(125 days)
Not Found
No
The description focuses on the physical process of reverse osmosis and heat sanitization, with no mention of AI or ML technologies.
No
Explanation: The device is a water treatment system intended for use in hemodialysis applications. It purifies water used to prepare dialysate, but it does not directly treat a patient's medical condition. It is a component of a larger system used in a therapeutic process, but not a therapeutic device itself.
No
The device is a water treatment system used to purify water for hemodialysis applications. It does not diagnose any condition or disease.
No
The device description clearly outlines a physical water treatment system with components like pumps, membranes, and valves, indicating it is a hardware device with potentially integrated software for control and monitoring.
Based on the provided text, the AmeriWater Centurion 1500+ Reverse Osmosis System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to purify water for use in making dialysate for hemodialysis. This is a water treatment process, not a diagnostic test performed on biological samples.
- Device Description: The device description focuses on the physical process of reverse osmosis to remove contaminants from water. It does not describe any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes in biological samples
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition
- Reagents or assays
The device is clearly described as a water treatment system used as a component in a larger water purification system for hemodialysis. While the quality of the water is critical for the medical procedure, the device itself is not performing a diagnostic function.
N/A
Intended Use / Indications for Use
The AmeriWater Centurion 1500+ Reverse Osmosis Systems are water treatment systems intended for use in hemodialysis applications. They are designed to pre-treat and purify potable water for use in making dialysate for hemodialysis and to meet current AAMI and Federal (U.S.) standards. The device is intended to be a component in a complete water purification system, and is not a complete water treatment system. It must be preceded by pre-treatment devices, and may need to be followed by post-treatment devices as well to meet current AAM and Federal (U.S.) standards. The Centurion 1500+ Reverse Osmosis System is intended for use in a hospital, clinic, dialysis center, or for home care for single patient use. The device includes an integrated heat sanitization process.
Product codes (comma separated list FDA assigned to the subject device)
FIP
Device Description
The AmeriWater Centurion 1500+ Reverse Osmosis System is a water treatment system intended for use in hemodialysis applications. The system is designed to remove organic and inorganic substances and contaminants from potable water. The purified (or treated) water will then be used to prepare and dilute dialysate concentrate to form dialysate. The AmeriWater Centurion 1500+ Reverse Osmosis System is intended to be used in hospitals, clinics, dialysis centers, and for home care use. There is no direct contact between the patient and any part of the device invasive. Materials that contact that contact the product water include: Nylon, Polypropylene, Stainless Steel, EPDM, and Thin Film Composite Membrane (Polyamide). The Centurion 1500+ Reverse Osmosis System purifies water by applying pressure (greater than the osmotic pressure difference) to the feed water to reverse the water flow through a semi-permeable membrane so that the water moves from a more concentrated solution to a less concentrated solution resulting in purified permeate flow. The feed water enters the Centurion through an inlet solenoid valve filling the feed water tank. A high pressure pump forces water from the feed tank through the RO membrane where it is split into permeate which has passed through the membrane and the concentrate which passes over the membrane and carries the contaminants to drain. The AmeriWater Centurion 1500+ Reverse Osmosis System produces water that meets current AAMI and Federal (U.S.) standards for water used in hemodialysis applications.
The AmeriWater Centurion 1500+ Reverse Osmosis System also includes a built in heat sanitization feature. Heat sanitization can be activated manually using the HEAT SANITIZATION function from the controller's main menu. The frequency of thermal sanitization will depend upon usage and application demands. Monitoring of the system for bacterial content should be conducted at regular intervals to determine the optimum frequency for thermal sanitization.
