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The Hollow Fibre Membrane Oxygenator HMO 1010 is intended for use in an extracorporeal perfusion circuit to oxygenate blood and remove carbon dioxide and to temper blood during short duration cardiopulmonary bypass procedures lasting 6 hours or less.

The Hollow Fibre Membrane Oxygenator Quadrox HMO 1010 is a blood gas exchanger with integrated heat exchanger. In open heart surgery it is used in an extracorporeal perfusion circuit first to oxygenate blood and remove carbondioxide second to regulate the blood temperature during short duration cardiopulmonary bypass procedures lasting 6 hours or less.

The oxygenation system is principally based on microporous polypropylene hollow fiber membranes. The heat exchanger is made of thight polyethylene fibers. The QUADROX consists of two membrane compartments. In the first chamber of the oxygenator, sheets of heat exchanger fibers and sheets of microporous oxygenation fibers are arranged crosswise. In the second chamber only sheets of the oxygenation fibers are arranged.

Blood enters the housing via the inlet connector and is distributed into a pre-chamber. Then the blood streams through the membrane package. In the first section it is tempered and oxygenated. In the second part only oxygenation and removal of carbondioxide takes place.

Positioned and integrated at the top of the oxygenator is a de-airing membrane. This membrane is a hydrophobic membrane allowing only gaseous substances to pass through the membrane but fluids are held back. The de-airing membrane allows easier priming, deairing and elimination of air throughout the whole procedure. To prime the oxygenator the Luer cap has to be removed. It should be kept open during perfusion to eliminate air continuously.

Acceptance Criteria and Device Performance for Jostra Medizintechnik AG Hollow Fibre Membrane Oxygenator Quadrox HMO 1010

This document outlines the acceptance criteria and performance data for the Hollow Fibre Membrane Oxygenator Quadrox HMO 1010, based on the provided 510(k) summary. The device was found to be substantially equivalent to the Affinity Hollow Fiber Oxygenator by Avecor Cardiovascular, Inc.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the substantial equivalence determination to the predicate device. The performance data for the Quadrox HMO 1010 are compared to the predicate device's specifications.

Note: For parameters listed as "unknown" for the predicate device, the performance of the Quadrox HMO 1010 was assessed against general safety and effectiveness standards, and determined to be acceptable. The critical factor for substantial equivalence is that these differences do not raise new questions of safety or effectiveness.

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

The document does not explicitly state the sample size for specific "test sets" in the traditional sense of a clinical study. The evaluation primarily relies on in-vitro bench testing and in-vivo animal testing. The provenance of this data is Germany, where Jostra Medizintechnik AG is located. The nature of the data is likely retrospective as it compares the new device to an existing predicate.

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

This information is not provided in the summary. For device testing of this nature (bench and animal), the ground truth is established through standardized testing protocols and measurements, rather than expert consensus on diagnostic interpretation.

4. Adjudication Method for the Test Set

Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or patient outcomes. For this type of device submission, which focuses on in-vitro and animal testing, an explicit adjudication method is not applicable or described. Performance is evaluated against objective measurements and established scientific criteria.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study was not conducted as described in the provided summary. This type of study is more relevant for diagnostic AI devices where human reader performance is a key metric. The current submission focuses on the safety and effectiveness of a medical device (oxygenator) through physical/chemical performance and biocompatibility.

6. Standalone Performance Study

A standalone (algorithm only without human-in-the loop performance) study was not explicitly conducted. However, the in-vitro bench testing and animal testing can be considered a form of standalone performance evaluation for the device itself, independent of human interaction beyond standard operational procedures. This evaluated the device's technical specifications and functionality directly.

