(86 days)
The Prisma® System is indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload and for therapeutic plasma exchange in patients with disease where removal of plasma components is indicated.
The Prisma System is indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload and for therapeutic plasma exchange in patients with disease where removal of plasma components is indicated. All treatment administered via the Prisma® System must be prescribed by a physician. The Prisma® System is designed for use on critically ill patients in the intensive care unit to provide the following treatments: SCUD (slow Continuous Ultrafiltrtion), CVVH (Continuous Veno-Venous Hemofiltration), CVVHD (Continuous Veno-Venous Hemodialysis), CVVHDF (Continuous Veno-venous Hemodialfiltration) and TPE (Therapeutic Plasma Exchange). The Prisma® System consists of the Prisma Control Unit and a series of disposable extracorporeal blood circuits (Prisma Sets) to allow four types of continuous renal replacements therapies as well as therapeutic plasma exchange (TPE) therapy. The blood circuit utilized will be dependent on the individual patient's therapy and needs.
The Prisma Control Unit performs the following functions:
- Loads and primes the Prisma Set automatically.
- Pumps blood through the blood flowpath of the set.
- Delivers anti-coagulant solution into blood flowpath.
- Controls fluid removal/plasma loss from the patient.
- Pumps sterile replacement solution/fluid and/or sterile dialysate. Pumps effluent.
- Monitors the system and alerts the operator to abnormal situations through alarms.
Here's a breakdown of the acceptance criteria and the study information for the Prisma® 3.10 System, based on the provided document:
This document is a 510(k) summary for a medical device seeking substantial equivalence to a predicate device. It primarily focuses on comparing the new device (Prisma® R03.10A System) to a legally marketed predicate device (Prisma® System V 3.03) to demonstrate that it is as safe and effective. The "acceptance criteria" here refers to the performance specifications of the device itself and its equivalence to the predicate, rather than statistical performance metrics of an AI model.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly list "acceptance criteria" in a separate section, but the comparison table between the predicate and modified device effectively serves this purpose. The acceptance criterion is that the performance of the modified device (Prisma® R03.10A) must be equivalent to or better than the predicate device (Prisma® System V 3.03) across various operational parameters.
| Parameter | Acceptance Criteria (Predicate Device Performance - Prisma® System V 3.03) | Reported Device Performance (Modified Device - Prisma® System R03.10A) |
|---|---|---|
| Indications for Use | Continuous solute and/or fluid removal in patients with acute renal failure or fluid overload and for therapeutic plasma exchange in patients with disease where removal of plasma components is indicated. | Continuous solute and/or fluid removal in patients with acute renal failure or fluid overload and for therapeutic plasma exchange in patients with disease where removal of plasma components is indicated. |
| Dedicated Disposable Sets | M60/M100 (K032431), 66D pre and post dilution sets, PF2000N (PMA P830063) HF1000 | M60/M100 (K032431), 66D pre and post dilution sets, PF2000N (PMA P830063) HF1000 |
| Replacement Solutions Used | Sterile commercial fluid labeled for intravenous injection or solution prepared in the hospital pharmacy. Prescribed by physician. | Sterile commercial fluid labeled for intravenous injection or solution prepared in the hospital pharmacy. Prescribed by physician. |
| Dialysate Solutions Used | AAMI RD-5 Standard dialysate solution, composition prescribed by physician and Prismasate (K013448). None used for TPE. | AAMI RD-5 Standard dialysate solution, composition prescribed by physician and Prismasate (K013448). None used for TPE. |
| Anticoagulation | Delivered continuously or in bolus into blood path at a point before blood enters the dialyzer. | Delivered continuously or in bolus into blood path at a point before blood enters the dialyzer. |
| Fluid Removal Rate (Patient) | SCUF: up to 2 L/hr. | |
| CVVH: up to 1 L/hr. | ||
| CVVHD: up to 1 L/hr. | ||
| CVVHDF: up to 1 L/hr. | ||
| TPE: 0 - 1000 ml/hr. | SCUF: up to 2 L/hr. | |
| CVVH: up to 1 L/hr. | ||
| CVVHD: up to 1 L/hr. | ||
| CVVHDF: up to 1 L/hr. | ||
| TPE: 0 - 1000 ml/hr. | ||
| Blood Flow Rate | Up to 180 ml/min. | Up to 180 ml/min. |
| Fluid Replacement Rate | SCUF: 0 L/hr. | |
| CVVH: up to 4.5 L/hr. | ||
| CVVHD: 0 L/hr. | ||
| CVVHDF: up to 2 L/hr. | ||
| TPE: up to 2 L/hr. | SCUF: 0 L/hr. | |
| CVVH: 0, or 0.1 to 4.5 L/hr. | ||
| CVVHD: 0 L/hr. | ||
| CVVHDF: 0, or 0.1 to 2 L/hr. | ||
| TPE: up to 2 L/hr. (Note: Modified device adds 0 or 0.1 options for CVVH and CVVHDF, which is an improvement/expansion of options) | ||
| Effluent Flow Rate | SCUF: up to 2 L/hr. | |
| CVVH: up to 5.5 L/hr. | ||
| CVVHD: up to 3.5 L/hr. | ||
| CVVHDF: 10-5500 ml/hr | ||
| TPE: up to 3 L/hr. | SCUF: up to 2 L/hr. | |
| CVVH: up to 5.5 L/hr. | ||
| CVVHD: up to 3.5 L/hr. | ||
| CVVHDF: 10-5500 ml/hr | ||
| TPE: up to 3 L/hr. | ||
| Primary Solute Removal Mechanism | SCUF: Convection | |
| CVVH: Convection | ||
| CVVHD: Diffusion | ||
| CVVHDF: Convection & Diffusion | ||
| TPE: Convection | SCUF: Convection | |
| CVVH: Convection | ||
| CVVHD: Diffusion | ||
| CVVHDF: Convection & Diffusion | ||
| TPE: Convection | ||
| Transmembrane Pressure (TMP) | See table below (same for both devices) | See table below (same for both devices) |
