(233 days)
Not Found
No
The device description focuses on mechanical components and filtration, with no mention of AI/ML terms or functionalities. The performance studies are clinical trials evaluating the mechanical effectiveness of the filter.
Yes.
The device is used in cardiac surgery procedures to remove particulate emboli, which directly treats a medical condition and aims to restore health.
No
The device is described as a filter and associated components designed to capture and remove particulate emboli during cardiac surgery. Its function is to physically remove substances from the bloodstream, not to diagnose a condition or disease.
No
The device description clearly outlines physical components (filter, cartridge housing, plunger mechanism) made of conventional medical grade materials, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The EMBOL-X Aortic Filter is a surgical device designed to be physically inserted into the aorta during cardiac surgery. Its purpose is to capture and remove particulate matter directly from the bloodstream within the body.
- Lack of Specimen Analysis: The device does not analyze any specimens taken from the body. It interacts directly with the blood flow within the body.
Therefore, the EMBOL-X Aortic Filter is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The EMBOL-X Aortic Filter is indicated for use with the EMBOL-X Aortic Cannula in cardiac surgery procedures to capture and remove particulate emboli from the ascending aorta and heart during and following cross clamp removal in patients aged 60 years and older undergoing first time non-emergent CABG or isolated aortic or mitral valve repair/replacement.
Product codes
DTM
Device Description
The EMBOL • X 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 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
patients aged 60 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
The EMBOL.X ICEM 2000 trial: prospective, multi-center, 1:1 randomized, controlled equivalency study.
Sample size: 1289 patients (645 randomized to EMBOL•X Aortic Filter, 644 randomized to control).
Data source: 22 sites within the United States and Canada.
Annotation protocol: An independent Clinical Events Committee (CEC) adjudicated the major clinical endpoints and events.
Primary safety measure: a composite endpoint comprised of neurologic deficit (mild and severe), renal insufficiency (with and without dialysis), gastrointestinal (GI) complications, perioperative Myocardial Infarction (MI), limb-threatening peripheral embolism (Limb Ischemia), and Death, measured from time of randomization through hospital discharge or 30 days, whichever occurred first.
Primary effectiveness endpoint: capture of particulate emboli by the filter (Treatment arm only) in at least 75% of the filtered patients, with particulate debris visually confirmed by light microscopy.
Results: Primary safety endpoint was met (17.1% vs. 18.9%, p= 1 Particle: 598 (96.8%)
Lower 95% Confidence Bound on Percent of Filters Which Captured >= 1 Particle: 95.3%
Predicate Device(s)
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
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
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: | K022071 | |
|---|---|---|
| Date Prepared: | February 13 2003 | FEB 1 4 2003 |
| Applicant: | EMBOL•X, Inc. | |
| Address: | 645 Clyde Avenue, Mountain View, CA 94043 | |
| Phone Number: | 650/390-0280 | |
| Fax Number: | 650/390-0282 | |
| Contact Person: | Jean Chang | |
| Trade Name: | EMBOL•X® Aortic Filter | |
| Common Name: | Arterial Line Blood Filter | |
| Classification Name: | Filter, Blood, Cardiopulmonary Bypass, Arterial Line; 21 CFR §870.4260; | |
| Class II |
The EMBOL • X Aortic Filter device consists of three primary components: Device 1.) a distal heparin-coated mesh filter, mounted onto a flexible frame to Description: 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 Aortic Filter utilizes conventional medical grade materials and processes, and is provided packaged, labeled, and sterile, intended for single-use.
1
- The EMBOL-X Aortic Filter is indicated for use with the EMBOL-X Intended Use: Aortic Cannula in cardiac surgery procedures to capture and remove particulate emboli from the ascending aorta and heart during and following cross clamp removal in patients aged 60 years and older undergoing first time non-emergent CABG or isolated aortic or mitral valve repair/replacement.
