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510(k) Data Aggregation
(233 days)
EMBOL-X, INC.
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.
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.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Primary Safety Measure | Composite of post-operative clinical events (Neurologic deficit, Renal insufficiency, GI complications, Perioperative MI, Limb-threatening peripheral embolism, Death) statistically equivalent to standard treatment. | 17.1% composite event rate for Treatment arm vs. 18.9% for Control arm (p |
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(185 days)
EMBOL-X, INC.
The EMBOL-X Aortic Cannula is indicated for the perfusion of the ascending aorta during cardiopulmonary bypass (CPB) surgery where procedures may require the hemostatic introduction and removal of compatible intravascular devices into the vascular system.
The EMBOL-X® Aortic Cannula consist of a standard 3/8" ID wire reinforced tube body having a curved J-tip end and a flange for suture attachment. Attached to the side of the J-tip end is an Introducer port having a single lumen housing and a removable self-venting keyed snap-lock Obturator. The outer portion of the J-tip includes a radiused groove that accepts the complimentary radiused distal end of the provided Obturator. With the Obturator inserted, the Obturator provides a smooth, minimally disruptive fit along the J-tip's radiused groove. Removal of the Obturator from the Introducer port reveals a channel through which a physically compatible device may be introduced through the Introducer's hemostatic valve and along the groove of the J-tip. The Introducer port acts as an intravascular hemostasis conduit that can accommodate the introduction of intravascular devices with an exit diameter ranging from 12 FR to 14 FR in size. The Obturator is removed only when intravascular access with a device is necessary. The EMBOL-X Aortic Cannulas have an insertion diameter size of 24 FR. All models are a J-tip configuration whose tips are made from metal or plastic. The device is packaged sterile and non-pyrogenic, is single use only, and come with a separate optional use porous vent plug for cannula venting.
The EMBOL-X Aortic Cannula is indicated for the perfusion of the ascending aorta during cardiopulmonary bypass (CPB) surgery where procedures may require the hemostatic introduction and removal of compatible intravascular devices into the vascular system.
Here's an analysis of the provided text regarding the device's acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Biocompatibility | All materials must be biocompatible. | "All materials used in the EMBOL-X Aortic Cannula are shown to be biocompatible." |
| Functional Performance | Joint strength, gasket seal integrity, and flow rate should be substantially equivalent or better than the predicate device(s). | "In-vitro bench test results for joint strength, gasket seal integrity, and flow rate PERFORMANCE characteristics was substantially equivalent or better than in performance to the TESTS: predicate device(s)." This statement implies that the device met this criterion by demonstrating performance either equal to or superior to the predicate devices in these specific areas. |
| Substantial Equivalence | The device must be substantially equivalent to legally marketed predicate devices in terms of intended use and technological characteristics. | The FDA letter (K020693) explicitly states, "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications of use stated in the enclosure) to legally marketed predicate devices..." The submission also states: "The EMBOL-X Aortic Cannula is technologically and substantially equivalent to the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly mentions in-vitro bench tests. These tests are typically conducted on a controlled number of manufactured units of the device, rather than on patient data.
- Sample Size for Test Set: Not specified. The document states "bench test results" which implies testing was performed on a sample of the manufactured device. The exact number of units tested for joint strength, gasket seal integrity, and flow rate is not provided.
- Data Provenance: In-vitro bench testing. This means the data was generated in a laboratory setting, not from human or animal subjects. Therefore, there is no country of origin or retrospective/prospective distinction in the typical sense for clinical studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable in this context. The study described is in-vitro bench testing, not a clinical study involving diagnosis or interpretation by experts. Therefore, there's no "ground truth" to be established by clinical experts for these specific performance metrics. The ground truth for bench tests is typically defined by engineering specifications and physical measurements.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies when multiple human readers interpret data to resolve discrepancies. For in-vitro bench testing, measurements are taken according to predefined protocols, and results are compared against engineering specifications, eliminating the need for reader adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The studies mentioned are in-vitro bench tests comparing the device's physical performance characteristics (joint strength, seal integrity, flow rate) to predicate devices. These are not studies involving human readers and AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is not applicable. The device described is a medical instrument (Aortic Cannula), not a software algorithm or AI. Therefore, there are no "standalone" algorithm performance studies relevant to this submission.
7. Type of Ground Truth Used
The ground truth for the in-vitro bench tests was based on engineering specifications and physical measurements of the device's performance characteristics (joint strength, gasket seal integrity, and flow rate). The performance was then compared to the same metrics for predicate devices.
8. Sample Size for the Training Set
This information is not applicable. As this is an in-vitro bench test for a physical medical device, there is no "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. There is no training set for a physical device's in-vitro bench testing, so no ground truth was established for it in this context.
