FX CorAL dialyzers are intended for hemodialysis (HD), hemodiafiltration (HDF), hemofiltration (HF), and isolated ultrafiltration in patients with acute kidney injury or chronic kidney disease when conservative therapy is judged to be inadequate.

Device Description

The FX CorAL dialyzers are high-flux, single-use, steam-sterilized hemodialyzers. The dialyzers are provided blood pathway sterile and non-pyrogenic. The dialyzers allow for the transfer of water and solutes between blood and dialysate using semipermeable, hollow fiber membranes.

AI/ML Overview

The provided text describes a 510(k) premarket notification for Fresenius Medical Care's FX CorAL dialyzers. It outlines the device, its intended use, and the performance data submitted to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Key Takeaway: The provided document is a 510(k) summary for a medical device (dialyzers), which focuses on demonstrating "substantial equivalence" to existing cleared devices rather than providing a detailed clinical trial report with specific acceptance criteria tables and detailed performance data like an AI/ML device would. The performance criteria are primarily related to the physical and functional aspects of the dialyzer and its ability to clear solutes.

1. Table of Acceptance Criteria and Reported Device Performance:

The document summarizes performance testing but does not present a formal table of "acceptance criteria" alongside specific numerical "reported device performance" for each criterion. Instead, it states:

"All testing met predetermined acceptance criteria and demonstrated that, like the predicate devices, the FX CorAL dialyzers are safe and effective for their intended use."

However, it does list Key Performance Specifications/Characteristics as Urea clearance. It then provides a table of "Typical Urea Clearance (mL/min)" for different FX CorAL dialyzers:

Trade Name	Flow Rate Conditions (mL/min) Qb	Flow Rate Conditions (mL/min) Qd	Flow Rate Conditions (mL/min) Qf	Typical Urea Clearance (mL/min)
FX CorAL 60 Dialyzer	300	500	0	270
FX CorAL 80 Dialyzer	300	500	0	277
FX CorAL 100 Dialyzer	300	500	0	282
FX CorAL 120 Dialyzer	300	500	0	285
FX CorAL 600 Dialyzer	300	500	75	285
FX CorAL 800 Dialyzer	300	500	75	288
FX CorAL 1000 Dialyzer	300	500	75	292

Other performance tests are listed under "Performance Data" (Table 3), but without numerical acceptance criteria or results. These include:

Blood Compartment Volume: "Results were compared with the acceptance criteria."
Clearance: For Sodium (marker for urea), Creatinine, Phosphate, Vitamin B12, β2-Microglobulin. "Calculated by analyzing test samples over the specified range of blood, dialysate, and filtration flow rates."
Protein Sieving Coefficient: "Calculated in accordance with ISO 8637-1 First Edition 2017-11."
Ultrafiltration (Blood Kuf): "Calculated as the slope from a plot of the measured ultrafiltration rate (UFR) over the applied transmembrane pressure (TMP) range versus the applied TMP."
Pressure Drop: Both blood and dialysate compartments.
Structural Integrity (Dialyzer Integrity): Positive and negative pressure decay measured.
Blood Compartment Integrity (Membrane Integrity): Observed for air bubbles.
Simulated Shipping and Distribution: Performance testing after simulation to demonstrate product and package integrity and sterility are maintained.

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

Manufacturing/In-vitro Performance Testing (Test Set): The document does not specify the exact sample sizes (N number of dialyzers) used for the various in-vitro performance tests (e.g., urea clearance, pressure drop, integrity). It generally refers to "test samples."
Clinical Studies: Three (3) "outside the U.S. (OUS) clinical trials" were conducted. The document does not specify the sample size for these trials.
Data Provenance: The in-vitro performance data is generated from laboratory testing of the device itself (dialyzers). The clinical trial data is from "outside the U.S. (OUS) clinical trials." The data provenance is described as including "post-market surveillance." The clinical trials would be prospective studies, evaluating safety and performance.

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

For Manufacturing/In-vitro Test Set: No external experts are mentioned for establishing ground truth. The ground truth for these tests is based on established engineering principles, ISO standards (e.g., ISO 8637-1), and internal quality control measurements as described in the "Test Method Description" column of Table 3.
For Clinical Trials: The document states that clinical trials "evaluated safety and performance" and found "comparable safety to the reference dialyzers without new safety signals." While healthcare professionals (physicians, nurses) were involved in these trials, the document does not specify the number or qualifications of "experts" used to establish ground truth in the sense of an independent review, as would be typical for image-based AI/ML devices. The "ground truth" here would be clinical outcomes, safety endpoints, and performance metrics observed in patients.

