(80 days)
No
The description focuses on the physical components and function of a dialyzer, a passive device for filtering blood. There is no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is intended for hemodialysis, hemodiafiltration, hemofiltration, and isolated ultrafiltration in patients with acute kidney injury or chronic kidney disease, which are therapeutic interventions.
No
Explanation: The device, Optiflux dialyzers, is described as a treatment device for hemodialysis, hemodiafiltration, hemofiltration, and isolated ultrafiltration in patients with kidney disease. It functions by transferring water and solutes between blood and dialysate, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states that the Optiflux dialyzers are physical devices made of a semi-permeable membrane and housing, designed for single use hemodialysis. It describes physical components and their function in the dialysis process.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for hemodialysis, hemodiafiltration, hemofiltration, and isolated ultrafiltration in patients with kidney conditions. These are therapeutic procedures, not diagnostic tests performed on samples outside the body.
- Device Description: The description clearly states the device is a dialyzer that facilitates the transfer of water and solutes between blood and dialysate through a membrane. This is a physical process for removing waste and excess fluid from the blood, not a method for analyzing a sample to diagnose a condition.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes (proteins, genes, metabolites, etc.)
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
The device is a therapeutic medical device used in the treatment of kidney disease.
N/A
Intended Use / Indications for Use
Optiflux dialyzers are intended for hemodialysis, hemodiafiltration, hemofiltration, and isolated ultrafiltration in patients with acute kidney injury or chronic kidney disease when conservative therapy is judged to be inadequate.
Product codes
KDI
Device Description
The Optiflux dialyzers are part of the FMCRTG family of single use dialyzers which allow for the transfer of water and solutes between blood and the dialysate through a semi-permeable membrane. The Optiflux dialyzers are available in three (3) sizes. The sizes are differentiated by housing size, fiber count per bundle, and effective membrane surface area.
The Optiflux dialyzers are single use dialyzers manufactured from Advanced Fresenius polysulfone, polycarbonate, silicone, polyurethane, and high-density polyethylene. The dialyzers are provided with the blood pathway sterile and non-pyrogenic. The dialyzers are sterilized using e-beam radiation.
Optiflux dialyzers are high-flux, sterile devices designed for single use hemodialysis and hemodiafiltration for the treatment of acute kidney injury or chronic kidney disease. The dialyzer is configured to connect to a bloodline set which connects to a patient's vascular access system when used with a dialysis machine equipped with ultrafiltration control. During treatment, blood is pumped from the patient's body through an extracorporeal circuit, one component of which is the dialyzer contains a semi-permeable membrane that allows for diffusion and/or convection to transport toxins and excess fluid from the blood compartment (fiber lumen) to the dialysate or filtrate compartment. Dialyzers utilize a counter-current flow in which dialysate and blood flow in opposite directions in the dialyzer during hemodialysis. 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
Optiflux dialyzers are used in environments where acute and chronic dialysis 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 8637-1:2017 and Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers, August 1998. Testing conducted to support the expanded Indications for Use statement and increased maximum dialysate flow rate is summarized in Table 3.
Test Conducted: Clearance – Sodium (marker for urea), Creatinine, Phosphate, Vitamin B12, Β2- Microglobulin. Test Method Description: Calculated by analyzing test samples over the specified range of blood, dialysate, and filtration flow rates.
Test Conducted: Protein Sieving Coefficient. Test Method Description: 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 taken again after another 15 min. The sieving coefficient was calculated in accordance with Section 5.6.2.4 of ISO 8637-1:2017.
Test Conducted: Pressure Drop. Test Method Description: 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.
Test Conducted: Blood Kuf. Test Method Description: Calculated as the slope from a plot of the measured transmembrane pressure versus the ultrafiltration rate.
Results of all testing met predetermined acceptance criteria and demonstrated that, like the predicate devices, the Optiflux dialyzers are safe and effective for their intended use.
Biocompatibility Testing: Testing was performed to confirm the biological safety of the Optiflux dialyzers in support of the labeling changes: Hemocompatibility, Mechanical Hemolysis.
