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510(k) Data Aggregation
(199 days)
5008X Hemodialysis System
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) |
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(248 days)
5008X Hemodialysis System
Machine:
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-invasure 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.
DIASAFEPlusUS Filter:
The DIASAFE®plusUS is intended for the preparation of ultrapure dialysate and sterile, non- pyrogenic 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 Hemodialysis Bloodlines (hereinafter referred to as "5008X Bloodlines") are available in three (3) configurations:
- -5008X HDF Hemodialysis blood tubing set catalog number 03-5100-7 (hereinafter referred to as the "Standard Bloodline")
- -5008X HDF Hemodialysis blood tubing set with access flow reversing connector (Twister®) catalog number 03-5150-2 (hereinafter referred to as the "Twister Bloodline")
- 5008X HDF Hemodialysis blood tubing set with CLiC™ blood chamber catalog number 03-5100-7C (hereinafter referred to as the "CLiC 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 ANSI/AAMI/ISO 11663. The filter reduces microbial contaminants including endotoxins in the dialysate during hemodialysis treatment. The Diasafe filters are installed and exchanged on the 5008X Hemodialysis Machines using the DIAFIX™ Lock System. The DIAFIX™ Lock System is a standard feature on 5008X Hemodialysis Machines and is installed during machine production.
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 document is a 510(k) premarket notification for the Fresenius Medical Care 5008X Hemodialysis System, which includes the machine, Diasafe filters, 5008X Bloodlines, and CitraSure disinfectant. This type of document is a submission to the FDA to demonstrate that a medical device is substantially equivalent to a legally marketed predicate device.
It does not describe a study that uses a test set with ground truth established by experts to prove the device meets specific acceptance criteria in the context of an Artificial Intelligence (AI) or machine learning algorithm.
Therefore, I cannot provide the requested information, as the document does not contain details about:
- A table of acceptance criteria and reported device performance for an AI/ML algorithm. The "Key Performance Specifications/Characteristics" table (Table 4) lists engineering specifications for the hemodialysis system components (e.g., flow rates, temperature ranges, filtration efficiency for the Diasafe filter, mechanical properties of bloodlines), not performance metrics for an AI system.
- Sample size used for the test set and data provenance: This is relevant for AI/ML validation, which is not described.
- Number of experts used to establish ground truth and their qualifications: Not applicable as there's no mention of expert-labeled ground truth for an AI/ML system.
- Adjudication method for the test set: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not conducted as this is not an AI/imaging device.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable, as this is not an AI/ML model.
- How the ground truth for the training set was established: Not applicable.
The document focuses on demonstrating substantial equivalence to predicate devices through various engineering tests, biocompatibility testing, electrical safety, software verification, and human factors validation for a hemodialysis system, not an AI/ML-driven diagnostic or therapeutic device.
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