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 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.

AI/ML Overview

The provided text describes the AquaC UNO H Water Purification System, a device intended for hemodialysis, and its premarket notification to the FDA. While it states that performance tests demonstrate compliance with various standards and that the device meets specifications, it does not provide detailed acceptance criteria or the specific results of a study in a manner that would allow for the direct completion of a table detailing "acceptance criteria" and "reported device performance."

Instead, it broadly states that:

"The results of all these tests show that all specifications and requirements have been met."
"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."

Given the information provided, it's impossible to create a table with specific numerical acceptance criteria and reported performance values. The document focuses on declaring that the device meets standards and specifications rather than detailing what those specific thresholds and measured outputs were.

Therefore, I cannot fulfill all parts of your request directly from the given text.

However, I can extract information related to the studies performed and other contextual details:

1. Table of Acceptance Criteria and Reported Device Performance:

Cannot be fully generated. The document states that performance testing was conducted "according to the specifications of the device" and that "all specifications and requirements have been met." However, it does not list these specific specifications or the measured performance values.

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified. The document mentions "non-clinical tests" and "Performance testing" but does not provide a sample size (e.g., number of units tested, duration of tests).
Data Provenance: The tests were performed by "internal and external testing laboratories." Given the manufacturer is based in Germany (Vivonic GmbH, Sailauf, Germany), it is highly probable that the data provenance is Germany or other European countries where these laboratories are located. The document does not specify whether the data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable / Not specified. This type of information (experts, ground truth, qualifications) is typically associated with clinical studies involving human interpretation or pathology, not with performance testing of a water purification system's technical specifications (like chemical, microbiological, electrical safety, or usability performance).

4. Adjudication method for the test set:

Not applicable / Not specified. Adjudication methods like 2+1 or 3+1 are used in clinical trials, particularly for expert review of medical images or outcomes where there might be disagreement. This is not reported for the technical performance testing of a water purification system.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. MRMC studies and "human readers with/without AI assistance" are relevant to AI/imaging diagnostics, not to a water purification system.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This relates to AI algorithms, not a physical water purification system. However, the software validation (according to IEC 62304) implies that the device's control algorithms were tested in a standalone manner. The document does not provide details on the performance outcomes of this specific testing.

7. The type of ground truth used:

Measurement against established standards and specifications. For chemical and microbiological testing, the ground truth would be the thresholds defined in ISO 13959 and ISO 23500. For electrical safety, it would be IEC 60601-1. For performance testing, it would be "the specifications of the device." These are objective, measurable standards, not expert consensus or pathology in the typical sense.

8. The sample size for the training set:

Not applicable. The device is a physical water purification system; it does not involve machine learning or AI models that require training sets in the customary sense.

9. How the ground truth for the training set was established:

Not applicable. See point 8.

Summary

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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)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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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 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 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 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

Regulation Number and Section

§ 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.