The BioPure HX2 Reverse Osmosis water purification system is designed to purify pre-treated water using reverse osmosis for making dialysate for hemodialysis applications. The device is intended to be a component in a complete water purification system. It must be preceded by pretreatment devices, and may need to be followed by post-treatment devices as well to meet current AAMI and Federal (U.S.) standards. BioPure HX2 is intended for use in water rooms in a hospital, clinic, or dialysis center. The device includes an integrated heat disinfection process.

The BioPure HX2 is available two different double pass configurations that supply 5 gallons per minute (gpm) and 11 gpm. Version HX2P-05 is a double pass triple membrane RO that produces up to 5 gpm of product water. Version HX2P-11 is a double pass six membrane RO that produces up to 11 gpm of product water.

Device Description

The device is a water purification system that uses reverse osmosis to remove contaminants from water that is used to dilute dialysis concentrate to form dialysate for use in hemodialysis equipment. The key feature of BioPure HX2 RO system is that it consists of two trains (1st and 2nd pass) of membrane elements. Feed water enters the unit and is directed through a pump into the 1st pass 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. The product water is then pumped directly through the 2nd pass membrane elements to further improve water quality of the final product water. As water flow across the membrane all types of water contaminants except dissolved gasses are removed and the purified product water is then supplied to hemodialysis equipment.

The BioPure HX2 is capable of generating purified water that meets AAMI water quality requirements for hemodialysis at a minimum of 3 US gallons/minute (11.30 liters/min). It must be used with appropriate pre and post treatment units, including at a minimum carbon adsorption media pretreatment in order to remove chlorine/chloramines. Additional pre and post treatment requirements may vary and are dependent on the quality of the local feed water supply and individual facility requirements.

The BioPure HX2 system is designed to maintain low microbiological levels in the flow pathway through regular heat disinfection and chemical sanitization. Notable components and features of the BioPure HX2 include:

Break Tank
Immersion Heater
1st Pass RO Booster Pump
1st Pass RO membrane
2nd Pass RO Booster Pump
2nd Pass RO membrane
Particle and Pyrogen Filter (Optional)
Piping
Water quality monitoring system
Programmable logic controller (PLC)
Heat disinfection and chemical sanitization capability
Audible and visual alarms
Automatic divert to drain mode upon start-up and anytime product quality parameters are not met.
System control via a touch-screen user interface

AI/ML Overview

The BioPure HX2 Reverse Osmosis Water Purification System is intended to purify pre-treated water for use in hemodialysis applications. The device is evaluated primarily against the requirements listed in FDA's Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis (May 1997) and the FDA recognized consensus standards - ISO 26722:2009 Water treatment equipment for hemodialysis applications and related therapies and ISO 13959:2009 Water for hemodialysis and related therapies.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly present a table of acceptance criteria with corresponding performance data in a structured format as requested. Instead, it lists the types of performance data provided to the FDA to support substantial equivalence. Based on the descriptive information, the key performance criterion is the ability to generate purified water meeting AAMI water quality requirements at a minimum flow rate.

Acceptance Criterion	Reported Device Performance	Comments
Water Quality	Meets AAMI water quality requirements for hemodialysis	This is a general statement. Specific AAMI parameters (e.g., conductivity, levels of specific contaminants) are not detailed in this summary document.
Minimum Flow Rate (HX2P-05)	Up to 5 gallons per minute (18.93 liters/min)	This meets or exceeds the stated minimum requirement of 3 US gallons/minute (11.30 liters/min).
Minimum Flow Rate (HX2P-11)	Up to 11 gallons per minute (41.64 liters/min)	This meets or exceeds the stated minimum requirement of 3 US gallons/minute (11.30 liters/min).
Microbiological Levels Control	Designed to maintain low microbiological levels through regular heat disinfection and chemical sanitization	The validation studies for Heat Disinfection Process and Chemical Sanitization confirm this aspect.
Safety & Effectiveness	Deemed safe and effective for its intended use	This is the overall conclusion drawn from all submitted testing.

