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510(k) Data Aggregation
(265 days)
MC3 Incorporated
The Nautilus(tm) Smart ECMO Module with integrated heat exchanger is intended to provide assisted long-term extracorporeal circulation and physiologic gas exchange (oxygenation and carbon dioxide removal) of the patient's blood for up to 48 hours in adult and pediatric adolescent patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. The integrated heat exchanger is intended to heat or cool the blood as needed during use. Integrated fluid path pressure, temperature, and oxygen saturation monitoring is achieved by built-in sensor modules and display.
The Nautilus(tm) ECMO Oxygenator with integrated heat exchanger is intended to provide assisted long-term extracorporeal circulation and physiologic gas exchange (oxygenation and carbon dioxide removal) of the patient's blood for up to 48 hours in adult and pediatric adolescent patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. The integrated heat exchanger is intended to heat or cool the blood as needed during use.
The Nautilus™ ECMO oxygenators are diffusion membrane oxygenators used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Blood enters the device and passes through both the heat exchange membrane, where temperature is adjusted, and the gas transfer membrane, where oxygen is added and carbon dioxide is removed.
The Nautilus™ Smart ECMO Module device contains integrated sensors with an electronic touch screen display. The following measured parameters are visible on the electronic display: inlet pressure, inlet oxygen saturation, outlet pressure, outlet oxygen saturation, and outlet blood temperature. The difference between the inlet and outlet pressure, delta pressure, is calculated and also displayed on the screen. The touchscreen display allows users to set alarm limits for all measured parameters. The Nautilus™ Smart ECMO Module will alarm visually and audibly when the limits are exceeded.
The devices are single-use, nontoxic, non-pyrogenic, and not made from natural latex rubber materials.
The provided text describes performance evaluations for the MC3 Nautilus Smart ECMO Module and Nautilus ECMO Oxygenator. However, it does not explicitly state "acceptance criteria" in a tabulated format and then directly link each criterion to "reported device performance" in a separate column. Instead, it presents various performance evaluations and their findings.
Based on the information provided, here's a structured summary attempting to address your request as closely as possible:
1. Table of acceptance criteria and the reported device performance
While explicit acceptance criteria are not tabulated with specific numerical targets, the document implies that the device is considered acceptable if its performance is "comparable or better" than a state-of-the-art device and meets the "special controls" and standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Gas Exchange (Oxygen and Carbon Dioxide Transfer) | Long-term Bench Gas Exchange testing (ISO 7199:2016): "Nautilus had comparable or better oxygen and carbon dioxide transfer rates... as a heparin coated state-of-the-art device, over 14-days of use." |
| Pressure Drop | Long-term Bench Gas Exchange testing (ISO 7199:2016): "...pressure drop performance as a heparin coated state-of-the-art device, over 14-days of use." |
| Clotting Prevention / Thrombogenicity | In-Vivo Study in Sheep (96 hours): "After 4 days, there were no clots in any location in the Nautilus device..." |
| Clinical information (Real World Evidence): "There were no reports of circuit clotting..." | |
| Integrity / Mechanical Failure | Non-clinical Performance: "...mechanical integrity... durability, reliability..." demonstrated substantial equivalence. |
| Clinical information (Real World Evidence): "There were no reports of... mechanical failure." | |
| Hemolysis | Performance Evaluations: "Hemolysis" was evaluated. |
| Clinical information (Real World Evidence): "Fifteen percent of patients had reports of hemolysis complications, of which none was directly attributed to the Nautilus™. One hemolysis complication was reported to have occurred after 27 days of operation, another was reported prior to Nautilus™ use while operating on a different oxygenator, and one was attributed to patient condition (sepsis) and pump clotting." (This implies hemolysis, when it occurred, was generally not attributed to the device itself.) | |
| Biocompatibility | "The subject device is demonstrated to be biocompatible for prolonged use in circulating blood in accordance with ISO 10993-1:2009 and in accordance with GLP (21 CFR 58)." |
| Sterility and Shelf-life | "Testing demonstrates the sterility of the subject device as provided and that it maintains its sterility, integrity, durability, and reliability over the stated shelf-life of the device." |
| Sensor Accuracy (for Smart ECMO Module) | Smart Module Testing: "Sensor Accuracy" was evaluated. |
| Reference Device (Sensor Module): "The sensor module functions are comparable to the Maquet CARDIOHELP System with regard to sensor accuracy..." | |
| Electrical Safety/EMC (for Smart ECMO Module) | Smart Module Testing: "Electrical Safety/EMC" was evaluated. |
| Non-clinical Performance: "...electromagnetic compatibility..." demonstrated substantial equivalence. | |
| Water Ingress Protection (for Smart ECMO Module) | Smart Module Testing: "Water Ingress Protection" was evaluated. |
| Adverse Events / Complications (e.g., infections, CNS events) | Clinical information (Real World Evidence): |
- "The most common complication reported was circuit exchange in twenty percent of patients..."
