(231 days)
Not Found
No
The document explicitly states that the system "utilizes no new water treatment technologies" and that "All components of the claimed device use identical scientific principles to perform their function." There is no mention of AI or ML in the description of the device's operation or components.
No.
The device purifies water used in hemodialysis and for equipment reprocessing, but it does not directly treat the patient or perform a therapeutic function itself.
No
The device is a water purification system used to produce purified water for hemodialysis and dialyzer reprocessing; it does not diagnose a medical condition.
No
The device description clearly outlines numerous hardware components including filters, RO units, deionization tanks, pumps, UV lamps, storage tanks, and more. It is a physical water purification system.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Mueller Water Conditioning's Water Purification System for Hemodialysis is designed to treat water used in hemodialysis. Its purpose is to remove contaminants from the water before it is used in the dialysis process, not to analyze or test biological specimens from a patient.
- Intended Use: The intended use clearly states it's for "use in hemodialysis treatment" and to "dilute dialysate concentrate to form dialysate and to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate." This is about preparing a substance (purified water) for a medical procedure, not diagnosing or monitoring a patient's condition through laboratory testing of their samples.
- Lack of Specimen Analysis: The device description and performance studies focus on the quality of the treated water, not on the analysis of patient samples.
Therefore, while it is a medical device used in a clinical setting, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Mueller Water Conditioning's Water Purification System for Hemodialysis is intended for use in hemodialysis treatment. The System is used to dilute dialysate concentrate to form dialysate and to remove organic, inorganic substances and microbial contaminants from water used to dilute dialysate and to produce purified water for dialyzer reprocessing, equipment rinse and disinfection. When used as a medical device, Federal law restricts this device to sale by or on the order of a physician.
Product codes
F1P
Device Description
The Mueller RO/Di system for hemodialysis treats incoming facility water to provide water conforming to AAMI standards for hemodialysis use in respect to organic and inorganic substances as well as microbial contaminants for water intended for use as dilute dialysate, as dilute dialysate, as dilute dialysate, bicarbonate, acetate and sterilant for dialyzer reprocessing.
The core components of the system include carbon filters along with reverse osmosis (RO) unit and portable exchange deionization tanks along with approve oxidants from organized and portable exchange deionization tanks along will rappigination of the equip nont will the water that are harmful to patient health. The specific onfiguration A Mi the water that are narmful to pallent health. "The Spoolle obling the minimum AAM depend upon the customer's water quality desires (specifications) beyond the minimum AAM standards.
Pretreatment is used before the RO unit to match the specific influent water quality to those Pretreatment is used before the RO unit to mater the oppositions. Prefections will include multi-media filtration, water softening, carbon filtration, and sediment filtration.
Post treatment is used after the RO unit to polish and monitor the water of any maters. Delinitiation Post treatment is used and to polici and many and many pumps, flow meters, Deionization machines.
The Mueller Water Conditioning, Inc. (MWCl) water purification system utilizes no new water The Mueller Water Conditioning, The RWVOr, nultimedia filtration, carticige filtration, care the occa reverse osmosis (R.O.), deionization, ultraviolet light and particulate filitration are the core reverse of treatment for this system. The storage, ping, repressures arrization, emergency memous of treathent for this System. - The cornmentation round out the efforts to ensure Dybasses, Samization, Tabeling, Training and Costered device we are claiming substantial equivalent proper delivery of the treateds ic principles to perform their function.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following data was obtained from a test system installed at our facility in Houston, TX. The water used for dialysis The following data was oblanced willity for determing the quality of the water used for dialysis, customer has the ultimate responsibility for determing the mater used for di customer has the ultimate responsibility for doternming . but the following results show the water tested to AAMI standards.
Results shown in table for: Sodium Water, Potassium, Water, Aluminum, Water, Calcium, Water, Copper, Water, Magnesium, Water, Selenium, Water, Zinc, Water, Chromium, Water, Chlorine, Chloramine, Lead, Water, Arsenic, Water, Mercury, Water, Cadmium, Water, Beryllium, Water, Antimony, Water, Thallium, Water, Silver, Water, Barium, Water, Fluoride, Water, Nitrate, Water, Sulfate, Water, pH, Resistivity.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
U.S. Filter Corporation Water Purification System for Hemodialysis 510(k) #K980182
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.
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Image /page/0/Picture/0 description: The image shows the word "Mueller" in a stylized, cursive font. The text is in black and stands out against a white background. A horizontal line is present underneath the word.
FEB 2 8 2005
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TER CONDITIONING, IN
Houston, Texas 77043 1500 Sherwood Forest Dr. . · Fax (713) 467-9018 (713) 467-3226
510(k) Summary
Mueller Water Conditioning, Inc. 1500 Sherwood Forest Dr. Houston TX 77043
Phone: 713/467-3226 Fax: 713/467-9018
| Contact: | |
|---|---|
| Date of summary preparation: |
David W. Mueller June 1, 2004
Device Name:
Proprietary Name: Common Name:
Mueller RO/DI System for Hemodialysis Water Purification System for Hemodialysis
Classification:
Class II CFR #876.5665 F1P Product Code:
Device claiming equivalence to:
U.S. Filter Corporation Water Purification System for Hemodialysis 510(k) #K980182
Image /page/0/Picture/17 description: The image shows a logo for "Water Quality". The logo consists of three curved lines on the left side, and the words "Water Quality" on the right side. The words are stacked on top of each other, with "Water" on top and "Quality" on the bottom. The logo is black and white.