2. Sample Size for Test Set and Data Provenance:

The document does not specify the sample sizes used for individual test sets for each type of validation (e.g., System and RO Membrane Performance, Heat Disinfection Process Validation). The data provenance is not explicitly stated as retrospective or prospective, nor does it mention the country of origin of the data. However, as this is a 510(k) submission to the US FDA, the testing would generally be expected to follow US regulatory guidelines and standards.

3. Number of Experts and Qualifications for Ground Truth:

This device is a water purification system, not a diagnostic device requiring expert interpretation of medical images or data. Therefore, the concept of "experts used to establish the ground truth" in the traditional sense of clinical diagnosis is not applicable. The "ground truth" for this device is based on objective chemical and physical measurements to confirm water quality parameters and system performance against established standards (AAMI, ISO). Validation of these measurements would be conducted by qualified engineers and technicians with expertise in water purification systems and relevant analytical techniques.

4. Adjudication Method:

Given that the ground truth is established through objective measurements and validated processes against predefined standards, an adjudication method (such as 2+1 or 3+1 used in medical image interpretation) is not relevant. Performance is determined by direct measurement against quantitative acceptance criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

An MRMC study is not applicable to a water purification system. MRMC studies are typically used to evaluate the diagnostic performance of medical imaging devices or AI algorithms where human readers interpret medical cases. This device's function is to purify water, not to assist human readers in making diagnoses.

6. Standalone Performance:

Yes, the testing described for the BioPure HX2 involves evaluating its standalone performance as a water purification unit. The listed data types such as "System and RO Membrane Performance", "Heat Disinfection Process Validation", and "Chemical Sanitization Validation" are all assessments of the device's inherent capabilities and performance without human-in-the-loop directly influencing the water purification process itself. While human operators manage the system, the performance metrics relate to the automated and technical functions of the device.

7. Type of Ground Truth Used:

The ground truth used for this device is based on objective measurements and established scientific/engineering standards.

AAMI Water Quality Requirements: These are standards for the chemical and microbiological purity of water used for hemodialysis.
ISO 26722:2009 and ISO 13959:2009: These are international standards for water treatment equipment and water quality for hemodialysis.
FDA Guidance: Provides regulatory expectations for such devices.

The "ground truth" is therefore derived from:

Analytical Chemistry Results: Measuring levels of contaminants, conductivity, etc.
Microbiological Testing: Assessing bacterial counts.
Engineering Specifications and Performance Data: For flow rates, pressure, temperature, etc.
Validation Protocols: Demonstrating the effectiveness of disinfection and sanitization cycles.

8. Sample Size for the Training Set:

The concept of a "training set" is typically associated with machine learning or AI models. The BioPure HX2 is a physical medical device (water purification system) and not an AI algorithm that undergoes a training phase. Therefore, there is no "training set" in this context. The device's design, engineering, and manufacturing would be based on established principles and validated through the testing mentioned above.

9. How the Ground Truth for the Training Set Was Established:

As there is no "training set" for this physical device, this question is not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Mar Cor Purification, a Cantel Medical Company. The logo consists of a circular graphic on the left, featuring several curved lines within the circle. To the right of the graphic, the words "MAR COR" are stacked on top of the word "PURIFICATION" in a bold, sans-serif font. Below the company name, the text "A Cantel Medical Company" is written in a smaller, serif font.

BioPure HX2 Reverse Osmosis Water Purification System

APR 3 0 2014

510(k) Summary

Mar Cor Purification, A Cantel Medical Company Manufacturer:

14550 28th Avenue North Address: Minneapolis, MN 55447 USA (800) 633-3080

Official Contact: Kinnari Shah, MS Regulatory Affairs Specialist

Trade Name: BioPure HX2 Water Purification System Common Name: Classification Name: Subsystem, water purification Product Code: FIP Device Class: I I 876.5665 Classification Reg:

Mar Cor Purification has supplied the following information to the US Food and Drug Administration to support substantial equivalence of the BioPure HX2 Reverse Osmosis (RO) Water Purification System to other RO water purification systems currently cleared for sale in the U.S.

