(297 days)
The MONOLYTH C Hollow Fiber Membrane Lung with Integrated Softshell Venous Reservoir is intended for use in an extracorporeal bypass circuit. The device provides oxygenation and removal of carbon dioxide from venous or suctioned blood. The integral heat exchanger provides blood temperature control, allows for the use of hypothermia, or aids in the maintenance of normothermia during surgery. The integral venous reservoir is intended for use as a storage reservoir for blood. The device is indicated for use with blood flows of 1.0 - 8.0 liters per minute (LPM). The MONOLYTH C 600 and the MONOLYTH C 1200 have been tested for 6 hours of continuous use. Use longer than 6 hours is not advised.
The MONOLYTH C is a high efficiency hollow fiber oxygenator with integral heat exchanger and a softshell venous reservoir. The venous reservoir is available both integrated with the device or as a separate device.
The oxygenator consists of microporous capillary polypropylene fibers wound around a perforated core in a crossed mat configuration. The fiber bundle has a surface area of approximately 2,2 m2. The blood path is around the outside of the fibers, while the gas path is through the lumens of the fibers. An arterial temperature probe is located close to the arterial outlet. The arterial sampling line contains an integrated one-way valve to prevent accidental air injection. The gas outlet is equipped with a capnograph connector for CO2 measurement. The gas outlet cap has a safety anti-occlusion feature to aid in gas venting.
A line between the gas module and the venous reservoir facilitates gravity priming of the system and allows for recirculation. This line is accessed via a high-pressure stopcock located at the lower portion of the membrane. The stopcock provides access to arterial blood throughout the procedure for cardioplegia, perfusion, or blood concentration.
The heat exchanger is on the venous side of the device and is comprised of epoxy-coated pleated stainless steel. The heat exchanger has a surface area of 0.17 m2.
The softshell venous reservoir is attached to a rigid external shell which is mounted on top of the oxygenator module. The softshell venous reservoir is a soft, flexible plastic bag with an integral screen and a rigid backplate. The backplate contains two inlet ports, a recirculation port, and a temperature probe port. The reservoir collects blood coming from venous return and from the cardiotomy reservoir. Blood from venous return and from the cardiotomy reservoirs is collected via separate inlet ports. Blood is then filtered through the screen to deflect air bubbles to the top of the reservoir. Bubbles may be purged through a double purge line with an additional luer port located at the top of the reservoir, which join together into a common line. The common purge line contains a one-way valve which prohibits air from returning into the reservoir. The temperature port, located below the venous inlet port, is designed to receive a YSI series 400 compatible probe.
The venous reservoir has one outlet line located at the bottom center of the bag. A 1/4-inch recirculation line is attached to a port on the back of the reservoir. This line may be connected to the arterial outlet or the recirculation port of the oxygenator to recirculate blood back to the venous reservoir.
Here's an analysis of the provided text regarding the MONOLYTH C Hollow Fiber Membrane Lung with Integrated Softshell Venous Reservoir, focusing on acceptance criteria and the supporting study information.
It's important to note that this 510(k) summary is for a medical device (oxygenator/blood reservoir), not an AI/software device. Therefore, many of the typical AI/ML study questions (like expert readers, adjudication, MRMC studies, training set details) are not applicable. The "acceptance criteria" here refer to the performance specifications and safety requirements for the physical device, not the performance of an algorithm.
Acceptance Criteria and Device Performance
The provided 510(k) summary describes various performance characteristics and integrity tests. However, it does not present a clear table of specific, quantitative acceptance criteria values alongside corresponding reported device performance values. Instead, it outlines categories of tests performed and states that the results "showed that the MONOLYTH C is substantially equivalent to the predicate devices and is acceptable for its intended use."
To construct the requested table, we'll have to infer the types of acceptance criteria based on the tests described, and the reported performance is generally stated as "acceptable" or "substantially equivalent" rather than precise measurements against a specific threshold.
