(423 days)
No
The summary describes a physical medical device (dialyzer) and its performance testing based on established standards and clinical trials, with no mention of AI or ML technology.
Yes
The device is used for hemodialysis, hemodiafiltration, hemofiltration, and isolated ultrafiltration in patients with kidney diseases, which are therapeutic interventions.
No.
The device description clearly states it is a dialyzer used for hemodialysis, hemodiafiltration, hemofiltration, and isolated ultrafiltration, which are treatment procedures for kidney conditions, not diagnostic procedures.
No
The device description clearly states it is a physical hemodialyzer, which is a hardware component.
Based on the provided text, the FX CorAL dialyzers are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for hemodialysis, hemodiafiltration, hemofiltration, and isolated ultrafiltration in patients with kidney conditions. These are procedures performed directly on the patient's blood to remove waste products and excess fluid.
- Device Description: The device description focuses on the physical characteristics of the dialyzer (high-flux, single-use, steam-sterilized, hollow fiber membranes) and its function in transferring water and solutes between blood and dialysate.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening. The FX CorAL dialyzer is used in vivo (within the body) as part of a treatment process.
Therefore, the FX CorAL dialyzer is a therapeutic medical device used for extracorporeal blood treatment, not an IVD.
N/A
Intended Use / Indications for Use
FX CorAL dialyzers are intended for hemodialysis (HD), hemodiafiltration (HDF), hemofiltration (HF), and isolated ultrafiltration in patients with acute kidney injury or chronic kidney disease when conservative therapy is judged to be inadequate.
Product codes (comma separated list FDA assigned to the subject device)
KDI
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.
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
The FX CorAL dialyzers are 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 8637-1 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 included: Blood Compartment Volume, Clearance – Sodium (marker for urea), Creatinine, Phosphate, Vitamin B12, β2-Microglobulin, Protein Sieving Coefficient, Ultrafiltration (Blood Kuf), Pressure Drop, Structural Integrity (Dialyzer Integrity), Blood Compartment Integrity (Membrane Integrity), and Simulated Shipping and Distribution. 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.
Three (3) outside the U.S. (OUS) clinical trials evaluated safety and performance of the proposed FX CorAL 600 dialyzer. The trials, as well as post-market surveillance, found a comparable safety to the reference dialyzers without new safety signals. The incidence of hypersensitivity and hypersensitivity-like reactions was well below the predefined threshold in each trial and in post-market surveillance.
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.
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.”
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 11, 2023
Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann Senior Director, Regulatory Affairs 920 Winter Street Waltham, Massachusetts 02451
Re: K220721
Trade/Device Name: FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000 Regulation Number: 21 CFR 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: April 11, 2023 Received: April 11, 2023
Dear Denise Oppermann:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Gema Gonzalez -S
Gema Gonzalez, MS Acting Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220721
Device Name
FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 600, FX CorAL 800, FX CorAL 800, FX CorAL 1000
Indications for Use (Describe)
FX CorAL dialyzers are intended for hemodialysis (HD), hemodiafiltration (HDF), hemofiltration (HF), and isolated ultrafiltration in patients with acute kidney injury or chronic kidney disease when conservative therapy is judged to be inadequate.
| 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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K220721 Page 1 of 6
5. 510(K) SUMMARY (K220721)
This 510(k) Summary is in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content of this 510(k) summary is provided in conformance with 21 CFR § 807.92.
5.1. Submitter's Information
| Name: | Fresenius Medical Care Renal Therapies Group, LLC |
|---|---|
| Address: | 920 Winter Street |
| Waltham, MA 02451-1457 | |
| Phone: | (781) 996-9103 |
| Fax: | (781) 699-9635 |
| Contact Person: | Denise Oppermann, Senior Director |
| Preparation Date: | 11 March 2022 |
5.2. Device Name
| Trade Name: | FX CorAL |
|---|---|
| Common Name: | Dialyzer |
| Regulation Name: | High Permeability hemodialysis system |
| Regulatory Class: | Class II per 21 CFR § 876.5860 |
| Product Code: | KDI |
| Product Code Name: | Dialyzer, High Permeability With or Without Sealed Dialysate System |
| FDA Review Panel: | Gastroenterology/Urology |
5.3. Legally Marketed Predicate Device
The legally marketed predicate devices are the F160NR, F200NR, and F250NR Optiflux Dialyzers cleared under K162488. These predicates have not been subject to a designrelated recall.
The Gambro Polyflux 140H, 170H, and 210H Capillary Dialyzers (K043342) are used as secondary predicate devices to support the expanded Indications for Use statement. The Asahi ViE-U Dialyzer (K162248) is used as a reference device to support the presence of vitamin E.
Device Description 5.4.
5.4.1. Device Identification
The FX CorAL dialyzers are the subject of this 510(k) and are available in seven (7) configurations as shown in Table 1.
