Prismaflex System 8.10

K171671 · Baxter Healthcare Corporation · KDI · Feb 23, 2018 · Gastroenterology, Urology

Device Facts

• Record ID: K171671
• Device Name: Prismaflex System 8.10
• Applicant: Baxter Healthcare Corporation
• Product Code: KDI · Gastroenterology, Urology
• Decision Date: Feb 23, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5860
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

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 Story

Prismaflex System 8.10 is a software-controlled extracorporeal blood treatment device. It automatically loads/primes disposable sets; pumps blood, anticoagulant, infusion solutions, and dialysate; controls patient fluid removal/plasma loss; and monitors system status with alarms. Used in clinical settings by trained operators. Device provides treatment data to external Patient Data Management Systems (PDMS). Output allows clinicians to manage renal replacement or plasma exchange therapies, benefiting patients with acute renal failure or fluid overload by maintaining fluid/solute balance.

Clinical Evidence

Bench testing only. No clinical data provided. Evidence consists of software and system verification and validation, including functional, performance, and safety testing, and compliance with international standards for medical electrical equipment, software lifecycle, and usability.

Technological Characteristics

Software-controlled extracorporeal blood pump system. Dimensions: 163cm x 49cm x 70cm; Weight: ~78kg. Connectivity: Provides data to external PDMS. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 60601-2-16, IEC 62304, IEC 62366. Not patient-contacting (uses cleared disposables).

Indications for Use

Indicated for patients ≥20 kg with acute renal failure/fluid overload requiring Continuous Renal Replacement Therapy (CRRT) or diseases requiring Therapeutic Plasma Exchange (TPE). Must be prescribed by a physician.

Regulatory Classification

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).

Special Controls

*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.”

Predicate Devices

• Prismaflex System 7.10 (K131516)

Submission Summary (Full Text)

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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.

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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 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 ([e-mail]) or phone [phone] 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

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#### 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)

| <span style="font-family: DejaVu Sans, sans-serif">✓</span> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |
|----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
|----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|

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#### 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: [phone] Fax: [phone] 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 [phone] Fax: [phone] Email: fortunato [e-mail]

## 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

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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

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| 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

