The USFilter/lonpure Med-RO™ Reverse Osmosis System is intended to supply water for use in the preparation of dialysate for hemodialysis patients and for other hemodialysis-related procedures such as cleaning, rinsing of equipment, and reprocessing of dialyzers. The water produced will meet the minimum water quality requirements as specified by ANSI/AAMI American National Standard for Water Treatment Equipment for Hemodialysis Applications RD 62:2001[RD-5: 1992 if Treatment Equipment for Temodiarysle Applications RD & LES T.(RE ST 1000 in conjunction with other components of a water treatment system as necessary with compatible input and output water requirements.

Device Description

The Med-RO™ Reverse Osmosis System is a machine used to purify water.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device called the "Med-RO™ Reverse Osmosis System." This submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria and performance metrics in the way one might find for a diagnostic or therapeutic device.

Here's an analysis of the provided text in relation to your request:

Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" and "reported device performance" as typically seen in clinical trials for diagnostic algorithms is not explicitly present in this document. The submission is for a water purification system used in hemodialysis. For such devices, acceptance criteria would likely relate to specific water quality parameters (e.g., conductivity, levels of specific contaminants) and performance would be measured against those parameters.

The closest the document comes to this is in the "Indications For Use" section, which states: "The water produced will meet the minimum water quality requirements as specified by ANSI/AAMI American National Standard for Water Treatment Equipment for Hemodialysis Applications RD 62:2001 [RD-5: 1992 if Treatment Equipment for Temodiarysle Applications RD & LES T.(RE ST 1000 in conjunction with other components of a water treatment system as necessary with compatible input and output water requirements."

Therefore, the acceptance criteria for this device are implicitly tied to the ANSI/AAMI standards for water quality in hemodialysis. The document does not report specific measurements of water quality from the Med-RO™ system in a table format. It states that non-clinical tests were performed and that "Based on the testing performed as well as the information provided, there are no changes in the performance, safety or effectiveness of the modified device." This implies that the device meets the functional requirements for water purification, and thus, by extension, the ANSI/AAMI standards, but no concrete data is presented here.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implicit)	Reported Device Performance (Implicit)
Water produced meets minimum water quality requirements as specified by ANSI/AAMI RD 62:2001 (or RD-5:1992) for hemodialysis applications.	The device's performance, safety, and effectiveness are comparable to the predicate device, which presumably meets the ANSI/AAMI standards. Non-clinical tests were performed to support this claim.

Study Information as per Request:

A table of acceptance criteria and the reported device performance
(See table above. Specific numerical data is not provided in the document.)
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A. The document explicitly states "Discussion of Clinical Test Performed: N/A." This indicates that no clinical test set was used for evaluating the device's performance in humans. The testing mentioned is "non-clinical." The submission is based on engineering design and performance verification, demonstrating that the modified device performs equivalently to the predicate device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- N/A. There was no clinical test set, and therefore no ground truth established by medical experts in this context. The "ground truth" for a water purification system would be the objective measurement of water quality against established engineering and medical standards (like ANSI/AAMI), not expert consensus on medical images or diagnoses.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. No clinical test set.
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
- N/A. This device is a water purification system, not an AI-assisted diagnostic or therapeutic tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is not an algorithm. The "standalone" performance here would refer to the Med-RO™ system's ability to purify water independently. The submission indicates non-clinical testing was done to verify this, but details of those tests are not provided in this summary.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance would be the direct measurement of water quality parameters (e.g., conductivity, total dissolved solids, specific ion concentrations, microbiological counts) against the specifications set by the ANSI/AAMI American National Standard for Water Treatment Equipment for Hemodialysis Applications RD 62:2001 (or RD-5:1992).
The sample size for the training set
- N/A. This is not an AI/ML device that requires a training set.
How the ground truth for the training set was established
- N/A. Not an AI/ML device.

Summary of the Study (as described in the document):

The submission describes a non-clinical study (or more accurately, a comparison based on non-clinical testing and engineering assessment) to demonstrate substantial equivalence of the Med-RO™ Reverse Osmosis System to a previously cleared predicate device (USFitter/lonpure, Inc. M-Series Reverse Osmosis Water Purification System).

The primary "study" performed was an engineering assessment and non-clinical testing to ensure that modifications to the device "will not negatively affect performance, safety, or effectiveness." The core argument for substantial equivalence is that the new device "contains the same fundamental scientific technology as the predicated device."

The study did not involve human subjects or clinical data in the manner often seen for diagnostic or therapeutic devices. Its "acceptance criteria" are implied to be adherence to the performance and safety characteristics of the predicate device and the relevant ANSI/AAMI water quality standards for hemodialysis. The document explicitly states "Discussion of Clinical Test Performed: N/A."

Summary

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MAR 8 2002

510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted by USFilter/lonpure, Inc. in accordance with the requirements of 21 CFR§807.92.

The assigned 510(k) number is:

Original Submitter's Name: 1 USFilter/Continental Water Systems
2 Submitter's Identification USFilter/lonpure, Inc. 725 Wooten Road Colorado Springs, CO 80915 719-570-9600

Date Summary Prepared 15 October 2001

3 Official Correspondent/Contact David A. Dentino 10 Technology Drive Lowell, MA 01851 978-614-7359
4 Name of the Device Med-RO™ Reverse Osmosis System
5 Predicated Device Information USFitter/lonpure, Inc. M-Series Reverse Osmosis Water Purification System

ర్ Device Description

The Med-RO™ Reverse Osmosis System is a machine used to purify water.

Intended Use 7

The Med-RO™ Reverse Osmosis System series is intended to be used as a component of a water purification system for Hemodialysis.

Comparison to Predicated Devices 8

The Med-RO™ Reverse Osmosis System unit contains the same fundamental scientific technology as the predicated device. Device modification, that will not negatively affect performance, safety , or effectiveness are detailed in Exhibit A section 1.

Discussion of Non-Clinical Test Performed for Determination of Substantial တ Equivalence is as follows:

Based on the testing performed as well as the information provided, there are no changes in the performance, safety or effectiveness of the modified device.

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013677 PAGE 2 2 OF

Discussion of Clinical Test Performed: 10 N/A

11 Conclusions:

As was true for the original USFilter/lonpure, Inc. M-Series Reverse Osmosis Water Purification Systems, the intended use of the Med-RO™ Reverse Osmosis system is
intended to purify water for Hemodialysis when used as a component of a complete water purification system.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 8 2002

U.S. Filter/Ionpure, Inc. C/o Mr. David A. Dentino Regulatory Compliance Manager USFilter/S&P 10 Technology Drive LOWELL MA 01851

Re: K013677 Trade/Device Name: Med-RO™ Reverse Osmosis System (Modified) Regulation Number: 21 CFR §876.5665 Regulation Name: Water purification system for hemodialysis Regulatory Class: II Product Code: 78 FIP Dated: February 5, 2002 Received: February 6, 2002

Dear Mr. Dentino:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your been wined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the 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.

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known):___K013677

Device Name: Med-RO™ Reverse Osmosis System

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C Hiradon

Prescription Use(Per 21 CFR 801.109)
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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.