(199 days)
The 5008X Hemodialysis System is intended for use in acute and chronic hemodialysis therapy. Therapy options include hemodialysis (HD), hemodiafiltration (HDF), hemofiltration (HF), and isolated ultrafiltration (ISO).
The 5008X™ system is indicated for intermittent hemodialysis treatment for patients with acute and chronic renal failure in a healthcare facility. Therapy options for patients weighing more than 40 kg include: Hemodiafiltration (HDF), Hemodialysis (HD), Hemofiltration (HF) and Isolated Ultrafiltration.
The 5008X™ Machine is equipped with a bibag system, but it may also be used with liquid bicarbonate using the connector included with the machine. The bibag system is indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure. The bibag system is intended to be used as one component in the preparation of dialysate according to a physician's prescription in a 3-stream proportioning hemodialysis machine equipped with the bibag module.
The 5008X™ Machine is available equipped with a Crit-Line Clip (CLiC) Monitor System.
The optional CLiC system is used to non-invasively measure hematocrit, oxygen saturation and percent change in blood volume in real time for application in the treatment of dialysis patients with the intended purpose of providing a more effective treatment for both the dialysis patient and the dialysis technician. Based on the data that the monitor provides, the clinician/nurse, under physician direction, intervenes (i.e. increases or decreases the rate at which fluid is removed from the blood) in order to remove the maximum amount of fluid from the dialysis patient without the patient experiencing the common symptoms of dialysis which include nausea, cramping and vomiting.
The DIASAFE®plusUS is intended for the preparation of ultrapure dialysate and sterile, nonpyrogenic substitution fluid from pretreated water and is not intended to provide primary purification. Attention must still be given to the chemical and microbiological quality of water and concentrates and the maintenance of supply systems (e.g. RO system, central delivery system).
The microbiological quality (microbial count [CFU/mL] and endotoxin measurement [EU/mL]) of the incoming water should be
The 5008X Hemodialysis System consists of the following:
- The 5008X Hemodialysis Machine
- Two (2) DIASAFE®plusUS Filters (hereinafter referred to as the "Diasafe filter(s)")
- The 5008X Bloodlines are available in five (5) configurations:
- 5008X HD/HDF – Standard Blood Tubing Set (hereinafter referred to as the "HD/HDF Standard Bloodline")
- 5008X HD/HDF – With Twister Blood Tubing Set (hereinafter referred to as the "HD/HDF Twister Bloodline")
- 5008X HD/HDF – With CLiC Blood Tubing Set (hereinafter referred to as the "HD/HDF CLiC Bloodline")
- 5008X HD Pre-Flush – Standard Blood Tubing Set (hereinafter referred to as the "HD Standard Bloodline")
- 5008X HD Pre-Flush – With Twister Blood Tubing Set (hereinafter HD Twister Bloodline")
- CitraSure™ Disinfectant
The 5008X Hemodialysis Machine is an electromechanical device. Software controls the machine during hemodialysis treatment, including fluid flow, mixing, heating, and alarms.
The Diasafe filter is a non-sterile dialysis fluid filter that produces ultrapure dialysate and sterile, non-pyrogenic substitution fluid as defined in ISO 23500-5. The filter reduces microbial contaminants including endotoxins in the dialysate during hemodialysis treatment.
The 5008X Bloodlines are single-use, ethylene oxide (EO) sterilized bloodlines.
CitraSure™ disinfectant is a liquid chemical disinfectant for chemical heat disinfection of the 5008X Hemodialysis Machine.
The provided FDA 510(k) clearance letter and summary for the 5008X Hemodialysis System pertains to a medical device for renal treatment. The document does not describe an AI/ML device, a comparative effectiveness study (MRMC), or a standalone AI algorithm performance study. Therefore, sections of your request related to those topics (e.g., sample size for test/training sets, data provenance, number of experts, adjudication methods, ground truth types, human reader improvement with AI) are not applicable and cannot be extracted from this document.
However, I can provide the acceptance criteria and a summary of the performance testing conducted to prove the device meets these criteria based on the provided text for the various components of the 5008X Hemodialysis System.
