(108 days)
The PrisMax control unit is intended for:
· Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload.
• Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated.
All treatments administered via the PrisMax control unit must be prescribed by a physician.
The PrisMax System is intended for Continuous Renal Replacement Therapy (CRRT) for patients with acute renal failure and/or fluid overload. The goals of acute renal failure treatments are removal of waste products, restoration of acid-base balance; correction of electrolyte imbalances (e.g., hyperkalemia), patient fluid balance, nutritional support, and other conditions in which fluid removal is needed. PrisMax System offers four Continuous Renal Replacement Therapy (CRRT) options: Slow Continuous Ultrafiltration (SCUF), Continuous Veno-Venous Hemofiltration (CVVH), Continuous VenoVenous Hemodialysis (CVVHD), and Continuous Venovenous Hemodialfiltration (CVVHDF). The proposed device PrisMax, which is the subject of this Traditional premarket notification (510(k)), consists of the PrisMax Control Unit System, Blood Tubing Sets and Accessories. Specific to this submission, is the accessory for blood warming and a blood tubing set for Therapeutic Plasma Exchange (TPE2000).
Here's a breakdown of the acceptance criteria and the study information for the PrisMax System Version 2, based on the provided document.
It's important to note that this document is a 510(k) summary for a medical device and not a study report for an AI/algorithm-based device. Therefore, many of the requested categories (like sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, standalone AI performance, and ground truth establishment for AI) are not applicable to this submission, as it concerns a physical medical device (CRRT/TPE system) and its software/accessories, not an AI model.
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the safety and performance requirements for a high permeability hemodialysis system, as demonstrated by equivalence to predicate devices and compliance with recognized standards. The "performance" here refers to the functional performance of the device's physical and software components.
| Feature / Acceptance Criteria (defined by equivalence to predicates and standards) | Reported Device Performance (PrisMax System Version 2) |
|---|---|
| Indications for Use | CRRT: For patients ≥20 kg with acute renal failure and/or fluid overload. TPE: For patients ≥20 kg with diseases where removal of plasma components is indicated. (Matches predicate Prismaflex sw8.10; expands beyond PrisMax V1) |
| Dedicated Disposable Sets | CRRT: M60/M100/M150, HF1000 & HF1400. TPE: TPE 2000 Set. (Matches predicate Prismaflex sw8.10; expands beyond PrisMax V1) |
| Syringe Sizes | 20 & 50 ml. (Matches PrisMax V1, differs slightly from Prismaflex sw8.10 which also has 30 ml) |
| Anticoagulation | User-controllable as continuous or bolus. (Matches predicates) |
| Dialysate Flow Rate (CVVH & CVVHDF) | Range: 0 to 8000 ml/hr, Increment: 10 ml/hr. (Matches PrisMax V1; finer increment than Prismaflex sw8.10's 50 ml/hr) |
| Dialysate Flow Rate Accuracy | ± 30 ml/hr. (Matches predicates) |
| Replacement solution / Fluid Flow Rate (CVVH & CVVHDF) | Range: 0 to 8000 ml/hr, Increment: 10 ml/hr. (Matches PrisMax V1; finer increment than Prismaflex sw8.10's 50 ml/hr) |
| Replacement solution / Fluid Flow Rate (TPE) | Range: 0 to 5000 ml/hr, Increment: 10 ml/hr. (Matches predicate Prismaflex sw8.10; adds TPE functionality not in PrisMax V1) |
| Replacement Flow Rate Accuracy | ± 30 ml/hr. (Matches predicates) |
| Blood Flow Rate | Range: 10-450 ml/min. (Matches predicates) |
| Blood Flow Rate Accuracy | ±10% of user set rate at nominal blood flow of 450 ml/min or the highest achievable disposable blood flow, having 37 °C, at an access pressure of -200 mmHg and without any PBP flow. (Matches predicates) |
| Pre-Blood Pump Flow Rate (SCUF) | Range: 0 to 2000 ml/hr. (Matches predicates) |
| Pre-Blood Pump Flow Rate (CVVH, CVVHD, CVVHDF) | Range: 0 to 4000 ml/hr. (Matches predicates) |
| Pre-Blood Pump Flow Rate (TPE) | Range: 0 to 1000 ml/hr. PBP Volume is 2000 ml/treatment for TPE2000. (Matches predicate Prismaflex sw8.10; adds TPE not in PrisMax V1) |
| Pre-Blood Pump Accuracy | ± 30 ml/hr. (Matches predicates) |
| Effluent Pump Flow Rate | Range: 0 to 10,000 ml/h, depending on therapy. (Matches predicates) |
| ECG Discharger | YES. (Matches predicates) |
| Therapies | SCUF, CVVH, CVVHD, CVVHDF, TPE. (Matches predicate Prismaflex sw8.10; adds TPE not in PrisMax V1) |
| Pumps | PBP solution, Replacement solution, Dialysate solution, Effluent, Blood. (Matches predicates) |
| Scales | Dialysate, Replacement, Effluent, Pre Blood Pump (PBP). (Matches predicates) |
| Trans Membrane Pressure (TMP) Alarms (CRRT) | Default: +300 mmHg. (Matches PrisMax V1, somewhat different from user settable +70 to +350 mmHg for Prismaflex sw8.10) |
| TMPa Alarms (TPE) | User settable: +50 to +100 mmHg, Default: +100 mmHg. (Matches predicate Prismaflex sw8.10; adds TPE not in PrisMax V1) |
| Dialysate Conductivity and Temperature Control | Not controlled by PrisMax. (Matches predicates) |
