(231 days)
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 and inorganic substances and microbial contaminants from water used to dilute dialysate. When used 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.
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. The water is 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 alarms to remove oxidants from the water that are harmful to patient health. The specific configuration of the equipment will depend upon the customer's water quality desires (specifications) beyond the minimum AAMI standards.
Pretreatment is used before the RO unit to match the specific influent water quality to those required by the RO unit manufacturer's specifications. Pretreatment 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 remaining contaminants. Deionization tanks, final filters, UV lamps, storage tanks, repressurization and recirculation pumps, flow meters, and resistivity monitors are examples of post treatment machines.
The Mueller Water Conditioning, Inc. (MWCI) water purification system utilizes no new water treatment technologies. Multimedia filtration, cartridge filtration, carbon filtration, reverse osmosis (R.O.), deionization, ultraviolet light and particulate filtration are the core methods of treatment for this system. The storage, piping, repressurization, recirculation, emergency bypasses, sanitization, labeling, training and customer service round out the efforts to ensure proper delivery of the treated water. All components of the claimed device use identical scientific principles to perform their function.
Here's an analysis of the provided text regarding the Mueller RO/DI System for Hemodialysis, focusing on acceptance criteria and the study proving it.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Mueller RO/DI System for Hemodialysis are the AAMI (Association for the Advancement of Medical Instrumentation) standards for water used in hemodialysis. The reported device performance is presented as a list of chemical component concentrations in the treated water.
| Component | Acceptance Criteria (Reference/AAMI Standard) | Reported Device Performance (Result) | Units | Meets or Exceeds AAMI Standards |
|---|---|---|---|---|
| Sodium Water | 70 | 0.054 | mg/L | Yes |
| Potassium, Water | 0.8 | <1.000 | mg/L | Yes |
| Aluminum, Water | 0.01 | <0.008 | mg/L | Yes |
| Calcium, Water | 0-2 | <0.050 | mg/L | Yes |
| Copper, Water | 0-0.1 | <0.005 | mg/L | Yes |
| Magnesium, Water | 0-4 | <0.050 | mg/L | Yes |
| Selenium, Water | 0-0.09 | <0.005 | mg/L | Yes |
| Zinc, Water | 0-0.1 | <0.005 | mg/L | Yes |
| Chromium, Water | 0-0.014 | <0.005 | mg/L | Yes |
| Chlorine | 0.5 | 0.0 | mg/L | Yes |
| Chloramine | 0.1 | 0.0 | mg/L | Yes |
| Lead, Water | 0-0.005 | <0.002 | mg/L | Yes |
| Arsenic, Water | 0-0.005 | <0.002 | mg/L | Yes |
| Mercury, Water | 0-0.0002 | <0.0002 | mg/L | Yes |
| Cadmium, Water | 0-0.001 | <0.0010 | mg/L | Yes |
| Beryllium, Water | 0-0.0004 | <0.0004 | mg/L | Yes |
| Antimony, Water | 0-0.006 | <0.006 | mg/L | Yes |
| Thallium, Water | 0-0.002 | <0.002 | mg/L | Yes |
| Silver, Water | 0-0.005 | <0.003 | mg/L | Yes |
| Barium, Water | 0-0.1 | <0.001 | mg/L | Yes |
| Fluoride, Water | 0-0.20 | <0.10 | mg/L | Yes |
| Nitrate, Water | 0-2.0 | <0.2 | mg/L | Yes |
| Sulfate, Water | 0-100 | <1.0 | mg/L | Yes |
| pH | (Not specified) | 5.7 | UNITS | (N/A) |
| Resistivity | (Not specified) | 0.769 | (N/A) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the numerical sample size for the test set. It refers to "the following data was obtained from a test system installed at our facility in Houston, TX." This implies a single test system operating under specific conditions to generate all the listed chemical measurement results.
- Data Provenance: The data was collected from a "test system installed at our facility in Houston, TX." This indicates it is prospective data, specifically collected for the purpose of demonstrating the device's performance. The country of origin for the data is the USA (Houston, Texas).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not describe the use of human experts to establish ground truth for this type of device. The ground truth here is based on analytical laboratory measurements of water quality, compared against established AAMI standards.
4. Adjudication Method for the Test Set
There is no mention of an adjudication method in the context of expert review for the test set. The validation is against a standardized chemical analysis.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable to this type of device. This device is a water purification system, and its performance is evaluated by objective chemical and physical measurements of the treated water, not by human interpretation of medical cases. Therefore, there is no "human readers improve with AI vs without AI assistance" effect size to report.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
The study presented here is effectively a standalone performance evaluation of the water purification system. The "algorithm" in this context is the physical and chemical processes of the device itself. The data reported (concentrations of various substances) directly reflects the output of the device without human intervention or interpretation in the performance measurement itself. Human operators set up and maintain the system, but the water purification process and its measurable output are standalone.
7. Type of Ground Truth Used
The type of ground truth used is analytical laboratory measurements of water quality, compared to established industry standards (AAMI Standards). For example, the measurement of "Sodium Water" at 0.054 mg/L is compared directly to the AAMI reference standard of 70 mg/L.
8. Sample Size for the Training Set
The document does not mention a training set. This is because the Mueller RO/DI System is a physical device, not an AI/machine learning algorithm. Therefore, it does not undergo a "training" phase in the computational sense. Its design and components (carbon filters, RO unit, deionization tanks, etc.) are based on established water treatment principles and engineering, not on data-driven machine learning.
9. How the Ground Truth for the Training Set Was Established
As there is no training set in the context of AI/machine learning, this point is not applicable. The "ground truth" for the device's design and functionality is based on scientific principles of water purification and manufacturing specifications for its components, ensuring they can achieve the desired water quality according to AAMI standards.
