UPT Series Medical RO Water System

K151637 · Specialty Water Technologies · FIP · Sep 23, 2015 · Gastroenterology, Urology

Device Facts

• Record ID: K151637
• Device Name: UPT Series Medical RO Water System
• Applicant: Specialty Water Technologies
• Product Code: FIP · Gastroenterology, Urology
• Decision Date: Sep 23, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5665
• Device Class: Class 2

Intended Use

UPT Series Medical Reverse Osmosis Water Treatment System is intended to be used to remove organic and inorganic contaminants from a tap water supply to dilute a dialysate concentrate for hemodialysis treatments, as well as for use for dialyzer reprocessing and dialysis equipment disinfecting and rinsing. This System is strictly for multi patient use, such as for a dialysis clinic or hospital serving multiple patients with a Central Water Purification System and is intended for use only with conventional hemodialysis treatments. It is not intended for use with high-flux, CRRT, or any other form of dialysis.

Device Story

Reverse osmosis (RO) water purification system; removes organic/inorganic contaminants and microbial matter from tap water to produce AAMI-compliant water for hemodialysis. Used in clinics/hospitals for multi-patient settings. System includes electronic touch screen interface for monitoring feed/product water pressure, flow, conductivity, and pump pressure. Safety features include automatic diversion to drain if product conductivity exceeds set-points, alarms for low supply pressure, high conductivity, high temperature, and power disturbances. Healthcare providers use output for dialysate preparation and equipment maintenance. Benefits include consistent water quality meeting ANSI/AAMI/ISO 13959:2014 standards, ensuring safe dialysate production for conventional hemodialysis.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing and compliance with AAMI/ISO standards for water quality and electrical safety.

Technological Characteristics

Reverse osmosis water purification system; FDA-NSF compliant water contact materials; electronic touch screen interface; wired remote alarm connectivity; no wireless/RF transmission. Electrical components comply with EN/IEC 61000-4-2, 4-3, 4-4, 4-8; UL/CSA recognized pumps. Produces water per ANSI/AAMI/ISO 13959:2014 and ANSI/AAMI/ISO 26722:2014.

Indications for Use

Indicated for multi-patient use in dialysis clinics or hospitals for conventional hemodialysis treatment, dialyzer reprocessing, and dialysis equipment disinfection/rinsing. Not indicated for high-flux, CRRT, or other dialysis forms.

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

• Matrix Series Digital Reverse Osmosis (K051620)
• Complete Water System Models MD610, 620, 630 and 640 (K041163)

Submission Summary (Full Text)

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

September 23, 2015

Specialty Water Technologies Alex Clark Compliance Manager 1020 Industrial Drive Orlinda, TN 37141

Re: K151637

> Trade/Device Name: UPT Series Medical Reverse Osmosis Water Treatment System Regulation Number: 21 CFR 876.5665 Regulation Name: Water purification system for hemodialysis Regulatory Class: II Product Code: FIP Dated: August 21, 2015 Received: August 24, 2015

Dear Alex Clark,

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 (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 [phone] or [phone] or at its Internet address

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

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 [phone] or [phone] or at its Internet address

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

Sincerely yours,

# Benjamin R. Fisher -S

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)

K151637

Device Name

UPT Series Medical Reverse Osmosis Water Treatment System

Indications for Use (Describe)

UPT Series Medical Reverse Osmosis Water Treatment System is intended to be used to remove organic and inorganic contaminants from a tap water supply to dilute a dialysate concentrate for hemodialysis treatments, as well as for use for dialyzer reprocessing and dialysis equipment disinfecting and rinsing.

This System is strictly for multi patient use, such as for a dialysis clinic or hospital serving multiple patients with a Central Water Purification System and is intended for use only with conventional hemodialysis treatments. It is not intended for use with high-flux, CRRT, or any other form of dialysis.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------------------------------------------------------|
| <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> |
| <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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# 510(k) Summary

#### 510(k) Number: _______________________________________________________________________________________________________________________________________________________________

| Manufacturer: | Specialty Water Technologies |
|----------------------|--------------------------------------------------------------|
| Address: | 1020 Industrial Drive<br>Orlinda, TN 37141<br>[phone] |
| Official Contact: | Alex Clark<br>Compliance Manager |
| Trade Name: | UPT Series Medical Reverse Osmosis Water Treatment<br>System |
| Common Name: | Water Purification System |
| Classification Name: | Water Purification System for Hemodialysis |
| Product Code: | 78 FIP |
| Device Class: | II |
| Classification Reg: | 876.5665 |

Specialty Water Technologies has provided the following information to the US Food and Drug Administration to support substantial equivalence of the UPT Series Medical Reverse Osmosis (RO) Water Purification System to other RO water purification systems currently cleared for sale in the U.S.

#### 1. Device Description

The UPT Series Medical Reverse Osmosis Water Treatment System is an accessory device that is intended for use with hemodialysis applications and is intended to remove orqanic and inorganic substances and microbial contaminates from tap water used to dilute dialysis concentrate to form dialysate. The UPT Series Medical Reverse Osmosis Water Treatment System will produce water as prescribed by the Association for the Advancement of Medical Instrumentation (AAMI) Standard ANSI/AAMI/ISO 13959:2014 Water for Hemodialysis and Related Therapies provided adequate flow rate of the feed (tap) water and compliance with existing drinking water standards and proper pre-treatment.

#### 2. Intended Use

UPT Series Medical Reverse Osmosis Water Treatment System is intended to be used to remove organic and inorqanic contaminants from a tap water supply to dilute a dialysate concentrate for hemodialysis treatments, as well as for use for dialyzer reprocessing and dialysis equipment disinfecting and rinsing.