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(216 days)
EMBOL-X, INC.
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(349 days)
EMBOL-X, INC.
The EMBOL-X Aortic Occlusion and Cardioplegia Cannula is intended for use during cardiopulmonary bypass (CPB) procedures to: (1) occlude the ascending aorta, (2) deliver cardioplegia solution, and (3) vent the aortic root.
The EMBOL-X Aortic Occlusion and Cardioplegia Cannula consists of a twolumen cannula with three lines and an elastomeric balloon mounted on a 14 French tip. The first cannula lumen is used to inflate the balloon. The inflated balloon occludes the ascending aorta, partitioning the aortic root from the remainder of the arterial circulation. The balloon is expandable to occlude a range of aortic diameters. A two-way stopcock maintains the inflation and deflation of the balloon. The second cannula lumen is attached to two separate lines. The first line is used to deliver antegrade cardioplegia solution, and the second line is used for venting the aortic root. A sliding flange, located at the base of the cannula hub, adjusts to accommodate for varying aortic diameters and assists in anchoring the device during use.
The provided text describes the EMBOL-X Aortic Occlusion and Cardioplegia Cannula, its intended use, and the studies conducted to demonstrate substantial equivalence to predicate devices, rather than a study against a pre-defined set of acceptance criteria with quantified performance metrics.
However, I can extract the information related to the device's performance demonstration and present it in a structured way to answer your request as closely as possible, interpreting "acceptance criteria" as the performance requirements that need to be met for clinical use and "reported device performance" as the outcomes of the performance studies.
1. Table of Acceptance Criteria and Reported Device Performance
Since explicit numerical acceptance criteria were not provided in the document, I will infer them from the stated "performance requirements for the intended clinical use" and the results from the studies.
| Acceptance Criteria (Inferred from intended use) | Reported Device Performance |
|---|---|
| I. Functional Performance: The device must effectively occlude the ascending aorta. | "Animal testing results demonstrated that the device occludes the ascending aorta." "Proper balloon occlusion is confirmed, then balloon volume is maintained by re-turning the stopcock to the 'closed' position." "If excessive bleedback is observed, the balloon volume is increased 1 cc at a time up to, but not exceeding, the maximum recommended balloon volume until complete occlusion is achieved." |
| The device must effectively deliver cardioplegia solution. | "Animal testing results demonstrated that the device... delivers cardioplegia to arrest the heart." "After occlusion is achieved, cardioplegia solution delivery is initiated." |
| The device must effectively vent the aortic root. | "The second cannula lumen is attached to two separate lines... the second line is used for venting the aortic root." |
| The device must maintain balloon inflation/occlusion. | "A two-way stopcock maintains the inflation and deflation of the balloon." |
| The device must be able to adjust to varying aortic diameters. | "The balloon is expandable to occlude a range of aortic diameters." "A sliding flange, located at the base of the cannula hub, adjusts to accommodate for varying aortic diameters." |
| II. Biocompatibility: The materials used must be biocompatible. | "Biocompatibility testing demonstrated that the materials used to fabricate the EMBOL-X Device are biocompatible and meet the requirements of FDA's guidance document, Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing (1995)." |
| III. Safety: The device must not be thrombogenic. | "Animal testing results demonstrated that the device... is not thrombogenic." |
| The device must not result in depletion of cellular components. | "Animal testing results demonstrated that the device... does not result in depletion of cellular components." |
| The device must not damage the vessel wall. | "Animal testing results demonstrated that the device... does not damage the vessel wall." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a numerical sample size. The document mentions "Animal testing results," implying a cohort of animals but no specific number is given.
- Data Provenance: Prospective (animal testing). The country of origin is not specified, but the submission is to the US FDA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- This information is not provided in the given text. The evaluations seem to be based on direct physiological observation and laboratory analysis within the animal study rather than expert interpretation of images or other subjective data.
4. Adjudication Method for the Test Set
- This information is not provided as the nature of the "test set" is an animal study with direct measurements and observations, not a study requiring adjudication of expert opinions.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. The document describes performance, biocompatibility, and animal testing to demonstrate substantial equivalence, not a study comparing human readers with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This question is not applicable as the device is a cardioplegia cannula, not an AI algorithm. Its performance is entirely mechanical/physiological in interaction with the human body.
7. Type of Ground Truth Used
- The "ground truth" for the animal study appears to be direct physiological observations and measurements during surgery, such as:
- Visual confirmation of aortic occlusion.
- Arrest of the heart due to cardioplegia delivery.
- Laboratory analysis for thrombogenicity and cellular component depletion.
- Histological examination for vessel wall damage.
8. Sample Size for the Training Set
- This question is not applicable as the device is a medical device, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable as the device is a medical device, not an AI algorithm requiring a training set.
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