(185 days)
No
The device description and performance studies focus on physical and chemical water purification processes (ion exchange, adsorption) and standard water quality testing. There is no mention of AI or ML in the document.
No.
Explanation: The device is a water purification system intended for use in hemodialysis facilities to provide purified water, not to directly treat patients.
No
The device is a water purification system used in hemodialysis to remove ions, chlorine, and chloramines from water. It is part of a larger water treatment system and does not directly diagnose medical conditions.
No
The device description clearly states the device is a physical tank filled with resin or activated carbon, which are hardware components.
Based on the provided text, the Ultrapure & Industrial Services Deionization Tanks and Carbon Exchange Tanks are not IVD (In Vitro Diagnostic) devices.
Here's why:
- Intended Use: The intended use is to purify water for use in hemodialysis. This is a process that treats the patient's blood, not a diagnostic test performed in vitro (outside the body) on a sample from the patient.
- Device Description: The devices are tanks filled with materials (resin and activated carbon) that physically and chemically remove impurities from water. They are part of a water treatment system, not a system designed to analyze biological samples.
- Lack of Diagnostic Function: The text does not describe any function related to diagnosing a disease, condition, or state of health. They are purely for water purification.
Therefore, these devices fall under the category of medical devices used in the treatment of patients, specifically for providing purified water for hemodialysis, rather than IVD devices used for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Ultrapure & Industrial Services Deionization Tanks are exchangeable/rechargeable mix bed tanks intended to remove ions from the water to a sufficient level to allow safe treatment of Hemodialysis patients. These deionization tanks are not to be used alone, but are intended to be a part of a larger water treatment system employing adequate pre-treatment and post treatment. Upon, exhaustion, these tanks will be replaced with other tanks containing newly regenerated resin, or new resin altogether.
The Ultrapure & Industrial Services Carbon Exchange Tanks are activated carbon tanks intended to remove chlorine and chioramines from the water to allow safe treatment of Hemodialysis patients. These carbon tanks are not to be used alone, but are intended to be part of a larger water treatment system employing adequate pre-treatment and post-treatment. Upon exhaustion, these tanks will be replaced with other tanks containing new activated carbon.
All Ultrapure & Industrial Services Deionizer and Carbon Exchange Tank Service for hemodialysis are intended to be used in a hemodialysis facility according to ANSI/AAMI-RD62:2006 standards to supply purified water for use in hemodialysis.
Product codes
FIP
Device Description
Deionizers: Ultrapure & Industrial Services Mixed Bed Deionization Exchange Tanks (DI) are Fiberglass Reinforced Polypropylene (FRP) tanks filled with mixed bed deionization resin. The tank sizes are common for the Dialysis industry with similar inlet and outlet fittings, PVC or Noryl heads and tank distributors. The DI Exchange Tanks are dedicated for ion exchange resin only. Our tanks are designed to deliver Association for the Advancement of Medical Instrumentation (AAMI) standard water through an ion exchange process to remove contaminantes from water being fed to the system. The DI system exchanges hydrogen ion (H+) for cations and hydroxyl ions (OH-) for anions in the feed water. The hydrogen and hydroxyl ions then combine to form pure water (H2O). The tanks are based on the AmeriWater Dialysis Deionizer Exchange Tanks K991519.
Similar to predicate AmeriWater, Ultra-Pure segregated aseptic exchange deionizer service in an on-line worker/polisher arrangement with a temperature compensated 1 megohm/cm resistance light monitor with audible alarm between the worker/polisher and a 0-19 megohm/cm temperatura compensated digital readout resistance meter with adjustable remote audio and visual alarm. Upon exhaustion, these tanks are replaced with other Deionization Tanks containing newly regenerated resin or with new resin altogether.
