Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, or any related technologies in the device description, intended use, or performance studies. The focus is on the functional performance and safety of the CRRT system.

Therapeutic

Yes
The device is intended for Continuous Renal Replacement Therapy (CRRT) for patients with acute renal failure and/or fluid overload, which directly falls under the definition of a therapeutic intervention.

Diagnostic

No

The device is intended for Continuous Renal Replacement Therapy (CRRT), which is a treatment modality, not a diagnostic one. It treats conditions like acute renal failure and fluid overload by filtering blood, it does not diagnose these conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the PrisMax System consists of a "PrisMax Control Unit and accessories for removing effluent," indicating the presence of hardware components beyond just software. The performance studies also mention testing related to electrical safety and electromagnetic compatibility, which are typically associated with hardware devices.

IVD (In Vitro Diagnostic)

Based on the provided information, the PrisMax control unit is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for Continuous Renal Replacement Therapy (CRRT) for patients with acute renal failure and/or fluid overload. This is a therapeutic treatment performed directly on the patient's blood, not a diagnostic test performed on a sample outside the body.
Device Description: The device description details a system for performing CRRT, which involves filtering and processing blood. This is a treatment process, not a diagnostic process.
Lack of Diagnostic Elements: There is no mention of analyzing biological samples (like blood, urine, etc.) to provide diagnostic information about a patient's condition. The device's function is to perform a therapeutic procedure.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The PrisMax system's purpose is to treat a condition, not to diagnose it.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

KDI

Device Description

The PrisMax System is intended for Continuous Renal Replacement Therapy (CRRT) for patients with acute renal failure and/or fluid overload. Reference the PrisMax control unit in Figure 1.

The goals of acute renal failure treatments are removal of waste products, restoration of acid-base balance; correction of electrolyte imbalances (e.g., hyperkalemia), patient fluid balance, nutritional support, and other conditions in which fluid removal is needed. 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 Hemodiafiltration (CVVHDF).

The proposed device PrisMax, which is the subject of this Traditional 510(k) premarket notification, consists of PrisMax Control Unit. Also included are accessories for removing effluent.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

patients weighing 20 kilograms or more

Intended User / Care Setting

physician / Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

In summary, the PrisMax Control Unit has successfully implemented performance requirements and subsequent outputs verifying and validating:

. The PrisMax design validation meets the user needs and intended use and is substantially equivalent to the predicate.
. The device complies with IEC60601-2-16 Hemodialysis Equipment. Testing was confirmed by CSA, the recognized test laboratory as part of the testing to 60601-1 Edition3.1. The testing specifically confirms the device meets the requirements for Essential Performance according to the particular standard.
. Electrical safety testing according to the most recent IEC60601-1 Edition 3.1 standard. The standard includes reports for software, alarms, usability, safety and performance.
Electromagnetic compatibility (EMC) testing.
Risk Assessment and risk control measures. A therapy level, product level and process level hazard analysis confirms the device doesn't perform in an unexpected or unsafe manor.
Labeling, Software including cybersecurity, Human Factors, have been successfully implemented.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K131516

Reference Device(s)

K110823

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.”

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with three heads, all facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 3, 2017

Baxter Healthcare Corporation Chris Scavotto Senior Manager Regulatory Affairs 32650 N. Wilson Road Round Lake, IL 60073

K163530 Re:

Trade/Device Name: PrisMax Regulation Number: 21 CFR§ 876.5860 Regulation Name: High Permeability Hemodialysis System Regulatory Class: II Product Code: KDI Dated: March 31, 2017 Received: April 4, 2017

Dear Chris Scavotto:

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.

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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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Joyce M. Whang -S

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

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Indications for Use

510(k) Number (if known)

K163530

Device Name PrisMax

Indications for Use (Describe)

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.

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

|X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Section 5. 510(k) Summary

December 15th, 2016

OWNER:

Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015

CONTACT PERSON:

Chris Scavotto Senior Regulatory Manager, Global Regulatory Affairs 32650 N Wilson Road Round Lake, IL 60073 Telephone: 763-463-4621 Fax: 763-463-4606

IDENTIFICATION OF THE DEVICE:

Common Name: Hemodialysis Delivery System Trade Name or Proprietary Name: PrisMax Classification Panel: 78 Gastroenterology and Urology Classification: High Permeability Hemodialysis System (876.5860) Class: Class II Product Code: 78KDI

Table 1. Product Code(s) for PrisMax System
---------------------------------------------	--	--	--

Code Number	Name
115369	PrisMax control unit
115370	PrisMax Accessory, Auto Effluent
115485	PrisMax Accessory, Auto Effluent Extension

PREDICATE DEVICE:

Table 2. Predicate Device(s)

Device	Company	Predicate 510(k)	Clearance Date
Prismaflex	Gambro Lundia AB	K131516	1/3/2014

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DESCRIPTION OF THE DEVICE:

The PrisMax System is intended for Continuous Renal Replacement Therapy (CRRT) for patients with acute renal failure and/or fluid overload. Reference the PrisMax control unit in Figure 1.

