(247 days)
No
The summary does not mention AI, ML, or any related technologies in the device description, intended use, or performance studies. The device appears to be a standard hemodialysis system with automated features for setup and fluid control.
Yes
The device is indicated for treating acute and/or chronic renal failure, and it performs hemodialysis, which is a therapeutic intervention to remove waste products from the blood.
No
The device is a hemodialysis system used for treating renal failure, which is a therapeutic function rather than a diagnostic one.
No
The device description clearly outlines multiple hardware components including the Hemodialysis Delivery (HD) Device, Dialysate Generator (DG) Device, and a single-use cartridge, in addition to software verification and validation testing.
Based on the provided text, the Moda-flx Hemodialysis System™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: An IVD device is used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Intended Use: The Moda-flx Hemodialysis System™ is used for treating patients with renal failure by performing hemodialysis. It directly interacts with the patient's blood to remove waste products and excess fluid.
- Device Description: The description focuses on the mechanical and fluid handling aspects of the system, including creating dialysate, controlling blood and dialysate flow, and administering heparin. It does not describe any components or processes for analyzing patient specimens for diagnostic purposes.
- Lack of Specimen Analysis: There is no mention of the device analyzing blood or other bodily fluids to provide diagnostic information. Its function is therapeutic, not diagnostic.
Therefore, the Moda-flx Hemodialysis System™ is a therapeutic medical device, not an IVD.
N/A
Intended Use / Indications for Use
The Moda-flx Hemodialysis System™ is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute, post-acute, or chronic care facility. Treatments must be administered under a physician's prescription, by a trained person who is considered competent in the use of the device.
Treatment types available include: Intermittent Hemodialysis (IHD), Sustained Low Efficiency Dialysis (SLED/ SLED/ SLEDD), and Prolonged Intermittent Renal Replacement Therapy (PIRRT).
The Moda-flx Hemodialysis System™ Cartridge is a single use, disposable arterial and venous bloodline set, with dialysate tubing, intended to provide extracorporeal access during hemodialysis. The Moda-flx Hemodialysis System™ Cartridge is compatible only with the Moda-flx Hemodialysis System TM.
Product codes
KDI, FIP, FJK
Device Description
The Moda-flx Hemodialysis System™ is a transportable hemodialysis system that consists of three parts: Hemodialysis Delivery (HD) Device. Dialysate Generator (DG) Device, and a single use Moda-flx Hemodialysis System™ Cartridge that provides extracorporeal access during hemodialysis. The Moda-flx Hemodialysis System™ Cartridge is only compatible with the Modaflx Hemodialysis System™. The system creates purified water from tap water; from this purified water and chemical concentrates, the system creates dialysate in real time. The chemicals used to create the dialysate are standard 45X concentrates.
Ultrafiltration is achieved by controlling the dialysate going in and coming out of the dialyzer independently, using pumps on the HD Device to control fluid flow from both the inlet and outlet of the dialyzer. An external bag of saline is used to provide solution infusions to combat hypotensive episodes. Saline is also used to prime the Moda-flx Hemodialysis System™ Cartridge prior to use.
Prescribed blood flow rate is generated by a peristaltic pump, while heparin is administered to prevent blood coagulation. All fluid pathways are disposable and easily installed and replaced. Once installed, the device will check the connections of the fluid pathways and the system will automatically prepare itself for treatment.
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
Acute, post-acute, or chronic care facility. Treatments must be administered under a physician's prescription, by a trained person who is considered competent in the use of the device.
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 following performance data were provided in support of the substantial equivalence determination.
- Biocompatibility testing
- Electrical safety and electromagnetic compatibility
- Software verification and validation testing
- Cybersecurity testing
- Reprocessing/disinfection testing
- Sterilization testing
- Shelf-life testing
- Bench performance testing, including clearance, transport and dialyzer integrity testing
- Usability testing
- Animal studies: no animal studies were required to support this submission.
- Clinical studies: no clinical studies were required to support this submission.
Key Metrics
Not Found
Predicate Device(s)
Tablo Hemodialysis System (K223248), Tablo Cartridge (K210782)
Reference Device(s)
Fresenius 2008T BlueStar Hemodialysis Machine (K222952), Fresenius 2008K BlueStar Hemodialysis Machine (K150708), Prismaflex System 7.10 (131516), Aksys PHD Personal Hemodialysis Kits (K010131)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5860 High permeability hemodialysis system.
(a)
Identification. A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K
uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.).
(3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).
(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ”
(2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,”
(3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,”
(4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and
(5) “Guidance for Hemodialyzer Reuse Labeling.”
0
Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
August 2, 2024
Diality, Inc. Amnon Talmor Director, Regulatory Affairs 181 Technology Drive, Suite 150 Irvine, CA 92618
Re: K233798
Trade/Device Name: Moda-flx Hemodialysis System and Cartridge Regulation Number: 21 CFR§ 876.5860 Regulation Name: High Permeability Hemodialysis System Regulatory Class: II Product Code: KDI, FIP, FJK Dated: June 28, 2024 Received: July 1, 2024
Dear Amnon Talmor:
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 (OS) 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
2
Indications for Use
Submission Number (if known)
Device Name
Moda-flx Hemodialysis System and Cartridge
Indications for Use (Describe)
The Moda-flx Hemodialysis System™ is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute, post-acute, or chronic care facility. Treatments must be administered under a physician's prescription, by a trained person who is considered competent in the use of the device.
Treatment types available include: Intermittent Hemodialysis (IHD), Sustained Low Efficiency Dialysis (SLED/ SLEDD), and Prolonged Intermittent Renal Replacement Therapy (PIRRT).
