EON Portable Reverse Osmosis Water Purification System

K171099 · Cantel · FIP · Jan 5, 2018 · Gastroenterology, Urology

Device Facts

• Record ID: K171099
• Device Name: EON Portable Reverse Osmosis Water Purification System
• Applicant: Cantel
• Product Code: FIP · Gastroenterology, Urology
• Decision Date: Jan 5, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5665
• Device Class: Class 2

Intended Use

The EON Portable Reverse Osmosis Water Purification System is intended to be used as a dialysis accessory to produce water through reverse osmosis for use with hemodialysis equipment. EON can be connected to hemodialysis equipment used in hospitals, clinics and in home environments, in conjunction with the appropriate pre and post treatment units, as part of a water treatment system designed to meet current AAMI and Federal (U.S.) standards. EON has optional heat disinfection cycles intended to disinfect the reverse osmosis (RO) machine and product loop, and connection tubing to the hemodialysis machine. EON's heat disinfection cycle to disinfect the connection tubing (heat forward cycle) is intended to be used only with hemodialysis machines which contain their own heat disinfection cycles and hence are able to tolerate high temperatures. EON is not intended to heat disinfect the hemodialysis machine.

Device Story

Portable water purification system; uses reverse osmosis to remove contaminants from feed water for hemodialysis dialysate preparation. Pump applies high hydrostatic pressure; forces water through RO membrane; produces purified water. Used in hospitals, clinics, and home environments; operated by healthcare personnel or patients. Features optional heat disinfection cycles for RO machine, product loop, and connection tubing (Heat Forward cycle). Heat Forward cycle requires hemodialysis machines capable of tolerating high temperatures. Benefits patient by maintaining low microbiological levels in water pathway; ensures water quality meets AAMI/Federal standards.

Clinical Evidence

No clinical data. Bench testing only. Performance testing verified Heat Forward cycle efficacy and heat disinfection effectiveness for microbial reduction. Electrical safety and EMC testing performed per IEC 61010 and IEC 61326. Biocompatibility testing performed per ISO 10993-5 to ensure water-contacting materials do not release toxic substances.

Technological Characteristics

Electro-mechanical portable RO system. Uses inline heater (vs tank heater in predicate). Materials verified via ISO 10993-5. Complies with IEC 61010 (electrical safety) and IEC 61326 (EMC). Features optional heat disinfection cycles for RO loop and connection tubing.

Indications for Use

Indicated for use as a dialysis accessory to produce reverse osmosis water for hemodialysis equipment 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

• Millenium HX (MHX) Portable Reverse Osmosis Water Purification System (K110578)

Submission Summary (Full Text)

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January 5, 2018

Cantel Katlin Adamski Regulatory Affairs Specialist 14550 28th Avenue North Minneapolis, MN 55447

Re: K171099

Trade/Device Name: EON Portable Reverse Osmosis Water Purification System Regulation Number: 21 CFR& 876.5665 Regulation Name: Water Purification System For Hemodialysis Regulatory Class: II Product Code: FIP Dated: December 6, 2017 Received: December 7, 2017

Dear Katlin Adamski:

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.

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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 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.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Charles Viviano -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

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# Indications for Use

510(k) Number (if known) K171099

#### Device Name

EON Portable Reverse Osmosis Water Purification System

#### Indications for Use (Describe)

The EON Portable Reverse Osmosis Water Purification System is intended to be used as a dialysis accessory to produce water through reverse osmosis for use with hemodialysis equipment. EON can be connected to hemodialysis equipment used in hospitals, clinics and in home environments, in conjunction with the appropriate pre and post treatment units, as part of a water treatment system designed to meet current AAMI and Federal (U.S.) standards.

EON has optional heat disinfection cycles intended to disinfect the reverse osmosis (RO) machine and product loop, and connection tubing to the hemodialysis machine. EON's heat disinfection cycle to disinfect the connection tubing (heat forward cycle) is intended to be used only with hemodialysis machines which contain their own heat disinfection cycles and hence are able to tolerate high temperatures. EON is not intended to heat disinfect the hemodialysis machine.

| 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)

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# Section 05 - 510(k) Summary

| Manufacturer: | Mar Cor - A Cantel Medical Company |
|-------------------|------------------------------------------------------------------|
| Address: | 14550 28th Avenue North<br>Minneapolis, MN 55447<br>763-509-1606 |
| Official Contact: | Katlin Adamski<br>Regulatory Affairs Specialist, Cantel |
| Date: | 06 December 2017 |
| Trade Name: | EON Portable Reverse Osmosis Water Purification System |
| Common Name: | Water Purification System |
| Regulation Name: | Water Purification System for Hemodialysis |
| Product Code: | FIP |
| Device Class: | II |
| Regulation No: | 876.5665 |

Cantel has supplied the following information to the US Food and Drug Administration to support substantial equivalence of EON Portable Reverse Osmosis Water Purification System to its predicate -Millenium HX (MHX) Portable Reverse Osmosis Water Purification System, 510(k) K110578 - currently cleared for sale in the U.S.

