ACCUSOL DIALYSIS SOLUTION

K041428 · Baxter Healthcare Corp · KPO · Aug 27, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K041428
• Device Name: ACCUSOL DIALYSIS SOLUTION
• Applicant: Baxter Healthcare Corp
• Product Code: KPO · Gastroenterology, Urology
• Decision Date: Aug 27, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Accusol Solutions are indicated for use as dialysis solutions in Continuous Renal Replacement Therapy.

Device Story

Accusol Dialysis Solution is a bicarbonate-based solution used in continuous renal replacement therapy (CRRT). It functions as a dialysate to facilitate solute removal and fluid balance in patients requiring renal replacement. The solution is supplied in a container system and is intended for clinical use by healthcare professionals in settings where CRRT is performed. It serves as a therapeutic medium to support renal function.

Clinical Evidence

No clinical data provided; substantial equivalence is based on formulation and design comparison to legally marketed predicate devices.

Technological Characteristics

Bicarbonate-based dialysis solution. Formulated with components and quantitative levels identical to predicate solutions (PrismaSate, BIASOL). Container system design, materials, and closure system are equivalent to predicate devices. No software or electronic components.

Indications for Use

Indicated for use as dialysis solutions in patients undergoing Continuous Renal Replacement Therapy (CRRT).

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 (K013448)
• Premixed Dialysate for Hemodiafiltration (K910270)
• BIASOL Liquid Concentrate (K895199)

Submission Summary (Full Text)

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AUG 2 7 2004

## 510(K) SUMMARY

:

| Submitter's Name: | David E. Curtin, RAC |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 1620 Waukegan Rd. MPGR-A2E |
| Phone: | [phone] |
| Fax: | [phone] |
| Contact: | David E. Curtin |
| Date Prepared: | 5/26/04 |
| Trade Name: | Accusol Dialysis Solution |
| Common Name: | Dialysis Solution |
| Classification Name: | Dialysate Concentrate for Hemodialysis (Liquid or Powder) per<br>21 CFR 876.5820 Hemodialysis System and Accessories. The<br>Product/Classification code is KPO. |
| Equivalent Predicate: | PrismaSate Dialysis Solutions, K013448<br>Gambro Renal Products<br>Premixed Dialysate for Hemodiafiltration, K910270<br>Baxter Healthcare Corporation<br>BIASOL Liquid Concentrate, K895199<br>Baxter Healthcare Corporation |
| Device Description: | Accusol Dialysis Solution is a bicarbonate based solution used<br>in continuous renal replacement therapies |
| Intended Use: | Accusol Solutions are indicated for use as dialysis solutions in<br>Continuous Renal Replacement Therapy |

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Summary of the Technological Characteristics Compared to the Predicate Device: Accusol Dialysis Solution is formulated of the same solution components to the same quantitative levels as dialysis solutions used to formulate the PrismaSate and BIASOL products. The Accusol Dialysis Solution container system is similar in design to the PrismaSate Dialysis Solution container system and to the materials of construction and closure system of the Premixed Dialysate for Hemodiafiltration products.

Additional Information Requested by FDA:

None to date

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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 symbol that resembles three stylized human figures or flowing lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 7 2004

David E. Curtin, RAC Associate Director, Regulatory Affairs Baxter Healthcare Corporation Renal Division 1620 Waukegan Road MCGAW PARK IL 60085

Re: K041428

Trade/Device Name: Accusol Dialysis Solution Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: 78 KPO Dated: August 19, 2004 Received: August 20, 2004

Dear Mr. Curtin:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have teviewed your becalling is the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure) to regard) the enactment date of the Medical Device Amendments, or to conninered prior to may 20, 1978, is eacordance with the provisions of the Federal Food, Drug, devices that have been rochise in assee approval of a premarket approval application (PMA). alle Costictle Act (110c) that do novice, subject to the general controls provisions of the Act. The r ou may, therefore, thanks of the Act include requirements for annual registration, listing of general controls provisions of wactice, labeling, and prohibitions against misbranding and adultcration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (600 a00 v). Existing major regulations affecting your device can be it may be subject to additions, 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 Flease be advised that I Dri 3 issualite somplies with other requirements of the Act that I DA has made a actestions administered by other Federal agencies. You must of any I ederal statutes and roguinents, including, but not limited to: registration and listing compry with an the rece I requirements, as 801); good manufacturing practice requirements as set (21 CFR Part 007), acoming (2) cegulation (21 CFR Part 820); and if applicable, the electronic forul in the quality systems (QS) res (sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Scetion 510(k) This letter will allow you to begin marketing; your active of your device of your device to a legally
premarket notification. The FDA finding of substantial equivalence of y premarket notification. The FDA inding of substantial equivalities and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFK Part 801), please
r on If you desire specific advice for your device on our laboling ought and on the regulation
contact the Office of Compliance at one of the following numbers, based on the regul number at the top of the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on the promotion and the regulation entitled, "Masbranding
Office of Compliance at [phone]. Also, please note the sencral Office of Compliance at [phone]. Associated on any obtain. Other general
by reference to premarket notification" (21CFR Part 807.97) you may obtained from the Divisio by reference to premarket noniticals under the Act may be obtained from the Division of Strall
information on your responsibilities under the Act may be obtained from the (80 information on your responsibilities three at its tall-free number [phone] or
Manufacturers, International and Consumer Assistance at its toll-first [phone] or Manufacturers, International and Colisumer resistance at to received.
[phone] or at its Internet address http://www.fda.gov/odch/dsma/dsmamain.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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## 510(K) Number (if known): _KOH 1428

Device Name: Accusol Dialysis Solution

## Indications for Use:

Accusol Solutions are indicated for use as dialysis solutions in Continuous Renal Replacement Therapy.

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

Concurrence of CDRH, Office Device Evaluation (ODE)

Prescription Use***_***_
(Per 21 CFR 801.109

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1/2/96)

David A. Bryson

(Division Sign-Off) Division of Reproductive, Abd and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________