| Ultrafiltration Rate | Off, 10 - 5500 ml/hr | Off, 10 - 5500 ml/hr |
| Dialysate Temperature | *N/A (no temperature control/monitoring) | *N/A (no temperature control/monitoring) |
| Dialysate Conductivity | **N/A (does not mix water and concentrates) | **N/A (does not mix water and concentrates) |
| Arterial and Venous Pressure | Operating Range -250 to +50 mmHg | |
| Accuracy ±10% of reading or ±8 mmHg, whichever is greater | Operating Range -250 to +50 mmHg | |
| Accuracy ±10% of reading or ±8 mmHg, whichever is greater |
TMP Alarm Limits (same for both Prisma® 3.03 & 3.10):
| Alarm Type | Default Limit | Option (if applicable) |
|---|---|---|
| "TMP Too High" Advisory Limit | +350 mmHg | +70 to +350 mmHg (Increment: 10 mmHg) |
| "Filter Is Clotting" Advisory | Advisory alarm occurs when one or more limits are reached. | |
| a) Filter pressure dropb (ΔP filter) variation | 100 mmHg | a) User settable: 10 to 100 mmHg greater than initial ΔP. (Increment: 10 mmHg) |
| b) TMP increase | Default: 150 mmHg | Service settable: 50 to 200 mmHg greater than initial TMP. (Increment: 5 mmHg) |
| "Filter Clotted" Warning Limit | (Filter pressure - return pressure) ≥ 250 mmHg OR one or both "Filter is Clotting" Advisory Limits reached AND TMP ≥ 450 mmHg. | N/A |
| "TMP Excessive" Caution Limit | TMP ≥ 450 mmHg | N/A |
Conclusion of Testing: "The successful non-clinical testing demonstrates the safety and effectiveness of the Prisma® R03.10A System when used for the defined indications for use and demonstrates that the device for which the 510(k) is submitted performs as well as or better than the legally marketed device."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical "sample size" for a dedicated test set in the context of clinical data or patient outcomes. The testing described is non-clinical, focusing on the device's functional performance.
- Data Provenance: The testing described is "non-clinical testing" including "unit testing, code inspections, testing targeted to the changes implemented in R03.10A, regression testing and human factors evaluations and testing that was performed by internal and external independent personnel with the appropriate skills." This indicates it was likely laboratory/bench testing and internal evaluations, not drawn from patient data. The country of origin for the data is not specified but is implied to be related to Gambro Renal Products (Lakewood, CO, USA). The study is prospective in the sense that the testing was conducted on the newly modified device.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: The document mentions "external independent personnel with the appropriate skills" for human factors evaluations and testing. However, it does not specify a number or detailed qualifications for these experts.
- Qualifications: "appropriate skills" is the only stated qualification. This type of device (a dialysis delivery system) typically involves engineers, regulatory affairs specialists, and potentially clinical users (e.g., intensive care unit nurses, nephrologists) for human factors, but no specific professional backgrounds or years of experience are listed.
4. Adjudication Method for the Test Set
No formal adjudication method (like 2+1 or 3+1) is described. The non-clinical testing appears to involve a structured testing protocol against predefined specifications and regulatory requirements. The "adjudication" would largely be whether the device passed or failed the specified tests, with "internal and external independent personnel" conducting and likely reviewing the results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. This type of study is typically for diagnostic imaging devices where human readers interpret images with and without AI assistance. The Prisma® 3.10 System is a hemodialysis delivery system, not a diagnostic imaging AI device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No "standalone" (algorithm-only) study was done in the context of an AI algorithm, as this device report predates the widespread regulatory discussions around AI and is a hardware/software system rather than a pure AI diagnostic. The device itself (the Prisma Control Unit) performs automated functions like pumping blood, delivering anticoagulants, controlling fluid removal, and monitoring with alarms, which could be considered its "standalone" functionality. The non-clinical testing assessed these automated functions.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is based on its functional specifications and comparison to the predicate device. It's established through:
- Engineering Specifications/Bench Testing: The device's ability to maintain flow rates, accurately measure pressures, and trigger alarms within defined limits during non-clinical, controlled tests.
- Performance Equivalence: The primary ground truth is demonstrating that the modified device performs "as well as or better than" the legally marketed predicate device (Prisma® System V 3.03) based on the operational parameters listed in the comparison table. This is a regulatory "ground truth" for substantial equivalence.
8. Sample Size for the Training Set
Not applicable. The document is for a medical device (hemodialysis delivery system), not an AI algorithm that typically has a "training set." The software within the device has likely undergone development and verification, but the concept of a "training set" as used in AI/machine learning is not relevant here.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of AI/machine learning for this device.
§ 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.”