AquaC UNO H
Device Facts
| Record ID | K143617 |
|---|---|
| Device Name | AquaC UNO H |
| Applicant | Vivonic GmbH |
| Product Code | FIP · Gastroenterology, Urology |
| Decision Date | Oct 19, 2015 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.5665 |
| Device Class | Class 2 |
Indications for Use
The AquaC UNO H Portable Water Purification System is a reverse osmosis unit intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients or related therapies. The AquaC UNO H can be connected to hemodialysis equipment used in hospitals, clinics and in home environments. This device is intended to be a complete water purification system, and is not a complete water treatment system. The reverse osmosis unit must be preceded by pre-treatment devices, and may need to be followed by posttreatment devices as well, to meet current AAMI/ANSI and FDA recognized U.S. standards.
Device Story
Microcontrolled, fully automatic reverse osmosis system; produces highly deionized water (permeate) for hemodialysis. Input: pretreated soft water (drinking water standard, filtered, iron-free, softened, chlorine-free). Operation: volumetric measurement of inlet water; storage in break tank; pump generates high pressure to drive water through polyamide thinfilm composite membrane. Output: permeate (to ring main/dialysis machine) and concentrate (to drain). Used in hospitals, clinics, and home environments. Includes heat disinfection function to prevent bacterial growth. Healthcare providers use the system to ensure water quality meets ISO 13959 standards for dialysis. Benefits patient by providing purified water for hemodialysis therapy.
Clinical Evidence
Bench testing only. Performance validated via chemical and microbiological testing (ISO 13959, ISO 23500), biocompatibility (ISO 10993), electrical/EMC safety (IEC 60601-1, IEC 60601-1-2), and usability (IEC 60601-1-6). Testing confirms device meets specifications and relevant standards for hemodialysis water purification.
Technological Characteristics
Reverse osmosis system; polyamide thinfilm composite membrane. Materials: PP, stainless steel, silicone, PSU, FEP, EPDM, PA, PVDF, Noryl GTX, titanium, ceramics. Features: microcontrolled, volumetric water measurement, heat disinfection. Standards: ISO 13959, ISO 23500, ISO 11663, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, IEC 62304, ISO 10993, ISO 14971, ISO 26722.
Indications for Use
Indicated for use with hemodialysis systems to remove organic/inorganic substances and microbial contaminants from water used for treating hemodialysis patients or related therapies in hospitals, clinics, and home environments.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
Submission Summary (Full Text)
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 19, 2015
Vivonic GmbH Andreas Hessberger Manager Regulatory Affairs Kurfuerst-Eppstein-Ring 4, Sailauf 63877 Germany
Re: K143617
> Trade/Device Name: AquaC UNO H Regulation Number: 21 CFR§ 876.5665 Regulation Name: Water purification system for hemodialysis Regulatory Class: II Product Code: FIP Dated: September 9,2015 Received: September 9, 2015
Dear Andreas Hessberger,
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. Iisting 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.
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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 (QS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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 FDA
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
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# Indications for Use
510(k) Number (if known) K143617
Device Name AquaC UNO H
#### Indications for Use (Describe)
The AquaC UNO H Portable Water Purification System is a reverse osmosis unit intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients or related therapies.
The AquaC UNO H can be connected to hemodialysis equipment used in hospitals, clinics and in home environments. This device is intended to be a complete water purification system, and is not a complete water treatment system. The reverse osmosis unit must be preceded by pre-treatment devices, and may need to be followed by posttreatment devices as well, to meet current AAMI/ANSI and FDA recognized U.S. standards.
Type of Use (Select *one* or *both*, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image is a solid light blue color. The color fills the entire frame, with no other objects or details present. The image is simple and minimalist, with the focus solely on the light blue hue.
Image /page/3/Picture/1 description: The image shows the logo for Vivonic Wassertechnik. The logo features the word "VIVONIC" in a bold, sans-serif font, with the word "wassertechnik" in a smaller, italicized font to the right. The word "VIVONIC" is surrounded by a stylized, geometric shape that resembles a gear or a water wheel. The overall design is clean and modern, with a focus on conveying a sense of technology and water-related services.
# 510(k) Summary As required by section 807.92(c)
# AquaC UNO H Water Purification System
## Contact Information
| Manufacturer: | Vivonic GmbH |
|---------------|-------------------------------|
| Address: | Kurfuerst-Eppstein-Ring 4 |
| | 63877 Sailauf / Germany |
| Phone: | (+49)6093 97130 |
| Fax: | (+49)6093 971315 |
| | |
| Contact: | Andreas Hessberger |
| | Manager Regulatory Affairs |
| Phone: | (+49)6093 971311 |
| Email: | andreas.hessberger@vivonic.de |
| Date: | 2014-12-17 |
## Device Identification
| Trade Name: | AquaC UNO H |
|-----------------------|-------------------------------|
| Common Name: | Water Purification System |
| Classification Name: | Subsystem, water purification |
| Product Code: | FIP |
| Device Class: | II |
| Classification Reg .: | 876.5665 |
Vivonic Wassertechnik GmbH
Kurfuerst-Eppstein-Ring 4 63877 Sailauf / Germany
Phone: +49 (0)6093 / 9713-0 FAX: +49 (0)6093 / 9713-15
Bank Account:
Sparkasse Aschaffenburg-Alzenau BİN 795 500 00
A/C No. 240 140 210, Swift: BYLA DE M1 ASA IBAN: DE 37 7955 0000 0240 1402 10
Certified according DIN EN ISO 9001:2008
and DIN EN ISO 13485:2007
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Image /page/4/Picture/0 description: The image shows the logo for Vivonic Wassertechnik. The logo features the word "VIVONIC" in a bold, sans-serif font, with the word "wassertechnik" in a smaller, teal-colored font to the right. The word "VIVONIC" is surrounded by a gray, stylized graphic that resembles a gear or a water wheel. The overall design is clean and modern.
