(67 days)
Revaclear hemodialyzers/diafilters are intended to purify blood in hemodialysis and hemodiafiltration. Revaclear devices are indicated for the treatment of chronic or acute renal failure.
The Revaclear hemodialyzers/diafilters are intended to purify blood in hemodialysis and hemodiafiltration. Revaclear devices are for single use, steam sterilized with sterile and non-pyrogenic fluid pathways. Revaclear devices are part of an extracorporeal system for dialysis treatments to be used under care of trained professionals of dialysis centers or hospitals. The Revaclear hemodialyzer family uses the hollow fiber dialyzer technology. Blood enters a blood inlet port, where it is distributed into membrane hollow fibers. At either end of the device, the membrane hollow fibers are potted in polyurethane to isolate the blood compartment from the dialysate compartment. By means of hydrostatic pressure, or transmembrane pressure (which is created by a combination of positive and negative pressures across the membrane), water along with certain low molecular weight solutes of the plasma pass through the membrane to the filtrate or dialysate compartment of the device. Toxins and waste products are removed from the patient's blood by means of diffusion and convection; they are eliminated via the dialysate/filtrate and the membrane during the treatment session. The dialysate exits the device via a dialysate/filtrate outlet port.
The provided text describes a 510(k) premarket notification for a medical device, the Revaclear hemodialyzer. The information is largely focused on demonstrating substantial equivalence to a predicate device based on technological characteristics and performance testing.
However, the document does not contain the kind of detailed information about acceptance criteria and study designs that would typically be found for an AI-based medical device. Specifically, it lacks:
- Acceptance criteria for AI performance: There are no metrics like sensitivity, specificity, AUC, or F1-score listed with numerical targets.
- AI study design details: No mention of training sets, test sets, data provenance for AI (country, retrospective/prospective), number of experts for ground truth, adjudication methods, MRMC studies, standalone AI performance, or how ground truth was established for AI models.
The "Performance Data" section in the document refers to performance characteristics of the hemodialyzer itself, such as clearance rates and flow resistance, which are assessed according to ISO 8637-1:2017. These are engineering and biological performance metrics for a physical device, not for an AI algorithm.
Therefore, based solely on the provided text, I cannot describe the acceptance criteria and the study that proves an AI device meets those criteria, as the document pertains to a traditional medical device (hemodialyzer) and not an AI/ML product.
If we assume this document were for an AI device and hypothetically fill in the blanks based on common FDA requirements for AI/ML medical devices, it would look something like this:
Hypothetical Acceptance Criteria and Study for an AI-Based Device (Not based on the provided text)
This section outlines the hypothetical acceptance criteria and a study design for an AI/ML-based medical device, as the provided document pertains to a physical hemodialysis device, not an AI product.
1. Table of Acceptance Criteria and Reported Device Performance (Hypothetical for an AI Device)
Let's assume the AI device assists in detecting a specific medical condition from images.
| Acceptance Criterion (Hypothetical) | Target | Reported Device Performance |
|---|---|---|
| Primary Endpoint: | ||
| Area Under the Receiver Operating Characteristic Curve (AUC) | ≥ 0.90 | 0.92 |
| Secondary Endpoints: | ||
| Sensitivity (True Positive Rate) | ≥ 85% | 88% |
| Specificity (True Negative Rate) | ≥ 75% | 78% |
| F1-Score | ≥ 0.80 | 0.83 |
Note: These are hypothetical criteria and performance values for an AI diagnostic device, as the provided text describes a physical hemodialyzer.
2. Sample Size Used for the Test Set and Data Provenance (Hypothetical)
- Sample Size: 500 unique patient studies (e.g., medical images, lab results).
- Data Provenance:
- Country of Origin: Data sourced from multiple diverse institutions across the United States, United Kingdom, and Germany to ensure generalizability.
- Retrospective/Prospective: Primarily retrospective data collected over the past 5 years. A smaller prospective cohort of 50 cases was also included to validate acute performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications (Hypothetical)
- Number of Experts: Three board-certified clinical experts.
- Qualifications:
- Expert 1: Radiologist with 15 years of experience in the specific disease area.
- Expert 2: Pathologist with 12 years of experience and specialized knowledge in the disease's histopathology.
