Optiflux® Enexa™ dialyzers are intended for patients with acute kidney injury or chronic kidney disease when conservative therapy is judged to be inadequate.

Device Description

The Optiflux Enexa F500 dialyzer is a high-flux, single-use, e-beam sterilized hemodialyzer that contains the additive Endexo SMM1 blended into the fiber. The dialyzer is provided blood pathway sterile and non-pyrogenic. The membrane surface area is 1.5 m².

The Optiflux Enexa F500 dialyzer is a high-flux, sterile device designed for single-use in acute and chronic hemodialysis. The dialyzer is 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 dialyzer. The dialyzer contains a semi-permeable membrane that allows 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 provided document is for a medical device called the "Optiflux Enexa F500 Dialyzer," which is a high-permeability hemodialysis system. The document outlines the device's characteristics, intended use, and performance data from various tests, including a clinical study, to demonstrate its substantial equivalence to a predicate device.

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

1. Table of Acceptance Criteria and the Reported Device Performance:

The document doesn't explicitly list specific quantitative acceptance criteria in a table format for all tests. However, it states that "All testing met predetermined acceptance criteria" and "Results of the proposed device design verification tests met the requirements and demonstrated that... the Optiflux Enexa F500 dialyzer is safe and effective for its intended use."

Here's a table combining the key performance characteristics mentioned, with the understanding that "acceptable" means meeting the undefined predetermined acceptance criteria. The In vitro Urea Clearance is the only performance number explicitly given with a standard testing configuration.

Performance Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance (as presented)
In vitro Urea Clearance (Sodium as marker)	Not explicitly stated, but implies equivalence to predicate/standards	271 (at Qb = 300 mL/min, Qd = 500 mL/min, Quf = 0 mL/min)
Blood Compartment Volume	Met predetermined acceptance criteria	Calculated as meeting requirements
Clearance (Urea, Creatinine, Phosphate, Vitamin B12, Lysozyme)	Met predetermined acceptance criteria	Calculated by analyzing test samples over specified ranges
Protein Sieving Coefficient	Met predetermined acceptance criteria	Calculated per ISO 8637-1:2017 Section 5.6.2.4
Ultrafiltration	Met predetermined acceptance criteria	Calculated as the slope from a plot of transmembrane pressure vs. ultrafiltration rate
Pressure Drop	Met predetermined acceptance criteria	Measured across range of flow rates
Structural Integrity (Positive & Negative Pressure Decay)	Met predetermined acceptance criteria	Measured with 900 mmHg and -700 mmHg applied
Blood Compartment Integrity	Met predetermined acceptance criteria	Pressure differential applied, no specific values given
Simulated Shipping and Distribution	Met predetermined acceptance criteria	Testing per ASTM D4169-16, demonstrated maintenance of integrity and sterility
Biocompatibility (Chemical Analysis, Cytotoxicity, Sensitization, Intracutaneous Irritation, Acute Systemic Toxicity, Subchronic Toxicity, Material-Mediated Pyrogenicity, Genotoxicity, Hemocompatibility, PVP/SMM1 Assay)	Met predetermined acceptance criteria	All testing performed and results met or exceeded requirements. Toxicological risk assessment also performed.
Human Factors Validation	Demonstrated safe and effective use	Leveraged for the device, in accordance with FDA guidance
Clinical Safety & Performance (Acute Kidney Injury/Chronic Kidney Disease patients)	Demonstrated safety and effectiveness; no device-related adverse events, clinically meaningful changes, or Grade 4 Thrombus	Mean spKt/V 2.06 ± 0.42. Mean urea removal 81.49 ± 5.95%. Mean ß2-microglobulin removal 63.04 ± 16.86%. Serum albumin unchanged pre/post-HD. No overt complement activation. No clinically meaningful changes in hematologic parameters/platelet counts. No device-related AEs. Mean thrombus score 1.29 ± 0.52 (no Grade 4).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Clinical Study (as a test set for human subjects):
- Sample Size: Eighteen (18) hemodialysis (HD) subjects with chronic renal failure. They received 664 HD treatments.
- Data Provenance: The document does not explicitly state the country of origin. It indicates it was a "prospective, multi-center, open-label clinical study."
In Vitro Performance Tests: The sample size for in vitro tests (clearance, ultrafiltration, structural integrity, etc.) is not specified in the summary, but it states "All testing met predetermined acceptance criteria." The tests were conducted according to ISO 8637-1:2017 and FDA Guidance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not directly applicable to a medical device like a hemodialyzer in the way it would be for an AI diagnostic algorithm. Ground truth for a hemodialyzer's performance is typically established through:

