PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPY

K072908 · Gambro Renal Products · KPO · Feb 4, 2008 · Gastroenterology, Urology

Device Facts

• Record ID: K072908
• Device Name: PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPY
• Applicant: Gambro Renal Products
• Product Code: KPO · Gastroenterology, Urology
• Decision Date: Feb 4, 2008
• 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.

Device Story

PrismaSate solutions are sterile, ready-to-use dialysate fluids packaged in flexible bags. Used in commercially available CRRT machines; physician prescribes specific chemical composition. During therapy, solution is perfused through the dialysis fluid compartment of a hemofilter/dialyzer. Dialysate is separated from patient blood by a semi-permeable membrane; waste products, fluids, and toxins pass from blood into dialysate via diffusion/convection for removal. Therapy aims to normalize blood chemistry in patients with acute renal failure or poisoning. Operated by clinicians in clinical settings.

Clinical Evidence

No clinical data provided; device is a sterile dialysate solution for established CRRT procedures.

Technological Characteristics

Sterile, ready-to-use liquid dialysate solution. Packaged in flexible bags. Chemical composition is prescribed by a physician. Functions via passive diffusion/convection across a semi-permeable membrane in a hemofilter/dialyzer.

Indications for Use

Indicated for use as a dialysate in Continuous Renal Replacement Therapy (CRRT) for the treatment of acute renal failure and other conditions requiring fluid or solute removal, such as drug poisoning with dialysable or filterable substances.

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

• Gambro Renal Products (K013448)
• NxStage Pureflow Solutions NxStage (K042045)

Submission Summary (Full Text)

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K072908
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## 510 (k) Summary

- Submitted by: Gambro 1845 Mason Avenue Daytona Beach, FL 32117
- Phone: [phone]
- Fax: [phone]
- Contact: Fei Law
- Date 09/28/2007
- Prepared:
- 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.
- Equivalent PrismaSate Dialysis Solutions for Continuous Renal Replacement Therapy (CRRT) Predicate: Gambro Renal Products, K013448

NxStage Pureflow Solutions NxStage, K042045

- Device Gambro PrismaSate solutions are sterile dialysate solutions for use in Continuous Description: 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 dialysable 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.
- 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 dialysable or filterable substances. The solutions are perfused through the dialysis fluid compariment 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 The modified PrismaSate Dialysis Solutions for Continuous Renal Replacement Device Therapy (CRRT) has the same intended use, indication for use, chemical concentration Comparison: 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/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird with three stylized wing segments.

4 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Fei Law Quality and Regulatory Manager U. S. Solutions Gambro® 1845 Mason Avenue DAYTONA BEACH FL 32117

Re: K072908

> Trade/Device Name: PrismaSate Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: KPO Dated: January 15, 2008 Received: January 28, 2008

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.

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 (OS) 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/cdrb/industry/support/index.html.

Sincerely yours,

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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## Page 1 of 1

510(k) Number (if known): Ko 7 2908

PrismaSate™ Device Name:

Indications For Use:

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

*Prescription Use* \$
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (QDE)

Hulin Reines

(Division Sigh-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

(Optional Format 3-10-98)