MODIFICATION TO VASCULAR SOLUTIONS PRONTO EXTRACTION CATHETER

K042937 · Vascular Solutions, Inc. · QEZ · Jan 31, 2005 · Cardiovascular

Device Facts

• Record ID: K042937
• Device Name: MODIFICATION TO VASCULAR SOLUTIONS PRONTO EXTRACTION CATHETER
• Applicant: Vascular Solutions, Inc.
• Product Code: QEZ · Cardiovascular
• Decision Date: Jan 31, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Pronto Extraction Catheter is a dual-lumen, monorail-design catheter used for aspiration and removal of emboli/thrombi from arterial vessels. Device features a rounded distal tip with a sloped extraction lumen opening, radiopaque marker for fluoroscopic visualization, and shaft markers for positioning relative to guide catheters. Operated by physicians in clinical settings; requires standard 6Fr guide catheter and ≤ 0.014" guidewire. Aspiration is performed manually using an included syringe, extension line, and stopcock. Includes a 74-micron filter basket for collecting aspirated material for laboratory analysis. Facilitates thrombus removal to restore blood flow.

Clinical Evidence

No clinical evaluations were conducted for this device; substantial equivalence is supported by non-clinical bench testing.

Technological Characteristics

Dual-lumen, monorail catheter; 0.065" outer diameter; 40-145 cm working lengths; accommodates ≤ 0.014" guidewires. Features radiopaque distal marker and shaft markers. Includes syringe, extension line, stopcock, and 74-micron filter basket. Mechanical aspiration principle.

Indications for Use

Indicated for removal of fresh, soft emboli and thrombi from arterial system 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

• Pronto Extraction Catheter (K032763)

Submission Summary (Full Text)

{0}------------------------------------------------

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. Deborah Neymark VP, RA, Clinical Research & Quality Systems 6464 Sycamore Court Minneapolis, Minnesota 55369

Re: K042937

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

Dear Deborah Neymark:

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 January 31, 2005. 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. Oconnell(@FDA.HHS.gov.

Sincerely,

Image /page/0/Picture/9 description: The image shows the name "Gregory W. O'connell -S" in a large, bold font on the left side of the image. On the right side of the image, it says "Digitally signed by Gregory W. O'connell -S" and "Date: 2021.10.08 10:30:17 -04'00'" in a smaller font. The text on the right side of the image appears to be a digital signature.

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

{1}------------------------------------------------

Image /page/1/Picture/1 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.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 3 1 2005

Ms. Deborah Neymark Vice President, Regulatory Affairs Vascular Solutions, Inc. 6464 Sycamore Court Minneapolis, MN 55369

Re: K042937

> Trade/Device Name: Pronto™ Extraction Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: II Product Code: DXE Dated: December 23, 2004 Received: January 4, 2005

Dear Ms. Neymark:

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

{2}------------------------------------------------

Page 2 – Ms. Deborah Neymark

comply with all the Act's requirements, including, but not limited to: registration and listing (21 l comply with all the Act's requirements, including, out internming ractices requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practices require CFR Part 807); labeling (21 CFK Part 801); good inamatating policable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the e forth in the quality systems (QS) regulation (21 -542 of the Act); 21 CFF 1000-1050.
product radiation control provisions (Sections 531-542 of the Action S product radiation control provisions (Sections 31 clevice as described in your Section 510(k)
This letter will allow you to begin martial sauvalene of your device to a legal This letter will allow you to begin market it your valence of your device of your device to a legally
premarket notification. The FDA finding of substantial equivales and thu premarket notification. The FDA finding of substantial equice 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
r the regulation and 10, 2019 10: Also, also, also, also, also, also, also, If you desire specific advice for your device on our naving blease not the regulation entitled, contact the Office of Compliance at (240) 2/0-0120. "Free B07.97). You may obtain
"Misbranding by reference to premarket notification" (21CFR Prom the Division of Small "Misbranding by reterence to premarket noninean (research et from the Division of Small
other general information on your responsibilities under the Act from the (800) 638-20 other general information on your respointers and toll-free number [phone] or
Manufacturers, International and Consumer Assistance at its toll-free number (index. html Manufacturers, Internet and Consumer Assistance at 10 to to to to be a Modustry/support/index.html.

Sincerely yours,

Donna R. Valiner

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

2

Enclosure

{3}------------------------------------------------

#### Indications for Use

510(k) Number (if known): _k 04-2937

Device Name: Vascular Solutions Pronto™ Extraction Catheter

Indications For Use:

The Vascular Solutions Pronto Extraction Catheter is indicated for the removal I he V ascular Soft emboli from vessels of the arterial systems.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

DONNA D. VACHER

-inn Sign-Off) f Cardiovascular Devices

Page 1 of _ 1

er 404-2931

{4}------------------------------------------------

K042937

### 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

| Common/Usual Name: | Embolectomy Catheter |
|-----------------------------|------------------------------------------------------------------------------------|
| Product Trade Name: | Pronto Extraction Catheter |
| Classification Name: | Class II<br>21 CFR 870.5150<br>Product Code, DXE |
| Manufacturer: | Vascular Solutions, Inc.<br>6464 Sycamore Court<br>Minneapolis, Minnesota 55369 |
| Establishment Registration: | 2134812 |
| Contact: | Deborah Neymark<br>Vice President, Regulatory Affairs |
| Performance Standards: | No performance standards have been developed under<br>section 514 for this device. |

#### Device Description:

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 fluotoscopic visualization. Two visible markers are located on the shaft of the catheter to provide guidance to the user concerning the relative position of the Pronto and the associated guide catheter. The catheter is a monoral design with a distal flexible region and a proximal stiff region. 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 luct 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.

### Intended Use:

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

{5}------------------------------------------------

# Summary of Non-Clinical Testing:

Summary of Non-Clinical Testing:
Non-clinical testing of this product modification included assessments of the durability of
the summer of this product modification included the marker bands and the mid-shaft bond.

# Summary of Clinical Testing:

Summary of Clinical Testing:
No clinical evaluations of this product for this use have been conducted.

## Predicate Devices:

Predicate Devices.
Currently marketed Pronto Extraction Catheter (K032763)

### Conclusions:

Conclusions:
The modified Pronto is substantially equivalent to the currently marketed Vascular Solutions Inc. Pronto Extraction Catheter.