The Moda-flx Hemodialysis System™ Cartridge is a single use, disposable arterial and venous bloodline set, with dialysate tubing, intended to provide extracorporeal access during hemodialysis. The Moda-flx Hemodialysis System™ Cartridge is compatible only with the Moda-flx Hemodialysis System TM.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
The-Counter Use (21 CFR 801 Subpart C)
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3
Moda-flx Hemodialysis System 510(k) Submission
| 510(k) Summary | |
|---|---|
| 1. Submitter | |
|---|---|
| Name: | Diality, Inc. |
| 181 Technology Drive #150 | |
| Irvine, CA 92618 | |
| Primary Contact: | Clayton Poppe |
| Chief Scientific Officer | |
| Diality, Inc. | |
| 1-949-916-5851 | |
| Submission Correspondent: | Amnon Talmor |
| Regulatory Affairs Director | |
| Diality, Inc. | |
| Submission Author: | Tori Anaya |
| Regulatory Affairs Specialist | |
| Diality, Inc. | |
| Date Prepared: | November 28, 2023 |
| 2. Device Classification | |
| Trade/Proprietary Name: | Moda-flx Hemodialysis System and Cartridge |
| Common/Generic Name: | Hemodialysis delivery system and disposable cartridge with water |
| purification system | |
| Classification Names: | High permeability hemodialysis system (21 CFR § 876.5860) |
| Water purification system for hemodialysis (21 CFR § 876.5665) | |
| Hemodialysis system and accessories (21 CFR § 876.5820) | |
| Product Codes: | KDI; FIP; FJK |
| Regulatory Class: | II |
-
- Predicate and Reference Devices
Predicate Devices:
- Predicate and Reference Devices
-
. Tablo Hemodialysis System (K223248)
-
Tablo Cartridge (K210782) ●
Reference Devices:
- Fresenius 2008T BlueStar Hemodialysis Machine (K222952) .
- . Fresenius 2008K BlueStar Hemodialysis Machine (K150708)
- Prismaflex System 7.10 (131516)
- Aksys PHD Personal Hemodialysis Kits (K010131) ●
- Indications for Use
4
The Moda-flx Hemodialysis System™ is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute, post-acute, or chronic care facility. Treatments must be administered under a physician's prescription, by a trained person who is considered competent in the use of the device.
Treatment types available include: Intermittent Hemodialysis (IHD), Sustained Low Efficiency Dialysis (SLED/ SLED/ SLEDD), and Prolonged Intermittent Renal Replacement Therapy (PIRRT).
The Moda-flx Hemodialysis System™ Cartridge is a single use, disposable arterial and venous bloodline set, with dialysate tubing, intended to provide extracorporeal access during hemodialysis. The Moda-flx Hemodialysis System™ Cartridge is compatible only with the Modaflx Hemodialysis System™.
5. Device Description
The Moda-flx Hemodialysis System™ is a transportable hemodialysis system that consists of three parts: Hemodialysis Delivery (HD) Device. Dialysate Generator (DG) Device, and a single use Moda-flx Hemodialysis System™ Cartridge that provides extracorporeal access during hemodialysis. The Moda-flx Hemodialysis System™ Cartridge is only compatible with the Modaflx Hemodialysis System™. The system creates purified water from tap water; from this purified water and chemical concentrates, the system creates dialysate in real time. The chemicals used to create the dialysate are standard 45X concentrates.
Ultrafiltration is achieved by controlling the dialysate going in and coming out of the dialyzer independently, using pumps on the HD Device to control fluid flow from both the inlet and outlet of the dialyzer. An external bag of saline is used to provide solution infusions to combat hypotensive episodes. Saline is also used to prime the Moda-flx Hemodialysis System™ Cartridge prior to use.
Prescribed blood flow rate is generated by a peristaltic pump, while heparin is administered to prevent blood coagulation. All fluid pathways are disposable and easily installed and replaced. Once installed, the device will check the connections of the fluid pathways and the system will automatically prepare itself for treatment.
6. Comparison to Predicate Device
The fundamental technological characteristics are consistent between the subject and predicates devices, including:
- High permeability delivery system
- Concentrate proportioning ●
- Dialysate preparation, delivery, quality and conductivity monitoring ●
- . Peristaltic blood pump
- . Pinch valves
- Touch screen user interface
- Software controlled
- Device specific extracorporeal blood tubing
- Used with legally marketed dialyzers ●
- . Ultrafiltration flow rate
- . Alarms
- Water purification system ●
5
Diality, Inc.
For the subject and predicate hemodialysis systems, differences include:
- Dialysate and blood flow rates
- Heparin pump ●
- Disinfection method ●
- Dialysate generation and ultrafiltration control
- Dialyzer integrity monitoring ●
- Venous pressure low limit
- Dialysate temperature range ●
- Fixed ratios
- Cart
For the blood tubing cartridge, differences include:
- Blood volume .
7. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
- Biocompatibility testing .
- Electrical safety and electromagnetic compatibility ●
- Software verification and validation testing ●
- Cybersecurity testing ●
- Reprocessing/disinfection testing
- Sterilization testing
- Shelf-life testing ●
- Bench performance testing, including clearance, transport and dialyzer integrity testing ●
- Usability testing ●
- Animal studies: no animal studies were required to support this submission. ●
- Clinical studies: no clinical studies were required to support this submission. ●
6. Conclusion
The results of design verification and validation testing of the Moda-flx Hemodialysis System™ demonstrate the substantial equivalence of the Moda-flx Hemodialysis System™ to the Tablo Hemodialysis System (K222952) and Tablo Cartridge (K210782).