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The Capiox® RX05 Hollow Fiber Oxygenator/Reservoir device is intended to be used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during cardiopulmonary bypass surgery.

The integral heat exchanger is used to warm or cool blood and/or perfusion fluid as it flows through the device.

The (detachable) hardshell reservoir is used to store blood during extracorporeal circulation from both the venous line and the cardiotomy line (via gravity or vacuum assisted venous drainage procedures). The reservoir contains a venous section that is comprised of a filter and defoamer to facilitate air bubble removal. The cardiotomy section of the reservoir contains a filter to remove particulate matter and a defoamer to facilitate air bubble removal.

The Capiox® RX05 Oxygenator/Reservoir can be used in procedures lasting up to 6 hours.

The Capiox® RX05 is for use with neonatal and infant patients when the required blood flow rate will not exceed 1.5L/min.

The modified Capiox® RX05 Oxygenator utilizes porous fiber technology to facilitate the transfer of gases between a blood-phase environment and a gas-phase environment for the intent of satisfying the gas exchange needs of a patient during cardiopulmonary bypass surgery. A fiber bundle offers the porous membrane surface to sufficiently permit the movement of gases through the walls of the hollow fibers via diffusion.

The modified Capiox® RX05 device has an integrated heat exchanger that is comprised of stainless steel encased in a polycarbonate housing. The stainless steel acts as a heat transfer material that permits heat that is generated from a temperature controlled external water bath to transverse across the walls of the stainless steel to effect the necessary temperature change upon circulating blood.

The subject of this Special 510(k) is a modification being made to the detachable Hardshell Reservoir. The reservoir component remains identical to the design of the original reservoir that was cleared by FDA with K022115 - except that a positive pressure relief valve will be included on the lid of the reservoir. The intent of the relief valve is to eliminate excessive pressure that could accumulate in a reservoir during bypass procedures.

The materials that are used in the construction of the Capiox® RX05 Hollow Fiber Oxygenator/Hardshell Reservoir includes, but are not limited to, nylon, polycarbonate, stainless steel, polyvinyl chloride, polyester, polyester, polyester, polyethylene terephthalate, stainless, polyethylere and X CastingTN polyethylene and X-Coating™.

This document is a 510(k) Summary for a modified medical device, the Capiox® RX05 Oxygenator/Reservoir. It describes a modification to an existing, cleared device, specifically the addition of a positive pressure relief valve to the hardshell reservoir. The submission focuses on demonstrating substantial equivalence to the predicate device (Terumo's Capiox® RX05 Oxygenator/Reservoir - K022115).

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of predetermined acceptance criteria with corresponding performance results. Instead, it lists performance evaluations conducted to demonstrate substantial equivalence, implying that the acceptance criteria are met if these evaluations show performance equivalent to the predicate device or demonstrate the proper functioning of the new feature.

Based on the "Performance Evaluations" section and "Comparison of Performance," here's an inferred table:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions several "in-vitro performance evaluations" but does not specify the sample sizes used for any of the tests. It also does not provide details on the data provenance in terms of country of origin or whether studies were retrospective or prospective. All studies described are in-vitro (laboratory) tests, not human or animal studies.

3. 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)

This section is not applicable to this submission. The device is a medical oxygenator/reservoir, and the evaluations are engineering/performance tests, not image-based diagnostics requiring expert interpretation to establish ground truth. The "ground truth" here is the physical and functional performance of the device against predefined engineering specifications or equivalence to the predicate.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable. The evaluations are described as objective performance tests (e.g., pressure measurements, sterility tests, physical integrity tests), which typically do not involve human adjudication in the sense of consensus reading or conflict resolution. The results are likely binary (pass/fail) or quantitative measurements against a standard.

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

This section is not applicable. The device is a physical medical device (an oxygenator/reservoir), not an AI-powered diagnostic tool, and the submission does not involve human readers or AI assistance.

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

This section is not applicable. The device is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance evaluations described consists of:

• Engineering specifications/standards: For parameters like pressure relief, flow rates, and physical integrity.
• Predicate device performance data: For demonstrating substantial equivalence in performance where applicable.
• Validated sterilization protocols: To achieve the specified SAL.
• International standards (ISO 10993): For biocompatibility assessment.

