MODIFICATION TO EMBOL-X INTRA-AORTIC FILTER: X-SMALL, SMALL, MEDIUM, LARGE, X-LARGE WITH HEPARIN COATED MESH

K062429 · Edwards Lifesciences Research Medical · DTM · Sep 27, 2006 · Cardiovascular

Device Facts

• Record ID: K062429
• Device Name: MODIFICATION TO EMBOL-X INTRA-AORTIC FILTER: X-SMALL, SMALL, MEDIUM, LARGE, X-LARGE WITH HEPARIN COATED MESH
• Applicant: Edwards Lifesciences Research Medical
• Product Code: DTM · Cardiovascular
• Decision Date: Sep 27, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4260
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Embol-X Intra-aortic filter is indicated for use with the Embol-X Access Device/Aortic Cannula in first time, non emergent cardiac surgery procedures requiring aortic crossclamp, to capture and remove particulate emboli from the ascending aorta and heart in patients aged 18 years and older.

Device Story

The EMBOL-X Intra-aortic Filter is a mechanical device designed to capture and remove particulate emboli during cardiopulmonary bypass (CPB). The filter is housed in a cartridge that locks into the lumen of the EMBOL-X Access Device/Aortic Cannula. A syringe-like plunger mechanism is used to insert the filter, which then expands to fill the diameter of the ascending aorta. The device is used temporarily during cardiac surgery. By capturing emboli, the filter aims to reduce the risk of embolic events in the patient. It is operated by surgical staff in an operating room setting.

Clinical Evidence

No clinical data provided; bench testing not required for this change.

Technological Characteristics

Mechanical intra-aortic filter; cartridge-based delivery system; expands to match ascending aorta diameter; five sizes available; used with EMBOL-X Access Device/Aortic Cannula.

Indications for Use

Indicated for patients aged 18 years and older undergoing first-time, non-emergent cardiac surgery requiring aortic crossclamp.

Regulatory Classification

Identification

A cardiopulmonary bypass arterial line blood filter is a device used as part of a gas exchange (oxygenator) system to filter nonbiologic particles and emboli (blood clots or pieces of foreign material flowing in the bloodstream which will obstruct circulation by blocking a vessel) out of the blood. It is used in the arterial return line.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions.”

Predicate Devices

• EMBOL-X Intra-aortic Filters

Submission Summary (Full Text)

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Edwards Lifesciences Special 510(k) Notification EMBOL-X Intra-aortic Filter

K062429

August 18, 2006

## Addendum 1 510(k) Summary

SEP 2 7 2006

## 510 (k) Summary

CONFIDENTIAL

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## 510(k) Summary

| Submitter: | Edwards Lifesciences Research Medical, Inc. |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Karen Jones, Regulatory Affairs Manager<br>6864 South 300 West<br>Midvale, UT 84047<br>801.565.6100 |
| Date Prepared: | August 11, 2006 |
| Trade Name: | EMBOL-X Intra-aortic Filters |
| Classification Name: | Class II, CFR 870.4260, DTM<br>Filter, Blood, Cardiopulmonary Bypass, Arterial Line |
| Predicate Device(s): | EMBOL-X Intra-aortic Filters |
| Device Description: | The EMBOL-X Intra-aortic Filter is provided in a cartridge<br>that locks into the filter lumen of the EMBOL-X Access<br>Device/Aortic Cannula, and is inserted through the lumen<br>by depressing a syringe like plunger mechanism. The filter<br>then opens to fill the diameter of the ascending aorta. The<br>filter is intended to be inserted temporarily during CPB.<br>Filters are manufactured in 5 sizes to conform to patient<br>anatomy. |
| Indications for Use: | The Embol-X Intra-aortic filter is indicated for use with the<br>Embol-X Access Device/Aortic Cannula in first time, non<br>emergent cardiac surgery procedures requiring aortic<br>crossclamp, to capture and remove particulate emboli from<br>the ascending aorta and heart in patients aged 18 years<br>and older. |
| Comparative Analysis: | It has been demonstrated that the EMBOL-X Intra-Aortic<br>Filter is comparable to the predicate device in design,<br>intended use, materials, and principle of operation. |
| Functional/Safety Testing: | Not required for this change. Safety data are not new for<br>this change. |
| Conclusion: | The EMBOL-X Intra-Aortic Filter is substantially equivalent<br>to the predicate device. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 7 2006

Edwards Lifesciences Research Medical c/o Ms. Karen Jones Regulatory Affairs Manager 6864 South 300 West Midvale, UT 84047

Re: K062429

EMBOL-X Intra-aortic Filter Regulation Number: 21 CFR 870.4260 Regulation Name: Cardiopulmonary Bypass Arterial Line Blood Filter Regulatory Class: Class II (two) Product Code: DTM Dated: September 15, 2006 Received: September 18, 2006

Dear Ms. Jones:

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 - Ms. Karen Jones

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), 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/cdri/industry/support/index.html.

Sincerely yours,

Dmna R. Vochner

A 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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August 18, 2006

510(k) Number (if known): J≤ 66 2429

EMBOL-X Intra Aortic Filter Device Name:

Indications for Use:

The Embol-X Intra-aortic filter is indicated for use with the Embol-X Access Device/Aortic Cannula in first time, non emergent cardiac surgery procedures requiring aortic crossclamp, to capture and remove particulate emboli from the ascending aorta and heart in patients aged 18 years and older.

Over-The-Counter Use AND/OR Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dma R.lachner

(Division Sign-Off, Division of Cardiovascular Devices

510(k) Number_K062429

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CONFIDENTIAL