The goals of acute renal failure treatments are removal of waste products, restoration of acid-base balance; correction of electrolyte imbalances (e.g., hyperkalemia), patient fluid balance, nutritional support, and other conditions in which fluid removal is needed. 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).

Image /page/4/Picture/5 description: The image shows a dialysis machine with a screen on top. The screen displays various parameters and readings related to the dialysis process. The machine has several tubes, pumps, and filters that are essential for the dialysis procedure. There are also bags hanging from the machine, which likely contain fluids used during the treatment.

Figure 1. PrisMax control unit

The proposed device PrisMax, which is the subject of this Traditional 510(k) premarket notification, consists of PrisMax Control Unit. Also included are accessories for removing effluent. The proposed device PrisMax uses the current marketed device

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Prismaflex as the predicate. The Prismaflex was previously cleared under 510(k) premarket notification K131516 (cleared on January 3rd, 2014).

INDICATIONS FOR USE:

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.

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:

The differences between the predicate Prismaflex 7.10 and the proposed device PrisMax as reflected in the Substantial Equivalence (SE) Table are considered substantially equivalent. Changes included in the SE table are marked and discussed in Table 3.

Identification of Predicate Device:

Trade Name: Prismaflex, 7.10
Manufacturer: Gambro Lundia AB, Sweden
Common Name: Hemodialysis Delivery System.
Clearance: K0131516 cleared in January 2014.

Identification of Proposed Device:

Trade Name: PrisMax, 1.0.6.0.
Manufacturer: Gambro UF Solutions, Minneapolis Minnesota
Common Name: Hemodialysis Delivery System.
Clearance: Pending.

PrisMax will not utilize the TPE2000 Blood Tubing Set. It will utilize the CRRT Blood Tubing sets referenced in the Substantial Equivalence Table (M60/M100/M150 + HF1000/HF1400) all which have been previously cleared. The predicate device Prismaflex was cleared in 2011 to include TPE2000 Blood Sets. The PrisMax is not

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requesting clearance for TPE Blood Sets. References to TPE have been removed from Table 3.

| Features | SE | Proposed
PrisMax 1.0.6.0 | Predicate
Prismaflex 7.10, K131516 |
|-----------------------------------------------------|----|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | SE | 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. | 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.

Table 3. Substantial Equivalence Table Device Comparison

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		Proposed	Predicate
Features	SE	PrisMax 1.0.6.0	Prismaflex 7.10, K131516
Patient Fluid
Removal
Performance
(Accuracy)	SE	± 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.	± 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.
Access Pressure
Sensor	SE	Range:
-250 to +450 mmHg
Accuracy:
±15 mmHg	Range:
-250 to +450 mmHg
Accuracy:
±15 mmHg
Return Pressure
Sensor	SE	Range:
-50 to +350 mmHg
Accuracy:
±5 mmHg	Range:
-50 to +350 mmHg
Accuracy:
±5 mmHg
Filter Pressure
Sensor	SE	Range:
-50 to +450 mmHg
Accuracy:
±15 mmHg	Range:
-50 to +450 mmHg
Accuracy:
±15 mmHg
Effluent Pressure
Sensor	SE	Range:
-350 to +400 mmHg (CRRT)
Accuracy:
±15 mmHg	Range:
-350 to +400 mmHg (CRRT)
Accuracy:
±15 mmHg
Control Unit
Software G	SE	Version 1.0.6.0	Version 7.10

Table 3: Foot notes:

A. Syringe Sizes: 20, 30 & 50 ml. Removed 30 ml.

. The 30ml syringe is removed due to infrequent use in the market. The device behavior in conjunction with the specified syringes remains strictly unchanged.
. The updated specification does not affect safety or effectiveness of the device.

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B. Dialysate Flow Rate: CVVH & CVVHDF: Range: 0 to 8000 ml/hr, Increment: 10 ml/hr. Updated the increment from 50ml/hr to 10ml/hr.

. The setting range was increased from 50 to 10ml/hr. This allows the practitioner to select a more precise setting and reduces limitation existing with a 50ml/hr increment.
The updated specification does not introduce new or increased risks to the system and does not introduce new questions of safety and effectiveness. Compliance of the PrisMax System to the updated specifications has been verified successfully. Successful validation has substantiated that the system does not raise new questions of safety and effectiveness.

