the shaft gradually increasing to the proximal region. The distal segment of the catheter that includes the guidewire lumen is coated with a hydrophilic coating to lubricate the catheter for ease of insertion.
The catheter also incorporates a Y-adapter with an aspiration port and a self sealing port with pre-loaded stylet. The stylet reinforces proximal shaft during delivery and is removed to allow aspiration of thrombus through the aspiration port.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels in the coronary and peripheral 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing: Device Verification Testing (DVT) was performed to support the equivalency of the Pronto LP extraction catheter to the predicate devices. DVT testing included: catheter tortuosity, catheter curve retention, catheter bond strength testing: hub, mid-shaft, and distal tip strength, catheter leakage under pressure, thrombus extraction, blood extraction rate testing, aspiration testing (with extension tube), packaging stylet removal force, 2nd guidewire placement, introducer passage, catheter kink testing, catheter deformation, mandrel/wire removal, guide catheter profile testing. The Pronto LP Extraction Catheter performance bench test results confirmed that the device performs as intended.
Biocompatibility: Biocompatibility testing in accordance with ISO 10993, "Biological Evaluation of Medical Devices" was provided. The material used in the Pronto LP extraction catheter has been demonstrated to be biocompatible.
The results of the testing provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its indications for use.
No clinical evaluations of this product have been conducted.
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™ V3 Extraction Catheter (K052232, K063371), Vascular Solutions QXT Extraction Catheter (K071727), Vascular Solutions Pronto™ Short Extraction Catheter (K051193)
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 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
Vascular Solutions, Inc. Doralie Poganski Director Regulatory Affairs 6464 Sycamore Court Minneapolis, Minnesota 55369
Re: K072810
Trade/Device Name: Pronto Low Profile (LP) Extraction Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ
Dear Doralie Poganski:
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 December 19, 2007. 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,
Digitally signed by Gregory W. Gregory W. O'connell -O'connell -S Date: 2021.05.20 09:49:28 -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/12 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines representing the branches of government. The text "U.S. DEPA" is visible at the bottom of the seal, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the top half of the seal.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 9 2007
Vascular Solutions, Inc. c/o Ms. Doralie Poganski Director Regulatory Affairs 6464 Sycamore Court Minneapolis, MN 55369
Re: K072810
Trade/Device Name: Pronto™ LP Extraction Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: November 21, 2007 Received: November 23, 2007
Dear Ms. Poganski:
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.
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
2
Page 2 - Ms. Doralie Poganski
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 Biometrics' (OSB) 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,
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): _________________
Device Name: Pronto™ LP Extraction Catheter
Indications for Use:
The Pronto LP extraction catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral system.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
ליו
(PLEASE DO NOT WRITE BELOW THIS LINE --CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Diac
4
Image /page/4/Picture/1 description: The image shows a logo for a company called "Vascular Solutions". The logo consists of two parts: an abstract graphic and the company name. The graphic is made up of a series of black squares arranged in a vertical, wave-like pattern. The company name is written in a bold, sans-serif font, with the word "Vascular" appearing on the top line and the word "Solutions" appearing on the bottom line.
DEC 1 9 7007
510(k) SUMMARY
510(k) Number: __
Date Prepared
September 28, 2007
Submitter Information
Submitter's Name/ Address:
Vascular Solutions, Inc. 6464 Sycamore Court Minneapolis, MN 55369
Establishment Registration 2134812
Contact Person:
Doralie Poganski Director, Regulatory Affairs (763) 656-4307 telephone (763) 656-4200 fax dpoganski@vascularsolutions.com
Device Information
Trade Name: Common Name: Classification Name: Product Code: Regulation:
ProntoTM Low Profile Extraction Catheter Embolectomy Catheter Embolectomy Catheter DXE Class II, 21 CFR 870.5150
Predicate Device(s)
- Vascular Solutions Pronto™ V3 Extraction Catheter (K052232, K063371) .
- Vascular Solutions QXT Extraction Catheter (K071727) .
- Vascular Solutions Pronto™ Short Extraction Catheter (K051193) .
Device Description
The Vascular Solutions Pronto™ Low Profile (LP) extraction catheter is a dual lumen catheter with related accessories. The Pronto LP will has a lower crossing
5
profile to provide compatibility with small vessels and deliverability through a standard 0.066" (6F) guide catheter alongside an additional 0.014" guidewire.
The catheter has a rounded distal tip with a protected, sloped opening of the extraction lumen to facilitate advancement of the catheter into the blood vessel and maximize extraction of thrombus through the extraction lumen. Incorporated within the catheter distal tip is a non-blood contacting radiopaque marker for fluoroscopic visualization. The catheter has a rapid exchange design with a distal flexible region with stiffness along the shaft gradually increasing to the proximal region. The distal segment of the catheter that includes the guidewire lumen is coated with a hydrophilic coating to lubricate the catheter for ease of insertion.
The catheter also incorporates a Y-adapter with an aspiration port and a self sealing port with pre-loaded stylet. The stylet reinforces proximal shaft during delivery and is removed to allow aspiration of thrombus through the aspiration port.
Intended Use/Indications for Use
The Pronto LP extraction catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral system.
Summary of Non-Clinical Testing
Performance Testing: Device Verification Testing (DVT) was performed to support the equivalency of the Pronto LP extraction catheter to the predicate devices. DVT testing included:
- catheter tortuosity ●
- catheter curve retention .
- catheter bond strength testing: hub, mid-shaft, and distal tip strength .
- catheter leakage under pressure .
- thrombus extraction .
- blood extraction rate testing ●
- . aspiration testing (with extension tube)
- packaging stylet removal force .
- 2nd guidewire placement .
- introducer passage .
- catheter kink testing .
- catheter deformation .
- mandrel/wire removal .
- guide catheter profile testing .
The Pronto LP Extraction Catheter performance bench test results confirmed that the device performs as intended.
6
Biocompatibility: Biocompatibility testing in accordance with ISO 10993, "Biological Evaluation of Medical Devices" was provided. The material used in the Pronto LP extraction catheter has been demonstrated to be biocompatible.
The results of the testing provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its indications for use.
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 LP extraction catheter to be substantially equivalent to the Vascular Solutions Pronto™ Short Extraction Catheter, Vascular Solutions Pronto™ V3 Extraction Catheter, and the Vascular Solutions Pronto™ QXT Extraction Catheter. The testing performed confirms that the Pronto LP extraction catheter will perform as intended.
7
Image /page/7/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized image of a bird, possibly an eagle, with its wings spread. The bird is composed of three curved lines that suggest feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 9 2007
Vascular Solutions, Inc. c/o Ms. Doralie Poganski Director Regulatory Affairs 6464 Sycamore Court Minneapolis. MN 55369
Re: K072810
Trade/Device Name: Pronto™ LP Extraction Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: November 21, 2007 Received: November 23, 2007
Dear Ms. Poganski:
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.
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
8
Page 2 - Ms. Doralie Poganski
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 Biometrics' (OSB) 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,
Bram D. Zuckerman, M.D.
Director
Division of Cardiovascular Devices
Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
9
Indications for Use Statement
510(k) Number (if known): _________________
Device Name: Pronto™ LP Extraction Catheter
Indications for Use:
The Pronto LP extraction catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral system.
X 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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)