(132 days)
No
The device description and performance studies focus on mechanical filtration and do not mention any computational or data-driven components indicative of AI/ML.
Yes
The device is designed to capture and remove particulate emboli, which directly addresses a health problem (embolism) and aims to restore or improve physiological function (blood flow efficiency and prevention of further complications like stroke).
No
Explanation: The device is an intra-aortic filter designed to capture and remove particulate emboli during cardiac surgery. Its function is interventional (therapeutic/preventive), not diagnostic. It does not provide information about a patient's condition or diagnose a disease.
No
The device description clearly outlines physical components (mesh filter, frame, cartridge housing, plunger mechanism) and materials, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The EMBOL-X Intra-aortic Filter is a surgical device designed to physically capture and remove particulate matter from the blood within the patient's aorta during cardiac surgery. It does not analyze or test specimens taken from the body.
- Intended Use: The intended use clearly describes a surgical intervention to remove emboli, not a diagnostic test performed on a sample.
Therefore, the EMBOL-X Intra-aortic Filter is a surgical device, 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 Aortic Cannula in first time, non-emergent cardiac surgery procedures to capture and remove particulate emboli from the ascending aorta and heart during and following cross clamp removal in patients aged 18 years and older.
Product codes
74 DTM
Device Description
The EMBOL•X Intra-aortic Filter device consists of three primary components: (1) a distal heparin-coated mesh filter, mounted onto a flexible frame to form a filter basket for particulate emboli capture and retention; (2) a locking cartridge housing for attachment to the EMBOL•X Aortic Cannula side port, permitting access to the aorta and to ensure correct orientation of the filter during use; and (3) a proximal syringe-like plunger mechanism to deploy and withdraw the distal basket into and from the aorta, via the cannula, during surgery. The filter is introduced surgically into the aorta via the previously placed cannula, and particulates are captured and removed as blood passes through the filter basket. The filter may remain in situ for up to 60 minutes. The EMBOL•X Intra-aortic Filter utilizes conventional medical grade materials and processes, and is provided packaged, labeled, and sterile, intended for single-use.
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
Data to support the expanded indications for the EMBOL-X Intra-aortic Filter were obtained from the post market European ICEM Registry of 1645 patients. Seventeen (17) centers in Europe enrolled patients in this prospective, consecutive enrollment registry.
The European Registry patient population was compared to the Filter Arm of the US IDE Study through analyses of the Composite Safety endpoint as defined in the US IDE Study (K022071).
The patient population of the Registry included the following patients: those undergoing combination CABG and valve surgery (14.9%); those who have had prior CABG or valve surgery (4.7%); those undergoing emergent cardiac surgery (1.5%); other cardiac surgery (eg. Myxoma excision. 2.7%) and patients less than 60 years (20.7%). In addition, there were a significant number European Registry patients who met the criteria for the US IDE Clinical Study or patients undergoing first time, non-emergent coronary artery bypass grafting (CABG), aortic valve replacement or mitral valve repair or replacement only, aged 60 years and older (51.9%).
A total of 98.2% of the EMBOL-X® Aortic Filters used in the Registry captured one or more particulates.
The composite safety endpoint was comparable between the IDE Eligible Registry patients and the Filter arm of the US IDE Study. There were no increases in the composite safety endpoint between the IDE Eligible Registry patients and the Non-IDE Eligible Registry patients which were combination CABG/Valve or re-operations. Patients undergoing emergent cardiac surgery had higher event rates and patients
§ 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
NOV 0 3 2003
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
1000
The following 510(k) Summary of Safety and Effectiveness information is provided in accordance with the requirements of 21 CFR §807.92 and SMDA 1990.
