The BioTrend Oxygen Saturation and Hematocrit System measures percent oxygen saturation and hematocrit of the blood in the extracorporeal circuit. The extracorporeal circuit is used for, but is not limited to, cardiopulmonary bypass, closed-chest support, and limb perfusion.

The modified BioTrend Oxygen Saturation and Hematocrit System is an on-line monitoring instrument that combines both venous (SvO2) and arterial (SaO2) oxygen saturation measurement with hematocrit (Hct) measurement. The BioTrend System consists of the BioTrend Instrument, two Sensor Cables, and a power cord. The BioTrend system is designed to be used with the Tri-optic Measurement Cells.

The Tri-optic Measurement Cell is a disposable device in the extracorporeal circuit that provides a sealed interface between the blood pathway and the BioTrend sensor cable. No change is being made to the Tri-optic Measurement Cell, which was previously cleared under K910421 and K012743.

Using fiber optic technology, the BioTrend System continuously measures the percentage of oxygen saturation and hematocrit and displays the results on large, easy-to-read, color-coded Light Emitting Diodes (LEDs). The display panel indicates operating status and error messages, and provides a means for system calibration.

BioTrend Sensor Cables connect to the BioTrend instrument and the in-line Tri-optic Measurement Cells (TMC) to transmit optical measurement signals. The BioTrend sensor cables isolate the patient from the instrument electronics, providing patient protection. The BioTrend instrument contains a built-in, rechargeable battery pack to provide the battery power. Consequently, the BioTrend instrument can be operated on AC or battery power. A continuous, built-in self-check immediately alerts the operator of equipment failure and displays a corresponding error code.

This submission (K093652) is for a modification to an existing device, the BioTrend Oxygen Saturation and Hematocrit System, and does not include a study to prove the device meets acceptance criteria related to clinical performance.

The modifications are to the hardware and software of the BioTrend Instrument, and the submission emphasizes that the "fundamental scientific technology and the intended use are unchanged." Consequently, clinical testing was not required to establish substantial equivalence.

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Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

This 510(k) submission for the modified BioTrend Oxygen Saturation and Hematocrit System (K093652) establishes substantial equivalence to its predicate device (K954501) through a series of preclinical (bench) tests. Clinical effectiveness was not evaluated as part of this submission, as the modifications were to the instrument's hardware and software, with no change to the core measurement technology, intended use, or performance claims. Therefore, specific clinical acceptance criteria, a multi-reader multi-case study, or a standalone algorithm performance study are not relevant to this submission.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with specific quantitative acceptance criteria or reported device performance for a clinical outcome. Instead, it lists various "Preclinical testing data were used to establish the performance characteristics of the modifications to this device." These tests were designed to ensure the modified device maintained its original performance and met safety requirements.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable in the context of a clinical performance study. The "test set" for this submission comprised various physical components and software modules of the BioTrend Instrument. The document specifies "Blood testing" was conducted, but it doesn't provide details on the number of blood samples or their characteristics.
• Data Provenance: Not applicable in the context of a clinical performance study. The tests were preclinical bench tests, not involving human subjects or clinical data collection.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This submission relies on engineering and scientific testing to demonstrate substantial equivalence, not expert consensus on clinical ground truth.

4. Adjudication Method for the Test Set

Not applicable. Clinical adjudication methods are not relevant to the bench testing conducted for this submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The submission explicitly states, "Clinical testing was not required to establish substantial equivalence."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

A "Software testing" was done "to verify the device meets the software requirements called out in the software requirements document." This implies testing of the algorithm's performance in isolation from user interaction, but it is not a standalone clinical performance study to assess accuracy against a clinical ground truth. The algorithm for oxygen saturation and hematocrit calculation remains the same as the predicate device.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the "Blood testing" mentioned, the ground truth would have been established by a reference method for measuring oxygen saturation and hematocrit. However, the document does not specify this method. For other tests (environmental, packaging, system, software, hardware, UL/TUV), the "ground truth" would be adherence to established engineering specifications, regulatory standards, and internal requirements documents.

8. The Sample Size for the Training Set

Not applicable. This device is an on-line monitoring instrument, not an AI/ML algorithm that undergoes a training phase for a specific diagnostic task from a dataset. The phrase "Same Algorithm used to calculate oxygen saturation and hematocrit" indicates that the core calculation method is pre-established and carried over from the predicate device.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as this device does not utilize a "training set" in the context of machine learning. The algorithm is based on established principles of optical measurement for oxygen saturation and hematocrit.

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The intended purpose of the MAQUET Blood Monitoring Unit BMU 40 is to monitor blood parameters during cardiopulmonary bypass (CPB) or similar procedures with extracorporeal circulation, which require continuous monitoring of the arterial and/or venous blood parameters: partial pressure of oxygen (pO2), temperature (Ta and Tv), oxygen saturation (SO2), hemoglobin (Hb) and hematocrit (Hct). Oxygen consumption (VO2) can also be calculated. Blood flow (QBlood) can be entered manually or values can be received from a connected heart-lung machine.

