BIOPURE PORTABLE RO SYSTEM,BIOPURE 4400 SERIES RO SYSTEM, BIOPURE 8400 SERIES RO SYSTEM,BIOPURE WATER PURFICATION PRETRE

K030348 · Biolab Equipment Canada , Ltd. · FIP · Oct 21, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K030348
• Device Name: BIOPURE PORTABLE RO SYSTEM,BIOPURE 4400 SERIES RO SYSTEM, BIOPURE 8400 SERIES RO SYSTEM,BIOPURE WATER PURFICATION PRETRE
• Applicant: Biolab Equipment Canada , Ltd.
• Product Code: FIP · Gastroenterology, Urology
• Decision Date: Oct 21, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5665
• Device Class: Class 2

Intended Use

The device is intended to remove organic and inorganic substances and microbial contaminants from water that is used to dilute dialysis concentrate to form dialysate, and to produce purified water for dialyzer reprocessing, and equipment rinse and disinfection.

Device Story

Biopure Series RO systems purify feed water via reverse osmosis; pressure forces water through semipermeable membrane, retaining impurities (dissolved inorganics, organics, bacteria, pyrogens) on feed side. Pretreatment components (boost pumps, filters, softeners, carbon filters) condition feed water by removing chlorine/chloramines. Product water distribution components (storage tanks, pumps, UV disinfection, hot water sanitization) deliver purified water meeting AAMI/ASAIO standards for hemodialysis. Systems range from 300 GPD to 100 GPM capacity. Used in home, hospital, or clinic settings by healthcare providers or patients (portable units). Output water used to dilute dialysis concentrate, reprocess dialyzers, and disinfect equipment. Benefits include consistent water quality for dialysis, reducing patient exposure to contaminants.

Clinical Evidence

Bench testing only. No clinical data provided. Performance metrics include rejection rates of >99% for microorganisms, pyrogens, particles, and organics (>300 MW), and 95%-99% for dissolved inorganics.

Technological Characteristics

Reverse osmosis membrane separation; pretreatment includes sediment/carbon filters, softeners, multimedia filters, dealkalizers. Product water distribution includes UV disinfection and hot water sanitization. Capacity: 300 GPD to 100 GPM. Meets ANSI/AAMI RD5-1992 standards.

Indications for Use

Indicated for water purification in hemodialysis applications. Supports patient populations ranging from 1 to 600 patients depending on system model (Portable, 4400, or 8400 series), used in home, hospital, or dialysis clinic settings.

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.

Predicate Devices

• Zyzatech Series RO systems (K964539)
• US Filter Water Purification System (K980182)

Submission Summary (Full Text)

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## 4. 510 (k) Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990 and 21CFR 807.92

#### Applicant

Biolab Equipment Canada Limited 505 Iroquois Shore Road, Unit 14 Oakville, Ontario L6H 2R3 David Weatherill - President Tel: [phone] Fax: [phone]

## Prepared by

J.P. Consulting Jerry Ponikvar --

128 Grandview Avenue Thornhill, Ontario L3T 1H6 [e-mail] E-Mail Telephone [phone] [phone] Fax

Jerry Ponikvar, will respond to any requests for additional information.

#### Device Name

Trade Names Biopure Portable RO System Biopure 4400 Series RO System Biopure 8400 Series RO System Biopure Water Purification Pretreatment Components Softeners Biopure Performa Softener

| Backwash Filters | Biopure Magnum Series Water Softener |
|------------------|-----------------------------------------|
| | Biopure Performa Filter |
| | Biopure Magnum Series Carbon Filter |
| | Biopure Magnum Series Multimedia Filter |

Service Deionization Biopure Service DI

Biopure Premium Grade Service Di BiopureCation Bed DI Biopure Anion Bed DI Biopure Auto DI

Organic Bed Service Carbon

Biopure Carbon Biopure Product Water Distribution Components

Biopure CIP System Biopure Hot Water Sanitization System

Common or Usual Names

Reverse Osmosis systems with pretreatment and product water distribution components

Classification Name

Water Purification System for Hemodialysis Regulatory Classification - Class II 21 CFR 876.5665 Product Code: 78 FIP

Biolab510KPremarketSubmittalA.doc

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510(K)Premarket Notification

#### Intended Use

The device is intended to remove organic and inorganic substances and microbial contaminants from water that is used to dilute dialysis concentrate to form dialysate, and to produce purified water for dialyzer reprocessing, and equipment rinse and disinfection.

