(37 days)
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.
The EMBOL-X Intra-aortic Filter is provided in a cartridge that locks into the filter lumen of the EMBOL-X Access Device/Aortic Cannula, and is inserted through the lumen by depressing a syringe like plunger mechanism. The filter then opens to fill the diameter of the ascending aorta. The filter is intended to be inserted temporarily during CPB. Filters are manufactured in 5 sizes to conform to patient anatomy.
This document is a 510(k) summary for the Edwards Lifesciences EMBOL-X Intra-aortic Filter. A 510(k) submission is typically for demonstrating substantial equivalence to a predicate device, not for establishing new performance criteria through a standalone study.
Therefore, many of the requested details about acceptance criteria and a study proving a device meets them are not applicable to this type of submission. This document focuses on demonstrating comparability to an already legally marketed device.
Here's a breakdown of the relevant information provided:
-
A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for this device. The core "acceptance criterion" for a 510(k) is substantial equivalence to a predicate device.
- Reported Device Performance:
Characteristic Reported Performance (via comparison to predicate) Design Comparable Intended Use Comparable Materials Comparable Principle of Operation Comparable
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. This submission is based on a comparison to a predicate device, not on a new clinical or performance study that would generate a test set with a specific sample size. The "Functional/Safety Testing" section explicitly states: "Not required for this change. Safety data are not new for this change."
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. See point 2.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. See point 2.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a physical intra-aortic filter, not an AI-driven diagnostic or assistive technology.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical intra-aortic filter, not a software algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. The "ground truth" for this 510(k) is the existing understanding and performance of the predicate device.
-
The sample size for the training set:
- Not applicable. No new training set or study was conducted for this 510(k). The device relies on demonstrating equivalence to an existing product.
-
How the ground truth for the training set was established:
- Not applicable. See point 8.
Summary of the Study (Comparison to Predicate Device):
The "study" or justification presented in this 510(k) is a comparative analysis demonstrating that the EMBOL-X Intra-aortic Filter is substantially equivalent to its predicate device (also named EMBOL-X Intra-aortic Filters). This comparison is based on:
- Design
- Intended use
- Materials
- Principle of operation
The submission explicitly states: "Functional/Safety Testing: Not required for this change. Safety data are not new for this change." This indicates that no new performance or safety studies were conducted specifically for this 510(k) application. The FDA's letter confirms substantial equivalence, allowing the device to be marketed.
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Edwards Lifesciences Special 510(k) Notification EMBOL-X Intra-aortic Filter
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 Manager6864 South 300 WestMidvale, UT 84047801.565.6100 |
| Date Prepared: | August 11, 2006 |
| Trade Name: | EMBOL-X Intra-aortic Filters |
| Classification Name: | Class II, CFR 870.4260, DTMFilter, 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 cartridgethat locks into the filter lumen of the EMBOL-X AccessDevice/Aortic Cannula, and is inserted through the lumenby depressing a syringe like plunger mechanism. The filterthen opens to fill the diameter of the ascending aorta. Thefilter is intended to be inserted temporarily during CPB.Filters are manufactured in 5 sizes to conform to patientanatomy. |
| Indications for Use: | The Embol-X Intra-aortic filter is indicated for use with theEmbol-X Access Device/Aortic Cannula in first time, nonemergent cardiac surgery procedures requiring aorticcrossclamp, to capture and remove particulate emboli fromthe ascending aorta and heart in patients aged 18 yearsand older. |
| Comparative Analysis: | It has been demonstrated that the EMBOL-X Intra-AorticFilter is comparable to the predicate device in design,intended use, materials, and principle of operation. |
| Functional/Safety Testing: | Not required for this change. Safety data are not new forthis change. |
| Conclusion: | The EMBOL-X Intra-Aortic Filter is substantially equivalentto the predicate device. |
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Image /page/2/Picture/11 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three stripes forming its body and wing. The eagle faces right and is positioned to the right of the text. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular fashion around the eagle.
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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 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
Page 1 of
CONFIDENTIAL
§ 870.4260 Cardiopulmonary bypass arterial line blood filter.
(a)
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.(b)
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.”