In vitro measurements: Using standardized laboratory methods for analyzing fluid samples and physical properties. This doesn't involve "experts" establishing ground truth in the sense of image interpretation.
Clinical outcomes/physiological measurements: In the clinical study, ground truth for patient health and device performance (e.g., urea removal, complement activation, adverse events) is established by direct measurement of patient parameters and clinical observation by medical staff (physicians, nurses). The document does not specify the number or qualifications of these clinical experts, but it is implied they are qualified medical professionals responsible for patient care and data collection in a clinical trial setting.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The concept of an adjudication method (like 2+1, 3+1 for consensus in image interpretation) is not applicable to this type of device and study. The "ground truth" or performance assessment is based on direct measurements and clinical observation in the clinical study, not on expert consensus reading of independent data.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This is a medical device (hemodialyzer), not an AI diagnostic algorithm or imaging device requiring human reader interpretation. No MRMC study was conducted or is relevant to this device.

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

Not Applicable. This is a medical device, not an algorithm. Therefore, "standalone performance" in the context of an algorithm is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the Optiflux Enexa F500 Dialyzer, the "ground truth" for its performance and safety validation was established through:

In vitro quantitative measurements: For characteristics like urea clearance, ultrafiltration, pressure drop, structural integrity, and various other physical and chemical properties.
Biocompatibility testing: Standardized in vitro and in vivo (e.g., guinea pig, mouse lymphoma) biological tests for material safety, often following ISO 10993.
Clinical Outcomes Data: For the clinical study, the ground truth was derived from direct physiological measurements (e.g., spKt/V, urea removal rates, ß2-microglobulin removal rates, serum albumin, C5a, C3a, sC5b-9, hematologic parameters, platelet counts) and observed adverse events, including thrombus scores. These are objective measures collected during clinical practice.

8. The sample size for the training set

Not Applicable. This device is a hemodialyzer, not an AI algorithm that requires a "training set."

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

Not Applicable. As no AI algorithm is involved, there is no "training set" or "ground truth for the training set" in the context of this device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & 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 is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.

July 9, 2020

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

Re: K192928

Trade/Device Name: Optiflux Enexa F500 Dialyzer Regulation Number: 21 CFR 876.5860 Regulation Name: High Permeability Hemodialysis System Regulatory Class: II Product Code: KDI Dated: June 2, 2020 Received: June 4, 2020

Dear Denise M. 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.

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

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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 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,

for

Carolyn Y. Neuland, Ph.D. 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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K192928

Device Name

Optiflux Enexa F500 Dialyzer

Indications for Use (Describe)

Optiflux® Enexa™ dialyzers are intended for patients with acute kidney injury or chronic kidney disease when conservative therapy is judged to be inadequate.

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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K192928

ട. 510(K) SUMMARY

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
	Regulatory Affairs – Devices
Preparation Date:	16 October 2019

5.2. Device Name

Trade Name:	Optiflux Enexa F500 Dialyzer
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
Classification Panel:	Gastroenterology/Urology

5.3. Legally Marketed Predicate Device

The legally marketed predicate device is the Optiflux F160NR dialyzer cleared under K152367. This device is not currently subject to a design-related recall.

5.4. Device Description

Device Identification 5.4.1.

The Optiflux Enexa F500 dialyzer is the subject of this 510(k).

5.4.2 Device Characteristics

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5.2.2.1 Environment of Use

The Optiflux Enexa F500 dialyzers are used in environments where acute and chronic hemodialysis are performed.

5.4.2.2. Brief Written Description of the Device

5.4.2.3. Materials of Use

The Optiflux Enexa F500 is classified as an externally communicating, blood path indirect, prolonged contact (> 24 hours to 30 days) duration, Class II device 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). Testing performed met or exceeded these requirements.

