The Mar Cor Purification Millenium HX 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.

The Millenium HX can be connected to hemodialysis equipment used in home environments, in conjunction with the appropriate pre and post treatment units, as a part of a water treatment system designed to meet current AAMI and Federal (U.S) standards.

Device Description

The device is a portable 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. 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 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 Millenium HX is capable of generating purified water that meets AAMI water quality requirements for hemodialysis at a minimum of 1.4 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 Millenium HX 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 Millenium HX include:

RO membrane .
System pump .
Water quality monitoring system .
Operating panel and programmable logic controller (OPLC) .
Heat disinfection and chemical sanitization capability .
Audible and visual alarms .
Automatic divert to drain mode upon start-up and anytime product water TDS is above . the quality set-point
System control via a touch-screen user interface .

AI/ML Overview

Let's analyze the provided document to extract the information required to describe the acceptance criteria and the study proving the device meets those criteria.

Based on the provided text, the device is a medical water purification system, not an AI/ML diagnostic or assistive device. Therefore, many of the typical criteria and study elements associated with AI/ML device approval (such as MRMC studies, ground truth establishment for images, expert adjudication, training/test set sample sizes, and specifics on expert qualifications) are not applicable to this document.

The document describes the Millenium HX Portable Reverse Osmosis Water Purification System, which is a water purification system for hemodialysis. The FDA's review focuses on its substantial equivalence to predicate devices based on its function, intended use, technology, and performance data related to water quality.

Here's how we can address the request based on the provided text:

Description of Acceptance Criteria and Study for Millenium HX Portable Reverse Osmosis Water Purification System

The Millenium HX Portable Reverse Osmosis Water Purification System is intended to produce purified water for hemodialysis equipment. The FDA cleared this device based on its substantial equivalence to previously cleared predicate devices (Millenium HX Portable Reverse Osmosis Water Purification System, 510(k) K110578 and WRO 300H, 510(k) K093608). The acceptance criteria primarily revolve around the device's ability to consistently produce water meeting the specified quality standards for hemodialysis, demonstrated through non-clinical performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a water purification system, the "performance" is about water quality parameters, flow rates, and functional consistency. The document refers to meeting AAMI (Association for the Advancement of Medical Instrumentation) and Federal (U.S.) standards for water quality for hemodialysis. Specific numerical acceptance criteria for all parameters are not explicitly detailed in the provided summary but are implied by adherence to these standards.

Acceptance Criteria (Implied from AAMI & Federal Standards)	Reported Device Performance (Summary)
Produce purified water for hemodialysis equipment	Meets AAMI water quality requirements for hemodialysis
Minimum flow rate of purified water	Achieves a minimum of 1.4 liters/min
Effective removal of contaminants	Removes all types of water contaminants except dissolved gasses
Maintain low microbiological levels	Designed to maintain low microbiological levels through regular heat disinfection and chemical sanitization
Automatic divert to drain if water quality below set-point	Automatic divert to drain mode upon start-up and anytime product water TDS is above the quality set-point

Note: Specific numerical limits for contaminants (e.g., maximum allowable levels of ions, endotoxins, bacteria) that are part of AAMI and Federal standards are not provided in this summary but would be the detailed acceptance criteria for such a device.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document describes "non-clinical performance data" including "System and RO Membrane Performance - Flow and product water quality verification over range of operating conditions" and "Software Verification." It does not specify a "sample size" in terms of patient data or a number of independent test cases in the way an AI/ML model would use them. Instead, it refers to testing of the physical system under various conditions. The sample size would relate to the number of tests performed on the physical system (e.g., number of runs, duration of tests, various inlet water conditions). This information is not detailed in the provided summaries.
Data Provenance: This refers to laboratory/bench testing of the device itself rather than patient data. The testing was conducted by Cantel (Mar Cor Purification, Inc.). The document does not specify the country of origin for the raw input water used in testing, but it's presumed to be part of the manufacturer's internal testing process. The study is inherently prospective in the sense that new testing was conducted specifically for this submission to verify performance metrics.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not Applicable: For a physical water purification device, "ground truth" is established by objective measurements using calibrated laboratory equipment to determine water quality parameters (e.g., conductivity meters for TDS, chemical assays for specific ions, microbiological cultures for bacterial counts). It doesn't involve human experts interpreting data to establish a "ground truth" for a diagnostic label. The "experts" involved would be those performing and analyzing the physical and chemical tests, presumably qualified laboratory technicians and engineers, but their number and specific qualifications are not detailed here.

4. Adjudication Method for the Test Set

Not Applicable: There is no interpretation or classification that would require adjudication. Performance is measured against predefined objective physical and chemical standards (AAMI and Federal regulations).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No: An MRMC study is relevant for diagnostic or assistive AI technologies where human reader performance is being evaluated with and without AI assistance. This device is a water purification system, not a diagnostic tool.

