(23 days)
The PRISMA™ System is indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload. All treatments administered via the PRISMA System must be prescribed by a physician.
In accordance with Section 510(k) of the Food, Drug and Cosmetics Act, Gambro Renal Care Products intends to introduce a modification of the Prisma Continuous Fluid Management System into commercial distribution. The modification creates an accessory sterile extension line that will allow the Prismatherm II Blood Warmer manufactured by Stihler Electronic GmbH (K991159) to be used with the Prisma system during continuous renal replacement therapy. The integration of the Blood Warmer into the Prisma System will provide gentle warming of the treated blood, prior to its return to the patient. No modifications of the Prisma Dialysis Control Unit were made as part of this change. A modification is made to the Prisma Blood Tubing Set that places two luer fittings into the tubing set return line proximal to the air detector. When using the optional Blood Warmer, the user separates the new luer fittings and attaches the new warmer Extension Line. New labeling is created for the Extension Line and the Blood Tubing Set.
This document is a 510(k) summary for a modification to the Gambro Renal Care Products' PRISMA CFM System, specifically to allow the use of an accessory blood warmer. It is not a study reporting on the performance of an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth cannot be extracted as it pertains to AI/ML device evaluations.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices. The "Safety and Effectiveness" section describes the approach taken to ensure the modification does not introduce new safety or effectiveness issues.
Here's an interpretation of the relevant sections in the context of a traditional medical device submission:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria (Implied): The modification must not introduce significant new safety and effectiveness issues compared to the predicate devices. This is assessed by ensuring:
- The design control system (21 CFR Part 820.30) is in place and addresses identified hazards.
- System-level verification and validation protocols are completed with "acceptable, pre-determined results."
- New hazards associated with the modification are considered in the design.
- Reported Device Performance:
- The modification "creates an accessory sterile extension line that will allow the Prismatherm II Blood Warmer...to be used with the Prisma system."
- The integration "will provide gentle warming of the treated blood, prior to its return to the patient."
- "No modifications of the Prisma Dialysis Control Unit were made as part of this change."
- The modified system "uses similar design, technology and safety systems as the predicate devices to perform heating of the patient blood in the return line."
- "There were no significant new safety and effectiveness issues identified by this modification."
- A list of all system level verification and validation protocols completed with acceptable, pre-determined results is provided in the notification (though not detailed in this summary).
Note: For a traditional device modification like this, acceptance criteria would typically involve engineering specifications, performance benchmarks (e.g., temperature control range, flow rates, sterility), and safety assessments, all aligned with the pre-determined results mentioned. This summary does not provide specific numerical criteria or performance data as it's a high-level overview for a 510(k).
2. Sample Size Used for the Test Set and Data Provenance:
- This information is not applicable. The document describes a device modification for which a 510(k) submission was made, not an AI/ML study involving a test set. Evaluation relies on engineering verification and validation, risk analysis, and comparison to predicate devices, rather than a "test set" in the context of an AI algorithm.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not applicable. There is no "ground truth" establishment in the context of an AI/ML study, nor a "test set" as defined for such. Device safety and effectiveness are established through design controls, testing protocols, and regulatory review by the FDA.
4. Adjudication Method for the Test Set:
- This information is not applicable. There is no "adjudication method" for a test set in this context.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC study was not done. This device is not an AI/ML diagnostic or assistive tool, so human reader performance with or without AI assistance is not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not done. This is a hardware modification for a medical device, not an AI algorithm.
7. The Type of Ground Truth Used:
- This information is not applicable. There is no concept of "ground truth" (e.g., pathology, outcomes data) as it would apply to an AI/ML diagnostic model. Device safety and effectiveness are established through engineering principles, bench testing, and regulatory requirements.
8. The Sample Size for the Training Set:
- This information is not applicable. There is no "training set" as this is a hardware modification, not an AI/ML model.
9. How the Ground Truth for the Training Set was Established:
- This information is not applicable, as there is no training set or associated ground truth.
§ 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.”