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.

AI/ML Overview

The provided document is a 510(k) premarket notification for the "Pronto™ LP Extraction Catheter". It outlines the device description, indications for use, and a summary of non-clinical testing performed to demonstrate substantial equivalence to predicate devices.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance:

The document describes "Device Verification Testing (DVT)" which includes a list of tests. While specific quantitative acceptance criteria are not explicitly stated in a table format, the general conclusion is provided.

Acceptance Criteria (Implicit)	Reported Device Performance
Catheter tortuosity performance	Device performs as intended
Catheter curve retention performance	Device performs as intended
Catheter bond strength performance (hub, mid-shaft, distal tip)	Device performs as intended
Catheter leakage under pressure performance	Device performs as intended
Thrombus extraction effectiveness	Device performs as intended
Blood extraction rate performance	Device performs as intended
Aspiration testing (with extension tube) performance	Device performs as intended
Packaging stylet removal force performance	Device performs as intended
2nd guidewire placement performance	Device performs as intended
Introducer passage performance	Device performs as intended
Catheter kink testing performance	Device performs as intended
Catheter deformation performance	Device performs as intended
Mandrel/wire removal performance	Device performs as intended
Guide catheter profile testing performance	Device performs as intended
Biocompatibility in accordance with ISO 10993	Material demonstrated to be biocompatible

2. Sample sized used for the test set and the data provenance:

Sample Size for Test Set: The document does not specify the sample size for individual tests conducted as part of the Device Verification Testing (DVT). It only lists the types of tests performed.
Data Provenance: The data provenance is described as "Non-Clinical Testing" and "Performance Testing" conducted by Vascular Solutions, Inc. This implies the data is retrospective (tests conducted on manufactured devices/components) and originates from the device manufacturer's internal testing. No specific country of origin for the data is mentioned beyond the submitter's location (Minneapolis, MN, USA).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not applicable. The "ground truth" for the non-clinical performance tests is based on objective measurements and engineering standards, not expert consensus.
Qualifications of Experts: Not applicable.

4. Adjudication method for the test set:

Adjudication Method: Not applicable. The non-clinical tests rely on direct measurements and pre-defined specifications rather than expert adjudication.

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:

MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a physical medical device (catheter) for thrombus extraction, not an AI-powered diagnostic or assistive tool. Therefore, the concept of "human readers improve with AI" is not relevant here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Standalone Performance: Not applicable. This is not an algorithm or AI device. The "standalone" performance here relates to the physical device's mechanical and functional properties. The DVT tests constitute this standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Type of Ground Truth: For the non-clinical tests, the ground truth is based on engineering specifications, physical measurements, and adherence to recognized standards (e.g., ISO 10993 for biocompatibility). For example, "catheter bond strength testing" would have a predefined acceptable range of force, and the test result either falls within that range or it does not.

8. The sample size for the training set:

Sample Size for Training Set: Not applicable. This device is not an AI/ML product; therefore, there is no "training set" in the context of machine learning.

9. How the ground truth for the training set was established:

How Ground Truth for Training Set was Established: Not applicable, as there is no training set for this device.

Summary

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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

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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

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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

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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

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K072810

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

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profile to provide compatibility with small vessels and deliverability through a standard 0.066" (6F) guide catheter alongside an additional 0.014" guidewire.

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.

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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.

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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.

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Page 2 - Ms. Doralie Poganski

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): _________________

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)

Regulation Number and Section

§ 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).