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.

Device Description

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.

AI/ML Overview

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.

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.

Summary

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K062090
Page 1 of 5

Traditional 510(k)
Prisma® 3.10 System

12.0 510(k) SUMMARY

OCT 1 8 2006

Submitter's Name	Gambro Renal Products
Address	10810 West Collins AvenueLakewood, CO 80215
EstablishmentRegistration Number	1713683
Date of Summary	July 23, 2006
Telephone Number	(303) 231-4094
Fax Number	(303) 542-5138
Contact Person	Thomas B. Dowell, Manager Regulatory Affairs
Name of the Device	Prisma ® R03.10A SystemCatalogue Number: 018089-507
Common or Usual Name	Hemodialysis Delivery System
Classification Name	Classification Name: High Permeability Hemodialysis SystemDevice Class: IIProduct Code: 78KDIRegulation Number: 876.5860
Indications for Use	The Prisma System is indicated for continuous solute and/or fluidremoval in patients with acute renal failure or fluid overload and fortherapeutic plasma exchange in patients with disease where removalof plasma components is indicated.
Identification of theLegally Marketed Device(Predicate Device)	Prisma ® 3.03 SystemCatalogue Number: 018089-507Classification Name: High Permeability Hemodialysis SystemDevice Class: IIProduct Code: 78KDIRegulation Number: 876.5860

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K062090
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Traditional 510(k)
Prisma® 3.10 System

510(k) SUMMARY, continued

Device Description	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:
	1. Loads and primes the Prisma Set automatically.
	2. Pumps blood through the blood flowpath of the set.
	3. Delivers anti-coagulant solution into blood flowpath.
	4. Controls fluid removal/plasma loss from the patient.
	5. Pumps sterile replacement solution/fluid and/or sterile dialysate. Pumps effluent.
	6. Monitors the system and alerts the operator to abnormal situations through alarms.

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Traditional 510(k)
Prisma® 3.10 System

510(k) SUMMARY, continued

Comparison Table

	PREDICATEPrisma ® System V 3.03	MODIFIED DEVICEPrisma ® System R03.10A
Indication for Use	The Prisma System is indicated forcontinuous solute and/or fluid removalin patients with acute renal failure orfluid overload and for therapeuticplasma exchange in patients withdisease where removal of plasmacomponents is indicated	The Prisma System is indicated forcontinuous solute and/or fluid removalin patients with acute renal failure orfluid overload and for therapeuticplasma exchange in patients withdisease where removal of plasmacomponents is indicated
DedicatedDisposable Sets	M60/M100 (K032431), 66D pre andpost dilution sets, PF2000N (PMAP830063) HF1000	M60/M100 (K032431), 66D pre andpost dilution sets, PF2000N (PMAP830063) HF1000
ReplacementSolutions Used	Sterile commercial fluid labeled forintravenous injection or solutionprepared in the hospital pharmacy.Prescribed by physician.	Sterile commercial fluid labeled forintravenous injection or solutionprepared in the hospital pharmacy.Prescribed by physician.
Dialysate SolutionsUsed	AAMI RD-5 Standard dialysatesolution, composition prescribed byphysician and Prismasate (K013448).None used for TPE.	AAMI RD-5 Standard dialysatesolution, composition prescribed byphysician and Prismasate (K013448).None used for TPE.
Anticoagulantion	Delivered continuously or in bolus intoblood path at a point before blood entersthe dialyzer.	Delivered continuously or in bolus intoblood path at a point before bloodenters the dialyzer.
Fluid RemovalRate from 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 ReplacementRate	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.
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/hrTPE: 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/hrTPE: up to 3 L/hr.
Primary SoluteRemovalMechanism	SCUF: ConvectionCVVHD: ConvectionCVVHD: DiffusionCVVHDF: Convection & DiffusionTPE: Convection	SCUF: ConvectionCVVHD: ConvectionCVVHD: DiffusionCVVHDF: Convection & DiffusionTPE: Convection
	PREDICATEPrisma® System V 3.03	MODIFIED DEVICEPrisma® System R03.10A
TransmembranePressure	See table below	See table below
Ultrafiltration Rate	Off, 10 - 5500 ml/hr	Off, 10 - 5500 ml/hr
DialysateTemperature	*N/A: See explanation below	*N/A: See explanation below
DialysateConductivity	**N/A: See explanation below	**N/A: See explanation below
Arterial andVenous Pressure	Operating Range -250 to +50 mmHgAccuracy ±10% of reading or ±8mmHg, whichever is greater	Operating Range -250 to +50 mmHgAccuracy ±10% of reading or ±8mmHg, whichever is greater