Carbon: Ultrapure & Industrial Services Carbon Exchange Tanks are Fiberglass Reinforced Polypropylene (FRP) tanks filled with new activated carbon. This carbón filtration, often referred to as granular activated carbón (GAC), will remove chlorine and chloramine that are almost always present in the source water through a chemical process knows as "adsorption". The tank sizes are common for the Dialysis industry with similar inlet and outlet fittings; PVC or Noryl heads and tank distributors. The Carbon Exchange Tanks are dedicated for carbon only. Ultrapure & Industrial Services always recommends that two tanks be installed in series, with the first tank providing the primary purification and the second tank serving as backup. Same recommendation is offered by the predicate. The tanks are based on the AmeriWater Dialysis Carbon Exchange Tanks K991519.
Dialysis segregated exchange process carbon service utilizes new virgin coal based granular activated carbon (GAC) of 12X40 mesh size with an iodine number of 1000 or greater. The tanks are disinfected with chlorine and cleaned before delivery to the dialysis application. Batch codes and dates are used to insure quality and freshness of the tanks. The tanks are re-bedded under our FDA/OS system with batch control of capacity, quality and microbiological control. Ultrapure & Industrial Services process includes a use of medical-grade carbon only followed by a 24-hour soak to fully wet the carbon followed by complete back-washing to remove any contaminants and provide a more natural pH product.
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
hemodialysis facility
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
A system performance test was run by simulating operational conditions. A system consisting of Carbon, and DI resins was set in place and operated. Quality testing of chlorine, chloramines and resistivity levels were monitored to ensure performance.
To qualify performance six (06) water samples were taken for validation purposes. Three samples of the raw feed water were drawn for use as a beginning foundation of the need for treatment. Three samples were taken from the final DI unit to validate performance meeting AAMI RD62 standards.
The water samples were sent to three separate labs: AmeriWater Laboratories, Culligan Water Testing Laboratory, and OXIDOR Laboratories, LLC.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing: A system performance test was run by simulating operational conditions. A system consisting of Carbon, and DI resins was set in place and operated. Quality testing of chlorine, chloramines and resistivity levels were monitored to ensure performance. Six water samples were taken for validation: three raw feed water samples and three samples from the final DI unit.
Lab Analysis Results:
- Analysis results from AmeriWater and Culligan show AAMI standard performance.
- Results from Oxidor Testing Laboratories show a reduction of TOC to non detectable limits.
- A table of lab analysis results from AmeriWater shows various components (Aluminum, Antimony, Arsenic, Barium, Beryllium, Cadmium, Calcium, Chromium, Copper, Fluoride, Iron, Lead, Magnesium, Mercury, Nitrate (as N), pH, Potassium, Resistivity, Selenium, Silver, Sodium, Sulfate, Thallium, TDS, Zinc) in feed water and treated water, and their comparison against AAMI Suggested Maximum Levels. All tested components in treated water met or exceeded the AAMI Standard. For instance, Aluminum was
§ 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.
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APR 2 5 2013
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510 (K) Summary
Ref: K123282
Mixed Bed Deionization (DI) and Carbon Exchange Tanks
Revision Date: February 25, 2013
-
- Prepared/Submitted by: Ultrapure & Industrial Services, LLC (UIS) 4429 Mint Way, Dallas, TX 75236
Contact Person: Wasif Asghar General Manager Telephone: (972) 432.9951
- Prepared/Submitted by: Ultrapure & Industrial Services, LLC (UIS) 4429 Mint Way, Dallas, TX 75236
-
- Devise Name: Deionization and Carbon Exchange Tanks for Dialysis
-
- Devise Classifications: Water Purification Component Class II Medical Device 21 CFR 876.5665, Product Code - FIP
-
- Predicate Devise: AmeriWater Dialysis and Carbon Exchange Tanks (K991519)
UIS Model Numbers:
| Deionization Tank Model No. | Carbon Tank Model No. |
|---|---|
| UIS-618-MB-D | UIS-618-GAC |
| UIS-818-MB-D | UIS-818-GAC |
| UIS-844-MB-D | UIS-844-GAC |
| UIS-1047-MB-D | UIS-1047-GAC |
| UIS-1447-MB-D | UIS-1447-GAC |
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ULTRAPURE & IN
K123282 page 2 of 9
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5. Device Description:
Deionizers: Ultrapure & Industrial Services Mixed Bed Deionization Exchange Tanks (DI) are Fiberglass Reinforced Polypropylene (FRP) tanks filled with mixed bed deionization resin. The tank sizes are common for the Dialysis industry with similar inlet and outlet fittings, PVC or Noryl heads and tank distributors. The DI Exchange Tanks are dedicated for ion exchange resin only. Our tanks are designed to deliver Association for the Advancement of Medical Instrumentation (AAMI) standard water through an ion exchange process to remove contaminantes from water being fed to the system. The DI system exchanges hydrogen ion (H+) for cations and hydroxyl ions (OH-) for anions in the feed water. The hydrogen and hydroxyl ions then combine to form pure water (H2O). The tanks are based on the AmeriWater Dialysis Deionizer Exchange Tanks K991519.