| 510(k) Number: | K031946 |
|---|---|
| Date Prepared: | OCTOBER 20 2003 |
| Applicant: | Edwards Lifesciences LLC |
| Address: | Research Medical Division, 6864 South 300 West, Midvale, UTAH |
| 84047 | |
| Phone Number: | 801 565 6231 |
| Fax Number: | 801 565 6177 |
| Contact Person: | Karen Jones |
| Trade Name: | EMBOL•X® Intra-Aortic Filter |
| Common Name: | Arterial Line Blood Filter |
| Classification Name: | Filter, Blood, Cardiopulmonary Bypass, Arterial Line; 21 CFR |
| §870.4260; Class II | |
| Device Description: | The EMBOL•X Intra-aortic Filter device consists of three primary |
| components: (1) a distal heparin-coated mesh filter, mounted onto a | |
| flexible frame to form a filter basket for particulate emboli capture and | |
| retention; (2) a locking cartridge housing for attachment to the EMBOL•X | |
| Aortic Cannula side port, permitting access to the aorta and to ensure | |
| correct orientation of the filter during use; and (3) a proximal syringe-like | |
| plunger mechanism to deploy and withdraw the distal basket into and | |
| from the aorta, via the cannula, during surgery. The filter is introduced | |
| surgically into the aorta via the previously placed cannula, and particulates | |
| are captured and removed as blood passes through the filter basket. The | |
| filter may remain in situ for up to 60 minutes. The EMBOL•X Intra-aortic | |
| Filter utilizes conventional medical grade materials and processes, and is |
provided packaged, labeled, and sterile, intended for single-use.
CONFIDENTIAL
1
-
The EMBOL-X Intra-aortic Filter is indicated for use with the EMBOL-X Intended Use: Aortic Cannula in first time, non-emergent cardiac surgery procedures to capture and remove particulate emboli from the ascending aorta and heart during and following cross clamp removal in patients aged 18 years and older.
Substantial equivalence is derived from a composite of characteristics Predicate from multiple predicate devices and detailed in K022071. The EMBOL-Devices: X Intra-aortic Filter is substantially equivalent in intended use, clinical application, principle of operation, design and materials, sterility and biocompatibility, and performance to the EMBOL-X Aortic Filter (K022071), the Medtronic Percusurge Guardwire plus temporary occlusion and aspiration system (K003992) and/or the Edwards Lifesciences AF-1025D/AF-1040D DURAFLO (heparin treated) arterial blood filter (K820044). -
The EMBOL-X Intra-aortic Filter has similar intended use, design intent, Technological principle of operation, materials, sterility and biocompatibility, accessory Characteristics: requirements, and labeling as that of the predicate devices. Any noted differences between the devices (specific indications for use, method of device delivery, specific physical dimensions and geometry) do not raise new types of safety or effectiveness questions, do not introduce new technological issues, and therefore do not impact the substantial equivalence of the EMBOL-X Intra-aortic Filter.
-
The results of biocompatibility, in-vitro (bench), and pre-clinical Non-Clinical Test (animal) tests from K022071 demonstrate that the EMBOL-X Intra-Results: aortic filter is sterile, biocompatible, meets established internal performance specifications, and satisfies the requirements of relevant external standards and applicable FDA guidance.
-
Data to support the expanded indications for the EMBOL-X Intra-aortic Summary of Clinical Filter were obtained from the post market European ICEM Registry of Studies: 1645 patients. Seventeen (17) centers in Europe enrolled patients in this prospective, consecutive enrollment registry.
The European Registry patient population was compared to the Filter Arm of the US IDE Study through analyses of the Composite Safety endpoint as defined in the US IDE Study (K022071).
2
The patient population of the Registry included the following patients: those undergoing combination CABG and valve surgery (14.9%); those who have had prior CABG or valve surgery (4.7%); those undergoing emergent cardiac surgery (1.5%); other cardiac surgery (eg. Myxoma excision. 2.7%) and patients less than 60 years (20.7%). In addition, there were a significant number European Registry patients who met the criteria for the US IDE Clinical Study or patients undergoing first time, non-emergent coronary artery bypass grafting (CABG), aortic valve replacement or mitral valve repair or replacement only, aged 60 years and older (51.9%).
A total of 98.2% of the EMBOL-X® Aortic Filters used in the Registry captured one or more particulates.
The composite safety endpoint was comparable between the IDE Eligible Registry patients and the Filter arm of the US IDE Study. There were no increases in the composite safety endpoint between the IDE Eligible Registry patients and the Non-IDE Eligible Registry patients which were combination CABG/Valve or re-operations. Patients undergoing emergent cardiac surgery had higher event rates and patients