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
hospital, clinic, dialysis center, or for home care
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)
Non-clinical testing was conducted to verify and validate the performance of the reverse osmosis function and the efficacy of the heat sanitization of bacteria. Results of performance testing indicate that the device produces water that meets current AAM and Federal (U.S.) standards. Microbiological testing results show evidence that the heat sanitization function is effective in the reduction of bacteria. Clinical studies show evidence that the device, when used in accordance with the instructions for use, will produce water that meets current AAMI and Federal (U.S.) standards for hemodialysis. Test results from biocompatibility testing, software validation, and electrical safety testing (in accordance with IEC 60601-1) indicate that the device is safe and effective for its intended purpose.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
1303 STANLEY AVENUE DAYTON, OH 45404 USA TEL 937-461-8833, 800-535-5585 FAX 937-461-1988 www.AMERIWATER.com
February 27, 2014
510(K) SUMMARY
| 510(K) Number: | K133783 |
|---|---|
| Submitter: | AmeriWater |
| Contact: | Brian R. Bowman, Quality & Regulatory Administrator |
| 1303 Stanley Avenue, Dayton, OH 45404 | |
| Phone: (937)461-8833 Fax: (937)461-1988 | |
| brianbowman@ameriwater.com | |
| Proprietary Name: | AmeriWater Centurion 1500+ Reverse Osmosis System |
| Common Name: | Reverse Osmosis System |
| Classification Name: | Water purification system for hemodialysis |
| Classification: | Class II Medical Device under §876.5665 |
| Panel: Gastroenterology | |
| Product Code: FIP | |
| Equivalent Devices: | K131904, AmeriWater MediQA Reverse Osmosis System |
K111740, AmeriWater MRO Portable Reverse Osmosis System MROS Device Description: The AmeriWater Centurion 1500+ Reverse Osmosis System is a water treatment system intended for use in hemodialysis applications. The system is designed to remove organic and inorganic substances and contaminants from potable water. The purified (or treated) water will then be used to prepare and dilute dialysate concentrate to form dialysate. The AmeriWater Centurion 1500+ Reverse Osmosis System is intended to be used in hospitals, clinics, dialysis centers, and for home care use. There is no direct contact between the patient and any part of the device invasive. Materials that contact that contact the product water include: Nylon, Polypropylene, Stainless Steel, EPDM, and Thin Film Composite Membrane (Polyamide). The Centurion 1500+ Reverse Osmosis System purifies water by applying pressure (greater than the osmotic
pressure difference) to the feed water to reverse the water flow through a semi-permeable membrane so that the water moves from a more concentrated solution to a less concentrated solution resulting in purified permeate flow. The feed water enters the Centurion through an inlet solenoid valve filling the feed water tank. A high pressure pump forces water from the feed tank through the RO membrane where it is split into permeate which has passed through the membrane and the concentrate which passes over the membrane and carries the contaminants to drain. The AmeriWater Centurion 1500+ Reverse Osmosis System produces water that meets current AAMI and Federal (U.S.) standards for water used in hemodialysis applications.
The AmeriWater Centurion 1500+ Reverse Osmosis System also includes a built in heat sanitization feature. Heat sanitization can be activated manually using the HEAT SANITIZATION function from the controller's main menu. The frequency of thermal sanitization will depend upon usage and application demands. Monitoring of the system for bacterial content should be conducted at regular intervals to determine the optimum frequency for thermal sanitization.
Indications for Use: The AmeriWater Centurion 1500+ Reverse Osmosis Systems are water treatment systems intended for use in hemodialysis applications. They are designed to pre-treat and purify potable water for use in making dialysate for hemodialysis and to meet current AAMI and Federal (U.S.) standards. The device is intended to be a component in a complete water purification system, and is not a complete water treatment system. It must be preceded by pre-treatment devices, and may need to be followed by post-
K133783
Page 1 of 3
1
treatment devices as well to meet current AAM and Federal (U.S.) standards. The Centurion 1500+ Reverse Osmosis System is intended for use in a hospital, clinic, dialysis center, or for home care for single patient use. The device includes an integrated heat sanitization process.
Statement of Substantial Equivalence: The AmeriWater Centurion is substantially equivalent to the AmeriWater MRO Portable Reverse Osmosis System (MROS) cleared for market under K111740, and the AmeriWater MediQA Reverse Osmosis System cleared for market under K131904. The following table compares and contrasts the predicate devices and the new device. This table along with the documentation included in this submission demonstrates that there are no new issues of safety or effectiveness associated with this design change, and that the new device is substantially equivalent to the predicate device.
| | Predicate Device
AmeriWater MEDIQA (K131904) | Predicate Device
AmeriWater MROS
(K111740) | AmeriWater
Centurion 1500+ |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The AmeriWater MediQA Reverse
Osmosis System is one
component of a water treatment
system designed to pre-treat and
purify potable water using reverse
osmosis for making dialysate for
hemodialysis applications. The
device is intended to be a
component in a complete water
purification system, and is not a
complete water treatment system.
It must be preceded by pre-
treatment devices, and may need
to be followed by post-treatment
devices as well to meet current
AAMI and Federal (U.S.)
standards. The AmeriWater
MediQA is intended for use in
water rooms in a hospital, clinic, or
dialysis center. The device
includes an integrated heat
sanitization process. | The AmeriWater MRO Portable
Reverse Osmosis Systems are
water treatment systems intended
for use in hemodialysis
applications. They are designed to
pre-treat and purify potable water
for use in making dialysate for
hemodialysis and to meet current
AAMI and Federal (U.S.)
standards. The AmeriWater
Portable MROS model is intended
for use in a hospital, clinic, dialysis
center, or for home care for single
patient use. The AmeriWater
Portable MRO1 model is for
treatment of up to two patients in a
hospital, clinic, or dialysis centers. | The AmeriWater Centurion 1500+
Reverse Osmosis Systems are
water treatment systems intended
for use in hemodialysis
applications. They are designed to
pre-treat and purify potable water
for use in making dialysate for
hemodialysis and to meet current
AAMI and Federal (U.S.)