- Expert 3: Clinician (e.g., Oncologist or Cardiologist, depending on the disease) with 10 years of experience in patient management for the condition.
4. Adjudication Method for the Test Set (Hypothetical)
- Method: "2+1" Adjudication.
- Initial review by two independent experts.
- If the two experts agreed on the ground truth, that label was accepted.
- If the two experts disagreed, a third, senior expert (the "1" in 2+1) reviewed the case and made the final decision. Cases where even the third expert could not definitively establish ground truth were excluded from the primary test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study (Hypothetical)
- Was it done? Yes, an MRMC study was conducted to evaluate the impact of AI assistance on human reader performance.
- Effect Size of Improvement:
- Without AI Assistance (Human-Only Baseline): Average AUC = 0.75
- With AI Assistance (Human + AI): Average AUC = 0.85
- Effect Size: Human readers demonstrated a statistically significant improvement of 0.10 AUC points when assisted by the AI device compared to unassisted reading. This translates to a 13.3% relative improvement in diagnostic accuracy.
6. Standalone (Algorithm Only) Performance (Hypothetical)
- Was it done? Yes.
- Standalone Performance: The algorithm-only performance on the test set showed:
- AUC: 0.90
- Sensitivity: 86%
- Specificity: 77%
7. Type of Ground Truth Used (Hypothetical)
- Type of Ground Truth: Hybrid approach:
- Expert Consensus: Primary ground truth established by expert consensus (as per point 4).
- Pathology: Confirmed by histopathological diagnosis for all cases where tissue biopsy was available (considered the gold standard for many conditions).
- Outcomes Data: Long-term patient follow-up and clinical outcomes data (e.g., disease progression, response to treatment) were used to corroborate uncertain cases where pathology was not available.
8. Sample Size for the Training Set (Hypothetical)
- Sample Size: 10,000 unique patient studies.
- This included a mix of positive and negative cases, as well as various disease severities and typical confounders.
9. How Ground Truth for the Training Set Was Established (Hypothetical)
- Ground Truth Establishment:
- For the initial large training set, a combination of clinical reports, electronic health records (EHR), and a larger set of less stringent expert review (e.g., single expert review or review by clinical residents overseen by an attending) was used.
- A subset of the training data (e.g., 20%) was fully annotated and reviewed by multiple experts, similar to the test set ground truth establishment process, to ensure high-quality labels for critical boundary cases and rare examples.
- Automated extraction of positive findings from structured diagnostic reports was also utilized where reliability was high, followed by manual validation of a representative sample.
Crucially, none of the above hypothetical information regarding AI acceptance criteria and study details is present in the provided text. The provided text is solely about the performance and safety of a physical hemodialyzer.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 21, 2022
Baxter Healthcare Corporation % Alberto Pancanti Manager, Global Regulatory Affairs Gambro Dasco S.p.A via Modenese 66 Medolla. Modena 41037 ITALY
Re: K213639
Trade/Device Name: Revaclear 500, Revaclear 400, Revaclear 300 Regulation Number: 21 CFR 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: November 17, 2021 Received: November 18, 2021
Dear Alberto Pancanti:
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.
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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 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 mediation-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 Acting 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
510(k) Number (if known)
Device Name Revaclear 300 Revaclear 400 Revaclear 500
Indications for Use (Describe)
Revaclear hemodialyzers/diafilters are intended to purify blood in hemodialysis and hemodiafiltration Revaclear devices are indicated for the treatment of chronic or acute renal failure
| 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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Image /page/3/Picture/1 description: The image shows the Baxter logo on the left side of the image. On the right side of the image, the text "K213639" is at the top, and the text "Page 1 of 8" is below it. The logo is in blue.
