AQUABPLUS,AQUABPLUS & AQUABPLUS B2,AQUABPLUS&AQUABPLUS HF,AQUABPLUS& AQUABPLUS B2& AQUABLUS HF

K133829 · Vivonic GmbH · FIP · Apr 22, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K133829
• Device Name: AQUABPLUS,AQUABPLUS & AQUABPLUS B2,AQUABPLUS&AQUABPLUS HF,AQUABPLUS& AQUABPLUS B2& AQUABLUS HF
• Applicant: Vivonic GmbH
• Product Code: FIP · Gastroenterology, Urology
• Decision Date: Apr 22, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5665
• Device Class: Class 2

Indications for Use

The AquaBplus Water Purification Systems are reverse osmosis units 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. These devices are intended to be a component in a complete water purification system, and are not complete water treatment systems. Each reverse osmosis unit must be preceded by pre-treatment devices, and may need to be followed by post-treatment devices as well, to meet current AAMI/ANSI/ISO and Federal (U.S.) standards.

Device Story

AquaBplus is a microcontrolled, fully automatic reverse osmosis (RO) system for producing highly deionized water for hemodialysis and dialysis concentrates. Input is pretreated, softened, filtered, chlorine-free drinking water. System uses polyamide thin-film composite membranes to remove organic/inorganic ions and microbial contaminants. Optional modules include AquaBplus B2 (second RO membrane filtration) and AquaBplus HF (for automatic heat disinfection of permeate ring main). Used in hospitals/dialysis centers; operated by clinical staff. Output is purified permeate transferred via pressure to a ring main or storage tank. Continuous operation minimizes idle time; chemical and hot water disinfection prevent bacterial growth. Benefits include consistent water quality meeting ISO 13959 standards for dialysis therapy.

Clinical Evidence

Bench testing only. No clinical data. Performance validated via chemical and microbiological testing (ISO 13959, ISO 23500), biocompatibility (ISO 10993), electrical/EMC safety (IEC 60601-1, IEC 60601-1-2), usability (IEC 60601-1-6), and software validation (IEC 62304).

Technological Characteristics

Microcontrolled RO system. Materials: Stainless steel (1.4404/1.4571), PP, PSU, PE, EPDM, PTFE, PVDF. Uses polyamide thin-film composite membranes. Features optional secondary RO module and heat disinfection module. Standards: ISO 13959, ISO 23500, ISO 11663, ISO 26722, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62304, ISO 10993, ISO 14971.

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. Requires pre-treatment and potentially post-treatment components to meet AAMI/ANSI/ISO standards.

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

• Gambro CWP 100 (K974899)
• Lauer AquaBoss EcoRO Dia I+II (HT) (K124059)

Submission Summary (Full Text)

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K133829
Page 1 of 4

Image /page/0/Picture/1 description: The image shows a logo for a company called VIVONIC wassertechnik. The logo consists of the word "VIVONIC" in bold, sans-serif font, with the word "wassertechnik" in a smaller, less bold font to the right. To the left of the word, there is a circular graphic design that appears to be made of small, rectangular shapes.

APR 2 2 2014

### 510(k) Summary

As required by section 807.92(c)

## AquaBplus Water Purification System

### Contact Information

| Manufacturer: | Vivonic GmbH |
|---------------|-------------------------------|
| Address: | Kurfuerst-Eppstein-Ring 4 |
| | 63877 Sailauf / Germany |
| Phone: | ([phone] |
| Fax: | ([phone] |
| Contact: | Andreas Hessberger |
| | Manager Regulatory Affairs |
| Phone: | ([phone] |
| Email: | [e-mail] |

2014-01-16 Date:

### Device Identification

Trade Name: AquaBplus Water Purification System Common Name: Classification Name: Subsystem, water purification Product Code: FIP Device Class: 11 876.5665 Classification Reg.:

Vivonic Wassertechnik GmbH urtuerst-Eppstein-Ring 4 3877 Salau / Gemany
hono: +49 (0)6093 / 9713-0 AX +49 (0)6093 / 9713-15

8 40 210 Swift BYLA DE M

Managing Director
Manfred Volker
Commercial Register: AG Aschaffenburg / HRB 7445
VAT ID: DE 812 809 157

Cartified Recombria DIN EN ISO 9001:200

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K133829
Page 20f4.

Image /page/1/Picture/1 description: The image shows a logo for a company called VIVONIC wassertechnik. The word "VIVONIC" is written in large, bold letters, with the word "wassertechnik" written in smaller letters to the right. To the left of the word VIVONIC is a circular design that is made up of small, rectangular shapes. The logo is simple and modern, and it is likely used to represent the company's brand.

### Claiming substantial equivalence to

K974899 Gambro CWP 100 reverse osmosis Lauer Aquaboss EcoRO Dia I+II (HT) K124059

### Device Description

The AquaBplus is a microcontrolled, fully automatic reverse osmosis which uses pretreated soft water for the production of highly deionized water for use by hemodialysis devices and for the preparation of dialysis concentrates.