This is primarily performance-based and regulatory standard-based ground truth, not clinical or diagnostic ground truth.

8. The sample size for the training set

This section is not applicable. The submission describes a device modification and performance testing, not the development or training of an algorithm or AI model.

9. How the ground truth for the training set was established

This section is not applicable for the same reason as point 8.

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The venous hardshell cardiotomy reservoir is used to collect, store and filter blood in extracorporeal circulation in cardiopulmonary bypass operations on pediatric patients for up to 6 hours: The reservoir can also be employed postoperatively as drainage and autotransfusion reservoir (e.g., for thorax drainage) to return the autologous blood to the patient which was removed from the thorax for the volume exchange.

The Neonatal and Pediatric Venous Hardshell Cardiotomy Reservoirs are developed for the use in the field of cardiopulmonary bypass operation. They are used as blood buffer in the extracorporeal circuit and as collecting and defoaming device for sucked blood. The Neonatal and Pediatric Reservoirs may be applied during the surgery in the extracorporeal circulation for collecting venous blood by gravitation or vacuum assist venous drainage (VAVD), air removal in venous blood, as a volume depot of blood, for collecting, defoaming and filtering cardiotomy blood. The Reservoirs may also be applied after the surgery on the intensive care unit for vacuum operated thoracic drainage and for the autotransfusion of autologous blood. If the application occurs in the intensive care unit the reservoir which was employed in the operation is usually used. The blood contacting surfaces are coated optionally with SOFTLINE Coating. The Neonatal and Pediatric Reservoirs are sterile and non-pyrogenic devices, for single use only and are not to be re-sterilized by the user.

Here's an analysis of the provided text, focusing on acceptance criteria and the study proving adherence:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" in the sense of specific thresholds for a device's performance metrics (e.g., "filtration efficiency must be >X%"). Instead, the acceptance criteria are framed as compliance with recognized standards and demonstrating substantial equivalence to predicate devices. The "reported device performance" is essentially a statement of compliance.

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

The document does not specify a sample size for any "test set" in the traditional sense of a clinical trial or large-scale device performance study. The testing described is primarily laboratory and bench testing against international standards (ISO 10993-1, ISO 15674) and direct comparison to a predicate device.

• Sample Size: Not specified.
• Data Provenance: The studies were likely conducted internally by the manufacturer (Maquet Cardiopulmonary AG) or by contracted laboratories, as part of the regulatory submission process.
• Retrospective or Prospective: Not explicitly stated, but typically, this type of non-clinical testing is prospective, meaning it's conducted specifically to support the 510(k) submission. There is no indication of patient data being used in this summary.

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

This information is not applicable and not provided in the document. The "ground truth" for this medical device (a cardiotomy reservoir) is established by adherence to recognized engineering standards (e.g., ISO) and functional performance metrics, not by expert interpretation of data like in an AI/diagnostic imaging context. The "experts" involved would be engineers, biocompatibility specialists, and quality control personnel performing the tests according to standard protocols.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in studies involving human interpretation (e.g., reading medical images) where there can be disagreement among experts. For device performance testing against objective standards (like ISO norms for a physical device), the results are typically quantitative measurements that either pass or fail the specified criteria, not subjective interpretations requiring adjudication.

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

This information is not applicable and not provided. This document describes a physical medical device (a blood reservoir) and its regulatory clearance based on substantial equivalence and compliance with standards. It is not an AI algorithm or a diagnostic imaging device that would involve human readers or AI assistance.

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

This information is not applicable and not provided. The device is a physical hard-shell cardiotomy reservoir, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on:

• Compliance with International Standards: Specifically ISO 10993-1 (Biologic Evaluation) and ISO 15674 (Hard-shell cardiotomy/venous reservoir systems). These standards define performance characteristics, safety requirements, and test methods.
• Comparison to Predicate Devices: Demonstrating that the new device performs as safely and effectively as legally marketed predicate devices (Capiox Reservoir RX 05 Baby and Resevoir D101 Dideco Kids Infant) in terms of indications for use, integrity, performance, biocompatibility, and sterility.

No pathology, expert consensus, or outcomes data from patients are mentioned for establishing the "ground truth" of the device itself for this 510(k) submission.

8. The Sample Size for the Training Set

This information is not applicable and not provided. There is no "training set" as this is not an AI/machine learning device.