## Device Description

The Biopure Series RO systems purify feed water through reverse osmosis a membrane separation process. In reverse osmosis, pressure is applied to force water through a semipermeable membrane, while leaving impurities on the feed side of the membrane. The membrane allows the solvent (water) to pass through but retains a large percentage of impurities such as dissolved inorganics, organics, bacteria, and pyrogens. The water that passes through the membrane (permeate), has significantly less contamination than the feed water. while the reject stream, which remains upstream of the membrane, has a much higher concentration than the feed stream.

The purpose of a pretreatment to reverse osmosis is to remove chlorinel chloramines and condition the feed water supplying the RO machine. The pretreatment section may include feed water boost pumps, a temperature blend valve, chemical feed unit, sediment/carbon cartridge filters, water softeners, multi media filters, carbon filters and dealkalizers.

The RO unit removes more than 99% of all micro-organisms, pyrogens, particles, and organics with a molecular weight greater than 300, and up to 95% of all dissolved inorganics. The elements of an RO unit include a prefilter, RO pressure pump, and RO membranes.

The purpose of a product water distribution system is to deliver water that meets or exceeds AAMI/ASAIO standards for water treatment equipment and water quality requirements for hemodialysis point of use. Additional product water treatment is intended to control or eliminate bacteria prior to point of use. The product water treatment system may include a storage tank, distribution pump, a distribution loop, UV disinfection, and hot water sanitization.

Depending on the series and model, Biopure water purification systems produce from 300 GPD (gallons per day) to 100 GPM (gallons per minute) at 75% recovery rate. Rejection of total dissolved solids and monovalent ions is in the range of 95%-99% depending on feed water characteristics. Colloids, bacteria, and organics larger than a 200 molecular weight are rejected at greater than 99%.

Biopure water purification systems product water that meets the requirements of ANSI / AAMI RD5-1992, Hemodialysis Systems.

#### Predicate Devices

The Biopure Series RO systems, pre-treatment components, and product water components are substantially equivalent to the following legally marketed devices: Zyzatech Series RO systems, K964539 US Filter Water Purification System, K980182 These devices use reverse osmosis technology to purify water for hemodialysis applications.

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OCT 2 1 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biolab Equipment Canada, Ltd. c/o Mr. Jerry Ponikvar, P.Eng J. P. Consulting 128 Grandview Avenue Thornhill, Ontario CANADA L3T 1H6

Re: K030348

Trade/Device Name: Biopure Portable RO System Biopure 4400 Series RO System Biopure 8400 Series RO System Biopure Water Purification Pretreatment Components Biopure Product Water Distribution Components Regulation Number: 21 CFR §876.5665

Regulation Name: Water purification system for hemodialysis Regulatory Class: II Product Code: 78 FIP Dated: July 22, 2003 Received: July 23, 2003

Dear Mr. Ponikvar:

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 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 Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx. Ixxx | [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" (21CFR Part 807.97) you may obtain. 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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# 3. Statement of Indications for Use

Applicant: Biolab Equipment Canada Limited

Establishment Registration # 9710313

510 (k) Number (if Known): K030348

Device Name:

Biopure Portable RO System Biopure 4400 Series RO System Biopure 8400 Series RO System Biopure Water Purification Pretreatment System Components Biopure Product Water System Components

Classification Name:

Water Purification System for Hemodialysis Regulatory Classification - Class II 21 CFR 876.5665 Product Code: 78 FIP

Indications for Use:

The device is intended to remove organic and inorganic substances and microbial contaminants from water that is used to dilute dialysis concentrate to form dialysate and to produce purified water for dialyzer reprocessing, and equipment rinse and disinfection. Enclosed below is a chart indicating the physical differences of the different systems, areas of use, and patient population.

| System Model | Biopure Portable | Biopure 4400 | Biopure 8400 |
|---------------------|--------------------------------------------------------------------------------------------|--------------------------------|---------------------------------|
| Area of Use | Home or hospital use, this systems allows dialysis treatment to patients not near a clinic | Hospital or Dialysis Clinics | Large Dialysis Clinics |
| Patient Population | 1 to 3 | 3 to 50 | 65 to 600 |
| Physical Dimensions | 39" x 12.5" x 28" | 72"x24"x32" to<br>72"x18"x144" | 76"x32"x122" to<br>76"x44"x162" |
| Weight | 120 to 135 lbs | 220 to 1610 lbs | 1200 - 8000 lbs |

Prescription Use (Per 21 CFR 801.109)

Nancy C. Brogdon

(Division Sign-Off) (Division of Reproductive, Abdominal, and Radiological D 510(k) Number

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