POSSIS ANGIOJET RAPID THOMBECTOMY CATHETERS--F105 CATHETER MODEL 3030C, LF140 CATHETER MODEL 3040C

K972610 · Possis Medical, Inc. · QEZ · Apr 11, 2000 · Cardiovascular

Device Facts

• Record ID: K972610
• Device Name: POSSIS ANGIOJET RAPID THOMBECTOMY CATHETERS--F105 CATHETER MODEL 3030C, LF140 CATHETER MODEL 3040C
• Applicant: Possis Medical, Inc.
• Product Code: QEZ · Cardiovascular
• Decision Date: Apr 11, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AngioJet System, with the Catheter, is intended for breaking apart and removing thrombotic obstructions from infra-inguinal peripheral arteries ≥ 2.0 mm in diameter.

Device Story

AngioJet Rapid Thrombectomy Catheter is a single-use device used with a pump set and drive unit to perform mechanical thrombectomy. The catheter is introduced percutaneously and advanced over a guidewire to the target lesion. Operation involves delivering a high-velocity saline jet through orifices at the catheter's distal tip. This creates a localized low-pressure zone via the Bernoulli/venturi effect, which entrains, macerates, and disassociates thrombus. The same jets provide dynamic pressure to drive debris through an exhaust lumen and out of the body. Used by physicians in clinical settings, the device allows for rapid removal of thrombotic obstructions. It benefits patients by providing an alternative to standard intra-arterial infusion of urokinase, demonstrating higher thrombus removal effectiveness, lower rates of distal embolization, and improved clinical outcomes including higher amputation-free survival and primary patency.

Clinical Evidence

Clinical evidence based on a prospective non-randomized cohort study comparing AngioJet treatment for peripheral arterial thrombus to literature-reported outcomes for standard intra-arterial urokinase infusion. AngioJet demonstrated higher effectiveness in complete thrombus removal and lower rates of distal embolization requiring intervention. At six and twelve-month follow-up, the AngioJet group showed fewer deaths, higher amputation-free survival, and higher primary patency compared to the urokinase group. No evidence suggested increased frequency or severity of procedure-related complications (dissection/perforation) with AngioJet.

Technological Characteristics

Constructed of steel and plastic materials. Employs a rheolytic (high-velocity saline jet) principle to create a venturi effect for thrombus maceration and evacuation. Dual-lumen catheter design: one lumen for high-pressure saline delivery via stainless steel hypodermic tubing, one for debris evacuation. Sterile, single-use, Class II device. Compatible with a multi-use drive unit and pump set. Dimensions are within the range of predicate embolectomy catheters.

Indications for Use

Indicated for patients with thrombotic obstructions in infra-inguinal peripheral arteries ≥ 2.0 mm in diameter.

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

• Fogarty Arterial Embolectomy Catheter (Pre-1976 device)
• Applied Vascular Arterial Embolectomy Catheter (K901627)
• Possis AngioJet Rapid Thrombectomy Catheters (K960970)

Submission Summary (Full Text)

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October 8, 2021

Possis Medical, Inc. James Gustafson V.P. Of Quality Systems And Reg./clinical Affairs 9055 Evergreen Blvd., N.w. Minneapolis, Minnesota 55433-8003

Re: K972610

Trade/Device Name: AngioJet Rapid Thrombectomy Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ, KRA

Dear James Gustafson:

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 April 11, 2000. 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, [phone], Gregory.Oconnell(@FDA.HHS.gov.

Sincerely,

Gregory W. Digitally signed by Gregory W. O'connell -S O'connell -S Date: 2021.10.08
10:39:45-04'00'

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 1 2000

Mr. James D. Gustafson Possis Medical, Inc. 9055 Evergreen Boulevard NW Minneapolis, MN 55433

K972610 Re: AngioJet® LF140 Rheolytic Thrombectomy Regulatory Class: II (two) Product Code: DXE Dated: February 28, 2000 February 29, 2000 Received:

Dear Mr. Gustafson:

We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. James D. Gustafson

Electronic Product Radiation Control provisions, or other Federal laws or This letter will allow you to begin marketing your device requlations. as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

sincerely yours,

Chistopher M. Ashton

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# ANGIOJET® LF140 CATHETER INDICATION FOR USE STATEMENT

## FEBRUARY 2000

The AngioJet System, with the Catheter, is intended for breaking apart and removing thrombotic obstructions from infra-inguinal peripheral arteries ≥ 2.0 mm in diameter.

Christopher Ah for Dillard

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K972610

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APR 1 1 2000

K972610

## POSSIS ANGIOJET RAPID THROMBECTOMY SYSTEM 510(K) SUMMARY

### SUBMITTER INFORMATION

ANCIOJET e o l y t i c " t h r o m b e c t o m y s y s t e m

| SUBMITTER NAME | Possis Medical, Inc. (PMI) |
|----------------|-------------------------------------------------------------------------------------------------------|
| ADDRESS | 9055 Evergreen Boulevard NW<br>Minneapolis, MN 55433 |
| PHONE NUMBER | [phone] |
| FAX NUMBER | [phone] |
| CONTACT | Primary<br>James D. Gustafson<br>Vice President of Quality Systems<br>and Regulatory/Clinical Affairs |
| | Alternate<br>Timothy J. Kappers<br>Supervisor, Regulatory Affairs & Compliance |
| SUMMARY DATE | February 28, 2000 |

DEVICE NAMES

| TRADE NAME | Possis AngioJet Rapid Thrombectomy Catheter:<br>LF140 Catheter, Model 3040C |
|---------------------|-----------------------------------------------------------------------------|
| COMMON NAME | Embolectomy / Thrombectomy Catheter |
| CLASSIFICATION NAME | Embolectomy Catheter (21 CFR 870.5150) |

