(360 days)
Not Found
No
The summary describes a physical hemodialyzer device and its performance characteristics, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is intended for patients with acute kidney disease when conservative therapy is inadequate, indicating its use for treatment rather than diagnosis or prevention.
No
The device description indicates it is a hemodialyzer used to treat acute kidney disease, not to diagnose it. Its function is to clear substances like urea and sodium from the blood, which is a treatment, not a diagnostic process.
No
The device description clearly states it is a "high-flux, single-use, ethylene oxide (EO) sterilized hemodialyzer," which is a physical hardware device used in hemodialysis.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "patients with acute kidney disease when conservative therapy is judged to be inadequate." This describes a therapeutic intervention (hemodialysis) performed directly on the patient, not a test performed on a sample taken from the patient to diagnose or monitor a condition.
- Device Description: The description details a "hemodialyzer," which is a device used to filter blood outside the body during dialysis. This is a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information for diagnosis, monitoring, or screening
- Using reagents or assays
The device is clearly a therapeutic device used in the treatment of kidney disease.
N/A
Intended Use / Indications for Use
Optiflux Dialyzers are intended for patients with acute kidney disease when conservative therapy is judged to be inadequate.
Product codes (comma separated list FDA assigned to the subject device)
KDI
Device Description
The Optiflux F180NR dialyzer is a high-flux, single-use, ethylene oxide (EO) sterilized hemodialyzer. The dialyzer is provided blood pathway sterile and non-pyrogenic. The membrane surface area is 1.7 m2. The Optiflux F180NR dialyzer is a high-flux, sterile device designed for single-use 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Used in environments where acute and chronic hemodialysis are performed.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was conducted in accordance with ISO 8637:2010 and Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers, August 1998. Testing conducted included: Blood Compartment Volume, Clearance – Sodium (marker for urea), Vitamin B12, Creatinine, Phosphate, and Lysozyme, Protein Sieving Coefficient, Ultrafiltration, Pressure Drop, Structural Integrity, Blood Compartment Integrity, and Simulated Shipping and Distribution.
Biocompatibility testing was performed to support the biological safety of the Optiflux F180NR dialyzer, including Chemical Analysis - Extractables and Leachables, Cytotoxicity, Sensitization, Intracutaneous Irritation, Acute Systemic Toxicity, Systemic Toxicity, Short-Term Repeated Exposure, Material-Mediated Pyrogenicity, Genotoxicity (Bacterial Reverse Mutation Assay, in vitro Mouse Lymphoma Gene Mutation Assay), Hemocompatibility (ASTM Hemolysis (Direct and Indirect - Extract), Complement Activation - SC5b-9 fragment, ASTM Partial Thromboplastin Time, Mechanical Hemolysis, in vitro Thrombogenicity Assay, Platelet and Leukocyte Function), and PVP Testing. A toxicological risk assessment was also performed.
Human factors (HF) validation testing was leveraged to demonstrate safe and effective use.
All testing met predetermined acceptance criteria, demonstrating the device is safe and effective for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.”
0
Image /page/0/Picture/0 description: The image contains 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.
September 21, 2020
Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann Senior Director, Regulatory Affairs 920 Winter Street Waltham, Massachusetts 02451
Re: K192707
Trade/Device Name: Optiflux F180NR Dialyzer Regulation Number: 21 CFR 876.5860 Regulation Name: High Permeability Hemodialysis System Regulatory Class: Class II Product Code: KDI Dated: August 20, 2020 Received: August 21, 2020
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.
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
1
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 (OS) 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,
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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192707
Device Name Optiflux® F180NR Dialyzer
Indications for Use (Describe)
Optiflux Dialyzers are intended for patients with acute kidney disease when conservative therapy is judged to be inadequate.
Type of Use (Select one or both, as applicable)
X 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."
3
Image /page/3/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 chevron shapes stacked on top of each other.
510(K) SUMMARY 5.
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: | 26 September 2019 |
5.2. Device Name
| Trade Name: | Optiflux F180NR 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 F180NRe dialyzer cleared under K152367. This device has not been subject to a design-related recall.
Device Description 5.4.
5.4.1. Device Identification
The Optiflux F180NR dialyzer is the subject of this 510(k).
5.4.2. Device Characteristics
The Optiflux F180NR dialyzer is a high-flux, single-use, ethylene oxide (EO) sterilized hemodialyzer. The dialyzer is provided blood pathway sterile and non-pyrogenic. The membrane surface area is 1.7 m2.
4
Image /page/4/Picture/0 description: The image shows the logo for Fresenius Medical Care. The logo consists of a blue geometric shape on the left and the text "FRESENIUS MEDICAL CARE" on the right. The geometric shape is made up of three chevrons stacked on top of each other. The text is in a bold, sans-serif font and is also blue.
5.4.2.1. Environment of Use
The Optiflux F180NR dialyzer is used in environments where acute and chronic hemodialysis are performed.
5.4.2.2. Brief Written Description of the Device
The Optiflux F180NR dialyzer is a high-flux, sterile device designed for single-use 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.