Similar to predicate AmeriWater, Ultra-Pure segregated aseptic exchange deionizer service in an on-line worker/polisher arrangement with a temperature compensated 1 megobm/cm resistance light monitor with audible alarm between the worker/polisher and a 0-19 megohm/cm temperatura compensated digital readout resistance meter with adjustable remote audio and visual alarm. Upon exhaustion, these tanks are replaced with other Deionization Tanks containing newly regenerated resin or with new resin altogether.
| UIS Deionizer Exchange Tank Models | ||
|---|---|---|
| Model Number | Cubic Feet | Flow in GPM |
| UIS-618-D | 0.27 | 0.5 |
| UIS-818-D | 0.47 | 1.0 |
| UIS-844-D | 1.25 | 2.5 |
| UIS-1047-D | 1.90 | 3.8 |
| UIS-1447-D | 3.60 | 7.2 |
Divert to drain is now required by AAMI. When deionizer water resistivity drops below 1 megohm the deionized water dumps to drain.
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ULTRAPURE & UDDISTRIAL SERVICES,
Carbon: Ultrapure & Industrial Services Carbon Exchange Tanks are Fiberglass Reinforced Polypropylene (FRP) tanks filled with new activated carbon. This carbón filtration, often referred to as granular activated carbón (GAC), will remove chlorine and chloramine that are almost always present in the source water through a chemical process knows as "adsorption". The tank sizes are common for the Dialysis industry with similar inlet and outlet fittings; PVC or Noryl heads and tank distributors. The Carbon Exchange Tanks are dedicated for carbon only. Ultrapure & Industrial Services always recommends that two tanks be installed in series, with the first tank providing the primary purification and the second tank serving as backup. Same recommendation is offered by the predicate. The tanks are based on the AmeriWater Dialysis Carbon Exchange Tanks K991519.
K123282 page 3 of 9
31
Dialysis segregated exchange process carbon service utilizes new virgin coal based granular activated carbon (GAC) of 12X40 mesh size with an iodine number of 1000 or greater.
The tanks are disinfected with chlorine and cleaned before delivery to the dialysis application. Batch codes and dates are used to insure quality and freshness of the tanks. The tanks are re-bedded under our FDA/OS system with batch control of capacity, quality and microbiological control. Ultrapure & Industrial Services process includes a use of medical-grade carbon only followed by a 24-hour soak to fully wet the carbon followed by complete back-washing to remove any contaminants and provide a more natural pH product.
| UIS Carbon Exchange Tank Models | ||
|---|---|---|
| Model Number | Cubic Feet | Flow in GPM |
| UIS-618-GAC | 0.27 | 0.5 |
| UIS-818-GAC | 0.47 | 1.0 |
| UIS-844-GAC | 1.25 | 2.5 |
| UIS-1047-GAC | 1.90 | 3.8 |
| UIS-1447-GAC | 3.60 | 7.2 |
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ULTRAPURE & IN
6. Indication of Use:
- A. The Ultrapure & Industrial Services (UIS) Deionization Tanks are 0 exchangeable/rechargeable mix bed tanks intended to remove ions from the water to a sufficient level to allow safe treatment of Hemodialysis patients. These deionization tanks are not to be used alone, but are intended to be a part of a larger water treatment system employing adequate pre-treatment and post treatment. Upon, exhaustion, these tanks will be replaced with other tanks containing newly regenerated resin, or new resin altogether.
