(73 days)
Not Found
No
The device description focuses on the physical components and function of a hemodialyzer, which is a passive filter. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The device is used for extracorporeal blood purification during intermittent renal replacement therapies (hemodialysis, hemodiafiltration, and isolated ultrafiltration) for patients suffering from renal insufficiency, indicating a therapeutic purpose.
No
The device is a hemodialyzer used for extracorporeal blood purification, which is a treatment for renal insufficiency, not for diagnosing a condition.
No
The device description clearly describes a physical hemodialyzer with hollow fiber membranes, indicating it is a hardware device, not software only.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states the device is for "extracorporeal blood purification during intermittent renal replacement therapies." This involves processing blood outside the body to remove waste products and excess fluid.
- Device Description: The description details how the device works by transferring water and solutes between blood and dialysate using a semipermeable membrane. This is a physical process of filtration and diffusion, not a diagnostic test performed on a sample.
- Lack of Diagnostic Activity: There is no mention of analyzing a sample (blood, urine, etc.) to provide information about a patient's health status, disease, or condition. The device's function is therapeutic, not diagnostic.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform such a function.
N/A
Intended Use / Indications for Use
The FX CorAL hemodialyzers are intended for single use only for extracorporeal blood purification during intermittent renal replacement therapies hemodialysis (HD), hemodiafiltration (HDF) using pre-, post or mixed-dilution modes, and isolated ultrafiltration for patients suffering from renal insufficiency.
The FX CorAL hemodiafilters are intended for single use only for extracorporeal blood purification during intermittent renal replacement therapies hemodialysis (HD), hemodiafiltration (HDF) using pre-, post or mixed-dilution modes, and isolated ultrafiltration for patients suffering from renal insufficiency.
Product codes
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
The proposed FX CorAL dialyzers are identical to the predicate FX CorAL dialyzers with respect to manufacturing, design, sterilization method, and materials. The proposed labeling changes do not impact the performance of the dialyzers. The data provided in K220721 remains applicable for the performance evaluations.
- Biocompatibility Testing: The proposed FX CorAL dialyzers are identical to the predicate FX CorAL dialyzers with respect to manufacturing, design, sterilization method, and materials. The proposed labeling changes do not impact the biological safety of the dialyzers. The data provided in K220721 remains applicable for biological, hematological, and chemical evaluations.
- Human Factors Validation Testing: The FX CorAL dialyzers were validated for 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): Not applicable. The FX CorAL dialyzers are not electrical mechanical devices.
- Software Verification and Validation Testing: Not applicable. The FX CorAL dialyzers do not contain software.
- Animal Studies: No animal studies were performed.
- Clinical Studies: No clinical studies were performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key Performance Specifications/Characteristics: Urea clearance is a key performance specification of the FX CorAL dialyzers. FMCRTG uses sodium clearance as a marker for urea clearance because sodium and urea exhibit similar movement across the membrane. Urea clearance data from the Instructions for Use (IFU) is provided in Table 2, where Qb = blood flow rate, Qd = dialysate flow rate, and Qf = filtration flow rate. The Qf is equal to the ultrafiltration rate (Quf) plus the substitution flow rate (Qs), where Qs = 0 in hemodialysis.
| 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 |
Predicate Device(s)
Reference Device(s)
Not Found
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.”
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Image /page/0/Picture/0 description: The image shows the logo for 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" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format. The logo is simple and professional, and it is easily recognizable.
February 28, 2025
Fresenius Medical Care Renal Therapies Group, LLC Timothy Groves Regulatory Affairs - Senior Lead 920 Winter Street Waltham, Massachusetts 02451
Re: K243874
Trade/Device Name: FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX CorAL 120 (F00012972); FX CorAL 600 (F00012973); FX CorAL 800 (F00012974); FX CorAL 1000 (F00012975) Regulation Number: 21 CFR 876.5860 Regulation Name: High Permeability Hemodialysis System Regulatory Class: Class II Product Code: KDI Dated: December 17, 2024 Received: December 17, 2024
Dear Timothy Groves:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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-regulatory
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Maura Rooney -S
Maura Rooney Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity, and Transplant Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K243874
Device Name
FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX CorAL 120 (F00012972); FX CorAL 600 (F00012973); FX CorAL 800 (F00012974); FX CorAL 1000 (F00012975)
Indications for Use (Describe)
The FX CorAL hemodialyzers are intended for single use only for extracorporeal blood purification during intermittent renal replacement therapies hemodialysis (HD), hemodiafiltration (HDF) using pre-, post or mixed-dilution modes, and isolated ultrafiltration for patients suffering from renal insufficiency.
The FX CorAL hemodiafilters are intended for single use only for extracorporeal blood purification during intermittent renal replacement therapies hemodialysis (HD), hemodiafiltration (HDF) using pre-, post or mixed-dilution modes, and isolated ultrafiltration for patients suffering from renal insufficiency.
| 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)
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Image /page/4/Picture/0 description: The image shows the Fresenius Medical Care logo. The logo consists of a blue geometric shape on the left and the words "FRESENIUS MEDICAL CARE" in blue on the right. The geometric shape is made up of three downward-pointing chevrons stacked on top of each other. The words "FRESENIUS" and "MEDICAL CARE" are stacked on top of each other.
510(K) SUMMARY 1.
This 510(k) Summary is in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content of this 510(k) summary is provided in conformance with 21 CFR § 807.92.
