(42 days)
Not Found
Not Found
No
The device description focuses on mechanical components and aspiration, with no mention of AI/ML capabilities or data processing for decision-making.
Yes
Explanation: The device is indicated for the removal of fresh, soft emboli and thrombi from vessels of the arterial system, which directly addresses a medical condition (emboli and thrombi) within the body (arterial system). This falls within the definition of a therapeutic device designed to cure, mitigate, treat, or prevent disease.
No
The device is an extraction catheter designed to remove emboli and thrombi, which is a therapeutic function, not a diagnostic one. While it includes a filter for laboratory analysis of removed material, the primary indication and function described are for extraction, not for diagnosing a condition.
No
The device description clearly details a physical catheter with lumens, a distal tip, radiopaque markers, coatings, and accessories like syringes and filters. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The primary intended use is the removal of emboli and thrombi from vessels. This is a therapeutic procedure performed in vivo (within the body).
- Device Description: The device is a catheter designed for mechanical extraction. While it includes a filter basket for potential laboratory analysis of the removed material, the device itself is not performing a diagnostic test on a sample in vitro (outside the body).
- Lack of Diagnostic Function: The device does not analyze biological samples to provide information about a patient's health status, disease, or condition. It is a tool for removing material from the body.
- Focus on Procedure: The description and testing summaries focus on the performance of the catheter in the extraction procedure, not on the accuracy or reliability of a diagnostic test.
While the removed material could be used for subsequent in vitro diagnostic testing, the Pronto V3 Extraction Catheter itself is a medical device used for a therapeutic intervention.
N/A
Intended Use / Indications for Use
The Pronto V3 Extraction Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels of the arterial systems.
Product codes (comma separated list FDA assigned to the subject device)
OEZ, DXE
Device Description
The Pronto V3 extraction catheter is a dual lumen catheter with related accessories. The extraction lumen allows for the aspiration and removal of embolic material (thrombus/debris) using the included syringe, extension line and stopcock. The catheter has a rounded distal tip with a protected, sloped opening of the extraction lumen to facilitate atraumatic advancement of the catheter into the blood vessel and maximize extraction of emboli/thrombi through the extraction lumen. Incorporated within the catheter distal tip is a non-blood contacting radiopaque marker for fluoroscopic visualization. The catheter is a monorail design with a distal flexible region with stiffness along the shaft tapering to a stiff proximal region. The distal segment of the catheter is coated with a hydrophilic coating to lubricate the catheter for ease of insertion. The catheter has an approximate outer diameter of 0.065 inches, allowing delivery through standard 6Fr. guide catheters. The smaller wire lumen of the catheter is able to accommodate guide wires that are ≤ 0.014" in diameter. The catheter will be available in working lengths of 40 to 145 cm with the length changes being made in the proximal rail section. The proximal end of the catheter incorporates a standard luer adapter to facilitate the attachment of the catheter to the included extension line, stopcock, and syringe. A 74 micrometer filter basket (not identified in the schematic below) is included for assistance in filtering the blood removed during the procedure for laboratory analysis of thrombus.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels of the arterial systems
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)
Summary of Non-Clinical Testing: Testing conducted included assessments of the design verification of the Pronto V3 Extraction Catheter along with biocompatibility assessments. The results of this battery of tests confirmed the suitability of the Pronto V3 Extraction Catheter for its intended use.
Summary of Clinical Testing: 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.
The Pronto V3 Extraction Catheter is similar in intended use to the Vascular Solutions, Inc. Pronto Extraction Catheter and the Medtronic Export™ Aspiration Catheter.
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.
September 15, 2021
Vascular Solutions, Inc. Sara Coon Sr. R.A. Associate 6464 Sycamore Court Minneapolis, Minnesota 55369
Re: K052232
Trade/Device Name: Pronto V3 Extraction Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: OEZ
Dear Sara Coon:
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, 2005. 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 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 U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a bird in flight, composed of three curved lines.
