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510(k) Data Aggregation
(60 days)
Fresenius Medical Care Renal Therapies Group, LLC
Ask a specific question about this device
(246 days)
Fresenius Medical Care Renal Therapies Group, LLC
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 ≥ 20kg and ≤ 40 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.
The 2008T BlueStar Hemodialysis Machine is an electromechanical device. Software controls the machine during hemodialysis treatment, including fluid flow, mixing, heating, and alarms.
The 2008T BlueStar Hemodialysis 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. Balancing chambers control the incoming flow and outgoing flow of the dialysate fluid during ultrafiltration. During hemodialysis, the extracorporeal blood circuit is monitored for venous and arterial blood pressures as well as for the presence of air and blood.
The 2008T BlueStar Hemodialysis Machine has automation features (independent internal conductivity testing, auto priming, auto start, CDX auto on, assisted reinfusion) to minimize user workload and improve user experience. The 2008T BlueStar Hemodialysis Machine includes SLED (Sustained Low Efficiency Dialysis), Low Volume, and Isolated Ultrafiltration therapy options. The 2008T BlueStar Hemodialysis Machine also accommodates the use of the Patient Card system, a dialysis treatment information system.
Based on the provided FDA 510(k) Clearance Letter, the device in question is the 2008T BlueStar Hemodialysis Machine. This document is a Class II Medical Device submission, which means it relies on substantial equivalence to a predicate device, rather than a clinical trial proving new efficacy. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context are focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than establishing new clinical effectiveness benchmarks through a de novo study.
The primary study type proving the device meets the "acceptance criteria" for 510(k) clearance is a comparison to a predicate device and supporting non-clinical performance and safety testing.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The "acceptance criteria" for a 510(k) submission are typically related to demonstrating that the new device meets the same performance specifications as the predicate and does not raise new questions of safety or effectiveness. The reported device performance is presented as its features and specifications.
| Feature / Acceptance Criteria (Derived from Predicate) | Reported Device Performance (2008T BlueStar Hemodialysis Machine) |
|---|---|
| Intended Use Equivalence | Identical to predicate (K231125): "The 2008T Machine is intended for use in acute and chronic hemodialysis therapy." |
| Indications for Use Equivalence | Identical to predicate. Includes acute and chronic dialysis therapy in a healthcare facility, with options for Isolated Ultrafiltration, SLED, and low volume hemodialysis (patients ≥20kg and ≤40kg). Accommodates low/high flux dialyzers. Restrictions: not for SLED on patients ≤40kg, plasma replacement, patients |
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(199 days)
Fresenius Medical Care Renal Therapies Group, LLC
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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(116 days)
Fresenius Medical Care Renal Therapies Group, LLC
Bicarby™ Dialysate solutions are indicated for use as a dialysis fluid for adult patients in acute care settings, requiring Kidney Replacement Therapies (KRT).
Ci-Ca Dialysate solutions are indicated for use as a dialysis fluid for adult patients in acute care settings, requiring Kidney Replacement Therapies (KRT).
The Bicarby and Ci-Ca solutions are single-use, sterile, ready-to-use dialysis solutions consisting of sodium chloride, potassium chloride, magnesium chloride, calcium chloride (select solutions), sodium bicarbonate, and glucose. The calcium-containing solutions are available in five (5) formulations, while the calcium-free solutions are available in three (3) formulations. The Bicarby and Ci-Ca solutions are single-use, steam sterilized dialysis solutions for use in Kidney Replacement Therapy (KRT). The solutions are each provided in a 2-compartment bag. One compartment contains 4.75 L of a slightly alkaline bicarbonate solution and the other compartment contains 0.25 L of an acidic electrolyte, glucose solution. The 2 solutions are mixed before use by opening the peel seam between the compartments, yielding 5 L of a ready-to-use sterile solution. The dialysate bags are made of a gas barrier foil, a material manufactured without PVC, latex, or plasticizer. The calcium-containing solutions are designed for modalities using heparin anticoagulation, while the calcium-free solutions are intended for modalities using regional citrate anticoagulation (RCA). The calcium-free solutions sustain the anticoagulatory effect of citrate in the filter. Therefore, a separate infusion of calcium is mandatory when using these solutions.
The provided FDA 510(k) clearance letter (K243786) is for Bicarby and Ci-Ca Dialysate solutions, which are dialysis fluids. This type of device is classified as a Class II medical device (Hemodialysis system and accessories, product code KPO).
The provided documentation describes the acceptance criteria and supporting studies for these dialysate solutions, not for a software algorithm or AI-powered medical device that would have performance metrics like sensitivity, specificity, or AUC. The studies conducted are primarily focused on the physical, chemical, and biological safety and performance of the solution and its container system, rather than an AI device's diagnostic or predictive capabilities.
Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth types, training set sample size, ground truth for training set) are not applicable to this type of device and the information provided in the 510(k) summary.
Below is a summary of the available information relevant to acceptance criteria and supporting studies for the Bicarby and Ci-Ca Dialysate solutions:
Acceptance Criteria and Device Performance (Not Applicable in the traditional sense for an AI device)
For this type of device (dialysis solutions), "acceptance criteria" relate to meeting specifications for chemical composition, sterility, packaging integrity, and biocompatibility rather than diagnostic performance metrics. The document details the key performance specifications for the chemical components.