1.1. Submitter's Information
| Name: | Fresenius Medical Care Renal Therapies Group, LLC |
|---|---|
| Address: | 920 Winter Street |
| Waltham, MA 02451-1457 | |
| Phone: | (781) 460-1087 |
| Fax: | (781) 699-9635 |
| Contact Person: | Timothy Groves, Senior Lead |
| Preparation Date: | 17 December 2024 |
1.2. 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 |
1.3. Legally Marketed Predicate Device
The legally marketed primary predicate devices are the FX CorAL 60, 80, 100, 120, 600, 800, and 1000 Dialyzers cleared under K220721. The predicate has not been subject to a designrelated recall.
Device Description 1.4.
1.4.1. 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.
| Trade Name | Product Number | Surface Area (m2) |
|---|---|---|
| FX CorAL 60 | F00012969 | 1.4 |
| FX CorAL 80 | F00012970 | 1.8 |
| FX CorAL 100 | F00012971 | 2.2 |
Table 1: FX CorAL Dialyzers
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| Trade Name | Product Number | Surface Area (m²) |
|---|---|---|
| FX CorAL 120 | F00012972 | 2.5 |
| FX CorAL 600 | F00012973 | 1.6 |
| FX CorAL 800 | F00012974 | 2.0 |
| FX CorAL 1000 | F00012975 | 2.3 |
Table 1: FX CorAL Dialvzers
1.4.2. 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.
1.4.3. Environment of Use
The FX CorAL dialyzers are used in environments where acute and chronic hemodialysis are performed.
1.4.4. 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.
1.4.5. Materials of Use
The FX CorAL dialyzers are classified as external communicating devices having direct contact via circulating blood and chronic long-term use exposure ( > 30 days, Classification C) in accordance with FDA guidance Use of International Standard ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process (08 September 2023).
| Component | Material |
|---|---|
| Housing | Polypropylene |
| Potting Resin | Polyurethane |
| Fiber Bundle | Polysulfone-polyvinylpyrrolidone blend, a-tocopherol (vitamin E) |
| Sealing Ring | Silicone |
The FX CorAL dialyzers' components are composed of the following materials:
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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.
| Component | Material |
|---|---|
| Flange | Polypropylene |
| Blood Port Cap(s) | Polypropylene and Silicone |
| Dialysate Port Cap(s) | Styrol-Ethylen-Butylen-Styrol, Polypropylene |
1.4.6. Key Performance Specifications/Characteristics
Urea clearance is a key performance specification of the FX CorAL dialyzers. FMCRTG uses sodium clearance as a marker for urea clearance because sodium and urea exhibit similar movement across the membrane. Urea clearance data from the Instructions for Use (IFU) is provided in Table 2, where Qb = blood flow rate, Qd = dialysate flow rate, and Qf = filtration flow rate. The Qf is equal to the ultrafiltration rate (Quf) plus the substitution flow rate (Qs), where Qs = 0 in hemodialysis.
| 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
1.5. Intended Use
Removal of uremic toxins including excess water and correction of blood electrolytes and acidbase balance in an extracorporeal treatment.
Indications for Use 1.6.
FX CorAL 60, 80, 100, and 120 Dialyzers:
The FX CorAL hemodialyzers are intended for single use only for extracorporeal blood purification during intermittent renal replacement therapies hemodialysis (HD), hemodiafiltration (HDF) using pre-, post or mixed-dilution modes, and isolated ultrafiltration for patients suffering from renal insufficiency.
FX CorAL 600, 800, and 1000 Dialyzers:
The FX CorAL hemodiafilters are intended for single use only for extracorporeal blood purification during intermittent renal replacement therapies hemodialysis (HD), hemodiafiltration (HDF) using pre-, post or mixed-dilution modes, and isolated ultrafiltration for patients suffering from renal insufficiency.
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Image /page/7/Picture/0 description: The image shows the Fresenius Medical Care logo. The logo consists of a blue geometric shape on the left and the words "FRESENIUS MEDICAL CARE" in blue on the right. The geometric shape is made up of three chevrons stacked on top of each other.
1.7. Comparison of Technological Characteristics with the Predicate Device
The following technological characteristics of the proposed FX CorAL dialyzers are equivalent to the predicate FX CorAL dialyzers (K220721):
- Intended Use and Indications for Use ●
- Principle of Operation ●
- Design and Configuration ●
- Technological Characteristics ●
- Materials
- Performance Requirements ●
1.8. Performance Data
The proposed FX CorAL dialyzers are identical to the predicate FX CorAL dialyzers with respect to manufacturing, design, sterilization method, and materials. The proposed labeling changes do not impact the performance of the dialyzers. The data provided in K220721 remains applicable for the performance evaluations.
1.8.1. Biocompatibility Testing
The proposed FX CorAL dialyzers are identical to the predicate FX CorAL dialyzers with respect to manufacturing, design, sterilization method, and materials. The proposed labeling changes do not impact the biological safety of the dialyzers. The data provided in K220721 remains applicable for biological, hematological, and chemical evaluations.
Human Factors Validation Testing 1.8.2.
The FX CorAL dialyzers were validated for 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) 1.8.3.
Not applicable. The FX CorAL dialyzers are not electrical mechanical devices.
1.8.4. Software Verification and Validation Testing
Not applicable. The FX CorAL dialyzers do not contain software.
Animal Studies 1.8.5.
No animal studies were performed.
Clinical Studies 1.8.6.
No clinical studies were performed.
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Image /page/8/Picture/0 description: The image contains the logo for Fresenius Medical Care. On the left is a blue symbol that looks like three chevrons stacked on top of each other, pointing downwards. To the right of the symbol is the text "FRESENIUS MEDICAL CARE", with "FRESENIUS" on top of "MEDICAL CARE". The text is also in blue.
1.9. Conclusion
The intended use, indications for use, principle of operation, technological characteristics, design, materials, and performance requirements are substantially equivalent to those of the predicate device. 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.