- "Ten percent of patients had reports of blood infections on ECMO, which is similar to the rate of infections (11%) previously reported by others."
- "One patient suffered a CNS infarction event (5%), and another patient, a CNS hemorrhage." |
| Compatibility with other circuit devices | Technological Characteristics: "The subject device is designed to be compatible with other extracorporeal circuit devices and accessories." |
The studies collectively show that the Nautilus device meets performance expectations by being comparable to or better than predicate/reference devices and established clinical norms, and by demonstrating safety and efficacy in various testing environments.
2. Sample size used for the test set and the data provenance
- Long-term Bench Gas Exchange testing: The sample size isn't explicitly stated as a number of devices, but it refers to "MC3 Nautilus oxygenators from accelerated age populations" and "competitive heparin coated oxygenators."
- Provenance: In vitro, conducted according to ISO 7199:2016, using bovine blood/plasma.
- In-Vivo Study in Sheep:
- Sample size: A total of 15 sheep. Specifically, 10 sheep were used to evaluate the Nautilus device (at either 2 or 5 L/min), and 5 control animals were studied with a state-of-the-art heparin-coated device (at 2 L/min).
- Provenance: Prospective animal study.
- Clinical information (Real World Evidence):
- Sample size: Not explicitly stated as a number of patients, but data were collected from patients at 7 centers in 4 countries. The average duration of ECMO support was 378.5 hours (15.8 days), with a range of 17 to 1271 hours (52.9 days). Given these durations, it implies a significant number of patient-hours of use.
- Provenance: Retrospective, voluntarily entered into the ELSO registry from initial real-world clinical experience. Data from 7 centers in 4 countries.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the text. The studies described are performance-based (bench, in-vivo) and real-world data collection, rather than studies requiring expert adjudication of device performance in a diagnostic sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the text. The studies described (bench, animal, real-world registry data) do not appear to involve a human adjudication process for establishing a "ground truth" in the way a diagnostic algorithm might be evaluated.
5. 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
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, nor any evaluation of human readers improving with AI assistance. The device is an ECMO module/oxygenator, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not directly applicable. The device (ECMO module/oxygenator) is a medical device that physically interacts with a patient's blood, not an algorithm. The "Smart Module" has integrated sensors and an electronic display, which would operate in a "standalone" algorithmic sense for its sensor functions, but its primary function as an ECMO device is not an algorithm. The sensor accuracy was evaluated as part of "Smart Module Testing."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Long-term Bench Gas Exchange testing: Ground truth for gas exchange and pressure drop was established by measurements according to the ISO 7199:2016 standard using bovine blood, providing objective scientific measurements.
- In-Vivo Study in Sheep: Ground truth for clotting was established by direct observation ("no clots in any location") and confirmation of oxygenator functionality in the animal model.
- Clinical information (Real World Evidence): Ground truth for complications and device performance in a clinical setting was derived from clinical observation and patient outcomes data voluntarily entered into the ELSO registry by clinicians at the participating centers.
8. The sample size for the training set
This information is not applicable/provided. The device is a physical medical device, not a machine learning algorithm that requires a "training set" for its operation in the way an AI diagnostic tool would.
9. How the ground truth for the training set was established
This information is not applicable/provided, as the concept of a "training set" does not apply to this type of device.
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(11 days)
MC3 Incorporated
Intended for single use by a trained physician to assist in vessel cannulation.
The MC3 Vascular Access Kit consists of component devices that are already cleared by FDA, as well as various sized dilator devices. The subject devices include dilators that are 13, 16, 20, 24, 26, and 28 French (FR). These dilators are all made of Colorite PVC, 9566M-RAD14. The MC3 logo and size indicator are legibly printed at the hub end of the dilator using NAZDAR VF111 Black Ink with NAZDAR VF190 Ink Thinner. These dilators are packaged together in the MC3 Vascular Access Kit with other devices already cleared by FDA in accordance with the FDA convenience kit guidance. All kit contents are sterile (EtO), nonpyrogenic, and single use only. The current FDA cleared devices of the kit include a stainless steel Guidewire; a Stepped Dilator, starting at 8Fr. on the tip transitioning to 10Fr.; a singlewall introducer needle, with protector, that is designed to introduce up to a 0.038" guidewire into the vasculature; a long handle, disposable #11 safety scalpel used for incisions during operational procedures; and a 10ml silicone double seal stopper syringe with luer slip. Peripheral access to the vein is gained using the needle, syringe, and scalpel. The guidewire is then inserted into the vessel through the needle is removed. A dilator is then chosen by the physician and inserted over the guidewire into the vessel. The dilator is then removed and the next sized dilator is inserted in the same manner until the desired dilation is achieved. The single-use devices are then disposed after use.