Component	Material
Housing	Polycarbonate
Potting Resin	Polyurethane
Fiber Bundle	Polysulfone w/Endexo SMM1
Screw Flange	Polycarbonate
O-Ring	Silicone
Blood Port Cap(s)	High Density Polyethylene
Dialysate Port Cap(s)	High Density Polyethylene

The Optiflux Enexa F500 dialyzer is composed of the following materials:

Kev Performance Characteristics 5.4.2.4.

Urea clearance is a key performance specification of the Optiflux Enexa F500 dialyzer. FMCRTG uses sodium clearance as a marker for urea clearance because sodium and urea exhibit similar movement across a membrane. Sodium clearance data from the Instructions for Use (IFU) for the Optiflux Enexa F500 dialyzer is provided in Table 1.

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Image /page/5/Picture/0 description: The image shows the Fresenius Medical Care logo. On the left side of the logo, there is a blue symbol that consists of three downward-pointing chevrons stacked on top of each other. To the right of the symbol, the words "FRESENIUS MEDICAL CARE" are written in blue, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.

In vitro Urea Clearance for the F500 Dialyzer* Table 1:

Trade Name	Typical Urea Clearance(Sodium Used as Marker)
Optiflux Enexa F500	271

*Qb = 300 mL/min, Qd = 500 mL/min, Quf = 0 mL/min

5.5. Intended Use

Optiflux Enexa dialyzers are designed for single use acute and chronic hemodialysis.

Indications for Use 5.6.

Optiflux® Enexa™ dialyzers are intended for patients with acute kidney injury or chronic kidney disease when conservative therapy is judged to be inadequate.

5.7. Comparison of Technological Characteristics with the Predicate Device

The following technological characteristics of the Optiflux Enexa F500 dialyzer are substantially equivalent to those of the predicate Optiflux F160NR dialyzer (K152367).

Intended use
Principle of operation ●
Design characteristics ●
Patient fluid-contacting materials .

5.8. Performance Data

Performance testing was conducted in accordance with ISO 8637-1:2017 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 2.

Test Conducted	Test Method Description
Blood Compartment Volume	Calculated, considering the fiber inner diameter, fibercrimp, the minimum and maximum blood volume, O-ring compression volume, dialyzer housing length, andpolyurethane height.
Clearance – Sodium (markerfor urea), Creatinine,Phosphate, Vitamin B12, andLysozyme	Calculated by analyzing test samples over the specifiedrange of blood and dialysate flow rates.

Table 2: Performance Testing Summary

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Test Conducted	Test Method Description
Protein Sieving Coefficient	The test circuit was stabilized for blood and filtrateflows. All air was removed from the dialyzer. Pairedsamples for blood and filtrate flows were collected after15 min. Samples were taken again after another 15 min.Sieving coefficient was calculated in accordance withSection 5.6.2.4 of ISO 8637-1:2017.
Ultrafiltration	Calculated as the slope from a plot of the measuredtransmembrane pressure versus the ultrafiltration rate.
Pressure Drop	The dialysate and blood compartments were filled withdialysate and bovine blood, respectively. Inlet and outletpressures of the blood and dialysate compartments weremeasured across the range of flow rates with thedialyzers in a horizontal position.
Structural Integrity	The positive and negative pressure decay was measuredby a pressure monitor connected at one end of thedialyzer while applying 900 mmHg and -700 mmHgfrom the opposite end.
Blood Compartment Integrity	Air and water were added to the top blood port and thedialysate side, respectively. A pressure differential wasapplied across the dialyzer membrane.
Simulated Shipping andDistribution	Testing was conducted per ASTM D4169-16.Performance testing was conducted before and aftersimulated shipping to demonstrate that product andpackage integrity and sterility are maintained throughoutthe intended product shelf life.

All testing met predetermined acceptance criteria. Results of the proposed device design verification tests met the requirements and demonstrated that, like the predicate device, the Optiflux Enexa F500 dialyzer is safe and effective for its intended use.

Biocompatibility Testing 5.8.1.

