FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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.

All treatments administered via the PrisMax control unit must be prescribed by a physician.

Device Description

The PrisMax System is intended for Continuous Renal Replacement Therapy (CRRT) for patients with acute renal failure and/or fluid overload. The 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 consists of PrisMax Control Unit and accessories for removing effluent.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the PrisMax device, which is a high-permeability hemodialysis system. The core of this submission is to demonstrate the substantial equivalence of the PrisMax to a predicate device, the Prismaflex.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based solely on the provided text. It's important to note that a 510(k) summary often summarizes extensive testing, so not all details of the actual studies might be present in this brief document.

First and foremost, this document describes a device comparison for substantial equivalence to a predicate, not a study evaluating clinical performance against a specific disease outcome or a MRMC study. Therefore, some of the requested information (like effect size of human readers improving with AI, or number of experts for ground truth) is not applicable to this type of regulatory submission. The acceptance criteria here are about equivalence to the predicate device's established performance parameters and safety.

1. Table of Acceptance Criteria and the Reported Device Performance

The acceptance criteria are generally that the PrisMax device performs at least as well as or equivalently to the predicate Prismaflex device for various technical specifications. The reported device performance is the PrisMax's specification for that feature. The table below is extracted directly from the "Table 3. Substantial Equivalence Table Device Comparison" in the provided document. The "Acceptance Criteria" column reflects the predicate device's performance, as the goal is to demonstrate equivalence or improvement without raising new safety/effectiveness concerns.

Feature	Acceptance Criteria (Predicate Prismaflex 7.10, K131516)	Reported Device Performance (Proposed PrisMax 1.0.6.0)
Indications for use	Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. All treatments administered via the Prismaflex control unit must be prescribed by a physician.	Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. All treatments administered via the PrisMax control unit must be prescribed by a physician.
Dedicated Disposable Sets Available in U.S.	For CRRT: M60/M100/M150, HF1000 & HF1400	For CRRT: M60/M100/M150, HF1000 & HF1400
Syringe Sizes	20, 30 & 50 ml	20 & 50 ml
Anticoagulation	User-controllable as continuous or bolus	User-controllable as continuous or bolus
Dialysate Flow Rate CVVH & CVVHDF (Range)	0 to 8000 ml/hr	0 to 8000 ml/hr
Dialysate Flow Rate CVVH & CVVHDF (Increment)	50 ml/hr	10 ml/hr
Dialysate Flow Rate Accuracy	± 30 ml/hr	± 30 ml/hr
Replacement solution / Fluid Flow Rate CVVH & CVVHDF (Range)	0 to 8000 ml/hr	0 to 8000 ml/hr
Replacement solution / Fluid Flow Rate CVVH & CVVHDF (Increment)	50 ml/hr	10 ml/hr
Replacement Flow Rate Accuracy	± 30 ml/hr	± 30 ml/hr
Blood Flow Rate (Range)	10-450 ml/min	10-450 ml/min
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	±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
Pre-Blood Pump Flow Rate SCUF (Range)	0 to 1000 ml/hr (but actual was 0 to 2000 ml/hr)	0 to 2000 ml/hr
Pre-Blood Pump Flow Rate CVVH, CVVHD, CVVHDF (Range)	0 to 4000 ml/hr	0 to 4000 ml/hr
Pre-Blood Pump Accuracy	± 30 ml/hr	± 30 ml/hr
Effluent Pump Flow Rate (Range)	0 to 10,000 ml/h, Depending on the therapy selected.	0 to 10,000 ml/h, Depending on the therapy selected.
ECG Discharger	YES	YES
Therapies	SCUF, CVVH, CVVHD, CVVHDF	SCUF, CVVH, CVVHD, CVVHDF
Pumps	PBP solution, Replacement solution, Dialysate solution, Effluent, Blood	PBP solution, Replacement solution, Dialysate solution, Effluent, Blood
Scales	Dialysate, Replacement, Effluent, Pre blood (PBP)	Dialysate, Replacement, Effluent, Pre blood (PBP)
Trans Membrane Pressure Alarms (TMP CRRT)	User settable: +70 to +350 mmHg, Default: +350 mmHg	Default: +300 mmHg
Dialysate Conductivity and Temperature	Not controlled by Prismaflex	Not controlled by PrisMax
Patient Fluid Removal Performance (Range)	0 to 2000 ml/hr	0 to 2000 ml/hr
Patient Fluid Removal Performance (Increment)	10 ml/hr	5 ml/hr
Patient Fluid Removal Performance (Accuracy)	± 30 ml/hr, ± 70 ml/3hr, ± 300 ml/24hr. Scales calibrated at ambient temperature at which they will be used. Ambient temperature change less than ±3 °C (5.4 °F) during treatment.	± 30 ml/hr, ± 70 ml/3hr, ± 300 ml/24hr. Scales calibrated at ambient temperature at which they will be used. Ambient temperature change less than ±3 ℃ (5.4 °F) during treatment.
Access Pressure Sensor (Range)	-250 to +450 mmHg	-250 to +450 mmHg
Access Pressure Sensor (Accuracy)	±15 mmHg	±15 mmHg
Return Pressure Sensor (Range)	-50 to +350 mmHg	-50 to +350 mmHg
Return Pressure Sensor (Accuracy)	±5 mmHg	±5 mmHg
Filter Pressure Sensor (Range)	-50 to +450 mmHg	-50 to +450 mmHg
Filter Pressure Sensor (Accuracy)	±15 mmHg	±15 mmHg
Effluent Pressure Sensor (Range)	-350 to +400 mmHg (CRRT)	-350 to +400 mmHg (CRRT)
Effluent Pressure Sensor (Accuracy)	±15 mmHg	±15 mmHg
Control Unit Software	Version 7.10	Version 1.0.6.0

