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 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.

AI/ML Overview

The provided document is a 510(k) premarket notification decision letter and summary for a water purification system. It does not contain information about software or AI, and therefore does not have the kind of performance data, study designs, or ground truth information typically associated with AI/ML device submissions.

The document discusses the UPT Series Medical Reverse Osmosis Water Treatment System, which is a physical device intended to remove contaminants from tap water for hemodialysis. The criteria and "study" proving its acceptance are based on its ability to produce water meeting known standards, rather than statistical performance metrics of an AI model.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard)	Reported Device Performance (Reference)
Produces water as prescribed by AAMI Standard ANSI/AAMI/ISO 13959:2014 Water for Hemodialysis and Related Therapies	"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." (Page 3) and "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" (Page 5)
Water treatment equipment functionality as per ANSI/AAMI/ISO 26722:2014	"and ANSI/AAMI/ISO 26722:2014, Water Treatment Equipment for Hemodialysis Applications and Related Therapies, when used as directed." (Page 5)
Electrical safety and EMC compliance	"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 Magnetic Field", "UL Approved / Recognized for safety", "All pumps used are UL recognized (UR) and CSA Approved for safety" (Page 5)
Water contact materials	"FDA-NSF Compliant" (Page 4)
Safety Features (e.g., diversion to drain on high conductivity, alarms)	"100% Diversion to drain above product conductivity set-point", "Low Supply Pressure Alarm", "High Product Water Conductivity Alarm", "High Supply Water Temperature Shut Down", "Power Disturbance Alarm", "Remote Alarm (Nurses Station)" (Page 4)

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

The document does not describe a "test set" in the context of an AI/ML device. The "study" refers to the device's ability to consistently output water meeting specific AAMI standards. The evaluation likely involved testing physical prototypes or production units to verify their functionality and water quality output under various operating conditions. No specific sample size or provenance for such testing is mentioned, as it is a device performance verification, not a data-driven model evaluation.

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

Not applicable. The "ground truth" here is objective water quality standards (AAMI/ISO standards) and functional safety requirements, not expert consensus on medical images or clinical outcomes.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. This is not a study involving human interpretation of data.

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. This is a water purification system, not an AI/ML medical device where human reader performance is relevant.

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

Not applicable. This device does not involve an algorithm with standalone performance. Its performance is the physical output of purified water meeting specified quality metrics.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device is established regulatory and industry standards for water quality used in hemodialysis:

ANSI/AAMI/ISO 13959:2014: Water for Hemodialysis and Related Therapies
ANSI/AAMI/ISO 26722:2014: Water Treatment Equipment for Hemodialysis Applications and Related Therapies
Electrical Safety Standards: EN/IEC 61000 series, UL, CSA approvals.

These are objective, quantitative standards for the physical and chemical properties of the water produced, and the safety of the equipment.

8. The sample size for the training set

Not applicable. This device is not an AI/ML model that undergoes training.

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

Not applicable. This device is not an AI/ML model that undergoes training using a ground truth dataset.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

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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510(k) Summary

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Manufacturer:	Specialty Water Technologies
Address:	1020 Industrial DriveOrlinda, TN 37141(615) 654-4441
Official Contact:	Alex ClarkCompliance Manager
Trade Name:	UPT Series Medical Reverse Osmosis Water TreatmentSystem
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

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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	Specifications	Predicate Devices
Specifications	UPT Series Medical ReverseOsmosis Water Treatment System	Matrix Series Digital ReverseOsmosis	Complete Water System ModelsMD610, 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 ContactMaterials	FDA-NSF Compliant	FDA-NSF Compliant	FDA-NSF Compliant
Pre-TreatmentOptions	Based upon site specific feedwater chemical analysis	Based upon site specific feed waterchemical analysis	Based upon site specific feed waterchemical analysis
	Feed water Pre-Treatment mayinclude:	Feed water Pre-Treatment mayinclude:	Feed water Pre-Treatment mayinclude:
	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)
OperationalFeatures	Electronic Touch Screen Interface	Electronic Touch Screen Interface	Electronic Touch Screen Interface
	All components mounded on anopen frame for accessibility	All components mounted on anopen frame for accessibility	All components mounted on an openframe for accessibility
	Electronic Monitoring of:	Electronic Monitoring of:	Electronic Monitoring of:
	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 aboveproduct conductivity set-point	100% Diversion to drain aboveproduct conductivity set-point	100% Diversion to drain aboveproduct conductivity set-point
	Low Supply Pressure Alarm	Low Supply Pressure Alarm	Low Supply Pressure Alarm
	High Product Water ConductivityAlarm	High Product Water ConductivityAlarm	High Product Water Conductivity ShutDown
	High Supply Water TemperatureShut Down	High Supply Water TemperatureShut Down	High Supply Water Temperature ShutDown
	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 betterultra-filtration	May include 0.5 micron or betterultra-filtration	May include 0.5 micron or betterultra-filtration
Post-TreatmentPerformance	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.

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.