The Prismaflex control unit is intended for:
· Continuous Renal Replacement Therapy (CRT) 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 Prismaflex control unit must be prescribed by a physician.

Device Description

The Prismaflex control unit is a software controlled device that performs the following functions:
Loads and primes the Prismaflex disposable set automatically.
• Pumps blood through the blood flow path of the Prismaflex disposable set.
· Delivers anticoagulant solution into the blood flow path.
• Pumps sterile infusion solutions into the blood flow path of the Prismaflex disposable set according to therapy in use.
· Pumps sterile dialysate into the fluid compartment of the filter in CRRT therapies.
· Controls the patient fluid removal or plasma loss according to the therapy in use.
• Monitors the system and alerts the operator to abnormal situations through alarms.
· Provides treatment data to an external Patient Data Management Systems (PDMS)

AI/ML Overview

The provided document, a 510(k) premarket notification letter from the FDA to Baxter Healthcare Corporation for the Prismaflex System 8.10, is a regulatory submission for a medical device. It does not contain information about an AI/ML-based medical device software or a study that proves a device meets acceptance criteria in the context of an AI/ML system's performance metrics (like sensitivity, specificity, or AUC).

The document details the device's substantial equivalence to a predicate device (Prismaflex System 7.10) based on its functional parameters, physical characteristics, and adherence to performance standards for a hemodialysis system. The "acceptance criteria" here refer to the predefined performance ranges and characteristics of the device itself (e.g., dialysate flow rate accuracy, blood flow rate accuracy, pressure sensor accuracy), and the "study" is the non-clinical testing (software and system verification and validation) done to prove that the updated Prismaflex System 8.10 meets these established parameters and functions equivalently to its predecessor.

Therefore, I cannot extract the requested information, which pertains to AI/ML device performance and testing, from this document. The document primarily focuses on demonstrating substantial equivalence for a non-AI/ML medical device based on established performance specifications and regulatory compliance.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out to the right of it.

February 23, 2018

Baxter Healthcare Corporation Rick Lukacovic Manager, Regulatory Affairs 32650 North Wilson Road Round Lake, IL 60073

Re: K171671

Trade/Device Name: Prismaflex System 8.10 Regulation Number: 21 CFR§ 876.5860 Regulation Name: High Permeability Hemodialysis System Regulatory Class: II Product Code: KDI Dated: January 23, 2018 Received: January 26, 2018

Dear Rick Lukacovic:

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 prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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.

{1}------------------------------------------------

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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Image /page/1/Picture/6 description: The image shows the name "Charles Viviano -S" in a simple, sans-serif font. The text is horizontally aligned and appears to be the primary focus of the image. The background is plain and does not distract from the text.

For Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

K171671

Device Name

Prismaflex System 8.10

Indications for Use (Describe)

The Prismaflex control unit is intended for:

· Continuous Renal Replacement Therapy (CRT) 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 Prismaflex control unit must be prescribed by a physician.

Type of Use (Select one or both, as applicable)

✓ Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
----------------------------------------------------------------------------------------------------------	----------------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Section 5. 510(k) Summary

1. SUBMITTER'S NAME:

Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015

Establishment Registration #: 1416980

2. CONTACT PERSON:

Richard Lukacovic Regulatory Affairs Manager Baxter Healthcare Corporation Telephone: 224 270 2476 Fax: 224 270 4119 fax Email Rick Lukacovic(@Baxter.com

Alternately, please contact: Tito Aldape Director, Global Regulatory Affairs Baxter Healthcare Corporation 32650 N. Wilson Road Round Lake, IL 60073 Telephone 224-270-4867 Fax: 224 270 4119 Email: fortunato aldape@baxter.com

3. IDENTIFICATION OF THE DEVICE:

Trade/Device Name: Prismaflex System 8.10 Classification Panel: Gastroenterology/Urology Regulation Number: 21 CFR 876.5860 Regulation Name: High permeability hemodialysis system. Regulatory Class: II Product Code: KDI

{4}------------------------------------------------

This submission for Prismaflex System 8.10 is a change to the Prismaflex Control Unit which has been updated to Software Version 8.10 and has undergone hardware and labeling changes. None of these changes affect the performance parameters discussed in Table 2 Substantial Equivilence Table.

4. PREDICATE DEVICE:

Device	Predicate 510(k)	Clearance Date
Prismaflex System 7.10	K131516	January 3, 2014

5. DESCRIPTION OF THE DEVICE:

Image /page/4/Picture/6 description: The image shows a medical device on a stand with wheels. The device has a screen at the top and several buttons and dials on the front. The stand is made of metal and has a green base with four wheels. The device is likely used for medical treatments or procedures.

The Prismaflex control unit is a software controlled device that performs the following functions:

Loads and primes the Prismaflex disposable set automatically.

• Pumps blood through the blood flow path of the Prismaflex disposable set.

· Delivers anticoagulant solution into the blood flow path.