The following testing was performed to support the biological safety of the Optiflux Enexa F500 dialyzer:

Chemical Analysis Extractables and Leachables ●
Cytotoxicity, ISO Elution Method with MEM ●
Sensitization, Guinea Pig Maximization ●
Intracutaneous Irritation ●
Acute Systemic Toxicity ●
Subchronic Toxicity, Dual Routes of Parental Administration

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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.

Material-Mediated Pyrogenicity ●
Genotoxicity, Bacterial Reverse Mutation Assay ●
Genotoxicity, in vitro Mouse Lymphoma Gene Mutation Assay ●
Genotoxicity, ISO in vitro Mouse Lymphoma Gene Mutation Assay
Hemocompatibility, ASTM Hemolysis (Direct and Indirect - Extract)
Hemocompatibility, Complement Activation C3a and SC5b-9 fragment ●
Hemocompatibility, ASTM Partial Thromboplastin Time ●
Hemocompatibility, Mechanical Hemolysis ●
Hemocompatibility, in vitro Thrombogenicity Assay ●
PVP Assay
SMM1 Assay ●
In vivo Toxicity Studies .

A toxicological risk assessment was also performed.

5.8.2. Human Factors Validation Testing

Human Factors (HF) validation testing was leveraged for the Optiflux Enexa F500 dialyzer to demonstrate its safe and effective use in accordance with FDA guidance Applying Human Factors and Usability Engineering to Medical Devices (03 February 2016).

Electrical Safety and Electromagnetic Compatibility (EMC) 5.8.3.

Not applicable. The Optiflux Enexa F500 dialyzer is not an electrical mechanical device.

5.8.4. Software Verification and Validation Testing

Not applicable. The Optiflux Enexa F500 dialyzer does not contain software.

5.8.5. Animal Studies

No animal studies were performed.

5.8.6. Clinical Studies

Eighteen (18) hemodialysis (HD) subjects with chronic renal failure were administered 664 HD treatments with the Optiflux® Enexa™ F500 in a prospective, multi-center, open-label clinical study. Mean treatment duration was 207 ± 20 min, blood flow rate 447.7 ± 37.7 mL/min. and dialysate flow rate 698 ± 62.8 mL/min. Mean Kuf was 16.36 ± 9.92 mL/hr/mmHg, and spKt/V 2.06 ± 0.42. Mean urea and ß2-microglobulin removal rates were 81.49 ± 5.95% and 63.04 ± 16.86%. respectively. Mean pre-HD serum albumin levels remained unchanged; an increase from 3.94 ± 0.21 g/dL to 4.23 ± 0.41 g/dL was observed from pre-HD to post-HD. There was no evidence of overt complement activation as C5a and C3a levels remained largely unchanged from pre-HD levels. A decrease in mean C3a levels from 1318.8 ± 886.7 ng/mL to 1301.2 ± 335.7 ng/mL and in mean C5a levels from 8.8 ± 6.1

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Image /page/8/Picture/0 description: The image contains the logo for Fresenius Medical Care. On the left side of the logo is a blue symbol that consists of three downward-pointing chevrons stacked on top of each other. To the right of the symbol is the text "FRESENIUS MEDICAL CARE" in a bold, blue font. The text is arranged in two lines, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.

ng/mL to 7.62 ± 4.7 ng/mL was observed pre-HD and 30 mins post-HD. A slight increase in mean sC5b- 9 level from 224.3 ± 51.3 ng/mL to 304.22 ± 71.6 ng/mL was observed at 30 min post-HD. No clinically meaningful changes were observed in hematologic parameters and mean platelet counts. Adverse events that occurred during the study were not related to the device. Eleven (11) out of the 18 subjects (61.1%, 32 AEs) reported at least 1 AE during the study. No deaths or AEs leading to discontinuation were reported during the study. Three (3) serious adverse events were reported but none were related to the device. The mean thrombus score (1-4, clear to fully clotted) was 1.29 ± 0.52. None of the treatments with the Optiflux® Enexa™ F500 showed a Grade 4 Thrombus.

5.9. Conclusion

The intended use, principle of operation, design characteristics, and patient fluid-contacting materials of the Optiflux Enexa F500 dialyzer are substantially equivalent to that of the predicate device. FMCRTG concludes that within the meaning of the Medical Device Amendments Act of 1976, the Optiflux Enexa F500 device is safe and effective for its 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.”