WATER PURIFICATION SYSTEM

K022448 · Purity Water Company of San Antonio, Inc. · FIP · May 28, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K022448
• Device Name: WATER PURIFICATION SYSTEM
• Applicant: Purity Water Company of San Antonio, Inc.
• Product Code: FIP · Gastroenterology, Urology
• Decision Date: May 28, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5665
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Purify water for hemodialysis treatment in dialysis centers/facilities having multiple treatment stations. Purify water for hemodialysis treatment in hospital intensive care units, critical care units, pediatric intensive care units, and other acute care applications within a hospital setting.

Device Story

Water purification system for hemodialysis (PWC3.5.1) processes feed water to produce purified water for clinical use. System components include booster pump, multimedia filtration, water softener, carbon filter, reverse osmosis, storage tank, ultra-filtration, and deionization tanks. Audible and visual alarms monitor system status. Used in dialysis centers and hospital acute care settings; operated by trained clinical staff. System performance is verified by post-installation laboratory analysis of product water to ensure compliance with AAMI RD62:2001 standards. Output is purified water meeting required contaminant levels for hemodialysis, supporting safe patient treatment.

Clinical Evidence

No clinical data. Bench testing only. System performance validated against AAMI Standard RD62:2001 and USP Total Organic Carbon requirements via independent laboratory analysis of product water samples.

Technological Characteristics

System includes booster pump, multimedia filtration, water softener, carbon filter, reverse osmosis, storage tank, ultra-filtration, and deionization tanks. Complies with AAMI RD62:2001. Features audible and visual alarms. Non-networked, standalone industrial-scale purification system.

Indications for Use

Indicated for patients requiring hemodialysis treatment in dialysis centers, facilities, or hospital settings including intensive care, critical care, and pediatric intensive care units.

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

• Better Water, Inc. Water Purification System for Hemodialysis

Submission Summary (Full Text)

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# MAY 28 2003

## K022448 Page 1 of 3

## Summary of Safety and Effectiveness Information

The following information is furnished in accordance with 21 CFR 807.92(a) :

- Submitter's name and address: 1.
Purity Water Company 1119 Paulsun San Antonio, Texas, 78219-3182

- Submitter's telephone number: 2.
(210 227-3601

#### 3. Contact person:

Mr. Bill Herrera

- Date this 510(k) summary prepared: May 28, 2003 4 .
- Trade/proprietary name of the device: 5 .

Water Purification System for Dialysis

- Classification name of the device: 6 .
Water purification system for dialysis

#### 7. Legally marketed predicate device to which substantial equivalence is claimed:

Better Water, Inc. Water Purification System for Hemodialysis

#### Description of the device that is the subject of this 8. premarket notification:

Water purification system for hemodialysis.

PWC3.5.1

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### Summary of Safety and Effectiveness Information

#### 9. Indications for use:

- Purify water used in hemodialysis treatment in dialysis . centers/facilities having multiple treatment stations.
- Purify water used in hemodialysis treatment in hospital intensive care units, critical care units, pediatric intensive care units, and other acute care applications within a hospital setting.

### 10. Technological characteristics:

The typical customized system is configured with booster pump, multimedia filtration, water softener, carbon filter, reverse osmosis, storage tank, ultra-filtration, deionization tanks, audible and visual alarms, and other components that purify water as a function of feed water quality and required capacity. The system product water complies with the AAMI Standard RD62:2001, Water Treatment Equipment for Hemodialysis Applications.

510(k) Summaries for those submissions in which a determination of substantial equivalence is also based on performance data shall also contain the following information in accordance with 21 CFR 807.92(b) :

### 11. Non-clinical: Brief discussion of the non-clinical tests submitted, referenced, or relied upon in this submission:

Following the installation of the water purification system a sample of the product water produced by the system is taken and analyzed by an independent laboratory to determine the level of contaminants in the water. These laboratory results are compared with the maximum permitted level for each contaminant in order to determine that the product water purified by the system meets the customer's requirements for purified water. This method was also used by the predicate device to demonstrate compliance with recognized acceptable contaminant levels in product water.

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## Summary of Safety and Effectiveness Information

The performance test results of the candidate device complied with the requirements of :

- AAMI Standard RD62:2001, Water Treatment Equipment for ● Hemodialysis Applications
- USP: Total Organic Carbon ●

### 12. Clinical:

There are no clinical tests submitted, referenced, or relied upon in this submission.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 28 2003

Purity Water Company c/o Mr. Bert Hudson President Hudson Consulting, Inc. 803 Evian SAN ANTONIO TX 78258

Re: K022448

Trade/Device Name: Purity Water Company Water Purification System Regulation Number: 21 CFR §876.5665 Regulation Name: Water purification system for hemodialysis Regulatory Class: II Product Code: 78 FIP Dated: February 25, 2003 Received: February 27, 2003

Dear Mr. Hudson:

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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Page 2

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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Page 1 of 1

510(k) number (if known): K022448 Device name: Water purification system Indications for use of the device: Purify water for hemodialysis treatment in dialysis centers/facilities having multiple treatment stations. Purify water for hemodialysis treatment in hospital intensive care units, critical care units, pediatric intensive care units, and other acute care applications within a hospital setting. (Please do not write below this line. Continue on another page if needed.) Concurrence of CBER, Office of Device Evaluation (ODE) Prescription Use Over-the-Counter Use or (Per 21 CFR 801.109) (Optional format 1-2-96)

> Division of Reprocuctive, Abdomina and Raciological Devices 510(k) Number