Table of Acceptance Criteria (Key Performance Specifications) and Reported Device Performance
| Chemical Component | Acceptance Criteria (Ionic Contribution, mEq/L, mixed) - as designed/specified | Reported Device Performance (Implied to meet specification) |
|---|---|---|
| Calcium-containing solutions | ||
| Sodium (Na+) | 140 | Implied to meet 140 |
| Potassium (K+) | 0, 2, 3, or 4 | Implied to meet 0, 2, 3, or 4 |
| Magnesium (Mg2+) | 1.0 or 1.5 | Implied to meet 1.0 or 1.5 |
| Calcium (Ca2+) | 2.5 or 3.0 | Implied to meet 2.5 or 3.0 |
| Chloride (Cl-) | 109, 111, 112, or 113 | Implied to meet 109, 111, 112, or 113 |
| Bicarbonate (HCO3-) | 35 | Implied to meet 35 |
| Glucose (g/L) | 1 | Implied to meet 1 |
| Calcium-free solutions | ||
| Sodium (Na+) | 133 or 140 | Implied to meet 133 or 140 |
| Potassium (K+) | 2 or 4 | Implied to meet 2 or 4 |
| Magnesium (Mg2+) | 1.5 | Implied to meet 1.5 |
| Calcium (Ca2+) | 0 | Implied to meet 0 |
| Chloride (Cl-) | 116.5, 118.5, or 120.5 | Implied to meet 116.5, 118.5, or 120.5 |
| Bicarbonate (HCO3-) | 20 or 25 | Implied to meet 20 or 25 |
| Glucose (g/L) | 1 | Implied to meet 1 |
Note: The document states these are the "Key Performance Specifications," meaning the solutions are manufactured to these specific ionic contributions. The "Reported Device Performance" is implied to meet these specifications as part of the manufacturing and quality control process, which are regulated under GMP but specific quantified "performance" results are not provided in this 510(k) summary.
Study Information (as applicable to a dialysis solution):
A. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
* Not Applicable in the context of an AI device's test set. The studies conducted are primarily engineering, chemical, and biological evaluations, not data-driven performance assessments.
* For Biocompatibility, "testing was conducted to evaluate the material changes in accordance with ISO 10993-1:2018 and FDA guidance document...". This implies lab-based testing.
* For Human Factors Validation Testing, it was stated that "The Bicarby and Ci-Ca solutions were found to be safe and effective for their intended users, uses, and use environments." The sample size for this human factors study is not provided in the summary.
B. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
* Not Applicable. No "ground truth" establishment by medical experts for a test set of images/data is relevant here. The ground truth for chemical composition is defined by the formula and analytical testing. Biocompatibility experts would assess the results of the specific biological tests.
C. Adjudication method (e.g. 2+1, 3+1, none) for the test set
* Not Applicable. This concept is for clinical or diagnostic studies involving human readers, not for chemical solutions or their packaging.
D. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
* No. This is a dialysis solution, not an AI diagnostic system.
E. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
* Not Applicable. This is a medical device (dialysate solution), not an algorithm.
F. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
* For chemical composition: Defined chemical formula and analytical testing standards.
* For physical properties (e.g., shipping, connector integrity): Engineering specifications and test standards.
* For biocompatibility: Reference to international standards (ISO 10993-1:2018) and established biological endpoints (Cytotoxicity, Sensitization, Irritation, Material Mediated Pyrogenicity, Hemocompatibility, Genotoxicity) with a toxicological risk assessment.
G. The sample size for the training set
* Not Applicable. This is a manufactured product, not a machine learning model.
H. How the ground truth for the training set was established
* Not Applicable. This is a manufactured product, not a machine learning model.
Summary of Performance Data Conducted:
The device's substantial equivalence to predicate devices was supported by the following performance data:
- Shipping and Distribution Testing: Demonstrated "the integrity and robustness of the bag system packaging within the distribution environment."
- HF-Connector Testing:
- Evaluated torque for removing protective cap and male/female connector torque.
- Evaluated breaking strength of the cone.
- Evaluated leakage and tightness of connectors.
- Evaluated pull-out force of connectors and injection ports.
- Biocompatibility Testing: Conducted in accordance with ISO 10993-1:2018 and FDA guidance. Assessed endpoints including Chemical Characterization, Cytotoxicity, Sensitization, Irritation, Material Mediated Pyrogenicity, Hemocompatibility, and Genotoxicity. A toxicological risk assessment was also performed. These tests confirm the safety of the materials used in the container closure system.
- Human Factors Validation Testing: Concluded the solutions were "safe and effective for their intended users, uses, and use environments."
- Not Applicable for this device type: Electrical Safety and Electromagnetic Compatibility (EMC), Software Verification and Validation Testing, Animal Studies, Clinical Studies.
Conclusion:
The 510(k) summary concludes that the Bicarby and Ci-Ca solutions are substantially equivalent to the predicate devices and are safe and effective for their intended use, based on the non-clinical performance testing summarized above, primarily focusing on materials, packaging integrity, and chemical specifications.