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| | Predicate<br>Prismaflex System 7.10<br>K131516 | Device<br>Prismaflex System 8.10 | Difference |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Devices | The Prismaflex control unit is<br>intended for: | The Prismaflex control unit is<br>intended for: | same |
| Indication for<br>Use | Continuous Renal Replacement<br>Therapy (CRRT) for patients<br>weighing 20 kilograms or more with<br>acute renal failure and/or fluid<br>overload.<br>Therapeutic Plasma Exchange<br>(TPE) therapy for patients weighing<br>20 kilograms or more with diseases<br>where removal of plasma<br>components is indicated.<br>All treatments administered via the<br>Prismaflex control unit must be<br>prescribed by a physician. | Continuous Renal Replacement<br>Therapy (CRRT) for patients<br>weighing 20 kilograms or more<br>with acute renal failure and/or fluid<br>overload.<br>Therapeutic Plasma Exchange<br>(TPE) therapy for patients<br>weighing 20 kilograms or more<br>with diseases where removal of<br>plasma components is indicated.<br>All treatments administered via the<br>Prismaflex control unit must be<br>prescribed by a physician. | same |
| | Dedicated<br>Disposable Sets<br>Available in<br>U.S. | For CRRT:<br>M60/M100/M150<br>HF1000 & HF1400<br><br>For TPE:<br>TPE 2000 Set | For CRRT:<br>M60/M100/M150<br>HF1000 & HF1400<br><br>For TPE:<br>TPE 2000 Set |
| Syringe | | 20, 30 & 50 ml | 20, 30 & 50 ml |
| Anticoagulation | User-controllable as continuous or<br>bolus | User-controllable as continuous or<br>bolus | same |
| Dialysate Flow<br>Rate | CVVH & CVVHDF:<br>Range: 0 to 8000 ml/hr<br>Increment: 50 ml/hr | CVVH & CVVHDF:<br>Range: 0 to 8000 ml/hr<br>Increment: 50 ml/hr | same |
| Dialysate Flow<br>Rate<br>Accuracy | ± 30 ml/hr | ± 30 ml/hr | same |
| Devices | Predicate<br>Prismaflex System 7.10<br>K131516 | Device<br>Prismaflex System 8.10 | Difference |
| Replacement<br>solution / Fluid<br>Flow Rate | CVVH & CVVHDF:<br>Range: 0 to 8000 ml/hr<br>Increment: 50 ml/hr<br><br>TPE:<br>Range: 0 to 5000 ml/hr<br>Increment: 10 ml/hr | CVVH & CVVHDF:<br>Range: 0 to 8000 ml/hr<br>Increment: 50 ml/hr<br><br>TPE:<br>Range: 0 to 5000 ml/hr<br>Increment: 10 ml/hr | same |
| Replacement<br>Flow Rate<br>Accuracy | ± 30 ml/hr | ± 30 ml/hr | same |
| Blood Flow<br>Rate | Range: 10-450 ml/min. | Range: 10-450 ml/min. | same |
| Blood Flow<br>Rate Accuracy | ±10% of user set rate at nominal<br>blood flow of 450 ml/min or the<br>highest achievable disposable bloodflow at 37° C at an access pressure<br>of -200 mmHg and without any PBP<br>flow. | ±10% of user set rate at nominal<br>blood flow of 450 ml/min or the<br>highest achievable disposable<br>blood flow at 37° C at an access<br>pressure of -200 mmHg and<br>without any PBP flow. | same |
| Pre-Blood<br>Pump Flow<br>Rate | CRRT Range<br>Range: 0 to 4000 ml/hr<br>TPE Range<br>Range: 0 to 1000 ml/hr<br><br>Note: Total PBP Volume is<br>2000 ml/treatment for TPE | CRRT Range<br>Range: 0 to 4000 ml/hr<br>TPE Range<br>Range: 0 to 1000 ml/hr<br><br>Note: Total PBP Volume is<br>2000 ml/treatment for TPE | same |
| Pre-Blood<br>Pump Accuracy | ± 30 ml/hr | ± 30 ml/hr | same |
| Effluent Pump<br>Flow Rate | 0 to 10000 ml/hr depending on the<br>therapy | 0 to 10000 ml/hr depending on the<br>therapy | same |
| ECG<br>Discharger | YES | YES | same |
| Devices | Predicate<br>Prismaflex System 7.10<br>K131516 | Device<br>Prismaflex 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 |
| Transmembrane<br>Pressure<br>TMP (CRRT)<br>TMPa (TPE) | TMP:<br>User settable: +70 to +350 mmHg<br>Default: +350 mmHg<br>TMPa:<br>User settable; +50 to +100 mmHg<br>Default: +100 mmHg | TMP:<br>User settable: +70 to +350 mmHg<br>Default: +350 mmHg<br>TMPa:<br>User settable; +50 to +100 mmHg<br>Default: +100 mmHg | same |
| | | | |
| | | | |
| Dialysate<br>Conductivity<br>and<br>Temperature | Dialysate Conductivity and<br>Temperature are not controlled by<br>Prismaflex | Dialysate Conductivity and<br>Temperature are not controlled by<br>Prismaflex | same |
| Patient Fluid<br>Removal<br>Performance<br>Range | 0 to 2000 ml/hr maximum for<br>CRRT<br>0 to 1000 ml/hr for TPE<br>Increment: 10 ml/hr | 0 to 2000 ml/hr maximum for<br>CRRT<br>0 to 1000 ml/hr for TPE<br>Increment: 10 ml/hr | same |
| | | | |
| | | | |
| Patient Fluid<br>Removal<br>Performance<br>Range<br>Accuracy | ± 30 ml/hr<br>± 70 ml/3hr<br>± 300 ml/24hr<br>Scales calibrated at ambient<br>temperature at which they will be<br>used. Ambient temperature change<br>less than ±3 °C<br>(5.4 °F) during treatment | ± 30 ml/hr<br>± 70 ml/3hr<br>± 300 ml/24hr<br>Scales calibrated at ambient<br>temperature at which they will be<br>used. Ambient temperature change<br>less than ±3 °C<br>(5.4 °F) during treatment | same |
| | | | |
| | | | |
| | | | |
| Devices | Predicate<br>Prismaflex System 7.10<br>K131516 | Device<br>Prismaflex System 8.10 | Difference |
| Access Pressure<br>and Accuracy | Range -250 to +450 mmHg<br>Accuracy ±15 mmHg | Range -250 to +450 mmHg<br>Accuracy ±15 mmHg | same |
| Return Pressure<br>and Accuracy | Range -50 to +350 mmHg Accuracy<br>±5 mmHg | Range -50 to +350 mmHg<br>Accuracy ±5 mmHg | same |
| Filter Pressure<br>Sensor | Range -50 to +450 mmHg<br>Accuracy ±10% of reading or ±8<br>mmHg | Range -50 to +450 mmHg<br>Accuracy ±10% of reading or ±8<br>mmHg | same |
| Effluent<br>Pressure Sensor | Range -350 to +400 mmHg (CRRT)<br>Range -350 to +350 mmHg (TPE)<br>Accuracy ±10% of reading or ±8<br>mmHg | Range -350 to +400 mmHg<br>(CRRT)<br>Range -350 to +350 mmHg (TPE)<br>Accuracy ±10% of reading or ±8<br>mmHg | same |
| TPE Settings: | Pre-treatment Hematocrit<br>Range: 10 to 60%<br>Increment: 1%<br>Default: 30% | Pre-treatment Hematocrit<br>Range: 10 to 60%<br>Increment: 1%<br>Default: 30% | same |
| TPE Settings | Total Replacement Volume<br>Range: 0 to 10,000 ml<br>Increment: 100 ml<br>Default: 3000 ml | Total Replacement Volume<br>Range: 0 to 10,000 ml<br>Increment: 100 ml<br>Default: 3000 ml | same |
| TPE Settings | Patient Plasma Loss Rate<br>Range: 0, or 10 to 1000 ml/hr<br>Increment: 10 ml/hr<br>Default: 0 ml/hr | Patient Plasma Loss Rate<br>Range: 0, or 10 to 1000 ml/hr<br>Increment: 10 ml/hr<br>Default: 0 ml/hr | same |
| TPE Settings | Replacement Container Volume<br>Range: 0 to 5000 ml<br>Increment: 10 ml | Replacement Container Volume<br>Range: 0 to 5000 ml<br>Increment: 10 ml | same |

## Table 2. Substantial Equivelence Table

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## Table 2. Substantial Equivelence Table

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## Table 2. Substantial Equivelence Table

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#### 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:

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- . 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.

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# 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.