1. Device Description

The device is a water purification system that uses reverse osmosis to remove contaminants from water that is used to dilute dialysis concentrate to form dialysate for use in hemodialysis equipment. The key feature of BioPure HX2 RO system is that it consists of two trains (11 and 2 " pass) of membrane elements. Feed water enters the unit and is directed through a pump into the 1st pass 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. The product water is then pumped directly through the 200 pass membrane elements to further improve water quality of the final product water. As water flow across the membrane all types of water contaminants except

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Image /page/1/Picture/0 description: The image shows the logo for MAR COR Purification, a Cantel Medical Company. The logo consists of a circular graphic on the left, with several curved lines inside. To the right of the graphic is the text "MAR COR" in large, bold letters, with "PURIFICATION" underneath in a smaller font. Below that, it says "A Cantel Medical Company" in a smaller font.

K133149 Page 2 of 4

dissolved gasses are removed and the purified product water is then supplied to hemodialysis equipment.

Break Tank .
Immersion Heater .
1st Pass RO Booster Pump .
1ª Pass RO membrane .
2nd Pass RO Booster Pump .
2nd Pass RO membrane .
Particle and Pyrogen Filter (Optional) .
Piping .
Water quality monitoring system .
Programmable logic controller (PLC) .
Heat disinfection and chemical sanitization capability .
Audible and visual alarms .
Automatic divert to drain mode upon start-up and anytime product quality parameters are . not met.
System control via a touch-screen user interface .

2. Intended Use

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BioPure HX2 510(k) Summary

may need to be followed by post-treatment devices as well to meet current AAMI and Federal (U.S.) standards. BioPure HX2 is intended for use in water rooms in a hospital, clinic, or dialysis center. The device includes an integrated heat disinfection process.

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

The BioPure is equivalent in function and indications to the Mar Cor's (formerly Biolab Equipment Canada Ltd.) - 4400 HX Water purification system (K030348) and Mar Cor's Millenium HX Portable Reverse Osmosis water Purification System (K110578).

Both the subject and predicate devices have the same intended use, principle of operation and basic functions. All devices have equivalent indications for use and intended performance.

4. Summary of Non-Clinical Performance Data

Mar Cor Purification has provided testing to show that the BioPure HX2 is safe and effective for its intended use based on the requirements listed in FDA's Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis (May 1997) and the FDA recognized consensus standards - ISO 26722:2009 Water treatment equipment for hemodialysis applications and related therapies and ISO 13959:2009 Water for hemodialysis and related therapies. The following types of data were provided to FDA to support substantial equivalence to predicate devices and to demonstrate that the BioPure HX2 performs as intended.

System and RO Membrane Performance .
. Heat Disinfection Process Validation
. Chemical Sanitization Validation
Material Compatibility and Biocompatibility .
Software Validation .
Electrical Safety and Electromagnetic Compatibility .

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Image /page/3/Picture/0 description: The image shows the logo for Mar Cor Purification, a Cantel Medical Company. The logo consists of a circular graphic on the left, with several curved lines inside. To the right of the graphic, the words "MAR COR" are printed in large, bold letters, with "PURIFICATION" printed in smaller letters below. Underneath the company name, the text "A Cantel Medical Company" is printed in a smaller font.

Premarket Notification 510(k) BioPure HX2 510(k) Summary

K133149 Page 4 of 4

Risk Analysis .

5. Conclusion

Mar Cor Purification has provided appropriate premarket notification information in the form of a 510(k) to support the substantial equivalence of the BioPure HX2 to legally marketed predicate devices. The information and performance data provided indicates that the BioPure HX2 is safe and effective for its intended use when used in accordance with the device labeling.

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

April 30, 2014

Mar Cor Purification, Inc. - A Cantel Medical Company % Kinnari Shah, MS Regulatory Affairs Specialist Medivators, Inc. 14605 28th Avenue North Minneapolis, MN 55447

Re: K133149

Trade/Device Name: BioPure HX2 Regulation Number: 21 CFR8 876.5665 Regulation Name: Water purification system for hemodialysis Regulatory Class: Il Product Code: FIP Dated: March 28, 2014 Received: March 31, 2014

Dear Kinnari Shah,

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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Page 2 - Kinnari Shah, MS

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/CDRHQffices/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 (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»

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): K133149

Device Name: BioPure HX2

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mar Cor Purification Attachment 3 - Page 1 of 1

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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.