ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104307

K071336 · Possis Medical, Inc. · QEZ · Aug 24, 2007 · Cardiovascular

Device Facts

• Record ID: K071336
• Device Name: ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104307
• Applicant: Possis Medical, Inc.
• Product Code: QEZ · Cardiovascular
• Decision Date: Aug 24, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AngioJet XPEEDIOR 120 Rheolytic Thrombectomy Catheter is intended for use with the AngioJet System in breaking apart and removing thrombus from: - infra-inguinal peripheral arteries ≥ 3.0 mm in diameter, - upper extremity peripheral veins > 3.0 mm in diameter and - ilcofemoral and lower extremity veins ≥ 3.0 mm in diameter.

Device Story

The XPEEDIOR Rheolytic Thrombectomy Catheter is a percutaneous device used in conjunction with the AngioJet System. It utilizes high-velocity saline jets contained within the catheter to create a localized suction effect (rheolytic principle). This mechanism breaks apart and removes thrombus from peripheral arteries and veins. The device is operated by a physician in a clinical setting. By mechanically fragmenting and aspirating thrombi, the catheter restores blood flow in the targeted vessels, potentially improving patient outcomes in cases of peripheral vascular occlusion.

Clinical Evidence

The submission relies on existing preclinical and clinical experience to support the expanded indications for use. No new clinical trials were conducted for this specific 510(k) notification.

Technological Characteristics

Percutaneous catheter utilizing high-velocity saline jets for rheolytic thrombectomy. Operates via the AngioJet System. Designed for use in vessels ≥ 3.0 mm in diameter. No changes to materials, design, or sterilization from predicate devices.

Indications for Use

Indicated for patients requiring thrombus removal from infra-inguinal peripheral arteries (≥ 3.0 mm), upper extremity peripheral veins (> 3.0 mm), and ileofemoral/lower extremity veins (≥ 3.0 mm).

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

• AngioJet XPEEDIOR Rheolytic Thrombectomy Catheter (K040013)
• AngioJet XPEEDIOR Rheolytic Thrombectomy Catheter (K052256)
• AngioJet XPEEDIOR Rheolytic Thrombectomy Catheter (K061951)

Submission Summary (Full Text)

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September 15, 2021

Possis Medical, Inc. Frank Freedman Senior Regulatory Affairs Associate 9055 Evergreen Blvd., N.w. Minneapolis, Minnesota 55433-8003

Re: K071336

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

Dear Frank Freedman:

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 24. 2007. 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: 2021.09.15
O'connell -S 10:15:22 -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

AUG 2 4 2007

Possis Medical, Inc. c/o Frank B. Freedman, Ph.D. Senior Regulatory Affairs Associate 9055 Evergreen Boulevard NW Minneapolis, MN 55433-8003

Re: K071336

XPEEDIOR™ Rheolytic Thrombectomy Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II (Two) Product Code: DXE, KRA Dated: July 18, 2007 Received: July 19, 2007

Dear Dr. Freedman:

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. Iisting 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 - Frank B. Freedman, Ph.D.

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 sct 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 Biometric's (OSB's) 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,

una R. Vochner

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

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Enclosure

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# Indications for Use

510(k) Number (if known): K071336

Device Name: XPEEDIOR™ Rheolytic Thrombectomy Catheter

Indications For Use:

The AngioJet XPEEDIOR 120 Rheolytic Thrombectomy Catheter is intended for use with the AngioJet System in breaking apart and removing thrombus from:

- infra-inguinal peripheral arteries ≥ 3.0 mm in diameter, ●
- upper extremity peripheral veins > 3.0 mm in diameter and .
- ilcofemoral and lower extremity veins ≥ 3.0 mm in diameter. .

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

Over-The-Counter Use (21 CFR 807 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)

Janna R. Vachner

(Division Sign-Off) Division - Cardiovascular Devices

510(k) Number_K031336

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#### 5. 510(k) Summary

| Submitter: | Frank B. Freedman, Ph.D.<br>Possis Medical, Inc.<br>9055 Evergreen Boulevard, N.W.<br>Coon Rapids, MN 55433<br>Phone: [phone]<br>Fax: [phone] | | AUG 24 2007 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|-------------|
| Contact Person: | Primary Contact<br>Frank B. Freedman<br>Possis Medical, Inc. | Secondary Contact<br>Mark D. Stenoien<br>Possis Medical, Inc. | |
| Device Common Name: | Thrombectomy Catheter | | |
| Device Trade Name: | XPEEDIORTM Rheolytic Thrombectomy Catheter | | |
| Device Classification Name: | Embolectomy Catheter | | |
| Predicate Devices: | AngioJet XPEEDIOR® Rheolytic™ Thrombectomy Catheter<br>(K040013, K052256 and K061951) | | |

## Device Description

When used with the AngioJet System, the XPEEDIOR Rheolytic Thrombectomy Catheter uses high velocity saline jets to percutaneously break-up and remove thrombus. These saline jets are contained within the Catheter and provide the suction that produces this effect.

#### Indications for Use

The currently cleared XPEEDIOR Catheter indications for use were expanded to include breaking apart and removing thrombus from:

- . infra-inguinal peripheral arteries > 3.0 mm in diameter,
- . upper extremity peripheral veins > 3.0 mm in diameter and
- . ileofemoral and lower extremity veins > 3.0 mm in diameter."

## Comparison to Predicate Devices

No design, packaging, sterilization or other device change was required to expand the AngioJet XPEEDIOR Rheolytic Thrombectomy Catheter indications for use (K040013, K052556 and K061951).

## Supporting Information

Applicable preclinical and clinical experience support the expanded indications for use.