#### 1. Intended Use

The EON Portable Reverse Osmosis Water Purification System is intended to be used as a dialysis accessory to produce water through reverse osmosis for use with hemodialysis equipment. EON can be connected to hemodialysis equipment used in hospitals, clinics and in home environments, in conjunction with the appropriate pre and post treatment units, as part of a water treatment system designed to meet current AAMI and Federal (U.S.) standards.

EON has optional heat disinfection cycles intended to disinfect the reverse osmosis (RO) machine and product loop, and connection tubing to the hemodialysis machine. EON's heat disinfection cycle to disinfect the connection tubing (heat forward cycle) is intended to be used only with hemodialysis machines which contain their own heat disinfection cycles and hence are able to tolerate high temperatures. EON is not intended to heat disinfect the hemodialysis machine.

#### 2. Device Description

The device is a portable water purification system which uses reverse osmosis to remove contaminants from water that is used to dilute dialysis concentrate to form dialysate for use in hemodialysis equipment. Feed water enters the unit and is directed through a pump into a RO membrane. The pump applies a high hydrostatic pressure that forces water from the concentrated (feed) side to the dilute (product) side of the RO membrane. As water flows across the membrane purified water is produced. Both devices are designed to maintain low microbiological levels in the flow pathway by using optional cycles which perform heat disinfection on the entire RO machine and

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loop. The subject device also has an optional Heat Forward cycle which is intended to heat disinfect the connection tubing to the hemodialysis machine.

#### Comparison to Other Devices in Commercial Distribution Within the United States 3.

EON is equivalent in intended use, function and fundamental technology to its predicate device, Millenium HX (MHX) Portable Reverse Osmosis Purification System cleared under 510(k) K110578.

#### Similarities between Subject and Predicate Devices

EON is equivalent in function, intended use, scientific technology, principle of operation, performance characteristics and components to MHX. Both the subject and predicate devices utilize chemical sanitization and heat disinfection of the RO loop and machine.

#### Differences between Subject and Predicate Devices

The only difference between the devices is that the subject device has an optional Heat Forward cycle which is used to heat disinfect the connection tubing between EON and the hemodialysis machine.

A device comparison table which supports substantial equivalence of the subject device to the predicate device is provided below:

| Critical Parameters | Subject Device - EON | Predicate Device - MHX (K110578) |
|-------------------------------------------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Trade Name | EON Portable Reverse Osmosis Water<br>Purification System | MHX Portable Reverse Osmosis Water<br>Purification System |
| Regulation Number | 876.5665 | 876.5665 |
| Device Class | Class II | Class II |
| Certification Panel | Gastroenterology/Urology | Gastroenterology/Urology |
| Product Code | FIP | FIP |
| Intended Use | To produce purified water through<br>reverse osmosis for use with<br>hemodialysis equipment. | To produce purified water through<br>reverse osmosis for use with<br>hemodialysis equipment. |
| Type of Machine<br>Function | Electro-mechanical | Electro-mechanical |
| Mechanism of Action | Reverse Osmosis | Reverse Osmosis |
| Heat disinfect RO<br>svstem | Yes | Yes |
| Optional heat<br>disinfection of<br>connection tubing | Yes | No |
| Portable | Yes | Yes |
| Heater | Inline heater | Tank heater |

#### Table 1 - Device Comparison Table

#### 4. Summary of Non-Clinical Performance Data

Cantel has conducted the following testing to demonstrate that EON is safe and effective for its intended use:

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- Performance Testing performance testing has been conducted on the subject device to ensure it performs with the same safety and effectiveness as the predicate device. The below list briefly discusses the performance testing.
- Heat Forward Cycle Verification Testing Demonstrates the ability of the subject O device's heat forward cycle to provide water for thermal disinfection to the connection tubing.
- Heat Disinfection Validation Testing Demonstrates the effectiveness of the subject o device's heat disinfection cycle to reduce microbial contaminants.
- Electrical Safety and Electromagnetic Compatibility Electrical safety and electromagnetic ● compatibility testing has been conducted to demonstrate compliance with IEC 61010 and IEC 61326.
- Biocompatibility - Biocompatibility testing has been conducted to demonstrate compliance with ISO 10993-5. The testing was performed to demonstrate that the water contacting materials contained in the subject device are compatible with the intended use of the device and do not release toxic substances into the purified product water.

#### 5. Conclusion

Based on the intended use, fundamental technology and performance data, the subject device is substantially equivalent to and is as safe and as effective as the legally marketed predicate device.