(158 days)
The Pure Water, Inc. Water Purification System is intended to be used in the purification of water to be used to dilute dialysate concentrate and in the reprocessing of dialyzers for reuse.
The Pure Water, Inc. Water Purification System uses Reverse Osmosis technology to produce pure water. Reverse Osmosis utilizes a semi-permeable membrane and high hydrostatic pressure. Pretreatment is used for the purpose of removing elements present in the source water that can damage the RO membranes. The storage and distribution components of the system serves to deliver pure water produced by the RO to the point of use. The Pure Water, Inc. Water Purification System can be customized to best meet the water needs of the user.
This document is a 510(k) summary for a water purification system, not a study report for a diagnostic or AI-driven device. Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth establishment is not applicable to this submission.
Here's a breakdown of the relevant information from the provided text:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Meets or exceeds all Association for the Advancement of Medical Instrumentation (AAMI) National Standards for Hemodialysis. | The Pure Water, Inc. Water Purification System meets or exceeds all Association for the Advancement of Medical Instrumentation (AAMI) National Standards for Hemodialysis. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a 510(k) premarket notification for a water purification system, not a study involving a test set of data. The "performance" relates to compliance with engineering standards, not diagnostic accuracy on a dataset.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth, in the context of an expert establishing it for a test set, is relevant for diagnostic devices or those involving interpretation. This device is a water purification system. Compliance with AAMI standards is typically verified through engineering tests and quality control, not expert review of a "test set."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring adjudication is described.
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 an AI-driven device or one that involves human readers for interpretation.
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.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is adherence to the Association for the Advancement of Medical Instrumentation (AAMI) National Standards for Hemodialysis. This is an engineering and quality standard, not a clinical ground truth like pathology or expert consensus.
8. The sample size for the training set
Not applicable. There is no training set for this type of device.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
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JAN 2 4 200
Image /page/0/Picture/1 description: The image shows a logo for "Pure Water 2000". The logo is circular and contains an image of ocean waves. The text "Pure Water" is written in a semi-circle above the waves, and the number "2000" is written on the left side of the logo.
305 W. Market Street Anderson, SC 29624 Phone: (864) 375-0105 Fax: (864) 226-1384
K992786 p.1/1
510(k) Summary
Submitter Information:
| Company Name: | Pure Water, Inc. |
|---|---|
| Company Address: | 305 West Market Street |
| Anderson, South Carolina | |
| Company Phone: | (864) 375-0105 |
| Company Fax: | (864) 226-1384 |
| Contact Person: | Rhonda S. McCoy |
| Prepared: | August 17, 1999 |
Pure Water, Inc. Water Purification System Trade Name:
Classification Name:Water Purification System for Hemodialysis
- The Pure Water, Inc. Water Purification System is substantially Equivalency: equivalent to Better Water's Water Purification System for Hemodialysis (510(k) #: K920186) and ZyzaTech Water System, Inc.'s Water Purification Systems and Components and Portable Reverse Osmosis Systems (510(k) #: K964539), which are currently in commercial distribution.
- The Pure Water, Inc. Water Purification System uses Reverse Device Description: Osmosis technology to produce pure water. Reverse Osmosis utilizes a semi-permeable membrane and high hydrostatic pressure.
Pretreatment is used for the purpose of removing elements present in the source water that can damage the RO membranes.
The storage and distribution components of the system serves to deliver pure water produced by the RO to the point of use.
The Pure Water, Inc. Water Purification System can be customized to best meet the water needs of the user.
The Pure Water, Inc. Water Purification System meets or exceeds all Association for the Advancement of Medical Instrumentation (AAMI) National Standards for Hemodialysis.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 4 2000
Ms. Rhonda S. McCoy Office Manager Pure Water, Inc. 305 West Market Street Anderson, South Carolina 29624 Re: K992786
Pure Water, Inc. Water Purification System Dated: November 23, 1999 Received: November 26, 1999 Regulatory Class: Il 21 CFR §876.5665/Procode: 78 FIP
Dear Ms. McCov:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requiation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regult in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, 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):_K992786
Device Name: Pure Water, Inc. Water Purification System for Hemodialysis
Indications For Use:
The Pure Water, Inc. Water Purification System is intended to be used in the The Puter Water Tunneation of water to be used to dilute dialysate concentrate and in the reprocessing of dialyzers for reuse.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Donald A. D'Amato
of Reproductive, Abdominal, ENT, and Radiological Dev 510(k) Number
Prescription Use
(Per 21 CFR 801.109) √
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 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.