C. Replacement solution / Fluid Flow Rate: CVVH & CVVHDF: Range: 0 to 8000 ml/hr, Increment: 10 ml/hr. Updated the increment from 50ml/hr to 10ml/hr.

. The range was increased from 50 to 10ml/hr. This allows the practitioner to select a more precise setting and reduces limitation existing with a 50ml/hr increment.
The updated specification does not introduce new or increased risks to the system and does not introduce new questions of safety and effectiveness. Compliance of the PrisMax System to the updated specifications has been verified successfully. Successful validation has substantiated that the system does not raise new questions of safety and effectiveness.

D. Pre-Blood Pump Flow Rate: SCUF: Range: 0 to 2000 ml/hr. Align with Predicate device Prismaflex from clearances K110823 and K131516.

. The Prismaflex SE table incorrectly states a range of 0 to 1000 ml/hr vs. the actual of 0 to 2000 ml/hr. As per Prismaflex requirement sss 1283, the predicate device has operated at the Range: 0 to 2000 ml/hr since the original clearance in 2005. The PrisMax is equivalent in practice and requirements. The Prismaflex SE table will be updated on the next submission.
The updated specification does not introduce new or increased risks to the system and does not introduce new questions of safety and effectiveness. Compliance of the PrisMax System to the updated specifications has been verified successfully. Successful validation has substantiated that the system does not raise new questions of safety and effectiveness.

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E. Trans Membrane Pressure Alarms TMP (CRRT): User settable: +70 to +350 mmHg, default +350 mmHg. Implemented fixed default of +300 mmHg.

. User Settable TMP was removed due to infrequent use in the predicate device and to reduce risk of use-error handling during set up.
Increase usability by removing steps during set up.
Implement lowered default to reduce risk.

The updated specification does not introduce new or increased risks to the system and does not introduce new questions of safety and effectiveness. Compliance of the PrisMax System to the updated specifications has been verified successfully. Successful validation has substantiated that the system does not raise new questions of safety and effectiveness.

F. Patient Fluid Removal Performance (Range): 0 to 2000 ml/hr Increment: 5 ml/hr.

Updated the increment from 10ml/hr to 5ml/hr.

. Increase setting range by improving increment range of setting from 10 to 5ml/hr. This allows the practitioner to select a more precise setting and reduces limitation existing with a 10ml/hr increment.
The updated specification does not introduce new or increased risks to the system and does not introduce new questions of safety and effectiveness. Compliance of PrisMax System to the updated specifications has been verified successfully. Successful validation has substantiated that the system does not raise new questions of safety and effectiveness.

G. Control Unit Software: Software version 1.0.6.0 or Rev. A, from Prismaflex 7.10.

The device software on the PrisMax has been implemented correctly. The software has been verified and validated subsequent to risk analysis. The verification and validation tests including Human Factors and Software Validation. The software does not raise questions of safety and effectiveness. PrisMax is considered substantially equivalent to the predicate device Prismaflex.

Substantial Equivalence Summary

The differences between the PrisMax System and its predicate device do not introduce new questions of safety and effectiveness. All modifications have been verified and

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validated per Design Controls Activities. As shown through successful verification and validation testing, the PrisMax Control Unit is considered substantially equivalent to its predicate.

DISCUSSION OF NONCLINICAL TESTS:

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.

In summary, the PrisMax Control Unit has successfully implemented performance requirements and subsequent outputs verifying and validating:

. The PrisMax design validation meets the user needs and intended use and is substantially equivalent to the predicate.
. The device complies with IEC60601-2-16 Hemodialysis Equipment. Testing was confirmed by CSA, the recognized test laboratory as part of the testing to 60601-1 Edition3.1. The testing specifically confirms the device meets the requirements for Essential Performance according to the particular standard.
. Electrical safety testing according to the most recent IEC60601-1 Edition 3.1 standard. The standard includes reports for software, alarms, usability, safety and performance.
Electromagnetic compatibility (EMC) testing.
Risk Assessment and risk control measures. A therapy level, product level and process level hazard analysis confirms the device doesn't perform in an unexpected or unsafe manor.
Labeling, Software including cybersecurity, Human Factors, have been successfully implemented.

SUBSTANTIAL EQUIVALENCE DECISION

Based on the the information provided in this premarket notification, Baxter Healthcare Corporation believes the proposed PrisMax is substantially equivalent, for purposes of section 510(k) of the Federal Food, Drug and Cosmetic Act only, to the predicate device identified in this premarket notification.