(296 days)
The EndoPur Endotoxin 10" Filter Flat is intended to filter water used in hemodialysis devices. It assists in providing hemodialysis quality water. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (Reverse Osmosis, Deionization, etc.).
The EndoPur Endotoxin 10" Filter Flat is a hollow fiber ultrafilter that retains bacteria, viruses, endotoxin and particulate from water used in hemodialysis.
The document provided describes a 510(k) premarket notification for a medical device called the "EndoPur Endotoxin 10" Filter Flat." This device is a water purification filter for hemodialysis. The information primarily focuses on establishing substantial equivalence to a predicate device through non-clinical performance data.
Here's an analysis based on your request, highlighting what is and isn't available in the provided text:
1. Table of acceptance criteria and the reported device performance
The document doesn't explicitly present a formal table of acceptance criteria with corresponding performance results in a structured format. However, it lists the types of tests performed and implies that the results were "acceptable" or demonstrated "substantial equivalence."
| Test Category | Implied Acceptance Criteria (Based on context) | Reported Device Performance (Summary) |
|---|---|---|
| Flow Rate vs. Pressure Drop | Performance comparable to predicate devices. | Tested; implied to be acceptable and substantially equivalent to the predicate. |
| Pyrogen Removal | Effective removal of pyrogens (endotoxins). | Tested; implied to be acceptable and substantially equivalent to the predicate. |
| Virus Challenge Test | Effective removal/inactivation of viruses. | Tested; implied to be acceptable and substantially equivalent to the predicate. |
| Bacteria Challenge Test | Effective removal/inactivation of bacteria. | Tested; implied to be acceptable and substantially equivalent to the predicate. |
| Disinfection Compatibility | Compatible with specified disinfection processes. | Tested; implied to be acceptable and substantially equivalent to the predicate. |
| Biocompatibility Testing | Safe, with no significant extractables/leachables or toxicity concerns. | Exhaustive Extractable and Leach testing performed, evaluated by a toxicologist, and found to be safe. |
| Residual Levels (after disinfection) | Acceptable residual levels after disinfection processes on accelerated aged product, per ANSI/AAMI 13959. | All results were found to be acceptable. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document does not specify the sample sizes used for each of the performance tests (Flow Rate, Pyrogen Removal, Virus Challenge, Bacteria Challenge, Disinfection Compatibility, Biocompatibility).
- Data Provenance: The study was conducted by Nephros, Inc. (the device manufacturer) for regulatory submission to the FDA. The country of origin of the data is implicitly the USA, as Nephros, Inc. is located in River Edge, NJ. The data is retrospective in the sense that it was generated as part of a premarket notification for an existing device design.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The concept of "ground truth" as typically applied to diagnostic algorithms (e.g., expert consensus on clinical images) is not directly applicable here as this is a physical filter device. For the biocompatibility testing, a toxicologist was used to evaluate the exhaustive extractable and leach testing results and found them to be safe. The number of toxicologists is not specified (e.g., "a toxicologist" usually implies one unless otherwise stated).
4. Adjudication method for the test set
Not applicable. The tests performed are objective laboratory and engineering tests for device performance, not subjective assessments requiring adjudication like clinical image interpretation.
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 diagnostic device, and no MRMC studies or human-in-the-loop performance evaluations were conducted or are relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm. The "standalone performance" refers to the filter's ability to perform its function (e.g., removing contaminants) independently, which is what the "Assessment of Non-clinical Performance Data" describes.
7. The type of ground truth used
For the performance tests:
- Pyrogen Removal, Virus Challenge, Bacteria Challenge: The "ground truth" would be established by validated laboratory assays and measurement techniques for detecting and quantifying these biological contaminants (e.g., using known concentrations of pyrogens, viruses, or bacteria and measuring the reduction after filtration).
- Biocompatibility: The "ground truth" is established by standard toxicological assessment methods and guidelines (e.g., AAMI/ISO standards) which evaluate the potential for adverse biological reactions. The outcome is assessed by a toxicologist.
- Residual Levels: The "ground truth" is established by chemical analytical methods to quantify residual levels against pre-defined acceptable limits (e.g., as per ANSI/AAMI 13959).
8. The sample size for the training set
Not applicable. This device is not an AI/machine learning algorithm, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
§ 876.5665 Water purification system for hemodialysis.
(a)
Identification. A water purification system for hemodialysis is a device that is intended for use with a hemodialysis system and that is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. This generic type of device may include a water softener, sediment filter, carbon filter, and water distillation system.(b)
Classification. Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.