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

Not Applicable (in the AI/ML sense): The device (Millenium HX) is the "standalone" entity here in that its performance as a water purification system is evaluated directly. There is no separate "algorithm" to be evaluated independently of the device's function. The device's "performance" characteristics (flow, water quality, safety features) are tested and verified.

7. The Type of Ground Truth Used

Objective Measurement/Reference Standards: The ground truth for the performance of this device is established by physical, chemical, and microbiological measurements of the purified water, compared against pre-defined regulatory and industry standards (AAMI and Federal [U.S.] standards) for water quality suitable for hemodialysis. This would involve laboratory testing to confirm levels of contaminants, conductivity, flow rates, and microbiological purity.

8. The Sample Size for the Training Set

Not Applicable: This is not an AI/ML device that requires a "training set" of data to learn from. Its operation is based on physical principles (reverse osmosis) and engineered design.

9. How the Ground Truth for the Training Set was Established

Not Applicable: Since there is no training set for an AI/ML model, this question is not relevant. The "development" and "validation" of such a device are based on engineering principles, materials science, and testing against known physical and chemical standards.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

October 3, 2019

Mar Cor Purification, Inc. % Mark Arnold Regulatory Affairs Manager, Life Sciences Cantel 9800 59th Ave. N Plymouth, MN 55442

Re: K192398

Trade/Device Name: Millenium HX Regulation Number: 21 CFR 876.5665 Regulation Name: Water Purification System for Hemodialysis Regulatory Class: II Product Code: FIP Dated: August 27, 2019 Received: September 3, 2019

Dear Mark Arnold:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

{1}------------------------------------------------

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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Carolyn Y. Neuland, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K192398

Device Name

Millenium HX Portable Reverse Osmosis Water Purification 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for CANTEL. The logo consists of a blue and green globe on the left, followed by the word "CANTEL" in blue, sans-serif font. The globe is made up of curved stripes of blue and green, giving it a three-dimensional appearance. The word "CANTEL" is written in all capital letters and is positioned to the right of the globe.

October 2, 2019

Millenium HX Portable Reverse Osmosis Water Purification System

Section 07 - 510(k) Summary

Manufacturer:	Mar Cor Purification, Inc.
Address:	14550 28th Avenue NorthMinneapolis, MN 55447844-348-5636
Official Contact:	Mark ArnoldRegulatory Affairs Manager, Cantel
Trade Name:	Millenium HX
Common Name:	Water Purification System
Classification Name:	Water Purification System for Hemodialysis
Product Code:	FIP
Device Class:	II
Regulation No:	21 CFR 876 5665

Cantel has supplied the following information to the US Food and Drug Administration to support substantial equivalence of the Millenium HX Portable Reverse Osmosis Water Purification System to its predicates - Millenium HX Portable Reverse Osmosis Water Purification System, 510(k) K110578 and WRO 300H, 510(k) K093608 - both currently cleared for sale in the U.S.

1. Device Description

CONFIDENTIAL

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the Cantel logo. The logo features a blue and green globe-like design on the left, followed by the word "CANTEL" in large, bold, blue letters. The globe design consists of curved segments in varying shades of blue and green, creating a layered effect.

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.

RO membrane .
System pump .
Water quality monitoring system .
Operating panel and programmable logic controller (OPLC) .
Heat disinfection and chemical sanitization capability .
Audible and visual alarms .
Automatic divert to drain mode upon start-up and anytime product water TDS is above . the quality set-point
System control via a touch-screen user interface .

2. Intended Use

The Millenium HX 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 a part of a water treatment system designed to meet current AAMI and Federal (U.S) standards.

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

The Millenium HX is equivalent in intended use, functions and fundamental technology to its predicate devices, the Mar Cor Millenium HX Portable Reverse Osmosis Water Purification System (K110578) and Mar Cor (formerly Gambro) WRO 300H (K093608). All of the products are portable reverse osmosis water purification systems with the same intended use and equivalent indications for use.

Similarities between Subject and Predicate Devices

The Millenium HX is equivalent in function, intended use, scientific technology, principle of operation, performance characteristics and components its predicates. Both the subject and predicate devices utilize chemical sanitization and heat disinfection of the RO loop and machine.

CONFIDENTIAL

Page 29 of 268

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for Cantel Medical. The logo consists of a blue and green globe on the left, followed by the word "CANTEL" in large, blue, sans-serif letters. The globe is made up of several curved segments of blue and green.

Differences between Subject and Predicate Devices

The subject device is identical in build to the Millenium HX Portable Reverse Osmosis Water Purification System (K110578), except it uses the membrane from the WRO 300H (K093608), and has several minor component changes to adjust for dimensional fit.

4. Summary of Non-Clinical Performance Data

Cantel has conducted the following testing to demonstrate that the use of the WRO 300H membrane in the Millenium HX is safe and effective for its intended use:

System and RO Membrane Performance - Flow and product water quality verification over range of operating conditions
Software Verification

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 devices.

CONFIDENTIAL

Page 30 of 268

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.