(203 days)
K#945559
K#945559
No
The device description details a physical water treatment system using standard filtration and sterilization methods, with no mention of AI or ML components.
No.
The device is a water treatment system for hemodialysis, which purifies water used to form dialysate, but it does not directly treat the patient. It's an ancillary device for a therapeutic procedure rather than a therapeutic device itself.
No
The device is a water treatment system for hemodialysis, designed to remove contaminants from water. It does not diagnose any medical conditions or analyze biological samples for diagnostic purposes.
No
The device description clearly outlines a physical water treatment system with multiple hardware components including filters, reverse osmosis units, ultrafilters, and UV sterilization. It is not solely software.
Based on the provided information, the WaterVault Cube Water Treatment System for HemoDialysis is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to treat water used to dilute dialysate concentrate for hemodialysis. This is a process that prepares a solution for use in a medical procedure (hemodialysis), not a test performed on a sample taken from the human body to diagnose a condition.
- Device Description: The device description details a water purification system using various physical and chemical processes (softening, carbon filtration, reverse osmosis, ultrafiltration, UV sterilization) to remove contaminants from water. This is a water treatment system, not a device designed to analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
Therefore, the WaterVault Cube Water Treatment System for HemoDialysis falls under the category of a medical device used in the preparation of a solution for a medical procedure, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
78 FIP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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. (Results are provided as a table for various components, feed water mg/l, permeate mg/l, AAMI Standard mg/l, and whether it Meets or Exceeds AAMI Standard for each component).
Key Metrics
Based upon the above water assay, the water produced meets or exceeds AAMI standards for water to be used in the preparation of dialysate.
Predicate Device(s)
K#945559
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
4/28/99
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 FDA | |
| Cleared Reverse Osmosis Unit |
Pretreatment Equipment Sized
Based upon water analysis
And RO Mfg. Requirements | Makes Use Of Existing FDA
Cleared Reverse Osmosis Unit
Pretreatment Equipment Sized
Based upon water analysis
And RO Mfg. Requirements |
| SAFETY FEATURES: | Makes Use Of Existing Features
Incorporated in Design of RO Unit | Makes Use Of Existing Features
Incorporated in Design of RO Unit |
| WATER CONTACT
MATERIALS: | FDA NSF Compliant | FDA NSF Compliant |
| PERFORMANCE
SPECIFICATIONS: | Delivery Of Specified Quantity
Of AAMI Standard Quality | Delivery Of Specified Quantity
Of AAMI Standard Quality |
| CAPACITY: | Determined By RO Capacity | Determined By RO Capacity |
How The Device Works:
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.
1
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 Water
mg/l | Permeate
mg/l | AAMI Standard
mg/l | Meets or Exceeds
AAMI 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.
2
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
3
Page 1 of 1
K983512 510(k) Number (if known):_
Device Name: Water Vault Cube, Water Treatment System for HemoDialysis
Indications For Use:
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.
(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)
OR
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.