Image /page/0/Picture/18 description: The image shows a logo or emblem with the word "MEMBER" in bold, uppercase letters across the top. Below "MEMBER" is the text "COMMUNITY ASSOCIATIONS INSTITUTE" stacked in three lines. The text is in a simple, sans-serif font and appears to be part of an organization's branding.
Image /page/0/Picture/20 description: The image shows a logo of the state of Texas with four water droplets superimposed on it. Each droplet contains a letter: T, W, A, and Q. The droplets are arranged in a circular pattern in the center of the state outline, suggesting a focus on water-related issues within Texas.
Image /page/0/Picture/21 description: The image shows a black and white circular logo. The letters 'HAA' are prominently displayed in the center of the circle in a bold, sans-serif font. Encircling the letters is text that appears to read 'HOUSING ASSOCIATION YORK'. The text is arranged along the perimeter of the circle, creating a border around the central letters.
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KCL 994
PAGE 2 OF 5
DEVICE DESCRIPTION
The Mueller RO/Di system for hemodialysis treats incoming facility water to provide water The Mueller RO/Di system for hemodialysis use in respect to respect to reganic and inorganic and intraganic conforming to AAMI standards for hemodiatists for water intended for use as dilute lialysate, as dilute lialysate, as dilute lialysate, Substances as well as well as microbia.
bicarbonate, acetate and sterilant for dialyzer reprocessing.
The core components of the system include carbon filters along with reverse osmosis (RO) unit The core components of the system include carbeth alarms to remove oxidants from
and portable exchange deionization tanks along with approve oxidants from organized and portable exchange delonization tanks along will rappigination of the equip nont will
the water that are harmful to patient The specific onfiguration A Mi the water that are narmul to pallent health. "The Spoolle obling the minimum AAM
depend upon the customer's water quality desires (specifications) beyond the minimum AAM standards.
Pretreatment is used before the RO unit to match the specific influent water quality to those Pretreatment is used before the RO unit to mater the oppositions. Prefections will include multi-media filtration, water softening, carbon filtration, and sediment filtration.
Post treatment is used after the RO unit to polish and monitor the water of any maters. Delinitiation Post treatment is used and to polici and many and many pumps, flow meters, Deionization machines.
The Mueller Water Conditioning, Inc. (MWCl) water purification system utilizes no new water The Mueller Water Conditioning, The RWVOr, nultimedia filtration, carticige filtration, care the occa reverse osmosis (R.O.), deionization, ultraviolet light and particulate filitration are the core reverse of treatment for this system. The storage, ping, repressures arrization, emergency memous of treathent for this System. - The cornentation round out the efforts to ensure Dybasses, Samization, Tabeling, Training and Costered device we are claiming substantial equivalent proper delivery of the treateds ic principles to perform their function.
Below is a summary for each component of the system.
Multimedia Filters
MWCI uses multimedia filters constructed of materials that are F.D.A. or "NSF" aproved. MWCT USes Intuitinedia illiers constractor or thysician direction, either time clock or meter-Dependant upon System Toquilting and e, twin or twin alternating configuration. Where time intitutions may be used, ones, in a creating the relay precludes R.O operation during filter backwash operations.
Water Softeners
MWCI uses water softeners constructed of materials that are F.D.A. or "NSF" approved. MWCI USes Water Sonchere Sonotrants and physician direction, either time clock or meter-initiated Dependant upon system roquirements and pri jor twin alternating configuration. Where time clock softeners thay be used, citier in a onglo, thir or while while would be not of the softener regeneration.
Carbon Filtration
Chloramines and chlorine are both filtered utilizing carbon filtration in a "worker-polisher" Grilliannes and chionne are bon microler after each filter. Minimum empty bed contact time Connguration with Test personing and Classes as recommended by the FDA. (EDOT) of of of minuted is informe and chloramine breakthrough prior to each patient shift. MWOr recommonde touting for only in either system. Both utilize carbon with a Dypass piping of the Garbon illuralism is is where single-patient systems are in use, MWCI allows milling in soo fourile handon. In theatless where minimum standards EBCT can be met, but in no instances is a multi-patient system installed without worker-polisher carbon tank configuration unless so directed by the attending physician.
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Cartridge Filtration
MWCI uses R.O. particulate cartridge filtration of non-cotton construction. Where an its includion ta MWCT uses H.O. panticulate carmoge intration of non octastalled with isolation valves to
be shut down for cartridge replacement, dual filter housings are installed with is of be snut down for carthuge replacement while the R.O. is in operation. MWCl uses 1 or 5 micron cartridge filtration of melt-blown construction.