Public Health Service
SEP 2 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Vascular Solutions, Inc. c/o Ms. Sara L. Coon Senior Regulatory Affairs Associate 6464 Sycamore Court Minneapolis, MN 55369
Re: K052232 Pronto V3TM Extraction Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: II Product Code: DXE Dated: August 16, 2005 Received: August 17, 2005
Dear Ms. Coon:
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. Sara L. Coon
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Duna R. Vochner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Enclosure
3
Indications For Use Statement
- K052232 - - - - - - - - - - - - - - - -510(k) Number:
Vascular Solutions Pronto V3™ Extraction Catheter Device Name:
Indications for Use:
The Pronto V3 Extraction Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels of the arterial systems.
x Prescription Use (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 IFNEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
DARINA R. lochner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number Kos 222232
Page 1 of _ | _ | _ _
4
okl. 2 8 2005
Appendix A: Summary of Safety and Effectiveness
| Common/Usual Name: | Embolectomy Catheter |
|---|---|
| Product Trade Name: | Pronto V3™ Extraction Catheter |
| Classification Name: | Unclassified |
| Product Code, DXE | |
| Manufacturer: | Vascular Solutions, Inc. |
| 6464 Sycamore Court | |
| Minneapolis, Minnesota 55369 | |
| Establishment Registration: | 2134812 |
| Contact: | Sara L. Coon |
| Senior Regulatory Affairs Associate | |
| (763) 656-4300 phone | |
| (763) 656-4250 fax | |
| Performance Standards: | No performance standards have been developed |
| under section 514 for this device. |
Device Description:
The Pronto V3 extraction catheter is a dual lumen catheter with related accessories. The extraction lumen allows for the aspiration and removal of embolic material (thrombus/debris) using the included syringe, extension line and stopcock. The catheter has a rounded distal tip with a protected, sloped opening of the extraction lumen to facilitate atraumatic advancement of the catheter into the blood vessel and maximize extraction of emboli/thrombi through the extraction lumen. Incorporated within the catheter distal tip is a non-blood contacting radiopaque marker for fluoroscopic visualization. The catheter is a monorail design with a distal flexible region with stiffness along the shaft tapering to a stiff proximal region. The distal segment of the catheter is coated with a hydrophilic coating to lubricate the catheter for ease of insertion. The catheter has an approximate outer diameter of 0.065 inches, allowing delivery through standard 6Fr. guide catheters. The smaller wire lumen of the catheter is able to accommodate guide wires that are ≤ 0.014" in diameter. The catheter will be available in working lengths of 40 to 145 cm with the length changes being made in the proximal rail section. The proximal end of the
5
catheter incorporates a standard luer adapter to facilitate the attachment of the catheter to the included extension line, stopcock, and syringe. A 74 micrometer filter basket (not identified in the schematic below) is included for assistance in filtering the blood removed during the procedure for laboratory analysis of thrombus.
Intended Use:
The Pronto V3 Extraction Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels of the arterial systems.
Summary of Non-Clinical Testing:
Testing conducted included assessments of the design verification of the Pronto V3 Extraction Catheter along with biocompatibility assessments. The results of this battery of tests confirmed the suitability of the Pronto V3 Extraction Catheter for its intended use.
Summary of Clinical Testing:
No clinical evaluations of this product have been conducted.
Predicate Devices:
The Pronto V3 Extraction Catheter is similar in intended use to the Vascular Solutions, Inc. Pronto Extraction Catheter and the Medtronic Export™ Aspiration Catheter.
Conclusions:
The Pronto V3 Extraction Catheter is substantially equivalent to the Pronto Extraction Catheter and the Export Aspiration Catheter. The testing performed confirms that the Pronto V3 Extraction Catheter will perform as intended.
6
Image /page/6/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
SEP 2 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Vascular Solutions, Inc. c/o Ms. Sara L. Coon Senior Regulatory Affairs Associate 6464 Sycamore Court Minneapolis. MN 55369
Re: K052232 Pronto V3TM Extraction Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: II Product Code: DXF Dated: August 16, 2005 Received: August 17, 2005
Dear Ms. Coon:
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.
7
Page 2 - Ms. Sara L. Coon
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincercly yours.
Duna R. Vochner
☑ Bram D. Zuckerman, M.D.
Director
Division of Cardiovascular Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
8
Indications For Use Statement
K052232 510(k) Number:
Vascular Solutions Pronto V3™ Extraction Catheter Device Name:
Indications for Use:
The Pronto V3 Extraction Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels of the arterial systems.
× Prescription Use (Part 21 CFR 801 Subpart D)
::
の 2007年の1000年の1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には1000年には1000年に10000000000000000000000000000000000000000000000000
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dauna R. Lochner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number Ko 5 2 2 3 2
Page 1 of ____________________________________________________________________________________________________________________________________________________________________