The WaterVault Cube Water Treatment System for HemoDialysis is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate.

Device Description

Organic, inorganic and microbial contaminants are removed from water supplied to hemodialysis clinics for use in the dilution and preparation of dialysate solutions used in hemodialysis machines. The water treatment system includes a means of tempering the water and pretreatment, followed by reverse osmosis, ultrafiltration and UV sterilization. Pretreatment includes water softening to remove hardness and Granular Activated Carbon treatment to remove Chloramines in addition to filament cartridge filters to control particulate solids. Reverse Osmosis utilizes a pressure gradient to reverse the process water diffusion across a semipermeable membrane, concentrating the contaminants which are subsequently rejected as concentrate. Water forced through the membrane known as "Permeate" is then passed through a hollow fiber ultra filter to remove microorganisms, pyrogens and endotoxins. A UV light source that provides a minimum of 30,000 microwatts/cm2 sec limits further bacterial growth in the treated water.

AI/ML Overview

The Water Vault Cube, Water Treatment System for Hemodialysis, underwent nonclinical testing to demonstrate its performance against AAMI (Association for the Advancement of Medical Instrumentation) standards for water used in the preparation of dialysate.

1. Table of Acceptance Criteria and Reported Device Performance

Component	Acceptance Criteria (AAMI Standard mg/l)	Reported Device Performance (Permeate mg/l)	Meets or Exceeds Acceptance Criteria
Calcium	2	1	Yes
Magnesium	4	1	Yes
Sodium	70	1	Yes
Potassium	8	1	Yes
Fluoride	0.2	0.1	Yes
Chlorine	0.5	0.02	Yes
Chloramines	0.1	0.02	Yes
Nitrate	2	0.1	Yes
Sulfate	100	5	Yes
Copper	0.1	0.01	Yes
Barium	0.1	0.01	Yes
Zinc	0.1	0.02	Yes
Aluminum	0.01	0.01	Yes
Arsenic	0.005	0.005	Yes
Lead	0.005	0.003	Yes
Silver	0.005	0.005	Yes
Cadmium	0.001	0.001	Yes
Chromium	0.014	0.005	Yes
Selenium	0.05	0.005	Yes
Mercury	0.0002	0.0002	Yes

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The test results are based on a single sample test of a "demonstration unit."
Data Provenance: The data is retrospective, derived from tests performed on a specific demonstration unit (Osmonics Solorss reverse osmosis unit, Serial Number 96-61650-11). The country of origin is not explicitly stated but implied to be the United States, given the FDA filing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The ground truth for this device is based on quantifiable chemical analysis against established industry standards (AAMI Standards), not expert human assessment.

4. Adjudication Method for the Test Set

Not applicable. The device performance is assessed through direct chemical analysis (quantitative measurements), not through human adjudication.

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 a water treatment system, not an AI-powered diagnostic device, so an MRMC study is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, a standalone test was performed. The device's performance was evaluated by analyzing the "Permeate" water it produced, independently of any human intervention or interpretation, against the AAMI standards.

7. The Type of Ground Truth Used

The ground truth used is AAMI Standards for water quality in hemodialysis. This is an objective, established standard for chemical contaminant levels.

8. The Sample Size for the Training Set

Not applicable. This device is a physical water treatment system, not a machine learning algorithm that requires a training set. The "design" of the system is based on established water purification principles.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As this is not an AI/ML device, there is no training set or ground truth in that context.

Summary

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4/28/99

K983512

5 | OK SUMMARY

Water Vault Corporation 2003 Blair Blvd Nashville, TN 37212 615-292-7336 Contact: Michael Peterson

Water Vault Cube, Watertreatment System for Hemodialysis Class II Device

Legally Marketed Predicate Device - MARCOR Water Treatment System For Hemodialysis K#945559

Jinnia Darriad

	Water Vault Inc.	Predicate Device
		MARCOR #K945559
INTENDED USE	Hemodialysis	Hemodialysis
EQUIPMENT:	Makes Use Of Existing FDACleared Reverse Osmosis UnitPretreatment Equipment SizedBased upon water analysisAnd RO Mfg. Requirements	Makes Use Of Existing FDACleared Reverse Osmosis UnitPretreatment Equipment SizedBased upon water analysisAnd RO Mfg. Requirements
SAFETY FEATURES:	Makes Use Of Existing FeaturesIncorporated in Design of RO Unit	Makes Use Of Existing FeaturesIncorporated in Design of RO Unit
WATER CONTACTMATERIALS:	FDA NSF Compliant	FDA NSF Compliant
PERFORMANCESPECIFICATIONS:	Delivery Of Specified QuantityOf AAMI Standard Quality	Delivery Of Specified QuantityOf AAMI Standard Quality
CAPACITY:	Determined By RO Capacity	Determined By RO Capacity

How The Device Works:

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5 | OK Summary

Nonclinical Test Results:

The following sample results were taken from tests of a demonstration unit using an Osmonics Solorss reverse osmosis unit Serial Number 96-61650-11

Component	Feed Watermg/l	Permeatemg/l	AAMI Standardmg/l	Meets or ExceedsAAMI Standard
Calcium	34.3	1	2	Yes
Magnesium	5.63	1	4	Yes
Sodium	5.68	1	70	Yes
Potassium	1.55	1	8	Yes
Fluoride	0.82	0.1	0.2	Yes
Chlorine	1.68	0.02	0.5	Yes
Chloramines	0.02	0.02	0.1	Yes
Nitrate	0.37	0.1	2	Yes
Sulfate	28.8	5	100	Yes
Copper	0.105	0.01	0.1	Yes
Barium	0.022	0.01	0.1	Yes
Zinc	0.115	0.02	0.1	Yes
Aluminum	0.221	0.01	0.01	Yes
Arsenic	0.005	0.005	0.005	Yes
Lead	0.101	0.003	0.005	Yes
Silver	0.005	0.005	0.005	Yes
Cadmium	0.001	0.001	0.001	Yes
Chromium	0.005	0.005	0.014	Yes
Selenium	0.005	0.005	0.05	Yes
Mercury	0.0002	0.0002	0.0002	Yes

Based upon the above water assay, the water produced meets or exceeds AAMI standards for water to be used in the preparation of dialysate.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, with three intertwined lines forming a shape similar to a bird or a wave.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 8 1999

Michael J. Peterson, P.E. President Water Vault, Inc. 2003 Blair Boulevard Nashville, Tennessee 37212 Re:

K983512 Water Vault Cube Dated: February 9, 1999 Received: February 10, 1999 Regulatory class: II 21 CFR §876.5665/Product code: 78 FIP

Dear Mr. Peterson:

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, 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 regulation (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 regulation may result 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

K983512 510(k) Number (if known):_

Device Name: Water Vault Cube, Water Treatment System for HemoDialysis

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Computers of experiences from the proportion of the controlled with the count
				Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

David A. Severson

(Optional Format 1-2-96)

(Division Sign-Off) Division of Reproductive, Abdominal, El and Radiological Devic 510(k) Number.

Regulation Number and Section

§ 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.