The Prismaflex ST set is for use only in conjunction with the PrismaFlex control unit or with the PrisMax control unit (in countries where PrisMax is cleared or registered).

All treatments administered via the PrismaFlex ST sets must be prescribed by a physician. The size, weight, state of uremia, cardiac status, and general physical condition of the patient must be carefully evaluated by the prescribing physician before each treatment.

If patients suffer from acute kidney injury and / or volume overload, the Prismatlex ST set is indicated for continuous renal replacement therapies (CRRT), in modalities such as:

· Slow Continuous UltraFiltration (SCUF)
· Continuous Veno-Venous Hemofiltration (CVVH)
· Continuous Veno-Venous HemoDialysis (CVVHD)
Continuous Veno-Venous HemoDiaFiltration (CVVHDF)

to perform fluid management and reduction of uremic toxins.

The Prismaflex ST100 and ST150 set is indicated for use in patients with a body weight equal or greater than 30 kg (661b) and Prismaflex ST60 set is indicated to patients with a body weight greater than 11kg (24lb).

Device Description

The Prismaflex ST60/ST100/ST150 set is a disposable, extracorporeal circuit for use with the PrismaFlex system, or with the PrisMax system. The Prismaflex ST60/ST100/ST150 set consists of an AN69 ST hollow fiber haemofilter/dialyser and tubing system.

These Prismaflex disposable sets allow the following fluid management and renal replacement therapies to be performed :

SCUF: Slow Continuous Ultrafiltration
CVVH: Continuous Veno-Venous Hemofiltration
CVVHD: Continuous Veno-Venous Hemodialysis
CVVHDF: Continuous Veno-Venous Hemodiafiltration

The fluid pathways of the Prismaflex set are guaranteed sterile and pyrogen-free. The Prismaflex set is sterilized by ethylene oxide (EO).

The shelf life of the Prismaflex ST60/ST100/ST150 sets is 24 months from the date of sterilization. The device is intended for single use.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Prismaflex ST set" (ST60/ST100/ST150 sets), a high permeability hemodialysis system. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices. The document focuses on non-clinical testing to support this claim.

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance values like a clinical trial report would for specific endpoints (e.g., sensitivity, specificity for diagnostic devices, or specific measurable outcomes for therapeutic devices).

Instead, it states that the device was evaluated against established international standards and internal performance requirements. The "reported device performance" is described qualitatively as meeting these standards and requirements.

Here's a synthesized representation based on the information provided, inferring "acceptance criteria" from the standards and tests mentioned:

Acceptance Criteria Category	Reported Device Performance (as stated)
Structural Integrity	Successfully verified and validated. Complies with ISO 8637-1 (mechanical characteristics).
Membrane Integrity	Successfully verified and validated. Complies with ISO 8637-1 (mechanical characteristics).
Ultrafiltration Rate	Successfully verified and validated. Complies with ISO 8637-1 (performance characteristics - ultrafiltration coefficient).
Clearances	Successfully verified and validated. Complies with ISO 8637-1 (performance characteristics - solute clearances).
Sieving Coefficients	Successfully verified and validated. Complies with ISO 8637-1 (performance characteristics - sieving coefficients).
Blood Pressure Drop	Successfully verified and validated. Complies with ISO 8637-1 (volume and pressure drop of blood compartment).
Total Volume of Blood	Successfully verified and validated. Complies with ISO 8637-1 (volume and pressure drop of blood compartment).
Priming Efficacy	Successfully verified and validated.
Shelf Life	Successfully verified and validated. 24 months from sterilization date. Complies with ISO 8637-1 (expiry date) and ISO 8638 (expiry date).
Sterilization Validation	Successfully verified and validated. EO sterilization. Complies with ISO 8637-1 (sterility) and ISO 8638 (sterility).
Pyrogenicity / LAL	Successfully verified and validated. Complies with ISO 8637-1 (non-pyrogenicity) and ISO 8638 (non-pyrogenicity).
EO Residuals	Successfully verified and validated.
Biocompatibility	Successfully verified through a battery of tests (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Material Mediated Pyrogen, Subacute/Subchronic Toxicity, Hemolysis) in accordance with ISO 10993-1, -4, -5, -10, -11.
Design Validation	The Prismaflex ST set design validation meets user needs and intended use, and is substantially equivalent to the predicate.
Tubing Compliance	Complies with ISO 8638 (tubing compliance).
Risk Assessment	Risk analysis confirms the device is appropriately designed, performs as expected, and in a safe manner.

2. Sample Size Used for the Test Set and Data Provenance

The provided text describes non-clinical bench and pre-clinical testing. These are laboratory-based tests of the device's physical and chemical properties, as well as its interaction with biological models (e.g., blood, cell cultures).