| Patient Fluid Removal Performance (CRRT) | Range: 0 to 2000 ml/hr, Increment: 5 ml/hr. (Finer increment than Prismaflex sw8.10's 10 ml/hr) |
| Patient Fluid Removal Performance (TPE) | Range: 0 to 1000 ml/hr, Increment: 5 ml/hr. (Finer increment than Prismaflex sw8.10's 10 ml/hr; adds TPE not in PrisMax V1) |
| Patient Fluid Removal Performance (Accuracy) | ± 30 ml/hr; ± 70 ml/3hr; ± 300 ml/24hr. (Matches predicates) |
| Scale Calibration | Scales calibrated at ambient temperature at which they will be used. Ambient temperature change less than ±3 °C (5.4 °F) during treatment. (Matches predicates) |
| Access Pressure Sensor | Range: -250 to +450 mmHg, Accuracy: ±15 mmHg. (Matches predicates) |
| Return Pressure Sensor | Range: -50 to +350 mmHg, Accuracy: ±5 mmHg. (Matches predicates) |
| Filter Pressure Sensor | Range: -50 to +450 mmHg, Accuracy: ±15 mmHg. (Matches PrisMax V1; different from Prismaflex sw8.10's ±10% or ±8mmHg) |
| Effluent Pressure Sensor (CRRT) | Range: -350 to +400 mmHg, Accuracy: ±15 mmHg. (Matches PrisMax V1; different from Prismaflex sw8.10's ±10% or ±8mmHg) |
| Effluent Pressure Sensor (TPE) | Range: -350 to +400 mmHg, Accuracy: ±15 mmHg. (Adds TPE not in PrisMax V1; different from Prismaflex sw8.10's ±10% or ±8mmHg) |
| TPE Specific Settings (Patient Hematocrit) | Not specified for PrisMax V2 in the comparative table. Prismaflex sw8.10 has Range: 10 to 60%, Increment: 1%, Default: 30%. |
| TPE Specific Settings (Total Replacement Volume) | Range: 0 to 10,000 ml, Increment: 0.1 ml, Default: 0 ml. (Finer increment and different default than Prismaflex sw8.10; adds TPE not in PrisMax V1) |
| TPE Specific Settings (Patient Plasma Loss Rate) | Range: 0, or 10 to 1000 ml/hr, Increment: 5 ml/hr, Default: 0 ml/hr. (Finer increment than Prismaflex sw8.10; adds TPE not in PrisMax V1) |
| TPE Specific Settings (Replacement Container Volume) | Range: 0 to 5000 ml, Increment: 0.1 ml. (Finer increment than Prismaflex sw8.10; adds TPE not in PrisMax V1) |
| Control Unit Software | PrisMax Version 2. (Updates from PrisMax Version 1) |
| Blood Warmer Accessory | Prismatherm Warmer, PrismaFlo Blood Warmer, Prismacomfort Blood Warmer, TherMax Blood Warmer. (Adds TherMax Blood Warmer) |
Study Information (Relevant to this device submission)
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Sample size used for the test set and the data provenance: Not applicable. This is a submission for a physical medical device and its accessories/software, not an AI/algorithm. Performance was evaluated through non-clinical functional testing, verification, and validation of the device components and system.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's functional performance is typically based on engineering specifications, physical measurements using calibrated equipment, and compliance with recognized standards.
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Adjudication method: Not applicable for an AI context. Device performance was assessed against predefined engineering specifications and regulatory standards in non-clinical testing.
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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. This is a medical device, not an AI diagnostic/classification system requiring human reader studies.
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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 software runs on the device to control its functions.
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The type of ground truth used:
- Engineering Specifications: The device's operating ranges, accuracies (e.g., flow rates, pressure sensors, fluid removal), and control parameters were tested against predetermined engineering specifications.
- Regulatory Standards: Compliance with recognized international standards (e.g., IEC60601-2-16 for Hemodialysis Equipment, IEC60601-1 for Electrical Safety, IEC60601-1-8 for Alarms, IEC60601-1-2 for EMC, ISO10993-1 for Biocompatibility).
- Successful Functional Performance: Verification and validation testing confirmed that the device and its accessories (including software) performed as intended and met user needs.
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The sample size for the training set: Not applicable. No AI model training set is mentioned or relevant for this device submission. The "software" referred to is control software, not a machine learning model.
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How the ground truth for the training set was established: Not applicable. There is no AI training set. Software verification and validation (V&V) involved testing against functional requirements derived from design specifications, risk analysis, and regulatory requirements.
§ 876.5860 High permeability hemodialysis system.
(a)
Identification. A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K
uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.).
(3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).
(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ”
(2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,”
(3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,”
(4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and
(5) “Guidance for Hemodialyzer Reuse Labeling.”