(121 days)
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.
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.
This document is a 510(k) summary for the Pronto™ .035" Extraction Catheter. It describes the device, its intended use, and a summary of non-clinical and clinical testing.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. Instead, it describes a series of "Device Verification Testing" performed to support equivalency to predicate devices. The performance is generally stated as "met all specified design and performance requirements."
Here's a breakdown based on the provided text:
| Acceptance Criteria (Inferred from Test Name) | Reported Device Performance |
|---|---|
| Catheter tortuosity | Met specified design and performance requirements |
| Catheter curve retention | Met specified design and performance requirements |
| Catheter bond strength (Hub & proximal shaft) | Met specified design and performance requirements |
| Catheter bond strength (Proximal to mid-shaft) | Met specified design and performance requirements |
| Catheter bond strength (Mid to distal shaft) | Met specified design and performance requirements |
| Catheter bond strength (Distal shaft to distal tip) | Met specified design and performance requirements |
| Catheter leakage under pressure | Met specified design and performance requirements |
| Extension tubing to male luer strength | Met specified design and performance requirements |
| Extension tubing to female luer strength | Met specified design and performance requirements |
| Thrombus extraction | Met specified design and performance requirements |
| Extraction rate testing | Met specified design and performance requirements |
| Aspiration testing (with extension tube) | Met specified design and performance requirements |
| Saline injection test | Met specified design and performance requirements |
| Contrast injection test | Met specified design and performance requirements |
| Silicone visual inspection | Met specified design and performance requirements |
| Packaging stylet removal force | Met specified design and performance requirements |
| Guidewire passage | Met specified design and performance requirements |
| Introducer passage | Met specified design and performance requirements |
| Biocompatibility (ISO 10993) | Demonstrated to be biocompatible |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for each individual performance test within the "Device Verification Testing." It only generally states that testing was performed. The provenance of the data is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective. Given the nature of a 510(k) submission for a medical device aiming for substantial equivalence, these tests are typically conducted in a laboratory setting by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable as the provided document describes non-clinical performance testing for a medical device (catheter), not a diagnostic or AI-based device that would require expert-established ground truth. The tests are mechanical and functional in nature.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable for the same reasons as point 3. Adjudication methods are typically used in clinical studies or studies involving human interpretation or subjective assessment, which is not the case for the described "Device Verification Testing."
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no MRMC comparative effectiveness study mentioned. This document pertains to the market clearance of a physical medical device (catheter), not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a physical catheter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "Device Verification Testing," the "ground truth" refers to pre-defined engineering specifications, material standards, and functional requirements for a medical device. For example, for "catheter bond strength," the ground truth would be a minimum acceptable force value. For "biocompatibility," the ground truth is adherence to ISO 10993 standards. It's not a ground truth derived from expert consensus, pathology, or outcomes data as seen in diagnostic studies.
8. The sample size for the training set
This section is not applicable. The document describes a physical medical device, not a machine learning model, therefore there is no training set.
9. How the ground truth for the training set was established
This section is not applicable for the same reasons as point 8.
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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
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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.
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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
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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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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)
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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
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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.
§ 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).