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 disinfection. If there is a need, the quality of the permeate could be raised by using the AquaBplus B2 as a second reverse osmosis (2nd membrane filtration step). The AquaBplus B2 is a module that will be installed after the AquaBplus (=main reverse osmosis).

To allow an automatic heat disinfection of the permeate ring main, the module AquaBplus HF could be installed afterwards the AquaBplus/AquaB2. The heat disinfection could take place in dialysis free times.

The produced dialysis permeate will be transferred to the permeate ring main by pressure, where it will be distributed to the different withdrawal units of the dialysis machines. Alternatively permeate could be transferred into a permeate storage tank system. A permeate distribution system (pump, filter, tubing) follows normally to a permeate storage system. In most cases, the feed line into the permeate storage tank is realized as a ring main. Because the most installation type is the ring main and to ease the following description, the components following the AquaBplus system is simply called "ring main".

Vivonic Wassertachnik GmbH urfuarsi-Ecostein-Ring 4 3877 Sailari / Germany
Phone: [phone] / 9713-0 AX: [phone] / 9713-15

00 009 552 NIB 0 140 210, Switt BYLA DE M1 AS 0000 0240 1402

Assaging Director Manfred Voile mmercial Reclater, AG

Cartified according DIN EN ISO 9001:2000 nd DIN EN ISO 13485:200

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14133829
Page 30 of 4

Image /page/2/Picture/1 description: The image shows a logo for a company called VIVONIC wassertechnik. The word "VIVONIC" is written in large, bold letters on the left side of the logo. To the right of the word "VIVONIC" is the word "wassertechnik" written in a smaller, italicized font. The logo also includes a circular design with several small, rectangular shapes around the perimeter.

### Materials used

Stainless steel (1.4404/1.4571) Polypropylene(PP) Polysulfone (PSU) Polyethylene (PE) Ethylene Propvlene Diene Monomer (EPDM) Polytretrafluoroethylene (PTFE) Polyvinylidene fluoride (PVDF)

### Indication for Use

The AquaBplus Water Purification Systems are reverse osmosis units 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. These devices are intended to be a component in a complete water purification system, and are not complete water treatment systems. Each reverse osmosis unit must be preceded by pre-treatment devices, and may need to be followed by post-freatment devices as well, to meet current AAMI/ANSI/ISO and Federal (U.S.) standards.

### Comparison to Predicate Devices

The AquaBplus water purification system is substantially equivalent to many other marketed devices that are used in heamodialysis. This includes the Predicate Devices Gambro CWP 100 and Lauer AquaBoss EcoRO Dia I+II (HT).

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. All system uses chemicals and hot water for disinfection.

fivonic Wassertochnik GmbH urtzent-Epostein-Ring Salauf / Gamar 49 (D)6093 / 9 778 / 6805000 8P+ : XX

Certified according DIN EN ISO 9001:2008
and DIN EN ISO 13485:2007

10 Sunft BYLA DE M1

tanacing Direct

દીવ

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14133829 Pusce 4 of 4

### Summary of Non-Clinical Performance Data

As non-clinical tests the following tests has been performed on the AquaBplus 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 1EC 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 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 AquaBplus water purification system is substantially equivalent to the predicate devices.

#### Conclusion

The AquaBplus 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 AquaBplus is safe and effective and performs at least as well as the predicate devices when used in accordance to the instruction of use.

Saund / Germa

Bank Account:
Sparkasse Aschaffenburg-Aizenau
BIN 705 500 00
A/C No 240 140 210, Swift: BYLA DE M1 A
IBAN: DE 37 7955 0000 0240 1402 10

Managing Director:
Manfred Völker
Commercial Register: AG Aschaffenburg / HRB 7445
VAT ID: DE 812 809 157

Allen DIN EN ISO 9001

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 22, 2014

Vivonic GmbH Andreas Hessberger Manager Regulatory Affairs Kurfuerst-Eppstein-Ring 4 Sailauf 63877 Germany

Re: K133829

> Trade/Device Name: AquaBplus; AquaBplus & AquaBplus B2; AquaBplus & AquaBplus HF; AquaBplus & AquaBplus B2 & AquaBplus HF Regulation Number: 21 CFR§ 876.5665 Regulation Name: Water purification system for hemodialysis Regulatory Class: II Product Code: FIP Dated: January 21, 2014 Received: January 23, 2014

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, 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.

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### Page 2 - Andreas Hessberger

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. 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

## Herbert P. Lerner -S

for

Beniamin 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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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

### Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

### 510(k) Number (if known) K133829

### Device Name

AquaBplus, AquaBplus & AquaBplus & AquaBplus & AquaBplus & AquaBplus & AquaBplus B2 & AquaBplus HF

### Indications for Use (Describe)

The AquaBplus Water Purification Systems are reverse osmosis units 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. These devices are intended to be a complete water purification system, and are not complete water treatment systems. Each reverse osmosis unit must be preceded by pre-treatment devices, and may need to be followed by post-treatment devices as well, to meet current AAMVANSI/ISO and Federal (U.S.) standards.

Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY . . . . .

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

# Herbert P. Lerner 2014.04.22 16:

FORM FDA 3881 (9/13)

、..

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