5.4.2.3. Materials of Use
The Optiflux F180NR dialyzer is classified as externally communicating, circulating blood, prolonged contact (> 24 hours to 30 days) duration, Class II (Category B) 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).
| Component | Material |
|---|---|
| Housing | Polycarbonate |
| Potting Resin | Polyurethane |
| Fiber Bundle | Polysulfone |
| Screw Flange | Polycarbonate |
| O-Ring | Silicone |
| Blood Port Cap(s) | High Density Polyethylene |
| Dialysate Port Cap | High Density Polyethylene |
The Optiflux F180NR dialyzer is composed of the following materials:
5.4.2.4. Key Performance Characteristics
Urea clearance is a key performance specification of the Optiflux F180NR 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 F180NR dialyzer is provided in Table 1.
5
Image /page/5/Picture/0 description: The image shows the logo for Fresenius Medical Care. On the left side of the logo is a blue symbol that looks like three downward-pointing arrows stacked on top of each other. To the right of the symbol is the text "FRESENIUS MEDICAL CARE" in blue, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
In vitro Urea Clearance for the F180NR Dialyzer* Table 1:
| Trade Name | Typical Urea Clearance
(Sodium Used as Marker) |
|-----------------|---------------------------------------------------|
| Optiflux F180NR | 278 |
*Qb = 300 mL/min, Qd = 500 mL/min, Quf = 0 mL/min
Intended Use 5.5.
Optiflux dialyzers are designed for single use acute and chronic hemodialysis.
Indications for Use 5.6.
Optiflux 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 F180NR dialyzer are substantially equivalent to those of the predicate Optiflux F180NRe dialyzer (K152367).
- Intended use ●
- Principle of operation
- Design characteristics
- Patient fluid-contacting materials: polysulfone, polycarbonate, polyurethane, and silicone
5.8. Performance Data
Performance testing was conducted in accordance with ISO 8637:2010 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, fiber crimp, |
| the minimum and maximum blood volume, O-ring | |
| compression volume, dialyzer housing length, and | |
| polyurethane height. | |
| Clearance – Sodium (marker for | |
| urea), Vitamin B12, Creatinine, | |
| Phosphate, and Lysozyme | Calculated by analyzing the test samples over the specified |
| range of blood and dialysate flow rates. | |
| Protein Sieving Coefficient | The test circuit was stabilized for blood and filtrate flows. All |
| air was removed from the dialyzer. Paired samples for blood | |
| and filtrate flows were collected after 15 min. Samples were |
Performance Testing Summary Table 2:
6
Image /page/6/Picture/0 description: The image contains 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 chevron shapes stacked on top of each other.
| Test Conducted | Test Method Description |
|---|---|
| taken again after another 15 min. Sieving coefficient was | |
| calculated in accordance with Section 5.6.2.4 of ISO | |
| 8637:2010. | |
| Ultrafiltration | Calculated as the slope from a plot of the measured |
| transmembrane pressure versus the ultrafiltration rate. | |
| Pressure Drop | The dialysate and blood compartments were filled with |
| dialysate and bovine blood, respectively. Inlet and outlet | |
| pressures of the blood and dialysate compartments were | |
| measured across the range of flow rates with the dialyzers in a | |
| horizontal position. | |
| Structural Integrity | The positive and negative pressure decay was measured by a |
| pressure monitor connected at one end of the dialyzer while | |
| applying 900 mmHg and -700 mmHg from opposite ends. | |
| Blood Compartment Integrity | Air and water were added to the top blood port and the |
| dialysate side, respectively. A pressure differential was | |
| applied across the dialyzer membrane. | |
| Simulated Shipping and | |
| Distribution | Testing was conducted per ASTM D4169-16. Performance |
| testing was conducted before and after simulated shipping to | |
| demonstrate that the product and package integrity and | |
| sterility are maintained throughout the intended product shelf | |
| life. |
Performance Testing Summary Table 2:
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 F180NR dialyzer is safe and effective for its intended use.
5.8.1. Biocompatibility Testing
Testing was performed to support the biological safety of the Optiflux F180NR dialyzer.
- Chemical Analysis - Extractables and Leachables
- . Cytotoxicity, ISO Elution Method with MEM
- Sensitization, Guinea Pig Maximization
- Intracutaneous Irritation
- Acute Systemic Toxicity
- Systemic Toxicity, Short-Term Repeated Exposure ●
- Material-Mediated Pyrogenicity
- Genotoxicity, Bacterial Reverse Mutation Assay ●
7
Image /page/7/Picture/0 description: The image contains 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.
- . 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, Mechanical Hemolysis
- Hemocompatibility, in vitro Thrombogenicity Assay ●
- Hemocompatibility, Platelet and Leukocyte Function
- PVP Testing .
A toxicological risk assessment was also performed.
5.8.2. Human Factors Validation Testing
Human factors (HF) validation testing was leveraged for Optiflux F180NR 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).
5.8.3. Electrical Safety and Electromagnetic Compatibility (EMC)
Not applicable. The Optiflux F180NR dialyzer is not an electrical mechanical device.
Software Verification and Validation Testing 5.8.4.
Not applicable. The Optiflux F180NR dialyzer does not contain software.
5.8.5. Animal Studies
No animal studies were performed.
5.8.6. Clinical Studies
No clinical studies were performed.
5.9. Conclusion
The intended use, principle of operation, design characteristics, and patient fluid-contacting materials of the Optiflux F180NR 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 F180NR device is safe and effective for its intended use.