Acceptance Criteria and Device Performance Summary for 5008X Hemodialysis System
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document lists "Key Performance Specifications/Characteristics" which serve as the acceptance criteria for each component. The "Reported Device Performance" column summarizes the claims made in the document regarding the device meeting these specifications through various tests.
| Feature/Test Objective | Acceptance Criteria (Specification/Characteristic) | Reported Device Performance (Summary of Test Results) |
|---|---|---|
| 5008X Machine | ||
| Maximum Blood Flow Rate | 600 mL/min | System Level Performance Testing and Functional Design Verification conducted. Results support substantial equivalence, safety, and efficacy. |
| Maximum Dialysate Flow Rate | 1000 mL/min | System Level Performance Testing and Functional Design Verification conducted. Results support substantial equivalence, safety, and efficacy. |
| Maximum Substitution Flow Rate | AutoSub plus: 400 mL/min; Manual substitution: 600 mL/min | System Level Performance Testing and Functional Design Verification conducted. Results support substantial equivalence, safety, and efficacy. |
| Net Fluid Removal | 0–4000 mL/hr; Accuracy: ± (1%UF + 0.15% of balanced fluid volume) | System Level Performance Testing and Functional Design Verification conducted. Results support substantial equivalence, safety, and efficacy. |
| Dialysis Time | Intermittent, typical time 4 hours | System Level Performance Testing and Functional Design Verification conducted. Results support substantial equivalence, safety, and efficacy. |
| Dialysis Fluid Composition | Volumetric, selectable: Acid 125–151 mEq/L Na+; Bicarbonate 25–40 mEq/L; Monitoring conductivity average accuracy: ± 1.5% | System Level Performance Testing and Functional Design Verification conducted. Results support substantial equivalence, safety, and efficacy. |
| Dialysis Fluid Temperature | Range 34°C–39°C. Fixed alarm window 33°C (or 32°C during BTM recirculation measurement and preparation) or above 40°C. | System Level Performance Testing and Functional Design Verification conducted. Results support substantial equivalence, safety, and efficacy. |
| Heparin Administration Rate | 0.1 to 9.9 mL/hr; Accuracy: ± 0.5mL or ± 6% | System Level Performance Testing and Functional Design Verification conducted. Results support substantial equivalence, safety, and efficacy. |
| Electrical Safety and EMC | IEC 60601-1-2 Edition 4.1 2020-09 compliance | EMC testing conducted in accordance with IEC 60601-1-2. |
| Software Verification & Validation | Functional and Performance Verification, Regression Testing, Code Reviews | Unit, integration, and system level software verification testing performed to demonstrate efficacy and confirm operation. |
| Human Factors Validation | Safe and effective use (per FDA guidance) | Human Factors Validation Testing conducted. |
| Diasafe Filter | ||
| Bacterial and Endotoxin Filtration | Produces sterile, non-pyrogenic substitution fluid from dialysis fluid with max incoming water quality 700 MPa | Testing performed. |
| Transparency of Transducer Protector | Clear to allow visual inspection of blood contamination | Testing performed. |
| Transducer Protector Leak Test | Maintain secure and leak-free connection when subjected to 2X max labeled pressure | Testing performed. |
| Arterial Pressure Dome Leak Test | Maintain secure and leak-free connection when subjected to 2X max labeled pressure | Testing performed. |
| CLiC Blood Chamber Lens Gap | 0.078 ± 0.005 in. | Testing performed to verify optical property. |
| Tubing Compliance Test | Capable of being occlusively clamped by venous line clamp of 5008X machine | Testing performed. |
| Clamp Occlusion Test | Air and liquid tightness occlusion at desired pressure and time | Testing performed. |
| Check Valve Cracking Pressure | Lower than 400 mbar | Testing performed. |
| Check Valve Pressure Drop | Specific range when substitution fluid pumped at certain flow rate | Testing performed. |
| Tube Transparency | Observe interface of air and liquid during passage of air bubbles | Testing performed. |
| Tube Resistance to Kinking | No kinking at worst-case bend radius when packaged (evaluate % flow reduction) | Testing performed. |
| Tube Clamping | Resist clamp occlusions by subjecting to desired pressure and cycles | Testing performed. |
| Tube Patency | Maintain patency after clamping and reopening (measure flow reduction) | Testing performed. |
| Air Bubble Trapping (Venous Chamber) | Able to trap incoming air bubbles larger than 20 µL | Testing performed. |
| Recirculation Connector Packaging | Burst strength, peel strength, dye penetration, microbial resistance | Testing performed. |
| Viral Retentiveness (Transducer Protector) | Prevent passage of bacteriophage (PhiX174) from patient to machine side up to 600 mmHg for 1 hr | Testing performed. |
| Sterility (Bloodlines) | Sterility assurance level (SAL) 10-6 | Sterilized by 100% ethylene oxide (EO). |
| EO Residuals (Bloodlines) |
§ 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.”