| Deionizer Tank Models | |
|---|---|
| Model Number | Cubic Feet |
| UIS-618-MB-D | 0.27 |
| UIS-818-MB-D | 0.48 |
| UIS-844-MB-D | 1.25 |
| UIS-1047-MB-D | 1.90 |
| UIS-MB-1447-D | 3.60 |
- B. The Ultrapure & Industrial Services Carbon Exchange Tanks are activated carbon tanks intended to remove chlorine and chloramines from the water to allow safe treatment of Hemodialysis patients. These carbon tanks are not be used alone, but are intended to be part of a larger water treatment system employing adequate pretreatment and post-treatment. Upon exhaustion, these tanks will be replaced with other tanks containing new activated carbon.
| Carbon Tank Models | ||
|---|---|---|
| Model Number | Cubic Feet | |
| UIS-618-GAC | 0.27 | |
| UIS-818-GAC | 0.47 | |
| UIS-844-GAC | 1.25 | |
| UIS-1047-GAC | 1.90 | |
| UIS-1447-GAC | 3.60 |
All Ultrapure & Industrial Services Deionizer and Carbon Exchange Tank Service for hemodialysis are intended to be used in a hemodialysis facility according to ANSI/AAMI-RD62:2006 standards to supply purified water for use in hemodialysis.
Ultrapure & Industrial Services, LLC 4429 Mint Way, Dallas, Texas 75236 Telephone: 972.432.9951 Fax: 972.432.9954 www.ultrapure.com
ব
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Image /page/4/Picture/0 description: The image shows the logo for Ultrapure & Industrial Services, LLC. The logo features a stylized droplet above the word "ULTRAPURE" in a bold, sans-serif font. Below that is the text "ULTRAPURE & INDUSTRIAL SERVICES, LLC" in a similar font, but slightly smaller in size. The overall design is simple and professional.
7. Comparison to Predicate: AmeriWater Exchange Tanks (K991519)
Ultrapure & Industrial Services, LLC exchange tanks for dialysis are substantially equivalent to the currently marketed AmeriWater Dialysis tanks and have not altered the fundamental scientific technologies used in the predicate device. The intended use of the exchange tanks for dialysis is the same as the intended use of the AmeriWater predicate device (K991519).
| (Predicate Device)
Ameriwater Dialysis Deionizer
Exchange Service (K991519) | Ultrapure & Industrial Services, LLC
Dialysis Deionizer
Exchange Service |
|--------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Carbon Filtration. Calgon's Centaur | *Carbon Filtration. Medical Grade Resin
Tech (AGC-40 MG) carbon. |
| FRP tanks manufactured by Park
International (Now Pentair), brand "Park" | **FRP tanks manufactured by Pentair
under brand name Park / Structure |
| MBD-10 Resin manufactured by ResinTech | MBD-10 Resin manufactured by
ResinTech |
| Resi-Lite 1 megohm audio/visual alarm
positioned between worker and polisher | Resi-Lite 1 megohm audio/visual alarm
positioned between worker and polisher |
| Interconnecting Tubing. High Purity PVC. | Interconnecting Tubing. High Purity PVC. |
| Connectors; Made of glass filled Noryl | Connectors; Made of glass filled Noryl |
| Heads and fill plugs: PVC schedule 80
machined head with PVC
PVC schedule 80
fill plug. | ***Heads and fill plugs: PVC schedule 80
machined head with PVC schedule 80 fill
plug or Glass filled Noryl head and fill
plug. |
| PVC schedule stand pipe and distributor
basket | PVC schedule stand pipe and distributor
basket |
Substantial Equivalence
MINOR DIFFERENCE
- For carbon media, the predicate uses Calgon's Centaur while Ultrapure & Industrial Services device uses ResinTech Medical Grade Activated Carbon AGC-40 MG. It is much superior premium grade curbon especially prepared for use in medical industry and is fully tested to AAMI standards. Both medias meet AAMI/RD62:2006 standards.
** Park International is now owned by Pentair Water Treatment. Tanks are sold under the nume of Park and Structure. Predicute AmeriWater uses the same manufacturer.
