PRISMAFLEX SYSTEM, VERSION 3.20

K072093 · Gambro · KDI · Feb 1, 2008 · Gastroenterology, Urology

Device Facts

• Record ID: K072093
• Device Name: PRISMAFLEX SYSTEM, VERSION 3.20
• Applicant: Gambro
• Product Code: KDI · Gastroenterology, Urology
• Decision Date: Feb 1, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5860
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Prismaflex® System is intended for Continuous Renal Replacement Therapy (CRRT) for patients with acute renal failure and/or fluid overload weighing 20 Kilograms or more. All treatments administered via the Prismaflex® must be prescribed via a physician.

Device Story

Prismaflex System 3.20 is a hemodialysis delivery system for CRRT; provides SCUF, CVVH, CVVHD, and CVVHDF therapies. Device manages blood flow, fluid removal, and solute clearance in patients with acute renal failure or fluid overload. System utilizes dedicated disposable sets (M60/M100, HF1000/HF1400) and integrated pumps/scales to control blood, dialysate, replacement, and effluent flows. Operated by clinicians in clinical settings; physician prescription required. System monitors pressures (access, return, transmembrane) and fluid balance; provides automated control of therapy parameters. Output includes real-time monitoring of patient fluid status and therapy progress, enabling clinicians to adjust treatment to restore acid-base balance, correct electrolyte imbalances, and manage fluid removal. Benefits include continuous, controlled renal replacement therapy for critically ill patients.

Clinical Evidence

Bench testing only. Evidence includes component-level hardware testing, software verification (unit testing, code inspections, regression testing), and human factors evaluations. Testing confirmed performance specifications for flow rates, pressure monitoring, and fluid removal accuracy.

Technological Characteristics

Hemodialysis delivery system; includes peristaltic pumps, load-cell based scales, and pressure sensors. Supports SCUF, CVVH, CVVHD, CVVHDF. Connectivity includes ECG discharger. Software-controlled operation with user-settable parameters for flow rates (0-8000 ml/hr) and pressures. Sterilization of disposables not specified. System is a Class II device under 21 CFR 876.5860.

Indications for Use

Indicated for patients weighing 20 kg or more with acute renal failure and/or fluid overload requiring Continuous Renal Replacement Therapy (CRRT).

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

• PrismaflexTM System 1.04 (K072093)

Submission Summary (Full Text)

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K072093
Page 1 of 5

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## 5.0 510(K) SUMMARY

| Submitter's Name | Gambro |
|------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address | 14143 Denver West Parkway<br>Lakewood, Colorado 80401 |
| Establishment<br>Registration Number | 2087532 |
| Date of Summary | July 27th, 2007 |
| Telephone Number<br>Fax Number | [phone]<br>[phone] |
| Contact Person | Thomas B. Dowell, Regulatory Affairs Project Manager |
| Name of the Device | Prismaflex® System 3.20<br>Catalogue Number: 107493 |
| Common or Usual Name | Hemodialysis Delivery System |
| Classification Name | Classification Name: High Permeability Hemodialysis System<br>Device Class: II<br>Product Code: 78KDI<br>Regulation Number: 876.5860 |
| Indications for Use | The Prismaflex® System is intended for Continuous Renal<br>Replacement Therapy (CRRT) for patients with acute renal failure<br>and/or fluid overload weighing 20 Kilograms or more. All<br>treatments administered via the Prismaflex® must be prescribed via a<br>physician. |
| Identification of the<br>Legally Marketed Device<br>(Predicate Device) | PrismaflexTM System 1.04<br>Catalogue Number: 6023014700<br>Classification Name: High Permeability Hemodialysis System<br>Device Class: II<br>Product Code: 78KDI<br>Regulation Number: 876.5860 |

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KC73093
Page 2 of 5

Traditional 510(k) Prismaflex® System 3.20

#### 510(k) SUMMARY, continued

The Prismaflex® System is intended for Continuous Renal Replacement Device Description Therapy (CRRT) for patients with acute renal failure and/or fluid overload weighing 20 Kilograms or more. All treatments administered via the Prismaflex® must be prescribed via a physician. 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. Prismaflex® System offers four Continuous Renal Replacement Therapy (CRRT) options: Slow Continuous Ultrafiltration (SCUF), Continuous Veno-Venous Hemofiltration (CVVH), Continuous Veno-Venous Hemodialysis (CVVHD), and Continuous Veno-venous Hemodialfiltration (CVVHDF).

