ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES

K041163 · Isopure, Corp. · FIP · Oct 7, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K041163
• Device Name: ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES
• Applicant: Isopure, Corp.
• Product Code: FIP · Gastroenterology, Urology
• Decision Date: Oct 7, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5665
• Device Class: Class 2

Intended Use

The Isopure Complete Water Purification System each device is intended for use in Hemodialysis and is intended to remove organic and inorganic contaminants from water used to dilute dialysate. These systems are to be use in Hospitals and/or Hemodialysis facilities.

Device Story

Water purification system for hemodialysis; removes organic/inorganic contaminants from water used to dilute dialysate. System configurations include direct feed and indirect feed models (MD610, MD620, MD630, MD640). MD610/MD620 utilize distribution pumps and ultra-filters; MD630/MD640 include deionization exchange tanks. MD640 features automatic pump alternation and dual-bank deionization for continuous operation. Used in clinical settings (hospitals/hemodialysis facilities) by trained personnel to ensure water quality meets standards for hemodialysis procedures. Output is purified water; ensures patient safety by preventing exposure to contaminants during dialysis.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Water purification system; includes distribution pumps, ultra-filters, and deionization exchange tanks. Configurations vary by pump redundancy (single/dual) and deionization capacity (none/single bank/dual bank with automatic alternation).

Indications for Use

Indicated for use in hospitals and hemodialysis facilities to remove organic and inorganic contaminants from water used to dilute dialysate for hemodialysis patients.

Regulatory Classification

Identification

A water purification system for hemodialysis is a device that is intended for use with a hemodialysis system and that is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. This generic type of device may include a water softener, sediment filter, carbon filter, and water distillation system.

Special Controls

*Classification.* Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

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 Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" encircles the eagle. The seal is black and white and has a simple, official design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 7 - 2004

Mr. Kevin Gillespie Isopure Corporation 129 Citizens Blvd. SIMPSONVILLE KY 40067

Re: K041163

Trade/Device Name: Isopure Complete Water System for Hemodialysis for Direct Feed Single or Multi-Patient Hemodialysis Facilities, Indirect Feed utilizing the MD610, MD620, MD630 and MD640 Ultra Filter System Regulation Number: 21 CFR §876.5665 Regulation Name: Water purification system for hemodialysis Regulatory Class: II Product Code: 78 FIP Dated: August 5, 2004 Received: August 9, 2004

Dear Mr. Gillespie:

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 (Premarket Approval), 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.

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 (0S) 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 Scction 510(k) I ms letter will anow you to ough manxeans of your device of your device to a legally premarket notification: "The PDF Intentig sifestion 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 If you desire specific advice for your devise to research 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" (21 CFR Also, picase note the regulation entrast, formation on your responsibilities under the Act from the 807.97). I ou may obtain other general miss and Consumer Assistance at its toll-free number (800) DWISION of Small Manufacturers, 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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## Indications for Use

## 510(k) Number: K041163

Device Name: Isopure Complete Water Purification System for direct feed Devroc Name: 100pnt Hemodialysis Facilities Indirect feed utilizing the MD610, MD620, MD630, MD640 Ultra Filter System.

## Indications For Use:

The Isopure Complete Water Purification System each device is intended for rne isopare Gomplete Hates and is intended to remove organic and inorganic use in Homoulalyolo objal contaminants from water used to dilute dialysate subotantoos and mioritorial These systems are to be use in Hospitals and/or Hemodialysis facilities.

Each indirect feed model has the following optional configuration: MD610 – Single distribution pump with a series of ultra-filters based on the required flow of the facility. The MD610 has no Deionization capabilities. MD620 – Dual multi-stage distribution pumps with a series of ultra-filters based on the required flow of the facility. The MD620 has no Deionization capabilities.

MD630 – Single multi-stage distribution pump with a series of ultra-filters MB600 - Girryering flow of the facility. The MD630 is equipped to process a single bank of medical grade Deionization exchange tanks.

a ongle bank on the stage distribution pumps with automatic pump alternation with a series of ultra-filters based on the required flow of the facility. The MD640 is equipped to process dual banks of medical grade Deionization exchange tanks. The MD640 is capable of operating continuously by automatically alternating between the two banks of exchange tanks.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801 Subpart D)

OR

Over-The-Counter Use (21 CFR 807 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy Brogdon

Division of Reproductive. A and Radiological Devic 510(k) Number

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