Export Advance Aspiration Catheter

K152335 · Medtronic, Inc. · DXE · Sep 18, 2015 · Cardiovascular

Device Facts

• Record ID: K152335
• Device Name: Export Advance Aspiration Catheter
• Applicant: Medtronic, Inc.
• Product Code: DXE · Cardiovascular
• Decision Date: Sep 18, 2015
• Decision: SESE
• Submission Type: Special
• 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. Device features include removable stylet, luer hub, strain relief, inner liner, braid wire, proximal/distal shafts, soft tip, marker band, and hydrophilic coating. Used in clinical settings by physicians; device is navigated to target vascular site. Aspiration removes embolic material; infusion delivers agents. Benefits include effective thrombus removal and targeted drug delivery. Modification from predicate involves dual-lumen (micro-lumen) section design change.

Clinical Evidence

No clinical investigation has been performed on the subject device. Substantial equivalence is supported by bench testing (design verification) and existing biocompatibility data from the predicate device.

Technological Characteristics

Dual-lumen catheter; features include removable stylet, luer hub, strain relief, inner liner, braid wire, proximal/distal shafts, soft tip, marker band, and hydrophilic lubricous coating. Microlumen sleeve material: Aesno MED Nylon 12 (AV100). Biocompatibility evaluated per ISO 10993-1:2009/AC: 2010.

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 vascular intervention.

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® Advance Aspiration Catheter (K130536)

Submission Summary (Full Text)

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

Medtronic Vascular Colleen Mullins Principal Regulatory Affairs Specialist 37A Cherry Hill Drive Danvers, MA 01923-5186

Re: K152335

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: Aug 17, 2015 Received: Aug 19, 2015

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, listing 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 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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 Industry and Consumer Education 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. Hillebrenner

for

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: K152335

### 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)

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# Special 510(k) Summary

| Submitter: | Medtronic Vascular<br>37A Cherry Hill Drive<br>Danvers, MA 01923-5186 |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Colleen Mullins<br>Principal 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: | August 17th, 2015 |
| 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: | K130536 - Medtronic Vascular<br>Export® Advance Aspiration 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>change to the dual lumen section (micro-lumen section) |
| 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<br>conducted in accordance with the recommendations<br>presented from the relevant FDA guidance to<br>demonstrate that the subject device Export Advance™<br>Aspiration Catheter has met the acceptance criteria and<br>performance similar to the predicate device.<br><br>Design Verification Testing: Given that the only<br>difference between the modified design for the subject<br>device and the commercially available design of the<br>predicate device is the dual lumen section, only<br>attributes impacted by the design modification were<br>tested. The design verification (bench) testing was<br>performed based upon the subject device performance<br>specifications. The tests performed for bench testing<br>included:<br>1. Profile Dimensions (Major & Minor Profile)<br>2. Microlumen Tear<br>3. 2D Track and Lesion Cross |
| | Biocompatibility Testing (GLP): The materials,<br>packaging and configuration of the subject device is<br>not changing as a result of the dual lumen design<br>change. The microlumen sleeve material is changing<br>from Pebax 4033 to Aesno MED Nylon 12(AV100)<br>This material is already in use on the Export Advance |
| | and cuff extension. Based on this information there is<br>no requirement for additional biocompatibility testing.<br>Existing biocompatibility data previously performed on<br>the subject device will apply to the proposed device. |
| | Pursuant to the ISO 10993-1:2009/AC: 2010-<br>Biological evaluation of medical devices - Part 1:<br>Evaluation and testing within a risk management<br>process; and 21 CFR 58 -Good Laboratory Practice<br>for Nonclinical Laboratory Studies; Medtronic<br>Vascular has concluded full biocompatibility testing on<br>the predicate device. |
| | 1. Cytotoxicity<br>2. In vitro Hemolysis<br>3. Systemic Toxicity<br>4. Sensitization<br>5. C3a Complement Activation<br>6. Sc5b9 Complement Activation<br>7. ISO Intracutaneous Reactivity<br>8. USP Material Mediated Pyrogen Study<br>9. In vivo Thromboresistance |
| | No new safety or effectiveness issues were raised<br>during the testing. The bench testing qualification and<br>biocompatibility testing demonstrated that the subject<br>device Export Advance™ Aspiration Catheter is<br>substantially equivalent to the predicate device. |
| Summary of Clinical<br>Data: | No clinical investigation has been performed on the<br>subject device Export Advance™ Aspiration 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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within the proximal outer jacket component, distal cuff,