The duration of application of the disposable products (arterial BMU Sensor and venous BMU Cell) is limited to six hours.

The BMU 40 is designed for continuous operation.

The Blood Monitoring Unit BMU 40 monitors blood parameters during cardiopulmonary bypass or similar procedures with extracorporeal circulation, which require continuous monitoring of the arterial and/or venous blood parameters

The Blood Monitoring Unit BMU 40 is blood monitoring system consisting of the following componens:

• the control unit (monitor, called BMU 40) which comprises a display i showing the actual measured sensor values and time course.
• Sterile single use connectors (BMU Sensor/ BMU Cell) to be clamped י on the probes, one in the venous line and one in the arterial line. The connectors are available in different sizes. BMU Sensor is connected to arterial probe and BMU Cell is connected to venous probe.

The provided text describes a medical device, the MAQUET Blood Monitoring Unit BMU 40, and its 510(k) submission for substantial equivalence. However, it does not contain the specific details about acceptance criteria, a study that proves the device meets those criteria, or the methodology of such a study in the format requested.

The document states that the performance characteristics of the BMU 40 were exhaustively tested and compared with the predicate device (CDI 500) and that the device performs as intended according to its performance specifications. It also lists areas that were tested such as "Performance", "Electrical and mechanical safety", "Software Validation", "Biocompatibility", "Sterility", and "Integrity".

Therefore, I cannot provide the requested table or detailed information about the study because the source document does not contain this level of detail.

The information provided only confirms that:

• The device is intended to monitor blood parameters during cardiopulmonary bypass.
• It was compared to predicate devices (CDI Blood Parameter Monitoring System 500 and M3 Monitor) for substantial equivalence in intended use, design, and performance.
• Testing was performed to demonstrate safety and effectiveness.

To answer your request, specific performance specifications and the results of those tests would be required, which are not present in the provided text.

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The IBC Quick Cell component was developed for use with the CDI Model 400 Blood Gas Monitoring System manufactured by 3M. The purpose of this report is to demonstrate the equivalence of the IBC Quick Cell component, as a substitute for the CDI Kwik Cell component.

The IBC Quick Cell component was developed for use with the CDI Model 400 Blood Gas Monitoring System manufactured by 3M. The final geometry of the IBC Quick Cell component is identical to the final geometry of the 3M Kwik Cell component, and both are fabricated from the same plastic materials. Performance of the IBC Quick Cell component within the CDI Model 400 Blood Gas Monitoring System is identical to the CDI Kwik Cell component. The materials were evaluated for toxicity and sterilization compatability requirements as well as for function.

The CDI Model 400 Blood Gas Monitoring System er ploys three photochemical sensors to measure pO3, pCO2 and pH. Additionally, there is a thermo-electronic sensor for the direct measurement of temperature. The Electronics also contain calculation programs which use the measured parameters to determine O2 Saturation (Venous side only) and Base Excess/[HCO3] (Arterial side only). To complete the necessary calculations for these approximations, the Hemoglobin content is also required. This value is internally set at a Hematocrit of 25%. This value is corrected by the user during the initial and any subsequent on line recalibrations.

The functional properties of the Quick Cells are determined by the final assembly geometry and the materials employed in construction, especially the membrane material. The final geometry of the IBC and CDI components are identical. Using chemical analysis, electron microscopy and information in the public domain, the membrane was sourced from the same supplier used by 3M.

Here's an analysis of the provided text, outlining the acceptance criteria and study details for the IBC Quick Cell Component:

IBC Quick Cell Component Acceptance Criteria and Study Analysis

The document details a study conducted to demonstrate the equivalence of the IBC Quick Cell component to the CDI Kwik Cell component, for use with the CDI Model 400 Blood Gas Monitoring System.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state numerical acceptance criteria for functional performance (e.g., pH difference

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The IBC Gas Cell component was developed for use with the CDI Model 300 Blood Gas Monitoring System manufactured by 3M. The IBC Gas Cell Component may be substituted for the CDI Gas Cell Component in the construction of Extracorporeal Custom Tubing Packs either by the manufacturer of such packs or by the end user to modify his or her pack as needed.

The IBC Gas Cell component was developed for use with the CDI Model 300 Blood Gas Monitoring System manufactured by 3M. The final geometry of the IEC Gas Cell component is identical to the final geometry of the 3M Gas Cell component, and both are fabricated from the same plastic materials. The functional properties of the Gas Cells are determined by the final assembly geometry and the materials employed in construction, especially the two membrane materials. The final geometry of the IBC and CDI components are identical. Using chemical analysis, electron microscopy and information in the public domain, the membranes were sourced from the same supplier used by 3M. The device employs three photochemical sensors to measure pO2, pCO2, and pH. Additionally, there is a thermo-electronic sensor for the direct measurement of temperature.