4. Adjudication Method for the Test Set:

For Manufacturing/In-vitro Test Set: No adjudication method is mentioned or applicable in the context of physical product testing. Performance is measured against predefined specifications.
For Clinical Trials: Adjudication methods are not described. Clinical trials typically have predefined endpoints and statistical analysis plans, but the specific process for adjudicating ambiguous clinical events (e.g., by an independent committee) is not detailed in this summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

Not applicable: This device is a physical medical device (dialyzer) and not an AI/ML algorithm for diagnostic imaging. Therefore, no MRMC study was performed, nor is an effect size for human readers improving with AI assistance relevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable: This is a physical device, not an algorithm. The performance data presented (e.g., urea clearance) is the "standalone" performance of the dialyzer itself, not an algorithm.

7. The Type of Ground Truth Used:

For Manufacturing/In-vitro Performance Testing:
- Validated Measurement Standards: Ground truth is based on physical and chemical measurements (e.g., sodium and urea concentration, flow rates, pressure) according to established international standards (ISO 8637-1) and internal test procedures.
- Benchmarking against Predicate Devices: Performance is also evaluated in comparison to predicate devices, implying that acceptable performance is considered to be comparable to these legally marketed devices.
For Clinical Trials:
- Clinical Outcomes/Safety Endpoints: "Safety and performance" were evaluated, and the incidence of hypersensitivity and hypersensitivity-like reactions was monitored. This indicates that patient outcomes and adverse events served as the clinical ground truth.

8. The Sample Size for the Training Set:

Not applicable: This document describes a physical medical device, not an AI/ML algorithm that requires a "training set." The dialyzers are manufactured according to a design, and performance is tested based on that design.

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

Not applicable: As there is no AI/ML training set, there is no corresponding ground truth establishment for it.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 11, 2023

Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann Senior Director, Regulatory Affairs 920 Winter Street Waltham, Massachusetts 02451

Re: K220721

Trade/Device Name: FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000 Regulation Number: 21 CFR 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: April 11, 2023 Received: April 11, 2023

Dear Denise Oppermann:

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 -S

Gema Gonzalez, MS 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) K220721

Device Name

FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 600, FX CorAL 800, FX CorAL 800, FX CorAL 1000

Indications for Use (Describe)

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/0 description: The image shows the Fresenius Medical Care logo. The logo consists of a blue abstract symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.

K220721 Page 1 of 6

5. 510(K) SUMMARY (K220721)

This 510(k) Summary is in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content of this 510(k) summary is provided in conformance with 21 CFR § 807.92.

5.1. Submitter's Information

Name:	Fresenius Medical Care Renal Therapies Group, LLC
Address:	920 Winter Street
	Waltham, MA 02451-1457
Phone:	(781) 996-9103
Fax:	(781) 699-9635
Contact Person:	Denise Oppermann, Senior Director
Preparation Date:	11 March 2022

5.2. Device Name

Trade Name:	FX CorAL
Common Name:	Dialyzer
Regulation Name:	High Permeability hemodialysis system
Regulatory Class:	Class II per 21 CFR § 876.5860
Product Code:	KDI
Product Code Name:	Dialyzer, High Permeability With or Without Sealed Dialysate System
FDA Review Panel:	Gastroenterology/Urology

5.3. Legally Marketed Predicate Device

The legally marketed predicate devices are the F160NR, F200NR, and F250NR Optiflux Dialyzers cleared under K162488. These predicates have not been subject to a designrelated recall.

The Gambro Polyflux 140H, 170H, and 210H Capillary Dialyzers (K043342) are used as secondary predicate devices to support the expanded Indications for Use statement. The Asahi ViE-U Dialyzer (K162248) is used as a reference device to support the presence of vitamin E.

Device Description 5.4.

5.4.1. Device Identification

The FX CorAL dialyzers are the subject of this 510(k) and are available in seven (7) configurations as shown in Table 1.

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Image /page/4/Picture/0 description: The image shows the logo for Fresenius Medical Care. The logo consists of a blue symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The symbol is made up of three downward-pointing chevrons stacked on top of each other. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.

K220721 Page 2 of 6

FX CorAL Dialyzer Traditional 510(k)

Table 1:FX CorAL Dialyzers
Trade Name	Product Number	Surface Area (m2)
FX CorAL 60	F00009216	1.4
FX CorAL 80	F00009217	1.8
FX CorAL 100	F00009218	2.2
FX CorAL 120	F00009219	2.5
FX CorAL 600	F00009220	1.6
FX CorAL 800	F00009221	2.0
FX CorAL 1000	F00009222	2.3

5.4.2. Device Characteristics

5.4.3. Environment of Use

The FX CorAL dialyzers are used in environments where acute and chronic hemodialysis are performed.