• Pumps sterile infusion solutions into the blood flow path of the Prismaflex disposable set according to therapy in use.

· Pumps sterile dialysate into the fluid compartment of the filter in CRRT therapies.

· Controls the patient fluid removal or plasma loss according to the therapy in use.

• Monitors the system and alerts the operator to abnormal situations through alarms.

· Provides treatment data to an external Patient Data Management Systems (PDMS)

Physical characteristics of Prismaflex Control Unit

{5}------------------------------------------------

Weight	Approximately 78 kg (172 lb) (without fluid bags and Prismaflex disposable set)
Height	Approximately 163 cm (64 in)
Width	Approximately 49 cm (19 in)
Base	Approximately 70 cm x 70 cm (28 in x 28 in)

Table 1. Physical Characteristics

5.1 INDICATIONS FOR USE:

The Prismaflex 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 Prismaflex control unit must be prescribed by a physician.

6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:

In Table 2 the Prismaflex System 8.10 is compared with the predicate Prismaflex System 7.10

{6}------------------------------------------------

	PredicatePrismaflex System 7.10K131516	DevicePrismaflex System 8.10	Difference
Devices	The Prismaflex control unit isintended for:	The Prismaflex control unit isintended for:	same
Indication forUse	Continuous Renal ReplacementTherapy (CRRT) for patientsweighing 20 kilograms or more withacute renal failure and/or fluidoverload.Therapeutic Plasma Exchange(TPE) therapy for patients weighing20 kilograms or more with diseaseswhere removal of plasmacomponents is indicated.All treatments administered via thePrismaflex control unit must beprescribed by a physician.	Continuous Renal ReplacementTherapy (CRRT) for patientsweighing 20 kilograms or morewith acute renal failure and/or fluidoverload.Therapeutic Plasma Exchange(TPE) therapy for patientsweighing 20 kilograms or morewith diseases where removal ofplasma components is indicated.All treatments administered via thePrismaflex control unit must beprescribed by a physician.	same
	DedicatedDisposable SetsAvailable inU.S.	For CRRT:M60/M100/M150HF1000 & HF1400For TPE:TPE 2000 Set	For CRRT:M60/M100/M150HF1000 & HF1400For TPE:TPE 2000 Set
Syringe		20, 30 & 50 ml	20, 30 & 50 ml
Anticoagulation	User-controllable as continuous orbolus	User-controllable as continuous orbolus	same
Dialysate FlowRate	CVVH & CVVHDF:Range: 0 to 8000 ml/hrIncrement: 50 ml/hr	CVVH & CVVHDF:Range: 0 to 8000 ml/hrIncrement: 50 ml/hr	same
Dialysate FlowRateAccuracy	± 30 ml/hr	± 30 ml/hr	same
Devices	PredicatePrismaflex System 7.10K131516	DevicePrismaflex System 8.10	Difference
Replacementsolution / FluidFlow Rate	CVVH & CVVHDF:Range: 0 to 8000 ml/hrIncrement: 50 ml/hrTPE:Range: 0 to 5000 ml/hrIncrement: 10 ml/hr	CVVH & CVVHDF:Range: 0 to 8000 ml/hrIncrement: 50 ml/hrTPE:Range: 0 to 5000 ml/hrIncrement: 10 ml/hr	same
ReplacementFlow RateAccuracy	± 30 ml/hr	± 30 ml/hr	same
Blood FlowRate	Range: 10-450 ml/min.	Range: 10-450 ml/min.	same
Blood FlowRate Accuracy	±10% of user set rate at nominalblood flow of 450 ml/min or thehighest achievable disposable bloodflow at 37° C at an access pressureof -200 mmHg and without any PBPflow.	±10% of user set rate at nominalblood flow of 450 ml/min or thehighest achievable disposableblood flow at 37° C at an accesspressure of -200 mmHg andwithout any PBP flow.	same
Pre-BloodPump FlowRate	CRRT RangeRange: 0 to 4000 ml/hrTPE RangeRange: 0 to 1000 ml/hrNote: Total PBP Volume is2000 ml/treatment for TPE	CRRT RangeRange: 0 to 4000 ml/hrTPE RangeRange: 0 to 1000 ml/hrNote: Total PBP Volume is2000 ml/treatment for TPE	same
Pre-BloodPump Accuracy	± 30 ml/hr	± 30 ml/hr	same
Effluent PumpFlow Rate	0 to 10000 ml/hr depending on thetherapy	0 to 10000 ml/hr depending on thetherapy	same
ECGDischarger	YES	YES	same
Devices	PredicatePrismaflex System 7.10K131516	DevicePrismaflex System 8.10	Difference
Therapies	SCUF	SCUF	same
	CVVH	CVVH	same
	CVVHD	CVVHD	same
	CVVHDF	CVVHDF	same
	TPE	TPE	same
Pumps	PBP solution	PBP solution	same
	Replacement solution	Replacement solution	same
	Dialysate solution	Dialysate solution	same
	Effluent	Effluent	same
	Blood	Blood	same
Scales	Dialysate	Dialysate	same
	Replacement	Replacement	same
	Effluent	Effluent	same
	Pre blood (PBP)	Pre blood (PBP)	same
TransmembranePressureTMP (CRRT)TMPa (TPE)	TMP:User settable: +70 to +350 mmHgDefault: +350 mmHgTMPa:User settable; +50 to +100 mmHgDefault: +100 mmHg	TMP:User settable: +70 to +350 mmHgDefault: +350 mmHgTMPa:User settable; +50 to +100 mmHgDefault: +100 mmHg	same