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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
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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 WATERCONDITIONING | U.S. FILTER |
|---|---|---|
| Intended Use: | Hemodialysis WaterTreatment | Hemodialysis WaterTreatment |
| Equipment: | Incorporates FDA-certifiedR.O. unit | Incorporates FDA-cert.fiedR.O. unit |
| Pre-Treatment Equipment: | Designed based upon wateranalysis, R.O. manufacturer'srequirement, and AAMI specs. | Designed based upon wateranalysis, R.O. manufacturer'srequirement, and AAMI specs. |
| Water Contact Materials: | FDA NSF Compliant | FDA NSF Compliant |
| Safety Features: | Utilizes R.O. safety features.Water conductivity/resistivityand tank water self-monitoredand alarmed. | Utilizes R.O. safety features.Water conductivity/resistivityand tank water self-monitoredand alarmed. |
| Performance: | Meets or exceeds AAMIStandards | Meets or exceed AAMIStandards |
| 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 | <1.000 | mg/L | 0.8 | Yes |
| Aluminum, Water | <0.008 | mg/L | 0.0.01 | Yes |
| Calcium, Water | <0.050 | mg/L | 0-2 | Yes |
| Copper, Water | <0.005 | mg/L | 0-0.1 | Yes |
| Magnesium, Water | <0.050 | mg/L | 0-4 | Yes |
| Selenium, Water | <0.005 | mg/L | 0-0.09 | Yes |
| Zinc, Water | <0.005 | mg/L | 0-0.1 | Yes |
| Chromium, Water | <0.005 | mg/L | 0-0.014 | Yes |
| Chlorine | 0.0 | mg/L | 0.5 | Yes |
| Chloramine | 0.0 | mg/L | 0.1 | Yes |
| Lead, Water | <0.002 | mg/L | 0-0.005 | Yes |
| Arsenic, Water | <0.002 | mg/L | 0-0.005 | Yes |
| Mercury, Water | <0.0002 | mg/L | 0-0.0002 | Yes |
| Cadmium, Water | <0.0010 | mg/L | 0-0.001 | Yes |
| Beryllium, Water | <0.0004 | mg/L | 0-0.0004 | Yes |
| Antimony, Water | <0.006 | mg/L | 0-0.006 | Yes |
| Thallium, Water | <0.002 | mg/L | 0-0.002 | Yes |
| Silver, Water | <0.003 | mg/L | 0-0.005 | Yes |
| Barium, Water | <0.001 | mg/L | 0-0.1 | Yes |
| Fluoride, Water | <0.10 | mg/L | 0-0.20 | Yes |
| Nitrate, Water | <0.2 | mg/L | 0-2.0 | Yes |
| Sulfate, Water | <1.0 | mg/L | 0.100 | Yes |
| pH | 5.7 | UNITS | ||
| Resistivity | 0.769 |
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Image /page/5/Picture/2 description: The image shows the seal of the Department of Health & Human Services (DHHS). The seal features a stylized bird with outstretched wings, symbolizing health and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird.
FEB 2 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. David W. Mueller Vice President Mueller Water Conditioning, Inc. 1500 Sherwood Forest Drive HOUSTON TX 77043
Re: K041884
K04186+
Trade/Device Name: Mueller RO/DI System for Hemodialysis Regulation Number: 21 CFR §876.5665 Regulation Name: Water purification system for hemodialysis Regulatory Class: II Product Code: 78 FIP Dated: January 31, 2005 Received: February 1, 2005
Dear Mr. Mueller:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have levewed your Secure 510(ts) probantially equivalent (for the indications for use stated in aoove and nave decemined the as treaticate devices marketed in interstate commerce prior to the enclosure) to legally mankelou products deal Device Amendments, or to devices that have been May 26, 1970, the Chacinent date of the Frederal Food, Drug, and Cosmetic Act (Act) that recrassified in accordatics with the proval application (PMA). You may, therefore, market the do not require approvat of a premiation of the Act. The general controls provisions of the Act device, subject to the general controls provices, 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 If your device is classified (300 additional controls. Existing major regulations affecting your Approval), It thay be subject to sour adentions, Title 21, Parts 800 to 898. In addition, FDA device can be nound in the concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advised mar PDA s issues is use ice complies with other requirements of the Act or any FDA has made a uccemination and your as read by other Federal agencies. You must comply with all the Federal statues and regulations administer of registration and listing (21 CFR Part 807); labeling Act s requirements, metuding, but hot mines is reguleements as set forth in the quality systems (QS) (21 CFR Part 801); good manafacturing product radiation control product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you'to begin manieing of substantial equivalence of your device to a legally premarket notheation: "The PDF missification 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), please If you desire specific active act of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the 00 : 7 / . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Nancy C. Brogdon
Nancy C. F Srogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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WATER CONDITIONIN
1500 Sherwood Forest Drive Houston, TX 77043 Tel: 713-467-3226 Fax: 713-467-9018
Indications for Use
510(k) Number (if known): __ K041884 _________________________________________________________________________________________________________________________________________
Mueller RO/DI System for Hemodialysis Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
Mueller Water Conditioning's Water Purification System for Hemodialysis is intended for use in Mueller Water Conditioning Water Panisation Cystoic and inorganic substances and t hemodialysis treatment. The System is used to dilute dialysate concentrate to form dialysate and to
microbial contaminants from water used to dilute dialysation. When used microbial contaminants from water about to allars and disinfection. When used as
produce purified water for dialyzer reprocessing, equipment rinse and discussion of a physic produce purnled water for dialyzer reproboooing, oquipment on the order of a physician.
a medical device, Federal law restricts this device to sale by or on the order of a ph
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 __
§ 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.