(65 days)
The RenaPure filter is a bacterial and endotoxin retentive filter intended for use in a centralized loop as the final step of a water purification cascade to provide standard dialysis water to machine servicing multiple patients. This filter is not intended to service as the sole means of water purification and therefore must be used in conjunction with other water treatment equipment.
The RenaPure filter is a 20" cartridge style filter in a polypropylene casing that contains dual-layered, 0.22 micron polyethersulfone (PES) pleated membranes which are separated by polypropylene screen layers. The PES membrane is charge modified with a positive charge coating, similar to the predicate device, that aids in removal of endotoxin by charge attraction. Filter configurations are based on an industry standard 222 header design with silicone O-rings at the open end of the filter and flat or fin end caps at the closed end. The filter cartridge is installed in a durable filter housing and operates in a dead-end mode. The filter is designed to remove bacteria and endotoxin from water used in hemodialysis with similar water flow characteristics as the predicate device. The filter provided non-sterile.
The provided text describes the regulatory clearance of the RenaPure Endotoxin Retentive Filter and includes a summary of non-clinical performance assessment, but it does not contain information about:
- Acceptance criteria expressed as specific quantitative thresholds for device performance.
- A comparative study with human readers (MRMC study) or effect sizes of AI assistance.
- Standalone algorithm performance.
- Sample sizes for test sets or training sets in the context of an AI/algorithm study.
- Data provenance, number of experts for ground truth, or adjudication methods for an AI/algorithm study.
- Ground truth type for training data.
The document focuses on the physical and functional performance of a medical device (a filter) through bench testing and biocompatibility assessment, not on the performance of a diagnostic AI algorithm.
Therefore, I cannot fulfill your request as the necessary information regarding acceptance criteria, study details, and AI performance metrics (including expert involvement, sample sizes, and ground truth establishment) is not present in the provided text.
The "Performance (bench) testing" section within the "Non-clinical Performance Assessment" is the closest to describing a study, but it lacks the specific details requested concerning acceptance criteria, ground truth, and expert involvement usually associated with AI algorithm evaluation.
What the document does state about performance assessment:
- Study type: Non-clinical bench testing.
- Tests performed:
- Flow/Pressure Drop measurements
- Endotoxin Retention
- Bacterial Retention
- Compatibility to Hot Water and Chemical Disinfections
- Housing Fit tests
- Compatibility with Deionized water
- Results: "Testing demonstrated that the RenaPure filter met the intended design requirements and will operate as a drop-in replacement to the predicate device."
- Biocompatibility: A series of biocompatibility tests, including exhaustive extraction and toxicological risk assessment, were performed. "All biocompatibility testing passed and the risk of any toxic leachates from the RenaPure filter were considered negligible."
- Ground Truth: For these physical device tests, the "ground truth" would be established by the physical measurements and chemical analyses themselves, validated against engineering specifications and regulatory standards. There are no "experts" in the sense of clinical readers establishing ground truth for perception tasks.
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July 19, 2023
Evoqua Water Technologies LLC Robert Dudek Product Compliance Manager 558 Clark Road Tewksbury, Massachusetts 01876
Re: K231410
Trade/Device Name: RenaPure Endotoxin Retentive Filter Regulation Number: 21 CFR 876.5665 Regulation Name: Water purification systems for hemodialysis Regulatory Class: Class II Product Code: FIP Dated: May 1, 2023 Received: May 15, 2023
Dear Robert Dudek:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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801; medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Gema Gonzalez -S
Gema Gonzalez Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
RenaPure Endotoxin Retentive Filter
Indications for Use (Describe)
The RenaPure filter is a bacterial and endotoxin retentive filter intended for use in a centralized loop as the final step of a water purification cascade to provide standard dialysis water to machine servicing multiple patients. This filter is not intended to service as the sole means of water purification and therefore must be used in conjunction with other water treatment equipment.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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| Submitter | Evoqua Water Technologies LLC558 Clark RoadTewksbury MA, 01876Owner/Operator :10057016 |
|---|---|
| Contact Person | Robert DudekManager, Product Compliancerobert.dudek@evoqua.com(978) 614-7359 |
| Date Prepared | May 10, 2023 |
| Device Name | RenaPure® Endotoxin Retentive Filter |
| Trade Name | RenaPure® Filter |
| Classification Name | Water purification system for hemodialysis, 21 CFR 876.5665 |
| Device Class | Class II |
| Certification Panel | Gastroenterology/Urology |
| Product Code | FIP |
| Predicate Device | Gambro Posiclear Filter - K061782 |
| Device Description | The RenaPure filter is a 20" cartridge style filter in a polypropylene casing thatcontains dual-layered, 0.22 micron polyethersulfone (PES) pleatedmembranes which are separated by polypropylene screen layers. The PESmembrane is charge modified with a positive charge coating, similar to thepredicate device, that aids in removal of endotoxin by charge attraction. Filterconfigurations are based on an industry standard 222 header design withsilicone O-rings at the open end of the filter and flat or fin end caps at theclosed end. The filter cartridge is installed in a durable filter housing andoperates in a dead-end mode. The filter is designed to remove bacteria andendotoxin from water used in hemodialysis with similar water flowcharacteristics as the predicate device. The filter provided non-sterile. |
| Indications for Use | The RenaPure filter is a bacterial and endotoxin retentive filter intended foruse in a centralized loop as the final step of a water purification cascade toprovide standard dialysis water to machine servicing multiple patients. Thisfilter is not intended to service as the sole means of water purification andtherefore must be used in conjunction with other water treatment equipment. |
| TechnologicalCharacteristics | Retention of bacteria by size exclusion (membrane pore size) and retention ofendotoxin by charge attraction (charge modified membrane) is achieved inthe same way for both the RenaPure filter and the predicate device. Materialsof construction are similar to the predicate device, with the exception that apolyethersulfone base membrane is used, this providing better heat stabilityfor hot water disinfection routines performed during use of the device. |
| Non-clinicalPerformanceAssessment | Performance (bench) testing has been performed which included (a) |
| Flow/Pressure Drop measurements, (b) Endotoxin Retention, (c) Bacterial | |
| Retention, (d) Compatibility to Hot Water and Chemical Disinfections, (e)Housing Fit tests, and (f) Compatibility with Deionized water. Testingdemonstrated that the RenaPure filter met the intended design requirementsand will operate as a drop-in replacement to the predicate device. | |
| Biocompatibility | A series of biocompatibility tests was performed on the RenaPure filter based |
| on it being used as an externally communicating, indirect blood contact | |
| device. This testing also included an exhaustive extraction test to identify | |
| extractables/leachables from the RenaPure filter followed by a toxicological | |
| risk assessment. Additional biocompatibility tests were performed after | |
| exposing the RenaPure to simulated hot water disinfection and chemical | |
| disinfection routines. All biocompatibility testing passed and the risk of any | |
| toxic leachates from the RenaPure filter were considered negligible. | |
| Conclusion |
510(k) Summary: RenaPure® Endotoxin Retentive Filter
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§ 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.