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Traditional 510(k)
Prisma® 3.10 System

510(k) SUMMARY, continued

TMP Alarm Limits in Prisma (same for 3_03 & 3_10)

Alarm	Default	Option
"TMP Too High"Advisory Limit	+350 mmHg	+70 to +350 mmHgIncrement: 10 mmHg
"Filter Is Clotting"Advisory Limits	Advisory alarm occurs	One or more limits are reached.
a) Filter pressure dropb (ΔP filter) variation	100 mmHg	a) User settable: 10 to 100 mmHggreater than initial ΔP.Increment: 10 mmHg
b) TMP increase	Default: 150 mmHg	Service settable: 50 to 200 mmHggreater than initial TMP.Increment: 5 mmHg
Filter Clotted" WarningLimit	Filter pressure minus returnpressure is ≥ 250 mmHg OR Oneor both of the "Filter is Clotting"Advisory Limits are reached andTMP is ≥ 450 mmHg.	N/A
"TMP Excessive" CautionLimit	TMP ≥ 450 mmHg	N/A

TMP = (Filter Pressure + Return Pressure)/2 - Effluent Pressure

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510(k) SUMMARY, continued

Dialysate conductivity is not applicable because the Prisma does not mix water and concentrates to produce dialysate. There is also no temperature control or monitoring included in Prisma. Accessory warmers for Prisma include appropriate protective measures. There are no conductivity or temperature controls or monitoring.

** The term Access Pressure in Prisma is equivalent to Arterial Pressure; the term Return Pressure in Prisma is equivalent to Venous Pressure. Prisma includes an Effluent Flow Rate in therapies where dialysate is not used, the effluent rate is the ultrafiltration rate (everything pulled in to the effluent bag is coming across the dialyzer membrane). In therapies where there is also a dialysate flow (CVVHD, CVVHDF), the ultrafiltration rate is the difference between effluent rate and the dialysate rate.

TMP (CRRT) and TMPa (TPE) are values calculated from measured pressures. There is no control to TMP (TMPa) in the system, but there are various alarms that are triggered by the calculated TMP.

Description and Nonclinical Testing: The nonclinical testing included unit testing, code inspections, testing Conclusion of 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.

Conclusion:

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.

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Image /page/5/Picture/1 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized depiction of an eagle or bird in flight. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the emblem in a circular fashion. The text is in a simple, sans-serif font.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

OCT 1 8 2006

Mr. Thomas B. Dowell Regulatory Project Manager Gambro Renal Products 10810 W. Collins Avenue LAKEWOOD CO 80215

Re: K062090

Trade/Device Name: Prisma® R03.10A System Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: July 23, 2006 Received: July 24, 2006

Dear Mr. Dowell:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce arior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that prove to the first and in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket 11 your ab, it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/5/Picture/10 description: The image is a circular logo with the text "FDA Centennial" and the years "1906-2006". The letters "FDA" are in a bold, stylized font in the center of the logo. Below the letters, the word "Centennial" is written in a cursive font. There are three stars below the word "Centennial". The logo is surrounded by a dotted circle.

Protecting and Promoting Public Health

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Page 2 -

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150

or at its Internet address http://www.fda.gov/cdrlv/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Traditional 510(k) Prisma® 3.10 System

Indications for Use

510(k) Number (if known): K062080

Device Name: Prisma® R03.10A System

Indications for Use:

"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."

Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David h. Ingram
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devic

510(k) Number.

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.”

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/hrTPE: 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/hrTPE: up to 3 L/hr.
Primary Solute Removal Mechanism	SCUF: ConvectionCVVH: ConvectionCVVHD: DiffusionCVVHDF: Convection & DiffusionTPE: Convection	SCUF: ConvectionCVVH: ConvectionCVVHD: DiffusionCVVHDF: Convection & DiffusionTPE: 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 mmHgAccuracy ±10% of reading or ±8 mmHg, whichever is greater	Operating Range -250 to +50 mmHgAccuracy ±10% of reading or ±8 mmHg, whichever is greater