PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUIUS RENAL REPLACEMENT THERAPY

K120333 · Gambro Renal Products · KPO · May 25, 2012 · Gastroenterology, Urology

Device Facts

• Record ID: K120333
• Device Name: PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUIUS RENAL REPLACEMENT THERAPY
• Applicant: Gambro Renal Products
• Product Code: KPO · Gastroenterology, Urology
• Decision Date: May 25, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Gambro PrismaSATE solutions are indicated for use as a dialysate in Continuous Renal Replacement Therapy. CRRT is used for the treatment of acute renal failure and in other cases necessitating fluid or solute removal, such as in the case of drug poisoning with dialyzable or filterable substances. The solutions are perfused through the dialysis fluid compartment of hemofilters/dialyzers. The dialysate is separated from the patient's blood by means of a semi-permeable membrane. Excess waste products, fluids and toxins found in the blood of a patient with acute renal failure pass through the membrane into the dialysate and eventually go to waste. The therapy is aimed at normalizing the blood.

Device Story

PrismaSATE is a sterile, liquid dialysate solution packaged in flexible bags; used in commercially available CRRT machines. A physician prescribes the specific chemical composition. During therapy, the solution is perfused through the dialysis fluid compartment of a hemofilter/dialyzer. The solution acts as a medium to remove excess waste products, fluids, and toxins from the patient's blood via a semi-permeable membrane. The device is used in clinical settings to normalize blood chemistry in patients with acute renal failure or poisoning. It provides a standardized, sterile fluid for solute exchange, facilitating the removal of dialyzable or filterable substances.

Clinical Evidence

No clinical data. Bench testing only, including stability studies for expiration dating and physico-chemical/biological evaluation of packaging materials.

Technological Characteristics

Sterile, liquid dialysate solution. Terminally sterilized via steam per ANSI/AAMI/ISO 17665-1 and ANSI/AAMI/ISO 11138-3. Packaged in flexible bags. Biocompatibility testing performed per internal procedures for medical device/drug container qualification.

Indications for Use

Indicated for use as a dialysate in Continuous Renal Replacement Therapy (CRRT) for patients with acute renal failure or conditions requiring fluid/solute removal, including drug poisoning.

Regulatory Classification

Identification

A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient. (2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860). (3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860). (4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.

Predicate Devices

• PrismaSATE Dialysis Solutions for Continuous Renal Replacement Therapy (CRRT) (K013448)
• PrismaSATE Dialysis Solutions for Continuous Renal Replacement Therapy (CRRT) (K072908)
• B. Braun Modified Bicarbonate Dialysate (K052393)

Submission Summary (Full Text)

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K120333
page 1 of 2

MAY 2 5 2012

## 510(k) SUMMARY

Submitted by: Gambro Renal Products Inc. 1845 Mason Avenue Daytona Beach, FL 32117

> Phone: [phone]

> > [phone] Fax:

Contact: Fei Law

Date Prepared: 05/21/2012

Trade Name: PrismaSATE

> Dialysis Solutions for Continuous Renal Replacement Therapy (CRRT) Common Name: Ready to Use Sterile Dialysate

Classification Dialysate Concentrate for Hemodialysis (Liquid or Powder) per Name: 21 CFR 876.5820. The Product/Classification Code is KPO.

PrismaSATE Dialysis Solutions for Continuous Renal Replacement Therapy (CRRT) Equivalent Predicate: Gambro Renal Products, K013448

> PrismaSATE Dialysis Solutions for Continuous Renal Replacement Therapy (CRRT) Gambro Renal Products, K072908

B. Braun Modified Bicarbonate Dialysate B. Braun, K052393

Device Description:

Gambro PrismaSATE solutions are sterile dialysate solutions for use in Continuous Renal Replacement Therapy (CRRT) for the treatment of acute renal failure and in other cases necessitating fluid or solute removal, such as in the case of drug poisoning with dialyzable or filterable substances. The solutions are intended to be used in commercially available continuous renal replacement therapy machines as dialysate. A physician prescribes the chemical composition of the solution to be used. The solutions are sterile, and packaged in flexible bags.

Testing, and Recognized Standards:

Expiration Dating: Stability studies for expiration dating are performed for Gambro PrismaSATE at controlled conditions, per an approved protocol and results have been provided.

Sterilization: Gambro PrismaSATE solutions are terminally sterilized using steam. The validation methods used follow ANSI/AAMI/ISO 17665-1 and ANSI/AAMI/ISO 11138-3.

Blocompatibility: The primary packaging material for PrismaSATE solution was tested per Gambro's procedure for physico-chemical and biological evaluation and qualification of materials for medical devices and drug containers. Tests performed included selected physico-chemical tests and biological tests, and have been provided.

Intended Use:

Gambro PrismaSATE solutions are indicated for use as a dialysate in Continuous Renal Replacement Therapy.

CRRT is used for the treatment of acute renal failure and in other cases necessitating fluid or solute removal, such as in the case of drug poisoning with dialyzable or filterable substances. The solutions are perfused through the dialysis fluid

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120333
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compartment of hemofilters/dialyzers. The dialysate is separated from the patient's blood by means of a semi-permeable membrane. Excess waste products, fluids and toxins found in the blood of a patient with acute renal failure pass through the membrane into the dialysate and eventually go to waste. The therapy is aimed at normalizing the blood.

Predicate Device Comparison:

The modified PrismaSATE Dialysis Solutions for CRRT has the same intended use, indication for use, chemical concentration range, and packaging characteristics as the predicate devices. There are no significant technological changes. Based on the above, the device is substantially equivalent to the stated predicates.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

## Public Health Service

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

Ms. Fei Law Quality and Regulatory Manager, US Solutions Gambro Renal Products Inc. · 1845 Mason Avenue DAYTONA BEACH FL 32117

MAY 2 5 2012

Re: K120333

> Trade/Device Name: PrismaSATE TM Regulation Number: 21 CFR§ 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: KPO Dated: May 8, 2012 Received: May 10, 2012

Dear Ms. Law:

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. 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

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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Dayane K-tuxhe

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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510(k) Premarket Notification

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## 4.0 Indications for Use Statement

Indications for Use

510(k) Number (if known):

20333

Device Name: PrismaSATE ™

Indications For Use:

Gambro PrismaSate solutions are indicated for use as a dialysate in Continuous Renal Replacement Therapy.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| Division of Reproductive, Gastro-Renal, and Urological Devices | Page 1 of 1 |
| 510(k) Number | K120333 |