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(50 days)
Fresenius Medical Care Renal Therapies Group, LLC
stay•safe® catheter extension set with Safe-Lock, 12 inch:
The stay•safe catheter extension set with Safe-Lock is indicated for use in patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis (PD) in a healthcare facility or at home. The stay•safe catheter extension set with Safe-Lock is used to connect a PD catheter with Safe-Lock compatible catheter adapter to PD systems that use stay•safe PIN technology.
stay•safe® catheter extension set with Luer-Lock, 6 inch;
stay•safe® catheter extension set with Luer-Lock, 12 inch;
and stay•safe® catheter extension set with Luer-Lock, 18 inch:
The stay•safe catheter extension set with Luer-Lock is indicated for use in patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis (PD) in a healthcare facility or at home. The stay•safe catheter extension set with Luer-Lock is used to connect a PD catheter with Luer-Lock catheter adapter to PD systems that use stay•safe PIN technology.
stay•safe® to Luer-Lock Adapter, 4 inch:
The stay•safe to Luer-Lock adapter is indicated for use in patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis (PD) in a healthcare facility or at home. The stay•safe to Luer-Lock adapter is used to connect a stay•safe catheter extension set to medical devices with a Luer-Lock connection.
The stay•safe® catheter extension set with Safe-Lock, 12 inch (Safe-Lock extension set) stay•safe® catheter extension set with Luer-Lock, 6 inch, stay•safe® catheter extension set with Luer-Lock, 12 inch, and stay•safe® catheter extension set with Luer-Lock, 18 inch (Luer-Lock extension sets), and stay•safe® to Luer-Lock adapter, 4 inch (Luer-Lock adapter), hereinafter collectively referred to as the "Catheter Extension Sets" are the subject devices of this 510(k).
The Safe-Lock extension set is a single-use device designed to connect a PD catheter to PD systems that use the stay•safe PIN technology. The Safe-Lock extension set is provided sterile and non-pyrogenic. The Safe-Lock extension set is sterilized using ethylene oxide (EO).
The Luer-Lock extension sets are single-use devices designed to connect a PD catheter to PD systems that use the stay•safe PIN technology. The Luer-Lock extension sets are provided sterile and non-pyrogenic. The Luer-Lock extension sets are sterilized using EO.
The Luer-Lock adapter is a single-use device designed to connect a stay•safe catheter extension set to a medical device with a Luer lock connector. The Luer-Lock adapter is provided sterile and non-pyrogenic. The Luer-Lock adapter is sterilized using EO.
The provided FDA 510(k) clearance letter (K250404) for Fresenius Medical Care Renal Therapies Group's stay•safe® catheter extension sets and adapter pertains to a Class II medical device (Peritoneal Dialysis System and Accessories, Product Code KDJ).
Crucially, this document details the substantial equivalence of the new device to a legally marketed predicate device (K173593), based on non-clinical performance testing and biocompatibility. It explicitly states that "No clinical studies were performed for the Catheter Extension Sets." This means the type of study typically associated with assessing an AI/Software as a Medical Device (SaMD) to meet acceptance criteria through human reader performance (like MRMC studies) or standalone algorithmic performance was not conducted because this is a physical medical device, not AI/SaMD.
Therefore, I will describe the acceptance criteria and supporting studies based on the provided document, acknowledging that they are for a physical medical device and not an AI/SaMD.
Acceptance Criteria and Study Proving Device Meets Acceptance Criteria
The acceptance criteria for the stay•safe® catheter extension sets and adapter are based on demonstrating substantial equivalence to a legally marketed predicate device (K173593) in terms of safety and efficacy. This is primarily achieved through non-clinical performance testing and biocompatibility assessments, rather than clinical efficacy studies involving human patient outcomes or AI performance metrics.
1. A table of acceptance criteria and the reported device performance:
The document doesn't provide a direct "table of acceptance criteria" with specific numerical targets and performance results for each test. Instead, it lists the types of performance tests conducted to support the determination of substantial equivalence. The implication is that the new devices met the predefined specifications for each test, which would be deemed "acceptable" for equivalence.
Based on the provided text, the categories of performance testing serve as the basis for acceptance. The "Reported Device Performance" is implicitly that the device met the requirements of each test, demonstrating substantial equivalence.
| Category of Performance Criteria (Acceptance Basis for Substantial Equivalence) | Reported Device Performance (Implicitly Met) |
|---|---|
| Physical/Mechanical Performance: | |
| - Weight Verification | Met specifications |
| - Length Verification | Met specifications |
| - Clamp Occlusion | Met specifications |
| - Clamp Compression | Met specifications |
| - Visual Inspection after Challenge Condition | Passed inspection after challenge |
| - Leak Test | Passed leak test |
| - Bond/Tensile Strength | Met strength requirements |
| - Shipping and Packaging (Integrity) | Maintained integrity during shipping/packaging |
| - Tubing Verification – Dimensional | Met dimensional specifications |
| Biocompatibility (Safety): | |
| - Chemical Characterization | Acceptable profile for patient contact |
| - Cytotoxicity | Non-cytotoxic |
| - Sensitization | Non-sensitizing |
| - Irritation | Non-irritating |
| - Systemic Toxicity (acute to chronic) | Non-systemically toxic |
| - Pyrogenicity | Non-pyrogenic |
| - Genotoxicity | Non-genotoxic |
| - Hemocompatibility | Hemocompatible |
| - Carcinogenicity | Non-carcinogenic |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact sample sizes (number of units tested) for each of the performance or biocompatibility tests. This information is typically detailed in the engineering test reports or biocompatibility reports submitted as part of the 510(k) package, but not in the summary letter itself.
