(30 days)
Not Found
No
The document describes a water purification system with standard components like a pump, membrane, and controller, and does not mention any AI or ML capabilities.
No
The device purifies water for hemodialysis equipment, it does not directly treat a medical condition.
No
Explanation: The device is described as a water purification system intended to produce water for use with hemodialysis equipment. Its function is to remove contaminants from water, not to diagnose a medical condition.
No
The device description clearly outlines multiple hardware components such as an RO membrane, system pump, water quality monitoring system, and an operating panel/programmable logic controller (OPLC). While it mentions software verification, the core functionality and components are hardware-based.
Based on the provided text, the Mar Cor Purification Millenium HX Portable Reverse Osmosis Water Purification System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to produce purified water for use with hemodialysis equipment. This water is used to dilute dialysis concentrate, which is then used in the hemodialysis process. This is a process that happens outside of the body, but the device itself is not performing a diagnostic test on a biological sample.
- Device Description: The description details a water purification system that uses reverse osmosis to remove contaminants from water. It focuses on the mechanical and chemical processes of water purification, not on analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes in biological samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on the analysis of biological samples.
The device is a medical device accessory used in conjunction with hemodialysis equipment, which is a life-sustaining treatment. Its function is to prepare the necessary fluid for that treatment, not to perform a diagnostic test.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FIP
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 .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home environments, hospitals, clinics.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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)
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.
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.
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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 North |
| Minneapolis, MN 55447 | |
| 844-348-5636 | |
| Official Contact: | Mark Arnold |
| Regulatory 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
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
CONFIDENTIAL
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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.
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 .
2. Intended Use
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 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
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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
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