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

Consider body and dialyzer surface area, blood flow, body weight and extracorporeal blood volume when selecting dialyzers for use with pediatric patients.

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.

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.

AI/ML Overview

The document describes the FX CorAL 40 and FX CorAL 50 dialyzers and their substantial equivalence to predicate devices, focusing on performance, materials, and intended use. There is no information provided in the document regarding acceptance criteria or performance of an AI/ML device.

The provided text describes a medical device clearance (K242053) for FX CorAL 40 and FX CorAL 50 dialyzers, which are high permeability hemodialysis systems. While the request asks about acceptance criteria and study details for an AI/ML device, the document focuses on the performance data of these physical medical devices. Therefore, much of the requested information regarding AI/ML specifics (like effect size of AI assistance, standalone algorithm performance, training set details, expert qualifications for ground truth) is not applicable to this submission.

However, I can extract the relevant information pertaining to the tests conducted for these dialyzers, which function as "acceptance criteria" for a physical device.

Here's a breakdown based on the provided document:

1. A table of acceptance criteria and the reported device performance:

The document lists performance tests conducted and states that "All testing met predetermined acceptance criteria." It does not explicitly list numerical acceptance criteria values for each test but provides typical performance results for urea clearance.

Test Conducted	Acceptance Criteria (Stated as met predetermined criteria)	Reported Device Performance (Typical Values)
Blood Compartment Volume	Results were compared with the acceptance criteria.	Not numerically specified, but stated to have met criteria.
Clearance – Sodium (marker for urea), Creatinine, Phosphate, Vitamin B12	Analyzed test samples over a specified range of flow rates.	FX CorAL 40 Dialyzer: Typical Urea Clearance: 178 mL/min (Qb=200, Qd=500, Qf=0)FX CorAL 50 Dialyzer: Typical Urea Clearance: 192 mL/min (Qb=200, Qd=500, Qf=0)
Protein Sieving Coefficient	Calculated in accordance with ISO 8637-1 First Edition 2017-11.	Not numerically specified, but stated to have met criteria.
Ultrafiltration (Blood Kuf)	Calculated as the slope from a plot of UFR over applied TMP range.	Not numerically specified, but stated to have met criteria.
Pressure Drop	Measured inlet and outlet pressures across flow rates.	Not numerically specified, but stated to have met criteria.
Blood Compartment Integrity	Evaluate the integrity of the blood compartment.	Not numerically specified, but stated to have met criteria.
Biocompatibility Testing	Update to toxicological risk assessment and specific tests met acceptance.	Specific tests (Chemical Analysis, Subchronic Toxicity, Genotoxicity, Hemocompatibility) were performed and met criteria.
Human Factors Validation Testing	Demonstrated safe and effective use in accordance with FDA guidance.	Not numerically specified, but stated to have met criteria.
Clinical Studies (spKt/V)	Adequacy of clearance with mean spKt/V values.	FX CorAL 40 Dialyzer: Mean spKt/V of 2.42FX CorAL 50 Dialyzer: Mean spKt/V of 2.08 (all tolerated)

2. Sample size used for the test set and the data provenance:

Performance Testing (in vitro): Sample size for each specific in vitro test (e.g., clearance, integrity) is not explicitly stated, but it's implied that multiple samples were tested to generate the "typical" values and ensure criteria were met.
Clinical Studies (retrospective):
- Sample Size: Fourteen (14) pediatric ESRD patients
- Data Provenance: Retrospective clinical data analysis. The country of origin is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable as the document describes a physical medical device (dialyzer), not an AI/ML diagnostic tool requiring expert interpretation for ground truth establishment. The "ground truth" for the dialyzer's performance is established through well-defined physical and chemical measurements following international standards (e.g., ISO 8637-1).

4. Adjudication method for the test set:

Not applicable. For physical device performance, the results are typically quantitative measurements against defined specifications, not subjective interpretations requiring adjudication.

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, as this is not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable, as this is not an AI/ML device.

7. The type of ground truth used:

In vitro Performance Tests: Ground truth is based on established physical and chemical measurement standards (e.g., ISO 8637-1 First Edition 2017-11) and direct laboratory measurements of parameters like clearances, sieving coefficients, ultrafiltration rates, and pressure drops.
Biocompatibility Testing: Ground truth is established through standardized biological evaluation tests as per FDA guidance and ISO 10993-1.
Clinical Studies: "Adequate clearance" (demonstrated by spKt/V values) and patient tolerance serve as clinical outcomes demonstrating the device's effectiveness in a real-world setting.

8. The sample size for the training set:

Not applicable, as this is not an AI/ML device and thus does not have a "training set" in that context.

9. How the ground truth for the training set was established:

Not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

March 21, 2025

Fresenius Medical Care Renal Therapies Group, LLC Timothy Groves Regulatory Affairs - Senior Lead 920 Winter Street Waltham, Massachusetts 02451

Re: K242053

Trade/Device Name: FX CorAL 40 (F00009214); FX CorAL 50 (F00009215) Regulation Number: 21 CFR 876.5860 Regulation Name: High Permeability Hemodialysis System Regulatory Class: Class II Product Code: KDI Dated: July 12, 2024 Received: February 21, 2025

Dear Timothy Groves:

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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory

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assistance/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

Maura Rooney 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

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K242053

Device Name

FX CorAL 40 (F00009214); FX CorAL 50 (F00009215)

Indications for Use (Describe)

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

Consider body and dialyzer surface area, blood flow, body weight and extracorporeal blood volume when selecting dialyzers for use with pediatric patients.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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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, also in blue. The symbol is made up of three downward-pointing chevrons stacked on top of each other.