5.4.4. Brief Written Description of the Device

The FX CorAL dialyzers are high-flux, sterile devices designed for single-use acute and chronic hemodialysis. The dialyzers are configured to connect to a bloodline set which connects to a patient's vascular access system when used with a hemodialysis machine equipped with ultrafiltration control. During hemodialysis, blood is pumped from the patient's body through an extracorporeal circuit, one component of which is the dialyzers contain semipermeable membranes that allow for diffusion and/or ultrafiltration to transport toxins and excess fluid from the blood compartment (fiber lumen) to the dialysate compartment. Dialyzers utilize a counter-current flow in which dialysate and blood flow in opposite directions in the dialyzer. The counter-current flow maintains the concentration gradient across the membrane for waste and fluid removal.

5.4.5. Materials of Use

The FX CorAL dialyzers are classified as externally communicating, blood path indirect, prolonged contact (>24 hours to 30 days) duration, Class II devices in accordance with FDA guidance Use of International Standard ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process (16 June 2016).

The FX CorAL dialyzers' components are composed of the following materials:

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K220721 Page 3 of 6

FX CorAL Dialyzer Traditional 510(k)

Component	Material
Housing	Polypropylene
Potting Resin	Polyurethane
Fiber Bundle	Polysulfone-polyvinylpyrrolidone blend, a-tocopherol (vitamin E)
Sealing Ring	Silicone
Flange	Polypropylene
Blood Port Cap(s)	Polypropylene
Dialysate Port Cap(s)	Styrol-Ethylen-Butylen-Styrol, Polypropylene

5.4.6. Key Performance Specifications/Characteristics

Urea clearance is a key performance specification of the FX CorAL dialyzers. FMCRTG uses sodium clearance as a marker for urea clearance because sodium and urea exhibit similar movement across the membrane. Urea clearance data from the Instructions for Use (IFU) is provided in Table 2, where Qb = blood flow rate, Qd = dialysate flow rate, and Of = filtration flow rate. The Qf is equal to the ultrafiltration rate (Quf) plus the substitution flow rate (Qs), where Qs = 0 in hemodialysis.

Trade Name	Flow Rate Conditions (mL/min)			Typical Urea Clearance (mL/min)
	Qb	Qd	Qf
FX CorAL 60 Dialyzer	300	500	0	270
FX CorAL 80 Dialyzer	300	500	0	277
FX CorAL 100 Dialyzer	300	500	0	282
FX CorAL 120 Dialyzer	300	500	0	285
FX CorAL 600 Dialyzer	300	500	75	285
FX CorAL 800 Dialyzer	300	500	75	288
FX CorAL 1000 Dialyzer	300	500	75	292

Table 2: in vitro Urea Clearance for the FX Coral Dialyzers

5.5. Intended Use

The FX CorAL dialyzers are designed for single use hemodialysis and hemo(dia)filtration for the treatment of acute kidney injury or chronic kidney disease.

5.6. Indications for Use

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Image /page/6/Picture/0 description: The image shows the logo for Fresenius Medical Care. The logo consists of a blue symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The symbol is made up of three downward-pointing chevrons stacked on top of each other. The text is in a bold, sans-serif font and is also blue.

K220721 Page 4 of 6

FX CorAL Dialyzer Traditional 510(k)

5.7. Comparison of Technological Characteristics with the Predicate Device

The following technological characteristics of the proposed FX CorAL dialyzers are equivalent to the predicate Optiflux dialyzers (K162488) and the secondary Gambro Polyflux dialyzers (K043342):

Intended Use
Design and configuration .
Technological characteristics .
Materials
Performance requirements ●

5.8. Performance Data

Performance testing was conducted in accordance with ISO 8637-1 First Edition 2017-11 and Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers, August 1998. Testing conducted to support the determination of substantial equivalence is summarized in Table 3.

