ANGIOJET XMI CATHETER - RAPID EXCHANGE (XMI-RX)

K042874 · Possis Medical, Inc. · QEZ · Nov 5, 2004 · Cardiovascular

Device Facts

• Record ID: K042874
• Device Name: ANGIOJET XMI CATHETER - RAPID EXCHANGE (XMI-RX)
• Applicant: Possis Medical, Inc.
• Product Code: QEZ · Cardiovascular
• Decision Date: Nov 5, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AngioJet XMI Catheter - Rapid Exchange is indicated for use with the AngioJet System in breaking apart and removing thrombus from infra-inguinal peripheral arteries ≥2mm in diameter.

Device Story

The AngioJet XMI Catheter is a sterile, single-use, 135 cm, 4.0 French embolectomy catheter; used with the AngioJet System to remove thrombus from infra-inguinal peripheral arteries. Principle of operation: high-velocity saline jets directed back into the catheter create a localized low-pressure zone at the distal tip (Bernoulli effect); this generates suction to break up and remove thrombus through an exhaust lumen. The device tracks over a 0.014" guidewire through a 6 French high-flow guide catheter. Operated by physicians in a clinical setting; the device allows for contrast injection during the procedure. Benefits include mechanical thrombus removal, restoring blood flow in peripheral arteries.

Clinical Evidence

No clinical data provided; substantial equivalence is based on functional design, indications for use, principles of operation, materials, and performance characteristics.

Technological Characteristics

4.0 French, 135 cm embolectomy catheter; utilizes high-velocity saline jet for Bernoulli-effect suction; tracks over 0.014" guidewire; compatible with 6 French guide catheters (≥0.068" ID); sterile, single-use; mechanical operation.

Indications for Use

Indicated for patients requiring thrombus removal from infra-inguinal peripheral arteries ≥2mm 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

• AngioJet LF140 Catheter (K972610)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym followed by the full name of the agency on the right. The FDA acronym is in a blue square, and the full name is in blue text. The seal features an eagle with outstretched wings.

October 8, 2021

Possis Medical, Inc. Mark Stenoien Manager, Clinical & Regulatory Affairs 9055 Evergreen Blvd., N.w. Minneapolis, Minnesota 55433-8003

Re: K042874

Trade/Device Name: Angiojet XMI Catheter - Rapid Exchange (XMI-RX) Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ, KRA

Dear Mark Stenoien:

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 November 5, 2004. 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,

Digitally signed by Gregory W. Gregory W. O'connell -S O'connell -S Date: 2021.10.08
10:28:57 -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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 5 2004

Possis Medical, Inc. c/o Mr. Mark Stenoien Manager, Clinical and Regulatory Affairs 9055 Evergreen Blvd. N.W. Minneapolis, MN 55433

Re: K042874

Trade Name: AngioJet XMI Catheter and Rapid Exchange (XMI - RX) Regulation Number: 21 CFR 870.5150 and 21 CFR 870.1210 Regulation Name: Embolectomy Catheter and Continuous Flush Catheter Regulatory Class: II (two) Product Code: DXE and KRA Dated: October 15, 2004 Received: October 18, 2004

Dear Mr. Stenoien:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave revious your betermined 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.

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Page 2 - Mr. Mark Stenoien

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 or any I 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) I mis letter will and n your 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely yours,

Diana R. Kirchner

Image /page/2/Picture/5 description: The image contains a handwritten signature or symbol on the left, which appears to be a combination of curved lines and possibly a letter 'A'. To the right of the signature, there are two lines of text, with the first line being 'B' and the second line being 'I'. The text is in a simple, sans-serif font and is aligned vertically.

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

Enclosure

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## Indications for Use

510(k) Number (if known): K042874

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The AngioJet XMI Catheter - Rapid Exchange is indicated for use with the AngioJet System in breaking apart and removing thrombus from infra-inguinal peripheral arteries ≥2mm in diameter.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duana P. Vorlanis

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K0428 7 4

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K042874

510(k) Summary

| Submitter: | Possis Medical, Inc.<br>9055 Evergreen Blvd. N.W.<br>Minneapolis, MN 55433 USA |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. James Gustafson<br>Vice President, Research, Development & Engineering<br>Possis Medical, Inc.<br>9055 Evergreen Blvd. N.W.<br>Minneapolis, MN 55433 USA<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared: | August 24, 2004 |
| Trade Name: | AngioJet® XMI® Catheter – Rapid Exchange (XMI® - RX) |
| Classification | 21 CFR 870.5150 |
| Name and No. | Embolectomy Catheter –Class II |
| Product Code: | DXE |
| Predicate Device | AngioJet LF140 Catheter under K972610 on 4/11/2000. |
| Device Description: | The AngioJet XMI Catheter – Rapid Exchange is a 135 cm, 4.0 French, sterile, single-use catheter designed for removing thrombus from vascular conduits. High velocity saline jets directed back into the Catheter create a localized low-pressure zone at the distal tip (Bernoulli effect) that results in suction, break-up, and removal of thrombus through the exhaust lumen. The Catheter is designed to track over a 0.014" guidewire and through a 6 French high flow guide wire catheter (0.068 inch minimum internal diameter), which allows sufficient passage of the Catheter with adequate clearance for injection of standard contrast medical, if desired. |
| Intended Use: | The AngioJet XMI Catheter – Rapid Exchange is indicated for use with the AngioJet System in breaking apart and removing thrombus from infra-inguinal peripheral arteries ≥2mm in diameter. |
| Statement of<br>Technological<br>Comparison | The subject device have the following similarities:<br>• The same indication for use;<br>• The same operating principle;<br>• The same basic design;<br>• The same manufacturing environment;<br>• The same sterilization process; and<br>• The same packaging configurations.<br>In summary, the AngioJet XMI Catheter – Rapid Exchange, as described in this submission is, in the opinion of Possis Medical Inc., substantially equivalent to the predicate device. |
| Conclusion: | The AngioJet XMI Catheter – Rapid Exchange as modified in this submission, is substantially equivalent to the predicate device, the LF140 Catheter K972610. This conclusion is based upon the similarities of the devices in terms of functional design, indication for use, principles of operation, materials, and performance characteristics. |

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