(113 days)
No
The summary describes a physical medical device (dialyzer) with no mention of software, algorithms, or data processing that would indicate AI/ML. The changes described are physical modifications to the device.
Yes.
The device's intended use is for hemodialysis, hemodiafiltration, hemofiltration, and isolated ultrafiltration in patients with acute kidney injury, which are therapeutic interventions.
No
The device is a dialyzer intended for hemodialysis, hemodiafiltration, hemofiltration, and isolated ultrafiltration in patients with acute kidney injury. It is a therapy device used for treatment, not for diagnosing conditions.
No
The device description clearly states it is a physical hemodialyzer with hollow fiber membranes, indicating it is a hardware device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for hemodialysis, hemodiafiltration, hemofiltration, and isolated ultrafiltration in patients with acute kidney injury. These are procedures performed directly on the patient's blood to remove waste products and excess fluid.
- Device Description: The device is a dialyzer, which is a component used in these procedures to facilitate the transfer of substances between blood and dialysate.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform such tests on samples. It is a therapeutic device used to treat the patient directly.
Therefore, the multiFlux 1000 dialyzer is a therapeutic medical device, not an In Vitro Diagnostic.
N/A
# Intended Use / Indications for Use
The multiFlux 1000 dialyzers are intended for hemodialysis (HD), hemodiafiltration (HDF), hemofiltration (HF), and isolated ultrafiltration in patients with acute kidney injury when conservative therapy is judged to be inadequate.
# Product codes (comma separated list FDA assigned to the subject device)
KDI
# Device Description
The multiFlux 1000 dialyzers are high-flux, single-use, steam-sterilized hemodialyzers. The dialyzer is 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 multiFlux 1000 dialyzers are high-flux, sterile devices designed for single-use acute 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 a semipermeable membrane that allows for diffusion and/or ultrafiltration to transport toxins and excess fluid from the blood compartment (fiber lumen) to the dialysate compartment. The 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
Not Found
# 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)
- Biocompatibility Testing: The multiFlux 1000 dialyzers are chemically equivalent to the predicate FX CorAL dialyzers per ANSI/AAMI/ISO 10993-18:2020, Annex C.4.d. The removal of the blue colorant from the flange component does not require additional biocompatibility testing.
- Human Factors Validation Testing: The multiFlux 1000 dialyzers were found to be safe and effective for their intended users, uses, and use environments.
- Electrical Safety and Electromagnetic Compatibility (EMC): Not applicable. The multiFlux 1000 dialyzers are not electrical mechanical devices.
- Software Verification and Validation Testing: Not applicable. The multiFlux 1000 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.)
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.
FX CorAL dialyzers ([K220721](https://510k.innolitics.com/search/K220721))
# 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.
Fresenius Optiflux dialyzer ([K203062](https://510k.innolitics.com/search/K203062)), NxStage Cartridge Express ([K232803](https://510k.innolitics.com/search/K232803))
# Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.5860 High permeability hemodialysis system.
(a)
Identification. A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K
uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.).
(3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).
(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ”
(2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,”
(3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,”
(4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and
(5) “Guidance for Hemodialyzer Reuse Labeling.”
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 31, 2024
Fresenius Medical Care Renal Therapies Group, LLC Timothy Groves Regulatory Affairs - Senior Lead 920 Winter Street Waltham, MA 02451
K240394 Re: Trade/Device Name: multiFlux 1000 (F00012408) Regulation Number: 21 CFR§ 876.5860 Regulation Name: High Permeability Hemodialysis System Regulatory Class: II Product Code: KDI Dated: February 8, 2024 Received: May 2, 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.
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).
1
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.
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-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, 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
2
Indications for Use
510(k) Number (if known) K240394
Device Name multiFlux 1000 (F00012408)
Indications for Use (Describe)
The multiFlux 1000 dialyzers are intended for hemodialysis (HD), hemodiafiltration (HDF), hemofiltration (HF), and isolated ultrafiltration in patients with acute kidney injury 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 shows the logo for Fresenius Medical Care. On the left is a blue icon that looks like three chevrons stacked on top of each other, pointing downwards. To the right of the icon is the text "FRESENIUS MEDICAL CARE" in blue, with "FRESENIUS" on top of "MEDICAL CARE".
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: | 08 February 2024 |
1.2. Device Name
| Trade Name: | multiFlux |
|---|---|
| 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 predicate device for the proposed multiFlux 1000 dialyzers is the FX CorAL dialyzers (K220721). This device is not currently subject to a design-related recall.
The Fresenius Optiflux dialyzer (K203062) is being used as a reference device to support the dialysate flange port length of the proposed multiFlux 1000 dialyzers. The NxStage Cartridge Express (K232803) is being used as a reference device to support the reduced blood and dialysate flow rates of the proposed multiFlux 1000 dialyzer.
Device Description 1.4.