- Data Provenance: The data originates from non-clinical laboratory testing conducted by Fresenius Medical Care Renal Therapies Group, LLC, the device manufacturer. This is by nature prospective testing, as it is performed specifically to support the 510(k) submission for the new devices. The country of origin of the data is implied to be within the US, given the submission is to the US FDA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable: For a physical medical device cleared via substantial equivalence based on non-clinical performance and biocompatibility testing, there are no "experts" in the sense of clinicians establishing a "ground truth" for a test set in the way one would for an AI/SaMD (e.g., radiologists annotating images). The "ground truth" for these tests is defined by engineering specifications, regulatory standards (e.g., ISO 10993-1 for biocompatibility), and established test methods. The "experts" involved are engineers and scientists responsible for designing, conducting, and interpreting these tests according to predefined protocols and standards. Their qualifications would be in relevant fields such as biomedical engineering, materials science, and toxicology.
4. Adjudication method for the test set:
- Not Applicable: As there are no human-read interpretations or clinical assessments requiring reconciliation, there is no "adjudication method" in the context of clinical expert consensus. Test results are objectively measured against predefined acceptance criteria (e.g., a leak test either passes or fails, a tensile strength measurement is or is not within specification). Any discrepancies in test results would be handled through standard quality control and engineering investigation procedures.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC study was not done. This type of study is specifically relevant for software/AI devices that assist human readers in diagnosing or interpreting medical images/data. The device in question is a physical catheter extension set and adapter, not an AI or imaging device. The document explicitly states: "No clinical studies were performed for the Catheter Extension Sets."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone performance study was not done. This is also relevant for AI/SaMD devices. The Catheter Extension Sets do not contain any software or algorithms. The document explicitly states: "Not applicable. The Catheter Extension Sets do not contain software."
7. The type of ground truth used:
- Engineering Specifications and Standardized Test Methods: The "ground truth" for the performance tests relies on established engineering specifications, mechanical properties of materials, and successful adherence to recognized industry standards (e.g., ISO for biocompatibility testing). For instance, a "leak test" has an objective pass/fail criterion based on absence of fluid leakage under defined pressure, not a clinical interpretation. Biocompatibility results are compared against toxicological limits and biological responses as defined by ISO 10993-1.
8. The sample size for the training set:
- Not Applicable: This pertains to machine learning models. As this is a physical medical device, there is no "training set."
9. How the ground truth for the training set was established:
- Not Applicable: There is no training set for this type of device.
In summary, the FDA's clearance for the stay•safe® catheter extension sets and adapter is based on a demonstration of substantial equivalence to an existing predicate device, supported by a comprehensive battery of non-clinical performance tests and biocompatibility assessments, validating its physical and material properties for its intended use, rather than clinical efficacy studies or AI/SaMD specific evaluations.
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(252 days)
Fresenius Medical Care Renal Therapies Group, LLC
FX CorAL HD dialyzers are intended for hemodialysis (HD), hemodiafiltration (HDF), hemofiltration (HF), and isolated ultrafiltration in patients, including pediatric patients, with acute kidney injury or chronic kidney disease when conservative therapy is judged to be inadequate.
Consider body and dialyzer surface area, blood flow, body weight and extracorporeal blood volume when selecting dialyzers for use with pediatric patients.
The FX CorAL dialyzers are high-flux, single-use, steam-sterilized hemodialyzers. The dialyzers are 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 FX CorAL dialyzers are high-flux, sterile devices designed for single-use acute and chronic 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 semipermeable membranes that allow for diffusion and/or ultrafiltration to transport toxins and excess fluid from the blood compartment (fiber lumen) to the dialysate compartment. 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.
The document describes the FX CorAL 40 and FX CorAL 50 dialyzers and their substantial equivalence to predicate devices, focusing on performance, materials, and intended use. There is no information provided in the document regarding acceptance criteria or performance of an AI/ML device.
The provided text describes a medical device clearance (K242053) for FX CorAL 40 and FX CorAL 50 dialyzers, which are high permeability hemodialysis systems. While the request asks about acceptance criteria and study details for an AI/ML device, the document focuses on the performance data of these physical medical devices. Therefore, much of the requested information regarding AI/ML specifics (like effect size of AI assistance, standalone algorithm performance, training set details, expert qualifications for ground truth) is not applicable to this submission.
However, I can extract the relevant information pertaining to the tests conducted for these dialyzers, which function as "acceptance criteria" for a physical device.