### Device Comparison Table

| | PREDICATE | MODIFIED DEVICE |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | PrismaflexTM System 1.04 | Prismaflex® System 3.20 |
| Indication for Use | The PrismaflexTM is indicated for<br>continuous solute and/or fluid<br>removal in patients with acute renal<br>failure or fluid overload. All<br>treatments administered by the<br>PrismaflexTM must be prescribed by a<br>physician. | The Prismaflex® System is intended<br>for Continuous Renal Replacement<br>Therapy (CRRT) for patients with<br>acute renal failure and/or fluid<br>overload weighing 20 Kilograms or<br>more. All treatments administered via<br>the Prismaflex® must be prescribed<br>via a physician. |
| Dedicated<br>Disposable Sets<br>Available in U.S. | M60/M100<br>HF1000 & HF1400 | M60/M100<br>HF1000 & HF1400 |
| Syringe | 10, 20 & 30 ml | 10, 20, 30 & 50 ml |
| Anticoagulation | User-controllable as continuous or<br>bolus | User-controllable as continuous or<br>bolus |
| Dialysate Flow Rate | CVVHD: 0 to 8000 ml/hr<br>CVVHDF: 0 to 4000 ml/hr<br>Increment: 50 ml/hr | CVVHD & CVVHDF<br>0 to 8000 ml/hr<br>Increment: 50 ml/hr |
| Dialysate Flow Rate<br>Accuracy | ±10% of user-set rate | ± 30 ml/hr |
| Replacement Flow<br>Rate | CVVH: 0 to 8000 ml/hr<br>CVVHDF: 0 to 4000 ml/hr<br>Increment: 50 ml/hr increment | CVVH & CVVHDF:<br>0 to 8000 ml/hr<br>Increment: 50 ml/hr |
| Replacement Flow<br>Rate Accuracy | ±10% of user-set rate | + 30 ml/hr |

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KC7222
Page 3 of 5

| | PREDICATE | MODIFIED DEVICE |
|--------------------|---------------------------------------|---------------------------------------|
| | Prismaflex System 1.04 | Prismaflex® System 3.20 |
| Blood Flow Rate | 10-450 ml/min. | 10-450 ml/min. |
| | Flow rate depends on the Prismaflex | Flow rate depends on the Prismaflex |
| | therapy/set combination selected by | therapy/set combination selected by |
| | operator | operator |
| | ±10% of user set point | ±10% of user set point |
| | Accuracy of blood flow is maintained | Accuracy of blood flow is maintained |
| Blood Flow Rate | if the inlet pressure is higher (less | if the inlet pressure is higher (less |
| Accuracy | negative) than -250 mmHg and the | negative) than -250 mmHg and the |
| | outlet pressure is lower than +350 | outlet pressure is lower than +350 |
| | mmHg | mmHg |
| Pre-Blood Pump | SCUF: 0 to 1,000 ml/hr | SCUF: 0 to 1,000 ml/hr |
| Flow Rate | CVVH, CVVHD, CVVHDF: | CVVH, CVVHD, CVVHDF: |
| | 0 to 8,000 ml/hr | 0 to 8,000 ml/hr |
| Pre-Blood Pump | ±10% of user-set rate | + 30 ml/hr |
| Accuracy | | |
| Effluent Pump Flow | 0 to 10,000 ml/hr depending on the | 0 to 10,000 ml/hr depending on the |
| Rate | therapy | therapy |
| ECG Discharger | YES | YES |
| | | |
| | SCUF | SCUF |
| Therapies | CVVH | CVVH |
| | CVVHD | CVVHD |
| | CVVHDF | CVVHDF |
| | Blood access line | Blood access line |
| Pumps | Dialysate inlet line | Dialysate inlet line |
| | Effluent outlet line | Effluent outlet line |
| | Replacement solution line | Replacement solution line |
| | Pre blood pump line | Pre blood pump line |
| Scales | Dialysate | Dialysate |
| | Replacement | Replacement |
| | Effluent | Effluent |
| | Pre blood pump | Pre blood pump |

