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2008K@home Hemodialysis Machine Indications for Use

The Fresenius 2008K@home is indicated for acute and chronic dialysis therapy in an acute or chronic facility. The 2008K@home is also indicated for hemodialysis in the home and must be observed by a trained and qualified person as prescribed by their physician .:

Wireless Wetness Detector (Wet Alert) Indications for Use

The Wireless Wetness Detector is indicated for use with the Fresenius 2008K@home Hemodialysis Machine and is an optional accessory to aid in the detection of blood and water leaks during hemodialysis. Home hemodialysis using the detector must be observed by a trained and qualified person as prescribed by their physician.

The 2008K@home Hemodialysis Machine with Wireless Detector is intended for short term (acute) and long term (chronic) dialysis treatment in a clinical facility and at home. In the home, a trained and qualified person must observe treatment as prescribed by a physician.

The 2008K@home Hemodialysis Machine is designed to provide hemodialysis treatment by controlling and monitoring both the dialysate and extracorporeal blood circuits. In the extracorporeal blood circuit, blood is continuously circulated from the patient through a dialyzer, where toxins are filtered out through a semi-permeable membrane, and returned to the patient. During this process, the extracorporeal blood circuit is monitored for venous and arterial blood pressures, and for the presence of air and blood.

The Wireless Wetness Detector system (branded as WetAlert) is an optional accessory to the 2008K@home. It is a multi-use, battery-powered device capable of detecting fluid leaks (i.e., blood or other conductive fluids). During treatment, the Wireless Wetness Detector transmits radio signals to the corresponding 2008K@home Hemodialysis Machine and will alert the 2008K@home Hemodialysis Machine if it detects a blood or water leak. During a wetness alarm, the 2008K@home Hemodialysis Machine will automatically stop the blood pump, close the venous clamp, and sound an alarm.

Modifications to the previously cleared 2008K@home with Wireless Wetness Detector system include:

• . 2008K@home Hemodialysis Machine- Replace the single receiver system with a dual antenna/receiver configuration for reception durability.
• . Wireless Wetness Detector- Change the Wireless Wetness Detector device body from a solid over-molded enclosure to a hollow, lighter weight, two-part bonded plastic case.
• . Wireless Wetness Detector- Modify the software to enhance the electrostatic immunity of the device.
• 2008K@home WetAlert Home User's Guide- The guide is being separated into a clinical . and a home version. Additional modifications include instructions and descriptions of changes.

The request describes the acceptance criteria and study that proves the device meets them, but the provided text does not contain detailed acceptance criteria or specific study results for quantitative performance metrics. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing exhaustive performance data.

However, based on the information provided, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list quantitative acceptance criteria with corresponding performance metrics. Instead, it states that "All testing...met the acceptance criteria." The overall acceptance criterion is based on demonstrating "substantial equivalence" to the predicate device in terms of safety and effectiveness, and functioning "as intended."

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

The document does not specify the sample size for the test set. It mentions "Design verification and validation tests were conducted," but does not provide details on the number of devices or scenarios used in these tests.

The data provenance is not explicitly stated as retrospective or prospective, nor does it mention the country of origin. The testing was conducted "according to existing FMCNA procedures, protocols, declared performance standards and guidelines of the quality system regulation (21 CFR 820)" by the manufacturer (Fresenius Medical Care North America) based in Waltham, MA, USA.

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

The document does not mention the use of experts to establish ground truth for testing. The testing appears to be based on engineering and performance validation against predefined specifications and regulatory guidelines rather than expert consensus on subjective data.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of adjudication methods as the testing described is technical verification and validation, not involving human interpretation of data for ground truth establishment.

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

No, an MRMC comparative effectiveness study was not done. The document focuses on the technical performance of the device and its equivalence to a predicate, not on human reader performance with or without AI assistance. The device is a "Wireless Wetness Detector" for fluid leaks, not an AI diagnostic tool.

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

Yes, standalone performance testing of the device was done. The "Wireless Wetness Detector system" is a device that autonomously detects fluid leaks, transmits signals, and triggers alarms and machine responses. The performance data discussed (wireless verification, electromagnetic compatibility, mechanical testing) all relate to the standalone function of the device and its components. The document explicitly states, "The performance of the modified 2008K@home machine and Wireless Wetness Detector (WetAlert) system was evaluated according to existing FMCNA procedures, protocols, declared performance standards and guidelines..." implying autonomous testing.