Here's a breakdown based on the provided document:
1. A table of acceptance criteria and the reported device performance:
The document lists performance tests conducted and states that "All testing met predetermined acceptance criteria." It does not explicitly list numerical acceptance criteria values for each test but provides typical performance results for urea clearance.
| Test Conducted | Acceptance Criteria (Stated as met predetermined criteria) | Reported Device Performance (Typical Values) |
|---|---|---|
| Blood Compartment Volume | Results were compared with the acceptance criteria. | Not numerically specified, but stated to have met criteria. |
| Clearance – Sodium (marker for urea), Creatinine, Phosphate, Vitamin B12 | Analyzed test samples over a specified range of flow rates. | FX CorAL 40 Dialyzer: Typical Urea Clearance: 178 mL/min (Qb=200, Qd=500, Qf=0) |
| FX CorAL 50 Dialyzer: Typical Urea Clearance: 192 mL/min (Qb=200, Qd=500, Qf=0) | ||
| Protein Sieving Coefficient | Calculated in accordance with ISO 8637-1 First Edition 2017-11. | Not numerically specified, but stated to have met criteria. |
| Ultrafiltration (Blood Kuf) | Calculated as the slope from a plot of UFR over applied TMP range. | Not numerically specified, but stated to have met criteria. |
| Pressure Drop | Measured inlet and outlet pressures across flow rates. | Not numerically specified, but stated to have met criteria. |
| Blood Compartment Integrity | Evaluate the integrity of the blood compartment. | Not numerically specified, but stated to have met criteria. |
| Biocompatibility Testing | Update to toxicological risk assessment and specific tests met acceptance. | Specific tests (Chemical Analysis, Subchronic Toxicity, Genotoxicity, Hemocompatibility) were performed and met criteria. |
| Human Factors Validation Testing | Demonstrated safe and effective use in accordance with FDA guidance. | Not numerically specified, but stated to have met criteria. |
| Clinical Studies (spKt/V) | Adequacy of clearance with mean spKt/V values. | FX CorAL 40 Dialyzer: Mean spKt/V of 2.42 |
| FX CorAL 50 Dialyzer: Mean spKt/V of 2.08 (all tolerated) |
2. Sample size used for the test set and the data provenance:
- Performance Testing (in vitro): Sample size for each specific in vitro test (e.g., clearance, integrity) is not explicitly stated, but it's implied that multiple samples were tested to generate the "typical" values and ensure criteria were met.
- Clinical Studies (retrospective):
- Sample Size: Fourteen (14) pediatric ESRD patients
- Data Provenance: Retrospective clinical data analysis. The country of origin is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as the document describes a physical medical device (dialyzer), not an AI/ML diagnostic tool requiring expert interpretation for ground truth establishment. The "ground truth" for the dialyzer's performance is established through well-defined physical and chemical measurements following international standards (e.g., ISO 8637-1).
4. Adjudication method for the test set:
Not applicable. For physical device performance, the results are typically quantitative measurements against defined specifications, not subjective interpretations requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable, as this is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is not an AI/ML device.
7. The type of ground truth used:
- In vitro Performance Tests: Ground truth is based on established physical and chemical measurement standards (e.g., ISO 8637-1 First Edition 2017-11) and direct laboratory measurements of parameters like clearances, sieving coefficients, ultrafiltration rates, and pressure drops.
- Biocompatibility Testing: Ground truth is established through standardized biological evaluation tests as per FDA guidance and ISO 10993-1.
- Clinical Studies: "Adequate clearance" (demonstrated by spKt/V values) and patient tolerance serve as clinical outcomes demonstrating the device's effectiveness in a real-world setting.
8. The sample size for the training set:
Not applicable, as this is not an AI/ML device and thus does not have a "training set" in that context.
9. How the ground truth for the training set was established:
Not applicable.
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(73 days)
Fresenius Medical Care Renal Therapies Group, LLC
The FX CorAL hemodialyzers are intended for single use only for extracorporeal blood purification during intermittent renal replacement therapies hemodialysis (HD), hemodiafiltration (HDF) using pre-, post or mixed-dilution modes, and isolated ultrafiltration for patients suffering from renal insufficiency.
The FX CorAL hemodiafilters are intended for single use only for extracorporeal blood purification during intermittent renal replacement therapies hemodialysis (HD), hemodiafiltration (HDF) using pre-, post or mixed-dilution modes, and isolated ultrafiltration for patients suffering from renal insufficiency.
The FX CorAL dialyzers are high-flux, single-use, steam-sterilized hemodialyzers. The dialyzers are 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 FX CorAL dialyzers are high-flux, sterile devices designed for single-use acute and chronic 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 semipermeable membranes that allow for diffusion and/or ultrafiltration to transport toxins and excess fluid from the blood compartment (fiber lumen) to the dialysate compartment. 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.
This document is an FDA 510(k) clearance letter for a medical device called FX CorAL hemodialyzers. It primarily discusses the substantial equivalence of the new device to a previously cleared predicate device, rather than presenting a detailed study proving the device meets specific acceptance criteria through a clinical or algorithmic performance study often seen with AI/ML devices.
Therefore, the information required to answer your questions regarding acceptance criteria and study details (especially for AI/ML performance, experts, ground truth, and sample sizes for training/test sets) is not present in the provided text. The document explicitly states:
- "No clinical studies were performed." (Page 8, Section 1.8.6)
- "Not applicable. The FX CorAL dialyzers do not contain software." (Page 8, Section 1.8.4 - implying no software verification/validation testing as would be done for an AI/ML device)
- "No animal studies were performed." (Page 8, Section 1.8.5)
The clearance is based on the new devices being identical to the predicate devices in manufacturing, design, sterilization method, and materials, with only labeling changes. The performance data for the predicate device (K220721) is deemed applicable.