1.4.1. Device Identification
The multiFlux 1000 dialyzers are the subject of this 510(k) and are available in one (1) configuration 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 geometric shape on the left and the text "FRESENIUS MEDICAL CARE" on the right. The geometric shape is made up of three chevrons stacked on top of each other, with the top chevron being the largest and the bottom chevron being the smallest. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
multiFlux 1000 Dialyzer Table 1:
| Part Number | Description |
|---|---|
| F00012408 | multiFlux 1000 |
1.4.2. Device Characteristics
The multiFlux 1000 dialyzers are high-flux, single-use, steam-sterilized hemodialyzers. The dialyzer is 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 multiFlux 1000 dialyzers are used in environments where acute hemodialysis is performed.
1.4.4. Brief Written Description of the Device
The multiFlux 1000 dialyzers are high-flux, sterile devices designed for single-use acute 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 a semipermeable membrane that allows for diffusion and/or ultrafiltration to transport toxins and excess fluid from the blood compartment (fiber lumen) to the dialysate compartment. The 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 multiFlux 1000 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 multiFlux 1000 dialyzers' components and materials are listed in Table 2.
| 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 |
multiFlux 1000 Dialyzer Compents and Materials Table 2:
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Image /page/5/Picture/0 description: The image shows the logo for Fresenius Medical Care. The logo consists of a blue geometric shape on the left, resembling three downward-pointing chevrons stacked on top of each other. To the right of the shape are the words "FRESENIUS" and "MEDICAL CARE" stacked on top of each other, also in blue. The text is in a bold, sans-serif font.
| 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 multiFlux 1000 dialyzers. FMCRTG uses sodium clearance as a marker for urea clearance because sodium and urea exhibit similar movement across the membrane. An example of urea clearance data from the Instructions for Use (IFU) is provided in Table 3, 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 3: in vitro Urea Clearance for the multiFlux 1000 Dialyzer
| Trade Name | Flow Rate Conditions (mL/min) | | | Typical Urea Clearance
(mL/min) |
|-------------------------|-------------------------------|----|----|------------------------------------|
| | Qb | Qd | Qf | |
| multiFlux 1000 dialyzer | 200 | 67 | 0 | 67 |
1.5. Intended Use
The multiFlux 1000 dialyzers are designed for single use hemodialysis and hemo(dia)filtration for the treatment of acute kidney injury.
Indications for Use 1.6.
The multiFlux 1000 dialyzers are intended for hemodialysis (HD), hemodiafiltration (HDF), hemofiltration (HF), and isolated ultrafiltration in patients with acute kidney injury when conservative therapy is judged to be inadequate.
1.7. Comparison of Technological Characteristics with the Predicate Device
The following technological characteristics of the multiFlux 1000 dialyzers are substantially equivalent to those of the predicate FX CorAL dialyzers (K220721):
- Intended Use ●
- Design ●
- Principle of Operation ●
- Materials ●
- Performance Specifications ●
1.8. Performance Data
The design of the predicate FX CorAL 600 dialyzer is used as a baseline for the development of the proposed multiFlux 1000 dialyzers. The following changes were made to the predicate device to develop the proposed device:
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Image /page/6/Picture/0 description: The image contains the logo for Fresenius Medical Care. On the left side of the logo 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 the top line and "MEDICAL CARE" on the bottom line. The text is also in blue.
- Removal of blue colorant from flange component ●
- o Extension of dialysate flange port (for thread interfacing)
These changes will allow users to distinguish between the FX CorAL 600 and multiFlux 1000 dialyzer models. The proposed multiFlux 1000 dialyzer labels will also contain information only pertinent to the acute use environment (i.e., all chronic use environment information will be removed).
All other physical attributes of the multiFlux 1000 dialyzers are identical to the cleared FX CorAL 600 dialyzer. The differences between the predicate and proposed devices do not impact any performance attributes. Therefore, all performance testing from the predicate device 510(k) (K220721) is being leveraged to support the proposed multiFlux 1000 dialyzers.
Biocompatibility Testing 1.8.1.
The multiFlux 1000 dialyzers are chemically equivalent to the predicate FX CorAL dialyzers per ANSI/AAMI/ISO 10993-18:2020, Annex C.4.d. The removal of the blue colorant from the flange component does not require additional biocompatibility testing.
1.8.2. Human Factors Validation Testing
The multiFlux 1000 dialyzers were found to be safe and effective for their intended users, uses, and use environments.
1.8.3. Electrical Safety and Electromagnetic Compatibility (EMC)
Not applicable. The multiFlux 1000 dialyzers are not electrical mechanical devices.
1.8.4. Software Verification and Validation Testing
Not applicable. The multiFlux 1000 dialyzers do not contain software.
1.8.5. Animal Studies
No animal studies were performed.
1.8.6. Clinical Studies
No clinical studies were performed.
1.9. Conclusion
The intended use, design, materials, principle of operation, and performance specifications of the multiFlux 1000 dialyzers are substantially equivalent to those of the predicate device. Differences between the multiFlux 1000 dialyzers and the predicate do not raise new concerns with regard to safety or efficacy. FMCRTG concludes that within the meaning of the Medical Device Amendments Act of 1976, multiFlux 1000 dialyzers are safe and effective for their intended use.