The provided document describes the predicate device and the studies conducted to demonstrate substantial equivalence, rather than detailing a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device. The device in question is the "MC3 Vascular Access Kit 21030," which consists of physical components like dilators, guidewires, needles, and scalpels for vessel cannulation. It is not an AI/ML device.
Therefore, many of the requested points, such as sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, are not applicable to this physical medical device submission.
However, I can extract the relevant information regarding the acceptance criteria and the performance for this device based on the non-clinical testing performed.
Updated Information based on the provided document:
1. A table of acceptance criteria and the reported device performance:
| Test | Description (Acceptance Criteria Implicit in Description) | Reported Device Performance |
|---|---|---|
| Dilator Buckling | Dilator body strength testing with objective acceptance criteria. (Implicitly, the device should not buckle under expected forces.) | All test articles met acceptance criteria. Mechanical integrity is more than adequate for the intended application. |
| Dilator Tensile Strength | Pull test with objective acceptance criteria. (Implicitly, the device should withstand pulling forces without breaking or deforming excessively.) | All test articles met acceptance criteria. Mechanical integrity is more than adequate for the intended application. |
| Guidewire Fit | 0.038" guidewire fits through dilator. (Implicitly, the internal lumen of the dilator must be patent and of sufficient size for the specified guidewire.) | All test articles met acceptance criteria. |
| Tip Cracking/Kinking | Splitting or cracking testing with objective acceptance criteria. (Implicitly, the dilator tip should not split or kink during use.) | All test articles met acceptance criteria. |
| Biocompatibility | Testing per ISO-10993 for an external communicating device in contact with circulating blood for limited duration less than 24 hours. (Implicitly, the materials should not cause adverse biological reactions.) | Under conditions of the study, the dilator materials are not cytotoxic, are not a sensitizer and not an irritant. |
| Packaging Integrity | Not explicitly described, but generally involves ensuring the sterile barrier and physical protection of the device. | "Verification and validation testing was used to establish the performance characteristics... Packaging Integrity" - Results implicitly met acceptance criteria as it was used to support substantial equivalence. |
| Transportation Integrity | Not explicitly described, but generally involves ensuring the device's integrity after transportation simulations. | "Verification and validation testing was used to establish the performance characteristics... Transportation Integrity" - Results implicitly met acceptance criteria as it was used to support substantial equivalence. |
| Sterilization Validation | Not explicitly described, but generally involves confirming the efficacy of the sterilization process. | "Verification and validation testing was used to establish the performance characteristics... Sterilization Validation" - Results implicitly met acceptance criteria as it was used to support substantial equivalence. |
| Functional Testing | Not explicitly described, but generally involves testing the device's ability to perform its intended function. | "Verification and validation testing was used to establish the performance characteristics... Functional Testing" - Results implicitly met acceptance criteria as it was used to support substantial equivalence. |
2. Sample size used for the test set and the data provenance:
For the non-clinical tests (Buckling, Tensile Strength, Guidewire Fit, Tip Cracking/Kinking, Biocompatibility), the document states "All test articles met acceptance criteria." This implies a sample size was used for each test, but the exact number for each specific test is not explicitly stated in the provided text.
The data provenance is from non-clinical laboratory testing conducted by the manufacturer, MC3 Incorporated. It is not patient data (retrospective or prospective) from specific countries.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This criterion is not applicable as the studies were in-vitro/lab-based non-clinical tests, not involving expert interpretation of data or images.
4. Adjudication method for the test set:
Not applicable for these types of non-clinical tests.
5. If a multi-reader multicase (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 as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable as this is not an AI/ML device.
7. The type of ground truth used:
For the mechanical and physical tests, the "ground truth" was established by objective engineering specifications and measurement standards. For biocompatibility, it was based on internationally recognized standards (ISO-10993).
8. The sample size for the training set:
Not applicable as this is not an AI/ML device.
9. How the ground truth for the training set was established:
Not applicable as this is not an AI/ML device.
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(178 days)
MC3 Incorporated
The MC3 Jugular Dual Lumen Catheter is a single use dual lumen catheter, which provides both venous drainage and reinfusion of blood via the jugular vein, that is indicated for use in patients with acute respiratory failure requiring Veno-Venous Extracorporeal Membrane Oxygenation, where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent.