Test Conducted	Test Method Description
Blood Compartment Volume	Calculated using the fiber volume and CAD software modeling forthe flange volume. Results were compared with the acceptancecriteria.
Clearance – Sodium (marker forurea), Creatinine, Phosphate,Vitamin B12, β2-Microglobulin	Calculated by analyzing test samples over the specified range ofblood, dialysate, and filtration flow rates
Protein Sieving Coefficient	The test circuit was stabilized for blood and filtrate flows. All airwas removed from the dialyzer. Paired samples for blood and filtrateflows were collected after 15 min. Samples were taken again afteranother 15 min. The sieving coefficient was calculated inaccordance with ISO 8637-1 First Edition 2017-11
Ultrafiltration (Blood Kuf)	Calculated as the slope from a plot of the measured ultrafiltrationrate (UFR) over the applied transmembrane pressure (TMP) rangeversus the applied TMP
Pressure Drop	Blood compartment: The blood compartment was perfused withhuman blood while the dialysate compartment was filled with NaClsolutionDialysate side: Both compartments were filled with dialysis fluid.Inlet and outlet pressures of the blood and dialysate compartmentswere measured across the range of flow rates with the dialyzers in ahorizontal position.

Table 3: Performance Testing Summary

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Image /page/7/Picture/0 description: The image shows the logo for Fresenius Medical Care. The logo consists of a blue symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The symbol is made up of three downward-pointing chevrons stacked on top of each other. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.

FX CorAL Dialyzer Traditional 510(k)

Test Conducted	Test Method Description
Structural Integrity (DialyzerIntegrity)	The positive and negative pressure decay was measured by apressure monitor connected at one end of the dialyzer after applying4.5 bar and -700 mmHg from the opposite ends and equilibrium wasreached
Blood Compartment Integrity(Membrane Integrity)	Water was added to the dialyzer. A pressure differential was appliedacross the dialyzer membrane via pressurized air. The outlet bloodport of the dialyzer was observed for air bubbles.
Simulated Shipping andDistribution	Testing was conducted per ASTM D4169-16. Performance testingwas conducted after simulated shipping and accelerated aging todemonstrate that product and package integrity, and sterility aremaintained throughout the intended product's shelf life.

Table 3: Performance Testing Summary

All testing met predetermined acceptance criteria and demonstrated that, like the predicate devices, the FX CorAL dialyzers are safe and effective for their intended use.

5.8.1. Biocompatibility Testing

Testing was performed to support the biological safety of the FX CorAL dialyzers:

Chemical Analysis Extractables and Leachables .
- । Targeted Quantitative Analyses
Cytotoxicity, ISO Neutral Red Uptake
Sensitization, ISO Guinea Pig Maximization
ISO Intracutaneous Irritation
ISO Acute Systemic Toxicity
ISO Subchronic Toxicity, Short-Term (14-Day) Repeated Exposure ●
. Material-Mediated Pyrogenicity
Genotoxicity, ISO Bacterial Reverse Mutation Assay
Genotoxicity, in vitro Mouse Lymphoma Gene Mutation Assay
Hemocompatibility, ASTM Hemolysis (Direct and Indirect - Extract)
Hemocompatibility, Complement Activation SC5b-9 fragment ●
Hemocompatibility, ASTM Partial Thromboplastin Time
Hemocompatibility, Platelet and Leukocyte Counts ●
Hemocompatibility, Mechanical Hemolysis ●
Hemocompatibility, in vitro Thrombogenicity Assay ●

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Image /page/8/Picture/0 description: The image shows the Fresenius Medical Care logo. The logo consists of a blue symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right, also in blue. The symbol is made up of three downward-pointing chevrons stacked on top of each other.

A toxicological risk assessment was also performed.

Human Factors Validation Testing 5.8.2.

A Human Factors assessment was conducted for the FX CorAL dialyzers to demonstrate their safe and effective use in accordance with FDA guidance Applying Human Factors and Usability Engineering to Medical Devices (03 February 2016).

5.8.3. Electrical Safety and Electromagnetic Compatibility (EMC)

Not applicable. The FX CorAL dialyzers are not electrical mechanical devices.

Software Verification and Validation Testing 5.8.4.

Not applicable. The FX CorAL dialyzers do not contain software.

5.8.5. Animal Studies

No animal studies were performed.

Clinical Studies 5.8.6.

Three (3) outside the U.S. (OUS) clinical trials evaluated safety and performance of the proposed FX CorAL 600 dialyzer. The trials, as well as post-market surveillance, found a comparable safety to the reference dialyzers without new safety signals. The incidence of hypersensitivity and hypersensitivity-like reactions was well below the predefined threshold in each trial and in post-market surveillance.

5.9. Conclusion

The intended use, technological characteristics, design, materials, and performance requirements are substantially equivalent to those of the predicate and secondary predicate devices. FMCRTG concludes that within the meaning of the Medical Device Amendments Act of 1976, the FX CorAL dialyzers are safe and effective for their intended use.

Regulation Number and Section

§ 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.”