DialysateConductivityandTemperature	Dialysate Conductivity andTemperature are not controlled byPrismaflex	Dialysate Conductivity andTemperature are not controlled byPrismaflex	same
Patient FluidRemovalPerformanceRange	0 to 2000 ml/hr maximum forCRRT0 to 1000 ml/hr for TPEIncrement: 10 ml/hr	0 to 2000 ml/hr maximum forCRRT0 to 1000 ml/hr for TPEIncrement: 10 ml/hr	same


Patient FluidRemovalPerformanceRangeAccuracy	± 30 ml/hr± 70 ml/3hr± 300 ml/24hrScales calibrated at ambienttemperature at which they will beused. Ambient temperature changeless than ±3 °C(5.4 °F) during treatment	± 30 ml/hr± 70 ml/3hr± 300 ml/24hrScales calibrated at ambienttemperature at which they will beused. Ambient temperature changeless than ±3 °C(5.4 °F) during treatment	same



Devices	PredicatePrismaflex System 7.10K131516	DevicePrismaflex System 8.10	Difference
Access Pressureand Accuracy	Range -250 to +450 mmHgAccuracy ±15 mmHg	Range -250 to +450 mmHgAccuracy ±15 mmHg	same
Return Pressureand Accuracy	Range -50 to +350 mmHg Accuracy±5 mmHg	Range -50 to +350 mmHgAccuracy ±5 mmHg	same
Filter PressureSensor	Range -50 to +450 mmHgAccuracy ±10% of reading or ±8mmHg	Range -50 to +450 mmHgAccuracy ±10% of reading or ±8mmHg	same
EffluentPressure Sensor	Range -350 to +400 mmHg (CRRT)Range -350 to +350 mmHg (TPE)Accuracy ±10% of reading or ±8mmHg	Range -350 to +400 mmHg(CRRT)Range -350 to +350 mmHg (TPE)Accuracy ±10% of reading or ±8mmHg	same
TPE Settings:	Pre-treatment HematocritRange: 10 to 60%Increment: 1%Default: 30%	Pre-treatment HematocritRange: 10 to 60%Increment: 1%Default: 30%	same
TPE Settings	Total Replacement VolumeRange: 0 to 10,000 mlIncrement: 100 mlDefault: 3000 ml	Total Replacement VolumeRange: 0 to 10,000 mlIncrement: 100 mlDefault: 3000 ml	same
TPE Settings	Patient Plasma Loss RateRange: 0, or 10 to 1000 ml/hrIncrement: 10 ml/hrDefault: 0 ml/hr	Patient Plasma Loss RateRange: 0, or 10 to 1000 ml/hrIncrement: 10 ml/hrDefault: 0 ml/hr	same
TPE Settings	Replacement Container VolumeRange: 0 to 5000 mlIncrement: 10 ml	Replacement Container VolumeRange: 0 to 5000 mlIncrement: 10 ml	same

Table 2. Substantial Equivelence Table

{7}------------------------------------------------

Table 2. Substantial Equivelence Table

{8}------------------------------------------------

Table 2. Substantial Equivelence Table

{9}------------------------------------------------

Table 2. Substantial Equivelence Table

7. DISCUSSION OF NONCLINICAL TESTS:

Testing was performed for the Prismaflex System 8.10, in order to determine substantial equivalence with predicate devices included:

{10}------------------------------------------------

. Software and system verification and validation including functional, performance and safety requirements; see section 16 for a summary and referenced reports
Compliance has been demonstrated to the following international standards ;
IEC 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-1-6: Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
IEC 60601-1-8: Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance -- Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
IEC 60601-2-16: Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
IEC 62304: Medical device software - Software life cycle processes
IEC 62366: Medical devices -- Application of usability engineering to medical devices

8. BIOCOMPATIBILITY:

The Prismaflex Control Unit is not in direct contact with patient. Patient contact is via 510(k) cleared or PMA approved medical devices.

9. STERILITY AND SHELF LIFE:

The Prismaflex Control Unit is not sold as sterile and therefore this section is not applicable. This device does not claim an expiration date.

{11}------------------------------------------------

10. CONCLUSION:

The successful testing of the Prismaflex System 8.10 demonstrates safety and effectiveness when used for the defined indications for use and is substantially equivalent to the predicate devices.

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.”