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Image /page/4/Picture/0 description: The image shows the logo for Fresenius Medical Care. The logo consists of a blue symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The symbol is made up of three downward-pointing chevrons stacked on top of each other. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
K220721 Page 2 of 6
FX CorAL Dialyzer Traditional 510(k)
| Table 1:
| FX CorAL Dialyzers | |||||
|---|---|---|---|---|---|
| Trade Name | Product Number | Surface Area (m2) | |||
| FX CorAL 60 | F00009216 | 1.4 | |||
| FX CorAL 80 | F00009217 | 1.8 | |||
| FX CorAL 100 | F00009218 | 2.2 | |||
| FX CorAL 120 | F00009219 | 2.5 | |||
| FX CorAL 600 | F00009220 | 1.6 | |||
| FX CorAL 800 | F00009221 | 2.0 | |||
| FX CorAL 1000 | F00009222 | 2.3 |
5.4.2. Device Characteristics
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.
5.4.3. Environment of Use
The FX CorAL dialyzers are used in environments where acute and chronic hemodialysis are performed.
5.4.4. Brief Written Description of the Device
The FX CorAL dialyzers are high-flux, sterile devices designed for single-use acute and chronic hemodialysis. The dialyzers are configured to connect to a bloodline set which connects to a patient's vascular access system when used with a hemodialysis machine equipped with ultrafiltration control. During hemodialysis, blood is pumped from the patient's body through an extracorporeal circuit, one component of which is the dialyzers contain semipermeable membranes that allow for diffusion and/or ultrafiltration to transport toxins and excess fluid from the blood compartment (fiber lumen) to the dialysate compartment. Dialyzers utilize a counter-current flow in which dialysate and blood flow in opposite directions in the dialyzer. The counter-current flow maintains the concentration gradient across the membrane for waste and fluid removal.
5.4.5. Materials of Use
The FX CorAL dialyzers are classified as externally communicating, blood path indirect, prolonged contact (>24 hours to 30 days) duration, Class II devices in accordance with FDA guidance Use of International Standard ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process (16 June 2016).
The FX CorAL dialyzers' components are composed of the following materials:
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K220721 Page 3 of 6
FX CorAL Dialyzer Traditional 510(k)
| Component | Material |
|---|---|
| Housing | Polypropylene |
| Potting Resin | Polyurethane |
| Fiber Bundle | Polysulfone-polyvinylpyrrolidone blend, a-tocopherol (vitamin E) |
| Sealing Ring | Silicone |
| Flange | Polypropylene |
| Blood Port Cap(s) | Polypropylene |
| Dialysate Port Cap(s) | Styrol-Ethylen-Butylen-Styrol, Polypropylene |
5.4.6. Key Performance Specifications/Characteristics
Urea clearance is a key performance specification of the FX CorAL dialyzers. FMCRTG uses sodium clearance as a marker for urea clearance because sodium and urea exhibit similar movement across the membrane. Urea clearance data from the Instructions for Use (IFU) is provided in Table 2, where Qb = blood flow rate, Qd = dialysate flow rate, and Of = filtration flow rate. The Qf is equal to the ultrafiltration rate (Quf) plus the substitution flow rate (Qs), where Qs = 0 in hemodialysis.
| Trade Name | Flow Rate Conditions (mL/min) | Typical Urea Clearance (mL/min) | ||
|---|---|---|---|---|
| Qb | Qd | Qf | ||
| FX CorAL 60 Dialyzer | 300 | 500 | 0 | 270 |
| FX CorAL 80 Dialyzer | 300 | 500 | 0 | 277 |
| FX CorAL 100 Dialyzer | 300 | 500 | 0 | 282 |
| FX CorAL 120 Dialyzer | 300 | 500 | 0 | 285 |
| FX CorAL 600 Dialyzer | 300 | 500 | 75 | 285 |
| FX CorAL 800 Dialyzer | 300 | 500 | 75 | 288 |
| FX CorAL 1000 Dialyzer | 300 | 500 | 75 | 292 |
Table 2: in vitro Urea Clearance for the FX Coral Dialyzers
5.5. Intended Use
The FX CorAL dialyzers are designed for single use hemodialysis and hemo(dia)filtration for the treatment of acute kidney injury or chronic kidney disease.
5.6. Indications for Use
FX CorAL dialyzers are intended for hemodialysis (HD), hemodiafiltration (HDF), hemofiltration (HF), and isolated ultrafiltration in patients with acute kidney injury or chronic kidney disease when conservative therapy is judged to be inadequate.
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Image /page/6/Picture/0 description: The image shows the logo for Fresenius Medical Care. The logo consists of a blue symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The symbol is made up of three downward-pointing chevrons stacked on top of each other. The text is in a bold, sans-serif font and is also blue.