Sample Size for Test Set: The document does not specify the exact number of units/sets tested for each performance characteristic. In bench testing for medical devices, this often involves a pre-defined number of samples per batch or according to a statistical sampling plan to ensure reliability and representativeness for the specific test (e.g., n=3, n=5, n=10 per test condition). However, these specific numbers are not disclosed in this summary.
Data Provenance: The data provenance is from non-clinical (bench and pre-clinical) laboratory testing. There is no mention of human subject data, retrospective, or prospective studies involving patients.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This question is not applicable to the type of study described. "Ground truth" established by experts (like radiologists for image analysis) is relevant for clinical studies, especially those involving human interpretation or diagnostic accuracy. The studies detailed here are non-clinical, focusing on the device's physical and chemical performance, where "ground truth" is typically defined by objective measurements against established engineering specifications and international standards, not expert consensus.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (e.g., 2+1, 3+1) refer to procedures for resolving disagreements among multiple human readers/experts in clinical studies, particularly in diagnostic accuracy assessments. As this is a non-clinical device performance study, such a method would not be used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. The document explicitly states that the safety and performance were evaluated through non-clinical testing. There is no mention of human readers, AI assistance, or comparative effectiveness studies involving human-in-the-loop performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This question is not applicable. The device described, the "Prismaflex ST set," is a medical device for blood purification (hemodialysis/hemofiltration), not an AI algorithm or a diagnostic tool that would typically have a "standalone" algorithmic performance. The "performance" here refers to its physical and functional operation.

7. Type of Ground Truth Used

The "ground truth" for these non-clinical tests is established by:

Objective Measurements: Directly measuring physical and chemical properties (e.g., ultrafiltration rate, clearances, pressure drop) using calibrated equipment.
International Standards: Compliance with recognized international standards (ISO 8637-1, ISO 8638, ISO 10993 series) which define acceptable ranges and methodologies.
Device Specifications: Meeting internal design specifications for the device.

There is no use of expert consensus, pathology, or outcomes data as "ground truth" in these non-clinical tests.

8. Sample Size for the Training Set

This question is not applicable. The Prismaflex ST set is a hardware medical device; its development and validation do not involve "training sets" in the context of machine learning or AI algorithms. The "training" that occurs is in the manufacturing and quality control processes to ensure consistency and adherence to specifications.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable, as there is no "training set" in the context of an AI/machine learning algorithm for this device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 1, 2022

Baxter Healthcare Corporation % Maud Humbert Senior Manager, Global Regulatory Affairs Gambro Industries 7 Avenue Lionel Terray, BP 126 Meyzieu. F-69883 FRANCE

Re: K212216

Trade/Device Name: Prismaflex ST set (ST60/ST100/ST150 sets) Regulation Number: 21 CFR 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: February 18, 2022 Received: March 3, 2022

Dear Maud Humbert:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Gema Gonzalez Acting Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K212216

Device Name Prismaflex ST set

Indications for Use (Describe)

The Prismaflex ST set is a single use device that provides blood purification through a semipermeable membrane.

The Prismaflex ST set is for use only in conjunction with the PrismaFlex control unit or with the PrisMax control unit (in countries where PrisMax is cleared or registered).

If patients suffer from acute kidney injury and / or volume overload, the Prismatlex ST set is indicated for continuous renal replacement therapies (CRRT), in modalities such as:

· Slow Continuous UltraFiltration (SCUF)
· Continuous Veno-Venous Hemofiltration (CVVH)
· Continuous Veno-Venous HemoDialysis (CVVHD)
Continuous Veno-Venous HemoDiaFiltration (CVVHDF)

to perform fluid management and reduction of uremic toxins.

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)

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510(k) Summary

OWNER:

Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015

CONTACT PERSON:

Fortunato Aldape Sr. Director, Global Regulatory Affairs One Baxter Parkway Deerfield, Illinois 60015

Telephone: T +1.224.948.4867 / M +1.224.358.8599

Date of Preparation: February 15, 2022

IDENTIFICATION OF THE DEVICE:

Common Name: High Permeability Hemodialyzer

Trade/Device Name: Prismaflex ST Set

Classification Panel: Gastroenterology/Urology

Regulation Number: 21 CFR 876.5860

Regulation Name: High Permeability Hemodialysis System

Regulatory Class: Class II

Product Code: KDI

Table 1. Code Numbers for Prismaflex ST set

Code Number	Name
107643US	Prismaflex ST60 set
107636US	Prismaflex ST100 set
107640US	Prismaflex ST150 set

PREDICATE DEVICE:

Table 2. Predicate Device(s)

Device	Company	Predicate 510(k)	Clearance Date
K041005	Gambro Industries, France	Prismaflex M60 and M100 sets	10/18/2004