Image /page/4/Picture/1 description: The image is a solid light blue color. The color is uniform throughout the image. There are no other objects or features in the image.
#### Claiming substantial equivalence to
K110578 Mar Cor Millenium HX K093608 Mar Cor WRO 300 H
#### Device Description
The AquaC UNO H Water Purification System is a microcontrolled, fully automatic reverse osmosis system with heat disinfection function which uses pretreated soft water for the production of highly deionized water, also called permeate.
The intended use of the reverse osmosis device is to remove organic and inorganic ions and microbiological contaminants from the feed water to fulfill the requirements of ISO 13959 'water for haemodialysis and related therapies'.
The feed water must be of drinking water standard, filtered, free of iron, softened and free of chlorine. Potentially critical limits must be monitored by regular checks.
Bacterial growth in the system must be prevented by continuous operation of the system with a minimum of idle times and by preventive measures such as chemical or heat disinfection.
The device consists of a water inlet section where the inflowing volume of water is volumetrically measured. The water is stored in a break tank and is used by the pump to generate high pressure. The pump generates the high pressure and transports the water to the membrane.
The permeate flows from the membrane through the conductivity cell to the permeate outlet into the ring main. The ring main can be connected directly to a dialysis machine.
The concentrate is discarded via the drain valve to the drain.
Vivonic Wassertechnik GmbH Kurtuerst-Eppstein-Ring 3877 Sailauf / Germa hone: +49 (0)6093 / 9713-0 AX: +49 (0)6093 / 9713-15
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Image /page/5/Picture/0 description: The image shows the logo for Vivonic Wassertechnik. The logo features the word "VIVONIC" in bold, black letters, with the word "wassertechnik" in a smaller, teal font to the right. To the left of the word "VIVONIC" is a gray, stylized gear or wheel design. The logo has a clean and modern look.
## Materials used
- Polypropylene (PP) Stainless steel Silicone Polysulfone (PSU) Fluorinated ethylene propylene (FEP) Ethylene propylene diene monomer (EPDM) Polyamide (PA) Polyvinylidene fluoride (PVDF) Noryl GTX Titan Ceramics
#### Indication for Use
The AquaC UNO H Portable Water Purification System is a reverse osmosis unit intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients or related therapies.
The AquaC UNO H can be connected to hemodialysis equipment used in hospitals, clinics and in home environments. This device is intended to be a component in a complete water purification system, and is not a complete water treatment system. The reverse osmosis unit must be preceded by pre-treatment devices, and may need to be followed by posttreatment devices as well, to meet current AAMI/ANSI and FDA recognized U.S. standards.
#### Comparison to Predicate Devices
The AquaC UNO H Water Purification System is substantially equivalent to many other marketed devices that are used in heamodialysis. This includes the Predicate Devices Mar Cor Millenium HX and Mar Cor WRO 300 H.
All systems utilize pretreated potable water and a reverse osmosis with a polyamide thinfilm composite membrane for the purification of water
All systems have the same intended use and they are located in hospitals, dialysis centers or home environment.
All system uses chemicals and hot water for disinfection.
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Image /page/6/Picture/0 description: The image is a solid light blue color. The image is a simple background with no discernible objects or patterns. The light blue color fills the entire frame. There are no other colors or shades present in the image.
Image /page/6/Picture/1 description: The image shows the logo for Vivonic Wassertechnik. The logo features the word "VIVONIC" in bold, black letters. Above and to the right of "VIVONIC" is the word "wassertechnik" in a smaller, teal font. The word "VIVONIC" is surrounded by a gray, geometric shape that resembles a stylized water wheel or gear.
## Summary of Non-Clinical Performance Data
As non-clinical tests the following tests has been performed on the AquaC UNO H Water Purification System:
- Software validation (according IEC 62304)
- Chemical and microbiological testing (according ISO 13959, ISO 23500)
- Biocompatibility testing (according ISO 10993)
- Electrical and electro-magnetically safety testing (according IEC 60601-1,IEC 606001-1-2)
- Usability testing (according IEC 60601-1-6)
- Performance testing (according to the specifications of the device)
The tests have been performed by internal and external testing laboratories. These tests demonstrate the compliance to the following standards:
- ISO 23500 First edition 2011-05-15
- ISO 11663 First edition 2009-04-15
- ISO 13959 Second edition 2009-04-15
- IEC 60601-1:2005
- IEC 60601-1-2:2007
- IEC 60601-1-6:2010
- IEC 60601-1-11:2010
- IEC 62304:2006
- ISO 10993:2009
- ISO 14971:2007, Corrected version 2007-10-01
- ISO 26722 First edition 2009-04-15
In addition each system will be tested according internal inspection requests that contain functional, safety and performance testing as well as the configuration of the devices.
The results of all these tests show that all specifications and requirements have been met and the AquaC UNO H water purification system is substantially equivalent to the predicate devices.
#### Conclusion
The AquaC UNO H Water Purification System is capable to meet relevant standards and specifications for the use in haemodialysis and related therapies. The information and performance data provided indicates that the AquaC UNO H is safe and effective and performs at least as well as the predicate devices when used in accordance to the instruction of use.
Vivonic Wassertechnik GmbH
Kurfuerst-Eppstein-Ring 4
63877 Sailauf / Germany
Phone: +49 (0)6093 / 9713-0
FAX: +49 (0)6093 / 9713-15
rtified according DIN EN ISO 9001:2 and DIN EN ISO 13485:2007
