EXPORT ADVANCE ASPIRATION CATHETER

K130536 · Medtronic, Inc. · QEZ · Jul 16, 2013 · Cardiovascular

Device Facts

• Record ID: K130536
• Device Name: EXPORT ADVANCE ASPIRATION CATHETER
• Applicant: Medtronic, Inc.
• Product Code: QEZ · Cardiovascular
• Decision Date: Jul 16, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Export Advance™ Aspiration Catheter is indicated for: • 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

Export Advance Aspiration Catheter is a dual-lumen catheter designed for aspiration of thrombus/debris from vascular sites and infusion of diagnostic/therapeutic agents. Operated by physicians in clinical settings, the device features a removable preloaded stylet to enhance deliverability and kink resistance. It functions as a mechanical tool for vascular intervention; the physician navigates the catheter to the target site, performs aspiration or infusion, and monitors the procedure via standard imaging. The device provides improved aspiration rates and trackability compared to its predecessor, potentially reducing procedure time and improving clinical outcomes in embolectomy or infusion procedures.

Clinical Evidence

No clinical investigation has been performed on the subject device. Substantial equivalence is supported by bench testing (design verification) and non-GLP in vivo studies. Bench testing included 23 performance metrics (e.g., profile dimensions, tensile strength, vacuum integrity, evacuation flow rate, particulate generation, and stiffness). Biocompatibility testing was conducted per ISO 10993-1:2009/AC:2010, including cytotoxicity, hemolysis, systemic toxicity, sensitization, complement activation, intracutaneous reactivity, pyrogenicity, and thromboresistance.

Technological Characteristics

Dual-lumen catheter featuring a removable stylet, luer hub, strain relief, inner liner, braid wire, proximal/distal shafts, soft tip, microlumen, marker band, and hydrophilic lubricous coating. Operates as a mechanical aspiration/infusion device. No energy source or software components.

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 in patients requiring such interventions.

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

• Export® AP Catheter (K120808)

Submission Summary (Full Text)

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July 27, 2020

Medtronic Inc. Colleen Mullins Principle Regulatory Affairs Specialist 37a Cherry Hill Drive Danvers, Massachusetts 01923

Re: K130536

Trade/Device Name: Export Advance Aspiration Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ, KRA

Dear Colleen Mullins:

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 July 16, 2013. 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], [e-mail].

Sincerely,

Gregory W. O'connell -S

Digitally signed by Gregory W. )'connell -S Date: 2020.07.27 08:04:14

Gregory O'Connell Assistant Director Plaque Modification Devices Team 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 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 16, 2013

Medtronic Inc. C/O Colleen Mullins 37a Cherry Hill Drive Danvers, MA 01923 US

Re: K130536

> Trade/Device Name: Export Advance™ Aspiration Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: June 5, 2013 Received: June 6, 2013

Dear Ms. Mullins:

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

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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); 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

M.A. Hillebrand

for

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 Export Advance™ Aspiration Catheter

## Indications for Use:

The Export Advance™ Aspiration Catheter is indicated for:

- -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)

M.A. Hillebrand

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## K130536 Traditional 510(k) Summary