Human Factors Validation Testing: A Human Factors assessment was conducted for the Optiflux dialyzers to demonstrate their safe and effective use in accordance with FDA guidance document Applying Human Factors and Usability Engineering to Medical Devices (03 February 2016).
Clinical Studies: No clinical studies were performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 28, 2020
Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann Senior Director, Regulatory Affairs 920 Winter Street Waltham, MA 02451
Re: K203062
Trade/Device Name: Optiflux® Series of Dialyzers F160NR, F180NR, F200NR Regulation Number: 21 CFR 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: December 15, 2020 Received: December 16, 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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,
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) K203062
Device Name
Optiflux® Series of Dialyzers F160NR, F180NR, F200NR
Indications for Use (Describe)
Optiflux dialyzers are intended for hemodiafiltration, hemofiltration, and isolated ultrafiltration in patients with acute kidney injury or chronic kidney disease when conservative therapy is judged to be inadequate.
X 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 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. 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.
K203062 Page 1 of 5
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: | 08 October 2020 |
5.2. Device Name
| Trade Name: | Optiflux® Series of Dialyzers |
|---|---|
| F160NR, F180NR, F200NR | |
| 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, F180NR and F200NR 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) will be used as secondary predicate devices to support the expanded Indications for Use statement.
Device Description 5.4.
The Optiflux dialyzers are part of the FMCRTG family of single use dialyzers which allow for the transfer of water and solutes between blood and the dialysate through a semi-permeable membrane. The Optiflux dialyzers are available in three (3) sizes. The sizes are differentiated by housing size, fiber count per bundle, and effective membrane surface area.
4
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 and is also blue.
Optiflux Dialvzers Traditional 510(k)
5.4.1. Device Identification
The proposed Optiflux dialyzers include the following sizes/models:
- Optiflux® F160NR Dialyzer ●
- Optiflux® F180NR Dialyzer .
- Optiflux® F200NR Dialyzer .
5.4.2. Device Characteristics
The Optiflux dialyzers are single use dialyzers manufactured from Advanced Fresenius polysulfone, polycarbonate, silicone, polyurethane, and high-density polyethylene. The dialyzers are provided with the blood pathway sterile and non-pyrogenic. The dialyzers are sterilized using e-beam radiation.
5.4.3. Environment of Use
Optiflux dialyzers are used in environments where acute and chronic dialysis are performed.
5.4.4. Brief Written Description of the Device
Optiflux dialyzers are high-flux, sterile devices designed for single use hemodialysis and hemodiafiltration for the treatment of acute kidney injury or chronic kidney disease. The dialyzer is configured to connect to a bloodline set which connects to a patient's vascular access system when used with a dialysis machine equipped with ultrafiltration control. During treatment, blood is pumped from the patient's body through an extracorporeal circuit, one component of which is the dialyzer contains a semi-permeable membrane that allows for diffusion and/or convection to transport toxins and excess fluid from the blood compartment (fiber lumen) to the dialysate or filtrate compartment. Dialyzers utilize a counter-current flow in which dialysate and blood flow in opposite directions in the dialyzer during hemodialysis. The counter-current flow maintains the concentration gradient across the membrane for waste and fluid removal.
5.4.5. Materials of Use
The Optiflux dialyzers are classified as externally communicating, circulating blood, prolonged contact (> 24 hours to 30 days) duration, Class II (Category B) 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" (04 September 2020).
The materials used in the manufacture of the components of the Optiflux dialyzers are listed in Table 1.
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Image /page/5/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. 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.
Optiflux Dialvzers Traditional 510(k)
| Component | Material |
|---|---|
| Housing | Polycarbonate |
| Potting Resin | Polyurethane |
| Fiber Bundle | Advanced Fresenius Polysulfone |
| Screw Flange | Polycarbonate |
| O-ring | Silicone |
| Blood Port Cap(s) | High Density Polyethylene |
| Dialysate Port Cap | High Density Polyethylene |
Optiflux Dialyzer Component Materials Table 1:
5.4.6. Key Performance Specifications and Characteristics
Urea clearance is a key performance specification of the Optiflux dialyzers. FMCRTG uses sodium clearance as a marker for urea clearance because sodium and urea exhibit similar movement across a membrane. Urea clearance data from the Instructions for Use (IFU) for the Optiflux series of dialyzers is provided in Table 2, where Qb= blood flow rate, Qa= dialysate flow rate, and Qr = filtration flow rate. The Qr is equal to the ultrafiltration flow rate (Qut) plus the substitution flow rate (Qs), where Qs=0 in hemodialysis.