7. The Type of Ground Truth Used

The ground truth used for testing would be objective, measurable conditions for leak detection and system response. For example:

• Leak Detection: Actual presence or absence of conductive fluid (blood or water) in controlled experimental setups.
• Wireless Performance: Successful transmission and reception of signals under various conditions.
• Electromagnetic Compatibility: Adherence to established standards for emissions and immunity.
• Mechanical Integrity: Resistance to physical stress as per engineering specifications.

These are established by engineering standards and controlled experiments rather than expert consensus on subjective data.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI. This device is an electromechanical system with software for control and signal processing, not a learning-based AI system that requires a training set.

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

Not applicable, as there is no mention of a training set for an AI/machine learning model.

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2008K@home Indications for Use:

The Fresenius 2008K@home is indicated for acute and chronic dialysis therapy in an acute or chronic facility. The 2008K@home is also indicated for hemodialysis in the home and must be observed by a trained and qualified person as prescribed by their physician.

Wireless Wetness Detector Indications for Use:

The Wireless Wetness Detector is indicated for use with the Fresenius 2008K@home hemodialysis machine and is an optional accessory to aid in the detection of blood and water leaks during hemodialysis. Home hemodialysis using the detector must be observed by a trained and qualified person as prescribed by their physician.

The Fresenius 2008K@home machine is a modified version of the 2008K 3stream hemodialysis machine. Modifications to the device interface are designed to improve and simplify the training and process of performing hemodialysis. This modified user interface is intended to make it easier for patients and/or their caregivers to deliver hemodialysis safely and effectively in the home environment.

Additionally, the wireless wetness detector (WetAlert), an optional accessory to the 2008K@home, is a disposable device that detects leaks. During treatment, the WetAlert device transmits radio signals to the corresponding 2008K@home hemodialysis machine and alerts the machine if it detects a blood or water leak. During a wetness alarm, the 2008K@home hemodialysis machine will automatically stop the blood pump, close the venous clamp, and sound an alarm.

The provided text describes the acceptance criteria and the study that proves the device meets them for the Fresenius 2008K@home with Wireless Wetness Detector.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Clinical Safety Data: Over 500 in-center and 500 home hemodialysis treatments were evaluated for safety. The provenance (country of origin) is not explicitly stated, but the submission is from "Fresenius Medical Care North America," suggesting the data is likely from North America. The data is retrospective, as it mentions "collected and evaluated safety data."
• Clinical Treatment Adequacy and Safety: 29 subjects who transitioned from in-center to home hemodialysis were evaluated. The provenance is not explicitly stated. The study type (retrospective/prospective) is not specified.
• Usability Testing: Conducted in "clinic and home settings." The sample size for usability testing is not specified. The provenance is not explicitly stated.
• Non-clinical Testing (Software, EMC, Electrical Safety, Full System): The sample size for these tests is not quantified in terms of units tested, but rather refers to the comprehensive nature of the testing. The data provenance is not specified.

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

The document does not explicitly state the number of experts used or their specific qualifications for establishing ground truth for any of the clinical or non-clinical studies. The clinical studies evaluated "safety data" and "treatment adequacy," implying clinical assessment by qualified medical professionals, but this is not detailed.

4. Adjudication Method

The adjudication method for any of the test sets (clinical or non-clinical) is not specified in the provided text.

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

No MRMC comparative effectiveness study is mentioned in the provided text, nor is there any discussion of AI assistance or human reader improvement with/without AI. This device is a hemodialysis machine with a wetness detector, not an AI-assisted diagnostic tool.

6. Standalone Performance Study (i.e., algorithm only without human-in-the-loop performance)

The document describes non-clinical performance (software, EMC, electrical safety, full system validation) and clinical performance studies, which involve the device functioning. The Wireless Wetness Detector functions "automatically stop the blood pump, close the venous clamp, and sound an alarm" during a wetness alarm. This indicates a standalone algorithmic function for detection and response.

