EXPORT XT CATHETER, EXPORT AP CATHETER

K120808 · Medtronic, Inc. · QEZ · Jun 7, 2012 · Cardiovascular

Device Facts

• Record ID: K120808
• Device Name: EXPORT XT CATHETER, EXPORT AP CATHETER
• Applicant: Medtronic, Inc.
• Product Code: QEZ · Cardiovascular
• Decision Date: Jun 7, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Removal/aspiration of embolic material (thrombus/debris) from vessels of the arterial system, and To sub selectively infuse/deliver diagnostics or therapeutics agents with or without vessel occlusion.

Device Story

Dual-lumen aspiration catheters designed for removal of thrombus/debris from arterial vasculature; also used for sub-selective infusion of diagnostic or therapeutic agents. Operated by physicians in clinical settings. Device features include luer hub, strain relief, inner liner, braid wire, proximal/distal shafts, and soft tip. Modification involves transition to PFOA-free PTFE resin for microlumen tubing. Device provides mechanical aspiration capability to clear arterial blockages, potentially improving patient outcomes by restoring blood flow.

Clinical Evidence

No clinical investigation performed. Substantial equivalence supported by bench testing and biocompatibility evaluation. Bench tests included shaft stiffness and microlumen wire pull-through. Biocompatibility testing included cytotoxicity, in vitro hemolysis, systemic toxicity, sensitization, complement activation (C3a, Sc5b9), intracutaneous reactivity, material-mediated pyrogenicity, and in vivo thromboresistance.

Technological Characteristics

Dual-lumen catheter; materials include PTFE (PFOA-free), braid wire, and polymer components. Features luer hub, strain relief, inner liner, and soft tip. Biocompatibility per ISO 10993-1. Non-powered, manual operation.

Indications for Use

Indicated for removal/aspiration of embolic material (thrombus/debris) from arterial vessels and sub-selective infusion/delivery of diagnostic or therapeutic agents with or without vessel occlusion.

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

• Medtronic Vascular Export XT Catheter (K061958)
• Medtronic Vascular Export AP Catheter (K081573)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 8, 2021

Medtronic Inc. c/o Anupama Gaur, Ph.D. Senior Regulatory Affairs Specialist 35-37a Cherry Hill Drive Danvers, Massachusetts 01923-5186

Re: K120808

Trade/Device Name: Medtronic Vascular Export XT Catheter, Medtronic Vascular Export AP Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ, KRA

Dear Dr. Gaur:

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 June 07, 2012. 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 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. Gregory W. O'connell -S ○'connell -S Date: 2021.02.08
08:18:32 -05'00'

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

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a caduceus, a symbol often associated with medicine and healthcare. The emblem is accompanied by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the emblem.

#### Public Health Service

JUN - 7 2012

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Medtronic Vascular c/o Anupama Gaur, Ph.D. Senior Regulatory Affairs Specialist 35-37A Cherry Hill Drive Danvers, MA 01923

Re: K120808

Trade/Device Name: Export XT and Export AP Catheters Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: May 10, 2012 Received: May 11, 2012

Dear Dr. Gaur ..

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

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

510(k) Number:

Device Name: Medtronic Vascular Export XT & Export AP Catheters

Indications for Use:

-

- Removal/aspiration of embolic material (thrombus/debris) from vessels of the arterial system, and
- To sub selectively infuse/deliver diagnostics or therapeutics agents with or without vessel occlusion.

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)

| (Division Sign-Off) |
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Division of Cardiovascular Devices
510(k) Number K120808
Page 1 of 1

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### Indications for Use

510(k) Number:

Device Name: Medtronic Vascular Export XT & Export AP Catheters

#### Indications for Use:

-

- Removal/aspiration of embolic material (thrombus/debris) from vessels of the
arterial system, and

- To sub selectively infuse/deliver diagnostics or therapeutics agents with or without vessel occlusion.
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)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K120808

Page 1 of 1

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K120808
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# 510(k) Summary

| Submitter: | Medtronic Vascular<br>35-37A Cherry Hill Drive<br>Danvers, MA 01923-5186 |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Anu Gaur<br>Senior Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone] |
| Alternate Contact | Fred Boucher<br>Director of Quality & Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared: | June 7th, 2012 |
| Trade Name: | Medtronic Vascular Export® XT Catheter<br>Medtronic Vascular Export® AP Catheter |
| Common Name: | Percutaneous Catheter |
| Classification<br>Name: | Embolectomy Catheter<br>Class II per 21 CFR 870.5150, Product Code DXE |
| Predicate Devices: | K061958 - Medtronic Vascular Export® XT Catheter<br>K081573 - Medtronic Vascular Export® AP Catheter |
| Device<br>Description: | The Export XT & Export AP Catheters are dual lumen catheters<br>used for the aspiration of thrombus and/or debris from a vascular<br>site. The Export XT & Export AP Catheters may also be used<br>for the infusion of diagnostic or therapeutic agents to a desired<br>vascular site. |
| Statement of<br>Intended Use: | Export XT & Export AP Catheters indications for use include:<br>- Removal/aspiration of embolic material (thrombus/debris)<br>from vessels of the arterial system, and<br>- To sub selectively infuse/deliver diagnostics or therapeutics<br>agents with or without vessel occlusion. |
| Comparison to the<br>predicate devices | A change in the processing aid (emulsifier) for the PTFE resin<br>used for the microlumen tubing in the distal end of the catheter.<br>The change replaces the PFOA emulsifier with a PFOA-Free<br>emulsifier. |
| Summary of<br>Technological<br>Characteristics: | The modified Medtronic Export XT & Export AP Catheters<br>involves the following features:<br>i. Luer Hub<br>ii. Strain Relief<br>iii. Inner Liner<br>iv. Braid Wire<br>v. Proximal Shaft<br>vi. Distal Shaft (Dual Lumen/Oversleeve)<br>vii. Soft Tip<br>viii. Microlumen (PTFE PFOA-Free) |
| Summary of Non-<br>clinical Data: | The bench testing qualification and the biocompatibility testing<br>for the material modification was conducted in accordance with<br>the recommendations from the relevant FDA guidance to<br>demonstrate that the proposed Export XT & Export AP<br>Catheters have met the acceptance criteria and performed<br>similarly to the predicate devices.<br>Bench Testing: The bench testing qualification was performed<br>specific to the material change. The tests performed for bench<br>testing included:<br>1. Shaft Stiffness Test.<br>2. Microlumen Wire Pull Through Test.<br>Biocompatibility Testing: Pursuant to the ISO 10993-1:2009 -<br>Biological evaluation of medical devices - Part 1: Evaluation<br>and testing within a risk management process; and 21 CFR 58 -<br>Good Laboratory Practice for Nonclinical Laboratory Studies;<br>Medtronic Vascular has concluded full biocompatibility testing<br>on the proposed device.<br>1. Cytotoxicity<br>2. In vitro Hemolysis<br>3. Systemic Toxicity<br>4. Sensitization<br>5. C3a Complement Activation<br>6. Sc5b9 Compliment Activation<br>7. ISO Intracutaneous Reactivity<br>8. USP Material Mediated Pyrogen Study<br>9. In vivo Thromboresistance<br>No new safety or effectiveness issues were raised during the |

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testing. The bench testing qualification and biocompatibility testing demonstrated that the proposed Export XT & Export AP Catheters devices are substantially equivalent to the predicate devices.

Summary of Clinical Data: No clinical investigation has been performed for these devices.

Conclusion from Data:

Medtronic Vascular has demonstrated that the proposed Export XT & Export AP Catheters are substantially equivalent to the predicate devices.