JUL 1 6 2013

| Submitter: | Medtronic Vascular<br>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 Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared: | May 20, 2013 |
| Trade Name: | Export Advance™ Aspiration Catheter |
| Common Name: | Percutaneous Catheter |
| Classification Name: | Embolectomy Catheter<br>Class II per 21 CFR 870.5150, Product Code DXE |
| Predicate Devices: | K120808 - Medtronic Vascular<br>Export® AP Catheter. |
| Device<br>Description: | The Export Advance™ Aspiration Catheter is a dual<br>lumen catheter used for the aspiration of thrombus<br>and/or debris from a vascular site. The Export<br>Advance™ may also be used for the infusion of<br>diagnostic or therapeutic agents to a desired vascular<br>site. |
| Statement of Intended<br>Use: | The Export Advance™ Aspiration Catheter is indicated<br>for:<br>• Removal/aspiration of embolic material<br>(thrombus/debris) from vessels of the arterial<br>system, and<br>• To sub selectively infuse/deliver diagnostics or<br>therapeutics agents with or without vessel<br>occlusion. |
| Comparison to the<br>predicate devices | The Export Advance™ Aspiration Catheter represents a<br>series of incremental performance improvements over<br>its predicate device Export® AP Catheter, with primary<br>attributes including, improved deliverability, improved<br>kink resistance, and improved aspiration rate; and<br>including a design feature of a removable preloaded<br>stylet. |
| Summary of<br>Technological<br>Characteristics: | The Export Advance™ includes the following features:<br>i. Removable Stylet<br>ii. Luer Hub<br>iii. Strain Relief<br>iv. Inner Liner<br>v. Braid Wire<br>vi. Proximal Shaft<br>vii. Distal Shaft (Dual Lumen/Oversleeve)<br>viii. Soft Tip<br>ix. Microlumen (wire lumen)<br>x. Distal Tip<br>xi. Marker band<br>xii. Hydrophilic lubricous coating |
| Summary of Non-clinical<br>Data: | Design verification (bench) testing qualification and<br>biocompatibility testing was conducted in accordance<br>with the recommendations presented from the relevant<br>FDA guidance to demonstrate that the subject device<br>Export Advance™ Aspiration Catheter has met the<br>acceptance criteria and performance similar to the<br>predicate device.<br><br><b>Design Verification Testing:</b> The design verification<br>(bench) testing was performed based upon the subject<br>device performance specifications. The tests performed<br>for bench testing included:<br>1. Profile Dimensions (Major & Minor Profile)<br>2. Guide Wire Lumen ID<br>3. Working Length<br>4. Proximal Shaft Tensile<br>5. Microlumen Tear<br>6. Tip Tensile<br>7. Marker Band Tensile<br>8. Hub Tensile<br>9. Stylet Hub Tensile<br>10. Vacuum Integrity |

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- 11. Pressure Integrity
- 12. Air Aspiration
- 13. Proximal Shaft Crush
- 14. Proximal Shaft Buckle
- 15. Evacuation Flow Rate
- 16. Particle Retrieval
- 17. 2D Track and Lesion Cross
- 18. Lubricity & Durability
- 19. Proximal Shaft Stiffness Room Temp
- 20. Proximal Shaft Stiffness Body Temp
- 21. Torque Strength
- 22. Distal Kink
- 23. Particulate Generation

## Pre-clinical Study (Non-GLP):

Medtronic Vascular conducted pre-clinical in vivo (non-GLP) studies for design evaluation on Export Advance. These in vivo studies results provided confirmatory evidence that the Export Advance design is suitable to meet the incremental performance attributes as compared with its predicate device. Export AP Catheter, and related comparative evaluations to support the substantial equivalence.

Biocompatibility Testing (GLP): Pursuant to the ISO

10993-1:2009/AC: 2010- Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process; and 21 CFR 58 -Good Laboratory Practice for Nonclinical Laboratory Studies; Medtronic Vascular has concluded full biocompatibility testing on the subject device.

- 1. Cytotoxicity
- 2. In vitro Hemolysis
- 3. Systemic Toxicity
- 4. Sensitization
- 5. C3a Complement Activation
- 6. Sc5b9 Complement Activation
- 7. ISO Intracutaneous Reactivity
- 8. USP Material Mediated Pyrogen Study
- 9. In vivo Thromboresistance

No new safety or effectiveness issues were raised during the testing. The bench testing qualification and biocompatibility testing demonstrated that the subject device Export Advance™ Aspiration Catheter is safe, effective, and substantially equivalent to the predicate device.

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| Summary of Clinical | No clinical investigation has been performed on the |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Data: | subject device Export Advance™ catheter. |
| Conclusion from Data: | Medtronic Vascular has demonstrated that the subject<br>device Export Advance™ Aspiration Catheter is<br>substantially equivalent to the predicate device. |

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