the removal/aspiration of embolic material (thrombus/debris) from vessels of the arterial system.
the removal/aspiration of thrombus from clotted synthetic dialysis grafts and arterio-venous fistulas.

Device Description

The Pronto Short 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 syringes, guidewire, and extension line with 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 vessels or synthetic grafts and to 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 an approximate outer diameter of 0.078 inches, allowing delivery through standard 6Fr introducer sheath. The catheter is an over the wire design. The smaller (wire) lumen of the catheter is able to accommodate guide wires that are ≤0.018" in diameter. The catheter will be available in working lengths of 40 to 65 cm. The proximal end of the catheter incorporates a y-junction luce adapter to facilitate the attachment of the catheter to the included extension line, stopcock, and two syringes. A 74 um filter basket and a 0.018"/80cm straight guidewire (not identified in the schematic below) are included for assistance in the thrombus removal procedure. The filter basket can be used to filter the blood removed during the procedure for laboratory analysis of thrombus. The straight guidewire will be provided packaged and sterile from Galt Medical (K021990). The Pronto Short is provided sterile and is intended for single use only.

AI/ML Overview

This document is a 510(k) premarket notification for the Vascular Solutions Pronto™ Short Extraction Catheter. It outlines the device's description, intended use, and a summary of non-clinical testing. Crucially, it states that no clinical evaluations of this product have been conducted. Therefore, it is not possible to describe acceptance criteria or a study that proves the device meets those criteria from the provided text.

Based on the available information:

No acceptance criteria are explicitly stated in terms of performance metrics. The submission relies on demonstrating substantial equivalence to predicate devices through non-clinical testing.
No study proving the device meets acceptance criteria is documented. The document explicitly states "No clinical evaluations of this product have been conducted."

The document focuses on demonstrating substantial equivalence to legally marketed predicate devices through non-clinical testing, rather than presenting a study against specific performance-based acceptance criteria for this particular device.

Here's a breakdown of the requested information based on the provided text, highlighting what is not available:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as quantifiable performance metrics for the device. The "acceptance" is based on demonstrating substantial equivalence through design verification and biocompatibility.
- Reported Device Performance: The document only states that "The results of this battery of tests confirmed the suitability of the Pronto Short Extraction Catheter for its intended use." No specific performance data (e.g., aspiration flow rates, clot removal efficiency percentages) from these non-clinical tests are provided.
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size: Not specified for the non-clinical testing.
- Data Provenance: Not specified for the non-clinical testing. It's safe to assume it's laboratory-based testing conducted by the manufacturer.
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):
- Not applicable. The "test set" in this context refers to non-clinical design verification and biocompatibility assessments, not a clinical study requiring expert ground truth establishment.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. As above, this pertains to non-clinical testing, not a clinical study requiring adjudication.
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:
- No. The document explicitly states "No clinical evaluations of this product have been conducted." Furthermore, this device is a physical catheter, not an AI-assisted diagnostic tool, so an MRMC study related to AI would be irrelevant.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical instrument, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. For non-clinical testing, ground truth would relate to engineering specifications, material properties, and biological safety standards, not clinical ground truth.
The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/machine learning device.
How the ground truth for the training set was established:
- Not applicable. There is no "training set."

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. Sara Coon Senior Regulatory Affairs Associate 6464 Sycamore Court Minneapolis, Minnesota 55369

Re: K051193

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

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 August 8, 2005. Specifically, FDA is updating this SE 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. Digitally signed by Gregory W. O'connell -S O'connell -S Date: 2021.10.08

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 8 - 2005

Vascular Solutions, Inc. c/o Ms. Sara L. Coon Senior Regulatory Affairs Associate Vascular Solutions, Inc. 6464 Sycamore Court Minneapolis, MN 55369

K051193 Re: Trade Name: Pronto Short Embolectomy Catheter Regulation Number: 21CFR §870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: II (two) Product Code: DXE Dated: May 6, 2005 Received: May 10, 2005

Dear Ms. Coon;

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 310(c) per ce is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regally manat date of the Medical Device Amendments, or to commerce prior to May 20, 1776, the encordance with the provisions of the Federal Food, Drug. devices that have been reclassined in access approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Ac and Cosmetic Act (Act) that do not request to the general controls provisions of the Act. The You may, therefore, market the device, belge of the Act include reguirements for annual registration, listing of general controls provisions of ractice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class II (PMA), it II your device is classified (Sec abore) als. Existing major regulations affecting your device can
onay be subject to such additional controls. Existing major may be subject to such additional controlior "Entrologically to 898. In addition, FDA may oc found in the Oous neements concerning your device in the Federal Register.