- Substantial equivalence is derived from a composite of characteristics Predicate from multiple predicate devices. The EMBOL.X Aortic Filter is Devices: substantially equivalent in intended use, clinical application, principle of operation, design and materials, sterility and biocompatibility, and performance to 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 Aortic Filter has similar intended use, design intent, Technological Characteristics: principle of operation, materials, sterility and biocompatibility, accessory 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 Aortic Filter.
- The results of biocompatibility, in-vitro (bench), and pre-clinical (animal) Non-Clinical Test tests demonstrate that the EMBOL·X Aortic Filter is sterile, Results: biocompatible, meets established internal performance specifications, and satisfies the requirements of relevant external standards and applicable FDA Guidance.
- Data to support the EMBOL•X Aortic Filter (and associated EMBOL•X Summary of Aortic Cannula) were obtained from the EMBOL.X ICEM 2000 trial. Clinical Studies: The purpose of this prospective, multi-center, 1:1 randomized, controlled equivalency study was to demonstrate the safety and effectiveness of the EMBOL•X Aortic Filter (and the associated EMBOL•X Aortic Cannula) in capturing particulate emboli during first-time non-emergent coronary artery bypass graft (CABG) or aortic/mitral valve repair/replacement procedures utilizing cardiopulmonary bypass. This study was conducted at 22 sites within the United States and Canada, and was comprised of 1289 patients, of which 645 were randomized to the EMBOL•X Aortic Filter, and 644 were randomized to control. An independent Clinical Events Committee (CEC) adjudicated the major clinical endpoints and events.
2
Summary of Clinical Studies (continued):
The primary safety measure was a composite endpoint comprised of the following post-operative clinical events, measured from the time of randomization (the operation) through hospital discharge or 30 days. whichever occurred first: Neurologic deficit (mild and severe); Renal insufficiency (with and without dialysis); Gastrointestinal (GI) complications; Perioperative Myocardial Infarction (MI); Limbthreatening peripheral embolism (Limb Ischemia); and Death. The primary effectiveness endpoint was the capture of particulate emboli by the filter (Treatment arm only) in at least 75% of the filtered patients, with particulate debris visually confirmed by light microscopy.
The patient population of this study was limited to 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. Of the 1289 patients studied. 927 (71.9%) were male. and 1042 (80.8%) were 65 years of age or older; 65 (5.0%) had a LVEF 24 hours
Transient neurologic deficit (TIA): An ischemic event of the central nervous system that causes a neurologic deficit persisting for 2.0 mg/dl or a 50% or greater increase over abnormal baseline prior to procedure
Renal insufficiency (dialysis): The new requirement for dialysis
O-Wave MI: New pathological Q-Waves in 2 or more contiguous leads
Non Q-Wave MI: CPK > 5x normal and CK-MB > 5x above the upper limit of normal for the institution, in the absence of new Q-Waves
Gastro-Intestinal Complications: include GI bleeding requiring transfusion; Pancreatitis with abnormal amylase/lipase requiring NG suction therapy; Cholecystitis requiring cholecystectomy or drainage; Mesenteric ischemia requiring exploration
Limb-threatening Peripheral Embolism: Acute onset of diminished pulse, altered pallor (discoloration, either hypo- or hyper-), and pain as evidence of limb-threatening peripheral ischemia
Table 2.
Echocardiographically Evident Endothelial Disruptions Observed through Imaging
| Treatment | Control | P-Value |
|---|---|---|
| n/N (%) | n/N (%) | |
| 42/456 (9.2) | 9/454 (2.0) | EMBOL•X Aortic Filter Device Name: |
Indications For Use: The EMBOL-X Aortic Filter is indicated for use with the EMBOL-X Aortic Cannula in cardiac surgery procedures to capture and remove particulate emboli from the ascending aorta and heart during and following cross clamp removal in patients aged 60 years and older undergoing first time non-emergent CABG or isolated aortic or mitral valve repair/replacement.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
DaCattun
Prescription Use
(Per 21 CFR §801.109) X
OR Over-The-Counter Use