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510(k) Data Aggregation
(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) |
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(30 days)
The 2008T BlueStar Hemodialysis Machine is indicated for acute and chronic dialysis therapy in a healthcare facility. Additional therapy options for patients receiving hemodialysis include: Isolated Ultrafiltration, Sustained Low Efficiency Dialysis (SLED), and low volume hemodialysis (patients weighing ≥ 20 kg). This machine accommodates the use of both low flux and high flux dialyzers. The SLED therapy option is not to be used for patients weighing ≤ 40 kg. The 2008T BlueStar Hemodialysis Machine is not to be used for plasma replacement therapies, for patients weighing less than 20 kg, or for renal therapies using substitution fluid.
bibag System (Optional):
The bibag system is used with three stream proportioning Hemodialysis Machines equipped with the bibag module such as the 2008T BlueStar Hemodialysis Machine and intended for use in bicarbonate hemodialysis for acute and chronic renal failure. The bibag is intended for extracorporeal bicarbonate hemodialysis according to a physician's prescription.
Crit-Line Clip Monitor (CLiC) (Optional):
The Crit-Line Clip Monitor is used with the 2008T BlueStar Hemodialysis Machine to non-invasively measure hematocrit, oxygen saturation and percent change in blood volume. The CLiC device measures hematocrit, percent change in blood volume and oxygen saturation 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 clinician. 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 complications of dialysis which include nausea, cramping and vomiting.
The 2008T Machine is an electromechanical device. Software controls the machine during hemodialysis treatment, including fluid flow, mixing, heating, and alarms. The 2008T Machine provides hemodialysis treatment by controlling and monitoring both the dialysate circuit and the extracorporeal blood circuit. The machine pumps blood from the patient's body through an extracorporeal circuit, one component of which is the dialyzer. The dialyzer contains a semi-permeable membrane that uses diffusion to transfer toxins and ultrafiltration to transport excess water from the blood into the dialysate circuit. In this separate dialysate circuit, the dialysate concentrates are mixed with purified water, heated, degassed, and delivered to the dialyzer through platinum cross-linked silicone tubing. Balancing chambers control the dialysate during treatment. During treatment, the extracorporeal blood circuit is monitored for venous and arterial blood pressures as well as for the presence of air and blood.
The provided text is a 510(k) summary for the Fresenius Medical Care 2008T BlueStar™ Hemodialysis Machine. This document outlines the device description, indications for use, comparison to a predicate device, and performance data to demonstrate substantial equivalence to a legally marketed device.
However, the information provided does not describe acceptance criteria and a study that proves a device meets those criteria in the context of an Artificial Intelligence (AI) or machine learning (ML) enabled medical device.
The document is for a hemodialysis machine, which is an electro-mechanical device, not an AI/ML device for diagnostic or predictive purposes. The "performance data" sections are related to physical and biological safety, functional verification, and material compatibility of the hemodialysis machine itself, not validation of an AI/ML algorithm's performance on a dataset.
Therefore, I cannot extract the requested information (table of acceptance criteria with reported device performance, sample sizes for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC study details, standalone performance, type of ground truth, training set size, and training ground truth establishment) as this document does not pertain to an AI/ML enabled medical device study.
To answer your request, I would need a document describing the validation of an AI/ML medical device.
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