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This System is strictly for multi patient use, such as for a dialysis clinic or hospital serving multiple patients with a Central Water Purification System and is intended for use only with conventional hemodialysis treatments. It is not intended for use with high-flux, CRRT, or any other form of dialysis.

| | Specifications | Predicate Devices | |
|-------------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------|
| Specifications | UPT Series Medical Reverse<br>Osmosis Water Treatment System | Matrix Series Digital Reverse<br>Osmosis | Complete Water System Models<br>MD610, 620, 630 and 640 |
| Manufacturer | Specialty Water Technologies | Better Water, Inc | Isopure Corporation |
| 510(k) Number | | K051620 | K041163 |
| Decision Date | | 11/18/2005 | 10/7/2004 |
| Classification | 876.5665, Class II | 876.5665, Class II | 876.5665, Class II |
| Product Code | 78 FIP | 78 FIP | 78 FIP |
| Water Contact<br>Materials | FDA-NSF Compliant | FDA-NSF Compliant | FDA-NSF Compliant |
| Pre-Treatment<br>Options | Based upon site specific feed<br>water chemical analysis | Based upon site specific feed water<br>chemical analysis | Based upon site specific feed water<br>chemical analysis |
| | Feed water Pre-Treatment may<br>include: | Feed water Pre-Treatment may<br>include: | Feed water Pre-Treatment may<br>include: |
| | Carbon Filtration | Carbon Filtration | Carbon Filtration |
| | Softeners | Softeners | Softeners |
| | Temperature Control | Temperature Control | Temperature Control |
| | Pressure Compensation | Pressure Compensation | Pressure Compensation |
| | Special Filtration | Special Filtration | Special Filtration |
| | Ultra-Violet (UV) | Ultra-Violet (UV) | Ultra-Violet (UV) |
| Operational<br>Features | Electronic Touch Screen Interface | Electronic Touch Screen Interface | Electronic Touch Screen Interface |
| | All components mounded on an<br>open frame for accessibility | All components mounted on an<br>open frame for accessibility | All components mounted on an open<br>frame for accessibility |
| | <b>Electronic Monitoring of:</b> | <b>Electronic Monitoring of:</b> | <b>Electronic Monitoring of:</b> |
| | Feed Water Pressure / Flow | Feed Water Pressure / Flow | Feed Water Pressure |
| | Product Water Pressure / Flow | Product Water Pressure / Flow | Product Water Pressure |
| | Membrane Feed Pressure | Membrane Feed Pressure | Membrane Feed Pressure |
| | Pump Pressure | Pump Pressure | Pump Pressure |
| | Reject Water Pressure / Flow | Reject Water Pressure / Flow | Reject Water Pressure / Flow |
| | Product Water Conductivity | Product Water Conductivity | Product Water Conductivity |
| | Feed Water Conductivity | Feed Water Conductivity | Feed Water Conductivity |
| Safety Features | 100% Diversion to drain above<br>product conductivity set-point | 100% Diversion to drain above<br>product conductivity set-point | 100% Diversion to drain above<br>product conductivity set-point |
| | Low Supply Pressure Alarm | Low Supply Pressure Alarm | Low Supply Pressure Alarm |
| | High Product Water Conductivity<br>Alarm | High Product Water Conductivity<br>Alarm | High Product Water Conductivity Shut<br>Down |
| | High Supply Water Temperature<br>Shut Down | High Supply Water Temperature<br>Shut Down | High Supply Water Temperature Shut<br>Down |
| | Power Disturbance Alarm | Power Disturbance Alarm | Power Disturbance Alarm |
| | Remote Alarm (Nurses Station) | Remote Alarm (Nurses Station) | Remote Alarm (Nurses Station) |
| | May include 0.5 micron or better<br>ultra-filtration | May include 0.5 micron or better<br>ultra-filtration | May include 0.5 micron or better<br>ultra-filtration |
| Post-Treatment<br>Performance | Delivery of AAMI Standard Water | Delivery of AAMI Standard Water | Delivery of AAMI Standard Water |

#### 3. Substantial Equivalence to Predicate Device

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#### 4. Safety and Effectiveness

The intended use and technological characteristics of the UPT Series Medical Reverse Osmosis Water Treatment System are similar or equivilant to the predicate devices indicated. Any differences between the device and the predicate devices have no significant influence on the safety or effectiveness of the product.

#### 5. Clinical Performance Data

Not required for determination of substantial equivilance for this type and class of device.

#### 6. Electromagnetic Compatibility & Safety

The water system does not contain any wifi, wireless or other transmitting or receiving devices. Any electrical connections between components are wired to include any remote alarms.

The electrical control components purchased and used in the construction of the components used for this water system comply with:

EN/IEC 61000-4-2 Electrostatic Discharges EN/IEC 61000-4-3 Radiated Fields and Transients / Burst EN/IEC 61000-4-4 Electrical Fast Transients / Burst EN/IEC 61000-4-8 Maqnetic Field UL Approved / Recognized for safety

All pumps used are UL recognized (UR) and CSA Approved for safety

## 7. Conclusion Drawn from Clinical and Nonclinical Test Data

As compared with the predicate devices, K051620 and K041663, the UPT Series Medical Reverse Osmosis Water Treatment System will produce water that will meet the minimum water quality requirements as specified by Association for the Advancement of Medical Instrumentation (AAMI) standard ANSI/AAMI/ISO 13959:2014, Water for Hemodialysis and Related Therapies; and ANSI/AAMI/ISO 26722:2014, Water Treatment Equipment for Hemodialysis Applications and Related Therapies, when used as directed.