(37 days)
EMBOL-X Intra-aortic Filters
Not Found
No
The summary describes a mechanical filter device and does not mention any AI or ML components or functionalities.
Yes.
The device is used to capture and remove particulate emboli from the ascending aorta and heart, which is a therapeutic intervention aimed at treating or preventing a medical condition (embolism).
No
The Embol-X Intra-aortic filter is indicated for capturing and removing particulate emboli, which is a therapeutic function, not a diagnostic one. It does not provide information about a patient's health status.
No
The device description clearly describes a physical filter and associated hardware components (cartridge, plunger mechanism) that are inserted into the body. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Embol-X Intra-aortic filter is a physical device inserted into the aorta during cardiac surgery. Its function is to mechanically capture and remove particulate emboli. It does not analyze biological samples or provide diagnostic information based on laboratory testing.
- Intended Use: The intended use clearly describes a surgical procedure and the physical removal of emboli, not a diagnostic test.
Therefore, the Embol-X Intra-aortic filter falls under the category of a medical device used in a surgical setting, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
DTM
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ascending aorta and heart
Indicated Patient Age Range
18 years and older
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
It has been demonstrated that the EMBOL-X Intra-Aortic Filter 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 for this change.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
EMBOL-X Intra-aortic Filters
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
0
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
1
510(k) Summary
| Submitter: | Edwards Lifesciences Research Medical, Inc. |
|---|---|
| Contact Person: | Karen Jones, Regulatory Affairs Manager |
| 6864 South 300 West | |
| Midvale, UT 84047 | |
| 801.565.6100 | |
| Date Prepared: | August 11, 2006 |
| Trade Name: | EMBOL-X Intra-aortic Filters |
| Classification Name: | Class II, CFR 870.4260, DTM |
| 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 |
| 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. | |
| 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. | |
| Comparative Analysis: | It has been demonstrated that the EMBOL-X Intra-Aortic |
| Filter 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 for |
| this change. | |
| Conclusion: | The EMBOL-X Intra-Aortic Filter is substantially equivalent |
| 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.
3
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
4
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