Section 5. 510(k) Summary
Nov 17, 2021
OWNER:
Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015
CONTACT PERSON:
Alberto Pancanti Manager, Regulatory Affairs Via Modenese, 66 40137 Medolla (MO), ITALY Telephone: +39 346 1831285
IDENTIFICATION OF THE DEVICE:
| Common Name : | Dialyzer, high permeability with or without sealed dialysatesystem |
|---|---|
| Trade/Device Name: | Revaclear (Models 300, 400, 500) |
| Regulation Number: | 21 CFR 876.5860 |
| Regulation Name: | High permeability hemodialysis system |
| Regulatory Class: | Class II |
| Product Code: | KDI |
| Classification Panel: | 78 Gastroenterology and Urology |
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| Device | Company |
|---|---|
| Revaclear 500 (new and representative device forthis Pre-Market Notification 510(k))Revaclear 400 (currently cleared under K130039)Revaclear 300 (currently cleared under K130039) | Gambro Dialysatoren GmbH1 |
Table 1. Proposed Device
PREDICATE DEVICE:
Table 2. Predicate Device
| Device | Company | Predicate 510(k) | Clearance Date |
|---|---|---|---|
| Polyflux 210H | Gambro Dialysatoren GmbH1 | K0305922 | 05/23/2003 |
| 1 Acquired by Baxter Healthcare | |||
| 2 K030592 includes the Polyflux 140H, Polyflux 170H, and Polyflux 210H. Polyflux 210H was chosen as the predicatedevice as it is the most similar in size to the proposed device. |
REFERENCE DEVICE FOR THE TECHNONOGICAL AND BIOLOGICAL CHARACTERISTICS OF THE PROPOSED DEVICE:
Table 3. Reference Device
| Device | Company | Reference 510(k) /513(f)(2) (De Novo) | Clearance Date |
|---|---|---|---|
| Revaclear 400 | Gambro Dialysatoren GmbH1 | K1300391 | 05/02/2013 |
| Theranova 500 | Gambro Dialysatoren GmbH2 | DEN1900422 | 08/28/2020 |
| 1 K130039 included the Revaclear 300 and Revaclear 400. Revaclear 400 was chosen as the technological referencedevice as it has the same fundamental technological characteristics as the proposed device. |
2 DEN190042 included the Theranova 500. Theranova 500 was chosen as the biological device as it is made up of the same material as the proposed device.
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DESCRIPTION OF THE DEVICE:
The Revaclear hemodialyzers/diafilters are intended to purify blood in hemodialysis and hemodiafiltration.
Revaclear devices are for single use, steam sterilized with sterile and non-pyrogenic fluid pathways.
Revaclear devices are part of an extracorporeal system for dialysis treatments to be used under care of trained professionals of dialysis centers or hospitals.
The Revaclear hemodialyzer family uses the hollow fiber dialyzer technology, which is an existing technology that has been on the market for almost 50 years. The mechanism of action and principles of operation of the hemodialyzer device are as follows:
Blood enters a blood inlet port, where it is distributed into membrane hollow fibers. At either end of the device, the membrane hollow fibers are potted in polyurethane to isolate the blood compartment from the dialysate compartment. (one sentence removed) By means of hydrostatic pressure, or transmembrane pressure (which is created by a combination of positive and negative pressures across the membrane), water along with certain low molecular weight solutes of the plasma pass through the membrane to the filtrate or dialysate compartment of the device. Toxins and waste products are removed from the patient's blood by means of diffusion and convection; they are eliminated via the dialysate/filtrate and the membrane during the treatment session. The dialysate exits the device via a dialysate/filtrate outlet port.
Diffusion is the major transport mechanism for urea and other small molecules, while convective transport mainly removes large uremic molecules. Convective transport is driven by the fluid flow across the membrane. Fluid balance is controlled by a dialysis monitor that can control ultrafiltration (UF) to achieve the prescribed net weight loss (ultrafiltration UF). In HDF excess UF across the membrane is accomplished thereby enhancing the middle molecule removal in comparison to HD. The excess UF applied during HDF treatments necessitates a corresponding infusion of a substitution fluid controlled by the monitor.
The basis for this premarket notification is a modification to the Revaclear product line
The modifications consist of
-
- adding a new size, Revaclear 500, to the product family currently made up of Revaclear 300 and Revaclear 400 hemodialyzers. The Revaclear 500 design has a
K213639 Page 3 of 8
- adding a new size, Revaclear 500, to the product family currently made up of Revaclear 300 and Revaclear 400 hemodialyzers. The Revaclear 500 design has a
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larger diameter housing and an increase in the number of hollow fibers as compared to the biggest size of the current product family, Revaclear 400. The Revaclear 500, being the new proposed device, has been considered the representative device of the entire Revaclear products family for this Pre-Market Notification 510(k)
- updating the indication for use for all the sizes, as suggested by FDA in the 2. previous Pre-Market Notification 510(k) submitted for Revaclear 500 (K180790) The intent of this premarket submission is to have a unique 510(k) pre-market notification for all the Revaclear family devices, inclusive of Models 300, 400, and 500
Baxter proposes to harmonize the indication for use between in the USA and outside of the USA to one uniform indication, applicable worldwide, and consequently the labeling elements for Revaclear products family (Models 300, 400 and, 500) and to split the Indications for use into Intended Use/Purpose and Indication for clarity purpose, as per the following:
INTENDED USE / PURPOSE
Revaclear hemodialyzers/diafilters are intended to purify blood in hemodialysis and hemodiafiltration .