Reverse Osmosis
MWCI uses only R.O. units that are registered Medical devices. Modification to the R.O. systems MWCT uses only 11.0. unlis that are regiored modificed by the manufacturer and as delivered by the manufacturer is forbladem aniest processions for external, remote alarms documented. H.O. systems area (typically in the nurses' station). Use of the remote for installation mo the dialysis treatment arou (typioany in the his in direct view of the system.
Water Storage
MWCI uses R.O. water storage tanks constructed of F.D.A. or "NSF" approved materials MWCI uses T.C. Watch Storago tanks ovents. Vent filters are replaced annually.
Repressurization/Recirculation
MWCI uses R.O. product water repressurization/recirculation pumps sized for adequate flow and MWCT uses H.O. product water repressunzation in originalism personalism of 3 pressure for the intended asc. While poculate, the flow point. Where Direct Feed systems rinay teet per second (ips) volonity at the lows for of the point where the loop return feeds to the F.O. intet. Where dual recirculation pumps are installed, the pumps shall be installed in a parallel intel. "While dual roomation ply to minimize water stagnation. This pump alternation shall be Comigation and allernatou wookly or automatically depending on the direction of the attending physician.
Piping
MWCI uses PVC schedule 80 piping and valves for water distribution post-R.O., unless otherwise MWOT ass I VO tonound ou piping and -R.O. piping may include a combination of galvanized, copper, brass and PVC piping and valving.
Deionization
Unless otherwise directed by the attending physician, MWCI uses mixed-bed deionization tanks in a series, "worker-polisher" configuration. MWCI uses a local 1-megohm quality control light on the "worker" tank, and a temperature compensated resistivity monitor on the "polisher" tank. The the worker tamily and a temporal calibration utilizing NIST traceable calibration equipment as directed by the monitor manufacturer unless otherwise directed by the attending physician. The monitor has a remote alarm capability or is itself installed in the common area (such as the nurses' station) of the unit, with the probe installed immediately after the polishing deionizer. The alarm set point of the resistivity monitor is set to indicate an alarm condition at 5 megohms, unless otherwise directed by the attending physician.
Final Filtration and U.V. Lamps
MWCI uses 0.2-micron absolute final filters and/or ultrafiltration in all system designs to remove bacterial contamination and control endotoxin levels. MWCI also uses UV lamps in all system designs unless otherwise directed by the attending physician, with the final filters installed downstream of the UV lamps.
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Emergency bypass
MWCI provides emergency bypass lines and valving that are clearly tagged and labeled. Usage MWCI provides emergency bypass intes and varing that are areany any and or their agents as identified by the customer.
SANITIZATION
To avoid additional valving and/or dead legs, introduction of sanitizing agents shall be via either To avoid additional valving andror dead logo, infroductions of eatherwise directed by the artending physician.
In summary, the MWCI system is quite similar in design and function to other systems already in your In surfifialy, the basic water purification components and methods are idential. Most of the mankelplace. The basic water pamilation components in of MWCI to provide reliable, costeffective treatment and design.
INTENDED USE STATEMENT
Mueller Water Conditioning's Water Treatment System for Hemodialysis is intended to be used Mueller Water Used in hemodialysis treatment by removing organic, increanic, and Tor punlying the water used in nomballary.com will be restricts this device to sale by or on the order of a physician.
| COMPARISON | MUELLER WATER
CONDITIONING | U.S. FILTER |
|--------------------------|-------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Intended Use: | Hemodialysis Water
Treatment | Hemodialysis Water
Treatment |
| Equipment: | Incorporates FDA-certified
R.O. unit | Incorporates FDA-cert.fied
R.O. unit |
| Pre-Treatment Equipment: | Designed based upon water
analysis, R.O. manufacturer's
requirement, and AAMI specs. | Designed based upon water
analysis, R.O. manufacturer's
requirement, and AAMI specs. |
| Water Contact Materials: | FDA NSF Compliant | FDA NSF Compliant |
| Safety Features: | Utilizes R.O. safety features.
Water conductivity/resistivity
and tank water self-monitored
and alarmed. | Utilizes R.O. safety features.
Water conductivity/resistivity
and tank water self-monitored
and alarmed. |
| Performance: | Meets or exceeds AAMI
Standards | Meets or exceed AAMI
Standards |
| Capacity: | Determined by R.O. Capacity | Determined by R.O. Capacity |
TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE DEVICE
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KC418821
PAGE 5 of 5
CONCLUSION OF PERFORMANCE DATA
The following data was obtained from a test system installed at our facility in Houston, TX. The water used for dielysis The following data was oblanced willity for determing the quality of the water used for dialysis,
customer has the ultimate responsibility for determing the mater used for di customer has the ultimate responsibility for doternming .
but the following results show the water tested to AAMI standards.
| COMPONENT | RESULT | UNITS | REFERENCE | MEETS OR EXCEEDS AAMI STANDARDS |
|---|---|---|---|---|
| Sodium Water | 0.054 | mg/L | 70 | Yes |
| Potassium, Water | Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR |
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David h. Ingram
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number __