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

This information is not applicable and not provided. Since there is no training set for an AI model, there's no ground truth established in this context.

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The CAPIOX® Cardiotomy Reservoir is designed to facilitate the removal of particulate matter and micro air bubbles from blood that is aspirated from the thoracic cavity and/or the left ventricle, and store it during extra corporeal circulation. The device may be used for procedures lasting up to 6 hours.

The design of the CAPIOX® Cardiotomy Reservoir is comprised of a hardshell casing that serves as a blood containment system within the bypass circuit. The upper portion of the reservoir consists of a hardshell lid assembly that contains the necessary inlet ports and vent ports. The total capacity of the reservoir is 1000 mL. The cardiotomy section of the CAPIOX® Cardiotomy Reservoir contains a defoamer and a filter to facilitate air removal and the removal of particulates from suctioned blood entering the reservoir.

Here's a breakdown of the acceptance criteria and the study information for the CAPIOX® Cardiotomy Reservoir, based on the provided text:

Summary of Acceptance Criteria and Device Performance

The device's acceptance criteria are implicitly tied to demonstrating "substantial equivalence" to predicate devices. This means that its performance must be comparable to, and not raise new questions of safety or effectiveness compared to, established devices already on the market. The study aims to prove this equivalence.

• Pressure Drop Cardiotomy Section:
• Filtration Efficiency Cardiotomy Section:
• Effects Upon Cellular Blood Components:
• Pressure Integrity Testing:
• Tubing Connection Strength:
• Filter Breakthrough Time:
  (Detailed results for these specific tests are not provided in the text, only that the tests were conducted.) |

Study Details:

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: Not explicitly stated. The document refers to "comparative studies" and "tests were conducted" without providing specific numbers of devices or test runs. Given the nature of medical device testing (e.g., sterilization, biocompatibility, mechanical performance), it would involve a sufficient number of units to ensure statistical validity and representativeness, but the exact count is not given.
   • Data Provenance: Not explicitly stated. However, given that Terumo Cardiovascular Systems (a US-based company) is submitting a 510(k) to the FDA, it is highly likely the testing was conducted in the US or in facilities compliant with US regulatory standards. The testing appears to be prospective in nature, as it was conducted specifically to demonstrate equivalence for this new device submission.

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

   • This type of device (a cardiotomy reservoir) does not typically involve expert consensus for "ground truth" in the way a diagnostic AI algorithm might. The "ground truth" for its performance is established through objective engineering and biological tests (e.g., measuring filtration efficiency, pressure drop, cellular damage, sterility, biocompatibility) against predetermined specifications or established predicate device performance.
   • Therefore, no information on the number or qualifications of experts establishing "ground truth" in this context is provided or relevant. The "ground truth" comes from the physical and chemical properties of the device and its interaction with blood.

3. Adjudication Method for the Test Set:

   • Not applicable. Adjudication methods like "2+1" or "3+1" are relevant for subjective interpretations (e.g., image reading by radiologists) used to establish ground truth for AI algorithms. For medical devices like this, the performance is measured objectively through assays and tests, not subjective expert judgment.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. The CAPIOX® Cardiotomy Reservoir is mechanical blood processing device, and its evaluation does not involve human "readers" or diagnostic tasks that would benefit from such a study.

5. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):

   • Not applicable. This device is not an algorithm or AI system. Its performance is inherently standalone in the sense that it functions physically and biologically without human "input" for its core operation (processing blood). The "standalone performance" is what the various engineering and biological tests were designed to assess.

6. Type of Ground Truth Used:

   • The "ground truth" is based on objective measurements, laboratory test results, and established standards. This includes:
     • Biocompatibility test results: Against ISO 10993 standards.
     • Sterilization validation: Against AAMI guidelines for SAL.
     • Physical performance measurements: Such as filtration efficiency, pressure drop, pressure integrity, tubing connection strength, and filter breakthrough time, benchmarked against predicate devices.
     • Cellular effects: Assessment of impact on blood components.

7. Sample Size for the Training Set:

   • Not applicable. This device is not an AI or machine learning model, so there is no concept of a "training set." The device itself is manufactured, and its performance is evaluated, not "trained."

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable, as there is no training set for a mechanical medical device like this.

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