(252 days)
No
The device description and performance studies focus on the physical properties and performance metrics of a hemodialyzer, which is a passive device for filtering blood. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a dialyzer, explicitly stated to be for "hemodialysis (HD), hemodiafiltration (HDF), hemofiltration (HF), and isolated ultrafiltration in patients... when conservative therapy is judged to be inadequate," which are all therapeutic interventions for kidney conditions.
No
The device description indicates that the FX CorAL dialyzers are used for hemodialysis, which is a treatment that removes waste and excess fluid from the blood, rather than for diagnosing a condition.
No
The device description clearly states that the FX CorAL dialyzers are physical, high-flux, single-use, steam-sterilized hemodialyzers with semipermeable, hollow fiber membranes. This indicates a hardware-based medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "hemodialysis (HD), hemodiafiltration (HDF), hemofiltration (HF), and isolated ultrafiltration in patients...". These are therapeutic procedures performed on the patient's body, not tests performed on samples taken from the body.
- Device Description: The description details how the dialyzer works to filter blood and remove waste and excess fluid from the patient's bloodstream. This is a direct treatment of the patient.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Detecting or measuring substances in a sample
- Use in a laboratory setting for testing
The device is a component of an extracorporeal circuit used for blood purification, which is a therapeutic intervention, not a diagnostic test.
N/A
Intended Use / Indications for Use
FX CorAL HD dialyzers are intended for hemodialysis (HD), hemodiafiltration (HDF), hemofiltration (HF), and isolated ultrafiltration in patients, including pediatric patients, with acute kidney injury or chronic kidney disease when conservative therapy is judged to be inadequate.
Consider body and dialyzer surface area, blood flow, body weight and extracorporeal blood volume when selecting dialyzers for use with pediatric patients.
Product codes (comma separated list FDA assigned to the subject device)
KDI
Device Description
The FX CorAL 40 and 50 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
pediatric patients, patients
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, Creatinine, Phosphate, Vitamin B12), Protein Sieving Coefficient, Ultrafiltration (Blood Kuf), Pressure Drop (Blood compartment and Dialysate side), and Blood Compartment Integrity. 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.
A retrospective clinical data analysis performed on the FX CorAL 40 and 50 dialyzers included fourteen (14) pediatric ESRD patients on HD treated for at least 12 consecutive weeks. FX CorAL 40 and 50 dialyzers provided adequate clearance with a mean spKt/V of 2.42 and 2.08 respectively, and all were tolerated.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
Typical Urea Clearance (mL/min):
FX CorAL 40 Dialyzer (Qb=200, Qd=500, Qf=0): 178
FX CorAL 50 Dialyzer (Qb=200, Qd=500, Qf=0): 192
mean spKt/V for pediatric ESRD patients: FX CorAL 40: 2.42, FX CorAL 50: 2.08
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 contains the logo of the U.S. Food and 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 features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
March 21, 2025
Fresenius Medical Care Renal Therapies Group, LLC Timothy Groves Regulatory Affairs - Senior Lead 920 Winter Street Waltham, Massachusetts 02451
Re: K242053
Trade/Device Name: FX CorAL 40 (F00009214); FX CorAL 50 (F00009215) Regulation Number: 21 CFR 876.5860 Regulation Name: High Permeability Hemodialysis System Regulatory Class: Class II Product Code: KDI Dated: July 12, 2024 Received: February 21, 2025
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 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-regulatory
2
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,
Gema Gonzalez -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
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
K242053
Device Name
FX CorAL 40 (F00009214); FX CorAL 50 (F00009215)
Indications for Use (Describe)
| FX CorAL HD dialyzers are intended for hemodialysis (HD), hemodiafiltration |
|---|
| (HDF), hemofiltration (HF), and isolated ultrafiltration in patients, including pediatric patients, |
| with acute kidney injury or chronic kidney disease when conservative therapy is judged to be |
| inadequate. |
Consider body and dialyzer surface area, blood flow, body weight and extracorporeal blood volume when selecting dialyzers for use with pediatric patients.
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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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
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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, also in blue. The symbol is made up of three downward-pointing chevrons 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.
Submitter's Information 1.1.
| 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: | 15 July 2024 |
1.2. Device Name
| Trade Name: | FX CorAL 40 (F00009214), FX CorAL 50 (F00009215) |
|---|---|
| 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 secondary predicate devices are the HemoFlow F3 and F4 Dialyzers (K190459). These predicates have not been subject to design-related recalls.