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K073093
Page 4 of 5

Traditional 510(k)
Prismaflex® System 3.20

| | PREDICATE | MODIFIED DEVICE |
|-----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | PrismaflexTM System 1.04 | Prismaflex® System 3.20 |
| Transmembrane<br>Pressure | User settable:<br>+70 to +300 mmHg<br>Default: +300 mmHg | User settable:<br>+70 to +300 mmHg<br>Default: +300 mmHg |
| Dialysate<br>Conductivity 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 |
| Patient Fluid<br>Removal<br>Performance Range | 0 to 2,000 ml/hr<br>Increment: 10 ml/hr | 0 to 2,000 ml/hr<br>Increment: 10 ml/hr |
| Patient Fluid<br>Removal<br>Performance Range<br>Accuracy | ± 30 ml/hr<br>± 600 ml/24hr<br>Scales calibrated at ambient<br>temperature at which they will be<br>used. Ambient temperature change<br>less than ± 3° C (5.4 °F) during<br>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 (5.4 °F) during<br>treatment. |
| Access Pressure and<br>Return Pressure | Access Pressure:<br>-250 to +300 mmHg<br>Return Pressure:<br>-50 to +350 mmHg | Access Pressure:<br>-250 to +300 mmHg<br>Return Pressure:<br>-50 to +350 mmHg |
| Access Pressure and<br>Return Pressure<br>Accuracy | ±10% of reading or ± 8mmHg<br>(whichever is greater) | ±10% of reading or ± 8mmHg<br>(whichever is greater) |

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KC7 2023
Page 5 of 5

Traditional 510(k) Prismaflex® System 3.20

### 510(k) SUMMARY, continued

| Description and | Conclusion of | Non-clinical Testing: |
|-----------------|---------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Testing | | The non-clinical testing performed for the Prismaflex® System 3.20 includes component level hardware testing, testing required to support the declarations of conformity to standards contained in this 510(k) submission, testing required by process to ensure compliance with other international standards applicable to hemodialysis machines as well the static and dynamic software testing, e.g. unit testing, code inspections, testing targeted to the changes implemented in software version 3.20, regression testing, human factors evaluations and testing that was performed by internal and external independent personnel with the appropriate skills. |

The successful non-clinical testing demonstrates the safety and
effectiveness of the Prismaflex® System when used for the defined indications for use and demonstrates that the device for which the 510(k) is submitted performs as well as or better than the legally marketed predicate device.

:

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.

FEB - 1 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Thomas B. Dowell Regulatory Affairs Project Manager GAMBRO 14143 Denver West Parkway LAKEWOOD CO 80401

K072093 Re:

> Trade/Device Name: Prismaflex® System 3.20 Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: December 21, 2007 Received: December 26, 2007

Dear Mr. Dowell:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce 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.

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

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

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Nancy C. Brogdon

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

Enclosure

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Traditional 510(k) Prismaflex® System 3.20

Indications for Use

510(k) Number (if known): K072093

Device Name: Prismaflex® System 3.20

Indications for Use:

The Prismaflex® System is intended for Continuous Renal Replacement Therapy (CRRT) for patients with acute renal failure and/or fluid overload weighing 20 Kilograms or more. All treatments administered via the Prismaflex® must be prescribed via a physician.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hely Reimer

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number ***_***__K912095

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