K220721 Page 4 of 6
FX CorAL Dialyzer Traditional 510(k)
5.7. Comparison of Technological Characteristics with the Predicate Device
The following technological characteristics of the proposed FX CorAL dialyzers are equivalent to the predicate Optiflux dialyzers (K162488) and the secondary Gambro Polyflux dialyzers (K043342):
- Intended Use
- Design and configuration .
- Technological characteristics .
- Materials
- Performance requirements ●
5.8. Performance Data
Performance testing was conducted in accordance with ISO 8637-1 First Edition 2017-11 and Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers, August 1998. Testing conducted to support the determination of substantial equivalence is summarized in Table 3.
| Test Conducted | Test Method Description |
|---|---|
| Blood Compartment Volume | Calculated using the fiber volume and CAD software modeling for |
| the flange volume. Results were compared with the acceptance | |
| criteria. | |
| 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 ISO 8637-1 First Edition 2017-11 | |
| Ultrafiltration (Blood Kuf) | Calculated as the slope from a plot of the measured ultrafiltration |
| rate (UFR) over the applied transmembrane pressure (TMP) range | |
| versus the applied TMP | |
| Pressure Drop | Blood compartment: The blood compartment was perfused with |
| human blood while the dialysate compartment was filled with NaCl | |
| solution | |
| Dialysate side: Both compartments were filled with dialysis fluid. | |
| 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 logo for Fresenius Medical Care. The logo consists of a blue symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The symbol is made up of three downward-pointing chevrons stacked on top of each other. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
FX CorAL Dialyzer Traditional 510(k)
| Test Conducted | Test Method Description |
|---|---|
| Structural Integrity (Dialyzer | |
| Integrity) | The positive and negative pressure decay was measured by a |
| pressure monitor connected at one end of the dialyzer after applying | |
| 4.5 bar and -700 mmHg from the opposite ends and equilibrium was | |
| reached | |
| Blood Compartment Integrity | |
| (Membrane Integrity) | Water was added to the dialyzer. A pressure differential was applied |
| across the dialyzer membrane via pressurized air. The outlet blood | |
| port of the dialyzer was observed for air bubbles. | |
| Simulated Shipping and | |
| Distribution | Testing was conducted per ASTM D4169-16. Performance testing |
| was conducted after simulated shipping and accelerated aging to | |
| demonstrate that product and package integrity, and sterility are | |
| maintained throughout the intended product's shelf life. |
Table 3: Performance Testing Summary
All testing met predetermined acceptance criteria and demonstrated that, like the predicate devices, the FX CorAL dialyzers are safe and effective for their intended use.
5.8.1. Biocompatibility Testing
Testing was performed to support the biological safety of the FX CorAL dialyzers:
- Chemical Analysis Extractables and Leachables .
- । Targeted Quantitative Analyses
- Cytotoxicity, ISO Neutral Red Uptake
- Sensitization, ISO Guinea Pig Maximization
- ISO Intracutaneous Irritation
- ISO Acute Systemic Toxicity
- ISO Subchronic Toxicity, Short-Term (14-Day) Repeated Exposure ●
- . Material-Mediated Pyrogenicity
- Genotoxicity, ISO Bacterial Reverse Mutation Assay
- Genotoxicity, in vitro Mouse Lymphoma Gene Mutation Assay
- Hemocompatibility, ASTM Hemolysis (Direct and Indirect - Extract)
- Hemocompatibility, Complement Activation SC5b-9 fragment ●
- Hemocompatibility, ASTM Partial Thromboplastin Time
- Hemocompatibility, Platelet and Leukocyte Counts ●
- Hemocompatibility, Mechanical Hemolysis ●
- Hemocompatibility, in vitro Thrombogenicity Assay ●
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A toxicological risk assessment was also performed.
Human Factors Validation Testing 5.8.2.
A Human Factors assessment was conducted for the FX CorAL dialyzers to demonstrate their safe and effective use in accordance with FDA guidance Applying Human Factors and Usability Engineering to Medical Devices (03 February 2016).
5.8.3. Electrical Safety and Electromagnetic Compatibility (EMC)
Not applicable. The FX CorAL dialyzers are not electrical mechanical devices.
Software Verification and Validation Testing 5.8.4.
Not applicable. The FX CorAL dialyzers do not contain software.
5.8.5. Animal Studies
No animal studies were performed.
Clinical Studies 5.8.6.
Three (3) outside the U.S. (OUS) clinical trials evaluated safety and performance of the proposed FX CorAL 600 dialyzer. The trials, as well as post-market surveillance, found a comparable safety to the reference dialyzers without new safety signals. The incidence of hypersensitivity and hypersensitivity-like reactions was well below the predefined threshold in each trial and in post-market surveillance.
5.9. Conclusion
The intended use, technological characteristics, design, materials, and performance requirements are substantially equivalent to those of the predicate and secondary predicate devices. FMCRTG concludes that within the meaning of the Medical Device Amendments Act of 1976, the FX CorAL dialyzers are safe and effective for their intended use.