The Gambro Polyflux 6H Dialyzer (K051520) is used as a reference device to support the expanded Indications for Use statement.
1.4. Device Description
1.4.1. Device Identification
The FX CorAL 40 and 50 dialyzers are the subject of this 510(k) and are available in two (2) configurations as shown in Table 1.
Table 1: FX CorAL Dialyzers
| Trade Name | Product Number | Surface Area (m2) |
|---|---|---|
| FX CorAL 40 | F00009214 | 0.6 |
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| Trade Name | Product Number | Surface Area (m2) |
|---|---|---|
| FX CorAL 50 | F00009215 | 1.0 |
Table 1: FX CorAL Dialyzers
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.
Brief Written Description of the Device 1.4.4.
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 |
| Flange | Polypropylene |
| Blood Port Cap(s) | Polypropylene, Silicone |
The FX CorAL dialyzers' components are composed of the following materials:
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Image /page/6/Picture/0 description: The image shows the Fresenius Medical Care logo. The logo consists of a blue abstract symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
| Component | Material |
|---|---|
| Dialysate Port Cap(s) | Styrene-Ethylene-Butylene-Styrene, 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.
Table 2: in vitro Urea Clearance for the FX Coral Dialyzers
| Trade Name | Flow Rate Conditions (mL/min) | | | Typical Urea Clearance
(mL/min) |
|----------------------|-------------------------------|-----|----|------------------------------------|
| | Qb | Qd | Qf | |
| FX CorAL 40 Dialyzer | 200 | 500 | 0 | 178 |
| FX CorAL 50 Dialyzer | 200 | 500 | 0 | 192 |
1.5. 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.
Indications for Use 1.6.
FX CorAL HD dialyzers are intended for hemodialysis (HD), hemodiafiltration (HDF), hemofiltration (HF), and isolated ultrafiltration in patients, including pediatric patients, with acute kidney injury or chronic kidney disease when conservative therapy is judged to be inadequate.
Consider body and dialyzer surface area, blood flow, body weight and extracorporeal blood volume when selecting dialyzers for use with pediatric patients.
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), secondary predicate Hemoflow F3 and F4 dialyzers (K190459), and reference Gambro 6H Polflux dialyzer (K051520):
- Intended Use
- Principle of operation
- Design characteristics
- Sterilization method
- Materials
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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.
- Performance requirements ●
1.8. 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. Due to design similarities, structural integrity and shipping and distribution testing submitted in K220721 is being leveraged to support the proposed FX CorAL 40 and 50 dialyzers.
| 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 | 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. | |
| Blood Compartment Integrity | Evaluate the integrity of the blood compartment |
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.
1.8.1. Biocompatibility Testing
The materials of the proposed FX CorAL 40 and 50 dialyzers are identical to the predicate FX CorAL dialyzers (K220271). Therefore, a subset of biocompatibility testing was performed to evaluate the smaller surface areas of the proposed dialyzers.
The toxicological risk assessment from the predicate FX CorAL dialyzers was updated to evaluate the biological safety in pediatric patients.
8
Testing performed to support the biological safety of the FX CorAL 40 and 50 dialyzers:
- . Chemical Analysis - Extractables (update to existing documentation)
- Chemical Analysis - Leachables
- ISO Subchronic Toxicity, Short-Term (14-Day) Repeated Exposure ●
- Genotoxicity, ISO Bacterial Reverse Mutation Assay ●
- Genotoxicity, in vitro Mouse Lymphoma Gene Mutation Assay ●
- Hemocompatibility, Mechanical Hemolysis ●
Human Factors Validation Testing 1.8.2.
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).
1.8.3. Electrical Safety and Electromagnetic Compatibility (EMC)
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.
1.8.5. Animal Studies
No animal studies were performed.
1.8.6. Clinical Studies
A retrospective clinical data analysis performed on the FX CorAL 40 and 50 dialyzers included fourteen (14) pediatric ESRD patients on HD treated for at least 12 consecutive weeks. FX CorAL 40 and 50 dialyzers provided adequate clearance with a mean spKt/V of 2.42 and 2.08 respectively, and all were tolerated.
1.9. Conclusion
The intended use, principle of operation, design characteristics, sterilization method, materials, and performance requirements are substantially equivalent to those of the predicate, secondary predicate, and/or reference devices. FMCRTG concludes that within the meaning of the Medical Device Amendments Act of 1976, the FX CorAL 40 and 50 dialyzers are safe and effective for their intended use.