DIASOL-BICARB

K020230 · Diasol, Inc. · KPO · Apr 23, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K020230
• Device Name: DIASOL-BICARB
• Applicant: Diasol, Inc.
• Product Code: KPO · Gastroenterology, Urology
• Decision Date: Apr 23, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Diasol-BiCarb Schutions are indicated for use in acute and chronic hemodialysis and have to be used in conjunction with Diasol acid concentrate or any other commercially available concentrate in the correct proportioning and AAMI standard water as Dialysate solution for hemodialysis .For use in 3 stream dialysis machines calibrated for use with acid and bicarbonate concentrate.

Device Story

Diasol-BiCarb is a liquid sodium bicarbonate solution used as a component of dialysate concentrate for hemodialysis. It is mixed with acid concentrate and AAMI standard water in 3-stream dialysis machines to create the final dialysate solution. The product is supplied in HDPE plastic containers, is non-sterile and non-pyrogenic, and undergoes gamma radiation. It is intended for use in both acute and chronic care dialysis settings. By providing the bicarbonate component of the dialysate, it facilitates the renal dialysis process for patients.

Clinical Evidence

No clinical data. Bench testing only, including microbiological cultures and LAL testing performed using AAMI-approved methods to ensure the product does not promote bacterial growth.

Technological Characteristics

Liquid sodium bicarbonate solution; HDPE plastic container; non-sterile, non-pyrogenic; gamma-radiated; intended for use with 3-stream dialysis machines; adheres to AAMI microbiological standards.

Indications for Use

Indicated for patients requiring acute or chronic hemodialysis therapy. Used in conjunction with acid concentrate and AAMI standard water in 3-stream dialysis machines.

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

• Renosol (K792213)
• Renosol (K781967)
• Sterilyte (K971053)

Submission Summary (Full Text)

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K020230 - P.01 of 2

# APR 2 3 2002

Diasol Inc.

#### 510K SUMMARY IN ACCORDANCE WITH SMDA '90 II.

SUBMITTER:

DIASOL INC. 13212 RAYMER ST. NORTH HOLLYWOOD, CA 91605 PHONE [phone] FAX [phone]

CONTACT

MONICA ABELES

November 29, 2001 DATE SUMMARY WAS PREPARED

| NAME OF DEVICE | DIASOL-BICARB |
|----------------------|-----------------------------------------------------|
| COMMON NAME | BICARBONATE FOR HEMODIALYSIS |
| CLASSIFICATION NAME | HEMODIALYSIS SYSTEMS AND<br>ACCESSORIES<br>CLASS II |
| PERFORMANCE STANDARD | NONE ESTABLISHED UNDER 514 OF FDA |
| PREDICATE DEVICE | RENOSOL K792213 and K781967<br>STERILYTE K971053 |

DEVICE DESCRIPTION:

Sodium Bicarbonate is part of the dialysate concentrate for hemodialysis. When mixed with AAM standard water and Acid Concentrate, it creates a dialysate solution for use in renal dialysis therapy.

read diarysis therepy .
Diasol-BiCarb solution is in a ready to use form that is convenient for use in chronic care dialysis unit as well as acute care,

dialysis thin as well as noter care.
Sodium bicarbonate Hemodialysis grade, a white, water soluble powder is mixed with South block one of the case your Chloride USP (for 36.83 proportioning) in adequate proportions to provide the bicarbonate part of the dialysate.

proportions to provide the breat benefits plastic container (HDPE) similar to the predicate.

The solution is non-sterile, non-pyrogenic. Finished product is gamma radiated. The southout is non-centions have been taken to assure that the finished product does not promote bacterial growth.

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# Diasol Inc.

AAMI microbiological standards are observed. LAL and microbiological cultures are performed on all batches using AAMI approved methods.

Our device has the same intended use as the predicate device , we use the same grade of raw material and same type of packaging as our predicates

CONCLUSIONS:

Diasol-BiCarb andSterilyte and Renasol are both the bicarbonate components of the dialysate, with the same intended use and similar composition

These similarities demonstrate substantial equivalence of Diasol-BiCarb to Renasol and Sterilyte.

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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 is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

### Public Health Service

**Food and Drug Administration**
**9200 Corporate Boulevard**
**Rockville MD 20850**

Ms. Monica Abeles DIASOL, Inc. 13212 Raymer Street NORTH HOLLYWOOD CA 91605 Re: K020230

Trade/Device Name: DIASOL-BiCarb Liquid Sodium Bicarbonate Regulation Number: 21 CFR 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: 78 KPO Dated: January 20, 2002

Received: January 23, 2002

Dear Ms. Abeles:

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 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); 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.

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This letter will allow you to begin marketing your device as described in your 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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours.

Nancy Cbrogdon

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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# b. STATEMENT OF INTENDED USE

### Device Name : Diasol-BiCarb

Indications for use: Diasol-BiCarb Schutions are indicated for use in acute and chronic hemodialysis and have to be used in conjunction with Diasol acid concentrate or any other commercially available concentrate in the correct proportioning and AAMI standard water as Dialysate solution for hemodialysis .For use in 3 stream dialysis machines calibrated for use with acid and bicarbonate concentrate.

Please do not write below this line

Concurrence of CDRH, Office of device evaluation (ODE)

Prescription Use Per 21 CFR 801.109 or

Over-the-counter Use

Nancy C Brogdon

(Division Sion O Division of Reproductive, Abdominal, and Radiological Devices 10230 510(k) Number .