The Pronto extraction catheter is a dual lumen catheter with related accessories. The extraction lumen allows for the aspiration and removal of emboli/thrombi 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 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 and a proximal stiff region. The distal portion of the catheter is coated with Tween (Polysorbate 80); this coating is to lubricate the catheter for ease of use. The catheter has an approximate outer diameter of 0.065 inches, allowing delivery through standard 6Ft. 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, in increments of 15 cm. 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 micron filter basket is included for assistance in filtering the blood removed during the procedure for laboratory analysis of thrombus.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Vascular Solutions Pronto™ Extraction Catheter, based on the provided documents:

Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state quantitative acceptance criteria in terms of specific performance metrics or thresholds. Instead, it indicates that the device met its intended use through non-clinical testing and benchmarking against predicate devices.

Acceptance Criteria Category	Specific Criteria (Implicit from document)	Reported Device Performance
Intended Use	Removal of fresh, soft emboli and thrombi from arterial vessels.	The device performs as intended for its indicated use.
Material Biocompatibility	Biocompatible with the human body.	Biocompatibility assessments were conducted and confirmed suitability.
Design Verification	Mechanical and physical characteristics meet design specifications.	Design verification assessments were conducted and confirmed suitability.
Safety	No undue risks during use.	The device is considered substantially equivalent to predicate devices, implying similar safety profiles.
Performance	Effective in blood vessel navigation and thrombus/emboli extraction.	The catheter's design (rounded distal tip, sloped opening, coating, guide wire compatibility, and outer diameter) facilitates advancement and maximizes extraction.
Sterility	Not explicitly stated, but implied for an invasive device.	Not explicitly stated in the provided text.
Shelf Life	Not explicitly stated, but implied for a medical device.	Not explicitly stated in the provided text.

Note: The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed quantitative performance metrics against pre-defined acceptance criteria. The "reported device performance" above is inferred from the overall claim of suitability and substantial equivalence.

Study Information

Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. The document explicitly states: "No clinical evaluations of this product have been conducted."
- Data Provenance: Not applicable, as there were no clinical studies. The non-clinical testing would have been conducted in a laboratory setting by the manufacturer, Vascular Solutions, Inc. (USA).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as no clinical studies were performed requiring expert ground truth for a test set.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable, as no clinical studies were performed.
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:
- Not applicable. This device is a physical medical device (catheter), not an AI-powered diagnostic or assistive tool. No MRMC study was conducted.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical device. It does not involve an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. For the non-clinical testing, the "ground truth" would have been specifications, engineering standards, and the physical properties of materials, rather than clinical ground truth types.
The sample size for the training set:
- Not applicable, as no clinical studies or machine learning algorithms were involved.
How the ground truth for the training set was established:
- Not applicable, as no training set was used.

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.

October 8, 2021

Vascular Solutions, Inc. Gregory Sachs Director Of Regulatory Affairs 6464 Sycamore Court Minneapolis, Minnesota 55369

Re: K032763

Trade/Device Name: Vascular Solutions Pronto Extraction Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ

Dear Gregory Sachs:

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, 2003. 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: 2021.10.08 10:16:28 -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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle.

DEC 1 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Vascular Solutions, Inc. c/o Mr. Gregory Sachs Director of Regulatory Affairs 6464 Sycamore Court, Minneapolis, MN 55369

Re: K032763

Vascular Solutions ProntoTM Extraction Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: II Product Code: 74 DXE Dated: December 8, 2003 Received: December 9, 2003

Dear Mr. Sachs:

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.

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Page 2 - Mr. Gregory Sachs

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours.

Alysa D. Hervey for

Bram 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:

1632163

Device Name:

Vascular Solutions Pronto™ Extraction Catheter

Indications for Use: The Pronto™ Extraction Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.

PRESCRIPTION USE X

SDM for BDZ
12/18/03

Elisa D. Htz for Brian Zucherm
(Division Sign-off) 12/18/03

(Division sign-on
Division of Cardiovascular Devices
510(k) Number K032763(SM. K

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K032763

DEC 1 9 2003

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

Common/Usual Name:	Embolectomy Catheter
Product Trade Name:	PRONTO Extraction Catheter
Classification Name:	UnclassifiedProduct Code, DXE
Manufacturer:	Vascular Solutions, Inc.6464 Sycamore CourtMinneapolis, Minnesota 55369
Establishment Registration:	2134812
Contact:	Gregory SachsDirector of Regulatory Affairs(763) 656-4210 phone(763) 656-4253 fax
Performance Standards:	No performance standards have been developed undersection 514 for this device.

Device Description:

Intended Use:

The Pronto Extraction Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.

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Summary of Non-Clinical Testing:

Testing conducted included assessments of the design verification of the Pronto Extraction Festange with biocompatibility assessments. The results of this battery of tests confirmed the suitability of the Pronto Extraction Catheter for its intended use.

Summary of Clinical Testing:

No clinical evaluations of this product have been conducted.

Predicate Devices:

The intended use of the Pronto Extraction Catheter is similar to the intended use of the Fogarty Thru-Lumen Embolectorny Catheter, the American Biomed Embolectomy Catheter and the LeMaitre Embolectomy Catheter.

Conclusions:

The Pronto Extraction. Catheter is substantially equivalent to the Fogarty Thru-Lumen Embolectomy Catheter, the American Biomed Embolectomy Catheter and the LeMaitte Embolectomy Catheter. The testing performed confirms that the Pronto Extraction Catheter will perform as intended.

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Image /page/6/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread. The eagle is facing to the right and has three lines representing its feathers.

DEC 1 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Vascular Solutions, Inc. c/o Mr. Gregory Sachs Director of Regulatory Affairs 6464 Sycamore Court, Minneapolis, MN 55369

K032763 Re:

Vascular Solutions Pronto™ Extraction Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: II Product Code: 74 DXE Dated: December 8, 2003 Received: December 9, 2003

Dear Mr. Sachs:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becament on 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 conninered prior to ritly 20, 2014 11 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 I ou may, dicrerore, manos 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 hay be subject to such adderal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Gregory Sachs

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA's issuance or a substantin other requirements of the Act
that FDA has made a determination that your device complies. You must that FDA has made a determination macyountion administed by other Federal agencies. You must or any Federal statures and regulations administered of registration and listing (2).
comply with all the Act's requirements, including, but not ansation spaction regultement comply with all the Act s requirements, mename, comments requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice the electronic CFR Part 807); labeling (21 CFR Part 801); good if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if any 1000 1050 forth in the quality systems (QS) regulation (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) This letter will allow you to begin marketing your antial equivalence of your device to a legally premarket notification. The PDA miding of substantal vour 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 CFK Part 809.10 for miry, for questions on the promotion and advertising of Compliance at (301) 594-4580. Tidatonenty Niance at (301) 594-4639. Also, please note the your device, please comact the other of concern to premarket notification" (21CFR Part 807.97).
regulation entitled, "Misbranding by reference to premarket and secured from t Other general information on your responsibilities under the Act may be obtained from the Other general information on your responsionated 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/dsma/dsmamain.html

Sincerely yours,

Elisa D. Herry for

Bram 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:

K632763

Device Namc:

Vascular Solutions Pronto™ Extraction Catheter

Indications for Use: The Pronto™ Extraction Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.

PRESCRIPTION USE X

984 for BDZ
12/18/03

Qlisabeth Htz for Brian Zucherm

12/18/03

(Division Sign-off)
Division of Cardiovascular Devices
510(K) Number K032763(SM.K

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).