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510(k) Data Aggregation
(88 days)
The Venofer Pump is an optional accessory for use with the Fresenius 2008 Series Hemodialysis Machines and is intended to administer Venofer® to treat iron deficiency anemia in patients with chronic kidney disease undergoing hemodialysis, where Venofer®, in conjunction with hemodialysis, is prescribed by a physician.
The Venofer Pump is an optional module for use on Fresenius 2008 Series Hemodialysis Machines and is designed to administer Venofer® during dialysis treatments and consists of a control panel, vial holder, fluid detector, and a peristaltic pump. The module is a self contained microprocessor controlled device that receives its power from the Fresenius 2008 Hemodialysis machine.
The provided text describes the Venofer Pump Version 1.3, an optional accessory for hemodialysis machines. This submission is a "Special 510(k)" for modifications to support the use of an additional blood tubing set. The document focuses on demonstrating substantial equivalence to a previously cleared device (K103564) and confirming that the modifications do not raise new questions of safety or effectiveness.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Verification Tests Conducted | Reported Device Performance/Outcome |
|---|---|---|
| Venofer Pump Performance | Functional testing to demonstrate the device performs as designed and expected. | The performance (verification) test results support the performance characteristics of the Venofer Pump. It was confirmed that the device does not perform in an unexpected and/or unsafe manner (system-level hazard analysis). Specific details of the performance metrics are not explicitly provided beyond this general statement. |
| Venofer Pump Safety | Electromagnetic compatibility (EMC) testing (IEC 60601-1-2: 2007) | Product safety testing demonstrates that the device performs per the FDA Consensus Standards. This specifically includes EMC testing. |
| Biocompatibility testing (AAMI / ANSI / ISO 10993-1:2009) | Biocompatibility testing was performed on all new materials that are patient-fluid contacting. The verification test results support the safety characteristics of the Venofer Pump. (No specific numerical results or pass/fail criteria are provided, only that testing was performed and supported safety). | |
| Venofer Pump Software | Software architecture SDD (Software Design Description) Unit test System and software requirements Traceability | Software testing demonstrates the device software meets the design input requirements. The testing includes required documentation as described in the guidance titled "Guidance for the Content of Premarket Submissions for Software." (No specific metrics like bug rates, code coverage, or pass/fail percentages are provided, only a general statement of meeting design input requirements and review of documentation). The phrase "Software release history" is also listed as documentation reviewed, suggesting a process was followed. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set for any of the verification activities (functional, safety, or software).
The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective. The studies described are non-clinical (verification) testing, not clinical trials on human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. Given that the studies are non-clinical verification tests, the "ground truth" would likely be established by engineering specifications, regulatory standards, or consensus standards, rather than expert clinical judgment in the traditional sense for medical imaging or diagnostic devices.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving human readers/interpreters, not for non-clinical device verification testing.
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
No MRMC comparative effectiveness study was done. This device is a pump for administering medication, not an AI-powered diagnostic or assistive device for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
No standalone algorithm performance study was done in the context of AI. The "standalone" performance described would be the functional performance of the pump itself, which was tested during "Venofer Pump Performance Testing." The device is a physical pump, not a diagnostic algorithm.
7. The Type of Ground Truth Used
For the non-clinical verification testing described:
- Performance Testing: The "ground truth" would be the device's design specifications and expected functional behavior.
- Safety Testing: The "ground truth" would be established by FDA Consensus Standards (e.g., IEC 60601-1-2 for EMC, AAMI / ANSI / ISO 10993-1 for biocompatibility).
- Software Testing: The "ground truth" would be the software design input requirements and functional specifications.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided. The Venofer Pump is a physical medical device, not an AI/machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and therefore not provided. As mentioned above, the device is not an AI/machine learning algorithm.
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