However, I can extract the general type of performance metric mentioned: Urea clearance.
Here's a breakdown of what can be inferred from the document and what cannot:
Acceptance Criteria & Device Performance:
The document doesn't explicitly state "acceptance criteria" in the format of a clinical trial endpoint or AI/ML performance metric. Instead, it refers to "Key Performance Specifications/Characteristics" for urea clearance (Table 2, Page 6). It also states that "FMCRTG uses sodium clearance as a marker for urea clearance because sodium and urea exhibit similar movement across the membrane."
Table of Performance (Inferred from "Typical Urea Clearance"):
| Trade Name | Flow Rate Conditions (mL/min) Qb | Flow Rate Conditions (mL/min) Qd | Flow Rate Conditions (mL/min) Qf | Typical Urea Clearance (mL/min) |
|---|---|---|---|---|
| FX CorAL 60 D. | 300 | 500 | 0 | 270 |
| FX CorAL 80 D. | 300 | 500 | 0 | 277 |
| FX CorAL 100 D. | 300 | 500 | 0 | 282 |
| FX CorAL 120 D. | 300 | 500 | 0 | 285 |
| FX CorAL 600 D. | 300 | 500 | 75 | 285 |
| FX CorAL 800 D. | 300 | 500 | 75 | 288 |
| FX CorAL 1000 D. | 300 | 500 | 75 | 292 |
Regarding the Study Details for AI/ML Performance:
Based on the provided text, the device is a physical medical device (hemodialyzer), not an AI/ML software device. As such, answers to most of your specific questions related to AI/ML study design are not applicable or the information is not provided.
- Sample size for the test set and data provenance: Not applicable in the context of an AI/ML test set. The performance data mentioned (Table 2) is in vitro (bench testing), not from a patient test set, and its specific provenance (country, retrospective/prospective) is not detailed.
- Number of experts used to establish ground truth: Not applicable. This refers to the ground truth for an AI/ML device, which is not what this document is about.
- Adjudication method: Not applicable for this type of device and study.
- MRMC comparative effectiveness study: Not applicable. The device does not involve human readers or AI assistance in diagnostic interpretation.
- Standalone (algorithm only) performance: Not applicable. The device is a physical hemodialyzer, not an algorithm.
- Type of ground truth used: For urea clearance, the ground truth would be based on in vitro laboratory measurements, likely chemical assays measuring concentrations before and after filtration, rather than expert consensus, pathology, or outcomes data.
- Sample size for the training set: Not applicable. There is no AI/ML model for which a training set would be required.
- How the ground truth for the training set was established: Not applicable, as there is no training set for an AI/ML model.
Summary of what is available in the text:
- Device Type: Hemodialyzers (physical medical devices).
- Performance Metrics: In vitro urea clearance (sodium clearance typically used as a marker).
- Study Type: Substantial equivalence a new device to a predicate device, noting that the new device is "identical" to the predicate, and hence the previous predicate's data applies.
- Clinical Studies: None performed for this 510(k) submission.
- Software/AI Component: None. The device "does not contain software."
- Animal Studies: None performed.
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(266 days)
Fresenius Medical Care Renal Therapies Group, LLC
AquaBplus: The AquaBplus is a modular reverse osmosis unit intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients or related therapies. This device is intended to be a component in a complete water purification system and is not a complete water treatment system. The reverse osmosis unit must be preceded by pre-treatment devices, and may need to be followed by post-treatment devices as well, to meet current AAMI /ANSI/ISO and Federal (U.S.) standards.
AquaB LITE: The AquaB LITE is a modular reverse osmosis unit intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients or related therapies. This device is intended to be a component in a complete water purification system and is not a complete water treatment system. The reverse osmosis unit must be preceded by pre-treatment devices, and mav need to be followed by posttreatment devices as well, to meet current AAMI/ANSI/ISO and Federal (U.S.) standards.
The AquaBplus and AquaB LITE are reverse osmosis (RO) water purification systems that use pretreated soft water to produce dialysis water for hemodialysis (HD) devices and for the preparation of dialysis concentrates.
The AquaBplus system is a modular system consisting of a base module that can be used on its own or in conjunction with other modules. AquaBplus is the base module. AquaBplus B2 is a second RO unit that can be added to increase the quality of dialysis water. AquaBplus HF is a flow heater unit that can be added to provide heat disinfection for the RingMain. The AquaBplus HF module can also supply hot product water to connected HD devices.
The AquaB LITE system is a basic version of the AquaBplus system. Like the AquaBplus, it is a modular system consisting of a base module that can be used on its own or in conjunction with other modules. AquaB LITE is the base module and B2 LITE is a second RO unit that can be added to increase the quality of dialysis water. AquaBplus HF is a flow heater unit that can be added to provide heat disinfection for the RingMain. The AquaBplus HF module can also supply hot product water to connected HD devices.