LEGALLY MARKETED
PREDICATE DEVICES

| | Fogarty Arterial Embolectomy Catheter<br>Baxter Healthcare Corp., Edwards U.S. Division<br>(Pre-1976 device)<br>Applied Vascular Arterial Embolectomy Catheter<br>Applied Vascular Devices, Inc.<br>K901627<br>Possis AngioJet Rapid Thrombectomy Catheters<br>Possis Medical, Inc.<br>K960970 |
|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

Summary - 1 Possis Medical, Inc. 9055 Evergreen Boulevard NW, Minneapolis, MN 55433-8003 phone: [phone] fax: [phone] toll free: 800.810.7677

Image /page/4/Picture/6 description: The image contains a logo for Possis Medical Inc. The logo features a stylized letter "M" inside a square on the left. To the right of the square is the text "POSSIS" in bold, sans-serif font, with "MEDICAL INC" written in a smaller font size below it.

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#### DEVICE DESCRIPTION:

The AngioJet Rheolytic Thrombectomy System consists of a single-use Catheter, single-use Pump Set, and multi-use Drive Unit. The same Drive Unit and Pump Set are compatible with various Catheters with different design features.

The Catheter tracks and operates over a guide wire and is introduced through a guide catheter. It may be operated only in conjunction with the Pump Set and Drive Unit. Catheter components include a manifold, shaft, and tip segments. The manifold contains connections for the high pressure saline supply and effluent removal lines on the Pump Set, and a hemostasis valve for sealing around the guide wire. The Catheter shaft is dual lumen: one lumen provides high pressure saline delivered to the Catheter tip through a stainless steel hypodermic tube; the other larger lumen is used for evacuation of thrombotic debris and for guide wire passage. The Catheter tip is a stainless steel sub-assembly through which the stainless steel hypodermic tubing extends and terminates distally in a closed loop. The loop contains proximally directed jet orifices aimed at the evacuation lumen entrance.

Thrombectomy is accomplished with the introduction of a pressurized saline jet stream through the directed orifices in the Catheter distal tip. The jets generate a localized low pressure zone via the Bernoulli effect, which entrains and macerates thrombus. The same jets also provide the dynamic pressure to drive thrombotic debris down the exhaust lumen of the Catheter and out of the body for disposal.

#### INTENDED USE:

The AngioJet System, with the Catheter, is intended for breaking apart and removing thrombotic obstructions from infra-inguinal peripheral arteries ≥ 2.0 mm in diameter.

#### SUMMARY OF TECHNOLOGICAL CHARACTERISTICS

The AngioJet LF140 Catheter is the subject of the present 510(k) and is identical to the Catheter model cleared under K960970. The AngioJet Catheter and Fogarty-type embolectomy / thrombectomy catheters share the following characteristics: both are Catheter mediated methods for mechanical thrombectomy. The diameter of the AngioJet Catheter is within the range of diameters available for the predicate device. Both the AngioJet Catheter and the predicate devices are constructed of steel and plastic materials, and are sterile, one time use class II medical devices.

The only technology difference between the AngioJet Catheter and the predicate devices is in the method that each uses to achieve mechanical thrombectomy. The Fogarty-type catheters use mechanical dislodgment and isolation to achieve thrombectomy. Using surgical introduction, the Fogarty-type device is advanced through the target lesion proximal to distal. The balloon at the distal tip is inflated with a suitable medium and the Catheter is dragged out of the vessel. The inflated

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balloon is occlusive inside the vessel lumen so the thrombus is dislodged and removed from the body through the access site.

By comparison, the AngioJet Drive Unit and Pump Set deliver a high-velocity stream of sterile saline through the hypotube to the distal tip of the Catheter. The saline exits the Catheter through holes which direct the stream of saline past a small open space and into the mouth of the exhaust lumen of the Catheter. These high-velocity saline jets create a venturi effect which produces a local area of very low pressure around the Catheter tip, which attracts thrombus into the region of high velocity jets, which in turn disassociate the thrombus into small particles and propel the debris down the effluent lumen of Catheter and out of the patient's body. The AngioJet Catheter is introduced percutaneously and advanced over a guidewire to the target lesion. The Catheter may be operated in the target vessel proximal to distal or distal to proximal.

#### SUMMARY OF CLINICAL RESULTS

The AngioJet LF140 Catheter has already been proven safe and effective in the treatment of patients with coronary thrombus. For peripheral arterial thrombus, an analysis was performed comparing clinical results from a prospective non-randomized cohort of patients treated with AngioJet for peripheral arterial thrombus to clinical results reported in the literature for a similar group of patients treated with standard intra-arterial infusion of urokinase.

AngioJet treatment resulted in a higher reported effectiveness for its primary function of thrombus removal (complete thrombus removal not requiring additional intervention to treat thrombus). A lower percentage of patients using AngioJet reported distal embolization events requiring additional thrombectomy aspiration or local thrombolytic intervention. Any dissection or vessel perforation that occurred in the AngioJet group was minor, without clinical sequelae.

The AngioJet study group also had dramatically fewer deaths (less than 50% of that reported for the urokinase group), higher amputation-free survival, and higher primary patency than the urokinase group, at both six and twelve month follow-up.

The analysis concluded that there was no evidence to suggest that either the frequency or severity of procedure-related complications were higher with use of AngioJet than with urokinase, and that one-year follow-up data suggests no increased risk of death, amputation, or loss of patency due to AngioJet treatment over that seen in patients treated with urokinase.

The results from this comparison are sufficient evidence to support an expansion of the indication for use of the AngioJet LF140 Catheter to include the treatment of thrombus in peripheral arteries and arterial conduits.