PRONTO LOW PROFILE (LP) EXTRACTION CATHETER, MODEL 5010

K072810 · Vascular Solutions, Inc. · QEZ · Dec 19, 2007 · Cardiovascular

Device Facts

• Record ID: K072810
• Device Name: PRONTO LOW PROFILE (LP) EXTRACTION CATHETER, MODEL 5010
• Applicant: Vascular Solutions, Inc.
• Product Code: QEZ · Cardiovascular
• Decision Date: Dec 19, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Pronto LP extraction catheter is a dual-lumen device designed for removal of fresh, soft emboli and thrombi from coronary and peripheral vessels. Device features a rounded distal tip with a sloped extraction lumen opening, a radiopaque marker for fluoroscopic visualization, and a rapid exchange design. Distal segment includes a hydrophilic coating for lubricity. Device incorporates a Y-adapter with an aspiration port and a self-sealing port with a pre-loaded stylet; stylet reinforces the proximal shaft during delivery and is removed to enable thrombus aspiration. Used in clinical settings by physicians; device is delivered through a 6F guide catheter alongside a 0.014" guidewire. Aspiration of thrombus is performed by the clinician to restore blood flow, potentially benefiting patients by clearing vascular obstructions.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing (DVT) including catheter tortuosity, curve retention, bond strength, leakage, thrombus extraction, blood extraction rate, aspiration testing, stylet removal force, guidewire placement, introducer passage, kink testing, deformation, and mandrel/wire removal. Biocompatibility testing performed per ISO 10993.

Technological Characteristics

Dual-lumen embolectomy catheter; rapid exchange design; hydrophilic coating on distal segment; radiopaque marker; Y-adapter with aspiration port and removable stylet. Materials biocompatible per ISO 10993. Designed for 6F guide catheter compatibility.

Indications for Use

Indicated for removal of fresh, soft emboli and thrombi from coronary and peripheral vessels.

Regulatory Classification

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.

Predicate Devices

• Vascular Solutions Pronto V3 Extraction Catheter (K052232, K063371)
• Vascular Solutions QXT Extraction Catheter (K071727)
• Vascular Solutions Pronto Short Extraction Catheter (K051193)

Submission Summary (Full Text)

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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, [phone], Gregory. [e-mail].

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 [phone]. 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 [phone] or [phone] 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)

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

## Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

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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 [phone] telephone [phone] fax [e-mail]

## 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.

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.

### 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.

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

{8}------------------------------------------------

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 [phone]. 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 [phone] or [phone] 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.

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)**