EXPORT ASPIRATION CATHETER

K023303 · Medtronic Vascular · NFA · Oct 29, 2002 · Cardiovascular

Device Facts

• Record ID: K023303
• Device Name: EXPORT ASPIRATION CATHETER
• Applicant: Medtronic Vascular
• Product Code: NFA · Cardiovascular
• Decision Date: Oct 29, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Export Aspiration Catheter is indicated for use with the GuardWire Temporary Occlusion and Aspiration System in coronary saphenous vein bypass grafts to: - · Contain and aspirate embolic material (thrombus/debris) while performing percutaneous transluminal coronary angioplasty or stenting procedures. - · To subselectively infuse/deliver diagnostic or therapeutic agents with or without vessel occlusion. - · The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid or peripheral vasculature.

Device Story

Export Aspiration Catheter is a dual-lumen catheter used with GuardWire Temporary Occlusion and Aspiration System. Main lumen provides aspiration/infusion; smaller distal lumen allows tracking over 0.14-inch guidewire. Includes 20cc aspiration syringe and line. Used by physicians in interventional cardiology during coronary procedures. Device facilitates evacuation of blood and debris from graft site into syringe; enables subselective infusion of agents. Benefits patient by reducing embolic risk during angioplasty/stenting.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design similarity to the predicate device.

Technological Characteristics

Dual-lumen catheter; aspiration/infusion lumen and single-operator guidewire lumen (distal end). Compatible with 0.14-inch guidewires. Includes 20cc aspiration syringe and line. Manufactured using same materials and processes as predicate.

Indications for Use

Indicated for patients undergoing percutaneous transluminal coronary angioplasty or stenting in coronary saphenous vein bypass grafts to contain/aspirate embolic material or deliver diagnostic/therapeutic agents. Not indicated for cerebral, carotid, or peripheral vasculature.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• GuardWire Temporary Occlusion and Aspiration System

Submission Summary (Full Text)

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001 2 9 2002

# Section 7 Summary of Safety and Effectiveness

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Pursuant to Section 12, Safe Medical Devices Act of 1990)

| | | 1. Identifying Information: | |
|----|----------------------------|-----------------------------|------------------------------------------------------------------------------------------------------------|
| | 1.1. | Submitters Name: | Medtronic AVE, Inc.<br>37A Cherry Hill Drive<br>Danvers, MA 01923 |
| | 1.2. | Contact Person: | Fred L. Boucher R.A.C.<br>[phone] |
| 2. | Classification Name: | | Device, Coronary Saphenous Vein Graft,<br>Temporary, for Embolization Protection<br>(21 CFR Part 870.1250) |
| 3. | Proprietary Name: | | Export Aspiration Catheter |
| 4. | Name of Predicate Devices: | | GuardWire Temporary Occlusion and<br>Aspiration System |

- 5. Description:
The Export Aspiration catheter is a dual lumen catheter for use with the GuardWire Temporary Occlusion and Aspiration System. The main (continuous) lumen of the catheter is the aspiration/infusion lumen while the smaller of the lumens is the guidewire lumen used to run over the GuardWire. The size of the wire lumen is sized so that the Export catheter may run over a 0.14-inch wire smoothly. Also, the wire lumen is designed as a single operator lumen, as such it is only present on a small section of the distal end of the catheter. The larger sized lumen is the aspiration lumen. A 20cc aspiration syringe is provided, as is an aspiration line. These are attached to the proximal end of the Export to facilitate blood and debris being evacuated from the site into the syringe.

- 6. Intended-Use:
The Export Aspiration Catheter was designed to be used with the GuardWire Temporary Occlusion and Aspiration System. The Export Aspiration Catheter has the same indications for use as does the GuardWire temporary Occlusion and Aspiration System.

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The Export Aspiration Catheter is indicated for use with the GuardWire Temporary Occlusion and Aspiration System in coronary saphenous vein bypass grafts to:

- · Contain and aspirate embolic material (thrombus/debris) while performing percutaneous transluminal coronary angioplasty or stenting procedures.
- · To subselectively infuse/deliver diagnostic or therapeutic agents with or without vessel occlusion.
- · The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid or peripheral vasculature.

## 7. Technology:

The Export Aspiration Catheters are manufactured in the same manner, using the same processes and materials, as the Export Aspiration Catheter that is contained in the GuardWire Temporary Occlusion and Aspiration System; the legally marketed predicate device. In addition to being technologically the same as the predicate device, the indications for use have not changed.

The Export Aspiration Catheter is substantially equivalent to the Export Aspiration Catheter contained in the GuardWire Temporary Occlusion and Aspiration System.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around an emblem. The emblem is a stylized representation of an eagle or bird-like figure, with three horizontal lines forming the body and a curved line representing the head and neck. The overall design is simple and conveys a sense of authority and professionalism.

Public Health Service

9200 Corporate Boulevard Rockville MD 20850

OCT 29 2002

Medtronic, Inc. c/o Mr. Fred L. Boucher, RAC Sr. Regulatory Affairs Manager 37A Cherry Hill Drive Danvers, MA 01923

Re: K023303

Trade Name: Export Aspiration Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Device, Coronary Saphenous Vein Graft, Temporary, for Embolization Protection Regulatory Class: Class II (two) Product Code: NFA Dated: October 2, 2002 Received: October 3, 2002

Dear Mr. Boucher:

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.

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. Fred L. Boucher, RAC

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 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) 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

J. O'Dell
B. 7-1
MD

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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age 1 of 1

### 510(k) Number: K023303

Device Name: Export Aspiration Catheter

Indications for Use:

The Export Aspiration Catheter is indicated for use with the GuardWire Temporary Occlusion and Aspiration System in coronary saphenous vein bypass grafts to:

- · Contain and aspirate embolic material (thrombus/debris) while performing percutaneous transluminal coronary angioplasty or stenting procedures.
- · To subselectively infuse/deliver diagnostic or therapeutic agents with or without vessel occlusion.
- · The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid or peripheral vasculature.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <span style="text-decoration: underline;">✓</span> |
|----------------------|----------------------------------------------------|
| (Per 21 CFR 801.109) | |

OR

| Over-The-Counter | <span style="text-decoration: underline;"></span> |
|------------------|---------------------------------------------------|
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(Optional Format(Optional Format 1-2-96)

Division of Cardiovascular & Respiratory Devices
510(k) Number K033035