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Page 2 - Ms. Sara 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 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,

Bram D. Zuckerman, M.D.

Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

ﺎﻡ

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Indications for Use Statement

510(k) Number: K051193

Device Name: Vascular Solutions Pronto™ Short Extraction Catheter

Indications for Usc: The Pronto™ Short Extraction Catheter is indicated for:

. . . . . . .
the removal/aspiration of embolic material (thrombus/debris) from vessels of . the arterial system.
the removal/aspiration of thrombus from clotted synthetic dialysis grafts and . arterio-venous fistulas.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

ﺘﺸﻨﻴﻨﻴﺎﺕ ﺳﻴ

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bhimimon

Cardlovascular Devices

Page 1 of /

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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

Common/Usual Name:	Embolectomy Catheter
Product Trade Name:	PRONTO™ Short Extraction Catheter
Classification Name:	UnclassifiedProduct Code, DXE
Manufacturer:	Vascular Solutions, Inc.6464 Sycamore CourtMinneapolis, Minnesota 55369
Establishment Registration:	2134812
Contact:	Sara L. CoonSenior Regulatory Affairs Associate(763) 656-4300 phone(763) 656-4250 fax
Performance Standards:	No performance standards have been developed undersection 514 for this device.

Device Description:

Intended Use:

The Pronto™ Short Extraction Catheter is indicated for the removal/aspiration of embolic material (thrombus/debris) from vessels of the arterial system and the removal/aspiration of thrombus from clotted synthetic dialysis grafts and arterio-venous fistulas.

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Summary of Non-Clinical Testing:

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

KOS1193 0.20f2

Summary of Clinical Testing:

No clinical evaluations of this product have been conducted.

Predicate Devices:

The Pronto Short Extraction Catheter is similar in intended use to the Cordis 7Fr Hydrolyser Thrombectomy Catheter, the XTD Thrombectomy Catheter, the Medtronic Export Aspiration Catheter, and the Vascular Solutions, Inc. Pronto Extraction Catheter.

Conclusions:

The Pronto Short Extraction Catheter is substantially equivalent to Cordis 7Fr Hydrolyser Thrombectomy Catheter, the XTD Thrombectomy Catheter, the Medtronic Export Aspiration Catheter, and the Vascular Solutions, Inc. Pronto Extraction Catheter. The testing performed confirms that the Pronto Short Extraction Catheter will perform as intended.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/6/Picture/2 description: The image is a seal for the U.S. Department of Health and Human Services. The seal is circular and contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a caduceus, which is a symbol of medicine.

AUG 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 Vascular Solutions, Inc. 6464 Sycamore Court Minneapolis, MN 55369

K051193 Re:

Trade Name: Pronto Short Embolectomy Catheter Regulation Number: 21CFR §870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: II (two) Product Code: DXE Dated: May 6, 2005 Received: May 10, 2005

Dear Ms. Coon;

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed in 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 conimer 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 he 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 - Ms. Sara Coon

Sincerely yours,

B.Zuckerman, M.D.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use Statement

KOS 1193 510(k) Number:

Vascular Solutions Pronto™ Short Extraction Catheter Device Name:

Indications for Use: The Pronto™ Short Extraction Catheter is indicated for:

the removal/aspiration of embolic material (thrombus/debris) from vessels of . the arterial system.
the removal/aspiration of thrombus from clotted synthetic dialysis grafts and . arterio-venous fistulas.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

سقت ت ت برعد برعد

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bhimmanon

1 Skelal lon of Cardlovascul ar Devices STOIkt Number

Page 1 of __

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).