The provided text describes a 510(k) summary for the IBC Gas Cell Component, demonstrating its equivalence to the CDI Gas Cell Component for use with the CDI Model 300 Blood Gas Monitoring System. The study primarily focuses on functional equivalence, assembly integrity, toxicity, and sterilization compatibility.

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of predetermined acceptance criteria in a quantitative format as one might expect for a modern regulatory submission. Instead, the acceptance criterion for the functional evaluation appears to be that the IBC Gas Cell component performs identically or shows no significant difference compared to the predicate CDI Gas Cell component. For other evaluations (assembly integrity, toxicity, sterilization), the criterion is generally "no leaks detected," "meet U.S.P. Plastic Class 6," "non-hemolytic," "low bioburden," and "meet FDA recognized standards for ethylene oxide residues."

2. Sample Size Used for the Test Set and Data Provenance

• Functional Evaluation:

  • Test Set Size: 10 IBC Gas Cell components and 10 CDI Gas Cell components were tested. Each component was subjected to a procedure that yielded 10 different readings for each parameter (pO2, pCO2, pH), resulting in 100 readings per component type for measured parameters. The table of results shows 10 samples (runs) for CDI and 10 samples (runs) for IBC, with averages based on these. For each run, multiple parameters were measured. The report mentions "200 data points for all measured and calculated parameters" which implies 100 for each.
  • Data Provenance: Prospective, simulated clinical setting using human blood (for initial priming) and later bovine blood (for clinical simulation leak test, hemolysis). The description doesn't explicitly state the country of origin of the blood, but the context is a US submission (510(k)).

• Assembly Integrity: 60 IBC Gas Cell Components.

• Clinical Simulation Leak Test: The same 60 samples from the Assembly Leak Test.

• Sensor Seal Integrity: 10 samples from the Assembly Leak Test section.

• Toxicity Testing (USP Class 6): Samples of clear plastic housing, elastomer seal, opaque white membrane, and clear membrane. (Number of samples not specified, but typically conducted on material batches).

• Hemolysis: 10 IBC gas cell components and 10 CDI gas cell components.

• Bioburden, ETO Residues, Pyrogenicity: Samples of the device (number not explicitly stated but sufficient for testing).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Functional Evaluation: The "ground truth" for the blood gas parameters (pO2, pCO2, pH) was established by an Instrumentation Laboratories Model 1420 Blood Gas Analyzer and an Instrumentation Laboratories Model 482 Co-Oximeter. These are reference laboratory instruments, not human experts.
• Other Tests (Integrity, Toxicity, Hemolysis, etc.): Ground truth was established by laboratory testing using established protocols (e.g., visual inspection for leaks, USP standards, GLP's, centrifugation for hemolysis). No human experts are mentioned as establishing ground truth in the sense of consensus reading from images or complex diagnoses.

4. Adjudication Method for the Test Set

Not applicable. The ground truth for functional performance was objective measurements from laboratory instruments. For other tests, it was objective laboratory results or visual inspection against defined criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, this was not an MRMC comparative effectiveness study. This study evaluated the performance of a medical device (a gas cell component) in measuring blood gas parameters, not a diagnostic imaging algorithm that would typically involve multiple human readers interpreting cases. The comparison was device-to-device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, this study is inherently a "standalone" evaluation of the device component. The IBC Gas Cell Component is a physical component that functions within a larger blood gas monitoring system. Its primary output is the measurement of blood gas parameters. The study directly measures how accurately this component (in conjunction with the monitoring system) determines these parameters compared to a laboratory reference standard. There is no "human-in-the-loop" interaction in the output of the measurements that are being specifically evaluated for the gas cell component itself.

7. The Type of Ground Truth Used

• Functional Evaluation (pO2, pCO2, pH): Objective measurements from reference laboratory instruments (Instrumentation Laboratories Model 1420 Blood Gas Analyzer and Model 482 Co-Oximeter).
• Calculated Parameters ([HCO3], BE, SAT): These were derived from the measured parameters by the CDI Model 300 system's internal programs. The accuracy of these calculations themselves was not the primary focus of the equivalence study, but their errors were reported for general interest.
• Assembly Integrity/Leak Tests: Visual inspection (e.g., for leaks, presence of cellular components).
• Toxicity: Compliance with USP Plastic Class 6 standards (laboratory testing).
• Hemolysis: Visual inspection of plasma fraction after centrifugation (straw colored vs. pink/red).
• Bioburden, ETO Residues, Pyrogenicity: Laboratory analysis per established methods (e.g., C.G. Laboratories standard methods, USP).

8. The Sample Size for the Training Set

Not applicable. This device is a physical component, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The term "training" in this document refers to calibration of equipment.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for an AI/ML algorithm.

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