Ultrapure & Industrial Services, LLC 4429 Mint Way, Dallas, Texas 75236 Telephone: 972.432.9951 Fax: 972.432.9954 www.ultrapure.com
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INTRAPURE & INDU
K123282 page 6 of 9
હ
*** Heads and Fill plugs: Ultrapure and Industrial Services, LLC uses both PVC schedule 80 machined head with PVC schedule 80 fill plug (predicate AmeriWater R991519) and glass filled Noryl head and fill plug (predicates Aqua Systems K092481).
Note: All components used meet or exceed ANSVAAMI RD62-2006 standards.
Ultrapure and Industrial Services exchange tanks for both Deionization (DI) and Carbon (GAC) are fiberglass reinforced polypropylene (FRP) tanks. These tanks are 100% non-corrosive with inner-shell material of Seamless Polyethylene. The design parameters meet and exceed NSF, ASME & ANSI/AAMI RD62-2006 standards. Tanks are dedicated either for deionization or carbon and are not interchangeable. The tanks and sizes are similar to those used by the predicate AmeriWater (K991519) [Also predicates Aqua Sciences K102892]. Sizes are common and widely used in the dialysis industry and tank size utilization is based on water volume required for each individual clinic. Ultrapure & Industrial Services purchase all tanks from the same manufacturer as the predicate AmeriWater.
Deionization tanks from both Ultrapure & Industrial Services and AmeriWater are utilized to remove dissolved solids from the water. Both companies utilize mixed bed resin, consisting of cations and anions resins to remove the charged particles in the water. Both utilize parts and materials that are NSF and/or FDA approved.
Activated carbon tanks/filtration is utilized by both Ultrapure & Industrial Services and AmeriWater to filter out chlorine and chloramines from the water. Ultrapure utilizes the "bighest quality Medical Grade activated carbon that meets NSF and AAMI standards.
Both companies use two (2) carbon tanks in a series configuration. Both Ultrapure & Industrial Services and AmeriWater recommend that chlorine and chloramines are checked before each patient shift. Both companies utilize activated carbon with an iodine number of 1000 or greater. Ultrapure & Industrial Services recommends using dual carbon filtration in series in every dialysis water system installed, including single patient systems.
8. Performance Testing
A system performance test was run by simulating operational conditions. A system consisting of Carbon, and DI resins was set in place and operated. Quality testing of chlorine, chloramines and resistivity levels were monitored to ensure performance.
To qualify performance six (06) water samples were taken for validation purposes. Three samples of the raw feed water were drawn for use as a beginning foundation of the need for treatment. Three samples were taken from the final DI unit to validate performance meeting AAMI RD62 standards.
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K123282 page 7 of 9
7
The water samples were sent to three separate labs. To test for AAMI standards, a raw water feed sample and a treated water feed sample was sent to AmeriWater and Culligan Laboratories. To test for TOC, a raw water feed sample and a treated water feed sample was sent to Oxidor Testing Laboratory.
Analysis results from AmeriWater and Culligan show AAMI standard performance. Results from Oxidor Testing Laboratories show a reduction of TOC to non detectable limits. Analysis results and testing facility contacts are submitted along with this submission. {See Lab tests reports enclosed]
Test Labs Used
- V AmeriWater Laboratories (Test conformance to AAMI Standards) 1303 Stanley Ave, Dayton, OHIO 45404
- A Culligan Water Testing Laboratory (Test conformance to AAMI Standurds) 9399 W.Higgins Road, Suite#1100 Rosemont, IL 60018
- A OXIDOR Laboratories, LLC (Test for TOC) 1825 E. Plano Pkwy #160 Plano, TX 75074
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K123282 page 8 of 9
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LAB ANALYSIS (Testing Lab: AmeriWater)
၊
ﻤﻴﺮﺳ ﺴﻴﺮﺳ ﺍﻟ
| | Feed
Water | Treated | AAMI Suggested
Maximum Level | Meets or Exceeds |
|----------------|---------------|------------|---------------------------------|------------------|
| Component | mg/L | Water mg/L | mg/L | AAMI Standard |
| Aluminum | 0.001 |