standards. The device is intended
to be a component in a complete
water purification system, and is
not a complete water treatment
system. It must be preceded by
pre-treatment devices, and may
need to be followed by post-
treatment devices as well to meet
current AAMI and Federal (U.S.)
standards. The Centurion 1500+
Reverse Osmosis System is
intended for use in a hospital,
clinic, dialysis center, or for home
care for single patient use. The
device includes an integrated heat
sanitization process. |
| For Use In: | Hospitals, clinics, or dialysis
centers | Hospitals, clinics, dialysis centers,
home care | Hospitals, clinics, dialysis centers,
home care |
| Power Requirements | 208/230V; 60 Hz; 3-phase | 115V 60 Hz 20 Amp | 115V 60 Hz 20 Amp |
| Purification process | Reverse Osmosis | Reverse Osmosis | Reverse Osmosis |
| RO Membrane | Polyamide, thin film composite,
spiral wound | Polyamide, thin film composite,
spiral wound | Polyamide, thin film composite,
spiral wound |
| Rejection rates | Total dissolved salts > 96% | Total dissolved salts > 94% | Total dissolved salts > 98% |
| Permeate Flow Rates | 19 to 48 l/min at 10°C | 1.8 l/min at 10°C | 1.5 l/min at 10°C |
| Drain Requirements | Max 96 l/min | Max 3.6 l/min | Max 3.0 l/min |
| RO Disinfection | Chemical or Heat | Chemical | Chemical or Heat |
| Water Contacting
Materials | Polyamide, Polypropylene, CPVC,
Nitrile, EPDM, Stainless steel,
Polyacetal, PTFE, Viton(FKM),
Fiberglass, PA66 (Nylon), PET
Noryl | ABS, Acrylic, Carbon, Nylon, PVC,
Polyester, Polyethylene,
Polypropylene, Stainless Steel,
Tygon, Buna N | Nylon, Polypropylene, Stainless
Steel, EPDM, and TFC Membrane
(Polyamide) |
2
Summary of Performance Testing: Non-clinical testing was conducted to verify and validate the performance of the reverse osmosis function and the efficacy of the heat sanitization of bacteria. Results of performance testing indicate that the device produces water that meets current AAM and Federal (U.S.) standards. Microbiological testing results show evidence that the heat sanitization function is effective in the reduction of bacteria. Clinical studies show evidence that the device, when used in accordance with the instructions for use, will produce water that meets current AAMI and Federal (U.S.) standards for hemodialysis. Test results from biocompatibility testing, software validation, and electrical safety testing (in accordance with IEC 60601-1) indicate that the device is safe and effective for its intended purpose.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drue Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002
April 16, 2014
AmeriWater, Inc. Brian R. Bowman Quality and Regulatory Administrator 1303 Stanley Avenue Dayton, OH 45404
Re: K133783
Trade/Device Name: AmeriWater Centurion 1500 + Reverse Osmosis System Regulation Number: 21 CFR§ 876.5665 Regulation Name: Water purification system for hemodialysis Regulatory Class: II Product Code: FIP Dated: March 12, 2014 Received: March 20, 2014
Dear Brian R. Bowman,
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 (Act) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
4
Page 2 - Brian R. Bowman
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Herbert P. Lerner -S
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Ameriliorer
ច្បាទចេចចេចចេនចេននេះជាជាវេរ
1303 STANLEY AVENUE DAYTON, OH 45404 USA TEL 937-461-8833, 800-535-5585 FAX 937-461-1988 WWW.AMERIWATER.com
Image /page/5/Picture/3 description: The image contains two overlapping circles with text inside. The larger circle on the left has the text "Suez environnement". The smaller circle on the right has the text "Degremont" and a logo above it. The image appears to be a logo or emblem for a company or organization.
Indications for Use
510(k) Number (if known): K133783
Device Name: AmeriWater Centurion 1500+ Reverse Osmosis System
Indications For Use:
The AmeriWater Centurion 1500+ Reverse Osmosis Systems are water treatment systems intended for use in hemodialysis applications. They are designed to pre-treat and purify potable water for use in making dialysate for hemodialysis and to meet current AAM and Federal (U.S.) standards. The device is intended to be a component in a complete water purification system, and is not a complete water treatment system. It must be preceded by pre-treatment devices, and may need to be followed by post-treatment devices as well to meet current AAM and Federal (U.S.) standards. The Centurion 1500+ Reverse Osmosis System is intended for use in a hospital, clinic, dialysis center, or for home care for single patient use. The device includes an integrated heat sanitization process.
X 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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Herbert P. Leerne 2014.04.16 14:29:32