510(K) SUMMARY 1.

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.

Submitter's Information 1.1.

Name:	Fresenius Medical Care Renal Therapies Group, LLC
Address:	920 Winter Street
	Waltham, MA 02451-1457
Phone:	(781) 460-1087
Fax:	(781) 699-9635
Contact Person:	Timothy Groves, Senior Lead
Preparation Date:	15 July 2024

1.2. Device Name

Trade Name:	FX CorAL 40 (F00009214), FX CorAL 50 (F00009215)
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

1.3. Legally Marketed Predicate Device

The legally marketed primary predicate devices are the FX CorAL 60, 80, 100, 120, 600, 800, and 1000 Dialyzers cleared under K220721. The secondary predicate devices are the HemoFlow F3 and F4 Dialyzers (K190459). These predicates have not been subject to design-related recalls.

The Gambro Polyflux 6H Dialyzer (K051520) is used as a reference device to support the expanded Indications for Use statement.

1.4. Device Description

1.4.1. Device Identification

The FX CorAL 40 and 50 dialyzers are the subject of this 510(k) and are available in two (2) configurations as shown in Table 1.

Table 1: FX CorAL Dialyzers

Trade Name	Product Number	Surface Area (m2)
FX CorAL 40	F00009214	0.6

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Trade Name	Product Number	Surface Area (m2)
FX CorAL 50	F00009215	1.0

Table 1: FX CorAL Dialyzers

1.4.2. Device Characteristics

1.4.3. Environment of Use

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

Brief Written Description of the Device 1.4.4.

1.4.5. Materials of Use

The FX CorAL dialyzers are classified as external communicating devices having direct contact via circulating blood and chronic long-term use exposure (> 30 days, Classification C) 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 (08 September 2023).

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, Silicone

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

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Image /page/6/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.

Component	Material
Dialysate Port Cap(s)	Styrene-Ethylene-Butylene-Styrene, Polypropylene

1.4.6. 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 Qf = filtration flow rate. The Qf is equal to the ultrafiltration rate (Quf) plus the substitution flow rate (Qs), where Qs = 0 in hemodialysis.

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

Trade Name	Flow Rate Conditions (mL/min)			Typical Urea Clearance(mL/min)
	Qb	Qd	Qf
FX CorAL 40 Dialyzer	200	500	0	178
FX CorAL 50 Dialyzer	200	500	0	192

1.5. 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.

Indications for Use 1.6.

Consider body and dialyzer surface area, blood flow, body weight and extracorporeal blood volume when selecting dialyzers for use with pediatric patients.

1.7. Comparison of Technological Characteristics with the Predicate Device

The following technological characteristics of the proposed FX CorAL dialyzers are equivalent to the predicate FX CorAL dialyzers (K220721), secondary predicate Hemoflow F3 and F4 dialyzers (K190459), and reference Gambro 6H Polflux dialyzer (K051520):

Intended Use
Principle of operation
Design characteristics
Sterilization method
Materials

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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.

K242053

Performance requirements ●

1.8. 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. Due to design similarities, structural integrity and shipping and distribution testing submitted in K220721 is being leveraged to support the proposed FX CorAL 40 and 50 dialyzers.

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	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 NaClsolution
	Dialysate 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.
Blood Compartment Integrity	Evaluate the integrity of the blood compartment

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.

1.8.1. Biocompatibility Testing

The materials of the proposed FX CorAL 40 and 50 dialyzers are identical to the predicate FX CorAL dialyzers (K220271). Therefore, a subset of biocompatibility testing was performed to evaluate the smaller surface areas of the proposed dialyzers.

The toxicological risk assessment from the predicate FX CorAL dialyzers was updated to evaluate the biological safety in pediatric patients.

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Testing performed to support the biological safety of the FX CorAL 40 and 50 dialyzers:

. Chemical Analysis - Extractables (update to existing documentation)
Chemical Analysis - Leachables
ISO Subchronic Toxicity, Short-Term (14-Day) Repeated Exposure ●
Genotoxicity, ISO Bacterial Reverse Mutation Assay ●
Genotoxicity, in vitro Mouse Lymphoma Gene Mutation Assay ●
Hemocompatibility, Mechanical Hemolysis ●

Human Factors Validation Testing 1.8.2.

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).

1.8.3. Electrical Safety and Electromagnetic Compatibility (EMC)

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

1.8.4. Software Verification and Validation Testing

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

1.8.5. Animal Studies

No animal studies were performed.

1.8.6. Clinical Studies

A retrospective clinical data analysis performed on the FX CorAL 40 and 50 dialyzers included fourteen (14) pediatric ESRD patients on HD treated for at least 12 consecutive weeks. FX CorAL 40 and 50 dialyzers provided adequate clearance with a mean spKt/V of 2.42 and 2.08 respectively, and all were tolerated.

1.9. Conclusion

The intended use, principle of operation, design characteristics, sterilization method, materials, and performance requirements are substantially equivalent to those of the predicate, secondary predicate, and/or reference devices. FMCRTG concludes that within the meaning of the Medical Device Amendments Act of 1976, the FX CorAL 40 and 50 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.”