In vitro Urea Clearance for Optiflux Dialyzers* Table 2:
| Trade Name | Typical Urea Clearance (Sodium Used as Marker) | |
|---|---|---|
| Qf = 0 mL/min | Qf = 75 mL/min | |
| Optiflux F160NR Dialyzer | 271 | 285 |
| Optiflux F180NR Dialyzer | 277 | 285 |
| Optiflux F200NR Dialyzer | 280 | 289 |
- Qb = 300 mL/min, Qa = 500 mL/min
5.5. Intended Use
Optiflux dialyzers are designed for single use hemodialysis and hemodiafiltration for the treatment of acute kidney injury or chronic kidney disease.
5.6. Indications for Use
Optiflux dialyzers are intended for hemodialysis, hemodiafiltration, hemofiltration, and isolated ultrafiltration in patients with acute kidney injury or chronic kidney disease when conservative therapy is judged to be inadequate.
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Image /page/6/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.
5.7. Comparison of Technological Characteristics with the Predicate Device
The following technological characteristics of the proposed Optiflux dialyzers are equivalent to the predicate Optiflux dialyzers (K162488) and the secondary predicate Gambro Polyflux 140H, 170H, and 210H Capillary Dialyzers (K043342):
- Intended use
- Design and configuration ●
- Identical sterilization method, packaging, and sterility label claims as the ● predicate dialyzers
- Identical materials as the predicate dialyzers Advanced Fresenius ● polysulfone, polycarbonate, polyurethane, silicone, and high-density polyethylene
Performance Data 5.8.
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 expanded Indications for Use statement and increased maximum dialysate flow rate is summarized in Table 3.
| Test Conducted | Test Method Description |
|---|---|
| Clearance – 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 | 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 | |
| taken again after another 15 min. The sieving coefficient was | |
| calculated in accordance with Section 5.6.2.4 of ISO 8637- | |
| 1:2017. | |
| 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. |
Table 3: Performance Testing Summary
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Image /page/7/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. The symbol is made up of three downward-pointing arrows 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.
Table 3: Performance Testing Summary
| Test Conducted | Test Method Description |
|---|---|
| Blood Kuf | Calculated as the slope from a plot of the measured |
| transmembrane pressure versus the ultrafiltration rate. |
Results of all testing met predetermined acceptance criteria and demonstrated that, like the predicate devices, the Optiflux dialyzers are safe and effective for their intended use.
5.8.1. Biocompatibility Testing
Testing was performed to confirm the biological safety of the Optiflux dialyzers in support of the labeling changes:
- Hemocompatibility, Mechanical Hemolysis ●
5.8.2. Human Factors Validation Testing
A Human Factors assessment was conducted for the Optiflux dialyzers to demonstrate their safe and effective use in accordance with FDA guidance document 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 dialyzers are not electrical mechanical devices.
Software Verification and Validation Testing 5.8.4.
Not applicable. The Optiflux dialyzers do not contain software.
5.8.5. Animal Studies
No animal studies were performed.
Clinical Studies 5.8.6.
No clinical studies were performed.
5.9. Conclusion
The intended use, design and configuration, and materials of the Optiflux dialyzers are substantially equivalent to those of the predicate and secondary predicate devices. Testing and evaluations that were conducted to support the expanded Indications for Use statement and increased maximum dialysate flow rate, address the safety of the Optiflux dialyzers, and demonstrate that the Optiflux dialyzers perform as intended in the specified use conditions. FMCRTG concludes that within the meaning of the Medical Device Amendments Act of 1976, the Optiflux dialyzers are safe and effective for their intended use.