INDICATION
Revaclear devices are indicated for the treatment of chronic or acute renal failure.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:
The Revaclear 500 device has the same intended use as the predicate device. Gambro Polyflux 210H, excluding hemofiltration.
The Revaclear 500 device, labelled for single use, has the same design, materials, manufacturing process and function as the technological reference device, Revaclear 400 device. The predicate device, the Gambro Polyflux 210H, and technological reference device, the Revaclear 400 device, have been cleared for marketing in the United States under 510(k) premarket notifications K030592 and K130039, respectively. The intended population of the Revaclear 500 is identical to the predicate device, excluding patients requiring hemofiltration treatment.
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The membrane material used in the Revaclear 500 Device is a blend of polyarylethersulfone (PAES) and polyvinylpyrrolidone (PVP) which is identical to the membrane utilized in the technological reference devices Revaclear 400 and in the biological reference device Theranova 500.
Theranova 500 was granted marketing authorization under 513(f)(2) De Novo DEN190042 on Aug 28th 2020.
Table 4 provides a comparison of the proposed devices, the predicate device, and the technological and biological reference devices. These comparisons identify similarities and differences of the proposed devices to the current legally marketed devices to which substantial equivalency is claimed in terms of Indications for Use, Technological and Biological Characteristics.
| Table 4. Device Comparison for Proposed Device, Predicate Device, Technological | |
|---|---|
| and Biological Reference Devices |
| Features | Predicate DeviceGambro Polyflux210H (K030592) | TechnologicalReference DeviceRevaclear 400(K130039) | BiologicalReference DeviceTheranova 500(DEN190042) | Proposed DeviceAll Revaclear Models |
|---|---|---|---|---|
| IntendedUse | The capillarydialyzer/filter isintended for use inhemodialysis,hemodiafiltrationand hemofiltrationfor the treatment ofchronic or acuterenal failure | Revaclear 400 isindicated fortreatment of chronicand acute renalfailure byHemodialysis. | Theranova 500dialyzer is indicatedfor treatment ofchronic kidneyfailure byintermittenthemodialysis. | Revaclearhemodialyzers/diafiltersare intended to purifyblood in hemodialysisand hemodiafiltration |
| Indicationsfor Use | The capillarydialyzer/filter isintended for use inhemodialysis,hemodiafiltrationand hemofiltrationfor the treatment ofchronic or acuterenal failure. | Revaclear 400 isindicated fortreatment of chronicand acute renalfailure byHemodialysis. | Theranova 500dialyzer is indicatedfor treatment ofchronic kidneyfailure byintermittenthemodialysis. | Revaclear devices areindicated for thetreatment of chronic oracute renal failure. |
| Sterile | Yes | Yes | Yes | Same |
| Non-Pyrogenic | Yes | Yes | Yes | Same |
| Single Use | Yes | Yes | Yes | Same |
K213639 Page 5 of 8
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| Features | Predicate DeviceGambro Polyflux210H (K030592) | TechnologicalReference DeviceRevaclear 400(K130039) | BiologicalReference DeviceTheranova 500(DEN190042) | Proposed DeviceAll Revaclear Models |
|---|---|---|---|---|
| Materials | ||||
| Hollowfibermembrane | Blend ofPolyarylethersulfone(PAES),Polyvinylpyrrolidone(PVP), andPolyamide (PA) | Blend ofPolyarylethersulfone(PAES)Polyvinylpyrrolidone(PVP) | Blend ofPolyarylethersulfone(PAES)Polyvinylpyrrolidone(PVP) | Same |
| Pottingmaterial | Polyurethane (PUR) | Polyurethane (PUR) | Polyurethane (PUR) | Same |
| Housing | Polycarbonate (PC) | Polycarbonate (PC) | Polycarbonate (PC) | Same |
| Header | Polycarbonate (PC) | Polycarbonate (PC) | Polycarbonate (PC) | Same |
| Gasket /O-ring | Silicone rubber(SIR) | Silicone rubber(SIR) | Silicone rubber(SIR) | Same |
| Supportingring | Polypropylene (PP) | Polypropylene (PP) | Polypropylene (PP) | Same |
DISCUSSION OF NONCLINICAL TESTS:
Testing was conducted on the proposed devices, Revaclear 300, 400, 500. All test results meet the acceptance criteria, and support that the proposed device is appropriately designed for its intended use.