7. Type of Ground Truth Used

The ground truth for the device's performance was established through:

• Objective Measurements: For in-vitro bench testing (e.g., membrane surface area, priming volume, flow rates, pressure, heat exchanger performance factor, integrity testing).
• Standardized Biological Evaluation: For biocompatibility (in accordance with FDA Blue Book Memorandum - #G95-1, ISO 10993-1, and United States Pharmacopeia - XXIII), blood cell damage, sterility assurance level (SAL), EtO residuals, and pyrogen testing (Limulus Amebocyte Lysate (LAL) method).
• Physiological Outcomes: For in-vivo animal testing, though specific outcome measures are not detailed in this summary.

There is no mention of pathology or human patient outcomes data being used as ground truth for this specific application.

8. Sample Size for the Training Set

This information is not applicable or provided. The development of this medical device (oxygenator) does not involve a "training set" in the context of machine learning. The device design and manufacturing rely on engineering principles, materials science, and established medical device standards.

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

As there is no "training set" in the machine learning sense for this device, this question is not applicable. The underlying principles and data used for design and manufacturing are based on scientific understanding of cardiopulmonary bypass, material properties, and regulatory standards.

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The Jostra HL-20 Twin Pump is intended for use as an extra corporeal circulation device for perfusion appropriate to cardiopulmonary bypass procedures of six hours or less. It is only intended for use with the Jostra HL-20 Heart Lung Machine.

Not Found

The provided text describes a 510(k) submission for the Jostra HL-20 Twin Pump, aiming to demonstrate its substantial equivalence to a predicate device, the Jostra HL-20 Single Head Roller Pump. The submission focuses on functional and design similarities, rather than a clinical study evaluating diagnostic performance. Therefore, many of the requested categories for AI/diagnostic device studies (like sample size, ground truth, expert qualifications, MRMC studies, standalone performance) are not applicable or cannot be extracted directly from this document.

However, I can extract the acceptance criteria and performance related to the engineering and safety standards that the device adheres to, as this is the basis of the equivalence claim.

Acceptance Criteria and Reported Device Performance

Study Details (as inferable from the document, recognizing this is not a diagnostic AI study):

1. Sample size used for the test set and the data provenance: Not applicable. This is not a study involving a "test set" of patient data for diagnostic performance. The "performance data" mentioned in F and G likely refers to engineering tests and measurements on the device itself to verify it meets the specified standards.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic purposes is not established here. The "ground truth" in this context is adherence to established engineering and safety standards (e.g., IEC, EU Directives).
3. Adjudication method: Not applicable.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is not a diagnostic device or an AI system that interacts with human readers in a diagnostic context.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No. This is a mechanical/electronic medical device, not an algorithm.
6. The type of ground truth used: Not applicable in the context of diagnostic performance. The "ground truth" for the device's substantial equivalence claim is its conformity to established international safety and performance standards (e.g., EN93/42, IEC 601-1, EU 89/336).
7. The sample size for the training set: Not applicable. This device does not use machine learning or require a training set.
8. How the ground truth for the training set was established: Not applicable.

Summary of the "Study" (Demonstration of Equivalence):

The "study" or demonstration of equivalence for the Jostra HL-20 Twin Pump involves:

• Comparison to a Predicate Device: The new device (Twin Pump) is compared to a legally marketed predicate device (Single Head Roller Pump) regarding indications for use, technological characteristics (design, materials), and safety/effectiveness concerns.
• Adherence to Standards: Performance data (Attachment #5, not provided here) was submitted to demonstrate that the Twin Pump performs within its specifications and meets the acceptable limits of several key performance and safety standards:
  • EU Council Directive 93/42/EEC (General Medical Devices)
  • IEC 601-1, 2nd Edition: 1988 (Safety of Medical Electrical Equipment, Part 1: General Requirements)
  • EMC Directive 89/336/EEC 1993 (Electromagnetic Compatibility)
• Conclusion: The provided data demonstrated that the HL-20 Twin Pump model is "similar in materials, design and function to that of the predicate device" and that its performance falls within acceptable limits relative to established safety and performance standards. This leads to the FDA's determination of substantial equivalence.

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