This document is a 510(k) Premarket Notification letter for the AquaBplus and AquaB LITE water purification systems, which are used for hemodialysis. The document summarizes the device, its intended use, and the performance data that supports its substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided text:
Important Note: The provided document is an FDA 510(k) clearance letter and its associated summary. This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed results from a clinical or AI-driven study with specific acceptance criteria in the manner an AI/ML medical device might. The "performance data" sections focus on safety, general functionality, and adherence to relevant standards rather than a comparative effectiveness study with human readers or standalone AI performance. Therefore, many of the requested points regarding AI/ML study design (e.g., sample size for test/training sets, expert ground truth, MRMC studies) are not applicable or detailed in this type of submission.
The "device" in this context is a water purification system, not an AI/ML algorithm for image analysis or diagnosis.
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of "acceptance criteria" and "reported device performance" in the way one might for an AI/ML diagnostic device (e.g., sensitivity, specificity, AUC thresholds). Instead, the performance data section outlines the types of tests conducted to demonstrate that the device functions as intended and meets relevant standards to be deemed substantially equivalent. The acceptance criteria are implicitly meeting the specified standards and ensuring safety and effectiveness compared to the predicate.
| Test Conducted | Test Method Description & Implicit Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Essential Performance | Demonstrating that the device meets the following standards: |
- ISO 23500-1 (Preparation and quality management of fluids for haemodialysis and related therapies – Part 1: General requirements)
- ISO 23500-2 (Preparation and quality management of fluids for haemodialysis and related therapies – Part 2: Water treatment equipment for haemodialysis applications and related therapies)
- ISO 23500-3 (Preparation and quality management of fluids for haemodialysis and related therapies – Part 3: Water for haemodialysis and related therapies) | "Testing to demonstrate that the device meets the... standards." (Implicitly, the device did meet them to receive clearance.) |
| Software | Conformance with IEC 62304 Edition 1.1 (Medical device software – Software life cycle processes) | "Software verification within this submission is provided in accordance with IEC 62304..." (Implicitly met requirements). |
| Disinfection Validation| Validation of chemical and heat disinfection labeling in accordance with FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff" (17 March 2015). (Acceptance: Disinfection processes are effective as labeled.) | "Validation of chemical and heat disinfection labeling..." (Implicitly, the validation was successful). |
| Functional Verification| Complete system testing to verify the performance (e.g., conductivity and temperature) and functional (e.g., operating modes and generated alarms) requirements of the device. (Acceptance: Device operates as per design specifications for various parameters and modes.) | "Complete system testing to verify the performance... and functional... requirements of the device." (Implicitly, the device performed as required.) |
| Packaging | Packaging and transport verification according to ASTM D4169-16. (Acceptance: Packaging adequately protects the device during transport.) | "Packaging and transport verification according to ASTM D4169-16." (Implicitly, the packaging was found adequate.) |
| Biocompatibility | Testing conducted in accordance with ISO 10993-1:2020 and FDA guidance. Endpoints evaluated: Chemical Characterization, Toxicological Risk Assessment, Cytotoxicity, Sensitization, Irritation, Material-Mediated Pyrogenicity, Hemocompatibility. (Acceptance: Materials in contact with dialysis water are biologically safe.) | "Biocompatibility testing was conducted... The following endpoints were evaluated to support the biological safety..." (Implicitly, the testing supported biological safety.) |
| Electrical Safety & EMC| Electrical safety testing in accordance with ANSI/AAMI ES 60601-1:2005. Electromagnetic compatibility (EMC) in accordance with IEC 60601-1-2 Edition 4.0. (Acceptance: Device meets electrical safety and EMC requirements.) | "Electrical safety testing was conducted... EMC was conducted..." (Implicitly, the testing demonstrated compliance.) |
| Software V&V | System software verification testing to demonstrate effectiveness and confirm operation, in accordance with IEC 62304 and various FDA guidance documents on software functions, OTS software, and cybersecurity. (Acceptance: Software performs effectively and reliably, and meets regulatory guidelines for medical device software.) | "System software verification testing was performed to demonstrate the effectiveness of the software and to confirm the operation of the device." (Implicitly, positive results, leading to clearance.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable in the context of this device's testing. There is no "test set" of patient data or images as would be seen for an AI diagnostic algorithm. The testing described is hardware and software functional testing, validation against standards, and biocompatibility testing. These are typically performed on a limited number of physical units or material samples.
- Data Provenance: Not applicable. The "data" here refers to test results from engineering and laboratory evaluations, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. The ground truth for a water purification system is defined by engineering specifications, international standards (e.g., AAMI/ANSI/ISO), and validated chemical/microbiological testing methods, not by expert medical interpretation of images or patient outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This concept pertains to resolving discrepancies in expert labeling of data for AI/ML models.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study was not done. This type of study is specifically relevant for AI-assisted diagnostic tools that interact with human readers (e.g., radiologists interpreting images). The AquaBplus/AquaB LITE are water purification systems; they do not involve human diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is not an AI algorithm. Its "performance" is its ability to purify water according to specified parameters and standards, which is assessed through direct measurement and functional testing, not an isolated algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is established by:
- International and Federal Standards: ISO 23500 series, AAMI/ANSI. These define the acceptable parameters for water quality for hemodialysis.