Study Proving Device Meets Acceptance Criteria

The document states: "Performance testing was conducted on the PrisMax System to evaluate the functional performance of the system. The performance testing confirms PrisMax remains as safe and effective as Prismaflex and is substantially equivalent."

The nature of the "study" demonstrating this is predominantly nonclinical performance testing, verification, and validation against engineering and regulatory standards, and comparison to the predicate device's specifications.

Specifically, the document explicitly mentions:

Design validation: The PrisMax design validation meets user needs and intended use and is substantially equivalent to the predicate.
Compliance with IEC 60601-2-16 Hemodialysis Equipment: Testing confirmed by CSA, a recognized test laboratory, for essential performance.
Electrical safety testing: According to IEC 60601-1 Edition 3.1. This includes reports for software, alarms, usability, safety, and performance.
Electromagnetic compatibility (EMC) testing.
Risk Assessment and risk control measures: Hazard analysis (therapy level, product level, process level) confirming the device does not perform in an unexpected or unsafe manner.
Labeling, Software including cybersecurity, Human Factors: These have been successfully implemented.
Verification and validation tests: These were performed subsequent to risk analysis and include Human Factors and Software Validation.

The key changes and their justification for not raising new safety/effectiveness concerns are footnoted in Table 3:

Syringe Sizes (30ml removed): Due to infrequent use, device behavior unchanged.
Dialysate Flow Rate / Replacement Solution Flow Rate Increment (50ml/hr to 10ml/hr): Allows for more precise settings, verified and validated to comply to updated specifications without new risks.
Pre-Blood Pump Flow Rate (SCUF range clarification): Corrected the predicate's stated range to its actual operational range, showing PrisMax is equivalent. Verified and validated.
Trans Membrane Pressure Alarms (Fixed default of +300 mmHg, removed user settable): Removes infrequent use case, reduces use-error risk, increases usability, lowers default to reduce risk. Verified and validated.
Patient Fluid Removal Performance Increment (10ml/hr to 5ml/hr): Increases setting range, allows more precise setting. Verified and validated.
The software update (version 1.0.6.0) was verified and validated subsequent to risk analysis and includes Human Factors and Software Validation.

Details based on the provided text:

2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in terms of patient count or device unit count for the validation tests. These are typically engineering performance tests, not clinical trials with "patients." The performance tests would use a relevant number of devices or test conditions to ensure specifications are met.
- Data Provenance: The testing appears to be internal "performance testing" and "verification and validation" conducted by Baxter Healthcare Corporation and by a recognized test laboratory (CSA) for specific standards like IEC 60601-2-16. This is non-clinical, laboratory-based data, not patient data from a specific country.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of a 510(k) submission based on technical performance and equivalence to a predicate device, rather than a clinical diagnostic study requiring expert interpretation of results. The "ground truth" here is adherence to engineering specifications and safety standards.
4. Adjudication method for the test set:
- Not applicable, as this is not a study requiring human adjudication for diagnostic categorization. The "adjudication" is through engineering verification and validation processes against predefined technical specifications and standards.
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. This is a medical device for continuous renal replacement therapy, not an AI/diagnostic imaging device that would typically involve human readers. Therefore, an MRMC study is not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable in the way this question typically refers to AI algorithms. The device itself is a "standalone" system in its function, but its performance is verified through engineering tests against objective criteria, not an "algorithm only" performance separate from the device's integrated function. Its operation relies on physician prescription (human-in-the-loop for clinical application, but not for the device's technical performance evaluation).
7. The type of ground truth used:
- Engineering Specifications and Performance Standards: The "ground truth" for this submission is compliance with established engineering specifications for flow rates, accuracy, pressure ranges, alarm settings, and adherence to international safety standards (e.g., IEC60601 series). Additionally, the predicate device's cleared performance serves as a comparative ground truth for equivalence.
8. The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a "training set" in the conventional sense. The "training" for the device's development would be iterative engineering design and testing.
9. How the ground truth for the training set was established:
- Not applicable, as there is no "training set" in the AI/ML context. The functional requirements for the device are derived from clinical needs, regulatory standards, and the performance of previous generations of such devices.

Summary

Regulation Number and Section

§ 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.”