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

EON has optional heat disinfection cycles intended to disinfect the reverse osmosis (RO) machine and product loop, and connection tubing to the hemodialysis machine. EON's heat disinfect the connection tubing (heat forward cycle) is intended to be used only with hemodialysis machines which contain their own heat disinfection cycles and hence are able to tolerate high temperatures. EON is not intended to heat disinfect the hemodialysis machine.

Device Description

The device is a portable water purification system which 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 flows across the membrane purified water is produced. Both subject and predicate devices are designed to maintain low microbiological levels in the flow pathway by using optional cycles which perform heat disinfection on the entire RO machine and loop. The subject device also has an optional Heat Forward cycle which is intended to heat disinfect the connection tubing to the hemodialysis machine.

The EON is capable of generating purified water that meets AAMI water quality requirements for hemodialysis. 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 EON 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 EON 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 .
Heat forward cycle intended to heat disinfect connection tubing from the . Portable Reverse Osmosis Water Purification System to the hemodialysis machine.

AI/ML Overview

This document is an FDA 510(k) clearance letter for a medical device, specifically a water purification system. As such, it describes the device itself and its comparison to predicate devices, but it does not contain detailed information about acceptance criteria or a study proving the device meets those criteria in the context of an Artificial Intelligence/Machine Learning (AI/ML) enabled device.

The provided text focuses on:

Device Name: EON Portable Reverse Osmosis Water Purification System
Indication for Use: To produce water through reverse osmosis for use with hemodialysis equipment, and optional heat disinfection cycles.
Regulatory Classification: Class II, Product Code FIP (Water purification system for hemodialysis).
Comparison to Predicate Devices: EON Portable Reverse Osmosis Water Purification System (K171099) and WRO 300H (K093608). The key difference is the membrane used and minor component changes.
Non-Clinical Performance Data: Mentions "System and RO Membrane Performance Flow and product water quality verification over range of operating conditions" and "Software Verification."

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets those criteria as it pertains to an AI/ML device. The document describes a physical water purification system, not an AI/ML diagnostic tool.

If this were an AI/ML device, the detailed information requested (sample sizes, expert qualifications, etc.) would typically be found in a separate clinical study report or a more detailed submission summary, not typically in the top-level 510(k) clearance letter itself, which primarily confirms substantial equivalence.

However, if we were to hypothesize what such information would look like for an AI/ML device related to this context (e.g., an AI assessing water purity from sensor data), here's an example of how the requested table and study description might be presented. This is purely illustrative and not based on the provided document.

Hypothetical AI/ML Device for Water Purity Assessment in Hemodialysis

Let's imagine a hypothetical AI/ML device that analyzes sensor data from the EON Portable Reverse Osmosis Water Purification System to predict water purity levels and flag potential issues (e.g., microbial contamination risk, inadequate filtration) to assist hemodialysis technicians.

1. Table of Acceptance Criteria and Reported Device Performance (Hypothetical)

Acceptance Criteria Category	Specific Metric	Acceptance Criterion	Reported Device Performance (Hypothetical)
Accuracy	Sensitivity (for "Contaminated/Issue" flag)	≥ 95%	96.2% (95% CI: 95.5-96.8%)
	Specificity (for "Contaminated/Issue" flag)	≥ 90%	91.5% (95% CI: 90.8-92.2%)
	F1-Score	≥ 0.92	0.935
Precision	Mean Absolute Error (MAE) for TDS prediction	≤ 5 ppm	3.8 ppm
	Standard Deviation of Alerts (False Positives)	≤ 1 per 1000 operational hours	0.8 per 1000 operational hours
Robustness	Performance across different feed water types	Sensitivity & Specificity within ±2% of overall	Within ±1.5% across feed water types (Hard, Soft, Chlorinated)
	Performance under minor sensor drift	Performance metrics maintained with up to 5% sensor drift	Maintained at 4% drift, slight drop at 5% (<1% decrease)
User Experience (with AI)	Reduction in human review time for logs	≥ 20% reduction	25% reduction observed in human-in-the-loop study
	Reduction in missed critical alarms (human+AI)	100% detection of critical issues observed in test set	100% of critical issues detected

Study Proving Device Meets Acceptance Criteria (Hypothetical)

2. Sample Size and Data Provenance for Test Set:

Sample Size: 10,000 operational hours of sensor data, corresponding to approximately 500 distinct water purification cycles.
Data Provenance: Retrospective data collected from 15 hemodialysis clinics across the United States (70%), Germany (20%), and Japan (10%) over a 2-year period. Data anonymized and de-identified.

3. Number of Experts and Qualifications for Ground Truth:

Number of Experts: 5
Qualifications: Three board-certified Nephrologists with an average of 15 years of experience in hemodialysis and water quality management. Two clinical microbiologists with over 10 years of experience in water quality analysis for medical applications.

4. Adjudication Method for Test Set:

Method: 3+2 Adjudication. For each data segment requiring ground truth labeling (e.g., "contaminated" or "clean"), three primary experts (2 Nephrologists, 1 Microbiologist) independently reviewed sensor data, lab results (if available), and clinical logs to make an initial determination. If there was a disagreement among these three, the two remaining experts (1 Nephrologist, 1 Microbiologist) were brought in for a consensus discussion until a final label was agreed upon by at least 4 out of 5 experts. If consensus couldn't be reached, the data segment was excluded.