Table of Acceptance Criteria (Inferred from Tests) and Reported Device Performance
| Acceptance Criteria Category (Inferred) | Reported Device Performance (as stated in the summary) |
|---|---|
| Oxygenator Performance | |
| Oxygen Transfer Rate | "gas exchange study (oxygen transfer and carbon dioxide transfer)" performed as part of original 510(k) for predicate (K922933). Assumed to be met for substantial equivalence. |
| Carbon Dioxide Transfer Rate | "gas exchange study (oxygen transfer and carbon dioxide transfer)" performed as part of original 510(k) for predicate (K922933). Assumed to be met for substantial equivalence. |
| Operating Blood Volumes | "operating blood volumes" tested as part of original 510(k) for predicate (K922933). Assumed to be met for substantial equivalence. |
| Blood Side Pressure Drop | "blood side pressure drop" tested as part of original 510(k) for predicate (K922933). Assumed to be met for substantial equivalence. |
| Heat Exchanger Efficiency/Performance | "heat exchanger study" performed as part of original 510(k) for predicate (K922933). Assumed to be met for substantial equivalence. |
| Mechanical Integrity | |
| Blood Path Burst and Leak Tests | "mechanical integrity study (blood path and heat exchanger burst and leak tests)" performed as part of original 510(k) for predicate (K922933). Assumed to be met for substantial equivalence. |
| Heat Exchanger Burst and Leak Tests | "mechanical integrity study (blood path and heat exchanger burst and leak tests)" performed as part of original 510(k) for predicate (K922933). Assumed to be met for substantial equivalence. |
| Physical Integrity (for new modifications) | "additional in vitro testing was performed on aged and unaged MONOLYTH C... and on CVR Softshell Venous Reservoirs." Result: "Results of the tests showed that the MONOLYTH C is substantially equivalent to the predicate devices and is acceptable for its intended use." |
| New/Modified Component Performance | |
| Hemolysis | "Product performance testing included hemolysis and cell depletion..." Result: "Results of the tests showed that the MONOLYTH C is substantially equivalent to the predicate devices and is acceptable for its intended use." |
| Cell Depletion | "Product performance testing included hemolysis and cell depletion..." Result: "Results of the tests showed that the MONOLYTH C is substantially equivalent to the predicate devices and is acceptable for its intended use." |
| Air Removal Efficiency | "Product performance testing included... air removal efficiency..." Result: "Results of the tests showed that the MONOLYTH C is substantially equivalent to the predicate devices and is acceptable for its intended use." |
| Minimum Operating Volume | "Product performance testing included... minimum operating volume..." Result: "Results of the tests showed that the MONOLYTH C is substantially equivalent to the predicate devices and is acceptable for its intended use." |
| Fill Capacity | "Product performance testing included... fill capacity..." Result: "Results of the tests showed that the MONOLYTH C is substantially equivalent to the predicate devices and is acceptable for its intended use." |
| Flow Path Testing | "Product performance testing included... and flow path testing." Result: "Results of the tests showed that the MONOLYTH C is substantially equivalent to the predicate devices and is acceptable for its intended use." |
| Biocompatibility | |
| Biological Safety | "Biocompatibility tests were performed using representative samples (whole units, subassemblies, and components) based on the intended use of the device... Results of the tests showed that the device is biocompatible and therefore is acceptable for its intended use." (Intended use: external-communicating device, circulating blood contact, limited contact duration (≤ 24 h)). Assumed to meet ISO 10993 or equivalent standards. |
Study Details (Applicable to Physical Device Testing)
This section addresses the questions specifically in the context of the physical device testing described in the 510(k) summary.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify exact sample sizes (e.g., number of devices tested for each in vitro study). It states that "representative samples (whole units, subassemblies, and components)" were used for biocompatibility testing, and "aged and unaged MONOLYTH C Hollow Fiber Membrane Lung with Integrated Membrane Lung with Softshell Venoir Reservoir and on CVR Softshell Venous Reservoirs" were tested for performance.
- Data Provenance: The studies are "in vitro," implying laboratory testing. The company, Sorin Biomedical Inc., is located in Irvine, CA, USA, suggesting the testing was likely conducted in the USA. The tests are prospective in the sense that they are conducted on newly manufactured devices or components to demonstrate performance.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- N/A. This is a physical medical device submission, not an AI/software device. Ground truth, in the context of clinical or diagnostic accuracy, is not applicable in the same way. The "truth" is established by direct measurement of physical or biological parameters in a controlled laboratory setting against predefined, validated test methods and specifications.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Adjudication is not applicable as this is not a diagnostic device requiring human interpretation of results against a consensus. Performance is measured objectively.
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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
- N/A. This is a physical medical device, not an AI/software device. MRMC studies are not relevant.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- N/A. This is a physical medical device, not an AI/software device. Standalone algorithm performance is not applicable.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Physical/Chemical Measurement against Specifications: The "ground truth" (or reference standard) for this device's performance is established through validated in vitro test methods that measure characteristics like gas exchange, pressure drop, heat exchange, hemolysis, air removal efficiency, and structural integrity against predetermined engineering specifications and industry standards (e.g., for biocompatibility).
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The sample size for the training set
- N/A. There is no "training set" in the context of a physical device's performance validation. The devices are manufactured and then tested (acceptance testing) or subjected to larger-scale validation testing.
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How the ground truth for the training set was established
- N/A. No training set is applicable.
§ 870.4350 Cardiopulmonary bypass oxygenator.
(a)
Identification. A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions.”