- Engineering Specifications: Designed conductivity, temperature, flow rates, and failure modes.
- Validated Test Methods: Biocompatibility tests (e.g., ISO 10993), disinfection validation protocols, electrical safety, and EMC standards.
- Predicate Device Performance: The predicate device serves as a benchmark for substantial equivalence.
8. The sample size for the training set
- Not applicable. There is no "training set" as this device does not use machine learning.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set for an AI/ML model, there is no ground truth established for one.
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(113 days)
Fresenius Medical Care Renal Therapies Group, LLC
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.
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 provided text describes the multiFlux 1000 dialyzers' substantial equivalence to a predicate device (FX CorAL dialyzers, K220721) and does not contain information about acceptance criteria, a specific study proving the device meets acceptance criteria, or most of the detailed information requested in your prompt.
Specifically:
- Acceptance Criteria Table: No table of acceptance criteria and reported device performance is provided. The document states that the performance specifications are substantially equivalent to the predicate device and that all performance testing from the predicate device's 510(k) (K220721) is being leveraged.
- Sample Size and Data Provenance (Test Set): Not applicable, as there is no new performance study described for the multiFlux 1000 dialyzer. The document mentions in vitro urea clearance data as an example from the Instructions for Use, but this is typical performance data, not acceptance criteria for a new study.
- Number and Qualifications of Experts (Ground Truth - Test Set): Not applicable.
- Adjudication Method (Test Set): Not applicable.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No MRMC study was done. The document explicitly states "No clinical studies were performed."
- Standalone (Algorithm Only) Performance: Not applicable. The multiFlux 1000 dialyzers are physical medical devices (dialyzers), not software or AI algorithms. The document explicitly states "The multiFlux 1000 dialyzers do not contain software."
- Type of Ground Truth Used: Not applicable, as no new performance study is described. The in vitro urea clearance data is laboratory performance data.
- Training Set Sample Size: Not applicable. The device is not an AI/ML algorithm that requires training data.
- Ground Truth for Training Set: Not applicable.
Summary of Relevant Information from the Provided Text:
- Acceptance Criteria and Proof of Meeting Criteria: The submission claims substantial equivalence to the predicate FX CorAL dialyzers (K220721). The changes (removal of blue colorant, extension of dialysate flange-port) are stated not to impact performance attributes. Therefore, all performance testing from the predicate device's 510(k) (K220721) is leveraged to support the multiFlux 1000 dialyzers. An example of in vitro Urea Clearance data is provided in Table 3 (page 5), but this is not presented as an acceptance criterion from a new study specific to the multiFlux 1000.
- Human Factors Validation Testing: "The multiFlux 1000 dialyzers were found to be safe and effective for their intended users, uses, and use environments." The details of this testing (acceptance criteria, sample size, outcome metrics) are not provided.
- 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 blue colorant did not require additional biocompatibility testing. This implies that the previous biocompatibility testing for the predicate device is considered sufficient.
In essence, the document focuses on demonstrating substantial equivalence based on prior testing of a predicate device and states that no new clinical or animal studies, or software verification/validation, were performed for the multiFlux 1000 dialyzers.
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(148 days)
Fresenius Medical Care Renal Therapies Group, LLC
pureFLOW solutions are indicated for use as a dialysate in Continuous Renal Replacement Therapy.
pureFLOW solutions are single-use, sterile, ready-to-use dialysis solutions consisting of sodium chloride, potassium chloride, magnesium chloride, sodium bicarbonate, and glucose. The pureFLOW dialysis are available in four (4) formulations which differ in potassium chloride concentration.
The provided text does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/human reader study or standalone AI performance.
The document is a 510(k) summary for a medical device called "pureFLOW" solutions, which are dialysate solutions used in Continuous Renal Replacement Therapy (CRRT). The entire summary focuses on demonstrating substantial equivalence of the new pureFLOW solutions (manufactured in Mexico) to a predicate pureFLOW device (manufactured in Germany).
The performance data section (1.8 Performance Data) does detail various tests conducted to support substantial equivalence. However, these are engineering and chemical tests related to the physical properties and stability of the product and its packaging, not diagnostic performance of an AI or human readers.
Specifically, the "Performance Data" section discusses:
- 5 L Bag Hanging: Stability of eyelets.
- Shipping and Distribution: Integrity and robustness of packaging.
- Injection Port: Integrity and penetration force of septum and injection port.
- Temperature and Pressure Resistance: Performance of the bag under varying temperature and pressure.
- Gas Barrier: Integrity of the bag as a CO2 barrier.
- Biocompatibility Testing: Chemical characterization, cytotoxicity, sensitization, irritation, material mediated pyrogenicity, hemocompatibility, genotoxicity.
- Human Factors Validation Testing: Found safe and effective for intended users, uses, and environments (no specific details on methodology or metrics provided in this summary).
- Electrical Safety and Electromagnetic Compatibility (EMC): Not applicable.
- Software Verification and Validation Testing: Not applicable.
- Animal Studies: None performed.
- Clinical Studies: None performed.
Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving a device meets them in the context of AI performance, human reader performance, MRMC studies, or related ground truth establishment, as this information is not present in the provided document. The device in question is a medical solution, not a software device that would involve such studies.
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