The MC3 Jugular Dual Lumen Catheters are bi-caval dual lumen catheters supplied with an introducer to facilitate wire guided placement into the vasculature via percutaneous surgical methods (Seldinger type approach). The introducer is designed to follow a prepositioned standard 0.038" (0.97 mm) or 0.035" (0.89 mm) guide wire (not included). The introducer hub provides an area for grasping the introducer during insertion and when fully seated, indicates that the introducer is fully inserted. The catheter is wire reinforced for flexibility and kink-resistance and includes depth marks. Both the introducer and catheter are made of radiopaque materials and the catheter also includes tantalum radiopaque markers at the infusion port, proximal and distal drainage holes, and the catheter tip. The catheter body contains an integrated suture site for use during securement. An optional suture collar is provided and can be used for supplemental securement only. A dilator is also included. The dilators are the same diameter of the catheter and are designed to be used for dilation of the vessel. The catheters remain intact throughout the duration of use and withstand the forces associated with insertion, securement, connection to perfusion line, clamping, blood pressures, and removal.
This document describes the premarket notification for a medical device and provides information on its performance evaluations, but it does not contain acceptance criteria or a study proving the device meets those criteria in the context of diagnostic or AI-driven performance.
The document is a 510(k) summary for the MC3 Jugular Dual Lumen Catheter, which is a physical medical device (a catheter) used for Veno-Venous Extracorporeal Membrane Oxygenation (ECMO). The "performance evaluations" mentioned are for the physical characteristics and safety of the catheter itself (e.g., durability, flow, kink resistance, biocompatibility, sterility), not for a diagnostic algorithm or AI system's output.
Therefore, I cannot provide the requested information from the provided text, as it pertains to a different type of device and different evaluation criteria than what your questions imply (e.g., questions about ground truth, expert consensus, MRMC studies, standalone algorithm performance, training/test sets are relevant for AI/diagnostic devices, not for a physical catheter's mechanical performance).
If you have a document related to an AI/diagnostic device, please provide that.
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(168 days)
MC3 Incorporated
The MC3 26 Fr. QuickFlow™ Dual Lumen Catheter is a single use dual lumen catheter, which provides both venous drainage and reinfusion of blood via the femoral vein, that is indicated for use for up to 72 hours in patients with acute respiratory failure requiring partial Veno-Venous Extracorporeal Membrane Oxygenation (full hemodynamic support is not required and predicted flows needed to maintain adequate oxygenation do not exceed 31/min) where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent.
The MC3 28 Fr. QuickFlow™ Dual Lumen Catheter is a single use dual lumen catheter, which provides both venous drainage and reinfusion of blood via the femoral vein, that is indicated for use for up to 72 hours in patients with acute respiratory failure requiring partial Veno-Venous Extracorporeal Membrane Oxygenation (full hemodynamic support is not required and predicted flows needed to maintain adequate oxygenation do not exceed 3.5l/min) where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent.
The MC3 QuickFlow Dual Lumen Catheters are dual lumen catheters supplied with an introducer to facilitate wire guided placement into the vasculature by normal access techniques. The introducer is designed to follow a pre-positioned standard 0.038" (0.97 mm) or 0.035" (0.89 mm) guide wire (not included). The catheter is wire-reinforced for flexibility and kink-resistance and includes depth marks. Both the introducer and catheter are made of radiopaque materials and the catheter has radiopaque markers at the tip and most proximal set of drainage holes.
The devices are comprised of two separate thin-walled catheters made of silicone and polyurethane polymer and reinforced with a spring wire. The dual lumen design involves two catheters of different diameters joined together in a co-axial configuration. An arrangement of side holes in the outer (drainage) catheter allows for egress of blood. An open tip on the inner (return) catheter allow s for blood ingress. Unreinforced tube extensions with barbed connectors, allowing clamping and connection to the extracorporeal circuit, are joined to the wye junction. A tapered tip introducer is included to facilitate placement of the catheter into the blood vessel over a standard guide wire (not included). Securement of the device may be accomplished via a groove designed in the Y-connector to accept a suture and a suture around a 3/8" barb connector.
The provided text describes the MC3 QuickFlow Dual Lumen Catheter and its equivalency to a predicate device, focusing on its physical characteristics, intended use, and performance evaluations. However, it does not contain information related to an AI/ML device, nor does it present acceptance criteria or a study proving an AI/ML device meets such criteria.
The document is a 510(k) premarket notification for a medical device (a catheter), and the performance evaluations listed are typical for such hardware devices (durability, pressure/flow, kink resistance, etc.). There is no mention of "AI", "algorithm", "human readers", "MRMC", "ground truth" in the context of an AI-driven study, or any other terms that would suggest an AI/ML component.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving an AI/ML device meets those criteria based on the provided text, as the text pertains to a non-AI medical device.
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