(306 days)
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.
Water purification system for hemodialysis. 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.
The provided text describes a water purification system for dialysis and its compliance with relevant standards. Here's an analysis based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard / Parameter) | Reported Device Performance |
|---|---|
| AAMI Standard RD62:2001 (Water Treatment Equipment for Hemodialysis Applications) | Complied with requirements |
| USP: Total Organic Carbon (TOC) | Complied with requirements |
| Contaminant levels in product water | Met customer's requirements for purified water (by comparing with maximum permitted levels) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: A "sample of the product water produced by the system is taken" after installation. The exact number of samples or the duration of sampling is not specified.
- Data Provenance: The water samples are analyzed by an "independent laboratory." The country of origin of this data is not explicitly stated, but given the submission is to the FDA in the USA, it's likely the testing occurred within the USA or by a lab recognized by US standards. The testing is prospective in the sense that it's conducted after the installation of the system to verify its performance in a real-world setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is a water purification system, and the ground truth for its performance is established through laboratory analysis of water quality against predefined chemical and physical parameters, not through expert human interpretation of medical images or data.
4. Adjudication Method for the Test Set
Not applicable. The "ground truth" (compliance with standards) is determined by laboratory analysis and comparison to AAMI and USP standards, not by human adjudication of differing opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This is not a diagnostic device involving human readers or AI assistance in a medical interpretation context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical water purification system, not an algorithm. Its performance is measured by the quality of the water it produces.
7. The Type of Ground Truth Used
The ground truth used is based on objective standards and laboratory measurements:
- Compliance with AAMI Standard RD62:2001 for Water Treatment Equipment for Hemodialysis Applications.
- Compliance with USP (United States Pharmacopeia) standards for Total Organic Carbon.
- Comparison of measured contaminant levels to maximum permitted levels for purified water.
8. The Sample Size for the Training Set
Not applicable. This device does not use machine learning or AI that would require a "training set." It's a manufactured system whose performance is validated post-installation.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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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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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 | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
§ 876.5665 Water purification system for hemodialysis.
(a)
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.(b)
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.