Performance Data:
The performance characteristics of the Revaclear 500 device were determined according to the requirements of ISO 8637-1:2017 - Extracorporeal systems for blood purification -Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators. Table 5 contains the performance testing completed on the proposed devices, Revaclear 300, 400, 500. Based on performance test results, the Revaclear 500 device performs as expected for its intended use in hemodialysis and hemodiafiltration for chronic and acute treatment of renal disease.
| Test | Acceptance Criteria | Results |
|---|---|---|
| Urea clearance | Tested in accordance to ISO 8637-1:2017 | |
| Creatinine clearance | Tested in accordance to ISO 8637-1:2017 | |
| Vitamin B12 clearance | Tested in accordance to ISO 8637-1:2017 |
Table 5 . Performance Testing Summary
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| Test | Acceptance Criteria | Results |
|---|---|---|
| Phosphate clearance | Tested in accordance to ISO 8637-1:2017 | |
| Flow resistance of bloodcompartment | Tested in accordance to ISO 8637-1:2017 | |
| Flow resistance ofdialysate compartment | Tested in accordance to ISO 8637:2004 | |
| Ultrafiltrationcoefficient (UFC) | Tested in accordance to ISO 8637-1:2017 | |
| Sieving coefficient | Tested in accordance to ISO 8637-1:2017 | |
| Ultrafiltration rate | Tested in accordance to ISO 8637-1:2017 |
| Table 5 . Performance Testing Summarv | ||||
|---|---|---|---|---|
| --------------------------------------- | -- | -- | -- | -- |
Biocompatibility:
Biocompatibility assessments have been conducted based on ISO-10993 Biological Evaluation of Medical Devices and FDA Guidance: Use of International Standard ISO 10993-1, issued September 4, 2020 to the category of external communicating device, body contact with circulating blood and long-term (> 30 days) contact duration. The battery of biological testing included the following tests:
- Cytotoxicity
- Sensitization
- Irritation/ intracutaneous reactivity
- Material Mediated Pyrogenicity
- Systemic toxicity (acute)
- Repeat dose systemic toxicity (30-days)
- Genotoxicity
- Hemocompatibility
In addition, chemical analyses were performed to characterize the materials and to identify and quantify potential leachables as recommended by ISO 10993-1 and ISO 10993-18. A toxicological risk assessment was performed per ISO 10993-17.
Based on chemical and biological test results, the Revaclear 500 Device is appropriate for its intended use in hemodialysis and hemodiafiltration for chronic and acute treatment of renal failure.
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Sterility:
The Revaclear 500 device is sterilized using a Terminal Moist Heat Sterilization process and achieves a Sterility Assurance Level (SAL) of 106. The Revaclear 500 sterilization process conforms to ISO 17665-1:2006 Sterilization of Health Care Products -- Moist Heat -- Part 1: Requirements for the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices.
Shelf Life:
The Revaclear devices has been tested to provide a three (3) year shelf-life claim.
CONCLUSION:
Testing performed on the Revaclear 500 indicates that the device is substantially equivalent and performs comparably to the technological and biological reference devices that are currently marketed. Apart from hemofiltration, the same Intended use and Indications is claimed for the proposed device compared to the predicate device. The Revaclear hemodiayzers family (Models 300, 400, and 500) are substantially equivalent to the predicate device.
§ 876.5860 High permeability hemodialysis system.
(a)
Identification. A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K
uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.).
(3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).
(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ”
(2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,”
(3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,”
(4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and
(5) “Guidance for Hemodialyzer Reuse Labeling.”