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

Was it done? Yes.
Effect Size of Human Improvement (AI-assisted vs. without AI):
- Study Design: 10 hemodialysis technicians (readers) independently reviewed the 500 water purification cycles from the test set for potential issues.
- Phase 1 (Without AI): Technicians reviewed raw sensor data and log files. The average accuracy for identifying critical water purity issues was 78%.
- Phase 2 (With AI-Assistance): After a washout period, the same technicians reviewed the same cases, this time with the AI system providing alerts and risk scores. The average accuracy increased to 98%.
- Effect Size: The AI assistance led to an average 20% absolute improvement in the accuracy of human readers for identifying critical water purity issues (from 78% to 98%). The relative improvement was approximately 25.6% (20/78). A statistically significant difference (p < 0.001) was observed.

6. Standalone Algorithm Performance:

Was it done? Yes.
The standalone algorithm achieved a sensitivity of 96.2% and a specificity of 91.5% for detecting critical water purity issues on the test set, corresponding to the "Reported Device Performance" in the table above.

7. Type of Ground Truth Used:

Expert Consensus: The primary ground truth was established through expert consensus based on a comprehensive review of sensor data, real-world laboratory water quality reports (e.g., TOC, conductivity, microbial counts if available), and clinical documentation of any related adverse events or interventions. For verification, a subset of the cases with confirmed lab-diagnosed contamination was cross-referenced.

8. Sample Size for Training Set:

Sample Size: 50,000 operational hours of sensor data, corresponding to approximately 2,500 distinct water purification cycles.

9. How Ground Truth for Training Set was Established:

Initial ground truth for the training set was established primarily through automated labeling based on predefined thresholds from AAMI water quality standards, combined with routine laboratory analysis results for water quality parameters (e.g., TDS, conductivity, bacterial counts).
A subset of 10% of the training data was manually reviewed and verified by internal subject matter experts (engineers with hemodialysis system expertise) to correct any noisy or erroneous automated labels, employing a simpler 2-expert review process. This iterative approach helped refine the training data quality.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 16, 2020

Mar Cor Purification, Inc. Mark Arnold Regulatory Affairs Manager 14550 28th Avenue North Minneapolis, MN 55447

Re: K200670

Trade/Device Name: EON Portable Reverse Osmosis Water Purification System Regulation Number: 21 CFR 876.5665 Regulation Name: Water purification system for hemodialysis Regulatory Class: II Product Code: FIP Dated: March 9, 2020 Received: March 17, 2020

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.

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

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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 (OS) 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 mediation-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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K200670

Device Name

EON Portable Reverse Osmosis Water Purification System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X 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 MARCOR, a Cantel Medical Company. The logo consists of a blue circle with several horizontal lines running through it on the left. To the right of the circle is the text "MAR COR" in a larger, bolder blue font, with the text "A Cantel Medical Company" in a smaller blue font underneath.

March 9, 2020

EON

Portable Reverse Osmosis Water Purification System

Section 07 - 510(k) Summary

Manufacturer: Mar Cor Purification, Inc.
14550 28th Avenue North Address: Minneapolis, MN 55447 844-348-5636
Official Contact: Mark Arnold Regulatory Affairs Manager, Mar Cor Purification, Inc.

Trade Name:	EON Portable Reverse Osmosis Water Purification System
Common Name:	Water Purification System
Classification Name:	Water Purification System for Hemodialysis
Product Code:	FIP
Device Class:	II
Regulation No:	21 CFR 876.5665

Mar Cor Purification has supplied the following information to the US Food and Drug Administration to support substantial equivalence of the EON Portable Reverse Osmosis Water Purification System to its predicates - EON Portable Reverse Osmosis Water Purification System, 510(k) K171099 and WRO 300H, 510(k) K093608 - both currently cleared for sale in the U.S.

1. Device Description

CONFIDENTIAL

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Image /page/4/Picture/1 description: The image shows the logo for MARCOR, a Cantel Medical Company. The logo consists of a blue circle with white lines inside, followed by the text "MAR COR" in blue, and then the text "A Cantel Medical Company" in a smaller blue font. The logo is simple and professional, and the use of blue gives it a clean and modern look.

The EON 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 EON 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 .
Heat forward cycle intended to heat disinfect connection tubing from the . Portable Reverse Osmosis Water Purification System to the hemodialysis machine.

2. Intended Use

EON has optional heat disinfection cycles intended to disinfect the reverse osmosis (RO) machine and product loop, and connection tubing to the hemodialysis machine. EON's heat disinfection cycle to disinfect the connection tubing (heat forward cycle) is intended to be used only with hemodialysis machines which contain their own heat disinfection cycles and hence are able to tolerate high temperatures. EON is not intended to heat disinfect the hemodialysis machine.

CONFIDENTIAL

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Image /page/5/Picture/1 description: The image shows the logo for MARCOR, a Cantel Medical Company. The logo consists of a blue circle with white lines inside, followed by the text "MAR COR" in blue, with the text "A Cantel Medical Company" in a smaller font size below it. The logo is simple and clean, with a focus on the company name.

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

The EON is equivalent in intended use, functions and fundamental technology to its predicate devices, the Cantel EON Portable Reverse Osmosis Water Purification System (K171099) and Mar Cor (formerly Gambro) WRO 300H (K093608). All three products are portable reverse osmosis water purification systems with the same intended use and equivalent indications for use.

Similarities between Subject and Predicate Devices

EON 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.

Differences between Subject and Predicate Devices

The subject device is identical in build to the EON Portable Reverse Osmosis Water Purification System (K171099), 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

Mar Cor Purification has conducted the following testing to demonstrate that the use of the WRO 300H membrane in the EON 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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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.