7. The Type of Ground Truth Used

• Non-clinical Data: The ground truth for non-clinical tests (software validation, EMC, electrical safety, full system validation) would be based on engineering specifications, regulatory standards, and pre-determined functional requirements. "Pre-determined acceptance criteria" are explicitly mentioned.
• Clinical Safety Data: The ground truth for safety would be based on clinical outcomes, adverse event reporting, and standard medical safety assessments.
• Clinical Treatment Adequacy: The ground truth for treatment adequacy would be established by clinical measures of dialysis effectiveness (e.g., clearance rates, patient well-being, lab results), likely compared against established medical standards for hemodialysis.
• Usability Testing: The ground truth for usability would be based on observations of user interaction, task completion rates, error rates, and user feedback, evaluated against pre-defined usability criteria for safe and effective operation in both clinic and home environments.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI. The device described does not appear to be an AI/ML-based diagnostic or prognostic tool that would typically involve a separate training set for algorithm development. The "performance data" refers to validation and evaluation of the device as a whole.

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

As there is no explicit mention of a "training set" for an AI/ML algorithm, this question is not applicable based on the provided text. The ground truth for the device's intended function and performance was established through the various non-clinical and clinical testing methods described above, against pre-determined acceptance criteria and established medical standards for hemodialysis.

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The Fresenius 2008K is indicated for acute and chronic dialysis therapy.

The Fresenius 2008K and the Fresenius 3008 proportion concentrate and prepare and deliver deaerated dialysate fluid at the desired conductivity, temperature and specified pressure. The ultrafiltration control method is identical in both the Fresenius 2008K and the Fresenius 3008. which control ultrafiltration during dialysis by withdrawing a defined volume of fluid from the closed dialysate circuit. The primary difference between the Fresenius 2008K and the 3008 is the new user interface.

The provided text is a 510(k) Premarket Notification for the Fresenius 2008K Dialysate Delivery System. This submission focuses on demonstrating substantial equivalence to a predicate device (Fresenius 3008 Dialysate Delivery System) rather than proving performance against specific acceptance criteria for a new type of diagnostic or AI-powered device.

Therefore, many of the requested categories related to acceptance criteria, study design for performance, ground truth establishment, expert involvement, and AI-specific metrics (like MRMC studies or effect size of AI assistance) are not applicable to this type of regulatory submission.

Here's an analysis based on the available information:

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

• Not Applicable. This 510(k) submission for the Fresenius 2008K Dialysate Delivery System does not establish new performance acceptance criteria in the way a submission for a novel diagnostic or AI device would. Instead, it aims to demonstrate that its performance is equivalent to an already legally marketed predicate device (Fresenius 3008). The "acceptance criteria" are effectively that the new device performs fundamentally the same and for the same intended use as the predicate.
• The document states: "The technological characteristics of the Fresenius 2008K are equivalent to those of the Fresenius 3008. Both the Fresenius 2008K and the Fresenius 3008 proportion concentrate and prepare and deliver deaerated dialysate fluid at the desired conductivity, temperature and specified pressure. The ultrafiltration control method is identical in both the Fresenius 2008K and the Fresenius 3008. which control ultrafiltration during dialysis by withdrawing a defined volume of fluid from the closed dialysate circuit."

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

• Not Applicable. There is no mention of a "test set" in the context of clinical data or patient samples as would be used for a diagnostic device. The evaluation relied on "software validation, functional testing, and release testing" of the device itself.
• The data provenance is industrial testing, not patient data.

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)

• Not Applicable. As there is no test set based on clinical cases requiring expert interpretation, no experts were used for this purpose. The device's functionality was evaluated against engineering and design specifications.

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

• Not Applicable. No clinical test set or human adjudication process is described.

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

• Not Applicable. This is not an AI-powered device.

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

• Not Applicable. This is not an AI-powered device. The device operates independently for its intended function (dialysate delivery).

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

• Operational Ground Truth: The "ground truth" for this device's performance is its ability to correctly proportion concentrate, prepare, and deliver dialysate fluid at specified conductivity, temperature, and pressure, and to perform ultrafiltration control as designed. This is verified through "software validation, functional testing, and release testing" conducted by the manufacturer, rather than clinical outcomes or expert labels.

8. The sample size for the training set

• Not Applicable. This is not a machine learning device, so there is no "training set." The device is built following established engineering principles and validated through testing.

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

• Not Applicable. There is no training set for this device.

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