DIASOL-ADDITIVES

K020231 · Diasol, Inc. · KPO · Oct 21, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K020231
• Device Name: DIASOL-ADDITIVES
• Applicant: Diasol, Inc.
• Product Code: KPO · Gastroenterology, Urology
• Decision Date: Oct 21, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Diasol -- Additives are used in conjunction with Diasol acid concentrate, AAMI standard water and Sodium Bicarbonate as Dialysate solution for hemodialysis in 3 stream hemodialysis machines allowing the physician to customize the dialysate to meet the patient's needs. Diasol additives, Infusates and Infusate additives are for use with sorbent regenerated Dialysis and allows physicians to customize the dialysate to meet the patient's needs.

Device Story

Diasol-Additives are chemical additives used in hemodialysis to customize dialysate composition. The device is used in clinical settings by healthcare professionals during hemodialysis procedures. It functions by being mixed with Diasol acid concentrate, AAMI standard water, and sodium bicarbonate in 3-stream hemodialysis machines or sorbent regenerated dialysis systems. By allowing physicians to adjust the dialysate formulation, the device enables personalized treatment to meet specific patient physiological needs. The output is a modified dialysate solution used for extracorporeal blood treatment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Chemical additives for hemodialysis dialysate preparation. Designed for use with 3-stream hemodialysis machines and sorbent regenerated dialysis systems. Compliant with AAMI standards for water quality.

Indications for Use

Indicated for patients undergoing hemodialysis requiring customized dialysate solutions. Used in conjunction with Diasol acid concentrate, AAMI standard water, and sodium bicarbonate in 3-stream hemodialysis machines or sorbent regenerated dialysis systems.

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes extending from its head, representing health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" encircles the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 21 2002

Re: K020231

Ms. Monica Abeles Diasol, Inc. 13212 Raymer Street NORTH HOLL YWOOD CA 91605

Trade/Device Name: Diasol - Additives Regulation Number: 21 CFR \$876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II

Product Code: 78 KPO Dated: July 22, 2002 Received: July 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 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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## Diasol Inc.

## b. STATEMENT OF INTENDED USE

## Device Name : Diasol-Additives

Device Name . Diasol -- Additives are used in conjunction with Diasol acid concentrate, AAMI standard water and Sodium Bicarbonate as Dialysate solution for concentralia, 2011 homodialysis in 3 stream homodialysis machines allowing the physician to customize the dialysate to meet the patient's needs .

puysesan additives, Infusates and Infusate additives are for use with sorbent regenerated Dulysis and allows physicians to customize the dialysate to meet the patient's needs.

Please do not write below this line

Concurrence of CDRH, Office of device evaluation (ODE)

Prescription Use
Per 21 CFR 801.109

Over-the-counter Use

David A. Lippman

or

and Radiological 510(k) Number