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Baxter

Device	Company	Predicate 510(k)	Clearance Date
K080519	Gambro Industries, France	Prismaflex M150 set	06/13/2008
K190910	Gambro Industries, France	Prismaflex M60, M100 and M150sets (intended for use with Prismaxsystem)	07/25/2019

Table 2. Predicate Device(s)

DESCRIPTION OF THE DEVICE:

These Prismaflex disposable sets allow the following fluid management and renal replacement therapies to be performed :

SCUF: Slow Continuous Ultrafiltration
CVVH: Continuous Veno-Venous Hemofiltration
CVVHD: Continuous Veno-Venous Hemodialysis
CVVHDF: Continuous Veno-Venous Hemodiafiltration

The fluid pathways of the Prismaflex set are guaranteed sterile and pyrogen-free. The Prismaflex set is sterilized by ethylene oxide (EO).

The shelf life of the Prismaflex ST60/ST100/ST150 sets is 24 months from the date of sterilization. The device is intended for single use.

INDICATIONS FOR USE:

The Prismaflex ST set is a single use device that provides blood purification through a semipermeable membrane.

The Prismaflex ST set is for use only in conjunction with the PrismaFlex control unit or with the PrisMax control unit (in countries where PrisMax is cleared or registered).

All treatments administered via the PrismaFlex ST sets must be prescribed by a physician. The size, weight, state of uremia, cardiac status, and general physical

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condition of the patient must be carefully evaluated by the prescribing physician before each treatment.

If patients suffer from acute kidney injury and / or volume overload, the Prismaflex ST set is indicated for continuous renal replacement therapies (CRRT), in modalities such as:

Slow Continuous UltraFiltration (SCUF)
Continuous Veno-Venous Hemofiltration (CVVH)
Continuous Veno-Venous HemoDialysis (CVVHD)
. Continuous Veno-Venous HemoDiaFiltration (CVVHDF) to perform fluid management and reduction of uremic toxins.

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:

The Prismaflex ST set has the same intended use and the same technological characteristics compared to its predicate, the Prismaflex M set, in term of design, material, chemical composition, function and operation.

The safety and performance of Prismaflex ST set was evaluated through non-clinical testing. The bench and pre-clinical testing assessed the following aspects of the device:

Structural integrity
Membrane integrity
Ultrafiltration rate
Clearances
Sieving coefficients
Blood pressure drop
Total volume of blood in the set
Priming efficacy
Shelf life
Sterilization validation

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. Pvrogenicitv / LAL
. EO residuals
. Biocompatibility

DISCUSSION OF NONCLINICAL TESTS:

Performance Data:

Performance testing was conducted on the Prismaflex ST set to evaluate the functional performance of the device. In summary, the Prismaflex ST set has successfully implemented performance requirements and subsequent outputs verifying and validating:

. The Prismaflex ST set design validation meets the user needs and intended use and is substantially equivalent to the predicate.
. The device complies with the standard ISO 8637-1 First edition 2017-11, Extracorporeal systems for blood purification - Part 1:Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators. The testing specifically confirms the device meets the requirements for the mechanical characteristics (structural and blood compartment integrity), and the performance characteristics (solute clearances, sieving coefficients, ultrafiltration coefficient, volume and pressure drop of blood compartment, expiry date) according to this particular standard. The standard also includes requirements for biological safety, sterility and non pyrogenicity.
. The device also complies with the standard ISO 8638 Third edition 2010-07-01, Cadiovascular implants and extracorporeal blood circuit for hemodialyzers hemodialfilters and hemofilters. The standard includes requirements for biological safety, sterility, non pyrogenicity, mechanical characteristics, expiry date and tubing compliance.
. The labeling has been successfully implemented and meets the requirements of the above-mentioned standards.
. Risk Assessment and control measures: The risk analysis confirms the device is approprietly designed and performs as expected and in a safe manner.

Biocompatibility:

The biocompatibility evaluation for this device was conducted in accordance with ISO-10993-1 Fifth edition 2018-08, "Biological evaluation of medical devices Part 1:

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Evaluation and testing within a risk management process," as recognized by FDA and FDA guidance document Use of International Standard ISO-10993-1, "Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process". The battery of testing included the following tests:

. Cytotoxicity (per ISO 10993-5)
Sensitization (per ISO 10993-10)
Intracutaneous (Irritation) Reactivity (per ISO 10993-10) .
Acute Systemic Toxicity (per ISO 10993-11) ●
Material Mediated Pyrogen (per ISO 10993-11)
Subacute/Subchronic Toxicity (per ISO 10993-11)
Hemolysis (per ISO 10993-4)

CONCLUSION:

The summary includes the conclusions drawn from the nonclinical tests (discussed above) that demonstrate that the Prismaflex ST set is as safe, as effective, and performs as well as the predicate device.

The non-clinical data demonstrate that the subject device is substantially equivalent and performs comparably to the predicate device that is currently marketed for the same intended use.

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.”